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Related Manuals for AGFA DX-D 300
Summary of Contents for AGFA DX-D 300
- Page 1 DX-D 300 8207/050 User Manual 0172E EN 20181116 1653...
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Page 2: Table Of Contents
| DX-D 300 | Contents Contents Legal Notice ................4 Introduction to this Manual ........... 5 Scope .................6 About the safety notices in this document ....7 Disclaimer ..............8 Introduction ................9 Intended Use ............10 Intended User ............11 Configuration ............ - Page 3 DX-D 300 | Contents | iii Approved disinfectants ........ 42 Patient data security ..........43 Maintenance ............44 Environmental protection ........45 Safety Directions ............46 Operation ................49 Starting DX-D 300 ............50 Basic workflow using the DR Detector ......51 Step 1: retrieve the patient info ....52...
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Page 4: Legal Notice
Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or its affiliates. NX and DX-D 300 are trademarks 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 5: Introduction To This Manual
DX-D 300 | Introduction to this Manual | 5 Introduction to this Manual Topics: • Scope • About the safety notices in this document • Disclaimer 0172E EN 20181116 1653... -
Page 6: Scope
6 | DX-D 300 | Introduction to this Manual Scope This User Manual describes the features of the DX-D 300 System, an integrated Digital Radiography X-Ray System to be used as medical diagnostic aid in General Radiography and emergency departments. It explains how the different components of the DX-D 300 System work together. -
Page 7: About The Safety Notices In This Document
DX-D 300 | Introduction to this Manual | 7 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 8: Disclaimer
8 | DX-D 300 | Introduction to this Manual 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 9: Introduction
DX-D 300 | Introduction | 9 Introduction Topics: • Intended Use • Intended User • Configuration • Operation Controls • System Documentation • Options and Accessories • Product Complaints • Compliance • Connectivity • Labels • Messages • Installation •... -
Page 10: Intended Use
10 | DX-D 300 | Introduction Intended Use The DX-D 300 system is an integrated 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, pediatric or neonatal patients. -
Page 11: Intended User
DX-D 300 | Introduction | 11 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 12: Configuration
12 | DX-D 300 | Introduction Configuration DX-D 300 is a DR X-ray system (Direct Radiography X-ray system) that can be combined with components from a CR X-ray system. The complete DX-D 300 consists of the following components: • Vertical column with U-arm •... - Page 13 DX-D 300 | Introduction | 13 X-Ray Generator Control Mobile table DR Detector U-arm Vertical column X-Ray tube Figure 1: DX-D 300 configuration with integrated DR Detector 0172E EN 20181116 1653...
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Page 14: Operation Controls
14 | DX-D 300 | Introduction Operation Controls NX application and software console X-Ray generator control box DR Detector handle control buttons Collimator control panel U-arm control panel Figure 2: DX-D 300 operation controls Topics: • NX Application on the NX Workstation •... -
Page 15: Nx Application On The Nx Workstation
DX-D 300 | Introduction | 15 NX Application on the NX Workstation The NX application is used to define patient information, select exposures and process images. Figure 3: NX application The operation of the NX application is described in the NX User Manual, document 4420.. -
Page 16: Software Console On The Nx Workstation
16 | DX-D 300 | Introduction Software Console on the NX Workstation The Software Console is used to control X-Ray generator settings and X-Ray system position. The software console has two screens: Figure 4: X-Ray generator controls Figure 5: X-Ray system automatic po-... -
Page 17: Dr Detector Switch On The Nx Workstation
DX-D 300 | Introduction | 17 DR Detector Switch on the NX Workstation The DR Detector Switch is available in the title bar of the NX application. The DR Detector Switch shows which DR Detector is active and shows its status. - Page 18 18 | DX-D 300 | Introduction Meaning DR Detec- DR Detector is DR Detector is DR Detector is tor is ready initializing for off or discon- inactive (no for expo- exposure nected or in thumbnail se- sure error lected) 0172E EN 20181116 1653...
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Page 19: X-Ray Generator Control In The Operator Room
DX-D 300 | Introduction | 19 X-Ray generator control in the operator room The X-Ray generator control box contains buttons to switch on and off the X- Ray generator and a handswitch to make exposures. Figure 6: the X-Ray generator control box... -
Page 20: U-Arm Control Panel
20 | DX-D 300 | Introduction U-arm control panel On the U-arm.the control panel with touch screen console and control buttons to control X-Ray generator settings and U-arm position. DX-D MOVE Figure 7: U-arm control panel 0172E EN 20181116 1653... -
Page 21: Control Panel Of The Collimator
DX-D 300 | Introduction | 21 Control panel of the collimator The control panel of the automatic collimator: Figure 8: the control panel of the automatic collimator The display shows the dimensions of the collimated area and of the source image distance (SID) in centimeters or in inches. -
Page 22: Dr Detector Handle Control Buttons
22 | DX-D 300 | Introduction DR Detector handle control buttons The DR Detector handle control buttons to control the U-arm position Figure 9: DR Detector handle control buttons 0172E EN 20181116 1653... -
Page 23: U-Arm Remote Control
DX-D 300 | Introduction | 23 U-arm remote control The remote control to control U-arm position MOVE DETECTOR ROTATION TUBE ROTATION Figure 10: U-arm remote control 0172E EN 20181116 1653... -
Page 24: Portable Dr Detector
24 | DX-D 300 | Introduction 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 25: Emergency Stop Button
DX-D 300 | Introduction | 25 Emergency stop button Figure 11: Emergency stop button If a system malfunction causes an emergency situation involving the patient, operating personnel or any system component, activate the emergency stop. All motor driven system movements will be stopped. -
Page 26: Emergency Shutdown Power Switch
26 | DX-D 300 | Introduction 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 27: System Documentation
Technical documentation is available in the product service documentation which is available from your local support organization. The user documentation consists of: • DX-D 300 User Documentation CD (digital media). • NX User Documentation CD (digital media). • User documentation for the supported DR Detectors •... -
Page 28: The Dx-D 300 User Documentation
28 | DX-D 300 | Introduction The DX-D 300 User Documentation • DX-D 300 User Manual (this document), document 0172. • DX-D 300 U-arm User Manual, document 0171. • DX-D Software Console User Manual, document 0189. • DX-D Full Leg Full Spine User Manual, document 0179. -
Page 29: Options And Accessories
• DX Full Leg Full Spine Stand (for the DX-D Full Leg Full Spine application) • CR FLFS Cassette Holder (for the CR Full Leg Full Spine application) For options and accessories information, refer to the DX-D 300 U-arm User Manual, document 0171. -
Page 30: 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 31: Compliance
DX-D 300 | Introduction | 31 Compliance Topics: • General • Safety • Electromagnetic Compatibility • X-Ray Safety • Classification 0172E EN 20181116 1653... -
Page 32: General
32 | DX-D 300 | Introduction 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 33: Classification
DX-D 300 | Introduction | 33 Classification Type of protection against electric Class 1 Equipment shock Degree of protection against electric Type B Applied Parts shock Degree of protection against ingress IPX0 as defined in IEC60529. Ordi- of liquids nary equipment (enclosed equip- ment without protection against in- gress of liquids). -
Page 34: Connectivity
34 | DX-D 300 | Introduction 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: •... -
Page 35: Labels
DX-D 300 | Introduction | 35 Labels Lable Meaning This mark shows compliance of the equipment with Directive 93/42/EEC (for European Un- ion). This mark indicates that this is a Type B Equip- ment Serial number Manufacturer Date of manufacture... - Page 36 36 | DX-D 300 | Introduction Mark Meaning The 21 CFR Subchapter J label is positioned close to the type label. 0172E EN 20181116 1653...
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Page 37: Messages
The user must read these messages carefully. They will provide information on what to do from then on. This will be either performing an action to resolve the problem or to contact the Agfa service organization. Details on the contents of messages can be found in the service documentation which is available to Agfa service personnel. -
Page 38: Installation
1.5 m (EN) or 1.83 m (UL/ CSA) around the patient (according to the local valid regulation). The other components of the DX-D 300 are suitable for use within the patient environment. -
Page 39: Cleaning And Disinfecting
DX-D 300 | Introduction | 39 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 40: Cleaning
40 | DX-D 300 | Introduction Cleaning To clean the exterior of the equipment: 1. Stop the system. CAUTION: Wet cleaning of the equipment while it is connected to the electric circuit includes the risk of electric shock and of short circuit. -
Page 41: 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 42: Approved Disinfectants
42 | DX-D 300 | Introduction 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 43: Patient Data Security
DX-D 300 | Introduction | 43 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 44: Maintenance
44 | DX-D 300 | Introduction Maintenance Maintenance procedures are described in the DX-D 300 Owner’s Manual. 0172E EN 20181116 1653... -
Page 45: Environmental Protection
DX-D 300 | Introduction | 45 Environmental protection Figure 12: WEEE symbol Figure 13: 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 46: Safety Directions
Safety is only guaranteed when changes, additions, maintenance or repairs are carried out by an Agfa certified field service engineer. A non certified engineer performing a modification or service intervention on a medical device, acts on his own responsibility and makes the warranty void. - Page 47 Strictly observe all warnings, cautions, notes and safety markings within this document and on the product. CAUTION: All Agfa medical products must be used by trained and qualified personnel. CAUTION: Avoid unnecessary dose by checking before exposure if the DR...
- Page 48 48 | DX-D 300 | Introduction specified range, do not operate the system or use air conditioning. Warranty will be void if it is obvious that operating conditions are not met. CAUTION: Power failure can cause an image being lost.
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Page 49: Operation
DX-D 300 | Operation | 49 Operation Topics: • Starting DX-D 300 • Basic workflow using the DR Detector • Workflow for Full Leg Full Spine examination • Basic workflow using a CR cassette • Stopping the System 0172E EN 20181116 1653... -
Page 50: Starting Dx-D 300
50 | DX-D 300 | Operation Starting DX-D 300 Note: Allow the DR Detector to warm up before the DX-D 300 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. -
Page 51: Basic Workflow Using The Dr Detector
DX-D 300 | Operation | 51 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 •... -
Page 52: Step 1: Retrieve The Patient Info
52 | DX-D 300 | Operation 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. 0172E EN 20181116 1653... -
Page 53: Step 2: Select The Exposure
DX-D 300 | Operation | 53 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. U-arm with integrated DR Detector Portable DR Detector in the DR bucky Free exposure using a portable DR Detector The selected DR Detector is activated. -
Page 54: Step 3: Prepare The Exposure
54 | DX-D 300 | Operation Step 3: Prepare the exposure 1. In the examination room, position the U-arm: Press and hold the MOVE button on the U-arm control panel or remote control. The U-arm moves to the default position for the selected exposure. -
Page 55: Step 4: Check The Exposure Settings
DX-D 300 | Operation | 55 Step 4: Check the exposure settings Related Links DR Detector Switch on the NX Workstation on page 17 On the NX application: 1. Check if the DR Detector Switch displays the name of the DR Detector that's being used 2. -
Page 56: Step 5: Execute The Exposure
56 | DX-D 300 | Operation 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: The radiation indicator on the control console lights up during exposure release. -
Page 57: Step 6: Perform A Quality Control
DX-D 300 | Operation | 57 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 58: Workflow For Full Leg Full Spine Examination
58 | DX-D 300 | Operation Workflow for Full Leg Full Spine examination Refer to the DR Full Leg Full Spine User Manual (document 0179). The availability of DR Full Leg Full Spine depends on the configuration of the system. -
Page 59: Basic Workflow Using A Cr Cassette
DX-D 300 | Operation | 59 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. -
Page 60: Step 1: Retrieve The Patient Info
60 | DX-D 300 | Operation 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. 0172E EN 20181116 1653... -
Page 61: Step 2: Select The Exposure
DX-D 300 | Operation | 61 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. Cassette in the DR bucky... -
Page 62: Step 3: Prepare The Exposure
62 | DX-D 300 | Operation Step 3: Prepare the exposure 1. In the examination room, position the U-arm: Press and hold the MOVE button on the U-arm control panel or remote control. The U-arm moves to the default position for the selected exposure. -
Page 63: Step 4: Check The Exposure Settings
DX-D 300 | Operation | 63 Step 4: Check the exposure settings In the operator room at the software console, or in the examination room at the touch screen console: 1. Check if the exposure settings displayed on the console are suitable for the exposure. -
Page 64: Step 5: Execute The Exposure
64 | DX-D 300 | Operation Step 5: Execute the exposure In the operator room: Press the exposure button to execute the exposure. WARNING: The radiation indicator on the control console lights up during exposure release. In the operator room at the NX workstation: •... -
Page 65: Step 6: Repeat Steps 2 To 5 For The Next Subexposures
DX-D 300 | Operation | 65 Step 6: repeat steps 2 to 5 for the next subexposures 0172E EN 20181116 1653... -
Page 66: Step 7: Digitize The Image
66 | DX-D 300 | Operation 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. Note: You can also use an ID Tablet to identify the cassette and digitize it using any digitizer. -
Page 67: Step 8: Perform A Quality Control
DX-D 300 | Operation | 67 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 68: Stopping The System
68 | DX-D 300 | Operation 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 69: Problem Solving
DX-D 300 | Problem solving | 69 Problem solving Topics: • DR Detector is Exceeding the Maximum Working Temperature • DR Detector must be Recalibrated • DR Detector Problem 0172E EN 20181116 1653... -
Page 70: Dr Detector Is Exceeding The Maximum Working Temperature
70 | DX-D 300 | Problem solving 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 71: Technical Data
DX-D 300 | Technical Data | 71 Technical Data Topics: • DX-D 300 Technical Data • Fixed DR Detector Technical Data • Fixed DR Detector Technical Data • U-Arm Technical Data • Portable DR Detector Technical Data 0172E EN 20181116 1653... -
Page 72: Dx-D 300 Technical Data
72 | DX-D 300 | Technical Data DX-D 300 Technical Data The technical data are provided in this chapter or in the User Manual of the component. Table 1: Environmental conditions for the U-arm Environmental Conditions (during storage and transport) -
Page 73: Fixed Dr Detector Technical Data
DX-D 300 | Technical Data | 73 Fixed DR Detector Technical Data Manufacturer Manufacturer DR Detector Varex Imaging Corporation, 1678 So. Pioneer Rd, Salt Lake City, UT 84104, USA Supported models 4343R (part number 7965) CsI conversion screen 4343R (part number 7964) - Page 74 74 | DX-D 300 | Technical Data Reliability Estimated product life (if regularly serviced 100 000 RAD and maintained according to Agfa instruc- tions) 0172E EN 20181116 1653...
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Page 75: Fixed Dr Detector Technical Data
DX-D 300 | Technical Data | 75 Fixed DR Detector Technical Data Manufacturer Manufacturer DR Detector THALES AVS FRANCE SAS 460 Rue du Pommarin – BP122 38346 MOIRANS France Supported models Pixium RAD 4343 C-E CsI conversion screen Pixium RAD 4343 G-E... -
Page 76: Fixed Dr Detector Environmental Conditions
76 | DX-D 300 | Technical Data Fixed DR Detector environmental conditions Pixium RAD 4343 C-E Environmental Conditions (during normal operation) Temperature (ambient) between 15° and 35° Celsius Refer to environmental conditions of the X-ray sys- Humidity Atmospheric pressure Maximum altitude... -
Page 77: U-Arm Technical Data
DX-D 300 | Technical Data | 77 U-Arm Technical Data Manufacturer Manufacturer U-Arm Sedecal S.A. Polígono Ind. Rio de Janeiro 9-13 28110 Algete - Madrid Spain Refer to the DX-D 300 U-arm User Manual (document 0171) for technical data of the U-arm. 0172E EN 20181116 1653... -
Page 78: Portable Dr Detector Technical Data
78 | DX-D 300 | Technical Data Portable DR Detector Technical Data Refer to the DR Detector User Manual. 0172E EN 20181116 1653... -
Page 79: Remarks For Hf-Emission And Immunity
DX-D 300 | Remarks for HF-emission and immunity | 79 Remarks for HF-emission and immunity This equipment generates, uses, and can radiate radio frequency energy. CAUTION: The equipment may cause radio frequency interference to other medical or non medical devices and to radio communications. - Page 80 The DX-D 300 system is intended for use in the electromagnetic environment specified below. The customer or the user of this DX-D 300 system should assure that it is used in such an environment. Table 2: Guidance and manufacturer's declaration on electromagnetic...
- Page 81 DX-D 300 | Remarks for HF-emission and immunity | 81 Table 3: Guidance and manufacturer's declaration on electromagnetic immunity Immunity IEC 60601-1-2 Compliance Electromagnetic en- Test Test Level Level vironment - guid- ance Electrostatic ± 8 kV contact ± 8 kV contact...
- Page 82 82 | DX-D 300 | Remarks for HF-emission and immunity Magnetic field 30 A/m 30 A/m Magnetic field at the at the supply network frequency frequency should correspond to (50/60 Hz) the typical values as they are in a commer-...
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Page 83: Immunity To Rf Wireless Communication Equipment
DX-D 300 | Remarks for HF-emission and immunity | 83 (80% AM at (80% AM 1 kHz) at 1 kHz) Note: The ISM (industrial, scientific and medical) bands between 0.15 MHz and 80 MHz are 6.765 MHz to 6.795 MHz; 13.553 MHz to 13.567 MHz;...