AGFA DR 100e User Manual
Digital radiography
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Summary of Contents for AGFA DR 100e
- Page 1 DR 100e (Digital Radiography) 6012/001 6012/002 6012/003 6012/004 User Manual 0365B EN 20181015 0853...
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Page 2: Table Of Contents
| DR 100e (Digital Radiography) | Contents Contents Legal Notice ................5 Getting started ...............6 Introduction to this Manual ........... 7 Scope of this Manual ..........8 About the safety notices in this document ....9 System Documentation ..........10 Disclaimer ..............11... - Page 3 DR 100e (Digital Radiography) | Contents | iii Maintenance ............55 Preventive maintenance schedule ....55 Training ................57 Safety Directions ..............58 Basic Workflow ..............62 Starting the NX workstation and the DR Detector ..63 Retrieving the patient info ........64 Moving the unit ............
- Page 4 | DR 100e (Digital Radiography) | Contents Product Complaints ..........99 Environmental protection ........100 Technical Data ............101 DR 100e ............. 102 Anatomic program exposure parameters ..108 DAP meter ..........111 Collimator ..........112 X-ray generator and X-ray tube assembly ..
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Page 5: Legal Notice
Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or its affiliates. DR 100e and NX 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 6: Getting Started
6 | DR 100e (Digital Radiography) | Getting started Getting started Related Links Intended Use on page 13 Operation Controls on page 17 Safety Directions on page 58 Basic Workflow on page 62 0365B EN 20181015 0853... -
Page 7: Introduction To This Manual
DR 100e (Digital Radiography) | Introduction to this Manual | 7 Introduction to this Manual Topics: • Scope of this Manual • About the safety notices in this document • System Documentation • Disclaimer 0365B EN 20181015 0853... -
Page 8: Scope Of This Manual
8 | DR 100e (Digital Radiography) | Introduction to this Manual Scope of this Manual This manual contains information for safe and effective operation of the DR 100e mobile X-ray system, further referred to as the device. 0365B EN 20181015 0853... -
Page 9: About The Safety Notices In This Document
DR 100e (Digital Radiography) | Introduction to this Manual | 9 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 10: System Documentation
10 | DR 100e (Digital Radiography) | Introduction to this Manual System Documentation The documentation shall be kept with the system for easy reference. The most extensive configuration is described within this manual, including the maximum number of options and accessories. Not every function, option or accessory described may have been purchased or licensed on a particular piece of equipment. -
Page 11: Disclaimer
DR 100e (Digital Radiography) | 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
12 | DR 100e (Digital Radiography) | Introduction Introduction Topics: • Intended Use • Intended User • Configuration • Operation Controls • Messages • Labels • Installation • Radiation Protection • Cleaning and Disinfecting • Patient data security • Maintenance... -
Page 13: Intended Use
DR 100e (Digital Radiography) | Introduction | 13 Intended Use The DR 100e digital system is a mobile 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 14: Intended User
14 | DR 100e (Digital Radiography) | 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. -
Page 15: Configuration
DR 100e (Digital Radiography) | Introduction | 15 Configuration DR 100e is an integrated mobile Digital Radiography X-Ray System. Figure 1: DR 100e mobile X-Ray System with rotating column (type 6012/004 or 6012/002) 0365B EN 20181015 0853... - Page 16 16 | DR 100e (Digital Radiography) | Introduction Figure 2: DR 100e mobile X-Ray System with fixed column (type 6012/003 or 6012/001) 0365B EN 20181015 0853...
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Page 17: Operation Controls
DR 100e (Digital Radiography) | Introduction | 17 Operation Controls Exposure button Circuit breaker and equipotential node Power supply cable reel Rotating column Lock of the arm movement during transport X-ray generator and X-ray tube assembly Goniometer Collimator X-ray tube handle... - Page 18 18 | DR 100e (Digital Radiography) | Introduction X-ray tube rotation movement lock NX workstation with NX application and DR Detector Switch mounted on a mounting bracket Led beacon light X-ray generator control panel Handlebar with brake lever Remote control receiver (optional)
- Page 19 DR 100e (Digital Radiography) | Introduction | 19 • NX Workstation (all-in-one PC) • NX Application on the NX Workstation • DR Detector Switch • Portable DR Detector • Circuit breaker • X-ray generator control panel • Manual Collimator •...
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Page 20: Nx Workstation (All-In-One Pc)
20 | DR 100e (Digital Radiography) | Introduction NX Workstation (all-in-one PC) 1 2 3 4 Speaker volume Display on/off Display brightness Power button Figure 3: Control buttons 0365B EN 20181015 0853... -
Page 21: Nx Application On The Nx Workstation
DR 100e (Digital Radiography) | Introduction | 21 NX Application on the NX Workstation The NX application is used to define patient information, select exposures and process images. Figure 4: NX application The operation of the NX application is described in the NX User Manual, document 4420.. -
Page 22: Dr Detector Switch
22 | DR 100e (Digital Radiography) | Introduction DR Detector Switch 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. The DR Detector Switch can be used to activate another DR Detector. -
Page 23: Portable Dr Detector
DR 100e (Digital Radiography) | Introduction | 23 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 24: Circuit Breaker
24 | DR 100e (Digital Radiography) | Introduction Circuit breaker Figure 6: System with rotating column Figure 7: System with fixed column The equipment is protected by a circuit breaker against excessive mains fluctuations. To restore operation of the equipment after activation of the circuit breaker, return the switch to position "I". -
Page 25: X-Ray Generator Control Panel
DR 100e (Digital Radiography) | Introduction | 25 X-ray generator control panel Mains power indicator light. The indicator lights up when the device is connected to the mains and powered. Turn the device on. Control panel display for device status, X-ray parameters and messages. -
Page 26: Manual Collimator
26 | DR 100e (Digital Radiography) | Introduction Manual Collimator Longitudinal collimation Button to switch on the light field indicating the collimated area and the laser light indicating the center position. After pressing the button, they remain lit for a few seconds before automatically switching off. -
Page 27: Exposure Button
DR 100e (Digital Radiography) | Introduction | 27 Exposure button Step 1: preparation of the X-ray tube Step 2: exposure Figure 8: Exposure button 0365B EN 20181015 0853... -
Page 28: Infrared Remote Control
28 | DR 100e (Digital Radiography) | Introduction Infrared remote control Transmission indicator (yellow) Exposure button Collimator light button Battery status indicator (red) Figure 9: Infrared remote control The battery status indicator flashes once per second when the battery is near the end of life and twice per second when the battery must be replaced. -
Page 29: Connectors For The Hospital Network And For Registering A Dr Detector
DR 100e (Digital Radiography) | Introduction | 29 Connectors for the hospital network and for registering a DR Detector USB port to connect the IR Data Communication Unit for registering a DR Detector. Network connector to connect the NX workstation to the hospital network. -
Page 30: Led Beacon Light
30 | DR 100e (Digital Radiography) | Introduction Led beacon light Figure 12: Led beacon light (green) Table 1: Led beacon light Color Meaning Green The wireless DR Detector and the X-ray generator are ready for mak- ing an exposure. -
Page 31: Messages
DR 100e (Digital Radiography) | Introduction | 31 Messages Under certain conditions the system sounds a signal or shows a message on the display. Topics: • Sound signals • Status messages • Warning messages • Error messages 0365B EN 20181015 0853... -
Page 32: Sound Signals
32 | DR 100e (Digital Radiography) | Introduction Sound signals Signal Description 2 beeps Successful storage of exposure parameters in an ana- tomic program. 3 beeps X-ray exposure finished successfully 1 long beep (1 sec) Alarm or malfunction Status messages... -
Page 33: Warning Messages
DR 100e (Digital Radiography) | Introduction | 33 Warning messages Warning messages must be reset using the reset button in order to continue working. Figure 13: Reset button Message Description Action CLOCK ERR. System clock error Press the reset button to continue. - Page 34 34 | DR 100e (Digital Radiography) | Introduction Message Description Action MAX DOSE The doses counter has Press the F1 button and reached the maximum the reset button to reset value that can be dis- the value. played. DAP ERROR...
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Page 35: Error Messages
DR 100e (Digital Radiography) | Introduction | 35 Error messages Details on the contents of messages can be found in the service documentation which is available to service personnel. The device must be restarted in order to continue working. Message... - Page 36 36 | DR 100e (Digital Radiography) | Introduction Message Description Action INVERTER KV ERROR Press the reset button During the exposure, and repeat the expo- the kV value has de- sure. creased under 75% or increased over 110% of the requested value.
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Page 37: Labels
DR 100e (Digital Radiography) | Introduction | 37 Labels Topics: • General • Type label • Labeling of the collimator 0365B EN 20181015 0853... -
Page 38: General
38 | DR 100e (Digital Radiography) | Introduction General Always take into account the markings and labels provided on the inside and outside of the machine. A brief overview of these markings and labels and their meaning is given below. - Page 39 DR 100e (Digital Radiography) | Introduction | 39 Figure 15: Position of labels specific for system with fixed column Information label for the handlebar op- eration. Overcoming of obstacles. Transport position. Exposure hand switch 0365B EN 20181015 0853...
- Page 40 40 | DR 100e (Digital Radiography) | Introduction Circuit breaker on and off positions. Equipotential connector. Connector for moving grid. Left pedal brake lock. Right pedal brake lock. X-ray tube rotation lock. By turning the knob clockwise, the rota- tion unlocks.
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Page 41: Type Label
DR 100e (Digital Radiography) | Introduction | 41 Type label X-ray system Figure 16: Example of type label X-ray generator and X-ray tube assembly Figure 17: Example of type label The INMETRO label. 0365B EN 20181015 0853... -
Page 42: Labeling Of The Collimator
42 | DR 100e (Digital Radiography) | Introduction Labeling of the collimator The type label is located at the rear side Figure 18: Example of type label of the collimator. (A) Laser openings (B) Warning labels Avoid exposure. Radiation is emitted from this opening. -
Page 43: Installation
DR 100e (Digital Radiography) | Introduction | 43 Installation Installation and configuration is performed by an Agfa trained and authorized service engineer. Contact your local support organization for more information. Do not use the device in areas where there is a risk of fire. -
Page 44: Labeling The Dr Detectors
44 | DR 100e (Digital Radiography) | Introduction Labeling the DR Detectors CAUTION: Selecting the wrong DR detector can cause the need to retake the image. On a configuration with multiple wireless DR Detectors of the same type, it is required to apply labeling to the DR Detector containing a unique nickname for each DR Detector. -
Page 45: Equipotential Earth Connection
DR 100e (Digital Radiography) | Introduction | 45 Equipotential earth connection The device is supplied with an equipotential earth connection point. The device can only be used in areas that comply with local electrical safety norms and in environments suitable for medical activities. -
Page 46: Electrostatic Discharge
46 | DR 100e (Digital Radiography) | Introduction Electrostatic discharge CAUTION: Always resort to static procedures, protections and appropriate products before opening or during the handling of the equipment. This equipment includes electrostatically sensitive components. Non-compliance with electrostatic discharge procedures may cause damages to the components. Such damages to the components are not covered by any warranty. -
Page 47: Radiation Protection
DR 100e (Digital Radiography) | Introduction | 47 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 48: Cleaning And Disinfecting
48 | DR 100e (Digital Radiography) | 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. -
Page 49: Cleaning
DR 100e (Digital Radiography) | Introduction | 49 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 50 50 | DR 100e (Digital Radiography) | Introduction scouring powders, solvents, abrasives detergents or polishing abrasive. Do not use a special detergent if its properties are not sure. 0365B EN 20181015 0853...
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Page 51: 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 52: Disinfecting Safety Directions
52 | DR 100e (Digital Radiography) | Introduction 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 53: Approved Disinfectants
DR 100e (Digital Radiography) | Introduction | 53 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 54: Patient Data Security
54 | DR 100e (Digital Radiography) | Introduction 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 55: Maintenance
The manufacturer can't be considered responsible for any error, damage or injury caused by improper use or lack of maintenance of the equipment. Always consult the Agfa Service documentation and an AGFA trained and authorized Service engineer for complete maintenance schedules. - Page 56 56 | DR 100e (Digital Radiography) | Introduction Check for lack of oil and unusual noises in high voltage generator. Daily Check the locking and braking systems. 0365B EN 20181015 0853...
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Page 57: 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 58: Safety Directions
58 | DR 100e (Digital Radiography) | Safety Directions Safety Directions WARNING: Only qualified and authorized personnel shall operate this system. In this context ‘qualified’ means those persons legally permitted to operate this equipment in the jurisdiction in which the equipment is being used, and ‘authorized’ means those persons authorized by the authority controlling the use of the equipment. - Page 59 DR 100e (Digital Radiography) | Safety Directions | 59 WARNING: Do not use the device with patients if there is no adequate understanding of its capabilities and functions. Using the device without an adequate knowledge of its functioning can compromise the efficacy and/or reduce the safety of the patient, the user and other people nearby.
- Page 60 60 | DR 100e (Digital Radiography) | Safety Directions WARNING: Do not connect the equipment with anything other than specified. Doing so may result in fire or electric shock. WARNING: To avoid risk of electric shock, do not remove any covers.
- Page 61 DR 100e (Digital Radiography) | Safety Directions | 61 CAUTION: Damaged grid. Reduced image quality. Please handle the grids with special care. CAUTION: Laser radiation is potentially dangerous for skin and eyes. Do not stare directly or through optical instruments at the laser beam.
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Page 62: Basic Workflow
62 | DR 100e (Digital Radiography) | Basic Workflow Basic Workflow Topics: • Starting the NX workstation and the DR Detector • Retrieving the patient info • Moving the unit • Starting the device • Positioning • Selecting the exposure •... -
Page 63: Starting The Nx Workstation And The Dr Detector
Attach a fully charged battery pack to the DR Detector. b) Turn on the DR Detector. c) If needed, register the DR Detector to the DR 100e system. For detailed information about powering on the DR Detector, refer to the DR Detector user manual. -
Page 64: Retrieving The Patient Info
64 | DR 100e (Digital Radiography) | Basic Workflow Retrieving the patient info Note: If you use a wired network the network cable must be plugged in to be able to perform this step. 1. On the RIS, schedule the examinations. -
Page 65: Moving The Unit
DR 100e (Digital Radiography) | Basic Workflow | 65 Moving the unit CAUTION: Risk of tilting during use or transport on inclined floors. Do not use the unit on floors with an inclination higher than 5 degrees. Do not drive the unit on ramps with an inclination higher than 10 degrees. - Page 66 66 | DR 100e (Digital Radiography) | Basic Workflow 3. Lower the arm (A) to locked position. The lock (B) activates with a click. To assert that the arm is locked, turn the knob with the arrow towards the red dot.
- Page 67 DR 100e (Digital Radiography) | Basic Workflow | 67 0365B EN 20181015 0853...
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Page 68: Starting The Device
68 | DR 100e (Digital Radiography) | Basic Workflow Starting the device 1. Unroll the mains cable from the cable reel and extend it completely. 2. Plug the cable into a mains power socket. The mains power indicator lights up. If the mains power indicator does not light up, check if the switch of the circuit breaker on the front panel of the device is in position "I". -
Page 69: Positioning
DR 100e (Digital Radiography) | Basic Workflow | 69 Positioning WARNING: Monitor the patient position (hands, feet, fingers, etc.) with special care to avoid injury to the patient caused by unit movements. Patient hands must be kept away from mobile components of the unit. - Page 70 70 | DR 100e (Digital Radiography) | Basic Workflow 4. Point the X-ray tube towards the region of interest. The X-ray tube can be tilted in all directions: • Forward up to 102 degrees (A) • Backward up to 49 degrees (A) •...
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Page 71: Selecting The Exposure
DR 100e (Digital Radiography) | Basic Workflow | 71 Selecting the exposure 1. 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 X-ray generator control panel. -
Page 72: Preparing The Exposure
72 | DR 100e (Digital Radiography) | Basic Workflow Preparing the exposure 1. Check the position of the X-ray unit and the patient. WARNING: Liquids ingressing the DR Detector may cause malfunction and contamination. If there is a chance that the detector comes in contact with liquids (bodily fluids, disinfectants,...), the DR Detector must be wrapped in a protective... -
Page 73: Checking The Exposure Settings
DR 100e (Digital Radiography) | Basic Workflow | 73 Checking the exposure settings Topics: • On the NX application • On a DR Detector that has a status indicator • On the X-ray generator control panel • On the control panel... -
Page 74: On The Nx Application
74 | DR 100e (Digital Radiography) | Basic Workflow On the NX application 1. Check if the DR Detector Switch displays the name of the DR Detector that's being used 2. If a wrong DR Detector is displayed, select the right DR Detector by clicking the drop down arrow on the DR Detector Switch. -
Page 75: Executing The Exposure
DR 100e (Digital Radiography) | Basic Workflow | 75 Executing the exposure 1. Activate the preferred exposure control mode. Figure 25: Switch between remote control exposure button or wired exposure button. The indicator lights up when the remote control is enabled. - Page 76 76 | DR 100e (Digital Radiography) | Basic Workflow Topics: • Using the wired exposure button • Using the remote control exposure button 0365B EN 20181015 0853...
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Page 77: Using The Wired Exposure Button
DR 100e (Digital Radiography) | Basic Workflow | 77 Using the wired exposure button Completely extend the cable of the exposure button and keep as fas as possible from the radiation source. The cable of the exposure button can be extended up to 4 m. -
Page 78: Using The Remote Control Exposure Button
78 | DR 100e (Digital Radiography) | Basic Workflow Using the remote control exposure button The remote control is optional. Ensure that there is no other equipment with remote control nearby. Keep as fas as possible from the radiation source. The remote control operates at a distance of maximum 11 m from the device at any angle and within sight, through glass or leaded glass. -
Page 79: Performing A Quality Control
DR 100e (Digital Radiography) | Basic Workflow | 79 Performing a quality control In NX: 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: Stopping The Device
80 | DR 100e (Digital Radiography) | Basic Workflow Stopping the device CAUTION: Risk of damaging the device. Always grip the plug to disconnect the power cable. Don't disconnect the plug by pulling the cable. Handle connectors with care. 1. Bring the device to transport position. -
Page 81: Using The Nx Workstation With The X-Ray System Switched Off
DR 100e (Digital Radiography) | Basic Workflow | 81 Using the NX workstation with the X-ray system switched off The NX workstation can be left on while the X-ray device is switched off, for a limited period of time, less than ten minutes, e.g. for moving the device to the next patient. -
Page 82: Stopping The Nx Workstation And The Dr Detector
82 | DR 100e (Digital Radiography) | Basic Workflow Stopping the NX workstation and the DR Detector 1. On the NX workstation, go to the Main Menu. 2. Click the Show Desktop action button. The Windows desktop is shown. 3. Go to the Windows Start menu and select Shut down. -
Page 83: Using The 'Virtual Keyboard
DR 100e (Digital Radiography) | Basic Workflow | 83 Using the ‘virtual keyboard’ When selecting a text field, the virtual keyboard is displayed: Button Function Enter button Close button Floating virtual keyboard button After entering text, select another text field to continue typing or hide the virtual keyboard by clicking the Enter button. -
Page 84: Restriction On The Use Of Virtual Keyboard Software
84 | DR 100e (Digital Radiography) | Basic Workflow Note: Clicking the Close button may cause the virtual keyboard to remain hidden when entering the text field again. Restriction on the use of virtual keyboard software DR 100e contains software components licensed from Comfort Software Group. -
Page 85: Advanced Operation
DR 100e (Digital Radiography) | Advanced Operation | 85 Advanced Operation Topics: • Using a moving grid • Using a DAP meter • Hanging a leaded apron • Making an exposure using a cassette • Modifying the exposure parameters of an anatomic program... -
Page 86: Using A Moving Grid
86 | DR 100e (Digital Radiography) | Advanced Operation Using a moving grid CAUTION: The connected examination table or the bucky must be in compliance with IEC 60601-1 standard and must be connected to the equipment according to 93/42/CE medical devices directive and following amendments. -
Page 87: Using A Dap Meter
DR 100e (Digital Radiography) | Advanced Operation | 87 Using a DAP meter CAUTION: The installation and maintenance of the DAP meter can be performed only by authorized service personnel. The function of the DAP meter is to measure the dose-area product (μGy.m that is going out towards the patient, accumulated over all exposures. -
Page 88: Hanging A Leaded Apron
88 | DR 100e (Digital Radiography) | Advanced Operation Hanging a leaded apron CAUTION: The weight of a leaded apron hanging on the arm or directly on the X-ray tube assembly, could cause uncontrolled movements of the arm and trouble of positioning. Don't hang a leaded apron to the arm. -
Page 89: Making An Exposure Using A Cassette
DR 100e (Digital Radiography) | Advanced Operation | 89 Making an exposure using a cassette To make an exposure using a CR cassette, the manual exposure mode can be activated. Exposure parameters are set using the X-ray generator control panel by selecting an anatomic program or by entering exposure parameters for a free exposure. - Page 90 90 | DR 100e (Digital Radiography) | Advanced Operation Figure 36: Scroll pages d) Select an anatomic program by pressing the F2, F3 or F4 buttons, corresponding to the line on the display containing the selected program. Figure 37: Select anatomic program The selected anatomic group, anatomic program and exposure parameters are displayed.
- Page 91 DR 100e (Digital Radiography) | Advanced Operation | 91 3. Check the position of the X-ray unit and the patient. 4. Apply the required filter on the collimator. 5. Switch on the light localizer on the collimator. Adapt collimation if required.
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Page 92: Modifying The Exposure Parameters Of An Anatomic Program
92 | DR 100e (Digital Radiography) | Advanced Operation Modifying the exposure parameters of an anatomic program The anatomic program consists of six groups of six sets of exposure parameters, so 36 in total. The default X-ray exposure parameters for each exposure type can be customized. - Page 93 DR 100e (Digital Radiography) | Advanced Operation | 93 Figure 48: Small focus and large focus 4. Press and hold the F3 button and simultanuously press the anatomic programs button. Figure 49: Store exposure parameters The system sounds two beeps.
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Page 94: Product Information
94 | DR 100e (Digital Radiography) | Product Information Product Information Topics: • Options and Accessories • Compatibility • Compliance • Connectivity • Equipment Classification • Product Complaints • Environmental protection • Technical Data • Remarks for HF-emission and immunity... -
Page 95: Options And Accessories
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 96: General
96 | DR 100e (Digital Radiography) | 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 97: Connectivity
• DICOM • IHE DR 100e can be connected to a RIS system (input scheduling), a PACS system (output image/data management) and to a hardcopy device (output image). Connecting DR 100e to a wired network To connect DX-D 100 to a wired network: 1. -
Page 98: Equipment Classification
98 | DR 100e (Digital Radiography) | Product Information Equipment Classification Per EN/IEC60601-1, Medical Electrical Equipment, General Requirements for Safety 3rd Edition, this device is classified as following: Table 3: Equipment classification Class I equip- Equipment in which protection against electric shock does... -
Page 99: 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 100: Environmental Protection
100 | DR 100e (Digital Radiography) | Product Information Environmental protection Figure 51: WEEE symbol Figure 52: 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 101: Technical Data
DR 100e (Digital Radiography) | Product Information | 101 Technical Data Topics: • DR 100e • Anatomic program exposure parameters • DAP meter • Collimator • X-ray generator and X-ray tube assembly 0365B EN 20181015 0853... -
Page 102: Dr 100E
102 | DR 100e (Digital Radiography) | Product Information DR 100e Electrical connection Rated power supply 115 ÷ 230Vac ±10%, 50/60 Hz ± 5 Hz, 10A, standard monophase with ground conductor. Automatic setting of the equipment according to mains voltage. - Page 103 DR 100e (Digital Radiography) | Product Information | 103 73 - 92 kV max. 110 mAs 93 - 112 kV max. 100 mAs 113 - 125 kV max. 90 mAs X-ray filtration Filtration without DAP meter 3.1 mm Al @75kV Filtration including DAP meter 3.4 mm Al @75kV...
- Page 104 104 | DR 100e (Digital Radiography) | Product Information All dimensions are in mm. Linear tolerances ±5 mm, angular ±1°. Dimensions (in transport position) 700 x 1489 x 1504 mm width x length x height Handlebar height 932 mm Weight...
- Page 105 DR 100e (Digital Radiography) | Product Information | 105 747 mm Maximum lateral extension of the ± 90° Rotation of the column (β-swivel) ± 180° Rotation of the monobloc around the arm axis (α swivel) 151° (102° ahead, 49° back) Rotation of the monobloc around its axis (γ...
- Page 106 106 | DR 100e (Digital Radiography) | Product Information All dimensions are in mm. Linear tolerances ±5 mm, angular ±1°. Dimensions (in transport position) 618 x 1366 x 1483 mm width x length x height Handle height 949 mm Weight...
- Page 107 DR 100e (Digital Radiography) | Product Information | 107 manual Movement Wheels diameter front: 80 mm rear: 250 mm Environmental conditions Table 6: Environmental conditions of the mobile X-ray unit Environmental conditions (during normal operation) Room temperature between +10 °C and +40 °C...
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Page 108: Anatomic Program Exposure Parameters
108 | DR 100e (Digital Radiography) | Product Information Anatomic program exposure parameters The default X-ray exposure parameters for each exposure type can be customized. The device is delivered with a set of X-ray exposure parameters that are intended as a guideline. The default X-ray exposure parameters are only starting points that can be replaced by more specific X-ray exposure parameters developed by the operator. - Page 109 DR 100e (Digital Radiography) | Product Information | 109 Anatomic Focus µGym program Thora, Spine Large 76.39 Lumbar Large 118.84 Spine LAT Table 9: Anatomic group for examinations of the upper extremities Anatomic Focus µGym program Clavicle Small 16.81 Humerus Small 8.56...
- Page 110 110 | DR 100e (Digital Radiography) | Product Information Anatomic Focus µGym program Chest 2.0 kg Small 0.32 0.37 Chest 3.0 kg Small 0.54 Chest 4.0 kg Small 0.63 Chest 5.0 kg Small 0.75 Table 12: Anatomic group for examinations of children (II) Additional filter 1 mm Al + 0.2 mm Cu or 1 mm Al + 0.1 mm Cu...
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Page 111: Dap Meter
DR 100e (Digital Radiography) | Product Information | 111 DAP meter Model Diamentor CI-P Type Device for the dose area product meas- urement in X-ray diagnostics according to IEC 60580 standard. Principle of measurement Radiation measure with ionization chamber Measured quantity... -
Page 112: Collimator
112 | DR 100e (Digital Radiography) | Product Information Collimator Model R108 F Collimation Manual with internal light source, multilayer, squared field. Assembly plan from focus 80 mm (3.14") Coverage of the field at 100cm FFD minimum 0 cm x 0 cm... -
Page 113: X-Ray Generator And X-Ray Tube Assembly
DR 100e (Digital Radiography) | Product Information | 113 X-ray generator and X-ray tube assembly Table 13: X-ray generator and X-ray tube assembly Model name Rotating anode monobloc MHF2030 High voltage generator Thermo-tinned structure Max. power (100 kV - 320 32 kW Max. - Page 114 114 | DR 100e (Digital Radiography) | Product Information Figure 53: X22 0.8/1.3 Figure 54: X22 0.6/1.3 Table 14: X-ray tube Model name Rotating anode X22 0.8/1.3 X22 0.6/1.3 Specifications X-ray tube Rotation speed 3000 min‾¹ Nominal High voltage 130 kVp Nominal focus dim.
- Page 115 DR 100e (Digital Radiography) | Product Information | 115 1.3 mm large focus 1.3 mm large focus Nominal anodic power 16 kW small focus 11 kW small focus (IEC 60613) 32 kW large focus 32 kW large focus Anodic material...
- Page 116 116 | DR 100e (Digital Radiography) | Product Information CURVE DI CARICO SINGOLO - SINGLE LOAD RATING - ABAQUE DE CHARGE UNIQUE CURVE DI CARICO SINGOLO - SINGLE LOAD RATING - ABAQUE DE CHARGE UNIQUE 0.6 - 3 ~ - 3000 min 1.3 - 3 ~ - 3000 min...
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Page 117: Remarks For Hf-Emission And Immunity
DR 100e (Digital Radiography) | Product Information | 117 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 118 118 | DR 100e (Digital Radiography) | Product Information Harmonic emis- Class A frequency communication services. The user sion in accord- might need to take mitigation measures, such ance with IEC as relocating or re-orienting the equipment. 61000-3-2 Voltage fluctua-...
- Page 119 DR 100e (Digital Radiography) | Product Information | 119 accordance with IEC If the user wants the device ) for 25 peri- 61000-4-11 to work continuously, even ods at 0° when the energy supply is • 0% U for 250 pe-...
- Page 120 120 | DR 100e (Digital Radiography) | Product Information FM radio transmitters, cannot be precisely predetermined theoretically. An 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 121 DR 100e (Digital Radiography) | Product Information | 121 • Precautions on EMC • Cables, transducers and accessories 0365B EN 20181015 0853...
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Page 122: Enclosure Port Immunity To Rf Wireless Communication Equipment
122 | DR 100e (Digital Radiography) | Product Information Enclosure Port Immunity to RF wireless communication equipment Service 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 123: Precautions On Emc
DR 100e (Digital Radiography) | Product Information | 123 Precautions on EMC WARNING: The system should not be used adjacent to or stacked with other equipment and if adjacent or stacked use is necessary, the system should be observed to verify normal operation in the configuration in which it will be used. -
Page 124: 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 manual or spare parts not ordered from Agfa, may cause a higher emission of electromagnetic phenomena and/or may rise the susceptibility against it. remark function type;...