AGFA DR 100e User Manual

Digital radiography

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DR 100e (Digital Radiography)

6012/003

6012/004

User Manual

0365C EN 20240125 0921

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Page 1 DR 100e (Digital Radiography) 6012/003 6012/004 User Manual 0365C EN 20240125 0921...
Page 2: Table Of Contents
DR 100e (Digital Radiography) | Contents | ii Contents Legal Notice................... 5 Getting started..................5 Introduction to this Manual..............6 Scope of this Manual............................7 About the safety notices in this document....................8 System Documentation..........................9 Disclaimer................................ 10 Introduction..................10 Intended Use..............................11 Intended User..............................12 Configuration..............................
Page 3 Setting the exposure parameters on the X-ray generator control panel......79 Modifying the exposure parameters of an anatomic program............82 Product Information................83 Options and Accessories..........................84 Compatibility..............................85 Compliance..............................85 General..............................86 Safety..............................86 Electromagnetic Compatibility...................... 86 Laser Safety............................86 Connectivity..............................87 Connecting DR 100e to a wired network................... 87 0365C EN 20240125 0921...
Page 4 Equipment Classification..........................88 Product Complaints............................89 Environmental protection.......................... 90 Technical Data..............................91 DR 100e..............................92 Anatomic program exposure parameters..................98 DAP meter............................100 Manual collimator technical data....................101 X-ray generator and X-ray tube assembly................102 Remarks for HF-emission and immunity.....................105 Immunity to RF wireless communication equipment............108 Precautions on EMC........................
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: Introduction To This Manual
DR 100e (Digital Radiography) | Introduction to this Manual | 6 Introduction to this Manual • Scope of this Manual on page 7 • About the safety notices in this document on page 8 • System Documentation on page 9 • Disclaimer on page 10...
Page 7: Scope Of This Manual
DR 100e (Digital Radiography) | Introduction to this Manual | 7 Scope of this Manual This manual contains information for safe and effective operation of the DR 100e mobile X-ray sys- tem, further referred to as the device. 0365C EN 20240125 0921...
Page 8: About The Safety Notices In This Document
DR 100e (Digital Radiography) | Introduction to this Manual | 8 About the safety notices in this document The following samples show how warnings, cautions, instructions and notes appear in this docu- ment. The text explains their intended use. DANGER: A danger safety notice indicates a hazardous situation of direct, immediate dan- ger for a potential serious injury to a user, service engineer, patient or any other person.
Page 9: System Documentation
DR 100e (Digital Radiography) | Introduction to this Manual | 9 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 pur- chased or licensed on a particular piece of equipment.
Page 10: Disclaimer
DR 100e (Digital Radiography) | Introduction | 10 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. However, Agfa assumes no responsibility or liability for errors, inaccuracies or omissions that may appear in this document.
Page 11: Intended Use
DR 100e (Digital Radiography) | Introduction | 11 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 radi- ographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult, pediatric or neonatal patients.
Page 12: Intended User
DR 100e (Digital Radiography) | Introduction | 12 Intended User This manual has been written for trained users of Agfa products and trained diagnostic X–Ray clin- ical personnel who have received proper training. Users are those persons who actually handle the equipment and those who have authority over the equipment.
Page 13: Configuration
DR 100e (Digital Radiography) | Introduction | 13 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) 0365C EN 20240125 0921...
Page 14 DR 100e (Digital Radiography) | Introduction | 14 Figure 2: DR 100e mobile X-Ray System with ﬁxed column (type 6012/003) 0365C EN 20240125 0921...
Page 15: Operation Controls
DR 100e (Digital Radiography) | Introduction | 15 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 0365C EN 20240125 0921...
Page 16 DR 100e (Digital Radiography) | Introduction | 16 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) DR detector holder...
Page 17 DR 100e (Digital Radiography) | Introduction | 17 • X-ray generator control panel on page 22 • Manual Collimator on page 23 • Exposure button on page 24 • Infrared remote control on page 25 • Connectors for the hospital network and for registering a DR Detector on page 26 •...
Page 18: Musica Acquisition Workstation (Nx)
DR 100e (Digital Radiography) | Introduction | 18 MUSICA Acquisition Workstation (NX) The MUSICA Acquisition workstation is used to define patient information, select exposures and process images. Figure 3: MUSICA Acquisition workstation software The operation of the workstation application is described in the MUSICA Acquisition Workstation User Manual, document 4420.
Page 19: Dr Detector Switch
DR 100e (Digital Radiography) | Introduction | 19 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 20: Portable Dr Detector
DR 100e (Digital Radiography) | Introduction | 20 Portable DR detector When performing an exposure, keep in mind the following detector orientation aids: Table 1: Orientation aids Tube side icon, indicating the side that faces the X-ray tube Patient orientation marker, filled rectangle printed at the corner...
Page 21: Circuit Breaker
DR 100e (Digital Radiography) | Introduction | 21 Circuit breaker Figure 5: System with rotating column Figure 6: 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 22: X-Ray Generator Control Panel
DR 100e (Digital Radiography) | Introduction | 22 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 23: Manual Collimator
DR 100e (Digital Radiography) | Introduction | 23 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 24: Exposure Button
DR 100e (Digital Radiography) | Introduction | 24 Exposure button Step 1: preparation of the X-ray tube Step 2: exposure Figure 7: Exposure button 0365C EN 20240125 0921...
Page 25: Infrared Remote Control
DR 100e (Digital Radiography) | Introduction | 25 Infrared remote control Transmission indicator (yellow) Exposure button Collimator light button Battery status indicator (red) Figure 8: 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 26: Connectors For The Hospital Network And For Registering A Dr Detector
DR 100e (Digital Radiography) | Introduction | 26 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 27: Led Beacon Light
DR 100e (Digital Radiography) | Introduction | 27 Led beacon light Figure 11: Led beacon light (green) Table 2: Led beacon light Color Meaning Green The wireless DR Detector and the X-ray generator are ready for making an exposure. Yellow X-ray radiation is ongoing.
Page 28: Messages
DR 100e (Digital Radiography) | Introduction | 28 Messages Under certain conditions the system sounds a signal or shows a message on the display. • Sound signals on page 29 • Status messages on page 29 • Warning messages on page 30 • Error messages on page 31 0365C EN 20240125 0921...
Page 29: Sound Signals
DR 100e (Digital Radiography) | Introduction | 29 Sound signals Signal Description 2 beeps Successful storage of exposure parameters in an anatomic program. 3 beeps X-ray exposure finished successfully 1 long beep (1 sec) Alarm or malfunction Status messages Message Description Action READY The device is ready to perform an ex-...
Page 30: Warning Messages
DR 100e (Digital Radiography) | Introduction | 30 Warning messages Warning messages must be reset using the reset button in order to continue working. Figure 12: Reset button Message Description Action CLOCK ERR. System clock error Press the reset button to contin- INI. APR...
Page 31: Error Messages
DR 100e (Digital Radiography) | Introduction | 31 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 Description Action FAULTY POWER Error on the Charger or Chopper.
Page 32: Labels
DR 100e (Digital Radiography) | Introduction | 32 Labels • General on page 33 • Type label on page 36 • Labeling of the collimator on page 38 0365C EN 20240125 0921...
Page 33: General
DR 100e (Digital Radiography) | Introduction | 33 General Always take into account the markings and labels provided on the inside and outside of the ma- chine. A brief overview of these markings and labels and their meaning is given below. Figure 13: Position of the labels, illustrated on a system with rotating column Figure 14: Position of labels specific for system with ﬁxed column...
Page 34 DR 100e (Digital Radiography) | Introduction | 34 Information label for the handle- bar operation. Overcoming of obstacles. Transport position. Exposure hand switch Circuit breaker on and off posi- tions. 0365C EN 20240125 0921...
Page 35 DR 100e (Digital Radiography) | Introduction | 35 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 rotation unlocks. USB connector. Wired network connector. This connector is used to connect to the hospital network.
Page 36: Type Label
DR 100e (Digital Radiography) | Introduction | 36 Type label X-ray system Figure 15: Example of type label X-ray generator and X-ray tube assembly Figure 16: Example of type label The INMETRO label is positioned close to the type label. Safety warning, indicating that the manuals should be consulted.
Page 37 DR 100e (Digital Radiography) | Introduction | 37 Date of manufacture Type number Serial number This mark shows compliance of the equip- ment with Regulation 2017/745 (for European Union). This symbol on the products, and/or accompa- nying documents means that used electrical and electronic products should not be treated as, or mixed with general household waste.
Page 38: Labeling Of The Collimator
DR 100e (Digital Radiography) | Introduction | 38 Labeling of the collimator Figure 17: Example of type label The type label is located at the rear side of the collimator. (A) Laser openings (B) Warning labels Avoid exposure. Radiation is emitted from this opening.
Page 39: Installation
DR 100e (Digital Radiography) | Introduction | 39 Installation Installation and configuration is performed by an Agfa trained and authorized service engineer. Contact your local support organization for more information. Use the equipment only in rooms or areas that comply with all applicable laws (or regulations hav- ing the force of law), referring to the electrical safety of this type of medical device.
Page 40: Labeling The Dr Detectors
DR 100e (Digital Radiography) | Introduction | 40 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 la- beling to the DR detector containing a unique nickname for each DR detector.
Page 41: Equipotential Earth Connection
DR 100e (Digital Radiography) | Introduction | 41 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 environ- ments suitable for medical activities.
Page 42: Electrostatic Discharge
DR 100e (Digital Radiography) | Introduction | 42 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 war- ranty.
Page 43: Radiation Protection
DR 100e (Digital Radiography) | Introduction | 43 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. There- fore the X-ray operator should avoid exposure by X-ray radiation at all times.
Page 44: Cleaning And Disinfecting
DR 100e (Digital Radiography) | Introduction | 44 Cleaning and Disinfecting All appropriate policies and procedures should be followed to avoid contamination of the user/ staff, patients and other equipment. All necessary precautions shall be taken to avoid patient con- tact or contact with potential sources of contamination. Cleaning agents and disinfectants should only be used by trained people with required knowledge to complete the cleaning and disinfect- ing task in a save and effective way.
Page 45: Cleaning
DR 100e (Digital Radiography) | Introduction | 45 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 in- cludes the risk of electric shock and of short circuit.
Page 46: Disinfecting
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. UV disinfection is also not allowed.
Page 47: Disinfecting Safety Directions
DR 100e (Digital Radiography) | Introduction | 47 Disinfecting safety directions Warning: Using a disinfectant that can form an explosive or flammable gas mixtures is haz- ard to life and health because of explosion risk. Switch the equipment off before disinfect- ing. Allow the gas mixture to evaporate before switching the x-ray system back on.
Page 48: Approved Disinfectants
DR 100e (Digital Radiography) | Introduction | 48 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. http://www.agfahealthcare.com/global/en/library/overview.jsp?ID=41651138...
Page 49: Patient Data Security
17(4) and 18(8) of Annex I of the EU Medical Device Regulation 2017/745, must be implemented and used in connection with the use of the Agfa medical device by the Customer (User). These are minimum requirements and designed to protect against unauthorised access that could hamper the device from functioning as intended.
Page 50 DR 100e (Digital Radiography) | Introduction | 50 • User access rights to medical devices shall be reviewed for appropriateness and corrected as needed, at regular intervals not exceeding once a year. 0365C EN 20240125 0921...
Page 51: Maintenance
Your local Agfa or dealer representative can provide further information on training. The user must note the following information in the system documentation:...
Page 52: Safety Directions
Safety is on- ly 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 ser- vice intervention on a medical device, acts on his own responsibility and makes the warran- ty void.
Page 53: Basic Workflow
Warning: To avoid risk of electric shock, do not remove any covers. Changes, additions, maintenance or repairs must be carried out by an Agfa certified field service engineer. Warning: Do not remove protections or cables from the device, unless it is expressly re- quired in this User Manual, because inside are dangerous electrical voltages.
Page 54 DR 100e (Digital Radiography) | Basic Workflow | 54 • Preparing the exposure on page 64 • Checking the exposure settings on page 65 • Executing the exposure on page 67 • Performing a quality control on page 70 • Stopping the device on page 71 •...
Page 55: 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 man- ual.
Page 56: Retrieving The Patient Info
4. Start the examination. Note If the patient cannot be retrieved from the RIS you should enter patient data manually. In that case, you can use the ‘virtual keyboard’. Related information Connecting DR 100e to a wired network on page 87 0365C EN 20240125 0921...
Page 57: Moving The Unit
DR 100e (Digital Radiography) | Basic Workflow | 57 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 in- clination higher than 10 degrees.
Page 58 DR 100e (Digital Radiography) | Basic Workflow | 58 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. 4. Put the X-ray tube (A) in vertical position on both rotation axes (B and C).
Page 59 DR 100e (Digital Radiography) | Basic Workflow | 59 7. Move the unit holding the handlebar. 8. To overcome obstacles or small drops, press with the foot on the pedal for the tilting and, at the same time, pull the handlebar. 0365C EN 20240125 0921...
Page 60: Starting The Device
DR 100e (Digital Radiography) | Basic Workflow | 60 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 61: Positioning
DR 100e (Digital Radiography) | Basic Workflow | 61 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 mo- bile components of the unit. Intravenous tubing, catheters and other patient connected lines should be routed away from moving equipment.
Page 62 DR 100e (Digital Radiography) | Basic Workflow | 62 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) • To the side up to 180 degrees (B) The collimator can be rotated on its vertical axis up to 120 degrees in each direction.
Page 63: Selecting The Exposure
DR 100e (Digital Radiography) | Basic Workflow | 63 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 64: Preparing The Exposure
DR 100e (Digital Radiography) | Basic Workflow | 64 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, disinfec- tants,...), the DR Detector must be wrapped in a protective plastic bag while performing the ex-...
Page 65: Checking The Exposure Settings
DR 100e (Digital Radiography) | Basic Workflow | 65 Checking the exposure settings • On the NX application on page 66 • On a DR Detector that has a status indicator on page 66 • On the X-ray generator control panel on page 66 •...
Page 66: On The Nx Application
DR 100e (Digital Radiography) | Basic Workflow | 66 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 ar- row on the DR Detector Switch.
Page 67: Executing The Exposure
DR 100e (Digital Radiography) | Basic Workflow | 67 Executing the exposure 1. Activate the preferred exposure control mode. Figure 24: Switch between remote control exposure button or wired exposure button. The indicator lights up when the remote control is enabled. Each exposure control mode excludes the other one.
Page 68: Using The Wired Exposure Button
DR 100e (Digital Radiography) | Basic Workflow | 68 Using the wired exposure button Completely extend the cable of the exposure button and keep as far as possible from the radiation source. The cable of the exposure button can be extended up to 4 m. Stretching it further can dam- age the cable.
Page 69: Using The Remote Control Exposure Button
DR 100e (Digital Radiography) | Basic Workflow | 69 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 max- imum 11 m from the device at any angle and within sight, through glass or leaded glass.
Page 70: Performing A Quality Control
To prevent error mes- sages being displayed, halt the send queue and restart it when plugging in the network cable. Refer to the MUSICA Acquisition Workstation User Manual. Related information Connecting DR 100e to a wired network on page 87 0365C EN 20240125 0921...
Page 71: Stopping The Device
DR 100e (Digital Radiography) | Basic Workflow | 71 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 72: Using The Nx Workstation With The X-Ray System Switched Off
NX workstation. When stopping the NX workstation, also disconnect the mains cable from the mains socket. Related information Connecting DR 100e to a wired network on page 87 0365C EN 20240125 0921...
Page 73: Stopping The Nx Workstation And The Dr Detector
DR 100e (Digital Radiography) | Basic Workflow | 73 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 74: Using The 'Virtual Keyboard
DR 100e (Digital Radiography) | Basic Workflow | 74 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 click- ing the Enter button.
Page 75: Restriction On The Use Of Virtual Keyboard Software
DR 100e (Digital Radiography) | Advanced Operation | 75 Restriction on the use of virtual keyboard software DR 100e contains software components licensed from Comfort Software Group. These products may only be used as part of and in connection with DR 100e. Advanced Operation •...
Page 76: Using A Moving Anti-Scatter Grid
DR 100e (Digital Radiography) | Advanced Operation | 76 Using a moving anti-scatter 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 de- vices directive and following amendments.
Page 77: Using A Dap Meter
DR 100e (Digital Radiography) | Advanced Operation | 77 Using a DAP meter Caution: The installation and maintenance of the DAP meter can be performed only by au- thorized service personnel. The function of the DAP meter is to measure the dose-area product (μGy.m ) that is going out to- wards the patient, accumulated over all exposures.
Page 78: Hanging A Leaded Apron
DR 100e (Digital Radiography) | Advanced Operation | 78 Hanging a leaded apron Caution: The weight of a leaded apron hanging on the arm or directly on the X-ray tube as- sembly, could cause uncontrolled movements of the arm and trouble of positioning. Don't hang a leaded apron to the arm.
Page 79: Making An Exposure Using A Cassette
DR 100e (Digital Radiography) | Advanced Operation | 79 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 80 DR 100e (Digital Radiography) | Advanced Operation | 80 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 36: Select anatomic program The selected anatomic group, anatomic program and exposure parameters are displayed. The exposure parameters can still be adjusted.
Page 81 DR 100e (Digital Radiography) | Advanced Operation | 81 Related information Anatomic program exposure parameters on page 98 Modifying the exposure parameters of an anatomic program on page 82 X-ray generator control panel on page 22 0365C EN 20240125 0921...
Page 82: Modifying The Exposure Parameters Of An Anatomic Program
DR 100e (Digital Radiography) | Advanced Operation | 82 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 83: Product Information
DR 100e (Digital Radiography) | Product Information | 83 4. Press and hold the F3 button and simultanuously press the anatomic programs button. Figure 48: Store exposure parameters The system sounds two beeps. The new exposure parameters are stored in the anatomic program. Product Information •...
Page 84: Options And Accessories
DR 100e (Digital Radiography) | Product Information | 84 Options and Accessories • Infrared remote control • DAP meter • Second capacitor bank 0365C EN 20240125 0921...
Page 85: Compatibility
Compatibility The system must only be used in combination with other equipment or components if these are ex- pressly 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 86: General
DR 100e (Digital Radiography) | Product Information | 86 General • The product has been designed in accordance with Regulation (EU) 2017/745 on medical devices (MDR) Safety • IEC 60601-1 Electromagnetic Compatibility • IEC 60601-1-2 Laser Safety • IEC 60825-1 0365C EN 20240125 0921...
Page 87: Connectivity
DR 100e (Digital Radiography) | Product Information | 87 Connectivity DR 100e requires a TCP/IP network to exchange information with a number of other devices. The recommended minimum network performance is 100 Mbit for wired ethernet and IEEE 802.11 g for wireless network. Note A wireless network operating on variable speed or subject to interruptions will cause delays on the NX workstation.
Page 88: Equipment Classification
DR 100e (Digital Radiography) | Product Information | 88 Equipment Classification Per EN/IEC60601-1, Medical Electrical Equipment, General Requirements for Safety 3rd Edition, this device is classified as following: Table 4: Equipment classification Class I equipment Equipment in which protection against electric shock does not re- lay on basic insulation only, but includes a power supply cord with protective earth conductor.
Page 89: Product Complaints
Contact address: Agfa Service Support - local support addresses and phone numbers are listed on www.agfa.com Agfa - Septestraat 27, 2640 Mortsel, Belgium Agfa - Fax +32 3 444 7094...
Page 90: Environmental Protection
DR 100e (Digital Radiography) | Product Information | 90 Environmental protection Figure 50: WEEE symbol Figure 51: 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. It therefore requires the collection of WEEE, recovery and reuse or recycling.
Page 91: Technical Data
DR 100e (Digital Radiography) | Product Information | 91 Technical Data • DR 100e on page 92 • Anatomic program exposure parameters on page 98 • DAP meter on page 100 • Manual collimator technical data on page 101 • X-ray generator and X-ray tube assembly on page 102 0365C EN 20240125 0921...
Page 92 DR 100e (Digital Radiography) | Product Information | 92 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. Automatic line compensation. Standard outlet...
Page 93 DR 100e (Digital Radiography) | Product Information | 93 Product life Estimated product life (if regularly serviced Up to ten (10) years and maintained according to Agfa instruc- tions) 0365C EN 20240125 0921...
Page 94 DR 100e (Digital Radiography) | Product Information | 94 Dimensions Table 5: Dimensions of the system with rotating column Dimensions 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...
Page 95 DR 100e (Digital Radiography) | Product Information | 95 Weight 240 kg (without DR detector) 444 mm - 2153 mm Focus-floor distance (Z-axis) 2393 mm Maximum height 747 mm Maximum lateral extension of the arm ± 90° Rotation of the column (β-swivel) ± 180°...
Page 96 DR 100e (Digital Radiography) | Product Information | 96 Table 6: Dimensions of the system with ﬁxed column Dimensions 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...
Page 97 DR 100e (Digital Radiography) | Product Information | 97 Wheels diameter front: 80 mm rear: 250 mm Environmental conditions Table 7: Environmental conditions of the mobile X-ray unit Environmental conditions (during normal operation) Room temperature between +10 °C and +40 °C Humidity (non condensing)
Page 98: Anatomic Program Exposure Parameters
DR 100e (Digital Radiography) | Product Information | 98 Anatomic program exposure parameters The default X-ray exposure parameters for each exposure type can be customized. The device is de- livered 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 99 DR 100e (Digital Radiography) | Product Information | 99 Table 11: Anatomic group for examinations of the lower extremities Anatomic program Focus µGym Hip/Femur Small 12.5 64.73 Knee Small 15.07 Kneecap Small 24.18 Leg/Ankle Small 10.69 Foot Small 2.85 Toes Small 2.12 Table 12: Anatomic group for examinations of children (I) Additional filter 1 mm Al + 0.2 mm Cu or 1 mm Al + 0.1 mm Cu...
Page 100: Dap Meter
DR 100e (Digital Radiography) | Product Information | 100 DAP meter Model Diamentor CI-P Type Device for the dose area product measurement in X-ray diagnostics according to IEC 60580 standard. Principle of measurement Radiation measure with ionization chamber Measured quantity Dose area product Digital resolution 0.01 cGy x cm...
Page 101: Manual Collimator Technical Data
DR 100e (Digital Radiography) | Product Information | 101 Manual collimator technical data Model R108 F Manufacturer Ralco Via dei Tigli 13/G 20853 Biassono (MB), Italy Collimation Manual with internal light source, multilayer, squared field, laser field to determine the SID at 1 m.
Page 102: X-Ray Generator And X-Ray Tube Assembly
DR 100e (Digital Radiography) | Product Information | 102 X-ray generator and X-ray tube assembly Table 14: 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 mA) 32 kW Max. voltage to the tube 125 kV Max.
Page 103: Specifications
DR 100e (Digital Radiography) | Product Information | 103 Figure 52: X22 0.8/1.3 Figure 53: X22 0.6/1.3 Table 15: 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. (IEC 60336) 0.8 mm small focus...
Page 104 DR 100e (Digital Radiography) | Product Information | 104 Anodic angle 15° Thermal capacity of the anode 80 kJ (107 kHU) Max continuous anode dissipa- 300 W tion Min. inherent filtration (IEC 522) 0.7 mm Al eq. Tube material glass Figure 54: X22 0.8/1.3...
Page 105: Remarks For Hf-Emission And Immunity
DR 100e (Digital Radiography) | Product Information | 105 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 CFR 47 Part 15 Class A. This device was tested for a normal hospital environment as described above.
Page 106 DR 100e (Digital Radiography) | Product Information | 106 Resistance to Jamming Test Test level of profession- Electromagnetic Environment Guide- al medical equipment lines and basic EMC stan- dards Discharge of static electric- + 8 kV contact discharge Floors should consist of wood, concrete ity in accordance with IEC or ceramic tiles.
Page 107 DR 100e (Digital Radiography) | Product Information | 107 Disruptions are possible near devices that carry the follow- ing symbol: The field strength of stationary transmitters, such as base stations of radio telephones, mobile broadcasts for rural areas, amateur stations, and AM and FM radio transmitters, cannot be pre- cisely predetermined theoretically.
Page 108: Immunity To Rf Wireless Communication Equipment
DR 100e (Digital Radiography) | Product Information | 108 Immunity to RF wireless communication equipment Service ISM Band Distance Immunity test level (MHz) (V/m) 300-390 TETRA 400 430-470 GMRS 460; FRS 460 704-787 LTE Band 13, 17 800-960 GSM 800/900; TETRA 800, IDEN 820; CO- MA 850;...
Page 109: Precautions On Emc
DR 100e (Digital Radiography) | Product Information | 109 Precautions on EMC Warning: Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equip- ment and the other equipment should be observed to verify that they are operating normal-...
Page 110: Cables, Transducers And Accessories
DR 100e (Digital Radiography) | Product Information | 110 Cables, transducers and accessories Cables, transducers and accessories which were tested and found to comply with the collateral standard IEC60601-1-2 (EMC): Caution: Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.

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