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Summary of Contents for AGFA XF+10
- Page 1 XF⁺10, XF⁺14, XF⁺17 FXRD-2530FAW FXRD-3643FAW FXRD-4343FAW User Manual 0440A EN 20241015 0900...
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Page 2: Table Of Contents
XF⁺10, XF⁺14, XF⁺17 | Contents | ii Contents Legal Notice................... 5 Introduction to this Manual..............5 Scope..................................6 About the safety notices in this document....................7 Disclaimer................................8 Introduction to the DR Detector............8 Intended use..............................9 Intended User..............................10 Configuration..............................11 Equipment Classification..........................12 Non-medical equipment........................12 Options and Accessories..........................13 Operation Controls............................14 XF⁺10, XF⁺14, XF⁺17........................... - Page 3 XF⁺10, XF⁺14, XF⁺17 | Contents | iii Cleaning..............................49 Use of protective plastic bag......................50 Disinfecting............................51 Approved disinfectants........................52 Safety directions for disinfection....................53 Maintenance..............................54 Daily inspection..........................55 Half-yearly inspection........................56 Regular Inspection and Maintenance..................57 Replacement Parts Support......................58 Repair..............................59 Patient data security............................ 60 Requirements on the operating environment................60 Environmental Protection...........................62 Safety Directions............................63 Safety directions for the power supply..................
- Page 4 Switching temporarily to client mode..................108 Connecting the MUSICA Acquisition Workstation to another DR detector (access point mode)..........................109 Problem solving................. 109 Artifact in DR Detector images....................... 110 DR detector not ready for exposure......................111 Connecting to another workstation using NFC tags fails..............112 The MUSICA Acquisition Workstation is connected to the DR detector, but the DR detec- tor is not active (access point mode)....................
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Page 5: Legal Notice
Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or its affiliates. XF⁺10, XF⁺14 and XF⁺17 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 in- fringement. -
Page 6: Scope
XF⁺10, XF⁺14, XF⁺17 | Introduction to this Manual | 6 Scope This manual contains information for the safe and effective operation of the XD⁺10, XD⁺14 and XD⁺17 wireless DR detectors and peripheral equipment, further referred to as the DR detector. 0440A EN 20241015 0900... -
Page 7: About The Safety Notices In This Document
XF⁺10, XF⁺14, XF⁺17 | 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 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 8: Disclaimer
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 8 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 9: Intended Use
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 9 Intended use Indications for use The XF⁺10, XF⁺14 and XF⁺17 DR detectors are digital flat panel detectors that is used for screening and diagnosis of disease of injury. These detectors are intended for use by a qualified/trained doc- tor or technician on both adult subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. -
Page 10: Intended User
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 10 Intended User This manual is written for trained users of Agfa products. Users are considered as the persons who actually handle the equipment as well as the persons having authority over the equipment. Before attempting to work with this equipment, the user must read, understand, note and strictly observe all warnings, cautions and safety markings on the equipment. -
Page 11: Configuration
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 11 Configuration The DR detector is a component that can be integrated in an X-ray system and that communicates to a workstation. Multiple DR detectors can communicate to a single MUSICA Acquisition Worksta- tion. A DR detector can be used on more than one MUSICA Acquisition Workstation. Client mode: the detector connects to the workstation via the built-in access point of the System Control Unit (SCU). -
Page 12: Equipment Classification
Operation Continuous operation. Applied Parts The DR detector tube side is an applied part. Expected service life Up to seven (7) years (if regularly serviced and maintained according to Agfa in- structions) • Non-medical equipment on page 12 Non-medical equipment Following components are classified as non-medical equipment: •... -
Page 13: Options And Accessories
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 13 Options and Accessories • DR detector charging stand • DR detector battery • Power adapter with USB Type-C cable • DR detector battery charger The delivery contains a set of labels. When using multiple DR Detector, on the labels a nickname is written to identify the DR Detector. -
Page 14: Operation Controls
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 14 Operation Controls • XF⁺10, XF⁺14, XF⁺17 on page 15 • DR detector charging stand on page 18 • DR Detector dual battery charger on page 19 • System Control Unit on page 20 •... - Page 15 XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 15 XF⁺10, XF⁺14, XF⁺17 1 2 3 Power button with indicator light • Press to start the DR detector or to display the status of the DR detector. • Press and hold for 3 seconds to stop the DR detector. AP mode button •...
- Page 16 XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 16 Cover plate for the DR detector battery The battery supplies power to the detector during wireless communication. Latch securing the battery cover plate. Area for wireless charging and reading NFC tags. Infrared transmitter for communication with wireless charger. Figure 3: XF⁺10 detector rear side Figure 4: XF⁺14 detector rear side 0440A EN 20241015 0900...
- Page 17 XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 17 Figure 5: XF⁺17 detector rear side 0440A EN 20241015 0900...
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Page 18: Dr Detector Charging Stand
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 18 DR detector charging stand The battery charging stand has two slots to insert a DR detector. Slot A Slot B Power status indicator Status indicators for slot A and slot B • Yellow to indicate that the battery is charging. •... -
Page 19: Dr Detector Dual Battery Charger
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 19 DR Detector dual battery charger The dual battery charger is available depending on the configuration of the system. The battery charger has two slots to insert a battery. Connector for power adapter Status indicator of the top slot Status indicator of the bottom slot •... -
Page 20: System Control Unit
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 20 System Control Unit The System Control Unit is connected to the DR Detector via wireless network or via the DR Detec- tor cable. The System Control Unit is connected to the X-ray generator to synchronize the exposure, in a con- figuration with X-ray generator synchronization. -
Page 21: System Control Unit Lite
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 21 System Control Unit Lite The System Control Unit Lite is connected to the DR Detector via the DR Detector cable. The System Control Unit Lite is connected to the X-ray generator to synchronize the exposure, in a configuration with X-ray generator synchronization. -
Page 22: Dr Detector Cable
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 22 DR detector cable The DR detector cable connects the DR detector to the System Control Unit. The DR detector cable can be used for charging the battery of the DR detector, to power the DR de- tector and to transmit image data. -
Page 23: Dr Detector Switch
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 23 DR Detector Switch The DR Detector Switch is available in the title bar of the MUSICA Acquisition Workstation. 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 24 XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 24 DR Detector exposure synchronization Automatic expo- (empty) sure detection icon Meaning The active DR Detector is using The active DR Detector is using automatic exposure detection X-ray generator synchronization Note Depending on the installed software version, the icon may not be displayed. 0440A EN 20241015 0900...
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Page 25: System Documentation
Technical documentation is available in the product service documentation which is available from your local support organization. The most recent version of this document is available on https://www.agfa.com/he/global/en/inter- net/library • Wireless access point... -
Page 26: Training
Your local Agfa or dealer representative can provide further information on training. The user must note the following information in the system documentation: •... -
Page 27: Product Complaints
Manufacturer 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 28: 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 29: Compliance
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 29 Compliance • General on page 30 • Safety on page 30 • Electromagnetic Compatibility on page 30 • Radio Frequency on page 31 0440A EN 20241015 0900... -
Page 30: General
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 30 General • The product has been designed in accordance with the MEDDEV Guidelines relating to the appli- cation 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 Med- ical Devices). -
Page 31: Radio Frequency
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 31 Radio Frequency Declaration of conformity U.S.A. FCC Part 15.107(b) / Part 15.109(b) FCC Part 15 Subpart E 15.407 FCC Part 15 Subpart C 15.247 European Union (and EEA) ETSI EN 301 489-1 V2.1.1 ETSI EN 301 489-17 V3.1.1 EN 300 328 V2.1.1 EN 301 893 V2.1.1... -
Page 32: Connectivity
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 32 Connectivity • Wireless Communication on page 33 • Wired communication on page 34 0440A EN 20241015 0900... -
Page 33: Wireless Communication
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 33 Wireless Communication Wireless communication is established between the internal wireless module of the DR detector and the MUSICA Acquisition Workstation via the wireless access point. The DR detector is compli- ant with IEEE 802.11n/ac (2.4 GHz/5 GHz). The available frequency band varies depending on local radio laws and system requirements. -
Page 34: Wired Communication
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 34 Wired communication The use of accessories and cables other than those specified or sold by the manufacturer as re- placement parts, may result in increased radiation emissions or decreased stability of the equip- ment. -
Page 35: Installation
The equipment is mainly for use in X-ray exposure rooms, hospital wards and mobile medical ex- amination vehicles. To use it in other places, consult your sales representative or local Agfa dealer. Warning: Do not install or store the equipment in any of the locations listed below. Doing so may result in failure or malfunction, equipment falling, or fire or injury: •... - Page 36 XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 36 Figure 12: Patient’s vicinity 0440A EN 20241015 0900...
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Page 37: Messages
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 37 Messages Under certain conditions the DR detector shows a dialog box containing a message in the middle of the screen of the MUSICA Acquisition Workstation. This message informs the user that either a problem has occurred or that a requested action cannot be performed. -
Page 38: Labels
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 38 Labels Symbol Explanation On (power: connection to the mains) On (power: connection to the mains) for part of the equip- ment Off (power: disconnection from the mains) Off (power: disconnection from the mains) for part of the equipment Tube side Direct current... - Page 39 XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 39 Symbol Explanation Manufacturer Date of manufacture Medical device Serial number This mark shows compliance of the equipment with Direc- tive 93/42/EEC (for European Union). Indicates the autorized representative in the European Com- munity This mark shows compliance with both Canadian and U.S.
- Page 40 XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 40 Symbol Explanation Medicine that can only be given by a prescription from a doctor or a doctor's recommendation to use a certain medi- cine. (for U.S.A. only) Read and understand all instructions and warning labels in the product documentation before using the equipment.
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Page 41: Additional Labeling Of The Dr Detector
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 41 Additional labeling of the DR detector Type label on the back side of the DR detector. DR Detector identification label Label Meaning Writable label to identify and dedicate a DR Detector to an X-ray system bucky. -
Page 42: Additional Labeling Of The Dr Detector Battery
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 42 Additional labeling of the DR detector battery Type label on the back side of the battery. 0440A EN 20241015 0900... -
Page 43: Additional Labeling Of The Dr Detector Charging Stand
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 43 Additional labeling of the DR detector charging stand Type label on the bottom side of the DR detector charging stand. Slide the detector horizontally into the charging stand. Inserting it verti- cally may damage the contact pins. 0440A EN 20241015 0900... -
Page 44: Additional Labeling Of The Dr Detector Dual Battery Charger
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 44 Additional labeling of the DR detector dual battery charger Type label on the bottom side of the DR detector dual battery charger. 0440A EN 20241015 0900... -
Page 45: Additional Labeling Of The System Control Unit
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 45 Additional Labeling of the System Control Unit Type label on the bottom side of the System Control Unit. 0440A EN 20241015 0900... -
Page 46: Additional Labeling Of The Mini System Control Unit
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 46 Additional Labeling of the Mini System Control Unit Type label on the bottom side of the Mini System Control Unit. 0440A EN 20241015 0900... -
Page 47: Additional Labeling Of The System Control Unit Lite
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 47 Additional Labeling of the System Control Unit Lite Type label on the bottom side of the System Control Unit Lite. 0440A EN 20241015 0900... -
Page 48: Cleaning And Disinfecting
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 48 Cleaning and Disinfecting All appropriate policies and procedures should be followed to avoid contamination of the staff, pa- tients and equipment. All existing universal precautions should be extended to avoid potential con- taminations and to avoid patients coming into (close) contact with the device. The user is responsi- ble for selecting a disinfection procedure. -
Page 49: Cleaning
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 49 Cleaning To clean the exterior of the equipment: 1. Stop the system Warning: When the equipment is going to be cleaned, be sure to turn OFF the power of each device, and to unplug the power cord from the AC outlet. Never use anhydrous or high solvency alcohols, benzine, thinner or any other flammable cleaning agent. -
Page 50: Use Of Protective Plastic Bag
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 50 Use of protective plastic bag 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 plastic bag while performing the examination. It is considered good clinical practice to use a single-use protective bag in all cases where contact of the device or contaminants is expected, to avoid contamination of others. -
Page 51: 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 52: Approved Disinfectants
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 52 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 53: Safety Directions For Disinfection
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 53 Safety directions for disinfection Warning: When the equipment is going to be cleaned, be sure to turn OFF the power of each device, and to unplug the power cord from the AC outlet. Otherwise, it may result in fire or electric shock. -
Page 54: Maintenance
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 54 Maintenance Always consult the Agfa Service documentation and an Agfa trained and authorized service engi- neer for complete maintenance schedules. In order to ensure that the equipment is used safely and normally, be sure to inspect the equip- ment before use. -
Page 55: Daily Inspection
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 55 Daily inspection Warning: For safety reasons, be sure to turn OFF the power to each piece of equipment be- fore performing the following. Otherwise, an electric shock may result. 1. Ensure that cables are not damaged and cable jackets are not torn. 2. -
Page 56: Half-Yearly Inspection
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 56 Half-yearly inspection To indicate when the half-yearly calibration is due, a message is displayed on the MUSICA Acquisi- tion Workstation. Perform calibration half-yearly or when exposure conditions have changed significantly. For de- tails, refer to the DR Detector Calibration Key User Manual (0134). 0440A EN 20241015 0900... -
Page 57: Regular Inspection And Maintenance
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 57 Regular Inspection and Maintenance In order to ensure the safety of patients, operating personnel and third parties, and to maintain the performance and reliability of the equipment, be sure to perform regular inspection at least once a year. -
Page 58: Replacement Parts Support
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 58 Replacement Parts Support Parts required to maintain the functioning of the product will be stocked for seven years after dis- continuance of production, to allow for repair. 0440A EN 20241015 0900... -
Page 59: Repair
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 59 Repair The product can only be repaired in the factory. 0440A EN 20241015 0900... -
Page 60: 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 61 XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 61 • User access rights to medical devices shall be reviewed for appropriateness and corrected as needed, at regular intervals not exceeding once a year. 0440A EN 20241015 0900...
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Page 62: Environmental Protection
For more detailed information about take-back and recycling of this product please contact your local Agfa service organization and/or Agfa dealer. By ensuring this product is disposed of correct- ly, you will help prevent potential negative consequences for the environment and human health, which could otherwise be caused by inappropriate waste handling of this product. -
Page 63: Safety Directions
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 63 Safety Directions Warning: Safety is only guaranteed when an Agfa certified field service engineer has in- stalled the product. Warning: Improper changes, additions, maintenance or repair of the system can lead to personal injury, electrical shock and damage to the equipment. Safety is only guaranteed when changes, additions, maintenance or repairs are carried out by an Agfa certified field service engineer. - Page 64 XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 64 is higher than 35 ºC and the patient contact time is more than 10 minutes, the thermal en- ergy on the detector surface can sometimes have a detrimental effect on the patient. There- fore, in this case, the ambient temperature should be lowered to 35 ºC or below.
- Page 65 XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 65 • Safety directions for the power supply on page 66 • Safety directions for the System Control Unit on page 67 • Safety directions for the DR detector battery on page 68 0440A EN 20241015 0900...
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Page 66: Safety Directions For The Power Supply
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 66 Safety directions for the power supply Warning: Do not operate the equipment using any type of power supply other than the one indicated on the rating label. Otherwise, it may result in fire or electric shock. Warning: Do not use any power cords other than the one provided with this equipment. -
Page 67: Safety Directions For The System Control Unit
XF⁺10, XF⁺14, XF⁺17 | Introduction to the DR Detector | 67 Safety directions for the System Control Unit Warning: Do not block the ventilation ports to prevent overheating. Overheating can cause system malfunction and damages. Warning: Ensure continuous power supply to the system, with voltage and current accord- ing to the product specifications. -
Page 68: Safety Directions For The Dr Detector Battery
Make sure to turn off the detector before detaching a battery pack. When replacing the battery, only use batteries that are designated for the Agfa DR detectors. If you use a battery other than the specified one, the battery may explode, or electrolyte may spill out, resulting in a fire or electrical shock. -
Page 69: Getting Started
XF⁺10, XF⁺14, XF⁺17 | Getting started | 69 Otherwise, battery leakage, overheating or damage to the product may occur, resulting in electrical shock, burns, injury or fire. If the battery pack becomes heated or swollen, immediately replace the battery with a new one before using it. Otherwise, overheat, smoke, explosion, or fire may occur. The Lithium ion/polymer battery is recyclable. -
Page 70: Starting The Dr Detector
XF⁺10, XF⁺14, XF⁺17 | Getting started | 70 Starting the DR detector To start the DR detector: 1. If the DR detector is connected to the System Control Unit via the DR detector cable, check if the power cable of the System Control Unit is connected to the mains power. 2. -
Page 71: Related Information
XF⁺10, XF⁺14, XF⁺17 | Getting started | 71 • If the DR detector is configured in client mode and the displayed status is error, connect the DR detector to the MUSICA Acquisition Workstation. • If the DR detector is configured in access point mode, use the Windows wifi setting to connect the MUSICA Acquisition Workstation to the wireless network of the DR detector. -
Page 72: Basic Workflow Dr Detector
XF⁺10, XF⁺14, XF⁺17 | Getting started | 72 Basic Workflow DR Detector • Step 1: retrieve the patient info on page 73 • Step 2: select the exposure on page 73 • Step 3: prepare the exposure on page 74 • Step 4: check the exposure settings on page 75 •... -
Page 73: Step 1: Retrieve The Patient Info
XF⁺10, XF⁺14, XF⁺17 | Getting started | 73 Step 1: retrieve the patient info At the MUSICA Acquisition Workstation: 1. When a new patient comes in, define the patient info for the exam. 2. Start the exam. If the workstation is connected to a second monitor that is positioned outside the operator room, make sure that the patient data is not exposed to unauthorized persons. -
Page 74: Step 3: Prepare The Exposure
XF⁺10, XF⁺14, XF⁺17 | Getting started | 74 Step 3: prepare the exposure In the examination room: 1. Position the DR Detector. When using the bucky, check that the identification labels on the DR Detector and on the bucky match. Do not use a DR Detector that is dedicated to another bucky. 2. -
Page 75: Step 4: Check The Exposure Settings
XF⁺10, XF⁺14, XF⁺17 | Getting started | 75 Step 4: check the exposure settings On the DR Detector Switch: 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 76: Step 5: Execute The Exposure
XF⁺10, XF⁺14, XF⁺17 | Getting started | 76 Step 5: execute the exposure 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. Warning: Do not select another thumbnail until the preview image is visible in the active thumbnail. -
Page 77: Step 6: Perform A Quality Control
XF⁺10, XF⁺14, XF⁺17 | Getting started | 77 Step 6: perform a quality control At the MUSICA Acquisition 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. 3. -
Page 78: Positioning The Xf⁺10
XF⁺10, XF⁺14, XF⁺17 | Getting started | 78 Positioning the XF⁺10 Warning: Because the equipment cable is long, take care that cables do not become tangled during use. Also, be careful not to get your feet caught in the cable. It may cause a malfunc- tion of the equipment or injury to the user from tripping over the cable. - Page 79 XF⁺10, XF⁺14, XF⁺17 | Getting started | 79 Depending on the design of the bucky, the wired configuration may not support the use of the DR Detector in the bucky. 0440A EN 20241015 0900...
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Page 80: Positioning The Xf⁺14
XF⁺10, XF⁺14, XF⁺17 | Getting started | 80 Positioning the XF⁺14 Warning: Because the equipment cable is long, take care that cables do not become tangled during use. Also, be careful not to get your feet caught in the cable. It may cause a malfunc- tion of the equipment or injury to the user from tripping over the cable. - Page 81 XF⁺10, XF⁺14, XF⁺17 | Getting started | 81 Table 2: Skull AP portrait Figure 19: Skull AP portrait 1. Detector orientation (Portrait) 2. Patient orientation (AP) 3. Result on monitor Table 3: Chest PA Landscape Figure 20: Chest PA landscape 1. Detector orientation (Landscape) 2.
- Page 82 XF⁺10, XF⁺14, XF⁺17 | Getting started | 82 Table with bucky, land- scape The MUSICA Acquisition Workstation is configured for a specific patient orientation, either head left (default) or head right. Table 5: Wallstand bucky Wallstand with left loading bucky, portrait Wallstand with left loading bucky, landscape Wallstand with right load- ing bucky, portrait...
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Page 83: Positioning The Xf⁺17
XF⁺10, XF⁺14, XF⁺17 | Getting started | 83 Positioning the XF⁺17 Warning: Because the equipment cable is long, take care that cables do not become tangled during use. Also, be careful not to get your feet caught in the cable. It may cause a malfunc- tion of the equipment or injury to the user from tripping over the cable. - Page 84 XF⁺10, XF⁺14, XF⁺17 | Getting started | 84 Table 7: Wallstand bucky Wallstand with left loading bucky Wallstand with right loading bucky Depending on the design of the bucky, the wired configuration may not support the use of the DR Detector in the bucky. 0440A EN 20241015 0900...
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Page 85: Offline Image Acquisition Workflow
XF⁺10, XF⁺14, XF⁺17 | Getting started | 85 Offline image acquisition workflow A prerequisite for the offline image acquisition workflow is that the DR detector is configured to use automatic exposure detection. The offline image acquisition workflow is only intended for DR detectors that are used in a DR Retrofit solution. - Page 86 XF⁺10, XF⁺14, XF⁺17 | Getting started | 86 b) Select the exam type named Offline Mode and click OK. The offline imaging thumbnail is added to the Image Overview pane. 3. Select the new thumbnail in the Image Overview pane. A message is displayed to warn that the acquired images do not contain patient data and exam type, and to instruct that extra measures must be taken to avoid patient mix-up.
- Page 87 XF⁺10, XF⁺14, XF⁺17 | Getting started | 87 10.Assign the image to the right patient. Check the notes that were made while acquiring the offline images to match the image to the right patient. • If patient data is entered manually and this is the first image in the offline workflow for the current patient,click the Edit button in the Patient pane and fill in the correct patient data.
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Page 88: Guidelines For Pediatric Applications
XF⁺10, XF⁺14, XF⁺17 | Getting started | 88 Guidelines for Pediatric Applications Caution: Use special care when imaging patients outside the typical adult size range. Chil- dren are more radiosensitive than adults. Reducing dose for radiographic procedures while maintaining acceptable clinical image quality will benefit patients. Adopting the Image Gently campaign guidelines and reducing dose for radiographic procedures while maintaining acceptable clinical image quality will benefit patients. -
Page 89: Stopping The Dr Detector
XF⁺10, XF⁺14, XF⁺17 | Getting started | 89 Stopping the DR detector Depending on the configuration, the DR detector turns off automatically when the NX software is stopped. To stop the DR detector manually: 1. If the DR detector is connected to the System Control Unit via the DR detector cable, turn off the System Control Unit using the power switch. -
Page 90: Automatic Exposure Detection
XF⁺10, XF⁺14, XF⁺17 | Getting started | 90 Automatic exposure detection Depending on the configuration, the DR detector detects X-ray exposure to automatically perform the image acquisition. Before performing the exposure, the DR detector must be ready. Check the status of the DR detector in the DR Detector Switch. -
Page 91: Attaching The Handle Unit With Anti-Scatter Grid
XF⁺10, XF⁺14, XF⁺17 | Getting started | 91 Attaching the handle unit with anti-scatter grid Caution: To safely attach the handle unit for making exposures using the grid, follow these instructions. 1. Lay down the grid on a flat surface. 2. Lay the DR detector in the grid, bottom edge first, with the tube side facing down (1). 3. -
Page 92: Attaching The Handle Unit Without Anti-Scatter Grid
XF⁺10, XF⁺14, XF⁺17 | Advanced Operating | 92 Attaching the handle unit without anti-scatter grid To attach the handle unit for making exposures without using the grid 1. Lay down the handle unit on a flat surface. 2. Lay the DR detector in the handle unit, bottom edge first, with the tube side facing up (1). 3. -
Page 93: Viewing The Detector Status
XF⁺10, XF⁺14, XF⁺17 | Advanced Operating | 93 Viewing the detector status The status display on the side of the DR detector is turned off by default. The status display is controlled by pressing the power button (or the AP mode button). Power button with indicator light AP mode button Status display Figure 24: DR detector status display... -
Page 94: Battery Status
XF⁺10, XF⁺14, XF⁺17 | Advanced Operating | 94 Battery status Table 8: Battery status No battery is present, or battery charge level is below the mini- mum. If two batteries are in the detector, the minimum charge lev- el is 2%. If one battery is in the detector, the minimum charge level is 5%. -
Page 95: Connection Status
XF⁺10, XF⁺14, XF⁺17 | Advanced Operating | 95 Connection status Table 9: Access point mode: the DR detector is acting as access point for wireless network The DR detector is acting as access point for wireless net- work Table 10: Client mode: the DR detector is connected to a wireless network Preset Identifier (Default "Sy"... -
Page 96: Charging A Battery
XF⁺10, XF⁺14, XF⁺17 | Advanced Operating | 96 Charging a battery There are 5 ways to charge a battery (depending on the available accessories): • Put the detector in an empty slot of the DR detector charging stand. • Connect the power adapter with the USB Type-C cable to the DR detector. •... -
Page 97: Charging The Dr Detector In The Dr Detector Charging Stand
XF⁺10, XF⁺14, XF⁺17 | Advanced Operating | 97 Charging the DR detector in the DR detector charging stand A DR detector can be charged in either of both slots of the DR detector charging stand, or two detec- tors can be charged simultaneously. 1. Hold the DR detector with the tube side facing right. 2. -
Page 98: Charging The Dr Detector Using The Power Adapter
XF⁺10, XF⁺14, XF⁺17 | Advanced Operating | 98 Charging the DR detector using the power adapter Caution: Charge the battery in an environment within a temperature range of 15 to 35 °C. Not doing so may result in battery leakage, overheating or damage. Not doing so may also lead to a decrease in the battery efficiency or capacity. -
Page 99: Charging The Battery Using The Dr Detector Cable
XF⁺10, XF⁺14, XF⁺17 | Advanced Operating | 99 Charging the battery using the DR detector cable Connect the DR detector cable to charge the battery that is attached to the DR detector. The battery status can be read from the DR Detector Switch on the MUSICA Acquisition Workstation. While charging, the DR detector can still be used. -
Page 100: Charging A Battery In The Dual Battery Charger
XF⁺10, XF⁺14, XF⁺17 | Advanced Operating | 100 Charging a battery in the dual battery charger A battery can be charged in either of both slots of the battery charger, or two batteries can be charged simultaneously. 1. Insert a battery in an empty slot of the battery charger. Figure 27: Inserting the battery in the battery charger The corresponding status indicator lights up orange to indicate that the battery is charging. -
Page 101: Replacing The Battery
XF⁺10, XF⁺14, XF⁺17 | Advanced Operating | 101 Replacing the battery Note If another battery remains in the second battery bay, it is not required to turn off the DR detector while replacing the battery. 1. Turn off the DR detector. Press and hold the power button (approx. 3 seconds). If the DR detector cable or USB cable is connected to the detector, disconnect it. -
Page 102: Managing Network Connections In Client Mode Configuration
XF⁺10, XF⁺14, XF⁺17 | Advanced Operating | 102 Managing network connections in client mode configuration The DR detector is configured for client mode. Figure 28: Client mode Each workstation has an access point or a System Control Unit. Multiple DR detectors can be connected to a MUSICA Acquisition Workstation simultaneously. The DR detector can be used for examinations on multiple MUSICA Acquisition Workstation. -
Page 103: Connecting To Another Musica Acquisition Workstation (Client Mode)
XF⁺10, XF⁺14, XF⁺17 | Advanced Operating | 103 Connecting to another MUSICA Acquisition Workstation (client mode) The DR detector is configured in client mode. To connect the DR detector to another MUSICA Acquisition Workstation: 1. Take the DR detector near the MUSICA Acquisition Workstation. 2. -
Page 104: Connecting To Another Musica Acquisition Workstation Using Nfc Tags (Client Mode)
XF⁺10, XF⁺14, XF⁺17 | Advanced Operating | 104 Connecting to another MUSICA Acquisition Workstation using NFC tags (client mode) The DR detector is configured to use NFC tags. Up to five different tags can be configured per detec- tor. Each tag identifies a MUSICA Acquisition Workstation. 1. -
Page 105: Managing Network Connections In Access Point Mode Configuration
XF⁺10, XF⁺14, XF⁺17 | Advanced Operating | 105 Managing network connections in access point mode configuration The DR detector is configured for access point mode. Figure 31: Access point mode Multiple DR detectors can be used on the same MUSICA Acquisition Workstation, but they cannot be connected simultaneously. -
Page 106: Switching Between The Wireless Dr Detector And The Wireless Hospital Network
XF⁺10, XF⁺14, XF⁺17 | Advanced Operating | 106 Switching between the wireless DR detector and the wireless hospital network The MUSICA Acquisition Workstation can be configured to connect to a wireless DR detector as well as to a wireless hospital network. In a configuration without System Control Unit or without a wireless access point that is connect- ed to the workstation, the DR detector communicates via the internal wireless adapter of the MUSI- CA Acquisition Workstation. - Page 107 XF⁺10, XF⁺14, XF⁺17 | Advanced Operating | 107 4. Touch the Connect button. The network connection is switched to the selected wireless network. Related information Configuration on page 11 0440A EN 20241015 0900...
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Page 108: Switching Temporarily To Client Mode
XF⁺10, XF⁺14, XF⁺17 | Advanced Operating | 108 Switching temporarily to client mode The DR detector is configured in access point mode. The DR detector can be temporarily switched to client mode, to connect to another MUSICA Acqui- sition Workstation. The detector can be configured upon installation with a single MUSICA Acquisi- tion Workstation (with access point or System Control Unit) to which it will connect in this status. -
Page 109: Connecting The Musica Acquisition Workstation To Another Dr Detector (Access Point Mode)
XF⁺10, XF⁺14, XF⁺17 | Problem solving | 109 Connecting the MUSICA Acquisition Workstation to another DR detector (access point mode) The DR detector is configured in access point mode. Warning: If the network connection is interrupted, the MUSICA Acquisition Workstation may reconnect to different access point if the option Connect automatically in the Win- dows wifi settings is enabled. -
Page 110: Artifact In Dr Detector Images
XF⁺10, XF⁺14, XF⁺17 | Problem solving | 110 Artifact in DR Detector images Details An artifact is visible in the images produced by a DR Detector. Cause Exposure conditions have changed significantly since latest calibra- tion. Brief Solution Perform calibration of the DR Detector. For details, refer to the DR Detector Calibration Key User Manual (document 0134). -
Page 111: Dr Detector Not Ready For Exposure
XF⁺10, XF⁺14, XF⁺17 | Problem solving | 111 DR detector not ready for exposure Details The DR detector is turned on. The DR detector status icon on the DR Detector Switch is not green. Cause The DR detector is not connected to the MUSICA Acquisition Workstation. -
Page 112: Connecting To Another Workstation Using Nfc Tags Fails
XF⁺10, XF⁺14, XF⁺17 | Problem solving | 112 Connecting to another workstation using NFC tags fails Details No beep is heard when holding the detector close to the NFC tag. Cause The detector is not configured to read NFC tags or there is a hard- ware problem. -
Page 113: The Musica Acquisition Workstation Is Connected To The Dr Detector, But The Dr Detector Is Not Active (Access Point Mode)
XF⁺10, XF⁺14, XF⁺17 | Problem solving | 113 The MUSICA Acquisition Workstation is connected to the DR detector, but the DR detector is not active (access point mode) Details The DR detector is configured for access point mode. The Wifi settings in Windows show that the MUSICA Acquisition Workstation is con- nected to the DR detctor, but the DR Detector Switch shows an error status for the DR detector. -
Page 114: Images Are Not Sent To The Printer Or To The Pacs Archive
XF⁺10, XF⁺14, XF⁺17 | Problem solving | 114 Images are not sent to the printer or to the PACS archive Details The exam is closed, but the images are not sent to the printer or to the PACS archive. Cause The MUSICA Acquisition Workstation has not been connect- (only if the DR detector commu- ed to the hospital network. -
Page 115: Identifying Problems
Warning: Improper changes, additions, maintenance or repair of the system can lead to personal injury, electrical shock and damage to the equipment. 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 116 XF⁺10, XF⁺14, XF⁺17 | Technical Data | 116 • XF⁺14 technical data on page 119 • XF⁺17 technical data on page 121 • NFC reader technical data on page 123 • DR detector battery technical data on page 124 • DR detector charging stand technical data on page 125 •...
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Page 117: Xf⁺10 Technical Data
Manufacturer Manufacturer DR Detector Vieworks Co., Ltd. 41-3, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14055 Republic of Korea Distributor DR Detector Agfa NV Septestraat 27, B-2640 Mortsel - Belgium Original manufacturer model name XF⁺10 FXRD-2530FAW Electrical connection System Control Unit with DR detector cable DC 24 V, max. -
Page 118: Image Acquisition
XF⁺10, XF⁺14, XF⁺17 | Technical Data | 118 Weight 1.5 kg (without battery) 1.7 kg (incl. battery) Load Maximum load 200 kg on an area of 40 mm in diameter Maximum total load 400 kg over the whole detector surface Vibration tolerance 2 G during normal operation 5 G during storage and transport Shock tolerance 20 G during normal operation... -
Page 119: Xf⁺14 Technical Data
Manufacturer Manufacturer DR Detector Vieworks Co., Ltd. 41-3, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14055 Republic of Korea Distributor DR Detector Agfa NV Septestraat 27, B-2640 Mortsel - Belgium Original manufacturer model name XF⁺14 FXRD-3643FAW Electrical connection System Control Unit with DR detector cable DC 24 V, max. 0.625 A Power adapter with USB Type-C cable DC 18 V, max. - Page 120 XF⁺10, XF⁺14, XF⁺17 | Technical Data | 120 approx. 384.0 x 460.0 x 15.0 mm Dimensions width x length x height Weight 2.2 kg (without battery) 2.4 kg (incl. one battery) 2.6 kg (incl. two batteries) Load Maximum load 200 kg on an area of 40 mm in diameter Maximum total load 400 kg over the whole detector surface Vibration tolerance...
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Page 121: Xf⁺17 Technical Data
Manufacturer Manufacturer DR Detector Vieworks Co., Ltd. 41-3, Burim-ro 170beon-gil, Dongan-gu, Anyang-si, Gyeonggi-do, 14055 Republic of Korea Distributor DR Detector Agfa NV Septestraat 27, B-2640 Mortsel - Belgium Original manufacturer model name XF⁺17 FXRD-4343FAW Electrical connection System Control Unit with DR detector cable DC 24 V, max. 0.625 A Power adapter with USB Type-C cable DC 18 V, max. - Page 122 XF⁺10, XF⁺14, XF⁺17 | Technical Data | 122 approx. 460.0 x 460.0 x 15.0 mm Dimensions width x length x height Weight 2.75 kg (without battery) 2.95 kg (incl. one battery) 3.15 kg (incl. two batteries) Load Maximum load 200 kg on an area of 40 mm in diameter Maximum total load 400 kg over the whole detector surface Vibration tolerance...
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Page 123: Nfc Reader Technical Data
XF⁺10, XF⁺14, XF⁺17 | Technical Data | 123 NFC reader technical data Frequency range 13.560 MHz (RFID) 2412 MHz ~ 2472 MHz (802.11b/g/n 20 MHz BW) 2422 MHz ~ 2462 MHz (802.11n 40 MHz BW) 5745 MHz ~ 5825 MHz (802.11a/n 20/ac 20 MHz BW), 5755 MHz ~ 5795 MHz (802.11n 40/ac 40 MHz BW), 5775 MHz (802.11ac 80 MHz BW) Modulation system... -
Page 124: Dr Detector Battery Technical Data
XF⁺10, XF⁺14, XF⁺17 | Technical Data | 124 DR detector battery technical data Type of product Rechargeable lithium ion polymer battery pack Part number FXRB-04A Dimensions Dimensions (length x width x height) 189.0 mm x 89.0 mm x 6.65 mm Weight 185 g Battery output Output voltage DC +11.55 V Capacity... -
Page 125: Dr Detector Charging Stand Technical Data
XF⁺10, XF⁺14, XF⁺17 | Technical Data | 125 DR detector charging stand technical data Type of product Lithium ion battery pack charger Part number FXRR-01A Simultaneous charging 2 detectors Dimensions Dimensions (width x height x depth) 410.0 mm x 159.0 mm x 168.0 mm Weight 4040 g Electrical connection... -
Page 126: Dr Detector Dual Battery Charger Technical Data
XF⁺10, XF⁺14, XF⁺17 | Technical Data | 126 DR detector dual battery charger technical data Type of product Lithium ion battery pack charger Part number FXRC-04A Simultaneous charging 2 batteries Dimensions Dimensions (length ✕ width ✕ height) 304.0 mm ✕ 230.0 mm ✕ 15.0 mm Electrical connection Rated power supply DC +24 V, 3.33 A max. -
Page 127: System Control Unit
XF⁺10, XF⁺14, XF⁺17 | Technical Data | 127 System Control Unit Part number FXRS-03A Rated power supply AC100 to 240V, 50/60㎐, Max. 2.0-0.8A (input) Rated power supply DC +24V 3.25A, 78W (output) Wireless connection IEEE 802.11n (2.4 GHz/5 GHz) Dimensions (width x height x depth) 300 mm x 236 mm x 58 mm (140 mm antenna height) Weight... -
Page 128: Mini System Control Unit
XF⁺10, XF⁺14, XF⁺17 | Technical Data | 128 Mini System Control Unit Part number FXRS-04A DC +24V 2A max Rated power supply (input) Wireless connection IEEE 802.11n (2.4 GHz/5 GHz) Antenna 137mm (2EA, dual band) Cable connection port Gigabit Ethernet port (3EA) PoE (Power over Ethernet) Port (1EA) Dimensions (width x height x depth) 210 mm x 170 mm x 45 mm (140 mm antenna height) -
Page 129: System Control Unit Lite
XF⁺10, XF⁺14, XF⁺17 | Remarks for HF-emission and immunity | 129 System Control Unit Lite Part number FXRP-02A DC +24V 1A max Rated power supply (input) Cable connection port Gigabit Ethernet port (1EA) PoE (Power over Ethernet) Port (1EA) Dimensions (width x height x depth) 109 mm x 108 mm x 29.5 mm Weight 0.33 kg... -
Page 130: Emc (Electromagnetic Compatibility) Statements
XF⁺10, XF⁺14, XF⁺17 | Remarks for HF-emission and immunity | 130 EMC (Electromagnetic Compatibility) Statements Warning: This device has been tested for EMI/EMC compliance, but interference can still occur in an electromagnetically noisy location. Attempt to maintain a suitable distance be- tween electrical devices to prevent malfunction. Warning: Obtaining diagnostic images and transferring them to a PC (workstation) are the essential performance of the DR detector. -
Page 131: Electromagnetic Emissions
XF⁺10, XF⁺14, XF⁺17 | Remarks for HF-emission and immunity | 131 Electromagnetic emissions This device has been tested for a normal hospital environment as described below. The user of the device should ensure that it is used in such an environment. Nevertheless the HF-emission and immunity can be influenced by connected data cables depend- ing on length and the manner of installation. -
Page 132: Electromagnetic Immunity
XF⁺10, XF⁺14, XF⁺17 | Remarks for HF-emission and immunity | 132 Electromagnetic immunity This DR Detector is intended for operation in the electromagnetic environment given below. The user of the DR Detector should ensure that it is used in such an environment. Resistance to Jam- IEC 60601 Test Lev- Level of Agree- Electromagnetic Environ-... - Page 133 XF⁺10, XF⁺14, XF⁺17 | Remarks for HF-emission and immunity | 133 Conducted high 150 kHz to 80 150 kHz to 80 The electromagnetic field frequency distur- strength of a stationary bance variables in RF transmitter deter- in the ISM in the ISM accordance with mined by an electromag- bands 150 KHz to 80 bands 150 KHz to 80...
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Page 134: For U.s.a
XF⁺10, XF⁺14, XF⁺17 | Remarks for HF-emission and immunity | 134 For U.S.A. This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: • This device may not cause harmful interference. • This device must accept any interference received, including interference that may cause unde- sired operation.
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