| DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Contents Contents Legal Notice ................3 Introduction to this Manual ........... 4 Scope of this Manual ..........5 About the safety notices in this document ....6 Disclaimer ..............7 Introduction ................
Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or its affiliates. DX-D is a trademark 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.
4 | DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Introduction to this Manual Introduction to this Manual Topics: • Scope of this Manual • About the safety notices in this document • Disclaimer 0129E EN 20180312 0812...
DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Introduction to this Manual | 5 Scope of this Manual This manual contains information for safe and effective operation of the DX-D 10G, DX-D 10C, DX-D 20G and DX-D 20C portable DR Detector, further referred to as the DR Detector.
6 | DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Introduction to this Manual 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.
DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Introduction to this Manual | 7 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.
DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Introduction | 9 Intended Use The DR Detector is a wired radiographic digital X-ray imaging device commonly referred to as flat panel detector. It is designed for general radiography applications. The DR Detector will be used in a radiological environment by qualified staff to capture and route static X-ray images.
10 | DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Introduction System Documentation The documentation consists of a User manual (this document) and related documentation: • NX User Manual (4420). • NX Key User Manual (4421). • NX Getting Started Sheets (4424).
DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Introduction | 11 Product Complaints Any health care professional (for example a customer or a user) who has any complaints or has experienced any dissatisfaction with the quality, durability, reliability, safety, effectiveness, or performance of this product must notify Agfa.
12 | DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Introduction Compliance • 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).
DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Introduction | 13 Connectivity The DR Detector is connected to the control unit. The DR Detector’s control unit is connected to the mains power, to the NX workstation and to the X-ray generator.
14 | DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Introduction Messages Under certain conditions the system shows a dialog box in the middle of the screen containing a message, or a message is displayed in a fixed message area in the user interface.
DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Introduction | 15 Labels Symbol Explanation On (power: connection to the mains) Off (power: disconnection from the mains) Tube side Direct current Alternating current Protective earth (ground) This mark indicates that this is a Type B Equipment...
16 | DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | 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.
DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Introduction | 17 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.
18 | DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Introduction 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...
DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Introduction | 19 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.
20 | DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Introduction Approved disinfectants Refer to the Agfa website for specifications on the disinfectants that have been found compatible with the cover material of the device and can be used on the outer surface of the device.
DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Introduction | 21 Maintenance Always consult the Agfa Service documentation and an Agfa trained and authorized Service engineer for complete maintenance schedules. Maintenance of the DR Detector The DR Detector requires regular calibration. Calibration instructions are described in the DR Detector Calibration Key User Manual (doc 0134).
22 | DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Introduction Environmental protection Figure 1: WEEE symbol Figure 2: 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.
DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Safety Directions | 23 Safety Directions WARNING: Safety is only guaranteed when an Agfa certified field service engineer has installed the product. WARNING: Improper changes, additions, maintenance or repair of the equipment or the software can lead to personal injury, electrical shock and damage to the equipment.
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24 | DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Safety Directions CAUTION: Strictly observe all warnings, cautions, notes and safety markings within this document and on the product. CAUTION: Position the DR Detector control unit so that it is possible to disconnect the mains power connection if required.
DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Safety Directions | 25 Warranty will be void if it is obvious that operating conditions are not met. Limitations for patient contact This device is not intended to supply heat to a patient. However, during normal use, surfaces will become heated due to power dissipation.
26 | DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Basic Workflow Basic Workflow Topics: • Starting the DR Detector • Attaching the Grid • Positioning the DR Detector • Executing the Exposure • Stopping the DR Detector 0129E EN 20180312 0812...
DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Basic Workflow | 27 Starting the DR Detector Note: Depending on the integration, the DR Detector may be started automatically together with the X-ray system. To start the DR Detector: 1. Check if the DR Detector cable is connected to the control unit.
28 | DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Basic Workflow Attaching the Grid To attach the grid to the DR Detector 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.
DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Basic Workflow | 29 Positioning the DR Detector When performing an exposure, keep in mind the following detector orientation aids: • tube side • patient orientation marker Tube side of the detector...
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30 | DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Basic Workflow Below some examples to illustrate the importance of the detector orientation marker. Detector orientation (Portrait) Patient orientation (AP) Result on monitor Figure 7: Skull AP portrait Detector orientation (Landscape)
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DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Basic Workflow | 31 Table with bucky, landscape Note: NX is configured for a specific patient orientation, either head left (default) or head right. Table 2: Wallstand bucky Wallstand with left loading...
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32 | DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Basic Workflow Wallstand with right loading bucky, landscape 0129E EN 20180312 0812...
DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Basic Workflow | 33 Executing the Exposure Note: The DR Detector is activated only when an exposure is executed. The preparation cycle of the exposure is limited by a time-out. If an exposure is not initiated within seven seconds after the “Prep”...
34 | DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Basic Workflow Stopping the DR Detector Note: Depending on the integration, the DR Detector may be stopped automatically together with the X-ray system. To stop the DR Detector: Power off the DR Detector using the power switch at the back of the control unit.
DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Problem solving | 35 Problem solving Topics: • DR Detector must be recalibrated • DR Detector Problem 0129E EN 20180312 0812...
36 | DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Problem solving DR Detector must be recalibrated Details A message is displayed on NX indicating that the DR panel must be recalibrated. Cause DR Detector must be recalibrated at regular intervals.
DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Technical Data | 37 Technical Data DR Detector Technical Data Manufacturer Manufacturer DR Detector Varex Imaging Corporation, 1678 So. Pioneer Rd, Salt Lake City, UT 84104, USA Original manufacturer model name...
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38 | DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Technical Data Atmospheric pressure between 700 hPa and 1100 hPa Warming-up time 30 minutes Throughput Maximum number of image 150 acquisitions per hour acquisitions End of Life Estimated product life...
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DX-D 10C, DX-D 10G, DX-D 20C, DX-D 20G | Technical Data | 39 Maximum load Maximum total load 100 kg DX-D 10G DX-D 10C DX-D 20G DX-D 20C Maximum Linear Dose 75 µGy 50 µGy using RQA5 Minimum Modulation Transfer Function (MTF) using RQA5 1 lp/mm 0.45...
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