Related Manuals for AGFA 5400/516
Summary of Contents for AGFA 5400/516
- Page 1 DR Generator Sync Box, DR Retrofit Solution 5400/516 5400/526 User Manual 0319D EN 20191031 1011...
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Page 2: Table Of Contents
ii | DR Generator Sync Box, DR Retrofit Solution | Contents Contents Legal Notice ................4 Introduction to this Manual ........... 5 Scope of this Manual ..........6 Warnings, Cautions, Instructions and Notes ....7 Disclaimer ..............8 Introduction ................9 Intended Use ............10 Intended User... - Page 3 DR Generator Sync Box, DR Retrofit Solution | Contents | iii Step 4: check the exposure settings ....43 Step 5: execute the exposure ......44 Step 6: perform a quality control ....45 Stopping ..............45 Problem solving ..............46 NX receives black or underexposed DR image due to repeatedly pushing the exposure button ....47 NX receives black DR image when X-ray system not ready...
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Page 4: Legal Notice
DR Retrofit Solution and DR Generator Sync box are trademarks of Agfa NV, Belgium or one of its affiliates. All other trademarks are held by their respective owners and are used in an editorial fashion with no intention of infringement. -
Page 5: Introduction To This Manual
DR Generator Sync Box, DR Retrofit Solution | Introduction to this Manual | 5 Introduction to this Manual Topics: • Scope of this Manual • Warnings, Cautions, Instructions and Notes • Disclaimer 0319D EN 20191031 1011... -
Page 6: Scope Of This Manual
6 | DR Generator Sync Box, DR Retrofit Solution | Introduction to this Manual Scope of this Manual This manual contains information for safe and effective operation of the DR Retrofit Solution, further referred to as the system and the DR Generator Sync Box, further referred to as the device. -
Page 7: Warnings, Cautions, Instructions And Notes
DR Generator Sync Box, DR Retrofit Solution | Introduction to this Manual | 7 Warnings, Cautions, Instructions and Notes The following samples show how warnings, cautions, instructions and notes appear in this document. The text explains their intended use. Warning: Warnings are directions which, if they are not followed, can cause fatal or serious injuries to a user, engineer, patient or any other person or can lead to a mistreatment. -
Page 8: Disclaimer
8 | DR Generator Sync Box, DR Retrofit Solution | Introduction to this Manual Disclaimer Agfa assumes no liability for use of this document if any unauthorized changes to the content or format have been made. Every care has been taken to ensure the accuracy of the information in this document. -
Page 9: Introduction
DR Generator Sync Box, DR Retrofit Solution | Introduction | 9 Introduction Topics: • Intended Use • Intended User • Configuration • Equipment Classification • Options and Accessories • Operation Controls • System Documentation • Training • Product Complaints • Compatibility •... -
Page 10: Intended Use
10 | DR Generator Sync Box, DR Retrofit Solution | Introduction Intended Use The DR Retrofit Solution is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy for adult, pediatric and neonatal examinations. -
Page 11: Intended User
DR Generator Sync Box, DR Retrofit Solution | Introduction | 11 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 12: Configuration
12 | DR Generator Sync Box, DR Retrofit Solution | Introduction Configuration The DR Retrofit Solution consists of the following components: • DR Detector • NX workstation • DR Generator Sync Box The DR Retrofit Solution supports two levels of integration with the X-ray system. - Page 13 DR Generator Sync Box, DR Retrofit Solution | Introduction | 13 1. X-ray system 2. NX workstation with NX application and DR Software Console or DR Detector Switch 3. DR Detector 4. Replacement exposure button 5. DR Generator Sync Box 0319D EN 20191031 1011...
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Page 14: Equipment Classification
14 | DR Generator Sync Box, DR Retrofit Solution | Introduction Equipment Classification This device is classified as following: Table 1: Equipment classification Class I equipment Equipment in which protection against electric shock does not relay on basic insulation only, but includes a power supply cord with protective earth conductor. -
Page 15: Options And Accessories
DR Generator Sync Box, DR Retrofit Solution | Introduction | 15 Options and Accessories The delivery contains a set of labels. When using multiple DR Detectors, on the labels a nickname is written to identify the DR Detector. An identical label is attached to the bucky of the X-ray system to identify the dedicated workspace of each DR Detector. -
Page 16: Operation Controls
16 | DR Generator Sync Box, DR Retrofit Solution | Introduction Operation Controls The main operation controls are: • Power switch • Exposure button • DR Detector Switch on the NX workstation Warning: The exposure button of the original system should be disabled. -
Page 17: Exposure Button
DR Generator Sync Box, DR Retrofit Solution | Introduction | 17 Exposure button Preparing for exposure Press the exposure button down to the first pressure point and hold it for approximately 0.5 s to 2 s. The X-ray tube is prepared for performing an exposure. Starting the exposure Before starting the exposure: 1. -
Page 18: Dr Software Console
18 | DR Generator Sync Box, DR Retrofit Solution | Introduction DR Software Console The DR Software Console is available to support X-ray exposure parameter control on the NX workstation. It is displayed on the NX workstation next to the NX application. The DR Software Console is used to control the X-ray exposure settings. -
Page 19: Dr Detector Switch
DR Generator Sync Box, DR Retrofit Solution | Introduction | 19 DR Detector Switch The DR Detector Switch is available in the title bar of the NX application or in the device status frame of the DR Software Console. The DR Detector Switch shows which DR Detector is active and shows its status. -
Page 20: System Documentation
20 | DR Generator Sync Box, DR Retrofit Solution | Introduction System Documentation The DR Retrofit Solution user documentation consists of • DR Generator Sync Box, DR Retrofit Solution User Documentation CD (digital media) • NX User Documentation CD (digital media) •... -
Page 21: Training
The user must make sure that training is received in accordance with local laws or regulations that have the force of law. Your local Agfa or dealer representative can provide further information on training. The user must note the following information in the system documentation: •... -
Page 22: 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 23: Compatibility
Compatibility The system must only be used in combination with other equipment or components if these are expressly recognized by Agfa as compatible. A list of such equipment and components is available from Agfa service on request. Changes or additions to the equipment must only be carried out by persons authorized to do so by Agfa. -
Page 24: Compliance
24 | DR Generator Sync Box, DR Retrofit Solution | Introduction Compliance Topics: • General • Safety • Electromagnetic Compatibility • Environmental Compliance 0319D EN 20191031 1011... -
Page 25: General
DR Generator Sync Box, DR Retrofit Solution | Introduction | 25 General • The DR Retrofit Solution has been designed in accordance with the MEDDEV Guidelines relating to the application of Medical Devices and has been tested as part of the conformity assessment procedures required by 93/42/EEC Medical Device Directive (European Council Directive 93/42/EEC on Medical Devices). -
Page 26: Connectivity
26 | DR Generator Sync Box, DR Retrofit Solution | Introduction Connectivity The DR Generator Sync Box is connected to the NX workstation and the X-ray generator and replaces the interface to the original exposure button. The DR Generator Sync exposure button is connected to the DR Generator Sync Box device. -
Page 27: Installation
DR Generator Sync Box, DR Retrofit Solution | Introduction | 27 Installation Installation and configuration is performed by an Agfa trained and authorized service engineer. Contact your local support organization for more information. On a configuration with multiple DR Detectors of the same type, it is required to apply labeling to the DR Detector containing a unique nickname for each DR Detector. -
Page 28: Messages
28 | DR Generator Sync Box, DR Retrofit Solution | 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. -
Page 29: Labels
Unique device identifier, in text format and in machine readable format The most recent version of this docu- ment is available on http://www.agfa- healthcare.com/global/en/library/ index.jsp If the exposure button of the original sys- tem is visible, this label is attached. -
Page 30: Consulting The About Box
DR Retrofit solution. Figure 6: DR Retrofit About box (Displayed data may be different). Note: Always quote these details when you discuss any issues with Agfa service personnel. 2. Click on the dialog to close it. 0319D EN 20191031 1011... -
Page 31: Cleaning And Disinfecting
DR Generator Sync Box, DR Retrofit Solution | Introduction | 31 Cleaning and Disinfecting Cleaning and disinfecting procedures are described in the relevant modules of the device user documentation. All appropriate policies and procedures should be followed to avoid contamination of the staff, patients and device. All existing universal precautions should be extended to avoid potential contaminations and to avoid patients coming into (close) contact with the device. -
Page 32: Patient Data Security
(ISP), set in compliance with point 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 33 DR Generator Sync Box, DR Retrofit Solution | Introduction | 33 • Medical devices shall be on an isolated network segment that restricts communication of the medical devices to the systems that are required for the device to function. • Internal firewalls shall be put in place to improve upon network segmentation and to further restrict communications of medical devices to the systems (internal and external) that they need to interact with.
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Page 34: Maintenance
34 | DR Generator Sync Box, DR Retrofit Solution | Introduction 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). -
Page 35: Environmental Protection
DR Generator Sync Box, DR Retrofit Solution | Introduction | 35 Environmental protection Figure 7: WEEE symbol Figure 8: Battery symbol WEEE end user notice The directive on Waste Electrical and Electronic Equipment (WEEE) aims to prevent the generation of electric and electronic waste and to promote the reuse, recycling and other forms of recovery. -
Page 36: Safety Directions
Warning: Safety is only guaranteed when an Agfa certified field service engineer has installed the product. Warning: All Agfa medical products must be used by trained and qualified personnel. Warning: Improper changes, additions, maintenance or repair of the system can lead to personal injury and damage to the equipment. -
Page 37: Disconnecting The Dr Generator Sync Box From The Mains Power
DR Generator Sync Box, DR Retrofit Solution | Introduction | 37 Warning: The DR Detector or CR cassette are not intended to be used as a primary barrier to X-rays. The user is responsible for ensuring the safety of the operator, bystanders, and the subjects being radiographed. -
Page 38: Getting Started
38 | DR Generator Sync Box, DR Retrofit Solution | Getting started Getting started Topics: • Starting • Basic Workflow • Stopping 0319D EN 20191031 1011... -
Page 39: Starting
DR Generator Sync Box, DR Retrofit Solution | Getting started | 39 Starting 1. Power on the DR Detector. For detailed information about powering on the DR Detector, refer to the DR Detector user manual. 2. Start NX. For detailed information about starting up NX, refer to the NX User Manual, document 4420. -
Page 40: Step 1: Retrieve The Patient Info
40 | DR Generator Sync Box, DR Retrofit Solution | Getting started Step 1: retrieve the patient info At the NX workstation: 1. When a new patient comes in, define the patient info for the exam. 2. Start the exam. 0319D EN 20191031 1011... -
Page 41: Step 2: Select The Exposure
DR Generator Sync Box, DR Retrofit Solution | Getting started | 41 Step 2: select the exposure In the operator room: 1. At the NX workstation, select the thumbnail for the exposure in the Image Overview pane of the Examination window. The selected DR Detector is activated. -
Page 42: Step 3: Prepare The Exposure
42 | DR Generator Sync Box, DR Retrofit Solution | Getting started 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. -
Page 43: Step 4: Check The Exposure Settings
DR Generator Sync Box, DR Retrofit Solution | Getting started | 43 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. -
Page 44: Step 5: Execute The Exposure
44 | DR Generator Sync Box, DR Retrofit Solution | Getting started Step 5: execute the exposure In the operator room: Press the exposure button to execute the exposure. Warning: Use the replacement exposure button. The exposure button of the original system should be disabled. -
Page 45: Step 6: Perform A Quality Control
DR Generator Sync Box, DR Retrofit Solution | Getting started | 45 Step 6: perform a quality control At the NX workstation: 1. Select the image on which quality control is to be performed. 2. Prepare the image for diagnosis by using e.g. L/R markers or annotations. 3. -
Page 46: Problem Solving
46 | DR Generator Sync Box, DR Retrofit Solution | Problem solving Problem solving Topics: • NX receives black or underexposed DR image due to repeatedly pushing the exposure button • NX receives black DR image when X-ray system not ready for exposure •... -
Page 47: Nx Receives Black Or Underexposed Dr Image Due To Repeatedly Pushing The Exposure Button
DR Generator Sync Box, DR Retrofit Solution | Problem solving | 47 NX receives black or underexposed DR image due to repeatedly pushing the exposure button Details A black or underexposed image is arriving on the NX workstation. Cause The exposure button was pushed to the first pressure point and released without making an exposure. -
Page 48: Nx Receives Black Dr Image When X-Ray System Not Ready For Exposure
48 | DR Generator Sync Box, DR Retrofit Solution | Problem solving NX receives black DR image when X-ray system not ready for exposure Details A black image is arriving on the NX workstation. Cause On a system without DR Software Console, the expo- sure button was pushed while the X-ray system was not ready for exposure. -
Page 49: Wrong Modality Position Selected
DR Generator Sync Box, DR Retrofit Solution | Problem solving | 49 Wrong modality position selected Details The active modality position on the X-ray system does not match the selected modality position on the NX Workstation. Cause The modality position has been modified on the gener- ator console. -
Page 50: Exposure Blocked After Switching To Cr
50 | DR Generator Sync Box, DR Retrofit Solution | Problem solving Exposure blocked after switching to CR Details The exposure is set to CR using the DR Detector Switch. Expo- sure is blocked. Cause The X-ray generator console is not automatically set to free ex- posure. -
Page 51: Panel Status Remains In Error
DR Generator Sync Box, DR Retrofit Solution | Problem solving | 51 Panel status remains in error Details The panel status remains in error. Cause The generator is in error state. This situation applies only to Siemens generators. Brief Solution Restart the generator. -
Page 52: Technical Data
52 | DR Generator Sync Box, DR Retrofit Solution | Technical Data Technical Data Topics: • DR Retrofit Solution Technical Data • DR Generator Sync Technical Data • Fixed DR Detector Technical Data 0319D EN 20191031 1011... -
Page 53: Dr Retrofit Solution Technical Data
DR Generator Sync Box, DR Retrofit Solution | Technical Data | 53 DR Retrofit Solution Technical Data Technical data is available in the relevant modules of the user documentation. 0319D EN 20191031 1011... -
Page 54: Dr Generator Sync Technical Data
54 | DR Generator Sync Box, DR Retrofit Solution | Technical Data DR Generator Sync Technical Data Labeling Type 5400/516 Dimensions Depth 21.5 cm Width 33.5 cm Height 6.5 cm Weight 3.2 kg Electrical connection 100-240 V AC, 50/60 Hz Power consumption 40 W (max. -
Page 55: Fixed Dr Detector Technical Data
DR Generator Sync Box, DR Retrofit Solution | Technical Data | 55 Fixed DR Detector Technical Data Manufacturer Original manufacturer model 4343R (part number 7965) 4343R (part name number 7964) Manufacturer DR Detector Varex Imaging Corporation, 1678 So. Pioneer Rd, Salt Lake City, UT 84104, Electrical connection Operating voltage 90-240 V (AC) - Page 56 56 | DR Generator Sync Box, DR Retrofit Solution | Technical Data Estimated product life (if regular- 100000 RAD ly serviced and maintained ac- cording to Agfa instructions) Pixel Matrix Pixel size 139 µm (H,V) Pixel matrix 3072 (H) x 3072 (V)
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Page 57: Remarks For Hf-Emission And Immunity
DR Generator Sync Box, DR Retrofit Solution | Remarks for HF-emission and immunity | 57 Remarks for HF-emission and immunity It is hereby certified that the DR Generator Sync Box has interference suppression according to the EN 55011 Class A as well as the FCC Rules CR47 Part 15 Class A. - Page 58 58 | DR Generator Sync Box, DR Retrofit Solution | Remarks for HF-emission and immunity Harmonic emission Class B in accordance with IEC 61000-3-2 Voltage fluctua- Com- tions / flickering in plies accordance with IEC 61000-3-3 The device is used in a professional healthcare / radiological environment. Environmental conditions are stated in the user manual.
- Page 59 DR Generator Sync Box, DR Retrofit Solution | Remarks for HF-emission and immunity | 59 free of interruptions or a battery. Magnetic field at the 30 A/m Magnetic field at the net- supply frequency work frequency should cor- (50/60 Hz) in accord- respond to the typical values ance with IEC as they are in a...
- Page 60 60 | DR Generator Sync Box, DR Retrofit Solution | Remarks for HF-emission and immunity environment as a result of stationary high frequency transmitters. If the field strength of the device exceeds the test level given above, the device must be observed with regard to its normal operation at each place of use.
- Page 61 DR Generator Sync Box, DR Retrofit Solution | Remarks for HF-emission and immunity | 61 • Maintenance on EMC relevant parts 0319D EN 20191031 1011...
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Page 62: Immunity To Rf Wireless Communication Equipment
62 | DR Generator Sync Box, DR Retrofit Solution | Remarks for HF-emission and immunity 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;... -
Page 63: Precautions On Emc
DR Generator Sync Box, DR Retrofit Solution | Remarks for HF-emission and immunity | 63 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 equipment and the other equipment should be observed to verify that they are operating normally. -
Page 64: Cables, Transducers And Accessories
64 | DR Generator Sync Box, DR Retrofit Solution | Remarks for HF-emission and immunity 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... -
Page 65: Maintenance On Emc Relevant Parts
DR Generator Sync Box, DR Retrofit Solution | Remarks for HF-emission and immunity | 65 Maintenance on EMC relevant parts Concerning the EMC safety of the DR Generator Sync Box, no relevant parts could be inspected by the operator or by a service engineer before the end of lifetime.