Related Manuals for AGFA 6005/100 6005/200
Summary of Contents for AGFA 6005/100 6005/200
- Page 1 Full Leg Full Spine DR Retrofit System 6005/100 6005/200 User Manual 0326A EN 20211014 1141...
-
Page 2: Table Of Contents
ii | Full Leg Full Spine DR Retrofit System | Contents Contents Legal Notice ................4 Introduction to this Manual ........... 5 Scope of this Manual ..........6 About the safety notices in this document ....7 Disclaimer ..............8 Introduction to the Full Leg Full Spine application .... - Page 3 Full Leg Full Spine DR Retrofit System | Contents | iii Finalize the examination ..........50 Stopping the DR Full Leg Full Spine application ..51 Advanced Operation ............52 Manually adjusting a DR Full Leg Full Spine image ..To rotate all partial images ......54 To stitch a set of partial images ....
-
Page 4: Legal Notice
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. -
Page 5: Introduction To This Manual
Full Leg Full Spine DR Retrofit System | Introduction to this Manual | 5 Introduction to this Manual Topics: • Scope of this Manual • About the safety notices in this document • Disclaimer 0326A EN 20211014 1141... -
Page 6: Scope Of This Manual
6 | Full Leg Full Spine DR Retrofit System | Introduction to this Manual Scope of this Manual This manual contains information for the safe and effective operation of the Full Leg Full Spine DR Retrofit System and the following accessories: •... -
Page 7: About The Safety Notices In This Document
Full Leg Full Spine DR Retrofit System | 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 document. The text explains their intended use. DANGER: A danger safety notice indicates a hazardous situation of direct, immediate danger for a potential serious injury to a user,... -
Page 8: Disclaimer
8 | Full Leg Full Spine DR Retrofit System | 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 To The Full Leg Full Spine Application
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 9 Introduction to the Full Leg Full Spine application Topics: • Intended Use • Intended User • Connectivity • Configuration • Compliance • Equipment Classification •... -
Page 10: Intended Use
The system is intended to support acquisition of FLFS images in an X-ray system. Intended User This manual is written for trained users of Agfa products and trained clinical personnel. Users are considered as the persons who actually handle the equipment as well as the persons having authority over the equipment. Before... -
Page 11: Connectivity
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 11 Connectivity The NX workstation is connected to the X-ray system to exchange X-ray exposure parameters. The NX workstation requires a 100 Mbit ethernet network to exchange information with a number of other devices. -
Page 12: Configuration
12 | Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application Configuration Topics: • Full Leg Full Spine wall stand • External collimator 0326A EN 20211014 1141... -
Page 13: Full Leg Full Spine Wall Stand
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 13 Full Leg Full Spine wall stand The DR Full Leg Full Spine detector positioner (type 6005/100) contains a wall stand and a control unit. Wall-mounted base with height adjustment mechanism (optional) or fixed height wall-mounted base DR detector holder... - Page 14 14 | Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application Front panel containing the Full Leg Full Spine stitching grid Anti-scatter grid (optional) DR detector Internal mechanism to automatically position the detector and anti-scatter grid for making Full Leg Full Spine partial images Figure 2: DR detector holder Topics:...
- Page 15 Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 15 Front panel of the DR detector holder 425 x 425 mm = e?ective area 17 x 17 inch detector (DR 17e) Region of interest when using a 17x17 inch DR detector Width of the region of interest when using a 14x17 inch DR detector Center line for each position of the DR detector Overlap zone...
- Page 16 Anti-scatter grids are used to reduce scattered radiation and improve image quality. Grids are available as an option. Refer to the Agfa website for specifications on the anti-scatter grids that have been found compatible with the system and the DR Detectors.
-
Page 17: External Collimator
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 17 External collimator External collimator (type 6005/200, optional). Vertical column with internal mechanism to automatically position the collimator for making Full Leg Full Spine partial images X-ray collimator Initialization button Height adjustment button... -
Page 18: Compliance
18 | Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application Compliance Topics: • General • Safety • Electromagnetic Compatibility • Environmental Compliance 0326A EN 20211014 1141... -
Page 19: General
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 19 General • The DR Full Leg Full Spine detector positioner has been designed in accordance with Regulation (EU) 2017/745 on medical devices (MDR). •... -
Page 20: Equipment Classification
20 | Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application Equipment Classification Per EN/IEC60601-1, this device is classified as following: Table 2: Equipment classification Class I Equip- Equipment in which protection against electric shock does ment not rely on basic insulation only, but includes a power sup- ply cord with protective earth conductor. -
Page 21: System Documentation
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 21 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. -
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: Installation
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 23 Installation Installation and configuration is performed by an Agfa trained and authorized service engineer. Contact your local support organization for more information. -
Page 24: Accuracy Of Measurements
24 | Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application Accuracy of Measurements Distance measurements on DR Full Leg Full Spine images in NX are displayed with a resolution of one or more decimal places (such as 0.01 cm). You should be aware that the real measurement accuracy is generally considerably lower for a number of different reasons, many beyond the control of the product. -
Page 25: Labels
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 25 Labels This mark shows compliance of the equipment with Directive 93/42/EEC or with Regulation 2017/745 (for European Un- ion). This mark indicates that the equipment has a Type B applied part Date of manufacture Manufacturer... - Page 26 26 | Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application Pollution Control. (Only applicable to People’s Republic of Chi- na (PRC)). This symbol indicates the product contains hazard- ous materials in excess of the limits established by the Chinese Standards.
-
Page 27: Additional Labeling For The Wall Stand
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 27 Additional labeling for the wall stand Type label of the wall stand Figure 6: Sample of type label Additional labeling for the external collimator Type label of the collimator Figure 7: Sample of type label 0326A EN 20211014 1141... -
Page 28: Cleaning And Disinfecting
28 | Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application 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 contact or contact with potential sources of contamination. -
Page 29: Cleaning
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 29 Cleaning To clean the exterior of the equipment: 1. Stop the system. CAUTION: Wet cleaning of the equipment while it is connected to the electric circuit includes the risk of electric shock and of short circuit. -
Page 30: Disinfecting
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. Perform the procedure following the instructions for use, the disposal instructions and the safety instructions of the selected disinfectants and tools and of the hospital. -
Page 31: Approved Disinfectants
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 31 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 32: Maintenance
32 | Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application Maintenance No regular preventive maintenance is required other than described further in this chapter. Technical documentation is available in the product service documentation which is available from your local support organization. -
Page 33: Environmental Protection
Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application | 33 Environmental protection Figure 8: WEEE symbol Figure 9: 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 34 34 | Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application For battery replacements please contact your local sales organization. 0326A EN 20211014 1141...
-
Page 35: Safety Directions
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 36 36 | Full Leg Full Spine DR Retrofit System | Introduction to the Full Leg Full Spine application 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.
-
Page 37: Basic Workflow
Full Leg Full Spine DR Retrofit System | Basic Workflow | 37 Basic Workflow Topics: • Starting the DR Full Leg Full Spine application • Retrieve the patient info • Select the exposure • Prepare the Full Leg Full Spine configuration •... -
Page 38: Starting The Dr Full Leg Full Spine Application
38 | Full Leg Full Spine DR Retrofit System | Basic Workflow Starting the DR Full Leg Full Spine application Note: Connecting the external collimator while the Full Leg Full Spine wall stand is powered on, will lead to a restart of the Full Leg Full Spine wall stand together with the external collimator. -
Page 39: Retrieve The Patient Info
Full Leg Full Spine DR Retrofit System | Basic Workflow | 39 Retrieve the patient info In the operator room at the NX workstation: 1. When a new patient comes in, define the patient info for the exam. 2. Start the exam. 0326A EN 20211014 1141... -
Page 40: Select The Exposure
40 | Full Leg Full Spine DR Retrofit System | Basic Workflow Select the exposure One or more DR Full Leg Full Spine (FLFS) exam types can be configured. The number of partial images is defined in the exam type. In the operator room at the NX workstation: 1. -
Page 41: Prepare The Full Leg Full Spine Configuration
Full Leg Full Spine DR Retrofit System | Basic Workflow | 41 Prepare the Full Leg Full Spine configuration In the examination room, position the X-Ray system, the Full Leg Full Spine wall stand: 1. Insert the DR detector it in the Full Leg Full Spine wall stand. The DR Detector must be inserted in portrait position. -
Page 42: Prepare The Full Leg Full Spine Configuration With External Collimator
42 | Full Leg Full Spine DR Retrofit System | Basic Workflow Prepare the Full Leg Full Spine configuration with external collimator In the examination room, position the X-Ray system, the Full Leg Full Spine wall stand and the external collimator: 1. - Page 43 Full Leg Full Spine DR Retrofit System | Basic Workflow | 43 A floor mount lock is located at both sides of the external collimator. The exact position depends on the configuration. Position the lock right above the indicated position on the floor. Push the upper lever to fixate the lock. WARNING: Always position the external collimator exactly in the same position as defined during installation.
-
Page 44: Prepare The Examination
44 | Full Leg Full Spine DR Retrofit System | Basic Workflow Prepare the examination Position the patient. WARNING: Make sure that a DR detector is inserted in the Full Leg Full Spine wall stand. WARNING: Monitor the patient position (hands, feet, fingers, etc.) with special care to avoid injury to the patient caused by unit movements. -
Page 45: Execute The Exposures
Full Leg Full Spine DR Retrofit System | Basic Workflow | 45 Execute the exposures 1. Rotate the X-ray tube aligning the X-ray field to the first position of the DR detector as indicated on the front panel of the DR detector holder. 2. -
Page 46: Execute The Exposures With External Collimator
46 | Full Leg Full Spine DR Retrofit System | Basic Workflow Execute the exposures with external collimator In the operator room: 1. Press the exposure button to acquire the first partial image. The partial image is sent to the NX workstation. 2. -
Page 47: Perform A Quality Control
Full Leg Full Spine DR Retrofit System | Basic Workflow | 47 Perform a quality control In the operator room at the NX workstation, the DR Full Leg Full Spine image is displayed in the Stitching pane. Figure 12: Stitching pane Stitching is applied based on grid markers in the stitching grid and a correction is applied based on the alignment of the anatomical information in the image. - Page 48 48 | Full Leg Full Spine DR Retrofit System | Basic Workflow Button Parameter Indication that automatic stitching has been performed based on the alignment of the anatomical information in the image. Indication that patient movement is detected. Indication that automatic stitching has been performed based on the stitching grid.
- Page 49 Full Leg Full Spine DR Retrofit System | Basic Workflow | 49 M Indication that manual corrections have been applied to the align- ment of the partial images. G Indication that automatic stitching has been performed based on the stitching grid. A Indication that automatic stitching has been performed based on the alignment of the anatomical information in the image.
-
Page 50: Finalize The Examination
50 | Full Leg Full Spine DR Retrofit System | Basic Workflow Finalize the examination In the operator room: 1. Unlock the external collimator by pushing the lower lever of the floor mount lock. 2. Move the external collimator to its parking position and activate the brakes on the wheels to prevent unintended movement. -
Page 51: Stopping The Dr Full Leg Full Spine Application
Full Leg Full Spine DR Retrofit System | Basic Workflow | 51 Stopping the DR Full Leg Full Spine application 1. Disconnect the Full Leg Full Spine wall stand from the power supply. 2. Disconnect the external collimator from the Full Leg Full Spine wall stand. 0326A EN 20211014 1141... -
Page 52: Advanced Operation
52 | Full Leg Full Spine DR Retrofit System | Advanced Operation Advanced Operation Topics: • Manually adjusting a DR Full Leg Full Spine image • Rejecting a DR Full Leg Full Spine image • Making measurements • DAP reading when using the external collimator 0326A EN 20211014 1141... -
Page 53: Manually Adjusting A Dr Full Leg Full Spine Image
Full Leg Full Spine DR Retrofit System | Advanced Operation | 53 Manually adjusting a DR Full Leg Full Spine image Topics: • To rotate all partial images • To stitch a set of partial images • To align the partial images based on their projection on the stitching grid •... -
Page 54: To Rotate All Partial Images
54 | Full Leg Full Spine DR Retrofit System | Advanced Operation To rotate all partial images Rotate all partial images • Click the following button to rotate 90° clockwise: Figure 14: Rotate clockwise • Click the following button to rotate 90° counterclockwise: Figure 15: Rotate counterclockwise 0326A EN 20211014 1141... -
Page 55: To Stitch A Set Of Partial Images
Full Leg Full Spine DR Retrofit System | Advanced Operation | 55 To stitch a set of partial images To stitch a set of partial images: 1. In NX, go to the Examination window. 2. In the Image Overview pane, select the thumbnail of one of the partial images. -
Page 56: To Align The Partial Images Based On Their Projection On The Stitching Grid
56 | Full Leg Full Spine DR Retrofit System | Advanced Operation To align the partial images based on their projection on the stitching grid To align the partial images based on their projection on the stitching grid: Click Grid. Figure 16: Stitch mode: grid The anatomical structure in the partial images may not be aligned, due to patient movement during the examination. -
Page 57: To Align The Partial Images Based On The Analysis
Full Leg Full Spine DR Retrofit System | Advanced Operation | 57 To align the partial images based on the analysis of the anatomical information in the image To align the partial images based on the analysis of the anatomical infor- mation in the image: Click Anatomic. -
Page 58: To Manually Align Two Partial Images
58 | Full Leg Full Spine DR Retrofit System | Advanced Operation To manually align two partial images To manually align two partial images: 1. Click the Alignment button. Figure 20: Alignment button A detail of the overlapping area is displayed. Figure 21: Detail overlapping area 2. - Page 59 Full Leg Full Spine DR Retrofit System | Advanced Operation | 59 Restoring the origi- Click the Revert button. nal alignment Figure 22: Revert button The relative position of the partial images, compared to their initial relative position, is illustrated by two crosshairs displayed in the image, each of which is locked to the position of one of the partial images.
-
Page 60: To Turn The Black Borders Or Cropping On Or Off
60 | Full Leg Full Spine DR Retrofit System | Advanced Operation To turn the black borders or cropping on or off To turn the black borders or cropping on or off: Click the following icon: Figure 24: Crop/uncrop button 0326A EN 20211014 1141... -
Page 61: To Save The Stitched Image
Full Leg Full Spine DR Retrofit System | Advanced Operation | 61 To save the stitched image To save the stitched image: Click Accept. The DR Full Leg Full Spine image is available in the examination. Depending on the configuration settings, the stitching parameters are added to the image as a text annotation. -
Page 62: Making Measurements
62 | Full Leg Full Spine DR Retrofit System | Advanced Operation Making measurements Distance measurements on DR Full Leg Full Spine images in NX are calibrated based on the Estimated Radiographic Magnification Factor. The calibration factor is calculated based on: 1. - Page 63 Full Leg Full Spine DR Retrofit System | Advanced Operation | 63 Projection of the object on the DR Detector. This is the measured distance on a partial image on NX. Distance between the plane in which the measurement is made and the stitching grid.
-
Page 64: Dap Reading When Using The External Collimator
64 | Full Leg Full Spine DR Retrofit System | Advanced Operation DAP reading when using the external collimator When the external collimator is used, the collimator on the X-ray tube is opened to cover the complete stitching grid height of 116 cm. The external collimator reduces the exposed area to one third of the emitted X-ray beam. -
Page 65: Problem Solving
Full Leg Full Spine DR Retrofit System | Problem solving | 65 Problem solving Topics: • Anatomical stitching is not optimal • Stitching fails • Not all three DR detector positions are available 0326A EN 20211014 1141... -
Page 66: Anatomical Stitching Is Not Optimal
66 | Full Leg Full Spine DR Retrofit System | Problem solving Anatomical stitching is not optimal Table 6: Problem: Anatomical stitching is not optimal Details The anatomic information in the partial images cannot be automatically fully aligned. If the result of automatic stitching based on the alignment of the anatomical in- formation in the image is suspicious because of possible movement of the patient during the examination, this... -
Page 67: Stitching Fails
Full Leg Full Spine DR Retrofit System | Problem solving | 67 Stitching fails Table 7: Problem: Stitching fails Details The partial images cannot be stitched because the grid markers in the stitching grid are not visible in the parti- al images. -
Page 68: Not All Three Dr Detector Positions Are Available
68 | Full Leg Full Spine DR Retrofit System | Problem solving Not all three DR detector positions are available Table 8: Problem: Not all three DR detector positions are available Details After pushing the initialization button on the external collimator, not all three leds light up. -
Page 69: Technical Data
Full Leg Full Spine DR Retrofit System | Technical Data | 69 Technical Data Topics: • Full Leg Full Spine wall stand technical data • External collimator technical data • Remarks for HF-emission and immunity 0326A EN 20211014 1141... -
Page 70: Full Leg Full Spine Wall Stand Technical Data
70 | Full Leg Full Spine DR Retrofit System | Technical Data Full Leg Full Spine wall stand technical data Table 9: Full Leg Full Spine wall stand technical data Type 6005/100 Eelectrical connection operating 24V DC 2.0A voltage Dimensions Width: 735 mm (one handle) (without wall-mounted base) Height: 1374 mm... - Page 71 Full Leg Full Spine DR Retrofit System | Technical Data | 71 Table 10: Electrical connection of the external power supply Operating voltage Autoranging power supply from 100 to 240Vac, +10% Class I equipment Connected to earthed supply circuitry only Mains frequency 50/60Hz Current rating...
-
Page 72: External Collimator Technical Data
72 | Full Leg Full Spine DR Retrofit System | Technical Data External collimator technical data Table 11: External collimator technical data 6005/200 Type Electrical connection operating 24V DC 1.0A voltage Supplied by the Full Leg Full Spine wall stand Dimensions Width: 940 mm Height: 1970 mm... -
Page 73: Remarks For Hf-Emission And Immunity
Full Leg Full Spine DR Retrofit System | Technical Data | 73 Remarks for HF-emission and immunity This device is intended for operation in the electromagnetic environment given below. The user of the device should ensure that it is used in such an environment. - Page 74 74 | Full Leg Full Spine DR Retrofit System | Technical Data with IEC + 15 kV air dis- + 15 kV air dis- ramic tiles. The 610004-2 charge charge relative humidi- ty must be at least 30%, if the floor is made of synthetic materi- Fast transient...
- Page 75 Full Leg Full Spine DR Retrofit System | Technical Data | 75 accordance with ues as they are IEC 61000-4-8 in a commercial and clinical environ- ment. REMARK : U is the alternating current in the network before the application of the test level.
- Page 76 76 | Full Leg Full Spine DR Retrofit System | Technical Data d = 2.3 800 MHz to 2.5 GHz With P as the rated power of the transmit- ter in watts (W) in ac- cordance with the manufacturer infor- mation on the trans- mitter and d as the recommended protec-...
- Page 77 Full Leg Full Spine DR Retrofit System | Technical Data | 77 This device is intended for operation in an electromagnetic environment in which the radiated high frequency disturbance variables are monitored. The user of the device can help to prevent electromagnetic disruptions by maintaining the minimum distances between portable and mobile high frequency communication equipment (transmitters) and the device as recommended below, in accordance with the maximum...
- Page 78 78 | Full Leg Full Spine DR Retrofit System | Technical Data • Cables, transducers and accessories • For USA • For Canada 0326A EN 20211014 1141...
-
Page 79: Precautions On Emc
Full Leg Full Spine DR Retrofit System | Technical Data | 79 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 80: Immunity To Rf Wireless Communication Equipment
80 | Full Leg Full Spine DR Retrofit System | Technical Data 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 81: Cables, Transducers And Accessories
Full Leg Full Spine DR Retrofit System | Technical Data | 81 Cables, transducers and accessories There are no cables, transducers and other accessories in this device which can be replaced by the hospital. 0326A EN 20211014 1141... -
Page 82: For Usa
82 | Full Leg Full Spine DR Retrofit System | Technical Data For USA This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. -
Page 83: For Canada
Full Leg Full Spine DR Retrofit System | Technical Data | 83 For Canada This class A digital apparatus meets all requirements of the Canadian Interference-Causing Equipment Regulations. 0326A EN 20211014 1141...