Related Manuals for AGFA 5523/100
Summary of Contents for AGFA 5523/100
- Page 1 Bucky 5523/100 5523/110 5523/115 5523/120 5523/125 5523/200 5523/210 5523/215 5523/220 5523/225 5523/250 5523/260 5523/265 5523/270 5523/275 5523/300 5523/310 5523/320 User Manual 3253F EN 20210312 1125...
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Page 2: Table Of Contents
ii | Bucky | 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 ................9 Intended Use ............10 Intended User ............ - Page 3 Bucky | Contents | iii Product Information ............45 Compatibility ............46 Compliance ............. 46 General ............47 Safety ............47 Electromagnetic Compatibility ..... 47 Environmental Compliance ......47 Equipment Classification ......... 48 Product Complaints ..........49 Training ..............50 Technical Data ............51 Bucky Unit Technical Data ......
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Page 4: Legal Notice
All rights reserved. Published by Agfa NV B-2640 Mortsel - Belgium. No part of this document may be reproduced, copied, adapted or transmitted in any form or by any means without the written permission of Agfa NV 3253F EN 20210312 1125... -
Page 5: Introduction To This Manual
Bucky | Introduction to this Manual | 5 Introduction to this Manual Topics: • Scope of this Manual • About the safety notices in this document • Disclaimer 3253F EN 20210312 1125... -
Page 6: Scope Of This Manual
6 | Bucky | Introduction to this Manual Scope of this Manual This User Manual describes the features of the listed bucky types, further referred to as the bucky. The bucky is part of a DR system. • BT-Cassette-T-001 • BT-Cassette-T-GSS-001 •... -
Page 7: About The Safety Notices In This Document
Bucky | 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, engineer, patient or any other person. -
Page 8: Disclaimer
8 | Bucky | 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
Bucky | Introduction | 9 Introduction Topics: • Intended Use • Intended User • Installation • Labels • Cleaning and Disinfecting • Environmental protection 3253F EN 20210312 1125... -
Page 10: Intended Use
The device is not intended for mammography applications. Intended User This manual has been written for trained users of Agfa products and trained diagnostic X–Ray clinical personnel who have received proper training. Users are those persons who actually handle the equipment and those who have authority over the equipment. -
Page 11: Labels
Bucky | Introduction | 11 Labels Mark Meaning This mark shows compliance of the equipment with Regulation 2017/745 (for European Union). Date of manufacture Manufacturer Medical device Serial number Unique device identifier, in text format and in machine readable format The most recent version of this document is available on http:// www.agfahealthcare.com/global/en/library/index.jsp... - Page 12 12 | Bucky | Introduction Figure 2: (Sample of subtype 5523/125) Class II equipment. Pinch Points. The label is positioned on the lateral cover of the bucky or on the rotating platform. Maximum load capacity is 10 kg on the 10kg bucky drawer when it is pulled out.
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Page 13: Cleaning And Disinfecting
Bucky | Introduction | 13 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. The user is responsible for selecting a disinfection procedure. -
Page 14: Cleaning
14 | Bucky | Introduction 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 main power of the system. Never use anhydrous or high solvency alcohols, benzine, thinner or any other flammable cleaning agent. -
Page 15: 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 16: Disinfecting Safety Directions
16 | Bucky | Introduction Disinfecting safety directions WARNING: Using a disinfectant that can form an explosive or flammable gas mixtures is hazard to life and health because of explosion risk. Switch the equipment off before disinfecting. Allow the gas mixture to evaporate before switching the x-ray system back on. -
Page 17: Approved Disinfectants
Bucky | Introduction | 17 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 18: Environmental Protection
18 | Bucky | Introduction Environmental protection Figure 3: WEEE symbol WEEE end user notice The directive on Waste Electrical and Electronic Equipment (WEEE) aims to prevent the generation of electric and electronic waste and to promote the reuse, recycling and other forms of recovery. It therefore requires the collection of WEEE, recovery and reuse or recycling. -
Page 19: Safety Directions
The product must only be installed using released components and in released configurations. CAUTION: Strictly observe all warnings, cautions, notes and safety markings within this document and on the product. CAUTION: All Agfa medical products must be used by trained and qualified personnel. 3253F EN 20210312 1125... -
Page 20: Bucky
20 | Bucky | Bucky Bucky The bucky is installed in the radiographic table and in the radiographic wall stand. The bucky clamps the cassette or detector during exposure and centers them relative to the Automatic Exposure Control (AEC) and the grid. The bucky supports cassettes in standard formats as well as DR Detectors with cassette size format. - Page 21 Bucky | Bucky | 21 Topics: • Bucky configuration • Rotating the bucky • Loading of the bucky in the Radiographic Table • Loading of the bucky in the Radiographic Wall Stand • Unloading of the bucky in the Radiographic Table •...
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Page 22: Bucky Configuration
22 | Bucky | Bucky Bucky configuration Cassette only configuration The workflow with cassettes requires removing the cassette from the bucky after each exposure. The cassette has to be scanned using a digitizer to get the final image. The correct orientation of the cassette is applied by the way it is inserted in the bucky and there is no need to use the rotation mechanism. -
Page 23: Rotating The Bucky
Bucky | Bucky | 23 Rotating the bucky The cassette or detector in the bucky can be rotated without removing it from the clamping. To change the orientation of the cassette or detector in the bucky: 1. Open the bucky drawer halfway by pulling the front handle. 2. -
Page 24: Loading Of The Bucky In The Radiographic Table
24 | Bucky | Bucky Loading of the bucky in the Radiographic Table To load the bucky with a cassette or detector: 1. Open the bucky drawer completely by pulling the front handle. 2. Push the cassette or detector towards the rear slider to open the clamping mechanism wide enough to contain the cassette or detector. -
Page 25: Loading Of The Bucky In The Radiographic Wall Stand
Bucky | Bucky | 25 Loading of the bucky in the Radiographic Wall Stand To load the bucky with a cassette or detector: 1. Open the bucky drawer completely by pulling the front handle. 2. Rotate the drawer to portrait orientation. 3. -
Page 26: Unloading Of The Bucky In The Radiographic Table
26 | Bucky | Bucky Unloading of the bucky in the Radiographic Table To unload the bucky with a cassette or detector: 1. Open the bucky drawer completely by pulling the front handle. 2. Push firmly with both hands the cassette or detector towards the rear clamp to open the clamping mechanism. -
Page 27: Unloading Of The Bucky In The Radiographic Wall Stand
Bucky | Bucky | 27 Unloading of the bucky in the Radiographic Wall Stand To unload the bucky with a cassette or detector: 1. Open the bucky drawer completely by pulling the handle. 2. Rotate the carrier back to portrait position. 3. -
Page 28: Automatic Cassette Size Sensing
28 | Bucky | Bucky Automatic Cassette Size Sensing The ACSS functionality of the bucky detects the size and orientation of the CR cassette or the DR detector and allows the collimator to limit the collimated area accordingly. The collimation setting received from the NX workstation or the collimation area set by the user is automatically adjusted. -
Page 29: Centering And Collimating
Bucky | Bucky | 29 Centering and collimating Depending on the format of the cassette or detector inside the bucky and the body part to expose, collimation and centering of the X-ray field have to be applied before exposure. Centering The bucky center position is automatically aligned to the position of the X-ray tube stand. - Page 30 30 | Bucky | Bucky Any of the above conditions is not true. Collimating To set the X-ray collimation area, pull out the bucky drawer until the cassette or detector edge is visible. Align the X-ray collimation field to the size of the cassette or detector.
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Page 31: Bucky Types
Bucky | Bucky | 31 Bucky types The type of bucky installed in the system defines which functionality is available. Table 3: Modality positions Radiographic table 5523/100 5523/110 5523/115 5523/120 5523/125 5523/300 Radiographic wall stand, left loading 5523/200 5523/210 5523/215... - Page 32 32 | Bucky | Bucky Automatic cassette size sensing (ACSS) 5523/120 5523/125 5523/220 5523/225 5523/270 5523/275 Integraded charger for DR 14s DR Detector 5523/115 5523/125 5523/215 5523/225 5523/265 5523/275 Table 5: Bucky for fixed DR detector Radiographic table 5523/300 Radiographic wall stand, left loading 5523/310 Radiographic wall stand, right loading 5523/320...
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Page 33: Cassette And Detector Formats
Bucky | Bucky | 33 Cassette and detector formats To adjust the side clamps to the format of the cassette or detector, indications are available in cm (and inch, depending on the bucky type). Corresponding indications are printed on the wall stand cover to align the collimation area. The large format cassette or detector (43 cm x 35 cm or 17 inch x 14 inch) can be positioned either centered or aligned to the top of the bucky in landscape position. -
Page 34: Standard Cassette Formats
34 | Bucky | Bucky Standard cassette formats 35 cm x 43 cm 35 cm x 35 cm 24 cm x 30 cm 18 cm x 24 cm 15 cm x 30 cm 3253F EN 20210312 1125... -
Page 35: Dr Detector Formats And Orientation
Bucky | Bucky | 35 DR Detector formats and orientation For information on how to use the DR Detector in the bucky, refer to following sections and to the user manual of the DR Detector. Topics: • Orientation of DR 10s in the bucky •... -
Page 36: Orientation Of Dr 10S In The Bucky
36 | Bucky | Bucky Orientation of DR 10s in the bucky The clamps of the bucky may trigger the DR 10s power switch. To avoid switching off the detector when inserting it in the bucky, apply the orientation as described below. Topics: •... -
Page 37: Orientation Of Dr 14S In The Bucky
Bucky | Bucky | 37 Figure 11: Portrait orientation in the radiographic wall stand left loading Orientation in the radiographic wall stand right loading • To use the detector landscape orientation, insert the detector in landscape orientation. • To use the detector in portrait orientation: 1. - Page 38 38 | Bucky | Bucky 2. Rotate the detector in the bucky. Figure 13: Landscape orientation in the radiographic table Orientation in the radiographic wall stand left loading • To use the detector in landscape orientation, insert the detector in landscape orientation.
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Page 39: Orientation Of Dx-D 10C, Dx-D 10G In The Bucky
Bucky | Bucky | 39 Figure 15: Portrait orientation in the radiographic wall stand right loading Orientation of DX-D 10C, DX-D 10G in the bucky To avoid damage to the cable of the detector, there are restrictions on the orientation of the detector when loading the bucky. CAUTION: Inserting DX-D 10C, DX-D 10G using other orientations than described will damage the cable when closing the bucky or... -
Page 40: Using Dx-D 45C, Dx-D 45G Only Outside The Bucky
40 | Bucky | Bucky Orientation in the radiographic wall stand left loading • To use the detector in portrait orientation, insert the detector in portrait mode with the cable at upper left hand side. • To use the detector in landscape orientation: 1. -
Page 41: Grids
Bucky | Bucky | 41 Grids Anti-scatter grids are used to reduce scattered radiation and improve image quality. Grids are available as an option. For DR Detectors focused grids are used. Focused grids require centering of the X-ray source to the detector and a specific distance range between X-ray source and detector. -
Page 42: Anti-Scatter Grids
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 43: Grid Focal Distance Color Indication
Bucky | Bucky | 43 Grid focal distance color indication The handle of the grid is visible when the grid is inserted and its color indicates the focal distance of the grid. Focal Distance Color 100 cm 150 cm green 180 cm blue Parallell grid... -
Page 44: Grid Detection
44 | Bucky | Bucky Grid detection The grid detection functionality of the bucky detects the type of the grid and if the grid is correctly inserted in the bucky. The grid status reflects if the inserted grid is suitable for the selected exposure and the current SID and is displayed on the tube head display and on the Software Console. -
Page 45: Product Information
Bucky | Product Information | 45 Product Information Topics: • Compatibility • Compliance • Equipment Classification • Product Complaints • Training • Technical Data • Remarks for HF-emission and immunity 3253F EN 20210312 1125... -
Page 46: 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 47: General
Bucky | Product Information | 47 General • The product has been designed in accordance with Regulation (EU) 2017/745 on medical devices (MDR) • ISO 13485 • ISO 14971 Safety • IEC 60601-1 Electromagnetic Compatibility • IEC 60601-1-2, EN 60601-1-2 Topics: •... -
Page 48: Equipment Classification
48 | Bucky | Product Information Equipment Classification Per EN/IEC60601-1, Medical Electrical Equipment, General Requirements for Safety, this device is classified as following: Table 6: Equipment classification Class II equip- Equipment in which protection against electric shock does ment not rely on basic insulation only, but in which additional safety precautions such as double insulation or reinforced insulation are provided, there being no provision for protec- tive earthing or reliance upon installation conditions. -
Page 49: 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 50: 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 51: Technical Data
Bucky | Product Information | 51 Technical Data Topics: • Bucky Unit Technical Data Bucky Unit Technical Data Manufacturer Agfa NV Septestraat 27 2640 Mortsel, Belgium Type BT-Cassette-T-001 5523/100 BT-Cassette-T-GSS-001 5523/110 CASS BUCKY TABLE W/O ACSS INCL DET CHARG 5523/115... - Page 52 Bucky for DR Detector or CR cassette in 26.0 kg radiographic wall stand DX-D Fixed DR Detector bucky 13 kg Electrical connection (type 5523/100, 5523/200, 5523/250) Operating voltage 24 VDC Operating current 80 mA Electrical connection (type 5523/110, 5523/120, 5523/210, 5523/220, 5523/260, 5523/270,...
- Page 53 Bucky | Product Information | 53 Supported sizes 15x30 to 43x35 in portrait and landscape orien- tation Lifetime Expected lifetime for the bucky 10 years Environmental conditions Table 7: Environmental conditions for the X-ray system Environmental Conditions (during storage and transport) Temperature (ambient) between -15°...
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Page 54: Remarks For Hf-Emission And Immunity
54 | Bucky | Product Information Remarks for HF-emission and immunity It is hereby certified that the device has interference suppression according to the EN 55011 Class A as well as the FCC Rules CFR 47 Part 15 Class A. This device was tested for a normal hospital environment as described above. - Page 55 Bucky | Product Information | 55 Harmonic emis- Class A frequency communication services. The user sion in accord- might need to take mitigation measures, such ance with IEC as relocating or re-orienting the equipment. 61000-3-2 Voltage fluctua- Fulfilled tions / flickering in accordance with IEC 61000-3-3...
- Page 56 56 | Bucky | Product Information ded to use an energy supply • 0% U for 250 pe- free of interruptions or a riods 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...
- Page 57 Bucky | Product Information | 57 investigation of the location is recommended, to ascertain the electromagnetic 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 58 58 | Bucky | Product Information • Maintenance on EMC relevant parts 3253F EN 20210312 1125...
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Page 59: Immunity To Rf Wireless Communication Equipment
Bucky | Product Information | 59 Immunity to RF wireless communication equipment Service ISM Band Distance Immunity test level (MHz) (V/m) 300-390 TETRA 400 430-470 GMRS 460; FRS 460 704-787 LTE Band 13, 17 800-960 GSM 800/900; TETRA 800, IDEN 820;... -
Page 60: Precautions On Emc
60 | Bucky | Product Information 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 61: Maintenance On Emc Relevant Parts
Bucky | Product Information | 61 Maintenance on EMC relevant parts Concerning the EMC safety of the DR 400 device, no relevant parts could be inspected by the operator. EMC relevant parts will be inspected from AFGA service engineer within the regular service interval until the end of lifetime. The needed verifications are described in the service manual.