Related Manuals for AGFA 5522/100
Summary of Contents for AGFA 5522/100
- Page 1 WS-Manual-001, WS-Manual- T-001, WS-Manual-002, WS- Manual-T-002 5522/100 5522/200 5522/300 5522/400 User Manual 3252C EN 20191206 1610...
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Page 2: Table Of Contents
ii | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | 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 DR 400 ............ - Page 3 WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Contents | iii Maintenance of the radiographic table, radiographic wall stand and X-Ray Tube Stand Environmental protection ........39 Safety Directions ............40 General Safety Directions ......41 Safety directions for the radiographic wall stand ................43 Operation ................
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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 3252C EN 20191206 1610... -
Page 5: Introduction To This Manual
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to this Manual | 5 Introduction to this Manual Topics: • Scope of this Manual • About the safety notices in this document • Disclaimer 3252C EN 20191206 1610... -
Page 6: Scope Of This Manual
6 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to this Manual Scope of this Manual This User Manual describes the features of the WS-Manual-L-001, WS- Manual-R-001, WS-Manual-T-L-001 and WS-Manual-T-R-001, further referred to as the radiographic wall stand, that is part of the DR 400 system. 3252C EN 20191206 1610... -
Page 7: About The Safety Notices In This Document
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | 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 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | 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 Dr 400
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 400 | Introduction to DR 400 Topics: • Intended Use • Intended User • Applied Parts • Equipment Classification • Operation Controls • Training • Product Complaints • Compatibility • Compliance • Connectivity •... -
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: Equipment Classification
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 400 | Equipment Classification Per EN/IEC 60601-1, EN/IEC 60601-2-54, this device is classified as following: Table 1: Equipment classification Class I equipment Equipment in which protection against electric shock does not rely on basic insulation only, but in- cludes a fixed connection to mains power with pro- tective earth conductor. -
Page 12: Operation Controls
12 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR Operation Controls Topics: • Radiographic wall stand • Emergency stop button 3252C EN 20191206 1610... -
Page 13: Radiographic Wall Stand
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 400 | Radiographic wall stand The radiographic wall stand is used for positioning of patients standing upright or sitting towards the bucky for exposure. Figure 1: Radiographic wall stand with vertical bucky Related Links Radiographic wall stand on page 44... -
Page 14: Emergency Stop Button
14 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR Emergency stop button Figure 2: Emergency stop button If a system malfunction causes an emergency situation involving the patient, operating personnel or any system component, activate the emergency stop on the radiographic table. -
Page 15: 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 16: 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 17: 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 18: Compliance
18 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR Compliance The system is compliant with specific directives and standards. Topics: • General • Safety • Electromagnetic Compatibility • X-Ray Safety • X-Ray Accuracy • Environmental Compliance • Biocompatibility 3252C EN 20191206 1610... -
Page 19: General
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 400 | 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 • IEC 60601-1-6, EN 60601-1-6 •... -
Page 20: X-Ray Accuracy
20 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR For USA The system conforms to DHHS radiation Standards of 21CFR subchapter J as of the date of manufacture. X-Ray Accuracy The system fulfills the X-ray radiation accuracy according EN IEC 60601-2-54 with a variation of max. -
Page 21: Connectivity
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 400 | 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. The NX workstation communicates with other devices in the hospital network using one of the following protocols: •... -
Page 22: Installation
22 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR Installation Installation and configuration is performed by an Agfa trained and authorized service engineer. Contact your local support organization for more information. HF-emission and immunity The HF-emission and immunity can be influenced by connected data cables depending on length and the manner of installation. -
Page 23: Radiation Protection
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 400 | Radiation Protection X-ray radiation can cause serious damage to the health, therefore observe great care and ensure that protection against X-ray exposure is always applied. Some of the effects of X-ray radiation are cumulative and may extend over a period of time. -
Page 24: Monitoring Of Personnel
24 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR Monitoring of Personnel The monitoring checks the amount of X-ray radiation the personnel has been exposed to. It determines safety of the operators and it helps checking if safety measures of the X-ray environment are adequate. Inadequate or improper protection can lead to serious damage to the health. -
Page 25: Protected Area And Significant Zones Of Occupancy
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 400 | Protected area and significant zones of occupancy If the operator or staff does not need to be close to the patient during the exposure, the operator and staff use the protected area to control the following functions: •... - Page 26 26 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR WARNING: The radiation protection has to be applied to the patient and to the operator. Related Links Radiation Protection on page 23 Significant zones of occupancy at the radiographic wall stand 50 cm Phantom X-ray tube...
- Page 27 WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 400 | Protective device Wall DR Detector or cassette Significant zone of occupancy at the right side of the radiographic wall stand Significant zone of occupancy at the left side of the radiographic wall stand Figure 4: Significant zones of occupancy at the radiographic wall stand CAUTION:...
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Page 28: Labels
28 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR Labels Mark Meaning This mark shows compliance of the equipment with Regulation 2017/745 (for European Union). This mark indicates that this is a Type B Equipment Date of manufacture Manufacturer Medical device Serial number Unique device identifier, in text format and in machine readable... - Page 29 WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 400 | Further labels are listed and explained in the relevant modules of the System Documentation. Topics: • Warning labels on the radiographic wall stand • Additional Labeling of the radiographic wall stand 3252C EN 20191206 1610...
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Page 30: Warning Labels On The Radiographic Wall Stand
30 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR Warning labels on the radiographic wall stand Figure 5: Warning labels on the radiographic wall stand 3252C EN 20191206 1610... -
Page 31: Additional Labeling Of The Radiographic Wall Stand
Additional Labeling of the radiographic wall stand Type label on the lower right hand side of the radiographic wall stand. (Sample of subtype 5522/100) This mark indicates that this is a Type B Equipment Functional earth The bucky can be tilted to horizontal posi- tion. -
Page 32: Cleaning And Disinfecting
32 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 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. -
Page 33: Cleaning
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 400 | 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 34: 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 35: Disinfecting Safety Directions
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 400 | 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 36: Approved Disinfectants
36 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 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 37: Maintenance
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 400 | Maintenance Always consult the Agfa Service documentation and an AGFA trained and authorized Service engineer for complete maintenance schedules. Maintenance of the radiographic table, radiographic wall stand and X-Ray Tube Stand The X-ray unit and all components require regular maintenance to ensure the equipment is safe and reliable for operation. - Page 38 38 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR All steel cables of X-ray tube stand and radio- graphic wall stand shall be checked All steel cables of X-ray tube stand and radio- Every 36 months graphic wall stand shall be exchanged to maintain fault-free operation and ensure safety for patient and operator Replacing the coin cell battery of the X-ray genera-...
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Page 39: Environmental Protection
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 400 | Environmental protection Figure 6: WEEE symbol Figure 7: 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 40: Safety Directions
40 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR Safety Directions Topics: • General Safety Directions • Safety directions for the radiographic wall stand 3252C EN 20191206 1610... -
Page 41: General Safety Directions
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 400 | General Safety Directions WARNING: Safety is only guaranteed when an Agfa certified field service engineer has installed the product. WARNING: The product must only be installed using released components and in released configurations. - Page 42 42 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR CAUTION: All Agfa medical products must be used by trained and qualified personnel. 3252C EN 20191206 1610...
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Page 43: Safety Directions For The Radiographic Wall Stand
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Introduction to DR 400 | Safety directions for the radiographic wall stand WARNING: Unauthorized manipulation or opening of the equipment housing may lead to personal injuries and to property damage. Take all necessary precautions with respect to the applicable level of safety. -
Page 44: Operation
44 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Operation Operation Topics: • Radiographic wall stand Radiographic wall stand The radiographic wall stand allows vertical X-ray exposures of patients standing or sitting in front of the radiographic wall stand. The wall stand has two variants: •... - Page 45 WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Operation | 45 Wall Stand column Active workstation indicator Bucky Button to switch on the collimator light Front panel Vertical movement handle (both sides) Tilting extension Tilting handle Figure 8: Radiographic wall stand, vertical version and vertical tilting version CAUTION: The format indications on the front panel show the format of the cassette or detector.
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Page 46: Positioning The Radiographic Wall Stand
46 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Operation Positioning the Radiographic Wall Stand Vertical movement handle with brake switch Tilting angle scale Tilting handle Figure 9: Positioning controls DANGER: Make sure that no persons or objects are within the movement area of the system where they can collide with moving parts of the system. - Page 47 WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Operation | 47 CAUTION: The maximum load for the bucky movement in vertical direction is 20 kg. The bucky may slip downward when applying excessive load. Note: Do not move the bucky with excessive force to the end stop positions.
- Page 48 48 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Operation Figure 10: Wall stand position tracking disabled and enabled The button is highlighted. 3. Adjust the wall stand height. The X-ray tube stand is moving up or down accordingly. Note: The movement of the X-ray tube is automatically stopped if the distance between the X-ray tube head and the table top would become too small (less than 10 cm).
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Page 49: Radiographic Wall Stand Accessories
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Operation | 49 Radiographic Wall Stand Accessories WARNING: Using wrong accessories that cannot be properly attached to the system can lead to hazardous situations and injury. Use only original accessories provided by the manufacturer. Topics: •... - Page 50 50 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Operation 2. Grip the lower part of the handle. 3. Pull the handle forward 4. Adjust the angle. 5. Move the handle back to fix the position. Figure 12: Overhead handle Movement of the X-ray tube head is restricted in the neighbourhood of the handle, to avoid collisions.
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Page 51: Technical Data
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Technical Data | 51 Technical Data Topics: • Radiographic Wall Stand Technical Data Radiographic Wall Stand Technical Data Manufacturer Agfa NV Septestraat 27 2640 Mortsel, Belgium Type WS-Manual-001 5522/100 WS-Manual-T-001 5522/200 WS-Manual-002 5522/300 WS-Manual-T-002 5522/400... -
Page 52: Environmental Conditions
52 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Technical Data Front panel attenuation equivalent ≤ 0.7 mm Aluminum According to DIN EN 60601-1-3 with 100kV and HVL 3.6 mm Al FDA 21 CFR § 1020.30 (n) with 100kV and HVL 3.6 mm Al Weight Vertical radiographic wall stand 157 kg... - Page 53 WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Technical Data | 53 related User Manual for environmental conditions for the DR Detector or image plate. When using the DR Detector or image plate inside the bucky, take into account that the temperature inside the bucky can be up to 5°C higher than the temperature in the X-ray room.
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Page 54: Remarks For Hf-Emission And Immunity
54 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Remarks for HF- emission and immunity 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 CR47 Part 15 Class A. This device was tested for a normal hospital environment as described above. - Page 55 WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Remarks for HF- emission and immunity | 55 Harmonic emis- Class A might not offer adequate protection to radio- sion in accord- frequency communication services. The user ance with IEC might need to take mitigation measures, such 61000-3-2 as relocating or re-orienting the equipment.
- Page 56 56 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Remarks for HF- emission and immunity 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-...
- Page 57 WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Remarks for HF- emission and immunity | 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 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Remarks for HF- emission and immunity • Cables, transducers and accessories • Maintenance on EMC relevant parts 3252C EN 20191206 1610...
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Page 59: Immunity To Rf Wireless Communication Equipment
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Remarks for HF- emission and immunity | 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;... -
Page 60: Precautions On Emc
60 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Remarks for HF- emission and immunity 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: Cables, Transducers And Accessories
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Remarks for HF- emission and immunity | 61 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 62 62 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Remarks for HF- emission and immunity remark from; type; maximum length mandatory Table output terminal (x8 24V, 10 x AWG21 (0.5 mm light push button, double expo- 20 m sure protection); wall stand input terminal mandatory table output terminal (230 V);...
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Page 63: For Type 5520/200 Only
WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Remarks for HF- emission and immunity | 63 remark from; type; maximum length wired hand control 1.8 m For type 5520/200 only remark from; type; maximum length shielded table output terminal; 9 pin sub D; wall stand input terminal (CAN) 20 m 3252C EN 20191206 1610... -
Page 64: Maintenance On Emc Relevant Parts
64 | WS-Manual-001, WS-Manual-T-001, WS-Manual-002, WS-Manual-T-002 | Remarks for HF- emission and immunity 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.