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AGFA WS-Motorized-T-001 User Manual

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WS-Motorized-T-001
5522/600
User Manual
3255F EN 20210312 1125

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Summary of Contents for AGFA WS-Motorized-T-001

  • Page 1 WS-Motorized-T-001 5522/600 User Manual 3255F EN 20210312 1125...

  • Page 2: Table Of Contents

    | WS-Motorized-T-001 | 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 WS-Motorized-T-001 | Contents | iii Compliance ............. 45 General ............46 Safety ............46 Electromagnetic Compatibility .....46 X-Ray Safety ..........47 X-Ray Accuracy ..........47 Environmental Compliance ......47 Biocompatibility ...........47 Usability ............47 Equipment Classification ......... 48 Product Complaints ..........49 Environmental protection ........

  • 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 3255F EN 20210312 1125...

  • Page 5: Introduction To This Manual

    WS-Motorized-T-001 | Introduction to this Manual | 5 Introduction to this Manual Topics: • Scope of this Manual • About the safety notices in this document • Disclaimer 3255F EN 20210312 1125...

  • Page 6: Scope Of This Manual

    6 | WS-Motorized-T-001 | Introduction to this Manual Scope of this Manual This User Manual describes the features of the DR 600 System, an integrated X-Ray imaging system. It explains how the different components of the DR 600 System work together.

  • Page 7: About The Safety Notices In This Document

    WS-Motorized-T-001 | 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-Motorized-T-001 | 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

    WS-Motorized-T-001 | Introduction | 9 Introduction Topics: • Intended Use • Intended User • Applied Parts • Operation Controls • Installation • Radiation Protection • Labels • Cleaning and Disinfecting • Maintenance 3255F 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: Radiographic Wall Stand

    WS-Motorized-T-001 | Introduction | 11 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...

  • Page 12: Emergency Stop Button

    12 | WS-Motorized-T-001 | Introduction Emergency stop button If a system malfunction causes an emergency situation involving the patient, operating personnel or any system component, activate the emergency stop button. • On the front side of the radiographic table (right) •...
  • Page 13 WS-Motorized-T-001 | Introduction | 13 CAUTION: The emergency stop button does not switch off the voltage in the X-ray system. 3255F EN 20210312 1125...

  • Page 14: Installation

    14 | WS-Motorized-T-001 | Introduction 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 15: Radiation Protection

    WS-Motorized-T-001 | Introduction | 15 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 16: Monitoring Of Personnel

    16 | WS-Motorized-T-001 | Introduction 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 17: Protected Area And Significant Zones Of Occupancy

    WS-Motorized-T-001 | Introduction | 17 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 18 18 | WS-Motorized-T-001 | Introduction CAUTION: The radiation protection has to be applied to the patient and to the operator. Related Links Radiation Protection on page 15 Significant zones of occupancy at the radiographic wall stand 50 cm Phantom X-ray tube Focal spot label [—]...
  • Page 19 WS-Motorized-T-001 | Introduction | 19 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...

  • Page 20: Labels

    20 | WS-Motorized-T-001 | Introduction 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 21 WS-Motorized-T-001 | Introduction | 21 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 3255F EN 20210312 1125...

  • Page 22: Warning Labels On The Radiographic Wall Stand

    22 | WS-Motorized-T-001 | Introduction Warning labels on the radiographic wall stand Figure 5: Warning labels on the radiographic wall stand 3255F EN 20210312 1125...

  • Page 23: Additional Labeling Of The Radiographic Wall Stand

    WS-Motorized-T-001 | Introduction | 23 Additional Labeling of the Radiographic Wall Stand Type label on the rear side of the bucky. The type label information for each combina- tion of X-ray tube and X-ray generator is availa- ble in the technical data.

  • Page 24: Cleaning And Disinfecting

    24 | WS-Motorized-T-001 | Introduction Cleaning and Disinfecting All appropriate policies and procedures should be followed to avoid contamination of the staff, patients and equipment. All existing universal precautions should be extended to avoid potential contaminations and to avoid patients coming into (close) contact with the device. The user is responsible for selecting a disinfection procedure.

  • Page 25: Cleaning

    WS-Motorized-T-001 | Introduction | 25 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 26: 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 27: Disinfecting Safety Directions

    WS-Motorized-T-001 | Introduction | 27 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 28: Approved Disinfectants

    28 | WS-Motorized-T-001 | Introduction Approved disinfectants Refer to the Agfa website for specifications on the disinfectants that have been found compatible with the cover material of the device and can be used on the outer surface of the device.

  • Page 29: Maintenance

    WS-Motorized-T-001 | Introduction | 29 Maintenance Complete maintenance schedules are available in the Agfa service documentation for consultation by an Agfa trained and authorized service engineer. 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 30 30 | WS-Motorized-T-001 | Introduction Periodic maintenance The equipment shall have a technical mainte- Every 12 months or after nance to maintain fault-free operation and 75.000 cycles, whatever ensure safety for patient and operator. comes first All steel cables of X-ray tube head unit and ra-...

  • Page 31: Safety Directions

    WS-Motorized-T-001 | Safety Directions | 31 Safety Directions 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 32 32 | WS-Motorized-T-001 | Safety Directions 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. 3255F EN 20210312 1125...

  • Page 33: Radiographic Wall Stand

    WS-Motorized-T-001 | Radiographic Wall Stand | 33 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 bucky has two variants, depending on the orientation for loading a detector or cassette: •...
  • Page 34 34 | WS-Motorized-T-001 | Radiographic Wall Stand CAUTION: The format indications on the front panel show the format of the cassette or detector. Take into account that the actual area for imaging is smaller than indicated. The image of the exposed object is slightly magnified because there is a distance between the front panel and the cassette or detector.

  • Page 35: Positioning The Radiographic Wall Stand

    WS-Motorized-T-001 | Radiographic Wall Stand | 35 Positioning the Radiographic Wall Stand Vertical movement handle with brake switch Tilting angle scale Tilting handle Figure 8: 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 36 36 | WS-Motorized-T-001 | Radiographic Wall Stand To stop movement and lock the bucky into position, release the switch. CAUTION: The maximum load for the bucky movement in vertical direction is 20 kg. The bucky may slip downward when applying excessive load.

  • Page 37: Tracking The Radiographic Wall Stand

    WS-Motorized-T-001 | Radiographic Wall Stand | 37 Tracking the radiographic wall stand The position tracking button on the main screen of the tube head display indicates if tracking can be performed. Table 2: Tracking status Tracking can be performed but is not activated.
  • Page 38 38 | WS-Motorized-T-001 | Radiographic Wall Stand Table 3: Tracking status Tracking is activated. 2. Adjust the wall stand bucky height, the height of the X-ray tube or the alpha rotation of the X-ray tube head. The corresponding component (X-ray tube or wall stand bucky) is moving accordingly.

  • Page 39: Radiographic Wall Stand Accessories

    WS-Motorized-T-001 | Radiographic Wall Stand | 39 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 40: Patient Hand Grips

    40 | WS-Motorized-T-001 | Radiographic Wall Stand Patient hand grips The patient hand grips for wall stand are mounted fixed at the backside of the bucky. The patient uses these grips for stabilization and support of correct correct positioning, e.g. for chest exams.

  • Page 41: Mounting The Lateral Arm Rest

    WS-Motorized-T-001 | Radiographic Wall Stand | 41 Mounting the lateral arm rest CAUTION: The lateral arm rest can bear up to 20 kg. It is not intended to hold the whole weight of a patient. Take care that the lateral arm rest does not collide with the ceiling when moving the bucky upward manually.

  • Page 42: Spacer

    42 | WS-Motorized-T-001 | Radiographic Wall Stand Spacer The spacer allows examination of sitting patients by offering additional space to position legs and feed under the bucky. Figure 11: Spacer 3255F EN 20210312 1125...

  • Page 43: Wall Stand Fixation Kit

    WS-Motorized-T-001 | Radiographic Wall Stand | 43 Wall stand fixation kit For additional stability of the radiographic wall stand an additional fixation of the radiographic wall stand is provided. The kit is installed at backside of the radiographic wall stand under the head cover and then fixed to a wall. It has to be installed by service.

  • Page 44: Product Information

    44 | WS-Motorized-T-001 | Product Information Product Information Topics: • Compatibility • Compliance • Equipment Classification • Product Complaints • Environmental protection • Training • Technical Data • Remarks for HF-emission and immunity 3255F EN 20210312 1125...

  • Page 45: 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 46: General

    46 | WS-Motorized-T-001 | Product Information 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 • CSA C22.2 60601-1 •...

  • Page 47: X-Ray Safety

    WS-Motorized-T-001 | Product Information | 47 X-Ray Safety • IEC 60601-1-3 • IEC 60601-2-54 • IEC 60601-2-28 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 48: Equipment Classification

    48 | WS-Motorized-T-001 | Product Information Equipment Classification Per EN/IEC 60601-1, EN/IEC 60601-2-54, this device is classified as following: Table 5: 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 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: Environmental Protection

    50 | WS-Motorized-T-001 | Product Information Environmental protection Figure 12: WEEE symbol Figure 13: 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 51: 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 52: Technical Data

    52 | WS-Motorized-T-001 | Product Information Technical Data Topics: • Wall Stand Technical Data Wall Stand Technical Data Manufacturer Agfa NV Septestraat 27 2640 Mortsel, Belgium Type WS-Motorized-T-001 5522/600 Dimensions Height 2245 mm Width 610 mm (only front panel) 715 mm (with tilting handles)
  • Page 53 WS-Motorized-T-001 | Product Information | 53 FDA 21 CFR § 1020.30 (n) with 100kV and HVL 3.6 mm Al Weight Radiographic wall stand 196 kg Radiographic wall stand with spacer 205 kg Maximum load on the bucky (verti- 32 kg...

  • Page 54: Remarks For Hf-Emission And Immunity

    54 | WS-Motorized-T-001 | 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.
  • Page 55 WS-Motorized-T-001 | 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...
  • Page 56 56 | WS-Motorized-T-001 | 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-...
  • Page 57 WS-Motorized-T-001 | 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 | WS-Motorized-T-001 | Product Information • Cables, transducers and accessories • Maintenance on EMC relevant parts 3255F EN 20210312 1125...

  • Page 59: Immunity To Rf Wireless Communication Equipment

    WS-Motorized-T-001 | 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 | WS-Motorized-T-001 | 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: Cables, Transducers And Accessories

    WS-Motorized-T-001 | Product Information | 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...
  • Page 62 62 | WS-Motorized-T-001 | Product Information remark TP_T; type; maximum length (m) Master ME/ES Signal Basic wiring 3 x AWG22; CAN Signal Basic wiring / Extension Standard RS-232 cable not allowed (9 Pin D-SUB); Bucky D. exp. / Bucky se- Basic wiring 7 x AWG20;...
  • Page 63 WS-Motorized-T-001 | Product Information | 63 remark TP_WS; type; maximum length CAN Signal Basic wiring for DR 400-600 Standard RS-232 WS / Extension not allowed cable (9 Pin D- SUB); X8 24V Basic wiring for DR 400-600 2 x AWG16;...
  • Page 64 64 | WS-Motorized-T-001 | Product Information remark type; maximum length (m) 230V Power Supply Basic wiring 3x AWG18; PE Cable Basic wiring 1x AWG10; Basic wiring 2 x AWG22; LAN for THU Basic wiring CAT6 (Energy chain); HV 1 / 2 Basic wiring 3 x AWG16;...

  • Page 65: Maintenance On Emc Relevant Parts

    WS-Motorized-T-001 | Product Information | 65 Maintenance on EMC relevant parts Concerning the EMC safety of the DR 600 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.

This manual is also suitable for:

5522/600

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