AGFA CR 30-X User Manual
  1. Manuals
  2. Brands
  3. AGFA Manuals
  4. Measuring Instruments
  5. CR 30-X
  6. User manual

AGFA CR 30-X User Manual

Hide thumbs Also See for CR 30-X:
Table of Contents

Advertisement

Quick Links

See also: Service Manual , User Manual
CR 30-X
(type 5175/200, 5175/205)
CR 30-Xm
(type 5179/100)
User Manual
2386G EN 20120110

Advertisement

Table of Contents
loading

Related Manuals for AGFA CR 30-X

Summary of Contents for AGFA CR 30-X

  • Page 1 CR 30-X (type 5175/200, 5175/205) CR 30-Xm (type 5179/100) User Manual 2386G EN 20120110...
  • Page 2 Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or its affiliates. CR 30-X/CR 30-Xm, NX, ADC QS and ADC VIPS are trademarks of Agfa HealthCare N.V., 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 3: Table Of Contents

    Maintenance ....................25 Environmental Protection................28 Safety Directions ................... 29 Quality Control....................32 Chapter 2: Getting Started with the CR 30-X/CR 30-Xm ....33 Basic Features .................... 34 CR 30-X/CR 30-Xm Features ................. 34 Operating Modes................... 35 The User Interface ..................36 Starting the Device..................
  • Page 4 CR 30-X/CR 30-X Reading the Initialization Data of an Image Plate........45 Troubleshooting ..................46 Troubleshooting Checklist ................46 Removing a Jammed Image Plate..............50 Behavior in Case of Power Failure ..............52 Appendix A: Equipment Information Sheet ........53 Specifications .................... 54 Appendix B: Remarks for HF-emission and immunity ....59...

  • Page 5: Chapter 1: Introduction

    Chapter Introduction This chapter covers the following topics: Introduction to this Manual Introduction to CR 30-X/CR 30-Xm...

  • Page 6: Introduction To This Manual

    CR 30-X/CR 30-X Introduction to this Manual This section covers the following topics: Scope Warnings, Cautions, Instructions and Notes Disclaimer Scope This manual contains information for safe and effective operation of the CR 30-X and CR 30-Xm digitizer. Warnings, Cautions, Instructions and Notes The following samples illustrate how warnings, cautions, instructions and notes appear in this document.

  • Page 7: Disclaimer

    Disclaimer Agfa assumes no liability for use of this document if any unauthorized changes have been made to the content or format. Every care has been taken to ensure the accuracy of the information in this document.

  • Page 8: Introduction To Cr 30-X/Cr 30-Xm

    CR 30-X/CR 30-X Introduction to CR 30-X/CR 30-Xm This section covers the following topics: Intended Use Intended User Configuration System Documentation Training Product Complaints Compatibility Compliance Connectivity Installation Labels Cleaning and Disinfection Patient data security Environmental Protection Safety Directions Introduction...

  • Page 9: Intended Use

    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 10: Configuration

    The digitizer must not be connected to any version of the Agfa ADC QS or ADC VIPS software. digitizer Control PC Dedicated configuration For more information, refer also to the CR 30-X/CR 30-Xm System User Manual, document 2385. Introduction 2386G EN 20120110...

  • Page 11: System Documentation

    The documentation shall be kept with the system for easy reference. Technical documentation is available in the product service documentation which is available from your local support organization. Refer to the CR 30-X/CR 30-Xm System User Manual, document 2385, before operating the product. 2386G EN 20120110...

  • Page 12: Training

    CR 30-X/CR 30-X Training The user must have received adequate Agfa training on the safe and effective use of the product before attempting to work with it. Training requirements may vary from country to country. The user should ensure that training is received in accordance with local laws or regulations that have the force of law.

  • Page 13: Compatibility

    Compatibility The digitizer 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 14: Compliance

    CR 30-X/CR 30-X Compliance The digitizer has been designed in accordance with the MEDDEV Guidelines relating to the application of Medical Devices and have been tested as part of the conformity assessment procedures required by 93/42/EEC MDD (European Council Directive 93/42/EEC on Medical Devices).
  • Page 15 It is a multilateral agreement among participating countries and certification organizations. Agfa has produced a CB test report and claims national certification in all other member countries of the CB Scheme.

  • Page 16: Connectivity

    CR 30-X/CR 30-X Connectivity The digitizer is connected to the workstation via Ethernet connection and uses the DICOM protocol to communicate with the workstation. Installation Caution: When installing the digitizer, care must be taken to ensure that there is either a mains plug or an all-cable disconnecting device in the internal installation fitted near the digitizer and that it is easily accessible.
  • Page 17 CR 30-X/CR 30-X WARNING: The device is a table-top digitizer. The structure and stability of the table used, need to be suitable in relation with the size and weight of the system. The table should not be subject to excessive shock and vibrations from other sources, as this may disturb the operation of the digitizer.
  • Page 18 Identify the cassette as System Diagnosis Mammo - Flat Field Mammo. Check the flat field image on the NX workstation for homogeneity and stripe artifacts. In case of problems, please inform your local Agfa service representative. Introduction 2386G EN 20120110...

  • Page 19: Product Identification

    CR 30-X/CR 30-X Product Identification CR 30-X product description Type of product Table-top digitizer Commercial name CR 30-X 5175/200 Model number 5175/205 Agfa HealthCare N.V. Septestraat 27 Original seller / manufacturer 2640 Mortsel Belgium CR 30-Xm product description Type of product...

  • Page 20: Labels

    Do not put your fingers in the input slot of the digitizer, they can get hurt when caught between the cassette and the fixation. Insert the cassette as described in the basic workflow of the CR 30-X/ CR 30-Xm System User Manual, document 2385.
  • Page 21 CR 30-X/CR 30-X Cassette positioning. Insert the cassette as described in the basic workflow of the CR 30-X/ CR 30-Xm System User Manual, document 2385. Off (power: disconnection from the mains) On (power: connection to the mains) Note: The type label of the CR 30-Xm digitizer is placed at the chassis in the upper left corner when opening the front cover.
  • Page 22 CR 30-X/CR 30-X Safety Instructions for Laser Products CAUTION! CUIDADO! CLASS 3B LASER RADIATION: RAYO LASER CLASE 3B: WHEN OPEN AVOID DIRECT EVITAR LA EXPOSICIÓN AL HAZ EXPOSURE TO THE BEAM! CUANDO LA TAPA ESTÁ ABIERTA. VORSICHT ! ATTENTION! CLASS 1 LASER PRODUCT...

  • Page 23: Cleaning And Disinfection

    Details about cleaning can be found in the following pages. For cleaning and disinfection instructions of the plates and cassettes, refer to the CR 30-X/CR 30-Xm Plates and Cassettes User Manual. To clean the exterior of the digitizer: Switch off the digitizer.

  • Page 24: Patient Data Security

    CR 30-X/CR 30-X Patient data security It is the responsibility of the hospital to ensure how the patients’ legal requirements are to be met, how the security of the patient records are: • maintained and tested, • audited, • administered locally to cover risks from third party access, •...

  • Page 25: Maintenance

    Regular preventive maintenance needs to be done once a year or after 12000 cycles (whatever comes first). This maintenance can not be done by the user but has to be done by an Agfa certified field service engineer. Not performing the regular maintenance by appropriately certified people can have impact on warranty commitments.
  • Page 26 CR 30-X/CR 30-X To clean the optic unit, proceed as follows: Open the cassette unit. Take out the cleaning brush. Open the lid positioned at the right side. Open lid Introduction 2386G EN 20120110...
  • Page 27 CR 30-X/CR 30-X Clean the scan line. Your last movement must be continuous from the rear to the front. Re-insert the cleaning brush. Close the cassette unit Caution: Misuse of the bowden wire leads to bending, which causes a complicated replacement of the cleaning brush.

  • Page 28: Environmental Protection

    For more detailed information about take-back and recycling of this product please contact your local Agfa service organization and/or Agfa dealer. By ensuring this product is disposed of correctly, you will help prevent potential negative consequences for the environment and human health, which could otherwise be caused by inappropriate waste handling of this product.

  • Page 29: Safety Directions

    WARNING: Safety is only guaranteed when trained Agfa personnel has installed the digitizer. WARNING: All Agfa medical products must be used by Agfa trained and qualified personnel. WARNING: The user is responsible for judging image quality and controlling environmental conditions for diagnostic softcopy or print viewing.

  • Page 30: General Safety Instructions

    A regular quality control is recommended. • If you don’t operate the digitizer correctly or if you don’t have it serviced correctly, Agfa is not liable for resulting disturbances, damages or injuries. Introduction 2386G EN 20120110...
  • Page 31 CR 30-X/CR 30-X • If you notice conspicuous noise or smoke, disconnect the digitizer immediately. • Do not pour water or any other liquid over the device. • The digitizer complies with the EN 60601-1 and UL 60601-1 standards for Medical Electrical Equipment.

  • Page 32: Quality Control

    Quality Control Apply regular quality control according local regulations. If no specific regulations are valid, a regular quality control by means of the Agfa Auto QC2 tool is required at least once a month to maintain a safe and effective system.

  • Page 33: Chapter 2: Getting Started With The Cr 30-X/Cr 30-Xm

    Chapter Getting Started with the CR 30-X/CR 30-Xm This chapter explains how to perform the first basic actions on the digitizer. This chapter covers the following topics: Basic Features Starting the Device Basic Workflow Stopping the Device...

  • Page 34: Basic Features

    The digitizer permits re-erasing an image plate before reusing it. In specific cases, this is necessary to prevent ghost images caused by previous exposures or stray radiation from interfering with the image of interest. With the dedicated ID station of the CR 30-X/CR 30-Xm, the following features are available: •...

  • Page 35: Operating Modes

    All functions of the operator mode are described in this manual. Service Mode The service mode functions are reserved for trained service personnel. They are password protected, and they are described in a separate document. 2386G EN 20120110 Getting Started with the CR 30-X/CR 30-Xm...

  • Page 36: The User Interface

    The functions of the operator mode are described in this manual. The digitizer interfaces with the user via: • an erase button, • a status indicator. Status indicator Erase button DICOM Ethernet connection Main switch Getting Started with the CR 30-X/CR 30-Xm 2386G EN 20120110...
  • Page 37 Wait. IP into cassette Constant Service mode Check workstation for further • Warm up / Self-test information and detailed • Processing Software Flashing instructions. down • Error 2386G EN 20120110 Getting Started with the CR 30-X/CR 30-Xm...

  • Page 38: Starting The Device

    Note: During the self-test, you cannot activate any functions. If the digitizer has completed the self-test successfully, the digitizer enters the operator mode and the status indicator is continuously lighting up in green. Getting Started with the CR 30-X/CR 30-Xm 2386G EN 20120110...

  • Page 39: Basic Workflow

    CR 30-X/CR 30-X Basic Workflow Note: The basic workflow is described in the CR 30-X/CR 30-Xm System User Manual, document 2385. Briefly: The digitizer starts reading out the image plate as soon as it has received the complete identification data from the NX Station (via DICOM Ethernet).

  • Page 40: Stopping The Device

    Switching on the digitizer takes approximately 60 seconds. During this time emergency digitizing is not possible! To switch off, press the main switch to the Off (“0”) position. Main switch Getting Started with the CR 30-X/CR 30-Xm 2386G EN 20120110...

  • Page 41: Chapter 3: Operating Cr 30-X/Cr 30-Xm

    Chapter Operating CR 30-X/ CR 30-Xm This chapter provides information about functions that are available in operator mode. Finally you will find some preventive maintenance and troubleshooting guidelines. This chapter covers the following topics: Reading an Emergency Image Plate Re-erasing an Image Plate...

  • Page 42: Reading An Emergency Image Plate

    CR 30-X/CR 30-X Reading an Emergency Image Plate Note: Reading an emergency image plate is described in the CR 30-X/ CR 30-Xm System User Manual, document 2385. Briefly: In emergency situations, it is possible to open an emergency exam at the NX workstation without patient details and to digitize without having identified the cassette.

  • Page 43: Re-Erasing An Image Plate

    Press the erase button at the front side. The upper part of the status indicator is continuously lighting up in blue. The lower part of the status indicator is continuously lighting up in green. 2386G EN 20120110 Operating CR 30-X/CR 30-Xm...
  • Page 44 Remove the cassette from the cassette slot. To erase a second cassette, the erase mode has to be accessed again. Operating CR 30-X/CR 30-Xm 2386G EN 20120110...

  • Page 45: Reading The Initialization Data Of An Image Plate

    Reading the Initialization Data of an Image Plate Note: Reading the Initialization Data of an Image Plate is described in the CR 30-X/CR 30-Xm System User Manual, document 2385. Briefly: The initialization data stored in the RF-tag of the tray can be read via the digitizer.

  • Page 46: Troubleshooting

    Other errors need more detailed information and instructions to repair the malfunction, or they can only be fixed by a Service engineer. In this case, consult the ASAP UI (Agfa Service Access Package User Interface) messages on the control PC.
  • Page 47 CR 30-X/CR 30-X Errors During Operation If errors occur during operation, you can consult the Agfa Service Access Package (ASAP) messages on the control PC. The ASAP UI is independent from the NX Software. Status Condition Control PC message Action...
  • Page 48 After the image plate or cassette tray is missing. inserted correctly or unlocking: tray e.g. tray is Remove cassette.” use another cassette green, missing or was and call service. constant not inserted correctly. Operating CR 30-X/CR 30-Xm 2386G EN 20120110...
  • Page 49 Messages will stay active until the problem is solved or the dialog box message on the control PC is confirmed by clicking the OK button. Note: For error messages not listed in the table above, please refer to the instructions within the displayed error message text. 2386G EN 20120110 Operating CR 30-X/CR 30-Xm...

  • Page 50: Removing A Jammed Image Plate

    While handling the image plate, prevent exposing it to daylight as much as possible. To open the front cover: Simultaneously press the two buttons positioned underneath the feed table. Operating CR 30-X/CR 30-Xm 2386G EN 20120110...
  • Page 51 Note: Never use force to clear the jammed image plate. If it is not possible to gently remove the image plate, call your local service organization. Note: After a jam, the image plate can be used again if not damaged. Close the front cover. 2386G EN 20120110 Operating CR 30-X/CR 30-Xm...

  • Page 52: Behavior In Case Of Power Failure

    Behavior in Case of Power Failure Note: The description below is only applicable if an uninterruptible power supply (UPS) is put into the CR 30-X/CR 30-Xm System configuration. For more information, refer to the CR 30-X/CR 30-Xm System User Manual, document 2385.

  • Page 53: Appendix A: Equipment Information Sheet

    Appendix Equipment Information Sheet This appendix covers the following topic: Specifications...

  • Page 54: Specifications

    CR 30-X/CR 30-X Specifications Labelling 93/42 EEC 'Medical Devices' (Europe), EN 60601-1 ETL us certified, UL 60601-1 Second Edition c ETL us (North America) c ETL us c ETL certified CSA 22.2 No 601.1 Dimensions Length 786 mm Width 693 mm...

  • Page 55: Power Consumption

    Sunlight exposure 2500 lux Environmental conditions (during storage) In line with IEC721-3-1: 1K2 (CR 30-X) / 1K4 (CR 30-Xm) and 1M2 Temperature -25 °C to +55 °C Environmental conditions (during transport) In line with IEC721-3-2: 2K2 and 2M2 with following restrictions: Temperature -25 °C to +60 °C...
  • Page 56 • Standby max. 55 dB(A) Heat emission • Standby 60 W ≈ 204 BTU/h CR 30-X: 85 W ≈ 290 BTU/h • Average power consumption during scanning CR 30-Xm: 103 W ≈ 351 BTU/h CR 30-X: 190 W ≈ 648 BTU/h •...
  • Page 57 CR 30-X/CR 30-X Preventive maintenance Preventive maintenance frequency. Once a year or 12000 cycles, whatever comes Note: Needs to be done by an Agfa certified first. field service engineer. 1. BTU: British Thermal Unit 2386G EN 20120110 Equipment Information Sheet...
  • Page 58 CR 30-X/CR 30-X Equipment Information Sheet 2386G EN 20120110...

  • Page 59: Appendix B: Remarks For Hf-Emission And Immunity

    Appendix Remarks for HF-emission and immunity...

  • Page 60: Remarks For Hf-Emission And Immunity

    CR 30-X/CR 30-X Remarks for HF-emission and immunity The device has been tested for a normal hospital environment as described below. The user of the device should ensure that it is used in such an environment. Nevertheless the HF-emission and immunity can be influenced by connected data cables depending on length and the manner of installation.
  • Page 61 CR 30-X/CR 30-X 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. Resistance to IEC 60601 Level of Electromagnetic Jamming Test Test Level...
  • Page 62 CR 30-X/CR 30-X 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. Tests of Resistance IEC 60601 Level of Electromagnetic to Disruption...
  • Page 63 CR 30-X/CR 30-X The device uses a short range device class 1 (7 dBµA/m at 10 m) with ISM-Band 13.56 MHz). • REMARK 1: The higher value will apply at 80 MHz and 800 MHz. • REMARK 2: These Guidelines may not apply to all situations. The dispersion of electromagnetic waves is influenced by absorption and reflections from buildings, objects and people.
  • Page 64 CR 30-X/CR 30-X 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...
  • Page 65 CR 30-X/CR 30-X 2386G EN 20120110...
  • Page 66 0413 Printed in Belgium Published by Agfa HealthCare N.V., B-2640 Mortsel-Belgium 2386G EN 20120110...

This manual is also suitable for:

Cr 30-xm5179/1005175/2005175/205

Table of Contents