AGFA CR 30-X User manual

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

22386G EN 20120110
CR 30-X/CR 30-XM
Manufacturer: Agfa HealthCare NV, Septestraat 27, B-2640 Mortsel - Belgium
For more information on Agfa products and Agfa HealthCare products, please visit www.agfa.com.
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.
Agfa HealthCare N.V. makes no warranties or representation, expressed or implied, with respect to the accu-
racy, completeness or usefulness of the information contained in this document and specifically disclaims war-
ranties of suitability for any particular purpose. Products and services may not be available for your local area.
Please contact your local sales representative for availability information. Agfa HealthCare N.V. diligently
strives to provide as accurate information as possible, but shall not be responsible for any typographical error.
Agfa HealthCare N.V. shall under no circumstances be liable for any damage arising from the use or inability to
use any information, apparatus, method or process disclosed in this document. Agfa HealthCare N.V. reserves
the right to make changes to this document without prior notice.
Copyright 2012Agfa HealthCare N.V.
All rights reserved.
Published by Agfa HealthCare N.V.
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 HealthCare N.V.
0413

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Table of Contents
Chapter 1: Introduction.................................................................. 5
Introduction to this Manual ......................................................................... 6
Scope .............................................................................................................. 6
Warnings, Cautions, Instructions and Notes..................................................... 6
Disclaimer ....................................................................................................... 7
Introduction to CR 30-X/CR 30-Xm.............................................................. 8
Intended Use ................................................................................................... 9
Intended User.................................................................................................. 9
Configuration................................................................................................ 10
System Documentation ................................................................................. 11
Training ........................................................................................................ 12
Product Complaints ....................................................................................... 12
Compatibility ................................................................................................ 13
Compliance ................................................................................................... 14
Connectivity .................................................................................................. 16
Installation.................................................................................................... 16
Product Identification.................................................................................... 19
Labels............................................................................................................ 20
Cleaning and Disinfection.............................................................................. 23
Patient data security...................................................................................... 24
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..................................................................................... 38
Basic Workflow .......................................................................................... 39
Stopping the Device ................................................................................... 40
Chapter 3: Operating CR 30-X/CR 30-Xm..................................... 41
Reading an Emergency Image Plate ........................................................... 42
Re-erasing an Image Plate.......................................................................... 43

42386G EN 20120110
CR 30-X/CR 30-XM
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
Remarks for HF-emission and immunity ................................................... 60

Introduction
This chapter covers the following topics:
TIntroduction to this Manual
TIntroduction to CR 30-X/CR 30-Xm
Chapter 1

62386G EN 20120110Introduction
CR 30-X/CR 30-XM
Introduction to this Manual
This section covers the following topics:
QScope
QWarnings, Cautions, Instructions and Notes
QDisclaimer
Scope
This manual contains information for safe and effective operation of the
CR 30-XTM and CR 30-XmTM digitizer.
Warnings, Cautions, Instructions and Notes
The following samples illustrate how warnings, cautions, instructions and
notes appear in this document. The text explains their intended use.
The purpose of safety icons is to indicate at a glance the type of caution,
warning or danger.
WARNING: Warnings are directions which, if they are not followed,
can cause fatal or serious injuries to a user, engineer, patient or any
other person or can lead to a mistreatment.

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CR 30-X/CR 30-XM
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. However, Agfa assumes no responsibility or liability for errors,
inaccuracies or omissions that may appear in this document. To improve
reliability, function or design Agfa reserves the right to change the product
without further notice. This manual is provided without warranty of any kind,
implied or expressed, including, but not limited to, the implied warranties of
merchantability and fitness for a particular purpose.
Caution: Cautions are directions which, if they are not followed, can
cause damage to the equipment described in this manual or any other
equipment or goods and can cause environmental pollution.
Instruction: This sign is used typically in combination with the warning sign
when providing a specific instruction, which if followed exactly, should avoid
the subject of the warning.
Note: Notes provide advice and highlight unusual points. A note is not
intended as an instruction.
Note: In the United States, Federal Law stipulates that medical devices
should only be sold to, distributed and used by or by order of a licensed
physician.

82386G EN 20120110Introduction
CR 30-X/CR 30-XM
Introduction to CR 30-X/CR 30-Xm
This section covers the following topics:
QIntended Use
QIntended User
QConfiguration
QSystem Documentation
QTraining
QProduct Complaints
QCompatibility
QCompliance
QConnectivity
QInstallation
QLabels
QCleaning and Disinfection
QPatient data security
QEnvironmental Protection
QSafety Directions

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Intended Use
This device must only be used to scan exposed X-ray cassettes, containing an
erasable image plate (IP). The digitizer is part of a system, consisting of X-ray
cassettes with erasable phosphor image plates and a workstation where the X-
ray cassettes are identified and the resulting digital image information is
further processed and routed. It is intended that this device is only operated
in a radiological environment by qualified staff.
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.
Before attempting to work with this equipment, the user must read,
understand, note and strictly observe all warnings, cautions and safety
markings on the equipment.

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Configuration
The digitizer is always dedicated to a single workstation, on which the
identification software as well as the image processing software is running.
The identification data are transmitted from the workstation to the digitizer
via DICOM Ethernet. For more information, refer to the workstation’s On-line
Help manuals or contact your local service organization.
For more information, refer also to the CR 30-X/CR 30-Xm System User
Manual, document 2385.
Caution: The digitizer must not be connected to any version of the Agfa
ADC QSTM or ADC VIPSTM software.
digitizer
Control PC
Dedicated configuration

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2386G EN 20120110 Introduction
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System Documentation
The documentation consists of a User Manual (this document) and a System
Safety User Manual, document 3100.
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.

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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. Your local Agfa representative can provide further information on
training.
The user must note the following information in the preliminary section of
this manual:
QIntended Use
QIntended User
QSafety Directions
Product Complaints
Any health care professional (for example a customer or a user) who has any
complaints or has experienced any dissatisfaction in the quality, durability,
reliability, safety, effectiveness or performance of this product must notify
Agfa.
If the device malfunctions and may have caused or contributed to a serious
injury of a patient, Agfa must be notified immediately by telephone, fax or
written correspondence to the following address:
Agfa Service Support - local support addresses and phone numbers listed on
www.agfa.com
Agfa HealthCare N.V. - Septestraat 27 - 2640 Mortsel, Belgium.
Agfa HealthCare N.V. - Fax [phone].

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2386G EN 20120110 Introduction
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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. Such changes must comply with best engineering
practices and all applicable laws and regulations that have the force of law
within the jurisdiction of the hospital.
Accessory equipment connected to any interfaces must be certified according
to the respective IEC standards (e.g. IEC 950 for data processing equipment
and IEC 60601-1 for medical equipment). Furthermore all configurations
shall comply with the valid version of the system standard IEC 60601-1-1.
Everybody who connects additional equipment to the signal input part or
signal output part configures a medical system, and is therefore responsible
that the system complies with the requirements of the valid version of the
system standard IEC 60601-1-1. If in doubt, consult your local service
organization.

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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).
The digitizer has been designed in accordance with the IEC 60601-1, Ed. 2:
Medical electrical equipment - Part 1: General requirements for basic safety.
Certificates
The digitizer complies with:
•the general safety regulations:
IEC 60601-1 / EN 60601-1,
IEC 60601-1-1:2000 / EN 60601-1-1:2001,
IEC 62304:2006 / EN 62304:2006,
IEC 60601-1-6:2006 / EN 60601-1-6:2007,
IEC 60601-1-2:2007 / EN 60601-1-2:2007,
UL 60601-1:2003,
CAN/CSA C22.2 No. 601.1,
ISO 14971:2009, Medical devices - Application of risk management to medical
devices.
•the laser safety regulations:
IEC 60825-1:2001 / EN 60825-1:1994 + A1:2002 + A2:2001,
IEC 60825-1:2007 / EN 60825-1:2007,
DHHS/FDA 21 CFR, Parts 1040.10 and 1040.11;
•EN 540: 1993,
EN 980: 2008,
EN 1041: 2008,
ISO 18906: 2000,
EN ISO 13485: 2003 / AC: 2009;
•Additional standards for documentation,
IEC 62079 Ed. 1: Preparation of instructions - Structuring, content and
presentation
Note: The digitizer is in compliance with the EG regulation 93/42/EEC
Directive (Medical Device).

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Harmonization
This document has been prepared to comply with the Study Group 1 guidance
document of the Global Harmonization Task Force (GHTF) (www.ghtf.org).
To assist development of a consistent, harmonized definition for a medical
device that could be used within a global regulatory model would offer
significant benefits to the manufacturer, user, patient or consumer, and to
Regulatory Authorities and support global convergence of regulatory systems.
The IECEE CB Scheme is the world's first truly international system for
acceptance of test reports dealing with the safety of electrical and electronic
products. 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.
Radio Interference Suppression
It is hereby certified that the digitizer has interference suppression according
to the EN 55011 Class A as well as the FCC Rules CR47 Part 15 Class A.
WARNING: 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. This equipment generates,
uses and can radiate radio frequency energy and, if not installed and
used in accordance with the instruction manual, may cause harmful
interference to radio communications. Operation of this equipment
in a residential area is likely to cause harmful interference in which
case the user will be required to correct the interference at his own
expense.

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Connectivity
The digitizer is connected to the workstation via Ethernet connection and uses
the DICOM protocol to communicate with the workstation.
Installation
The digitizer is equipped with 2 handles at the bottom left and right sides to
move the device easily to another location. It is recommended to have at least
two persons lift the digitizer.
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.
Caution: The digitizer and the cassette storage shall be protected against
direct radiation in such a way, that the annual dose equivalent at the
place of installation will not exceed 1 mSv/a.
Caution: Do not lift the device by holding the input tray.
Caution: If the digitizer is installed inside an X-ray room it must be
protected from stray radiation by proper shielding.

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Mobile Use Installation
In case of an installation in a mobile environment, such as a bus, van, etc, the
manufacturer of the vehicle should ensure that all components of the system
are fixed or can be fixed safely for transport.
If the digitizer is installed in a mobile environment, it has to be secured
against moving. The optional earthquake kit for wall fixation should be used.
Image quality check after transport
The image quality check must be performed after installation of the digitizer in
a mobile environment and is recommended to be repeated after transport.
The check is done with a flat field exposure and should be performed with a
cassette of the largest format used at customer site.
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.
X-Ray source Exposure conditions
General radiography
It is recommended to expose the cassette with 2 exposures of
10 µGy or 1 mR each. Rotate the cassette 180° after the first
exposure to compensate for the heel effect.
Typical settings for 10 µGy or 1 mR are:
•75kV
•12mAs
• 130 cm SID
•largefocus
• 1.5 mm Copper filter
Identify the cassette as System Diagnosis GenRad - Flat Field.

18 2386G EN 20120110Introduction
CR 30-X/CR 30-XM
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.
Mammography
For Mammography only 1 exposure is needed and no rotation
of the cassette.
Remove the compression paddle before the exposure.
Tape an Aluminum filter at the tube exit.
Insert the cassette in the bucky and make an exposure with the
following settings:
• 28 kV
• 200 mAs
•Mo/Mo
•largefocus
• 2.0 mm Aluminum filter
If this leads to an overexposure, the mAs setting can be
reduced, but it should not be lower than 50 mAs.
Identify the cassette as System Diagnosis Mammo - Flat Field
Mammo.
X-Ray source Exposure conditions

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CR 30-X/CR 30-XM
Product Identification
CR 30-X product description
Type of product Table-top digitizer
Commercial name CR 30-X
Model number 5175/200
5175/205
Original seller / manufacturer
Agfa HealthCare N.V.
Septestraat 27
2640 Mortsel
Belgium
CR 30-Xm product description
Type of product Table-top digitizer
Commercial name CR 30-Xm
Model number 5179/100
Original seller / manufacturer
Agfa HealthCare N.V.
Septestraat 27
2640 Mortsel
Belgium

20 2386G EN 20120110Introduction
CR 30-X/CR 30-XM
Labels
General
Always take into account the markings and labels provided on the inside and
outside of the machine. A brief overview of these markings and labels and
their meaning is given below.
Safety warning, indicating that the manuals should be consulted before
making any connections to other equipment. The use of accessory equipment
not complying with the equivalent safety requirements of this digitizer may
lead to a reduced level of safety of the resulting system. Consideration
relating to the choice of accessory equipment shall include:
• Use of the accessory equipment in the patient vicinity,
• Evidence that the safety certification of the accessory equipment has been
performed in accordance with the appropriate IEC 601-1 and IEC 601-1-1
harmonized national standard.
In addition all configurations must comply with the medical electrical
systems standard IEC 601-1-1. The party that makes the connections acts as
system configurator and is responsible for complying with the systems
standard.
If required contact your local service organization.
In order to reduce the risk of electric shock, do not remove any covers.
Caution hot:
Keep hands clear from the erasure unit.
Supplementary protective earth connector:
Provides a connection between the digitizer and the potential equalization
busbar of the electrical system as found in medical environments. This plug
should never be unplugged before the power is turned off and the power plug
has been removed.
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.