CR 30-X

(type 5175/200, 5175/205)

CR 30-Xm
(type 5179/100)
User Manual
m

2386G EN 20120110
 CR 30-X/CR 30-XM

0413
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 2012 Agfa 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.

2 2386G EN 20120110
 CR 30-X/CR 30-XM

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

2386G EN 20120110
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 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

4 2386G EN 20120110
 Chapter 1
Introduction

This chapter covers the following topics:

T Introduction to this Manual

T Introduction to CR 30-X/CR 30-Xm
 CR 30-X/CR 30-XM

Introduction to this Manual

This section covers the following topics:

Q Scope

Q Warnings, Cautions, Instructions and Notes

Q Disclaimer

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.

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.

The purpose of safety icons is to indicate at a glance the type of caution,

warning or danger.

6 Introduction 2386G EN 20120110

 CR 30-X/CR 30-XM

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.

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.

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.

2386G EN 20120110 Introduction

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 CR 30-X/CR 30-XM

Introduction to CR 30-X/CR 30-Xm

This section covers the following topics:

Q Intended Use

Q Intended User

Q Configuration

Q System Documentation

Q Training

Q Product Complaints

Q Compatibility

Q Compliance

Q Connectivity

Q Installation

Q Labels

Q Cleaning and Disinfection

Q Patient data security

Q Environmental Protection

Q Safety Directions

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 CR 30-X/CR 30-XM

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.

2386G EN 20120110 Introduction

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 CR 30-X/CR 30-XM

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.

Caution: The digitizer must not be connected to any version of the Agfa
ADC QSTM or ADC VIPSTM software.

digitizer

Control PC

Dedicated configuration

For more information, refer also to the CR 30-X/CR 30-Xm System User
Manual, document 2385.

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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.

2386G EN 20120110 Introduction

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 CR 30-X/CR 30-XM

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:

Q Intended Use

Q Intended User

Q Safety 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 +32 3 444 7094.

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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.

2386G EN 20120110 Introduction

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 CR 30-X/CR 30-XM

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).

14 Introduction 2386G EN 20120110

 CR 30-X/CR 30-XM

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.

2386G EN 20120110 Introduction

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 CR 30-X/CR 30-XM

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.

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: 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.

16 Introduction 2386G EN 20120110

 CR 30-X/CR 30-XM

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.

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.

X-Ray source Exposure conditions

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:
• 75 kV
General radiography • 12 mAs
• 130 cm SID
• large focus
• 1.5 mm Copper filter
Identify the cassette as System Diagnosis GenRad - Flat Field.

2386G EN 20120110 Introduction

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 CR 30-X/CR 30-XM

X-Ray source Exposure conditions

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
Mammography • 200 mAs
• Mo/Mo
• large focus
• 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.

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.

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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

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 Table-top digitizer

Commercial name CR 30-Xm

Model number 5179/100

Agfa HealthCare N.V.
Septestraat 27
Original seller / manufacturer
2640 Mortsel
Belgium

2386G EN 20120110 Introduction

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 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.

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 CR 30-X/CR 30-XM

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.

2386G EN 20120110 Introduction

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 CR 30-X/CR 30-XM

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
LASERSTRAHLUNG KLASSE 3B: FAISCEAU LASER CLASSE 3B:
WENN ABDECKUNG GEÖFFNET QUAND CAPOT OUVERT ÉVITER
APPAREIL A LASER DE CLASSE 1
NICHT DEM STRAHL AUSSETZEN! DE S´EXPOSER AU RAYÓN!

LASERKLASSE 1

The digitizer is a Class 1 Laser Product. It uses one laser diode of a 80 mW

type, classification class IIIb, wavelength 640-670 nm. The laser beam’s
deflection frequency is 120 1/s up to 170 1/s. The laser beam divergence is
12 mrad.
Under normal operating conditions - device with all covers - there can be no
laser radiation outside the digitizer.
The technical concept does not allow the user to remove the top cover. The
concept provides maximum reliability that no image plate jam can occur in
the post scan area.
However, the user is allowed to open the front cover, e.g. to solve cassette or
image plate jams at the front side. When opening the front panel, all motor
driven system movements will be stopped (including the laser).

WARNING: User interventions other than those described in this

manual can be hazardous with regard to laser radiation.

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 CR 30-X/CR 30-XM

Cleaning and Disinfection

All appropriate policies and procedures should be followed to avoid

contamination of the staff, patients and device. All existing universal
precautions should be taken to avoid that the digitizer comes into contact
with potential contaminations. 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:

1 Switch off the digitizer.

2 Remove the power plug from the socket.

Switch off the UPS, if installed.

3 Wipe the exterior of the digitizer with a clean, soft, damp cloth.
Use a mild soap or detergent if required but never use ammonia-based cleaner.

Caution: Make sure no liquid gets in the digitizer.

Note: Do not open the digitizer for cleaning. No components inside the
digitizer require cleaning by the user.

4 Plug the power plug into the socket.

Switch on the UPS, if installed.

2386G EN 20120110 Introduction

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 CR 30-X/CR 30-XM

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,
• how the availability of the services is to be maintained in the event of
disaster.
It is the responsibility of the hospital to ensure how types of access are
identified, classified and reasons for access are justified.

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Maintenance

Preventive 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.

Cleaning and Disinfection

Refer to section “Cleaning and Disinfection” on page 23.

Cleaning the optical unit

The only maintenance action which you must perform is checking the image
quality. Refer to the User Manual of the NXTM Software.
Cleaning the optic unit is required if stripes parallel to the image plate
movement can be seen in the image. When you recognize this type of artefact,
when using the digitizer, clean the optic unit using the cleaning brush.

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 CR 30-X/CR 30-XM

To clean the optic unit, proceed as follows:

1 Open the cassette unit.

2 Take out the cleaning brush.

3 Open the lid positioned at the right side.

Open lid

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 CR 30-X/CR 30-XM

4 Clean the scan line. Your last movement must be continuous from the rear to
the front.

5 Re-insert the cleaning brush.

6 Close the cassette unit

Caution: Misuse of the bowden wire leads to bending, which causes a

complicated replacement of the cleaning brush.

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 CR 30-X/CR 30-XM

Environmental Protection

WEEE end user information

On August 13, 2005, the European Directive on Waste Electrical and
Electronic Equipment (WEEE) 2002/96/EC, amended by Directive 2003/
108/EC came into force.
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. This
directive has to be implemented into national law by the individual European
countries by August 13, 2005.
Due to the implementation into national law, specific requirements can be
different within the European Member States.
This symbol on the products, and/or accompanying documents means that
used electrical and electronic products should not be treated as, or mixed with
general household waste.
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. The
recycling of materials will help to conserve natural resources.

Battery Notice
This wheeled bin symbol on the products, and/or accompanying
documents means that the used batteries should not be treated as, or
mixed with general household waste.
Hg
This wheeled bin symbol on batteries or its packaging may be used in
combination with a chemical symbol. In cases where a chemical symbol is
available it indicates the presence of respective chemical substances. If your
equipment or replaced spare parts contain batteries or accumulators please
dispose of them separately according to local regulations.
For battery replacements please contact your local sales organization.

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 CR 30-X/CR 30-XM

Safety Directions

WARNING: The user must strictly observe all warnings, cautions,

notes and safety markings within this document and on the product.

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.

WARNING: The user must be aware that any error (crash / lock up)
leading to an image processing failure can cause loss of diagnostic
information.

WARNING: The user must follow the hospital quality assurance

procedures for covering the risks resulting from errors in the image
processing.

Caution: Position the digitizer so that it is possible to disconnect the

mains power connection if required.

Caution: The following actions may lead to serious risk of injury and
damage to the equipment as well as making the warranty void:
Q Changes, additions or maintenance to the Agfa products carried out
by persons without appropriate qualifications and training.
Q Using unapproved spare parts.

Caution: To avoid images being lost due to a power failure, the

workstation and the digitizer have to be connected to an uninterruptible
power supply (UPS) or an institutional standby generator.

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 CR 30-X/CR 30-XM

General safety instructions

• Make sure that the digitizer is constantly monitored in order to avoid
inappropriate handling, especially by children.
• Only trained service personnel must make repairs. Only authorized service
personnel must make changes to the digitizer.
• If there is any visible damage to the machine casing, do not start nor use
the digitizer.
• Do not override or disconnect the integrated safety features.
• Do not apply excessive shock or vibration to the digitizer during operation
(e.g. putting cassettes on top of the device). This may decrease the image
quality. Neither should the device be moved during operation.
• Switch off the device before performing any maintenance work or repairs.
Disconnect the digitizer from the mains before making repairs or
performing any maintenance activities during which live electrical
components may be exposed.
• As is the case for all technical devices, the digitizer must be operated, cared
for and serviced correctly. 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.

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 CR 30-X/CR 30-XM

• 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. This means that, although it is absolutely
safe, patients may not come in direct contact with the equipment.
Therefore the operator console must be placed outside a radius of 1.5 m
(EN) or 1,83 m (UL) around the patient (according to the local valid
regulation).

R = 1.5 m (1.83 m)
Patient environment
h= 2.5 m
(2.29 m)

Patient environment

• Perform no other operations on the digitizer than those described in this

document.
• Switch the system off before moving it. When reaching the new position,
switch the system on again.

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 CR 30-X/CR 30-XM

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.
For mammography, Agfa recommends to use the “Routine Quality Control
Tests for Full Field Digital Mammography Systems” document, created by the
NHSBSP (National Health Service Breast Screening Program, UK).

32 Introduction 2386G EN 20120110

 Chapter 2
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:

T Basic Features
T Starting the Device
T Basic Workflow
T Stopping the Device
 CR 30-X/CR 30-XM

Basic Features

CR 30-X/CR 30-Xm Features

The digitizer reads out the latent X-ray images on image plates and sends
them to the workstation.

Q The digitizer accepts one cassette containing one image plate at a time. The
digitizer:
• locks the cassette containing the image plate in the cassette slot,
• removes the image plate from the cassette,
• scans the image plate,
• converts the information of the latent image to digital data,
• transmits the image data to the preview station,
• erases the image plate and re-inserts it into the cassette,
• gives the image plate ID data the status 'erased',
• unlocks the cassette,
• transmits the digital image data to an image processing station
(‘destination’).

Q The digitizer permits assigning the status ‘emergency’ to an image.

Q 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.

Q With the dedicated ID station of the CR 30-X/CR 30-Xm, the following features
are available:
• quickly identifying cassettes without the need for an ID Tablet,
• reading the identification data of a cassette.

34 Getting Started with the CR 30-X/CR 30-Xm 2386G EN 20120110

 CR 30-X/CR 30-XM

Operating Modes

The digitizer can be operated in two modes: operator mode and service mode.

Operator Mode
The operator mode groups all basic functions which are aimed at
radiographers:
• Reading an image plate,
• Reading an emergency image plate,
• Re-erasing an image plate,
• Reading the identification data of a cassette.
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

35
 CR 30-X/CR 30-XM

The User Interface

The digitizer can be operated in two modes:

• the operator mode for basic operation,
• the service mode reserved for trained service personnel.
The functions of the operator mode are described in this manual.
The digitizer interfaces with the user via:
• an erase button,
• a status indicator.
1

1 Status indicator
2 Erase button
DICOM Ethernet
3
connection
4 Main switch

36 Getting Started with the CR 30-X/CR 30-Xm 2386G EN 20120110

 CR 30-X/CR 30-XM

The Erase Button

Press the erase button to start the erasing cycle of an image plate.
After pressing the erase button, the upper part of the status indicator is
continuously lighting up in blue and the digitizer starts erasing the image
plate of the cassette inserted next. If no cassette with image plate has been
inserted after 60 seconds, the system automatically returns to standby mode.
For more information, refer to ‘Re-erasing an Image Plate’ on page 43.

Status Indicator
The indicator informs the user by light signals about the status of the digitizer.
It is positioned at the front of the digitizer, so that it is visible from a distance.
The indicator is divided in two parts. The upper part is
blue
used to inform the operator about the image plate
erasing cycle progress and is only then lit. The lower part green or
is used for all other operational indications. red

Constant/
Color Status Action
Flashing
Activating the erasing
Blue Constant
cycle

• Standby mode • Proceed.

(Ready)
Constant
• Cassette is ready for • Remove cassette.
Green removal

Busy with scanning,

Flashing erasing and return of the Wait.
IP into cassette

Constant Service mode

• Warm up / Self-test Check workstation for further

Red • Processing Software information and detailed
Flashing instructions.
down
• Error

2386G EN 20120110 Getting Started with the CR 30-X/CR 30-Xm

37
 CR 30-X/CR 30-XM

Starting the Device

1 Make sure the digitizer is connected to the Control PC and that the Control PC is
running the appropriate NX Software.
For more information, refer to the NX User Manual.

2 Press the main switch.

Main switch

The machine starts the following operation sequence:

• initialization of all components,
• functional test of all components,
• check for presence of cassettes and/or IPs,
• establish connection to the Control PC.
During the self-test, which may take up to 60 seconds, the digitizer status indicator is
flashing red.

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.

38 Getting Started with the CR 30-X/CR 30-Xm 2386G EN 20120110

 CR 30-X/CR 30-XM

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).

2386G EN 20120110 Getting Started with the CR 30-X/CR 30-Xm

39
 CR 30-X/CR 30-XM

Stopping the Device

Before Switching Off
Check that the digitizer is not scanning an image plate. If the digitizer is
scanning an image plate, the status indicator is flashing green.

Switching Off
It is recommended to switch off the digitizer at the end of the day.

Note: Only switch off the digitizer if you do not intend to digitize emergency
image plates overnight. 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

40 Getting Started with the CR 30-X/CR 30-Xm 2386G EN 20120110

 Chapter 3
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:

T Reading an Emergency Image Plate

T Re-erasing an Image Plate
T Reading the Initialization Data of an Image Plate
T Troubleshooting
 CR 30-X/CR 30-XM

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.

42 Operating CR 30-X/CR 30-Xm 2386G EN 20120110

 CR 30-X/CR 30-XM

Re-erasing an Image Plate

At the end of a normal or emergency digitizing cycle, the digitizer returns an
erased image plate. However, in the following cases, you must re-erase the
image plate before re-using it in order to prevent ghost images from
interfering with the image of interest:
• GenRad: If the image plate has not been used for more than 48 hours.
• Mammography: If the image plate has not been used for more than 24
hours.
• If an image plate has been exposed to an exceptionally high X-ray dose.
In this case, deep layers of the image plate may still retain a latent image
after standard erasure. Leave the image plate to rest at least one day before
re-erasing it.

Note: To re-erase an image plate, you must push the Erase button at the front
side before you insert the cassette. After that, you have 1 minute to enter a
cassette. If you do not, the digitizer returns to the standby mode.

WARNING: When you change the X-ray exposure settings, you must
adapt the erasure level for the image plate accordingly.

To re-erase an image plate:

1 Check that the digitizer is ready for operation:

The status indicator is continuously lighting up in green.

2 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

43
 CR 30-X/CR 30-XM

3 Insert the cassette containing the image plate into the cassette slot [1] as shown
below.
Make sure to insert the cassette with the black side to the top and with the shutter
opening mechanism and the locking mechanism inside the digitizer.
Make sure that the cassette is firmly pushed up to the right side of the slot [2].
Otherwise, the digitizer cannot read the image plate.

As a result, the digitizer starts erasing the image plate:

• The upper part of the status indicator is continuously lighting up in blue.
• The lower part of the status indicator is flashing green.
When the digitizer has finished erasing the cassette, the upper part of the status
indicator is not lit and the lower part is constantly lit in green.

4 Remove the cassette from the cassette slot.

5 To erase a second cassette, the erase mode has to be accessed again.

44 Operating CR 30-X/CR 30-Xm 2386G EN 20120110

 CR 30-X/CR 30-XM

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.

2386G EN 20120110 Operating CR 30-X/CR 30-Xm

45
 CR 30-X/CR 30-XM

Troubleshooting

Troubleshooting Checklist

The troubleshooting for a malfunction of the digitizer consists of two parts:

• The first is always to check the status indicator on the digitizer.
• 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.

General Errors
Error Action
The digitizer does Check the power supply. If the power supply is ok, call your
not start up. local Service engineer.

46 Operating CR 30-X/CR 30-Xm 2386G EN 20120110

 CR 30-X/CR 30-XM

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
indicator
Cassette error

Empty cassette
“Empty cassette found at
(no image plate Red, flashing Remove the cassette
start-up. Remove cassette.”
in cassette)

Switch off the digitizer

and open the front
cover, see page 50. If
there is no image plate
visible in the transport
unit close and switch
on the digitizer. After
restart remove the
cassette from the
digitizer and check if
Empty cassette “Open digitizer to check for there is an image plate
(no image plate image plate jam or check
Red, constant inside the cassette.
in cassette) or for an empty cassette and
In case of an image
image plate jam. restart the digitizer.”
plate jam remove the
plate from the
transport unit
manually and close the
digitizer. Switch on
the digitizer. After
restart remove the
cassette and put the
image plate back into
the cassette.
Errors concerning Identification

Red, flashing.
Confirm the message
Error during “Error during read-out of After
with the OK button
read-out of the ID cassette chip data. Remove unlocking:
and re-identify the
data cassette.” green, cassette.
constant

2386G EN 20120110 Operating CR 30-X/CR 30-Xm

47
 CR 30-X/CR 30-XM

Status
Condition Control PC message Action
indicator
Confirm the message
with the OK button on
Red, flashing.
Error during “Error during writing on PC, remove the
writing on RF-tag cassette chip after After cassette, push the
unlocking:
after scanning successful scan. Erase the erase button on the
green,
process image plate again.” digitizer and re-enter
constant the cassette for a
manual erase cycle.

Digitizer errors
“Failure at erasure module.
Please restart digitizer. If
Erasure lamp
error remains, please Restart the digitizer or
failed during Red, constant
contact service. Image plate call service.
scanning cycle
must be erased after repair
again.”
“Image plate during self-
test in the digitizer
After power failure a
detected. The image plate remaining image
was moved back into the
plate, in the digitizer,
cassette. Please check Red, flashing.
Image plate will be detected and
whether the image is After the forementioned
detected in the
present at the PC and re- unlocking:
digitizer during error message will be
scan the cassette, if green,
self-test displayed.
necessary. If the image is constant
present, the cassette was In order to release the
cassette, confirm the
not erased possibly. Erase
message.
the cassette again in any
case.”

Digitizer cannot
detect the Red, flashing Open the cassette and
cassette chip on
“Cassette chip not readable After check if the tray is
the image plate
or cassette tray is missing. unlocking: inserted correctly or
tray e.g. tray is
Remove cassette.” green, use another cassette
missing or was
constant and call service.
not inserted
correctly.

48 Operating CR 30-X/CR 30-Xm 2386G EN 20120110

 CR 30-X/CR 30-XM

Status
Condition Control PC message Action
indicator
Check if Ethernet
cable is plugged in at
PC and digitizer.
Communication “Image transmission failed.
Visually check if the
error, Ethernet System is retrying. If image
Red, flashing Ethernet cable is
cable is not does not appear, please
damaged. If the error
plugged in restart the PC.”
remains restart PC and
digitizer or call
service.

Time-out after 5 “ID button not pressed

After ID Confirm the message
minutes if the ID within the timeout period.
button has on the PC and press
button of the Image plate was not
been pressed: the ID button of the
image processing scanned. Cassette stays
green, image processing
software was not clamped until ID data are
flashing software.
pressed. supplied by the operator.”

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

49
 CR 30-X/CR 30-XM

Removing a Jammed Image Plate

The user is allowed to open the front cover, e.g. to solve image plate jams at
the front side. When opening the front panel, all motor driven system
movements will be stopped (including the laser).

Note: The technical concept does not allow the user to remove the top cover.
The concept provides maximum reliability that no image plate jam can occur
in the post scan area.

Note: The digitizer always reads and digitizes the plate first, then erases it
and transports it back into the cassette. If a plate jam occurs before the plate
is scanned, there is a fair chance that you can recover the image by putting
the image plate back into the cassette and digitizing it again. While handling
the image plate, prevent exposing it to daylight as much as possible.

To open the front cover:

1 Simultaneously press the two buttons positioned underneath the feed table.

50 Operating CR 30-X/CR 30-Xm 2386G EN 20120110

 CR 30-X/CR 30-XM

2 Slide out the front cover.

3 Remove the jammed image plate.

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.

4 Close the front cover.

2386G EN 20120110 Operating CR 30-X/CR 30-Xm

51
 CR 30-X/CR 30-XM

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.

In case of a power failure, the system is still connected to the UPS. Two
situations are possible:
• Power failure after cassette insertion and before identification with the NX
workstation. The digitizer pushes the image plate back in the cassette
without scanning and releases the cassette. After the power supply returns,
the cassette must be inserted into the digitizer and identified again to read
out the image.
• Power failure after identification with the NX workstation. The image plate
is scanned and erased as usual. The scan cycle finishes when the cassette is
released. If the power supply is still not available, the digitizer will refuse
scanning other cassettes.

52 Operating CR 30-X/CR 30-Xm 2386G EN 20120110

 Appendix A
Equipment Information
Sheet

This appendix covers the following topic:

T Specifications
 CR 30-X/CR 30-XM

Specifications

Labelling
93/42 EEC 'Medical Devices' (Europe),
CE
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
Height 525 mm

Weight
Unpacked approximately 72 kg (158.73 lb)

Electrical connection
Autoranging power supply from: 100 V to
240 V, ac + 10%
Operating voltage
Class I with protection earth
Connect to earthed supply circuitry only.
Mains frequency 50/60 Hz
Current rating 1A 2A
Europe: min. 10 A, max. 16 A
Mains fuse protection
USA & Japan: min. 10 A, max. 15 A
Mains frequency 50/60 Hz

Network connectivity
RJ45 female, 10/100 Mbit/s autosensing,
Ethernet connector
shielding CAT5

54 Equipment Information Sheet 2386G EN 20120110

 CR 30-X/CR 30-XM

Power consumption
Standby
• 220 V - 240 V / 50-60 Hz configuration 60 W
• 100 V - 120 V / 50-60 Hz configuration 60 W
During operation
CR 30-X: max. 190 W
• 220 V - 240 V / 50-60 Hz configuration
CR 30-Xm: max. 220 W
CR 30-X: max. 190 W
• 100 V - 120 V / 50-60 Hz configuration
CR 30-Xm: max. 220 W

Uninterruptible power supply (optional)

120 V
UPS Powerware 5115
ABC ordering code: EGPSE
230 V
UPS Powerware 5115
ABC ordering code: EGPTG

Environmental conditions
recommended: 20 °C to 25 °C
Room temperature
allowed: 15 °C to 30 °C
Maximum temperature change 0.5 °C/min.
recommended: 30 % to 60 %
Relative humidity
allowed: 15 % to 75 % (non-condensing)
Magnetic field compliant with EN 61000-4-8, Level 2
not to be operated in direct sunlight, max.
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

2386G EN 20120110 Equipment Information Sheet

55
 CR 30-X/CR 30-XM

5-200 Hz (vertical, longitudinal, transversal

Vibration
axis)

Environmental conditions for mobile installation (during transport)

In line with IEC721-3-5: 5K2 and 5M2 with following restrictions:

Vibration 5-150 Hz (all axis), 1m/s², sinusoidal vibration

Environmental conditions for mobile installation (during operation)

In line with IEC721-3-3: 3K2 and 3M1 with following restrictions:
Temperature +15 °C to +30 °C
Relative Humidity 15% to 75% (non-condensing)
Vibration 40-200 Hz; 1m/s²; sinusoidal vibration

Warming-up time
Cold start fully operational after max. 30 min.
fully operational after self-test, on condition
that the digitizer:
Warm start • has not been switched off for more than
3 minutes.
• has been operational for at least 30 minutes.

Physical emissions
Noise emission (sound power level according to ISO 7779)
• During scanning max. 65 dB(A)
• Standby max. 55 dB(A)
Heat emission

• Standby 60 W ≈ 204 BTU/h1

• Average power consumption during CR 30-X: 85 W ≈ 290 BTU/h1

scanning CR 30-Xm: 103 W ≈ 351 BTU/h1

CR 30-X: 190 W ≈ 648 BTU/h1

• Peak power consumption during scanning
CR 30Xm: 220 W ≈ 751 BTU/h1

End of Life
Estimated product life
(if regularly serviced and maintained 7 yrs.
according to Agfa instructions)

56 Equipment Information Sheet 2386G EN 20120110

 CR 30-X/CR 30-XM

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

57
 CR 30-X/CR 30-XM

58 Equipment Information Sheet 2386G EN 20120110

 Appendix B
Remarks for HF-emission
and immunity
 CR 30-X/CR 30-XM

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.

Electromagnetic Environment
Emissions test Compliance
Guidelines
The digitizer uses RF energy only for its
internal function. Therefore, its RF
RF emissions in accordance with
Group 1 emissions are very low and are not likely to
CISPR 11
cause any interference in nearby electronic
equipment.
RF emissions in accordance with The digitizer is suitable for use in all
Class A
CISPR 11 establishments other than domestic, and
may be used in domestic establishments
Harmonic emissions in
Class A and those directly connected to the public
accordance with IEC 61000-3-2
low-voltage power supply network that
supplies buildings used for domestic
purposes, provided the following warning
is heeded.
WARNING: This device is intended for use
Voltage fluctuations / flicker by healthcare professionals only. This
emissions in accordance with Complies device may cause radio interference or may
IEC 61000-3-3 disrupt the operation of nearby equipment.
It may be necessary to take mitigation
measures, such as re-orienting or
relocating the digitizer or shielding the
location.

60 Remarks for HF-emission and immunity 2386G EN 20120110

 CR 30-X/CR 30-XM

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 Agreement Environment Guidelines
Floors should consist of wood,
Discharge of static + 6 kV contact + 6 kV contact
concrete or ceramic tiles. The
electricity in discharge discharge
relative humidity must be at
accordance with + 8 kV air + 8 kV air least 30%, if the floor is made of
IEC 61000-4-2 discharge discharge
synthetic material.
Fast transient
electrical + 2 kV for network + 2 kV for network The quality of the voltage
disturbance leads leads supplied should correspond to a
variables / bursts in + 1 kV for entry + 1 kV for entry typical commercial or clinical
accordance with and outlet leads and outlet leads environment.
IEC 61000-4-4
Impulse voltages + 1 kV push-pull + 1 kV push-pull The quality of the voltage
(surges) in voltage voltage supplied should correspond to
accordance with + 2 kV common + 2 kV common that of a typical commercial or
IEC 61000-4-5 mode voltage mode voltage clinical environment.
• < 5% Ur (> 95% • < 5% Ur (> 95%
breakthrough of breakthrough of
Ur) for ½ period Ur) for ½ period The quality of the voltage supply
Voltage • 40% Ur (> 60% • 40% Ur (> 60% should correspond to that of a
breakthroughs, breakthrough of breakthrough of typical commercial or clinical
short term Ur) for 5 periods Ur) for 5 periods environment.
interruptions and If the user wants the device to
• 70% Ur (30% • 70% Ur (30%
variations in the work continuously, even when
voltage supplied in breakthrough of breakthrough of the energy supply is interrupted,
accordance with Ur) for 25 Ur) for 25 it is recommended to use an
IEC 61000-4-11 periods periods energy supply free of
• < 5% Ur (95% • < 5% Ur (95% interruptions or a battery.
breakthrough of breakthrough of
Ur) for 5 s Ur) for 5 s
Magnetic field at Magnetic field at the network
the supply frequency should correspond to
frequency (50/60 3 A/m 3 A/m the typical values as they are in a
Hz) in accordance commercial and clinical
with IEC 61000-4-8 environment.
• REMARK : Ur is the alternating current in the network before the application of the test level.

2386G EN 20120110 Remarks for HF-emission and immunity

61
 CR 30-X/CR 30-XM

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 Test Level Agreement Environment
Use portable and mobile radio sets
at a safe distance from the device
(including the leads) not closer
than the recommended protective
distance, which is calculated
according to the equation suitable
for the transmission frequency.
Recommended protective
distance:
Conducted high
frequency disturbance 3 Veff
variables in 3 Veff d = 1.2 P
150 kHz
accordance with to 80 MHz
IEC 61000-4-6
Radiated high
frequency disturbance 3 V/m
variables in 80 MHz 3 V/m d = 1.2 P 80 MHz to 800 MHz
accordance with to 2.5 GHz
IEC 61000-4-3

d = 2.3 P 800 MHz to 2.5 GHz

With P as the rated power of the
transmitter in watts (W) in
accordance with the manufacturer
information on the transmitter
and d as the recommended
protective distance in metres (m).
The field strength of stationary
radio transmitters is lower than
the level of the agreementa at all
frequencies in accordance with an
on-site investigationb.
Disruptions are possible near
devices that carry the following
symbol:

62 Remarks for HF-emission and immunity 2386G EN 20120110

 CR 30-X/CR 30-XM

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.
a.The field strength of stationary transmitters, such as base stations of radio telephones, mobile
broadcasts for rural areas, amateur stations, and AM and FM radio transmitters, cannot be
precisely predetermined theoretically. An 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 level of agreement given above, the device must be
observed with regard to its normal operation at each place of use. In case of unusual performance
characteristics, it can be necessary to take additional measures, such as the re-orientation of the
device, for example.
b.The field strength will be lower than 3 V/m above the frequency range from 150 kHz to 80 MHz.

2386G EN 20120110 Remarks for HF-emission and immunity

63
 CR 30-X/CR 30-XM

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
communication equipment (transmitters) and the device as
recommended below, in accordance with the maximum output
power of the communications equipment.
Recommended Protective Distances between Portable and Mobile
High Frequency Communication Equipment and the Device
Rated Power of
Protective Distance in accordance with Transmission Frequency
the Transmitter

m
W
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2.5 GHz

d = 1.2 P d = 1.2 P d = 2.3 P

0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
The distance can be determined through the equation for each respective column.
P is the rated power of the transmitter in watts (W) according to the manufacturer information on
the transmitter, only for transmitters where the rated power is not mentioned in the above table.
• REMARK 1 : An additional factor of 10/3 has been used to calculate the recommended
protective distance of transmitters in the frequency range from 80 MHz to 2.5 GHz, to reduce
the probability that mobile portable communication equipment unintentionally brought into
the area of the patients will lead to a disruption.
• REMARK 2 : These Guidelines may not be relevant in all situations. The dispersion of
electromagnetic waves is influenced by absorption and reflections from buildings, objects and
people.

64 Remarks for HF-emission and immunity 2386G EN 20120110

 CR 30-X/CR 30-XM

2386G EN 20120110
65
 0413
Printed in Belgium
Published by Agfa HealthCare N.V., B-2640 Mortsel-Belgium
2386G EN 20120110