CR 30-X, CR 30-Xm

5175/200
5175/205
5179/100

User Manual

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 2 | CR 30-X, CR 30-Xm | Contents

Contents
Legal Notice ..........................................................................4
Introduction to this Manual ................................................... 5
Scope .........................................................................6
About the safety notices in this document .................. 7
Disclaimer ................................................................. 8
Introduction to CR 30-X/CR 30-Xm ....................................... 9
Intended Use ........................................................... 10
Intended User .......................................................... 10
System Configuration .............................................. 10
Main System Configuration ......................... 11
Configuration with Fast ID ...........................12
Configuration with ID Tablet ....................... 13
Optional System Components ...................... 14
Equipment Classification ......................................... 15
System Documentation ............................................16
Training ...................................................................17
Product Complaints ................................................. 18
Compatibility ...........................................................19
Compliance ............................................................. 20
General ........................................................21
Safety .......................................................... 21
Laser Safety ................................................. 21
Electromagnetic Compatibility .....................21
Harmonization ............................................ 21
Connectivity ............................................................ 22
Installation .............................................................. 23
Mobile Use Installation ................................ 24
Image quality check after transport ..............25
Product Identification .............................................. 27
Labels ...................................................................... 28
General ........................................................29
Safety Instructions for Laser Products .......... 32
Cleaning and Disinfection ........................................ 33
System components ..................................... 33
Patient data security ................................................ 34
Maintenance ............................................................35
Preventive Maintenance .............................. 36
Cleaning the optical unit .............................. 37
Recurrent safety tests ...............................................39
Environmental protection ........................................ 40
Safety Directions ......................................................41
General safety instructions ...........................42
Quality Control ........................................................44
Getting started .....................................................................45
Basic Features ..........................................................46

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CR 30-X/CR 30-Xm Features ........................47

Operating Modes ......................................... 48
The User Interface ....................................... 49
Starting the device ...................................................51
Basic Workflow using Fast ID ...................................53
Select a patient and start the exam ...............54
Insert the Cassette in the Digitizer ................55
Identify and Digitize the Image .................... 56
Check the image .......................................... 57
Remove the cassette and insert the next one ....
58
Basic Workflow using ID Tablet ............................... 59
Select a patient and start the exam ...............60
Identify the cassette ..................................... 61
Insert the Cassette in the Digitizer ................62
Digitize the Image ........................................63
Check the image .......................................... 64
Remove the cassette and insert the next one ....
65
Stopping the Device .................................................66
Before Switching Off ....................................67
Switching Off ...............................................68
Operating CR 30-X/CR 30-Xm ............................................. 70
Reading an Emergency Image Plate ......................... 71
Re-erasing an Image Plate ........................................72
Reading the Initialization Data of an Image Plate ..... 74
Reading the Initialization Data in a Configuration
with Fast ID ................................................. 75
Reading the Initialization Data in a Configuration
with ID Tablet ..............................................77
Troubleshooting ...................................................... 78
Digitizer Remote Display ............................. 79
Troubleshooting Checklist ........................... 80
Removing a Jammed Image Plate ................ 84
Behavior in Case of Power Failure ................ 86
Technical Data .....................................................................87
Specifications .......................................................... 88
Pixel matrix size .......................................................92
Remarks for HF-emission and immunity .............................. 93
Remarks for HF-emission and immunity .................. 93

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 4 | CR 30-X, CR 30-Xm | Legal Notice

Legal Notice

0413

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 accuracy, completeness or usefulness of the
information contained in this document and specifically disclaims warranties
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.
The original version of this document is in English.
Copyright 2015 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.

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Introduction to this Manual

Topics:

• Scope
• About the safety notices in this document
• Disclaimer

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Scope
This manual contains information for safe and effective operation of the
CR 30-XTM and CR 30-XmTM digitizer.

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About the safety notices in this document

The following samples show how warnings, cautions, instructions and notes
appear in this document. The text explains their intended use.
DANGER:
A danger safety notice indicates a hazardous situation of direct,
immediate danger for a potential serious injury to a user,
engineer, patient or any other person.

WARNING:
A warning safety notice indicates a hazardous situation which
can lead to a potential serious injury to a user, engineer, patient
or any other person.

CAUTION:
A caution safety notice indicates a hazardous situation which
can lead to a potential minor injury to a user, engineer, patient
or any other person.

An instruction is a direction which, if it is not followed, can

cause damage to the equipment described in this manual or any
other equipment or goods and can cause environmental
pollution.

A prohibition is a direction which, if it is not followed, can cause

damage to the equipment described in this manual or any other
equipment or goods and can cause environmental pollution.

Note: Notes provide advice and highlight unusual points. A note is

not intended as an instruction.

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Disclaimer
Agfa assumes no liability for use of this document if any unauthorized changes
to the content or format have been made.
Every care has been taken to ensure the accuracy of the information in this
document. 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 restricts this device to sale
by or on the order of a physician.

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Introduction to CR 30-X/CR 30-Xm

Topics:

• Intended Use
• Intended User
• System Configuration
• Equipment Classification
• System Documentation
• Training
• Product Complaints
• Compatibility
• Compliance
• Connectivity
• Installation
• Product Identification
• Labels
• Cleaning and Disinfection
• Patient data security
• Maintenance
• Recurrent safety tests
• Environmental protection
• Safety Directions
• Quality Control

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Intended Use
This digitizer 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.
The CR system is used in a radiological environment by qualified staff to read-
out, process and route static X-ray radiographic images.

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.

System Configuration
Topics:

• Main System Configuration

• Configuration with Fast ID
• Configuration with ID Tablet
• Optional System Components

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Main System Configuration

The system has the following configuration:
• The CR 30-X or CR 30-Xm digitizer, a digitizer for image plates retaining
latent X-ray images. The digitizer accepts one cassette containing one
image plate at a time.
• The NX workstation, either a dedicated CR workstation or two CR
workstations with ID Tablet, for cassette identification, image processing
and image transmission of digitized images received from the digitizer.
• Cassette and plate system: CR MD4.0T General and CR MD4.0T FLFS.
• For CR 30-Xm additionally: CR MM3.0T Mammo and CR MM3.0T
Extremities.

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Configuration with Fast ID

The digitizer is 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.

1. Digitizer
2. Control PC
The digitizer must not be connected to any version of the Agfa
ADC QSTM or ADC VIPSTM software.

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Configuration with ID Tablet

Two workstations can serve a shared digitizer, provided that each workstation
has an ID Tablet. There is no physical link required between the workstation
and the digitizer.
In this configuration, a cassette can be identified using any of the
workstations. The patient demographic data and examination data are
entered via the identification software and stored on the RF-tag of the cassette
via the ID Tablet.
The image is sent to the workstation where the cassette has been identified.
The image can not be rerouted to the other workstation.

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Optional System Components

Topics:

• Powerware 5115 UPS

• Full Leg Full Spine Application Components

Powerware 5115 UPS

The system can be extended with the Powerware 5115 uninterruptible power
system (UPS). The UPS is available in two voltage types: 110 V and 230 V.
The Powerware 5115 uninterruptible power system (UPS) protects the PC
when the main power supply has crashed, and avoids the loss of images. UPS
configuration requires special software. This software will be installed and
configured by an Agfa service technician.
With the Powerware 5115, you can safely eliminate the effects of power
disturbances and guard the integrity of your system.
To install the Powerware 5115 UPS into the system, proceed as follows:

1. Plug the UPS power cord into the input connector at the UPS rear panel.
2. Plug the other side of the UPS power cord into a power outlet.
3. Plug the digitizer and the NX workstation into the appropriate UPS output
receptacles.
In case of power failure, the batteries of the UPS supplies power to the
digitizer and the NX workstation.

Full Leg Full Spine Application Components

• CR FLFS Cassette and Plate set (e.g. CR MD4.0T FLFS).
• NX FLFS license (including Stitching software).
• CR Full Body Cassette Holder.
• Anti-scatter grid (optional).
• CR EasyLift (optional).
For more information and instructions on the FLFS application, refer to the
document 4408, CR Full Leg Full Spine User Manual.

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Equipment Classification
This device is classified as following:

Table 1: Equipment classification

Class I equipment Equipment in which protection against electric

shock does not relay on basic insulation only, but
includes a power supply cord with protective earth
conductor. For earth reliability always plug the
main power cord into an earthed mains power
outlet.

Type B equipment Not classified.

The patient does not get in contact with any part of
the equipment.

Water ingress This device does not have protection against

ingress of water.

Cleaning See section on cleaning and disinfecting.

Disinfection See section on cleaning and disinfecting.

Flammable anesthetics This device is not suitable for use in the presence of
a flammable anesthetic mixture with air, or in
presence of a flammable anesthetic mixture with
oxygen or nitrous oxide.

Operation Continuous operation.

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System Documentation
The documentation shall be kept with the system for easy reference. The most
extensive configuration is described within this manual, including the
maximum number of options and accessories. Not every function, option or
accessory described may have been purchased or licensed on a particular
piece of equipment.
Technical documentation is available in the product service documentation
which is available from your local support organization.
For safety precautions on stitching FLFS (Full Leg Full Spine) images, refer to
the “Safety Directions” section of the NX User Manual and the CR Full Leg Full
Spine User Manual.
The user documentation consists of:
• CR 30-X/CR 30-Xm User Documentation CD (digital media)
• NX User Documentation CD (digital media)
The CR 30-X/CR 30-Xm user documentation:
• CR 30-X/CR 30-Xm User Manual, (this document)
• CR 30-X/CR 30-Xm Plates and Cassettes User Manual, document 2387
• Getting Started with the ID Tablet, document 2287
The NX user documentation:
• NX User Manual, document 4420 and NX Key User Manual, document
4421
• CR Full Leg Full Spine User Manual, document 4408
• CR Mammography System User Manual, document 2344

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Training
The user must have received adequate training on the safe and effective use of
the system before attempting to work with it. Training requirements may vary
from country to country. The user must make sure that training is received in
accordance with local laws or regulations that have the force of law. Your
local Agfa or dealer representative can provide further information on
training.
The user must note the following information in the system documentation:
• Intended Use.
• Intended User.
• Safety Directions.

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Product Complaints
Any health care professional (for example a customer or a user) who has any
complaints or has experienced any dissatisfaction with 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, Agfa must be notified immediately by telephone, fax or written
correspondence to the following address:
Agfa Service Support - local support addresses and phone numbers are listed
on www.agfa.com
Agfa - Septestraat 27, 2640 Mortsel, Belgium
Agfa - Fax +32 3 444 7094

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Compatibility
The equipment 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 60950 for data processing equipment
or IEC 60601-1 for medical equipment). Furthermore all configurations shall
comply with the requirements for ME systems according to IEC 60601-1.
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 for ME systems according to
IEC 60601-1. If in doubt, consult your local service organization.

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Compliance
Topics:

• General
• Safety
• Laser Safety
• Electromagnetic Compatibility
• Harmonization

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General
• The product 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 Medical Device Directive (European Council Directive
93/42/EEC on Medical Devices).
• ISO 13485:2003 + Cor. 1:2009
• IEC 62366:2008
• ISO 14971:2009

Safety
• IEC 60601-1, EN 60601-1
• IEC 60601-1: 2005
• IEC 60601-1-1:2000, EN 60601-1-1:2001
• IEC 60601-1-6:2006, EN 60601-1-6:2007
• UL 60601-1:2003
• AAMI ES 60601-1:2005 + A2:2010
• CSA C 22.2 No.601.1:1990 + S1:1994 + A2:1998
• CSA C 22.2 No.60601-1:2008 + COR 2:2011

Laser Safety
• 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

Electromagnetic Compatibility
• IEC 60601-1-2:2007, EN 60601-1-2:2007

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.

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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.

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Installation
WARNING:
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.
WARNING:
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.

WARNING:
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.

WARNING:
Do not lift the device by holding the input tray.

WARNING:
If the digitizer is installed inside an X-ray room it must be
protected from stray radiation by proper shielding.

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.
Topics:

• Mobile Use Installation

• Image quality check after transport

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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.
WARNING:
Do not use the digitizer during transport.

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Image quality check after transport

WARNING:
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

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

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
• 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.

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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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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

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Labels
Topics:

• General
• Safety Instructions for Laser Products

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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 respective IEC standards (e.g. IEC
60950 for data processing equipment or IEC
60601-1 for medical equipment).
In addition all configurations must comply with the
requirements for medical electrical systems according
to IEC 60601-1. 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.
It is recommended to use the supplementary protective
earth connection as additional safety measure.

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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
chapter.

Cassette positioning.
Insert the cassette as described in the basic workflow
chapter.

Off (power: disconnection from the mains)

On (power: connection to the mains)

Type label

Date of manufacture

Manufacturer

Serial number

WEEE symbol

Device contains a transmitter module

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Laser Warning
Indicates the presence of a laser device.

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.

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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 EST Á ABIERTA.

VORSICHT ! ATTENTION!
CLASS 1 LASER PRODUCT
LASERSTRAHLUNG KLASSE 3B: FAISCEAU LASER CLASSE 3B:
APPAREIL A LASER DE CLASSE 1 WENN ABDECKUNG GEÖFFNET QUAND CAPOT OUVERT ÉVITER
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).
CAUTION:
User interventions other than those described in this
manual can be hazardous with regard to laser radiation.

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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 and its accessories
come into contact with potential contaminations. Details about cleaning can
be found in the following pages.
To clean the exterior of the digitizer:

1. Switch off the digitizer.

2. Remove the power plug from the socket.
CAUTION:
Damage or deterioration of safety provisions can cause
injury of the operator.
Remove the power plug from the socket before cleaning the
exterior of the device.
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.

System components
For cleaning and disinfection instructions of the plates and cassettes, refer to
the CR 30-X/CR 30-Xm Plates and Cassettes User Manual.
For cleaning and disinfection instructions of the ID Tablet, refer to the
document Getting Started with the ID Tablet.

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Patient data security

The user must ensure that the patients’ legal requirements are met and that
the security of the patient data is guarded.
The user must define who can access patient data in which situations.
The user must have a strategy available on what to do with patient data in
case of a disaster.

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Maintenance
Topics:

• Preventive Maintenance
• Cleaning the optical unit

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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.

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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.

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.

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1. Open lid
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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Recurrent safety tests

The device shall be tested according to IEC 62353* in a time interval of at
least 36 months or less if local regulations are different.
* Medical electrical equipment – Recurrent test and test after repair of medical
electrical equipment.

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Environmental protection

Figure 1: WEEE symbol

Li
Figure 2: Battery symbol

WEEE end user notice

The directive on Waste Electrical and Electronic Equipment (WEEE) aims to
prevent the generation of electric and electronic waste and to promote the
reuse, recycling and other forms of recovery. It therefore requires the
collection of WEEE, recovery and reuse or recycling.
Due to the implementation into national law, specific requirements can be
different within the European Member States. The WEEE 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 service organization and/or 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
The battery symbol on the products, and/or accompanying documents means
that the used batteries should not be treated as, or mixed with general
household waste. The battery 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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Safety Directions
WARNING:
Safety is only guaranteed when an Agfa certified field service
engineer has installed the product.

WARNING:
The user is responsible for judging image quality and controlling
environmental conditions for diagnostic softcopy or print
viewing.

WARNING:
The user must follow the hospital quality assurance procedures
for covering the risks resulting from errors in the image
processing

WARNING:
To avoid risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.

WARNING:
Position the digitizer so that it is possible to disconnect it from
the mains power if required.

WARNING:
The following actions may lead to serious risk of injury and
damage to the equipment as well as making the warranty
void:
Changes, additions or maintenance to the Agfa products carried
out by persons without appropriate qualifications and training.
Using unapproved spare parts
WARNING:
To avoid images being lost due to a power failure, the
workstation and the digitizer have to be connected to an
uninterruptable power supply (UPS) or an institutional standby
generator.
WARNING:
Operation outside of the specified environmental conditions
may lead to deterioration of image quality. For best results, keep
the environmental conditions within these specifications.

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CAUTION:
Strictly observe all warnings, cautions, notes and safety
markings within this document and on the product.

CAUTION:
All Agfa medical products must be used by trained and qualified
personnel.

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

CAUTION:
The digitizer is not suitable for scanning imaging plates (IPs)
exposed with a dose higher than 5000 µG.

CAUTION:
Bad image quality can cause a need to retake the image or
cause delayed diagnosis.
Do not operate the device in direct sunlight, max. 2500 lux.
CAUTION:
While every care has been taken, it is possible that minor errors
still exist in the product. It is unlikely that a minor error could
result in incorrect (unexpected) device operation.

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.

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• 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.
• 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).

1
2

1. Patient environment: R = 1.5 m (1.83 m)

2. Patient environment: h = 2.5 m (2.29 m)
• Position the digitizer in a way, that it could be easily unplugged in order to
achieve separation from mains.
• 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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Quality Control
WARNING:
Unnoticed image quality degradation can cause false
negative diagnosis.
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).

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Getting started
Topics:

• Basic Features
• Starting the device
• Basic Workflow using Fast ID
• Basic Workflow using ID Tablet
• Stopping the Device

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Basic Features
Topics:

• CR 30-X/CR 30-Xm Features

• Operating Modes
• The User Interface

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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.
• 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’).
• The digitizer permits assigning the status ‘emergency’ to an image.
• 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:
• quickly identifying cassettes without the need for an ID Tablet,
• reading the identification data of a cassette.

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

• Operator Mode
• 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.

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The User Interface

The digitizer interfaces with the user via:
• an erase button,
• a status indicator,
• a main switch.

2
1

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

Topics:
• The Erase Button
• Status Indicator

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

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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.

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 used to inform the
operator about the image plate erasing cycle progress and is only then lit. The
lower part is used for all other operational indications.
1

1. Blue
2. Green or red

Color Constant/ Status Action

Blinking

Activating the erasing

Blue Constant
cycle

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

Busy with scanning,

Flashing erasing and return of Wait.
the IP into cassette

Constant Service mode

• Warm up / Self-test Check workstation for

• Processing Software further information and
Blinking down detailed instructions.
• Error
Red
Blinking fast Digitizer not connected Refer to section
to Digitizer Remote ‘Troubleshooting’.
Display UI

Blinking - 3 Digitizer not connected

pulses to control PC

Related Links
Troubleshooting Checklist on page 80

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Starting the device

1. Turn on the UPS (optional accessory) to supply electricity to the control
PC and the digitizer.
Check whether the UPS is connected to a power outlet.
Press and hold the On button approximately one second until you hear the
UPS beep.
Note: Step 1 is only applicable if your system is extended with
an uninterruptible power supply (UPS).

2. Switch on the digitizer by pressing the main switch.

1. 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.

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3. Switch on the ID Tablet.

Only in a configuration with ID Tablet.
For more information, refer to the document Getting Started with the ID
Tablet.
4. 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.
5. Start NX.
For detailed information about starting up NX, refer to the NX User
Manual, document 4420.

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Basic Workflow using Fast ID

Topics:

• Select a patient and start the exam

• Insert the Cassette in the Digitizer
• Identify and Digitize the Image
• Check the image
• Remove the cassette and insert the next one

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Select a patient and start the exam

At the NX workstation:

1. Open the Worklist window of NX.

In the Worklist window, you can view and manage the exams that are
scheduled via the Worklist pane.
Note: When starting the NX software, the Worklist window is
the first window that appears after the NX Splash screen.

Note: Start the NX software on the NX workstation. Refer to the

NX User Manual, document 4420.

2. In the Worklist window, open a patient from the RIS or enter patient data
manually.

3 1 2

To open a patient from the RIS, select an Exam from the list (1) and click
on Start Exam (2).
To enter patient data manually, click New Exam (3) and enter patient data
and image data manually.
For more information, refer to the NX User Manual, document 4420.

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Insert the Cassette in the Digitizer

CAUTION:
Image quality may suffer if a cassette and plate is not scanned
soon after exposure. The Agfa phosphor has excellent dark
decay characteristics. Two hours after exposure, approximately
80% of the energy stored upon exposure is still available. The
image retention is better than 50% up to 24 hours after
irradiation. However, in order to preserve image quality, a
cassette and plate should be scanned no later than 2 hours after
exposure.
At the digitizer:

1. Check that the digitizer is ready for operation:

The status indicator on the digitizer constantly lights up in green.
2. Insert the cassette containing the exposed image plate into the cassette
slot [1] of the digitizer.
CAUTION:
Using a not supported cassette format can cause an
image being lost, a need to retake the image or delayed
diagnosis.
Only insert cassettes of a supported format in the digitizer.
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 to the right side of the slot [2].
Otherwise, the digitizer cannot read the image plate.

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Identify and Digitize the Image

An unidentified cassette is inserted in the digitizer. The NX software must be
operational, otherwise the digitizer is locked and the status indicator is
flashing red.
At the NX workstation:

1. Click ID in the examination window of NX.

In the Examination window, select the thumbnail in the Image overview
pane and click on ID to send the data to the digitizer.

2. As soon as the digitizer has received the complete identification data from
the NX workstation (via Ethernet) it will start digitizing the image plate.
The digitizer converts the information of the latent image to digital data.
3. After digitizing, the digitizer:
• Transmits the digital image data to the image processing station
(‘destination’).
• Erases the image plate and re-inserts it into the cassette.
• Gives the cassette ID data the status 'erased'.
• Unlocks the cassette.

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Check the image

At the NX workstation:

1. Select the relevant image on which quality control is to be performed.

2. Prepare the image for diagnosis by using e.g. L/R markers or annotations.
3. If the image is OK, send the image to a hardcopy printer and/or PACS
(Picture Archiving and Communication System).

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Remove the cassette and insert the next one

At the digitizer:

1. When the digitizer has finished treating the cassette, the status indicator
constantly lights up in green.
2. Remove the cassette from the cassette slot.
When the digitizer unlocks the cassette, it is ready to be re-used
immediately.
WARNING:
When CR MD4.xT plates and cassettes have not been used
for 48 hours, they must be erased manually. When CR
MM3.xT plates and cassettes have not been used for 24
hours, they must be erased manually.

Related Links
Re-erasing an Image Plate on page 72

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Basic Workflow using ID Tablet

Topics:

• Select a patient and start the exam

• Identify the cassette
• Insert the Cassette in the Digitizer
• Digitize the Image
• Check the image
• Remove the cassette and insert the next one

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Select a patient and start the exam

At the NX workstation:

1. Open the Worklist window of NX.

In the Worklist window, you can view and manage the exams that are
scheduled via the Worklist pane.
Note: When starting the NX software, the Worklist window is
the first window that appears after the NX Splash screen.

Note: Start the NX software on the NX workstation. Refer to the

NX User Manual, document 4420.

2. In the Worklist window, open a patient from the RIS or enter patient data
manually.

3 1 2

To open a patient from the RIS, select an Exam from the list (1) and click
on Start Exam (2).
To enter patient data manually, click New Exam (3) and enter patient data
and image data manually.
For more information, refer to the NX User Manual, document 4420.

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Identify the cassette

At the NX workstation:

1. Insert a cassette in the ID Tablet.

2. In the Examination window, select the right thumbnail in the Image
Overview.
3. Click ID or press F2.

The thumbnail is labelled with the code ‘ID’. The patient data is written to the
cassette.

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Insert the Cassette in the Digitizer

CAUTION:
Image quality may suffer if a cassette and plate is not scanned
soon after exposure. The Agfa phosphor has excellent dark
decay characteristics. Two hours after exposure, approximately
80% of the energy stored upon exposure is still available. The
image retention is better than 50% up to 24 hours after
irradiation. However, in order to preserve image quality, a
cassette and plate should be scanned no later than 2 hours after
exposure.
At the digitizer:

1. Check that the digitizer is ready for operation:

The status indicator on the digitizer constantly lights up in green.
2. Insert the cassette containing the exposed image plate into the cassette
slot [1] of the digitizer.
CAUTION:
Using a not supported cassette format can cause an
image being lost, a need to retake the image or delayed
diagnosis.
Only insert cassettes of a supported format in the digitizer.
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 to the right side of the slot [2].
Otherwise, the digitizer cannot read the image plate.

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Digitize the Image

1. The digitizer will start digitizing the image plate.
The digitizer converts the information of the latent image to digital data.
2. After digitizing, the digitizer:
• Transmits the digital image data to the image processing station
(‘destination’).
• Erases the image plate and re-inserts it into the cassette.
• Gives the cassette ID data the status 'erased'.
• Unlocks the cassette.

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Check the image

At the NX workstation:

1. Select the relevant image on which quality control is to be performed.

2. Prepare the image for diagnosis by using e.g. L/R markers or annotations.
3. If the image is OK, send the image to a hardcopy printer and/or PACS
(Picture Archiving and Communication System).

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Remove the cassette and insert the next one

At the digitizer:

1. When the digitizer has finished treating the cassette, the status indicator
constantly lights up in green.
2. Remove the cassette from the cassette slot.
When the digitizer unlocks the cassette, it is ready to be re-used
immediately.
WARNING:
When CR MD4.xT plates and cassettes have not been used
for 48 hours, they must be erased manually. When CR
MM3.xT plates and cassettes have not been used for 24
hours, they must be erased manually.

Related Links
Re-erasing an Image Plate on page 72

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Stopping the Device

Topics:

• Before Switching Off

• Switching Off

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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.

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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!

Note: After switch off, the device is still in stand-by mode. To

remove the device from the mains supply disconnect the mains
plug.

To stop the system:

1. Switch off the digitizer by pressing the main switch.

1. Main switch
2. Switch off the ID Tablet.
Only in a configuration with ID Tablet.
For more information, refer to the document Getting Started with the ID
Tablet.
3. Stop NX.
NX can be stopped in two ways:, either by logging out of Windows or by
using the Exit NX action button.
For detailed information about stopping NX, refer to the NX User Manual,
document 4420.
4. Turn off the UPS (optional accessory) to disconnect the control PC and the
digitizer.
Press and hold the Off button until the long beep ceases (approximately
five seconds).

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Note: Step 3 is only applicable if your system is extended with

an uninterruptible power supply (UPS).

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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.
Topics:

• Reading an Emergency Image Plate

• Re-erasing an Image Plate
• Reading the Initialization Data of an Image Plate
• Troubleshooting

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Reading an Emergency Image Plate

Note: Reading an emergency image plate is a licensed
functionality, necessary to facilitate the emergency cases and to
improve the workflow.

In emergency situations, it is possible to open an emergency exam at the NX

workstation without patient details and to digitize the image plate without
having identified the cassette.
For detailed information about the emergency license, refer to the NX
manuals.

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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.

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.
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.

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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.

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Reading the Initialization Data of an Image Plate

The initialization data stored in the RF-tag of the tray can be read via the NX
workstation.
Reading the initialization data of an image plate can be necessary in the
following cases:
• to find a specific cassette,
• to check if the IP sensitivity code (printed on the rear side of the IP) is
corresponding with the initialized data on the chip,
• to check if the correct IP was inserted after cleaning (in case of doubt),
• to check the cycle counter of the cassette,

Topics:

• Reading the Initialization Data in a Configuration with Fast ID

• Reading the Initialization Data in a Configuration with ID Tablet

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Reading the Initialization Data in a Configuration with Fast ID

1. Check that the system is ready for operation:
The status indicator on the digitizer constantly lights up in green.
2. Click on Read and Initialize Cassette (1) in the Functionality Overview
pane of the Main Menu window of the NX station.
The Read and Initialize Cassette pane (2) is opened in the middle section
of the Main Menu window:
1 2

For more information, refer to the NX Key User Manual, document 4421.
3. Click on the Read button at the NX workstation.
The digitizer waits for the cassette and the status indicator constantly
lights up in green.
4. Insert the cassette containing the image plate into the cassette slot [1] of
the digitizer 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 can not read the image plate.

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Once the cassette is locked, the status indicator on the digitizer is flashing
green.
The digitizer starts reading the initialization data.
5. When the digitizer has finished reading the initialization data, the cassette
is unlocked.
Once the cassette is unlocked, the status indicator constantly lights up in
green.
6. Remove the cassette from the cassette slot.
Note: You can only remove the cassette from the cassette slot
when the cassette is unlocked.

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Reading the Initialization Data in a Configuration with ID

Tablet
1. Click on Read and Initialize Cassette (1) in the Functionality Overview
pane of the Main Menu window of the NX station.
The Read and Initialize Cassette pane (2) is opened in the middle section
of the Main Menu window:
1 2

For more information, refer to the NX Key User Manual, document 4421.
2. Insert a cassette in the ID Tablet.
3. Click on the Read button at the NX workstation.

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Troubleshooting
Topics:

• Digitizer Remote Display

• Troubleshooting Checklist
• Removing a Jammed Image Plate
• Behavior in Case of Power Failure

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Digitizer Remote Display

Digitizer Remote Display is an application running on the NX PC.
To verify if Digitizer Remote Display is running, check if the Digitizer Remote
Display icon is present in the Windows taskbar:

To start the Digitizer Remote Display, go to the Windows Start menu >
Startup and click DigitizerRemoteDisplay.
The Digitizer Remote Display dialog contains information about the status of
the digitizer.

2
3

1. Error message
2. Error code
3. Date and time of error
4. Confirm button
5. Connection status and IP address

Digitizer Remote Display in a configuration with ID Tablet

If two workstations serve a shared digitizer, the Digitizer Remote Display is
available on only one of the workstations. In order to view the messages or to
perform an action required by an error condition, this workstation must be
started.

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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 Digitizer Remote Display messages on the control PC.
Related Links
Status Indicator on page 50

Topics:

• General Errors
• Connection Problems
• Errors During Operation

General Errors

Error Action

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

Connection Problems
CAUTION:
Operation failure of the device can cause delayed diagnosis.
Check if Digitizer Remote Display is running.

In case the status indicator of the digitizer is blinking red, the user should look
at the “status” of the Digitizer Remote Display to decide whether digitizer
internal problems or connection problems occurred.
If an error message is displayed on the NX PC, the user is informed which
actions to perform to solve the problem.
In case no error message is displayed on the screen, a connection problem
occurred.

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Condition Message at Status Action

Digitizer indicator
Remote
Display

Connection No error Red blinking Check if Digitizer

problem message on NX fast Remote Display is
between PC. running. Start/restart
digitizer and Digitizer Remote
the Digitizer Display.
Remote
Display.

Connection Red blinking - Check the Ethernet

problem 3 pulses cables. If the error
between remains, restart PC and
digitizer and digitizer or call service.
NX PC.

Errors During Operation

If errors occur during operation, you can consult the Digitizer Remote Display
messages on the control PC. The Digitizer Remote Display is independent
from the NX Software.

Status
Condition Control PC message Action
indicator

Cassette error

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

Switch off the digitizer

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

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Status
Condition Control PC message Action
indicator

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

Confirm the message

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

Digitizer errors

“Failure at erasure
module. Please
restart digitizer. If
Erasure lamp
error remains, please Red, Restart the digitizer or
failed during
contact service. constant call service.
scanning cycle
Image plate must be
erased after repair
again.”

“Image plate during Red, After power failure a

Image plate self-test in the flashing. remaining image
detected in digitizer detected. plate, in the digitizer,
the digitizer The image plate was After will be detected and
during self- moved back into the unlocking: the forementioned
test cassette. Please check green, error message will be
whether the image is constant displayed.

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Status
Condition Control PC message Action
indicator

present at the PC and

re-scan the cassette, if
necessary. If the
In order to release the
image is present, the
cassette, confirm the
cassette was not
message.
erased possibly. Erase
the cassette again in
any case.”

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

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

“ID button not

Time-out after
pressed within the After ID
5 minutes if Confirm the message
timeout period. button has
the ID button on the PC and press
Image plate was not been
of the image the ID button of the
scanned. Cassette pressed:
processing image processing
stays clamped until green,
software was software.
ID data are supplied flashing
not pressed.
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 confirm button.
Note: For error messages not listed in the table above, please refer
to the instructions within the displayed error message text.

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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.

2. Slide out the front cover.

3. Remove the jammed image plate.

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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.

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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.

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.

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Technical Data
Topics:

• Specifications
• Pixel matrix size

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Specifications
Labelling

93/42 EEC 'Medical Devices'

CE
(Europe), EN 60601-1

ETL us certified, UL 60601-1 Second

c ETL us Edition (North America), AAMI ES
60601-1:2005 + A2:2010

c ETL certified, CSA C 22.2 No 601.1,

c ETL us CSA C 22.2 No.60601-1:2008 + COR
2:2011
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

Operating current 2 A (100-120 V), 1 A (220-240 V)

Network connectivity

RJ45 female, 10/100 Mbit/s

Ethernet connector
autosensing, shielding CAT5
Power consumption

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Standby

• 220 V - 240 V / 50-60 Hz

configuration 60 W

• 100 V - 120 V / 50-60 Hz

configuration 60 W

During operation

• 220 V - 240 V / 50-60 Hz CR 30-X: max. 190 W

configuration CR 30-Xm: max. 220 W

• 100 V - 120 V / 50-60 Hz CR 30-X: max. 190 W

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,

Sunlight exposure
max. 2500 lux

Barometric pressure during

70 kPa to 106 kPa
operation

Related altitude on site 3000 m to 0 m

Environmental conditions (during storage)

In line with IEC721-3-1: 1K2 (CR 30-X) / 1K4 (CR 30-Xm) and 1M2

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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

5-200 Hz (vertical, longitudinal,

Vibration
transversal axis)
Environmental conditions for mobile installation (during transport)

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

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

Vibration
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)

40-200 Hz; 1m/s²; sinusoidal

Vibration
vibration
Warming-up time

Cold start fully operational after max. 30 min.

fully operational after self-test, on

condition that the digitizer:
• has not been switched off for more
Warm start
than 3 minutes.
• has been operational for at least
30 minutes.

Throughput
CR MD4.0T 35 x 43 cm 60 plates/hour
CR MD4.0T 35 x 35 cm 60 plates/hour
CR MD4.0T 24 x 30 cm 71 plates/hour
CR MD4.0T 18 x 24 cm 76 plates/hour
CR MD4.0T 15 x 30 cm 82 plates/hour
CR MM3.0T 24 x 30 cm 32 plates/hour
CR MM3.0T 18 x 24 cm 38 plates/hour

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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 CR 30-X: 85 W ≈ 290 BTU/h1

during scanning CR 30-Xm: 103 W ≈ 351 BTU/h1

• Peak power consumption during CR 30-X: 190 W ≈ 648 BTU/h1

scanning CR 30Xm: 220 W ≈ 751 BTU/h1
End of Life

Estimated product life (if regularly

serviced and maintained according 7 yrs.
to Agfa instructions)
Preventive maintenance

Preventive maintenance frequency.

Once a year or 12000 cycles, whatever
Note: Needs to be done by an Agfa comes first.
certified field service engineer.

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Pixel matrix size

Cassette type Format Resolution Width x Width x
(cm) (pixel/mm) Length Length
(pixels) (mm)
CR MD4.0T 35x43 10 3480 x 4248 348,0 x
General 424,8
CR MD4.0T 35x35 10 3480 x 3480 348,0 x
General 348,0
CR MD4.0T 24x30 10 2328 x 2928 232,8 x
General 292,8
CR MD4.0T 18x24 10 1728 x 2328 172,8 x
General 232,8
CR MD4.0T 15x30 10 1440 x 2928 144,0 x
General 292,8
CR MD4.0T 35x43 10 3480 x 4406 348,0 x
Genrad + FLFS 440,6
CR MM3.0T 24x30 20 4710 x 5844 235,5 x
Mammo 292,2
CR MM3.0T 18x24 20 3510 x 4644 175,5 x
Mammo 232,2
CR MM3.0T 24x30 20 4656 x 5856 232,8 x
Extremities 292,8
CR MM3.0T 18x24 20 3456 x 4656 172,8 x
Extremities 232,8

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Remarks for HF-emission and immunity

Remarks for HF-emission and immunity

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.
This device was tested for a normal hospital environment as described above.
The user of the device should ensure that it is used in such an environment.
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.
This device is intended for use by healthcare professionals only.
This device may cause radio interference or may disrupt the
operation of nearby equipment. It may be necessary to take
mitigation measures, such as re-orienting or relocating the
device or shielding the location.
CAUTION:
The HF-emission and immunity can be influenced by connected
data cables depending on length and the manner of installation.

Transmission Agreement Electromagnetic Environment

Measurements Guidelines

RF emissions in accordance Group 1 The device uses RF energy only

with CISPR 11 for its internal function.
Therefore, its RF emissions are
very low and are not likely to
cause any interference in nearby
electronic equipment.

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RF emissions in accordance Class A The device is suitable for use in

with CISPR 11 all establishments other than
domestic, and may be used in
Harmonic emissions in Class A domestic establishments and
accordance with IEC those directly connected to the
61000-3-2 public low-voltage power supply
network that supplies buildings
Voltage fluctuations / Complies
used for domestic purposes,
flicker emissions in provided the following warning
accordance with is heeded.
IEC 61000-3-3

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 Test Level of Electromagnetic

Jamming Level Agreement Environment
Test Guidelines

Discharge of ± 6 kV contact ± 6 kV contact Floors should consist

static discharge discharge of wood, concrete or
electricity in ceramic tiles. The
± 8 kV air ± 8 kV air
accordance relative humidity
discharge discharge
with IEC must be at least 30%,
61000-4-2 if the floor is made of
synthetic material.

Fast transient ± 2 kV for ± 2 kV for The quality of the

electrical network leads network leads voltage supplied
disturbance should correspond to
± 1 kV for entry ± 1 kV for entry
variables / a typical commercial
and outlet leads and outlet leads
bursts in or clinical
accordance environment.
with IEC
61000-4-4

Impulse ± 1 kV push-pull ± 1 kV push-pull The quality of the

voltages voltage voltage voltage supplied
(surges) in should correspond to
± 2 kV common ± 2 kV common
accordance that of a typical
mode voltage mode voltage
with IEC commercial or clinical
61000-4-5 environment.

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Voltage • < 5% Ur • < 5% Ur The quality of the

breakthrough (> 95% (> 95% voltage supply should
s, short term breakthroug breakthroug correspond to that of
interruptions h of Ur) for ½ h of Ur) for ½ a typical commercial
and variations period period or clinical
in the voltage • 40% U (> • 40% Ur (> environment. If the
r
supplied in 60% 60% user wants the device
accordance breakthroug breakthroug to work continuously,
with IEC h of Ur) for 5 h of Ur) for 5 even when the energy
61000-4-11 periods periods supply is interrupted,
it is recommended to
• 70% Ur (30% • 70% Ur (30%
use an energy supply
breakthroug breakthroug
free of interruptions
h of Ur) for h of Ur) for
or a battery.
25 periods 25 periods
• < 5% Ur • < 5% Ur
(95% (95%
breakthroug breakthroug
h of Ur) for 5 h of Ur) for 5
s s

Magnetic field 3 A/m 3 A/m Magnetic field at the

at the supply network frequency
frequency should correspond to
(50/60 Hz) in the typical values as
accordance they are in a
with IEC commercial and
61000-4-8 clinical environment.

• REMARK : Ur is the alternating current in the network before the

application of the test level.

Tests of IEC 60601 Level of Electromagnetic Environment

Resistance to Test Level Agreement
Disruption

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.

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Recommended protective
distance:

Conducted 3 Veff 3 Veff

high frequency d = 1.2
150 kHz to
disturbance
80 MHz
variables in
accordance
with
IEC 61000-4-6

Radiated high 3 V/m 3 V/m

frequency d = 1.2 80 MHz to 800
80 MHz to MHz
disturbance
2.5 GHz
variables in
accordance
with
IEC 61000-4-3

d = 2.3 800 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 agreement at all
frequencies in accordance with
an on-site investigation.
Disruptions are possible near
devices that carry the following
symbol:

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

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 CR 30-X, CR 30-Xm | Remarks for HF-emission and immunity | 97

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.
The field strength will be lower than 3 V/m above the frequency range from
150 kHz to 80 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.

Radio frequency communications equipment can effect medical electrical

equipment.
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 Protective Distance in accordance with Transmission

of the Frequency
Transmitter
m
W

150 kHz to 80 80 MHz to 800 800 MHz to 2.5

MHz MHz GHz

d = 1.2 d = 1.2 d = 2.3

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73

1 1.2 1.2 2.3

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 98 | CR 30-X, CR 30-Xm | Remarks for HF-emission and immunity

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.

2386I EN 20151020 1518

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