DX-G

(type 5170/100)
DX-M
(type 5170/200)

User manual
M

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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. DX-G, DX-M and NX are
trademarks of Agfa HealthCare N.V., Belgium or one of its affiliates. All other trademarks are held by their respec-
tive 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 con-
tact 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 2013 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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1 Introduction .......................................................................................7

Introduction to this Manual................................................................................ 8

Scope ................................................................................................................... 9
Warnings, Cautions, Instructions and Notes ......................................................... 9
Disclaimer.......................................................................................................... 10
Introduction to DX-G/DX-M .............................................................................. 11
Intended Use...................................................................................................... 12
Intended User .................................................................................................... 12
Configuration .................................................................................................... 13
System Documentation ...................................................................................... 13
Training ............................................................................................................. 14
Product Complaints............................................................................................ 14
Compatibility ..................................................................................................... 15
Compliance........................................................................................................ 15
Labelling ....................................................................................................... 16
Radio Interference Suppression ..................................................................... 16
Equipment Classification ............................................................................... 17
Installation ........................................................................................................ 18
Mobile Use Installation .................................................................................. 19
Labels ................................................................................................................ 26
Product Identification.................................................................................... 26
General ......................................................................................................... 27
Safety Instructions for Laser Products ............................................................ 30
Maintenance and Cleaning................................................................................. 31
Preventive Maintenance by the Service Engineer ........................................... 31
Maintenance by the User ............................................................................... 32
Recurrent Safety Tests ........................................................................................ 41
Patient Data Security ......................................................................................... 42
Safety Directions ................................................................................................ 43
General Safety Instructions............................................................................ 44
Quality Control .................................................................................................. 46

2 Getting Started with the DX-G/DX-M .........................................47

Basic Features................................................................................................... 48
DX-G/DX-M Features.......................................................................................... 48
Operating Modes ............................................................................................... 49
Operator Mode .............................................................................................. 49

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Service Mode.................................................................................................49
The User Interface ............................................................................................ 50
Status Indicator .................................................................................................. 51
Starting the Digitizer........................................................................................ 52
Basic Workflow (Scanning Images).................................................................. 54
Stopping the digitizer....................................................................................... 56
Before Switching Off ..........................................................................................56
Switching Off .....................................................................................................56

3 Operating DX-G/DX-M .................................................................. 57

Re-erasing an Image Plate ................................................................................ 58

Re-routing of an Image..................................................................................... 60
Turning the Volume of the Digitizer Signals and Beeps On or Off .................... 63
Changing the Brightness of the Touch Panel .................................................... 65
Retrieving Information About the Digitizer ......................................................67
Moving the Digitizer......................................................................................... 68
Troubleshooting and Errors during Operation................................................. 71
Status Indicator: continuously red ...................................................................... 71
Status Indicator: flashing red ............................................................................. 72
Digitizer does not Start up ..................................................................................73

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Appendix ..................................................................................................75

A Equipment Information Sheet ......................................................77

Specifications ................................................................................................... 78
Pixel Matrix Size ............................................................................................... 82

B Technical Documentation ..............................................................83

Compliance....................................................................................................... 84
Certificates ........................................................................................................ 84
Harmonization................................................................................................... 85
Connectivity ..................................................................................................... 86
Environmental Protection ................................................................................ 86
Remarks for HF-emission and immunity .......................................................... 88

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6 2321 E EN 20130722
1 Introduction
This chapter covers the following topics:

❑ Introduction to this Manual

❑ Introduction to DX-G/DX-M
 DX-G/DX-M

Introduction to this Manual

This section covers the following topics:

 Scope

 Warnings, Cautions, Instructions and Notes

 Disclaimer

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Scope
This manual contains information for safe and effective operation of the
DX-GTM/DX-MTM digitizers.

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.

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.

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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.

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Introduction to DX-G/DX-M
This section covers the following topics:

 Intended Use

 Intended User

 Configuration

 System Documentation

 Training

 Product Complaints

 Compatibility

 Compliance

 Installation

 Labels

 Maintenance and Cleaning

 Recurrent Safety Tests

 Patient Data Security

 Safety Directions

 Quality Control

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Intended Use
This device must only be used to scan exposed X-ray cassettes, containing an
erasable image plate (IP). The digitizer is part of a system, consisting of X-ray
cassettes with erasable phosphor image plates and a workstation where the X-
ray cassettes are identified and the resulting digital image information is
further processed and routed. It is intended that this device is only operated
in a radiological environment by qualified staff.

Intended User
This manual has been written for trained users of Agfa products and trained
diagnostic X–Ray clinical personnel who have received proper training.
Users are those persons who actually handle the equipment and those who
have authority over the equipment.
Before attempting to work with this equipment, the user must read,
understand, note and strictly observe all warnings, cautions and safety
markings on the equipment.

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Configuration
The digitizer is part of a CR system that has the following configuration:
• The digitizer, a digitizer for scan of image plates retaining latent X-ray
images. The digitizer accepts multiple cassettes at a time, to be scanned
sequentially.
• The NX workstation, one or more 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 HD5.x General, CR HD5.x FLFS, CR HD5.x
AEC, CR MD4.xR General and CR MD4.xR FLFS.
• For DX-M additionally, CR HM5.x Mammo or CR MM3.xR Mammo - mixed
use of both types in one digitizer will not be supported.
• The CR HD5.x General detector, CR HD5.x FLFS detector, CR HD5.x AEC
detector, CR MD4.xR General plate and cassette, CR MD4.xR FLFS plate and
cassette, CR HM5.x Mammo detector and CR MM3.xR Mammo plate and cas-
sette are generically referred to as ‘plates and cassettes’.

Note: For US DX-M is released in combination with CR HM5.x Mammo

detectors only.

System Documentation
The documentation consists of following items:
• DX-G and DX-M User Manual.
• DX-G and DX-M Workflow Sheets.
• AGFA CR Detectors, Plates and Cassettes (CR HD5.x, CR MD4.xR, CR HM5.x,
CR MM3.xR) User Manual.
• CR Full Leg Full Spine User Manual (4408).
• NX User Manual (4420).
• CR Mammography System User Manual (2344).
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.

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Training
The user must have received adequate, Agfa certified 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 must ensure that
training is received in accordance with local laws or regulations that have the
force of law. Your Agfa certified representative can provide further
information on certified training.
The user must note the following information in the preliminary section of
this manual:
• “Intended Use” on page 12.
• “Intended User” on page 12.
• “Safety Directions” on page 43.

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 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.

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

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
and 3: Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance.
Refer to Appendix B for an overview of applied standards.

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Labelling
 CE label: 93/42 EEC 'Medical Devices' (Europe), EN 60601-1

 ETLus label: AAMI ES60601-1 (North America)

 ETLc label: CSA 22.2 No. 60601-1-08 (Canada)

Radio Interference Suppression

It is hereby certified that the digitizer has interference suppression according
to the EN 55011 Class A as well as the FCC Rules CR47 Part 15 Class A.
WARNING: This equipment has been tested and found to comply
with the limits for a Class A digital device, pursuant to part 15 of
the FCC Rules. These limits are designed to provide reasonable
protection against harmful interference when the equipment is
operated in a commercial environment. This equipment generates,
uses and can radiate radio frequency energy and, if not installed
and used in accordance with the instruction manual, may cause
harmful interference to radio communications. Operation of this
equipment in a residential area is likely to cause harmful
interference in which case the user will be required to correct the
interference at his own expense.

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Equipment Classification

Class I Equipment Equipment in which protection against electric shock does

not rely on basic insulation only, but includes a power sup-
ply cord with protective earth conductor. For earth reli-
ability always plug the main power cord into an earthed
mains power outlet.

Type B Equipment Not applicable: The patient does not get in contact with
any part of the device.

Water Ingress This device does not have protection against ingress of
water.

Cleaning See section “Maintenance and Cleaning” on page 31.

Disinfection See section “Maintenance and Cleaning” on page 31.

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

Continuous Opera- The unit is suitable to run continuously.

tion

Table 1: Equipment classification

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Installation

Caution: Agfa recommends the installation of a UPS (uninterruptible

power supply) for the digitizer to overcome power failures of the
hospital power network and to prevent a resulting image-loss.

Digitizer installation and configuration is performed by an Agfa certified

service engineer.
The digitizer is foreseen to be installed in a stationary and weather protected
location. It is imperative to:
• avoid exposure to direct sunlight (e.g. never position the digitizer nearby a
window.)
• protect the digitizer against exceptional mechanical shocks (e.g. casement
doors,...)
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. There is a mobile version of the
digitizer available that provides externally accessible locking systems for the
fixation of the mechanics inside the device.
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: 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.

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Mobile Use Installation

If the digitizer is installed in a mobile environment, a special mobile version of
the DX-M is available that can be locked by the user for transport and un-
locked again for use.
The locking system consists of two handles on both sides of the digitizer and a
locking mechanism for the scan unit. The locking mechanism for the scan unit
is accessible on the front side of the digitizer and requires a locking tool which
is delivered with the mobile version.

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To lock the digitizer before transport:

1 In the Standby window, click the Configuration button.

The Rerouting window appears.

2 Click the Mobile use button.

Chest1200 VAM1254 T
Leg234 MORLS234
Foot865994 PREVIEWSTAT

3 Wait for the following message to be displayed: “Ready to fix transport locks.
Switch off the digitizer and fix transport locks.”
Switch off the digitizer with the main switch.

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4 On the right side of the digitizer, turn the two handles 180° clockwise till they
reach the locked position:

Locked Unlocked

Table 2: Locked and unlocked position of the handles

5 Repeat the same using the two handles on the left side of the digitizer.

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6 Insert the locking tool in the round opening in the front cover.

7 Push the tool towards the end and pull tight clockwise by use of the ratchet:

8 Remove the tool. The digitizer is now ready for transport.

Caution: If the digitizer is transported without the transport locks

attached the device can be damaged.

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To unlock the digitizer after transport:

1 Insert the locking tool in the round opening in the front cover.

2 Push the tool towards the end and turn it counterclockwise till mechanical
resistance can be felt.

3 On the right side of the digitizer, turn the two handles 180° counterclockwise
till they reach the unlocked position:

4 Repeat the same using the two handles on the left side of the digitizer.

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5 Switch on the digitizer.

Note: If the digitizer is switched on without removing the transport lock on

the front side, the following warning message is displayed: “Transport locks
are attached. Switch off the digitizer and remove transport locks.”

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

General radiography It is recommended to expose the cassette with 2 expo-

sures 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.

Table 3: Image quality check after transport

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X-Ray source Exposure conditions

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.

Table 3: Image quality check after transport

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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Labels
 Product Identification

 General

 Safety Instructions for Laser Products

Product Identification

DX-G - Product description

Type of product Floor-mounted buffer digitizer
Commercial name DX-G
Model number 5170/100
Original seller/manufacturer Agfa HealthCare N.V.
Septestraat 27
2640 Mortsel
Belgium

DX-M - Product description

Type of product Floor-mounted buffer digitizer
Commercial name DX-M
Model number 5170/200
Original seller/manufacturer Agfa HealthCare N.V.
Septestraat 27
2640 Mortsel
Belgium

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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 DX-G/DX-M 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 result-
ing system. Consideration relating to the choice of acces-
sory 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 pro-
cessing equipment or IEC 60601-1 for medical equip-
ment).
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 of
the DX-G/DX-M Workflow Sheets.
Off (power: disconnection from the mains)

On (power: connection to the mains)

Type label

Date of manufacture

Manufacturer

Serial number

WEEE Symbol, see section “Environmental Protection” on

page 86

Device contains a transmitter module, see section “Tech-

nical Documentation” on page 83

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Observe great care when handling the detectors. The needle

detector is shock sensitive and drops should be avoided.
When the detector has been dropped, put it aside and con-
tact your local service to check for functionality.

Caution: Do not use the detector again, a corrupt detector can damage
the digitizer!

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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 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 80 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.
However, the user is allowed to open the side cover, e.g. to clean the optical
unit or to change an air-filter. When opening the side 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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Maintenance and Cleaning

 Preventive Maintenance by the Service Engineer.

 Maintenance by the User.

Preventive Maintenance by the Service Engineer

Regular preventive maintenance needs to be done once a year or after 25000
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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Maintenance by the User

 Cleaning and Disinfection.

 Cleaning the exterior of the digitizer.

 Cleaning the touch panel.

 Cleaning the optical unit.

 Replacing the air-filter element

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 “AGFA CR Detectors, Plates and Cassettes (CR HD5.x, CR MD4.xR, CR
HM5.x, CR MM3.xR) User Manual”.

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Cleaning the exterior of the digitizer

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.

Cleaning the touch panel

To clean the touch panel:

1 Switch off the digitizer.

2 Remove the power plug from the socket.

Switch off the UPS, if installed.

3 Wipe the touch panel of the digitizer with a clean, soft, damp cloth. Use a com-
mercially available screen cleaner for monitors to clean the touch panel.

Caution: Do not pour liquid directly on the touch panel.

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4 Plug the power plug into the socket.

Switch on the UPS, if installed.

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 optical unit is required if stripes parallel to the image plate
movement within the digitizer can be seen in the image. When you recognize
this type of artefact, when using the digitizer, clean the optical unit using the
cleaning brush.

Image with two artefacts on it, a

black line and a white line.

To clean the optical unit:

1 Switch off the digitizer.

2 Remove the power plug from the socket.

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3 Open the right side cover of the digitizer.

Open the eye of the latching and turn the latch through 90° clockwise.

Note: In case of a mobile device the upper right lock has to be locked before
the side cover can be opened.

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4 Pull out the cleaning brush until you feel the stop position and put it back in the
digitizer.
Repeat this action 5 times.

5 Close the right side cover.

To close the right side cover, proceed as follows:

• Close the cover.

• Turn the latch through 90° counterclockwise and close the eye of the latching.
In case of a mobile device, unlock the upper right lock.

6 Plug the power plug into the socket.

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Replacing the air-filter element

Note: It is advised to replace the air-filter element at least once a year.

To change the air-filter element:

1 Switch off the digitizer.

2 Remove the power plug from the socket.

3 Open the right side cover of the digitizer.

Open the eye of the latching and turn the latch through 90° clockwise.
In case of a mobile device, lock the upper right lock before opening the side cover.

4 Open the right side door and locate the air-filter element inside the door open-
ing.

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5 Release the 2 clamps (1) to be able to remove the air filter frame (2).

1 3 2

6 Remove the old air-filter element (3).

7 Take-out the new air-filter element.

Contact your Agfa representative to order the air-filter element.
AGFA ordering code: CM+ 9.5170.9855

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8 Mount the air-filter element inside the rights side door as illustrated below.

Note: Mind the air flow arrows imprinted on the air filter when positioning
the air-filter inside the door. The air flow arrows should always point to the
inside of the machine.

9 Put back the air-filter frame.

• Insert the left side of the air-filter frame into the provided holes (4).
• Lock the right side of the air-filter frame using the 2 clamps (5).

2321 E EN 20130722
39
 DX-G/DX-M

4 5

10 Close the right side cover.

To close the right side cover, proceed as follows:

• Close the cover.

• Turn the latch through 90° counterclockwise and close the eye of the latching.
In case of a mobile device, unlock the upper right lock.

11 Plug the power plug into the socket.

40 2321 E EN 20130722
 DX-G/DX-M

Recurrent Safety Tests

The digitizer 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.

2321 E EN 20130722
41
 DX-G/DX-M

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 disas-
ter.
It is the responsibility of the hospital to ensure how types of access are
identified, classified and reasons for access are justified.

42 2321 E EN 20130722
 DX-G/DX-M

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 AGFA trained and

qualified 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: This device is intended for use by health care

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 digitizer or shielding the location.

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.

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:
 Changes, additions or maintenance to the Agfa products carried out
by persons without appropriate qualifications and certified train-
ing.
 Using unapproved spare parts.

2321 E EN 20130722
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 DX-G/DX-M

Note: To avoid images being lost due to a power failure, the workstation
and the digitizer can be connected to an uninterruptible power supply
(UPS) or an institutional standby generator.

General Safety Instructions

 Make sure that the digitizer is constantly monitored in order to avoid inappro-
priate handling, especially by children.

 Only service personnel with certified Agfa training 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. This
may decrease the image quality. Neither should the device be moved during
operation.

 Switch off the digitizer 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.

 If you do not operate the digitizer correctly or if you do not have it serviced cor-
rectly, 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.

Note: The DX-M only supports one type of mammography plates and cassettes
at a time. It has to be decided to use either CR HM5.x or CR MM3.xR.

44 2321 E EN 20130722
 DX-G/DX-M

 The digitizer complies with the EN 60601-1 and UL 60601-1 standards for Med-
ical 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 the radius as listed below around the
patient (according to the local valid regulation).

R
Patient vicinity
h

Patient vicinity

Figure 1: Patient environment

R = 1.5 m/4.9 feet (EN 60601-1) or 1.83 m/6 feet (UL 60601-1).

h = 2.5 m/8.2 feet (EN 60601-1) or 2.29 m/7.5 feet (UL 60601-1).

 Perform no other operations on the digitizer than those described in this docu-
ment.

 Switch the system off before moving it. When reaching the new position, fix the
digitizer in place and switch the system on again.

 The digitizer is suitable for use in all establishments other than domestic, and
may be used in domestic establishments and those directly connected to the
public low-voltage power supply network that supplies buildings used for
domestic purposes, provided the warning concerning radio interference in the
paragraph ‘Safety Directions’ is heeded.

2321 E EN 20130722
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 DX-G/DX-M

Quality Control
Regular Quality Control has to be applied according the local regulations. If
no specific regulations are valid, a regular quality control applied with the
Agfa Auto QC² tool at least once a month is required to maintain a safe and
effective system.
For Mammography, constant quality control can be applied with the Agfa
Auto QC Mammo tool or with the “Routine Quality Control Tests for Full Field
Digital Mammography Systems” document, created by the NHSBSP (National
Health Service Breast Screening Program, UK).

46 2321 E EN 20130722
2 Getting Started with the
DX-G/DX-M
This chapter explains how to perform the first basic actions on the digitizer.
This chapter covers the following topics:

❑ Basic Features
❑ The User Interface
❑ Starting the Digitizer
❑ Basic Workflow (Scanning Images)
❑ Stopping the digitizer
 DX-G/DX-M

Basic Features
 DX-G/DX-M Features.

 Operating Modes.

DX-G/DX-M Features
The digitizer reads out the latent X-ray images on image plates and sends
them to the workstation.

 The digitizer has an input and output buffer for 5 cassettes. Consecutively on
each cassette in the buffer, the digitizer:
• takes the cassette from the input buffer in 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,
• 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 the workstation.
• pushes the processed cassette into the output buffer.
• permits re-routing of images to another workstation (limited demographic
data of the 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
scattered radiation from interfering with the image of interest.

48 2321 E EN 20130722
 DX-G/DX-M

Operating Modes
The digitizer can be operated in two modes:

 Operator Mode

 Service Mode

Operator Mode
The operator mode groups all basic functions which are aimed at
radiographers:
• Re-erasing an image plate.
• Rerouting of images.
• Retrieving information with the information button.
• Changing touch panel properties (brightness and loudness of beeper).
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.

2321 E EN 20130722
49
 DX-G/DX-M

The User Interface

The digitizer has two operation 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:
• a touch panel which enables access to all functions,
• a status indicator.

Figure 2: User interface

1. Status indicator.
2. Touch panel.
3. On/Off switch (main switch).
4. Ethernet connection (located at the rear side).

50 2321 E EN 20130722
 DX-G/DX-M

Status Indicator
The indicator informs the user by light signals about the status of the digitizer
(e.g. image plate erasing cycle progress, operational indications such as warm
up,...). It is positioned at the front of the digitizer, so that it is visible from a
distance.

Color Constant/ Status Action

Flashing
Blue Constant Activating the erasure Enter cassettes into the
cycle. input buffer for erasing.
Flashing Proceeding with the era- Remove cassettes from
sure cycle. the output buffer.
Green Constant Stand-by mode (READY).
Flashing Busy with scanning and Enter cassettes into input
transporting cassette and buffer for scanning.
image plate.
Remove cassettes from
output buffer.
Red Constant •Service mode •Check digitizer touch
panel and workstation
display for further infor-
mation and detailed
instructions.
•Fatal error •Contact an Agfa certi-
fied service engineer.
Flashing •Warm up / Self-test Check digitizer touch
•Processing Software down panel and workstation
•Error display for further infor-
mation and detailed
instructions.

2321 E EN 20130722
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 DX-G/DX-M

Starting the Digitizer

Procedure:

1 Make sure the digitizer is connected to a workstation and that the workstation
is running the appropriate NX Software.

2 Make sure that the power plug is plugged into the socket.

3 Remove cassettes from the input buffer and input slot of the digitizer.

4 Press the main switch.

main switch

52 2321 E EN 20130722
 DX-G/DX-M

The Start Up screen is visible on the Touch panel:

The digitizer starts the following operation sequence:

• initialization of all components,

• functional test of all components,
• check for presence of cassettes and/or IPs.
During the warm-up and self-test, which may take up to 3 minutes, 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 opera-
tor mode and the status indicator is continuously lighting up in green. The Standby
screen is shown:

Note: The brightness of the touch panel is temporarily reduced after not
being used for a while.

2321 E EN 20130722
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 DX-G/DX-M

Basic Workflow (Scanning Images)

Note: The basic workflow is described in the DX-G/DX-M Workflow Sheets.

Workflow:

1 Identify the cassette with the ID Tablet and on a workstation.

2 Check that the digitizer is ready for operation.

The status indicator must be continuously lighting up green or green flashing.

3 Put the cassettes with the exposed and identified image plates in the input
buffer on the left side of the digitizer.
There can be up to five cassettes in the input buffer.

4 Be aware of the orientation of the cassettes:

Tube side of the cassette

Shutter opening and locking

mechanism

Figure 3: Cassette orientation

54 2321 E EN 20130722
 DX-G/DX-M

• Tube side must be faced to the operator.

• The shutter opening mechanism and locking mechanism must be pointed down, to
the slot of the digitizer.

5 The cassettes are digitized subsequently:

• The status indicator is green and blinking.
• The digitizer stores images to disk.
• The digitizer erases cassettes.
The progress of the digitizing is shown, per cassette, on the touch panel:

6 Take the processed cassettes from the output buffer on the right side.
When the digitizer has finished, the status indicator is continuously lighting up in
green.

2321 E EN 20130722
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 DX-G/DX-M

Stopping the digitizer

 Before Switching Off.

 Switching Off.

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
3 minutes. During this time emergency digitizing is not possible!

To switch off, press the main switch to the Off (“0”) position.

main switch

56 2321 E EN 20130722
3 Operating DX-G/DX-M
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:

❑ Re-erasing an Image Plate

❑ Turning the Volume of the Digitizer Signals and Beeps On or Off
❑ Changing the Brightness of the Touch Panel
❑ Retrieving Information About the Digitizer
❑ Moving the Digitizer
❑ Troubleshooting and Errors during Operation
 DX-G/DX-M

Re-erasing an Image Plate

At the end of a 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-eras-
ing it.

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 on the touch panel at the front side of the digitizer.

Erase button

The digitizer switches to erase mode.

The status indicator is continuously lighting up in blue.

58 2321 E EN 20130722
 DX-G/DX-M

3 Put the cassettes containing the image plate on the cassette buffer [1] of the
digitizer as shown below.
Make sure to insert the cassette with the black (tube) side to the front and with the
shutter opening mechanism and the locking mechanism down, towards the cassette
slot.

Tube side of the cassette

Shutter opening and locking

mechanism

Figure 4: Cassette orientation

As a result, the digitizer starts erasing the image plate and the status indicator is blue
flashing.
When the digitizer has finished erasing the cassette, the status indicator is constantly
lit in blue.

4 Remove the cassette with the erased image plates from the cassette output
buffer.

5 Press the Erase button again to switch to normal mode.

One minute after the last cassette has been processed, the digitizer switches from
“erasure” mode to “normal mode”.

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 10 seconds to
enter a cassette. If you do not, the digitizer returns to the standby mode.

2321 E EN 20130722
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 DX-G/DX-M

Re-routing of an Image
Normally, an image is sent to the workstation where it was identified. But in
case of transmission problems, the image can be rerouted on the digitizer and
sent to an alternative workstation.

WARNING: The demographic data selected during original

identification are lost. On the new workstation, the demographic
data have to be filled in manually.

To reroute an image

1 In the Standby window, click the Configuration button.

The Rerouting window appears.

60 2321 E EN 20130722
 DX-G/DX-M

Chest1200 VAM1254 T
Leg234 MORLS234
Foot865994 PREVIEWSTAT

1 2 3

1. Image UID.
2. Workstation.
3. Status: T - Transmitting (the digitizer is busy transmitting the image) / W - Warning (the image
transmission has failed; manual re-transmission to a new workstation necessary) / Q - Queued
(the image is in the transmission queue; a manual transmission to another workstation is possi-
ble).

2 Select the image you want to reroute.

Chest1200 VAM1254 T
Leg234 MORLS234
Foot865994 PREVIEWSTAT

2321 E EN 20130722
61
 DX-G/DX-M

3 Click the Destinations button.

The following window appears.

VAM1254
MORLS234
PREVIEWSTAT
MORWF452
MORWF475
HOUSE M.D.
E.R.
GRACE ANATOMY
AGFA
UZA 452
MY OFFICE

4 Select the new workstation and confirm by clicking the Confirm button.

62 2321 E EN 20130722
 DX-G/DX-M

Turning the Volume of the Digitizer

Signals and Beeps On or Off
You can turn the volume of digitizer signals and beeps on or off.

To turn the volume on or off:

1 In the Standby window, click the Configuration button.

Configuration button

The Configuration window appears:

Chest1200 VAM1254 T
Leg234 MORLS234
Foot865994 PREVIEWSTAT

2 Click the brightness/loudness button.

2321 E EN 20130722
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 DX-G/DX-M

The following window appears.

The active functionality lights up in

blue (here: volume ON)

3 Do one of the following:

• Turn the volume on by pressing the button.

• Turn the volume off by pressing the button.

As a result the selected button lights up in blue.

64 2321 E EN 20130722
 DX-G/DX-M

Changing the Brightness of the Touch

Panel
You can change the brightness of the touch panel on the digitizer.

To change the brightness:

1 In the Standby window, press the Configuration button.

Configuration button

The Configuration window appears:

Chest1200 VAM1254 T
Leg234 MORLS234
Foot865994 PREVIEWSTAT

2 Click the brightness/loudness button.

2321 E EN 20130722
65
 DX-G/DX-M

The following window appears.

Brightness Section of the

Configuration Screen

3 In the Brightness section on the lower part of the Configuration window, use
the + or - buttons to adjust the brightness.

66 2321 E EN 20130722
 DX-G/DX-M

Retrieving Information About the

Digitizer
To retrieve information:

1 In the Standby window, press the Information button.

Information button

The Information window appears, showing the IP Address, Name, Software version
and name of the primary NX workstation:

Confirmation button

2 Click the Confirm button to go back to the Standby window.

2321 E EN 20130722
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 DX-G/DX-M

Moving the Digitizer

To move the digitizer:

1 Switch off the digitizer.

2 Remove the power plug from the socket.

3 Unplug the ethernet cable.

4 Collect all cables together to prevent them from being crushed when moving
the digitizer.

5 Remove all cassettes from the input and output buffer.

6 Open the right side cover of the digitizer.

Open the eye of the latching and turn the latch through 90° clockwise.

68 2321 E EN 20130722
 DX-G/DX-M

7 Take the tool from the tool box at the inside of the right door.

8 Insert the tool in the opening and turn the screw counterclockwise, until the
digitizer is lifted up approximately 1,5-2 cm, until you encounter resistance.

1,5 - 2 cm
0.59 - 0.78 inch

The digitizer is ready to be moved to another location.

2321 E EN 20130722
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 DX-G/DX-M

9 Move the digitizer to the desired location.

WARNING: Observe great care when moving the digitizer to the

desired location. So please select a path free from inclinations and
thresholds to prevent the digitizer from shocks during movement.

10 Once on the desired site, turn the screw clockwise until the digitizer is fixed on
the ground and you encounter resistance.
Now the digitizer is ready for operation.

Caution: Operating the digitizer in a not-fixed condition may result in image

artefacts.

11 Put back the tool.

12 Reconnect all electrical connections.

• Reconnect the ethernet cable.
• Plug the power plug into the socket.

70 2321 E EN 20130722
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Troubleshooting and Errors during

Operation
The troubleshooting for a malfunction of the digitizer consists of three parts:
• The first is always to check the status indicator on the digitizer: during errors
it will continuously lighting up in red or flashing red.
• The second is checking why the digitizer does not start-up.
• Finally you can check the connection to the NX workstation.

Status Indicator: continuously red

If the status indicator is continuously lighting up in red, your digitizer deals
with a fatal error.

Proceed as follows:

1 Do not try to solve this problem.

2 Contact immediately your Agfa certified service engineer for more information.

Figure 5: Example fatal error (status indicator continuously red)

2321 E EN 20130722
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 DX-G/DX-M

Status Indicator: flashing red

If the status indicator is flashing red, your digitizer deals with an error that
can be remedied by the operator. Always follow the instructions that appear
on the touch panel.
For example; if you wrongly insert the cassette, with the exposed and
identified image plate, in the input buffer, the following instructions will
appear on the touch panel:

Proceed as follows:

1 Put the cassettes with the exposed and identified image plates wrongly in the
input buffer on the left side of the digitizer.

2 As a result, the digitizer moves the cassette into the intermediate position and
the following error message appears.

Figure 6: Example remediable error (status indicator flashing red)

3 Click the Confirm button.

4 Remove the cassette from the output buffer.

Now you can re-enter the cassette correctly.

72 2321 E EN 20130722
 DX-G/DX-M

Digitizer does not Start up

If the digitizer does not start up, check the power supply, wall socket and
safety fuse.
If the power supply is ok, call your local Service engineer.

2321 E EN 20130722
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 DX-G/DX-M

74 2321 E EN 20130722
Appendix
 DX-G/DX-M

76 2321 E EN 20130722
A Equipment Information
Sheet
This appendix covers the following topic:

❑ Specifications
❑ Pixel Matrix Size
 DX-G/DX-M

Specifications
Dimensions
Max. Height 1229 mm (48.4 inch)
Max Floor space WxD 660 mm x 510 mm
(26.0 inch x 20.1 inch)
Max Projected Floor space WxD 1150 mm x 510 mm
(45.3 inch x 20.1 inch)
Weight
Unpacked approximately 180.0 kg (396.8 lb)
Buffer
Input/output cassette buffer 5 cassettes
Integrated data buffer If the connection to the workstation is inter-
rupted (e.g. workstation is shut off), the digi-
tizer will finish actual scanning-job and
temporary store the image until the connec-
tion to the NX workstation is re-established. A
new cassette will only be accepted if the previ-
ous transmission job has been finished.
Greyscale resolution
Output to workstation 16 bits/pixel square root compressed
Electrical connection
Operating voltage Autosensing power supply from: 100 V to
240 V, AC +/- 10%
Operating current 6.3 A (100 - 120 V)
2.6 A (220 - 240 V)
Mains fuse protection Europe: 16 A
USA & Japan: 15 A
Mains frequency 50-60 Hz
Network connectivity
Ethernet connector

78 2321 E EN 20130722
 DX-G/DX-M

Power consumption (typical values)

220 V - 240 V / 50-60 Hz configuration

•Standby 87 W

•Average continuous scanning 237 W

•During scanning 590 W max.

100 V - 120 V / 50-60 Hz configuration

•Standby 92 W

•Average continuous scanning 245 W

•During scanning 621 W max.

Environmental conditions (during operation)

In line with IEC721-3-2: 2M2 and 2K2 with following restrictions:
Room temperature Agfa CR HM5.x Mammo: between
+20 °C and +30 °C (68 - 86°F)
Other plates and cassettes: between
+15 °C and +30 °C (59 - 86°F)
Maximum temperature change rate max. 0.5 °C/min (0.9°F/min)
Relative humidity between 15 % and 75 %
(non-condensing)
Light no exposure to direct sunlight, max. 2500 Lux
Environmental conditions (during storage)
Room temperature between -25 °C and 55 °C
Relative humidity between 10 % and 95 %
Barometric pressure between 70 kPa and 106 kPa
Environmental conditions (during transport)
Room temperature between -25 °C and 55 °C
Relative humidity maximum 85 %
Barometric pressure minimum 70 kPa
Environmental conditions for mobile installation (during transport)
In line with IEC721-3-5: 5M1 and 5K1 with following restrictions:
Room temperature between 10 °C and 40 °C

2321 E EN 20130722
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 DX-G/DX-M

Environmental conditions for mobile installation (during operation)

In line with IEC721-3-3: 3M1 and 3K2 with following restrictions:
Room temperature Agfa CR HM5.x Mammo: between
+20 °C and +30 °C (68 - 86°F)
Other plates and cassettes: between
+15 °C and +30 °C (59 - 86°F)
Relative humidity between 15 % and 75 %
(non-condensing)
Vibration 40 - 200 Hz; 1 m/s²; sinusoidal vibration
Barometric pressure/altitude
Highest pressure 106 kPa (at sea level)
Lowest pressure 70 kPa (3000 m above sea level)
Warming-up time
Cold start 3 min.
Physical emissions
Noise emission (sound power level according to ISO 7779)
During scanning max. 65 dB(A)
Standby max. 45 dB(A)
Heat emission per hour (typical values)
During continuous operation (with 245 Wh / 836 BTU
standard erasure time)
Standby 92 Wh / 314 BTU
Plates and cassettes
Compatible cassette/IP types DX-G •Agfa CR HD5.x General/FLFS/AEC.
•Agfa CR MD4.xR General/FLFS.
Compatible cassette/IP types DX-M •Agfa CR HD5.x General/FLFS/AEC.
•Agfa CR MD4.xR General/FLFS.
•Agfa CR HM5.x Mammo.
•Agfa CR MM3.xR Mammo.

80 2321 E EN 20130722
 DX-G/DX-M

Throughput (using the default erasure cycle)

The cassette throughput (plates/hour) •35 x 43 SR (HD5.x/MD4.xR): 83
depends on the cassette format and is •35 x 43 HR (HD5.x/MD4.xR): 72
based on the standard image plate •35 x 35 SR (MD4.xR): 83
erase dose.
•35 x 35 HR (MD4.xR): 71
•24 x 30 (HD5.x): 85
•24 x 30 (MD4.xR): 83
•18 x 24 (HD5.x): 93
•18 x 24 (MD4.xR): 90
•15 x 30 (HD5.x): 100
•15 x 30 (MD4.xR): 97
•24 x 30 (HM5.x): 41
•24 x 30 (MM3.xR): 40
•18 x 24 (HM5.x): 49
•18 x 24 (MM3.xR): 48
End of Life
Estimated product life 7 yrs.
(if regularly serviced and maintained
according to Agfa instructions)
Preventive maintenance
Preventive maintenance frequency. Once a year or 25000 cycles, whatever comes
first.
Note: Needs to be done by an Agfa certified
field service engineer.

1. BTU: British Thermal Unit

2321 E EN 20130722
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 DX-G/DX-M

Pixel Matrix Size

Cassette Format (cm) Resolution Width x Length Width x Length
type (pixel/mm) (pixels) (mm)
CR 35x43 HR 10 4248 x 3480 424.8 x 348.0
MD4.0R
General 35x35 HR 10 3480 x 3480 348.0 x 348.0
35x43 SR 6.66 2832 x 2320 424.8 x 348.0
35x35 SR 6.66 2320 x 2320 348.0 x 348.0
24x30 10 2928 x 2328 292.8 x 232.8
18x24 10 2328 x 1728 232.8 x 172.8
15x30 10 2928 x 1440 292.8 x 144.0
CR 35x43 10 4392 x 3480 439.2 x 348.0
MD 4.0R
FLFS
CR 35x43 HR 10 4200 x 3408 420.0 x 340.8
HD5.0
General/ 35x43 SR 6.66 2800 x 2272 420.0 x 340.8
AEC 24x30 10 2880 x 2256 288.0 x 225.6
18x24 10 2280 x 1656 228.0 x 165.6
15x30 10 2880 x 1344 288.0 x 134.4
CR 35x43 10 4368 x 3408 436.8 x 340.8
HD5.0
FLFS
CR 24x30 20 5844 x 4710 292.2 x 235.5
MM3.xR
Mammo 18x24 20 4644 x 3510 232.2 x 175.5

CR 24x30 20 5844 x 4708 292.2 x 235.4

HM5.x
Mammo 18x24 20 4644 x 3508 232.2 x 175.4

82 2321 E EN 20130722
B Technical Documentation
This appendix contains technical information. It is only available in English.

❑ Compliance
❑ Connectivity
❑ Environmental Protection
❑ Remarks for HF-emission and immunity
 DX-G/DX-M

Compliance
Certificates
Europe USA/Canada

EMC EN 60601-1-2:2007 FCC part 15

EN 300 330-2 V1.1.1:2001 CSA 22.2 No. 601.1.2
EN 301 489-1 V1.3.1:2001

Safety Medical Equipment

IEC 60601-1:1988 +A1: 1991: UL60601-1:2003

+ A2:1995
CSA C 22.2No.601.1:1990 +
IEC 60601-1: 2005 S1:1994 + A2:1998
ES 60601-1 1st Edition; CAN
CSA 22.2 no. 60601-1-08

Laser

IEC 60825-1:1993 + A1:1997 CFR parts 1040.10 and 1040.11

+ A2:2001
CSA-E60825-1-03

Note: The DX-G/DX-M is in compliance with the EG regulation 93/42/EEC

Directive (Medical Device).

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 DX-G/DX-M

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.

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 DX-G/DX-M

Connectivity
The digitizer is connected to one or more NX workstations via an ethernet
connection and uses a dedicated protocol to communicate with the
workstation.

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
Li mixed with general household waste.

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 DX-G/DX-M

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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 DX-G/DX-M

Remarks for HF-emission and

immunity
The DX-G/DX-M 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.

Emissions test Compliance Electromagnetic Environment Guide-

lines
RF emissions in accordance Group 1 The DX-G/DX-M 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.
RF emissions in accordance Class A WARNING: The DX-G/DX-M is
with CISPR 11 suitable for use in all establishments
Harmonic emissions in accor- Class A other than domestic, and may be used
dance with IEC 61000-3-2 in domestic establishments and those
directly connected to the public low-
Voltage fluctuations / flicker Complies
voltage power supply network that
emissions in accordance with
IEC 61000-3-3 supplies buildings used for domestic
purposes, provided the following
warning is heeded.

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 DX-G/DX-M

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 Environ-

Jamming Test Test Level Agreement ment Guidelines
Discharge of + 6 kV contact + 6 kV contact Floors should consist of
static electricity discharge discharge wood, concrete or ceramic
in accordance tiles. The relative humidity
with IEC 61000- + 8 kV air dis- + 8 kV air dis- must be at least 30%, if the
4-2 charge charge floor is made of synthetic
material.
Fast transient + 2 kV for net- + 2 kV for net- The quality of the voltage
electrical distur- work leads work leads supplied should correspond
bance variables to a typical commercial or
/ bursts in accor- + 1 kV for entry + 1 kV for entry clinical environment.
dance with IEC and outlet leads and outlet leads
61000-4-4
Impulse volt- + 1 kV push-pull + 1 kV push-pull The quality of the voltage
ages (surges) in voltage voltage supplied should correspond
accordance with to that of a typical commer-
IEC 61000-4-5 + 2 kV common + 2 kV common cial or clinical environment.
mode voltage mode voltage
Voltage break- •< 5% Ur •< 5% Ur The quality of the voltage
throughs, short (> 95% break- (> 95% break- supply should correspond to
term interrup- through of Ur) through of Ur) that of a typical commercial
tions and varia- for ½ period for ½ period or clinical environment.
tions in the •40% Ur (> 60% •40% Ur (> 60% If the user wants the device
voltage supplied breakthrough of breakthrough of to work continuously, even
in accordance Ur) for 5 periods Ur) for 5 periods when the energy supply is
with IEC 61000- •70% Ur (30% •70% Ur (30% interrupted, it is recom-
4-11 mended to use an energy
breakthrough of breakthrough of
Ur) for 25 peri- Ur) for 25 peri- supply free of interruptions
ods ods or a battery.
•< 5% Ur (95% •< 5% Ur (95%
breakthrough of breakthrough of
Ur) for 5 s Ur) for 5 s
Magnetic field at 3 A/m 3 A/m Magnetic field at the net-
the supply fre- work frequency should cor-
quency (50/60 respond to the typical values
Hz) in accor- as they are in a commercial
dance with IEC and clinical environment.
61000-4-8
Note: Ur is the alternating voltage.

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 DX-G/DX-M

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 Environment

to Disruption Test Level Agreement
Use portable and mobile radio sets at
a safe distance from the device
(including the leads) not closer than
the recommended protective dis-
tance, which is calculated according
to the equation suitable for the trans-
mission frequency.
Recommended protective distance:
Conducted high fre- 3 Veff 3 Veff
quency disturbance d = 1.2 P
variables in accor- 150 kHz
dance with to 80 MHz
IEC 61000-4-6
Radiated high fre- 3 V/m 3 V/m
quency disturbance d = 1.2 P 80 MHz to 800 MHz
variables in accor- 80 MHz
dance 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 accor-
dance with the manufacturer infor-
mation on the transmitter and d as
the recommended protective dis-
tance 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 investiga-
tionb.
Disruptions are possible near devices
that carry the following symbol:

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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 elec-
tromagnetic 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.

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 Frequency
of the Trans-
mitter
W m

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

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 DX-G/DX-M

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 infor-
mation 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.

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93
Printed in Belgium
Published by Agfa HealthCare N.V., B-2640 Mortsel-Belgium
2321 E EN 20130722