AGFA DR 18M User manual
DR 18M, DR 24M
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5400/528
User Manual
0380A EN 20180703 1429
Contents
Legal Notice ..........................................................................4
Introduction to this Manual ................................................... 5
Scope .........................................................................6
About the safety notices in this document .................. 7
Disclaimer ................................................................. 8
Introduction to the DR Detector .............................................9
Intended Use ............................................................10
Indications for Use ................................................... 11
Intended User ..........................................................12
Configuration .......................................................... 13
Equipment Classification ..........................................14
Non-medical equipment ...............................14
Operation Controls .................................................. 15
DR 18M, DR 24M ......................................... 16
DR Detector Switch on the NX Workstation ....
17
DR detector cable and control unit ............... 18
System Documentation ............................................20
Training ...................................................................21
Product Complaints ................................................. 22
Compatibility ...........................................................23
Compliance ..............................................................24
General ........................................................25
Safety .......................................................... 25
Electromagnetic Compatibility .....................25
X-ray devices ................................................25
Connectivity ............................................................ 26
Wired communication ................................. 26
Installation .............................................................. 27
Environment of Use ..................................... 27
Messages ................................................................. 28
Labels ...................................................................... 29
Additional Labeling of the DR detector .........31
Additional Labeling of the DR detector control
unit ..............................................................32
Cleaning and Disinfecting ........................................ 33
Cleaning ...................................................... 34
Disinfecting ................................................. 35
Use of protective plastic envelope .................36
Approved disinfectants .................................37
Safety directions for disinfection .................. 38
Maintenance ............................................................40
Daily inspection ........................................... 41
Half-yearly inspection ..................................42
Patient data security ................................................ 43
ii | DR 18M, DR 24M | Contents
0380A EN 20180703 1429
Environmental protection ........................................ 44
Safety Directions ......................................................45
Getting started .....................................................................48
Handling the DR detector ........................................ 49
Starting the DR detector .......................................... 50
Basic Workflow DR Detector .................................... 51
Step 1: retrieve the patient info ....................52
Step 2: select the exposure ...........................52
Step 3: prepare the exposure ........................52
Step 4: check the exposure settings ..............52
Step 5: execute the exposure ........................52
Positioning the DR detector ..................................... 54
Manual exposure table for examinations without AEC .
55
Verifying if an image is exposed correctly ................. 57
Special mammography views ...................................58
Automatic exposure detection ..................................59
Automatic Exposure Control with DR 18M ...............60
Stopping the DR Detector .........................................61
Problem solving ...................................................................62
No image available after exposure ........................... 63
DR image is not displayed ........................................ 64
Image shows artifacts .............................................. 65
Technical Data ..................................................................... 66
DR 18M, DR 24M ..................................................... 67
DR 18M, DR 24M control unit ..................................70
Remarks for HF-emission and immunity .............................. 71
EMC (Electromagnetic Compatibility) Statements ... 72
Cables, transducers and accessories ......................... 73
Electromagnetic emissions ....................................... 74
Electromagnetic immunity .......................................75
DR 18M, DR 24M | Contents | iii
0380A EN 20180703 1429
Legal Notice
0413
Agfa NV, Septestraat 27, B-2640 Mortsel - Belgium
For more information on Agfa products, please visit www.agfa.com.
Agfa and the Agfa rhombus are trademarks of Agfa-Gevaert N.V., Belgium or
its affiliates. DR 18M and DR 24M are trademarks of Agfa NV, 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 NV 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 NV diligently strives to provide as accurate information as
possible, but shall not be responsible for any typographical error. Agfa NV
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 NV reserves the right to make changes to this document
without prior notice. The original version of this document is in English.
Copyright 2018 Agfa NV
All rights reserved.
Published by Agfa NV
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 NV
4 | DR 18M, DR 24M | Legal Notice
0380A EN 20180703 1429
Scope
This manual contains information for the safe and effective operation of the
DR 18M and DR 24M DR Detectors and peripheral equipment, further
referred to as the DR detector.
6 | DR 18M, DR 24M | Introduction to this Manual
0380A EN 20180703 1429
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.
DR 18M, DR 24M | Introduction to this Manual | 7
0380A EN 20180703 1429
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.
8 | DR 18M, DR 24M | Introduction to this Manual
0380A EN 20180703 1429
Introduction to the DR Detector
Topics:
•Intended Use
•Indications for Use
•Intended User
•Configuration
•Equipment Classification
•Operation Controls
•System Documentation
•Training
•Product Complaints
•Compatibility
•Compliance
•Connectivity
•Installation
•Messages
•Labels
•Cleaning and Disinfecting
•Maintenance
•Patient data security
•Environmental protection
•Safety Directions
DR 18M, DR 24M | Introduction to the DR Detector | 9
0380A EN 20180703 1429
Intended Use
The DR 18M and DR 24M are flat panel digital X-ray detectors designed for
use in digital X-ray imaging of woman breast diagnosis (Mammography).
They upgrade an analog or CR mammography unit into a digital unit to
capture projection radiographic images in digital format within seconds,
eliminating the need for an X-ray film or an image plate as an image capture
medium.
The DR 18M and DR 24M is intended for mammography application only. The
DR detectors are designed to be equivalent in size to a conventional film and
CR image plate. The DR 18M is the appropriate size for a small bucky of any
mammography unit and the DR 24M is the appropriate size for a large bucky
of any mammography unit.
10 | DR 18M, DR 24M | Introduction to the DR Detector
0380A EN 20180703 1429
Indications for Use
The DX-D Retrofit Packages system is indicated for use in specific projection
Mammography applications to capture of display diagnostic quality
mammography images of human anatomy for adult examinations. The DX-D
Retrofit Packages system converts the screen-film or CR Mammography
system into a DR Mammography system. If the X-ray system contains
preconfigured exposure settings, they will be updated for use with the DR
detector and the system can no longer be used together with screen-film or CR
systems.
DR 18M, DR 24M | Introduction to the DR Detector | 11
0380A EN 20180703 1429
Intended User
This manual is written for trained users of Agfa products. Users are considered
as the persons who actually handle the equipment as well as the persons
having 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.
Only a physician or a legally certified operator should use this product.
12 | DR 18M, DR 24M | Introduction to the DR Detector
0380A EN 20180703 1429
Configuration
The DR Detector is a component that can be integrated in an X-ray system and
that communicates to a workstation. A workstation can communicate to a
single DR Detector. A DR Detector can communicate to a single workstation.
DR 18M, DR 24M | Introduction to the DR Detector | 13
0380A EN 20180703 1429
Equipment Classification
Per EN/IEC60601-1, Medical Electrical Equipment, General Requirements for
Safety 3rd Edition, 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 A Type B piece of equipment is one that provides a
particular degree of protection against electric
shock particularly regarding allowable leakage
current and reliability of the protective earth
protection.
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.
Non-medical equipment
Following components are classified as non-medical equipment:
• Workstation
• DR detector control unit
WARNING:
Do not use non-medical equipment in the patient’s vicinity.
14 | DR 18M, DR 24M | Introduction to the DR Detector
0380A EN 20180703 1429
DR 18M, DR 24M
1 2
4
3
3
4
2 1
4
1. Effective imaging area border and center position indication
2. Chest wall
3. Shock indicator
4. DR Detector cable connector
Figure 1: DR Detector operation controls
16 | DR 18M, DR 24M | Introduction to the DR Detector
0380A EN 20180703 1429
DR Detector Switch on the NX Workstation
The DR Detector Switch is available in the title bar of the NX application. The
DR Detector Switch shows which DR Detector is active and shows its status.
It is positioned in the title bar of the NX application.
Connection status
icon
(empty)
Meaning Wired DR Detector DR Detector is off or
disconnected
DR
Detector
status icon (blinking)
(empty)
Meaning DR Detector
is ready for
exposure
DR Detector is
initializing for
exposure
DR Detector is
off or
disconnected or
in error
DR Detector
is inactive
(no
thumbnail
selected)
DR 18M, DR 24M | Introduction to the DR Detector | 17
0380A EN 20180703 1429
DR detector cable and control unit
The DR detector cable connects the DR detector to the DR Detector control
unit.
The DR detector control unit connects the DR detector to the mains power
using a power supply and to the workstation.
Position all components appropriately to prevent that the DR detector cable or
the power cable are unintendedly disconnected.
1
1. Power switch
Figure 2: Front view of the control unit
5
4
6
7
1 2 3
1. Indicator light is on when the DR detector is active
2. Indicator light is on when the DR detector is connected
3. Indicator light is on when the DR detector power supply is on
4. DR detector cable
5. Connector for the DR detector cable
6. Connector for the network cable to the workstation
7. Connector for the power cable
Figure 3: Rear view of the control unit
5
1. DR detector cable
Figure 4: Side view of the DR detector
18 | DR 18M, DR 24M | Introduction to the DR Detector
0380A EN 20180703 1429
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.
The most recent version of this document is available on http://
www.agfahealthcare.com/global/en/library/index.jsp
20 | DR 18M, DR 24M | Introduction to the DR Detector
0380A EN 20180703 1429
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