AGFA DX-D 60C User manual

DX-D 60C, DX-D 60G
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6007/111
User Manual
0294B EN 20190221 1131

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 ................................................... 10
Intended User .......................................................... 10
Configuration .......................................................... 11
Equipment Classification ......................................... 12
Non-medical equipment ...............................12
Options and Accessories ...........................................13
Anti-scatter grids ......................................... 13
Operation Controls .................................................. 14
DX-D 60C, DX-D 60G ....................................15
System Control Unit .....................................16
DR Detector Switch on the NX Workstation ....
17
System Documentation ............................................ 19
Training ...................................................................20
Product Complaints ................................................. 21
Compatibility ...........................................................22
Compliance ............................................................. 23
General ........................................................24
Safety .......................................................... 24
Electromagnetic Compatibility .....................24
Radio Frequency ..........................................24
Connectivity ............................................................ 26
Wired communication ................................. 26
Installation .............................................................. 27
Environment of Use ..................................... 27
Messages ................................................................. 29
Labels ...................................................................... 30
Additional Labeling of the DR Detector ........ 33
Additional Labeling of the System Control Unit
34
Additional Labeling of the Mini System Control
Unit ............................................................. 35
Consulting the About box .............................36
Cleaning and Disinfecting ........................................ 37
Cleaning ...................................................... 38
Use of protective plastic bag .........................39
Disinfecting ................................................. 40
Approved disinfectants .................................41
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Safety directions for disinfection ..................42
Maintenance ............................................................43
Daily inspection ...........................................44
Half-yearly inspection .................................. 45
Regular Inspection and Maintenance ........... 46
Replacement Parts Support ..........................47
Repair ..........................................................48
Patient data security ................................................ 49
Environmental Protection ........................................ 50
Safety Directions ......................................................51
Safety directions for the power supply ..........55
Safety directions for the System Control Unit ...
57
Limitations for patient contact ..................... 58
Getting started .....................................................................59
Starting the DR Detector ..........................................60
Basic Workflow DR Detector .................................... 61
Step 1: retrieve the patient info ....................62
Step 2: select the exposure ...........................62
Step 3: prepare the exposure ........................63
Step 4: check the exposure settings ..............64
Step 5: execute the exposure ........................65
Step 6: perform a quality control ..................66
Positioning the DR Detector ......................... 67
Guidelines for Pediatric Applications ....................... 69
Stopping the DR Detector .........................................71
Automatic exposure detection ..................................72
Advanced Operating ............................................................ 73
Detector Status Indicators ........................................73
Problem solving ................................................................... 74
Artifact in DR Detector images ................................. 75
Identifying problems ................................................76
Technical Data .....................................................................78
DX-D 60C, DX-D 60G ................................................79
System Control Unit .................................................81
Mini System Control Unit .........................................82
Remarks for HF-emission and immunity .............................. 83
EMC (Electromagnetic Compatibility) Statements ... 84
Electromagnetic emissions .......................................85
Electromagnetic immunity .......................................86
For U.S.A. ................................................................ 89
DX-D 60C, DX-D 60G | Contents | iii
0294B EN 20190221 1131

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. DX-D 60C and DX-D 60G 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 2019 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 | DX-D 60C, DX-D 60G | Legal Notice
0294B EN 20190221 1131

Introduction to this Manual
Topics:
•Scope
•About the safety notices in this document
•Disclaimer
DX-D 60C, DX-D 60G | Introduction to this Manual | 5
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Scope
This manual contains information for the safe and effective operation of the
DX-D 60C and DX-D 60G DR Detectors and peripheral equipment, further
referred to as the DR Detector.
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0294B EN 20190221 1131

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.
DX-D 60C, DX-D 60G | Introduction to this Manual | 7
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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 the DR Detector
Topics:
•Intended Use
•Indications for Use
•Intended User
•Configuration
•Equipment Classification
•Options and Accessories
•Operation Controls
•System Documentation
•Training
•Product Complaints
•Compatibility
•Compliance
•Connectivity
•Installation
•Messages
•Labels
•Cleaning and Disinfecting
•Maintenance
•Patient data security
•Environmental Protection
•Safety Directions
DX-D 60C, DX-D 60G | Introduction to the DR Detector | 9
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Intended Use
The DR Detector is a wired radiographic digital X-ray imaging device
commonly referred to as flat panel detector. It is designed for general
radiography applications. The DR Detector will be used in a radiological
environment by qualified staff to capture and route static X-ray images.
The DR Detector is not intended for mammography applications.
Indications for Use
The DR Retrofit solution is indicated for use in general projection
radiographic applications to capture for display diagnostic quality
radiographic images of human anatomy. The DR Retrofit solution may be used
wherever conventional screen-film systems may be used.
The DR Retrofit solution is not indicated for use in mammography.
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.
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Configuration
The DR Detector is a component that can be integrated in an X-ray system and
that communicates to a workstation. Two wired DR Detectors can
communicate to a single workstation using the standard System Control Unit.
The configuration can include wireless DR Detectors.
7
3
4
1
8
1
5
2
6
1. DR Detector
2. DR Detector connector cable
3. System Control Unit
4. Workstation
5. Generator Sync Box
6. X-ray generator
7. Automatic exposure detection
8. X-ray generator synchronization
Figure 1: DR Detector configuration
Depending on the configuration, the Generator Sync Box may not be part of
the system.
Related Links
Automatic exposure detection on page 72
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Equipment Classification
Per EN/IEC60601-1, Medical Electrical Equipment, General Requirements for
Safety 3rd Edition, the DR Detector is classified as following.
Class I equip-
ment
Equipment in which protection against electric shock does
not relay on basic insulation only, but includes a power sup-
ply cord with protective earth conductor. For earth reliabili-
ty always plug the main power cord into an earthed mains
power outlet.
Type B equip-
ment
A Type B piece of equipment is one that provides a particu-
lar degree of protection against electric shock particularly
regarding allowable leakage current and reliability of the
protective earth protection.
Water ingress IP53
This device is protected against spraying water.
Flammable
anesthetics
This device is not suitable for use in the presence of a flam-
mable anesthetic mixture with air, or in presence of a flam-
mable anesthetic mixture with oxygen or nitrous oxide.
Operation Continuous operation.
Applied Parts The DR Detector tube side is an applied part.
Expected serv-
ice life
Up to seven (7) years
(if regularly serviced and maintained according to Agfa in-
structions)
Non-medical equipment
Following components are classified as non-medical equipment:
• System Control Unit
• Workstation
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Options and Accessories
The delivery contains a set of labels. When using multiple DR Detectors, on
the labels a nickname is written to identify the DR Detector. An identical label
is attached to the bucky of the X-ray system to identify the dedicated
workspace of each DR Detector.
Anti-scatter grids
Anti-scatter grids are used to reduce scattered radiation and improve image
quality. Grids are available as an option.
Refer to the Agfa website for specifications on the anti-scatter grids that have
been found compatible with the system and the DR Detectors.
http://www.agfahealthcare.com/global/en/library/overview.jsp?ID=54332498
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Operation Controls
Topics:
•DX-D 60C, DX-D 60G
•System Control Unit
•DR Detector Switch on the NX Workstation
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DX-D 60C, DX-D 60G



2
1 3 4
1. DR Detector connector
2. Status indicators
• Blue indicator shows data communication status.
• Orange indicator shows if the detector is ready.
• Green indicator shows power on/off status of the detector.
3. On/off switch
4. Effective imaging area border and center position indication
Figure 2: DR Detector operation controls
Related Links
Detector Status Indicators on page 73
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System Control Unit
The System Control Unit is connected to the DR Detector via the DR Detector
cable.
The System Control Unit is connected to the X-ray generator to synchronize
the exposure, in a configuration with X-ray generator synchronization.
The System Control Unit is connected to the workstation via wired network.
12
12
1. Power switch
2. Status indicator
• Blinking green: starting up
• Green: ready
• Blue: communicating to the detector
Figure 3: System Control Unit (SCU) and Mini System Control Unit (Mini
SCU)
WARNING:
Do not use the System Control Unit within the patient’s vicinity.
Related Links
System Control Unit on page 81
Mini System Control Unit on page 82
Safety directions for the power supply on page 55
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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.
The DR Detector Switch can be used to activate another DR Detector.
It is positioned in the title bar of the NX application.
Battery status
icon
(empty)
Meaning Full Medium Low Empty Wired DR Detector
Wireless DR Detector is off
or disconnected
Connec-
tion status
icon (wi-
fi/wired)
(empty)
Meaning Good Low Bad Wired DR
Detector
DR Detec-
tor is off or
disconnec-
ted
DR Detec-
tor status
icon (blinking)
(empty)
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Meaning DR Detec-
tor is ready
for expo-
sure
DR Detector is
initializing for
exposure
DR Detector is
off or discon-
nected or in
error
DR Detector is
inactive (no
thumbnail se-
lected)
DR Detector exposure synchronization
Automatic expo-
sure detection
icon
(empty)
Meaning The active DR Detector is
using automatic exposure
detection
The active DR Detector is
using X-ray generator syn-
chronization
Note: Depending on the installed software version, the icon may
not be displayed.
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System Documentation
The documentation consists of a User manual (this document) and related
documentation:
• NX User Manual (4420).
• NX Key User Manual (4421).
• NX Getting Started Sheets (4424).
• NX Problem Solving Sheets (4425).
• DX-D DR Detector Calibration Key User Manual (0134).
• DX-D System User Documentation (if applicable).
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
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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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