AGFA DX-D 400 User manual

DX-D 400
5420/100
5420/101
User Manual
0230D EN 20191209 1135

Contents
Legal Notice ..........................................................................4
Introduction to this Manual ................................................... 5
Scope of this Manual ..................................................6
Warnings, Cautions, Instructions and Notes ...............7
Disclaimer ................................................................. 8
Introduction to DX-D 400 .......................................................9
Intended Use ............................................................10
Intended User .......................................................... 11
Configuration .......................................................... 12
Equipment Classification ..........................................14
Options and Accessories ...........................................15
Anti-scatter grids ......................................... 15
Operation Controls .................................................. 16
NX Application on the NX Workstation .........17
DR Software Console ................................... 18
DR Detector Switch ......................................19
Exposure button .......................................... 20
Portable DR Detector ................................... 21
System Documentation ............................................22
The DX-D 400 User Documentation ..............22
Training ...................................................................23
Product Complaints ................................................. 24
Compatibility ...........................................................25
Compliance ............................................................. 26
General ........................................................27
Safety .......................................................... 27
X-Ray Safety ................................................ 27
Electromagnetic Compatibility ..................... 27
Connectivity ............................................................ 28
Installation .............................................................. 29
Messages ................................................................. 30
Labels ...................................................................... 31
DR Detector identification label ................... 33
Type label .................................................... 34
Additional Labeling of the X-Ray Generator
Control Box ..................................................35
Labeling of the DR Generator Sync Box ........36
Cleaning and Disinfecting ........................................ 37
Cleaning ...................................................... 38
Disinfecting ................................................. 39
Approved disinfectants ................................ 40
Patient data security ................................................ 41
Maintenance ............................................................42
Maintenance procedures ..............................42
Environmental protection ........................................ 43
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Safety Directions ......................................................44
Getting started .....................................................................47
Starting the System ................................................. 48
Performing an exposure using the DR Detector ........ 49
Step 1: retrieve the patient info ....................50
Step 2: select the exposure ........................... 51
Step 3: prepare the exposure ........................52
Step 4: check the exposure settings .............. 53
Step 5: execute the exposure ........................54
Step 6: perform a quality control ..................55
Performing an exposure using a CR cassette .............56
Step 1: retrieve the patient info .................... 57
Step 2: select the exposure ...........................58
Step 3: prepare the exposure ........................59
Step 4: check the exposure settings .............. 60
Step 5: execute the exposure ........................ 61
Step 6: repeat steps 2 to 5 for the next
subexposures ...............................................62
Step 7: digitize the image ............................. 63
Step 8: perform a quality control ..................64
Stopping the System ................................................ 65
Problem solving ...................................................................66
NX receives black or underexposed DR image due to
repeatedly pushing the exposure button ...................67
NX receives black DR image when X-ray system not ready
for exposure .............................................................68
Wrong modality position selected ............................ 69
Panel status remains in error ....................................70
Error E32 displayed on DX-D Software Console after
preparing for exposure .............................................71
Error E38, E39 or E40 displayed on the console after
preparing for exposure .............................................72
Technical Data ..................................................................... 73
DX-D 400 X-Ray System Technical Data ....................74
Fixed DR Detector Technical Data ............................ 75
Portable DR Detector Technical Data ........................77
DR Generator Sync Box Technical Data .................... 78
NX Workstation Technical Data ................................79
Technical Documentation .................................................... 80
Remarks for HF-emission and immunity .................. 80
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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 400 is a trademark 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
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Introduction to this Manual
Topics:
•Scope of this Manual
•Warnings, Cautions, Instructions and Notes
•Disclaimer
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Scope of this Manual
This User Manual describes the features of the DX-D 400 System, an
integrated X-Ray imaging system. It explains how the different components of
the DX-D 400 System work together.
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Warnings, Cautions, Instructions and Notes
The following samples show 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.
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 typically used in combination with the
warning sign when providing a specific instruction. If it is followed
exactly, it 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 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 DX-D 400
Topics:
•Intended 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
•Patient data security
•Maintenance
•Environmental protection
•Safety Directions
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Intended Use
• The DX-D 400 system is a General Radiography X-ray imaging system used
in hospitals, clinics and medical practices by physicists, radiographers and
radiologists to make, process and view static X-ray radiographic images of
the skeleton (including skull, spinal column and extremities), chest,
abdomen and other body parts on adult, pediatric or neonatal patients.
• Applications can be performed with the patient in the sitting, standing or
lying position.
• This device is not intended for mammography applications.
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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
DX-D 400 is a configurable DR (Direct Radiography X-Ray system), CR
(Computed Radiography) or film/screen X-ray system.
The complete DX-D 400 consists of the following components:
• Floor mounted tube stand
• RAD Table with integrated DX-D Fixed DR Detector or with DR Detector
bucky or cassette bucky
• RAD Wall Stand with integrated DX-D Fixed DR Detector or with DR
Detector bucky or cassette bucky
• Portable DR Detector
• DR Generator Sync Box
• X-ray generator
• X-ray generator control box
• X-ray tube with manual or automatic collimator
• NX workstation
The DR Detector bucky has two variants, supporting following formats:
• DR Detectors with a size equivalent to 14x17 inch (43x35 cm) and 43x35
CR Cassettes.
• DR Detectors with a size equivalent to 17x17 inch (43x43 cm)
DX-D 400 can be used in combination with:
• CR Digitizer
DX-D 400 has three main configurations:
1. DR configuration with X-ray exposure parameter control on the NX
workstation (5420/101).
• X-ray parameters are controlled using the DX-D Software Console on
the NX workstation.
2. CR configuration with X-ray exposure parameter control on the NX
workstation (5420/100).
• X-ray parameters are controlled using the DX-D Software Console on
the NX workstation.
3. CR configuration with X-ray exposure parameter control on the X-ray
console (5420/100).
• X-ray exposure parameters are controlled on the DX-D 400
Touchscreen Console or on the DX-D 400 overlay console.
• The NX workstation is optional.
The DR configuration contains a DR Generator Sync Box, to connect the DR
Detector, the X-Ray generator and the NX workstation.
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The DX-D Software Console is available on the NX workstation, to synchronize
the X-ray exposure parameters between the NX application and the generator.
12345 6 7
1. DR Generator Sync Box
2. NX workstation
3. Floor mounted tube stand
4. X-ray tube with collimator
5. DR Detector
6. RAD Table
7. RAD Wall Stand
Figure 1: DX-D 400 Configuration
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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 out-
let.
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 cur-
rent and reliability of the protective earth protec-
tion.
Water ingress This device does not have protection against in-
gress 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.
Related Links
Cleaning and Disinfecting on page 37
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Options and Accessories
The system is delivered with 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.
For information on options and accessories, refer to these manuals:
• DX-D 400 X-Ray System User Manual, document 0232.
• User manuals for the supported DR Detectors.
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
Refer to the DX-D 400 X-Ray System User Manual (document 0232) for a
description of the Touchscreen Console, the Overlay Console, the collimator
controls, the RAD Table controls and the RAD Wall Stand controls.
The main operation controls of the DX-D 400:
Topics:
•NX Application on the NX Workstation
•DR Software Console
•DR Detector Switch
•Exposure button
•Portable DR Detector
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NX Application on the NX Workstation
The NX application is used to define patient information, select exposures and
process images.
Figure 2: NX application
The operation of the NX application is described in the NX User Manual,
document 4420..
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DR Software Console
The DR Software Console is available to support X-ray exposure parameter
control on the NX workstation. It is displayed on the NX workstation next to
the NX application.
The DR Software Console is used to control the X-ray exposure settings.
The DR Software Console contains the DR Detector Switch.
Figure 3: DR Software Console
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DR Detector Switch
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.
The DR Detector Switch can also be used to switch to CR for making an
exposure on a cassette.
DR Detector Status
Battery status icon
Meaning Full Medium Low Empty
Connection status icon (wifi/
wired)
Meaning Good Low Bad Wired DR Detector
DR detector
status icon
(blinking)
?
Meaning Ready Initializing expo-
sure
Error Sleep One DR detector
must be selected
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Exposure button
Preparing for exposure
Press the exposure button down to the first pressure point and hold it for
approximately 0.5 s to 2 s.
The X-ray tube is prepared for performing an exposure.
Starting the exposure
Before starting the exposure:
1. Check if the exposure settings displayed on the console are suitable for the
exposure.
2. Check the Ready for Exposure status.
Press the exposure button down fully and keep it pressed until the exposure
has ended.
The radiation indicator on the control console lights up and a signal sounds to
indicate the exposure.
Note: Letting the exposure button go ends the exposure
immediately and the exposure can be underexposed.
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