DXD 400
DXD 400
DXD 400
5420/100
5420/101
User Manual
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
Legal Notice
0413
Published by Agfa NV
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.
• 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
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.
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.
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.
1 2 3 4 5 6 7
Equipment Classification
Per EN/IEC60601-1, Medical Electrical Equipment, General Requirements for
Safety 3rd Edition, this device is classified as following:
Water ingress This device does not have protection against in-
gress of water.
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.
Related Links
Cleaning and Disinfecting on page 37
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
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:
Figure 2: NX application
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.
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
DR detector
status icon ?
(blinking)
Exposure button
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.
Portable DR Detector
When performing an exposure, keep in mind the following detector
orientation aids:
1. Tube side
2. Patient orientation marker
For an overview of the operation controls of the DR Detector, refer to the user
manual of the DR Detector.
The DR Detector may come in contact with the patient.
Note: DR Detectors that operate wireless contain an RF
transmitter. For detailed information, refer to the DR Detector
User Manual.
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.
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.
Product Complaints
Any health care professional (for example a customer or a user) who has any
complaints or has experienced any dissatisfaction with the quality, durability,
reliability, safety, effectiveness, or performance of this product must notify
Agfa.
For a patient/user/third party in the European Union and in countries with
identical regulatory regimes (Regulation 2017/745/EU on Medical Devices);
if, during the use of this device or as a result of its use, a serious incident has
occurred, please report it to the manufacturer and/or its authorised
representative and to your national authority.
Manufacturer address:
Agfa Service Support - local support addresses and phone numbers are listed
on www.agfa.com
Agfa - Septestraat 27, 2640 Mortsel, Belgium
Agfa - Fax +32 3 444 7094
Compatibility
The system 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
practice and all applicable laws and regulations that have the force of law
within the jurisdiction of the hospital.
Compliance
The system is compliant with specific directives and standards.
Topics:
• General
• Safety
• X-Ray Safety
• Electromagnetic Compatibility
General
• The product has been designed in accordance with the MEDDEV
Guidelines relating to the application of Medical Devices and have been
tested as part of the conformity assessment procedures required by
93/42/EEC Medical Device Directive (European Council Directive
93/42/EEC on Medical Devices).
• ISO 13485
• IEC 62366
• ISO 14971
Safety
• IEC 60601-1
• UL 60601-1
• CAN/CSA C 22.2 No.601.1-M90
X-Ray Safety
• IEC 60601-2-54
For USA
The system conforms to DHHS radiation Standards of 21CFR subchapter J as
of the date of manufacture.
Electromagnetic Compatibility
• IEC 60601-1-2
Connectivity
On configurations with X-ray exposure parameter control on the NX
workstation, the NX workstation is connected to the X-ray system to exchange
X-ray exposure parameters.
Note: The connections between the components of the system
should not be disconnected or modified.
Installation
Installation and configuration is performed by an Agfa trained and authorized
service engineer. Contact your local support organization for more
information.
On a configuration with multiple DR Detectors of the same type, it is required
to apply labeling to the DR Detector containing a unique nickname for each
DR Detector. The nicknames must be configured on the NX Workstation. The
DR Detector Switch shows which DR Detector is active and shows its status, by
means of the nickname of 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.
Messages
Under certain conditions the system shows a dialog box in the middle of the
screen containing a message, or a message is displayed in a fixed message area
in the user interface. This message informs the user that either a problem has
occurred or that a requested action cannot be performed. The user must read
these messages carefully. It will provide information on what to do from then
on. This will be either performing an action to resolve the problem or to
contact the service organization. Details on the contents of messages can be
found in the service documentation which is available to service personnel.
Labels
Mark Meaning
Serial number
Manufacturer
Date of manufacture
Label Meaning
Dangerous voltage
Ionizing radiation
Pinch Points.
Risk of stumbling.
Further labels are listed and explained in the relevant modules of the System
Documentation.
Topics:
Type label
Mark Meaning
Functional earth
Medical equipotential
• Cleaning
• Disinfecting
• Approved disinfectants
Cleaning
To clean the exterior of the equipment:
Caution:
Do not use solvents such as anhydrous or high solvency
alcohols, thinner or benzine. Do not use any corrosive,
dissolving or abrasive cleaning or polishing detergents.
Doing so may damage the surface of the equipment. Using
unsuitable cleaning agents or methods can damage the
property when surface becomes dull and brittle (e.g. by
using alcohol-containing agents).
Note: Do not open the equipment for cleaning. No
components inside the device require cleaning by the user.
Disinfecting
WARNING:
To disinfect the device, use only disinfectants and disinfection
methods that are approved by Agfa and that correspond to the
national regulation and guidelines as well as explosion
protection.
If you plan to use other disinfectants, approval of Agfa is needed before use, as
most disinfectants can damage the device. UV disinfection is also not allowed.
Perform the procedure following the instructions for use, the disposal
instructions and the safety instructions of the selected disinfectants and tools
and of the hospital.
Items contaminated with blood or body fluids, which may contain blood-
borne pathogens, should be cleaned and then receive intermediate level
disinfection with a product having an EPA-registered claim for activity against
hepatitis B.
Approved disinfectants
Refer to the Agfa website for specifications on the disinfectants that have been
found compatible with the cover material of the device and can be used on the
outer surface of the device.
http://www.agfahealthcare.com/global/en/library/overview.jsp?ID=41651138
Maintenance
Always consult the Agfa Service documentation and an Agfa trained and
authorized Service engineer for complete maintenance schedules.
Maintenance procedures
Maintenance procedures for the X-ray system are described in the DX-D 400
Owner’s Manual.
Environmental protection
Battery notice
The battery symbol on the products, and/or accompanying documents means
that the used batteries should not be treated as, or mixed with general
household waste. The battery symbol on batteries or its packaging may be
used in combination with a chemical symbol. In cases where a chemical
symbol is available it indicates the presence of respective chemical substances.
If your equipment or replaced spare parts contain batteries or accumulators
please dispose of them separately according to local regulations.
For battery replacements please contact your local sales organization.
Safety Directions
Warning: Only qualified and authorized personnel shall
operate this system. In this context ‘qualified’ means those
persons legally permitted to operate this equipment in the
jurisdiction in which the equipment is being used, and
‘authorized’ means those persons authorized by the
authority controlling the use of the equipment. Full use
must be made of all radiation protection features, devices,
systems, procedures and accessories.
Warning: Strictly observe all warnings, cautions, notes and
safety markings within this document and on the product.
Getting started
Topics:
1. When a new patient comes in, define the patient info for the exam.
2. Start the exam.
1. At the NX workstation, select the thumbnail for the exposure in the Image
Overview pane of the Examination window.
The selected DR Detector is activated.
The DR Detector Switch shows which DR Detector is active and shows its
status.
• Red (flashing): starting up
• Green (constant): ready for exposure
2. At the X-ray generator console or on the DR Software Console, select the
exposure settings suitable for the exposure.
On systems with integration of X-ray exposure parameters, the default X-
Ray exposure parameters for the selected exposure are sent to the
modality and displayed on the DR Software Console.
WARNING:
Monitor the patient position (hands, feet, fingers, etc.) with
special care to avoid injury to the patient caused by unit
movements. Patient hands must be kept away from mobile
components of the unit. Intravenous tubing, catheters and other
patient connected lines should be routed away from moving
equipment.
Check if the status of the DR Detector is ready for exposure. If the status is
not ready for exposure, the DR Detector cannot be used for making an
exposure.
1. Check if the exposure settings displayed on the console are suitable for the
exposure.
2. Check the Ready for Exposure status.
Topics:
1. When a new patient comes in, define the patient info for the exam.
2. Start the exam.
1. Select the thumbnail for the exposure in the Image Overview pane of the
Examination window.
WARNING:
Monitor the patient position (hands, feet, fingers, etc.) with
special care to avoid injury to the patient caused by unit
movements. Patient hands must be kept away from mobile
components of the unit. Intravenous tubing, catheters and other
patient connected lines should be routed away from moving
equipment.
1. Check if the exposure settings displayed on the console are suitable for the
exposure.
2. Check the Ready for Exposure status.
The image will appear in the image overview pane of the examination
window.
2. Press the Power OFF button on the X-ray generator control box to switch
off the generator.
3. In a configuration with a wireless DR Detector, power off the DR Detector:
• turn off the DR Detector.
• remove the battery pack.
4. Switch off the DR Generator Sync.
Problem solving
Topics:
Related Links
Performing an exposure using the DR Detector on page 49
Related Links
Performing an exposure using the DR Detector on page 49
Brief Solution Check if the bucky of the X-ray system contains an un-
exposed CR cassette or a DR detector and if it is proper-
ly closed.
Click the OK button on the DX-D Software Console or
the Reset button on the DX-D 400 Touchscreen Console
or on the DX-D 400 overlay console until the error indi-
cation disappears on the console.
If the equipment remains inoperative, try restarting the
generator or call service. In this case, the generator can
still work in free exposure mode.
Brief Solution Adjust the orientation of the X-ray tube to match the se-
lected workstation.
Click the OK button on the DX-D Software Console or
the Reset button on the DX-D 400 Touchscreen Console
or on the DX-D 400 overlay console until the error indi-
cation disappears on the console.
If the equipment remains inoperative, try restarting the
generator or call service. In this case, the generator can
still work in free exposure mode.
Technical Data
Topics:
Supported models
Electrical Connection
Power consumption
Warming-up time
1 hour
Throughput
Pixel Matrix
Reliability
Labeling
Dimensions
Depth 21.5 cm
Width 33.5 cm
Height 6.5 cm
Weight 3.2 kg
Technical Documentation
This appendix contains technical information. It is only available in English.
Voltage dips, short 40% UT (60% 60% for The quality of the voltage
interruptions and dip in UT) for 5 5 peri- supply should correspond
voltage variations cycles ods to that of a typical commer-
on power supply 70% UT (30% 30% for cial or clinical environ-
input lines. dip in UT) for 25 peri- ment. If the user wants the
25 cycles ods device to work continuous-
IEC 61000-4-11
Recommended
separation dis-
tance
d = 1.2
d = 1.2 80
MHz to 800 MHz
d = 2.3 800
MHz to 2.5 GHz
where ’P’ is the
maximum output
power rating of
the transmitter in
watts (W) accord-
ing to the trans-
mitter manufac-
turer and ’d’ is the
recommended
separation dis-
tance in meters
(m).
Field strengths
from fixed RF
transmitters, as
determined by an
electromagnetic
site survey, should
be less than the
compliance level
in each frequency
rangeb).
Interference may
occur in the vicini-
ty of equipment
marked with the
following symbol:
• REMARK 1: The higher value will apply at 80 MHz and 800 MHz.
• REMARK 2: These Guidelines may not apply to all situations. The disper-
sion of electromagnetic waves is influenced by absorption and reflec-
tions from buildings, objects and people.
100 12 12 23
For transmitters rated at a maximum output power not listed above, the rec-
ommended separation distance ’d’ in meters (m) can be estimated using the
equation applicable to the frequency of the transmitter, where ’P’ is the max-
imum output power rating of the transmitter in watts (W) according to the
transmitter manufacturer.