DR 400
DR 400
DR 400
5520/100
5520/200
User Manual
Contents
Legal Notice ..........................................................................5
Introduction .......................................................................... 6
Introduction to this Manual ....................................... 7
Scope of this Manual ......................................8
Warnings, Cautions, Instructions and Notes ....
9
Disclaimer ................................................... 10
Introduction to DR 400 ............................................ 10
Intended Use ............................................... 11
Intended User .............................................. 12
Configuration .............................................. 13
Equipment Classification ............................. 16
Options and Accessories ...............................17
Operation Controls ...................................... 18
System Documentation ................................27
Training .......................................................28
Product Complaints ..................................... 29
Compatibility ...............................................30
Compliance ................................................. 31
Connectivity ................................................ 33
Installation .................................................. 34
Radiation Protection .................................... 35
Labels .......................................................... 40
Cleaning and Disinfecting ............................ 46
Patient data security .................................... 49
Maintenance ................................................50
Environmental protection ............................ 53
Safety Directions ..........................................54
Getting started .....................................................................58
Starting the System ..................................................59
Basic workflow using the DR Detector ......................60
Step 1: retrieve the patient info ....................61
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
Basic workflow using a CR cassette .......................... 67
Step 1: retrieve the patient info ....................68
Step 2: select the exposure ...........................69
Step 3: prepare the exposure ........................70
Step 4: check the exposure settings .............. 71
Step 5: execute the exposure ........................72
Step 6: repeat steps 2 to 5 for the next
subexposures ............................................... 73
Legal Notice
0413
Introduction
Topics:
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.
Caution: In the United States, Federal law restricts this device to
sale by or on the order of a physician.
Introduction to DR 400
Topics:
• Intended Use
• Intended User
• Configuration
• Equipment Classification
• Options and Accessories
• Operation Controls
• System Documentation
• Training
• Product Complaints
• Compatibility
• Compliance
• Connectivity
• Installation
• Radiation Protection
• Labels
• Cleaning and Disinfecting
• Patient data security
• Maintenance
• Environmental protection
• Safety Directions
Intended Use
• The DR 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 or pediatric 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
DR 400 is a configurable DR (Direct Radiography X-ray system) or CR
(Computed Radiography) X-ray system.
The complete DR 400 consists of the following components:
• RAD Table with an integrated DX-D Fixed DR Detector or with a bucky. In
the bucky a DR Detector or a CR cassette can be inserted.
• RAD Wall Stand with an integrated DX-D Fixed DR Detector or with a
bucky. In the bucky a DR Detector or a CR cassette can be inserted.
• X-ray tube stand mounted on the RAD Table
• X-ray generator integrated in the RAD Table
• X-ray generator console
• X-ray tube with manual or automatic collimator
• NX image processing software on the NX workstation
• DR Generator Sync Box (depending on the configuration)
• Automatic Exposure Control (AEC)
• Dose Area Product Meter (DAP, optional)
Depending on the configuration the following components are also available:
• Portable DR Detector
DR 400 can be used in combination with:
• DX-G
• DX-M
• CR 30-X (5175/2XX)
• CR 30-Xm
• CR 10-X
• CR 12-X
• CR 15-X
DR 400 has three main configurations:
1. DR configuration with X-ray exposure parameter control on the NX
workstation.
2. CR configuration with X-ray exposure parameter control on the NX
workstation.
3. Mixed DR and CR configuration with X-ray exposure parameter control on
the NX workstation.
X-ray parameters are controlled using the Software Console on the NX
workstation.
The Software Console is available on the NX workstation, to synchronize the
X-ray exposure parameters between the NX application and the generator.
Other configurable features include:
• Tube head display with controls for X-ray exposure parameters
• Position tracking for keeping constand SID on table and wall stand
• Bucky with automatic cassette size sensing (ACSS) and automatic
collimator
1 2 3 4 5 6
1. NX workstation
2. X-ray tube stand mounted on RAD Table
3. X-ray tube with collimator and tube head display
4. Portable DR Detector
5. RAD Table with integrated generator
6. RAD Wall Stand
Figure 1: DR 400 configuration for DR
Topics:
• Applied Parts
Applied Parts
Applied Parts refer to parts of the medical electrical equipment that in normal
use necessarily comes into physical contact with the patient for the equipment
to perform its function. This system includes the following Applied Parts:
Topics:
• RAD Table
• RAD Wall Stand
• DR Detector
RAD Table
• Table top of the RAD Table
• Patient hand grips (optional)
• Lateral cassette holder (optional)
• Mattress (optional)
• Compression belt (optional)
RAD Wall Stand
• Front panel of the RAD Wall Stand
• Overhead arm support (optional)
• Patient hand grips (optional)
DR Detector
• DR Detector
Equipment Classification
Per EN/IEC 60601-1:2005, EN/IEC 60601-2-54:2009, this device is classified
as following:
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 46
Operation Controls
Topics:
• RAD Table
• RAD Wall Stand
• Control Panel of the X-Ray Tube Stand
• NX Application on the NX Workstation
• Software Console
• DR Detector Switch
• X-ray generator mini console
• Manual collimator
• Automatic collimator
• DR Detector
• Emergency stop button
• Emergency shutdown power switch
RAD Table
The RAD Table is used for positioning of the patient lying or sitting over the
detector or the cassette in the bucky for exposure.
The RAD Table supports the patient and the detector or the cassette for free
exposure.
Related Links
RAD Table and X-Ray Tube Stand
Related Links
RAD Wall Stand on page 96
Figure 4: Control Panel of the X-Ray Tube Stand with tube head display
(controls for X-ray tube position and for X-ray exposure parameters)
Figure 5: Control Panel of the X-Ray Tube Stand with X-ray tube angle
display
Related Links
RAD Table and X-Ray Tube Stand on page 86
Chest PA
113 cm 35°
114 kV +2
Related Links
Tube head display on page 85
Software Console
The 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 Software Console is used to control the X-ray exposure settings.
The Software Console contains the DR Detector Switch.
DR Detector Switch
The DR Detector Switch is available in the device status frame of the Software
Console.
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 be switched to CR, depending on the
configuration.
DR Detector Status
DR detector
status icon ?
(blinking)
1 2 3
7
5
4 6 8
1. Power ON button
2. Power ON indicator
3. Power OFF button
4. Press and hold to prepare for exposure
5. Prepare ready indicator
6. Press and hold to start the exposure
7. Radiation indicator
8. Exposure button
Figure 10: X-ray generator mini console
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.
Manual collimator
The collimator sets the exposure field and displays it by means of a light field.
The collimator provides X-ray filtering using the integrated filters or by
inserting a filter in the rails.
A DAP meter (Dose Area Product Meter) can be mounted on the collimator by
inserting it in the rails.
Related Links
Ralco R221 Collimator Technical Data on page 167
Automatic collimator
The collimator sets the exposure field and displays it by means of a light field.
Related Links
Automatic Collimator on page 125
Automatic Cassette Size Sensing on page 114
Ralco R225 ACS Collimator Technical Data on page 168
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.
The emergency shutdown power switch for the room is typically located on
the wall and easy to access, often close to the power off switch of the X-ray
system. It is installed and labeled by customer.
System Documentation
The DR 400 user documentation consists of
• DR 400 User Documentation CD (digital media)
• NX User Documentation CD (digital media)
The DR 400 User Documentation CD contains:
• DR 400 User Manual (this document)
• DX-D Software Console, DR Tube Head Display User Manual, document
0389
• User manuals for the supported DR Detectors
• DX-D DR Detector Calibration Key User manual, document 0134
Other documentation available on the DR 400 User Documentation CD:
• DAP Datasheet
• X-ray Tube Documentation
• Collimator Datasheet
• AEC Datasheet
• X-ray Generator User Manual
• Test Report for IEC60601-1-3
• Test Report for DIN6868-150
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.
If the device malfunctions and may have caused or contributed to a serious
injury, Agfa must be notified immediately by telephone, fax or written
correspondence to the following 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
• Electromagnetic Compatibility
• X-Ray Safety
• X-Ray Accuracy
• Environmental Compliance
• Biocompatibility
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 13485:2003 + Cor. 1:2009
• ISO 14971:2009
Safety
• IEC 60601-1: 2005
• IEC 60601-1-6:2006, EN 60601-1-6:2007
• CSA C22.2 60601-1:2008
• AAMI ES 60601-1:2005
Electromagnetic Compatibility
• IEC 60601-1-2:2007, EN 60601-1-2:2007
Topics:
• For USA
• For Canada
For USA
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 installation manual, may cause harmful
X-Ray Safety
• IEC 60601-1-3:2008
• IEC 60601-2-54:2009
• IEC 60601-2-28:2010
For USA
The system conforms to DHHS radiation Standards of 21CFR subchapter J as
of the date of manufacture.
X-Ray Accuracy
The system fulfills the X-ray radiation accuracy according EN IEC 60601-2-54
with a variation of max. 0.05 (5%).
Environmental Compliance
• European Council Directive 1907/2006 (REACH)
• European Council Directive 2011/65/EU (RoHS 2)
• European Council Directive 2012/19/EU (WEEE)
Biocompatibility
• EN ISO 10993-1:2009
Connectivity
The NX workstation is connected to the X-ray system to exchange X-ray
exposure parameters.
The NX workstation requires a 100 Mbit ethernet network to exchange
information with a number of other devices.
The NX workstation communicates with other devices in the hospital network
using one of the following protocols:
• DICOM
• IHE
The NX workstation can be connected to a RIS system (input scheduling), a
PACS system (output image/data management) and to a hardcopy device
(output image).
Note: The connections between the components of the system are
separate from the hospital network and 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.
Radiation Protection
X-ray radiation can cause serious damage to the health, therefore observe
great care and ensure that protection against X-ray exposure is always
applied.
Some of the effects of X-ray radiation are cumulative and may extend over a
period of time. Therefore the X-ray operator should avoid exposure by X-ray
radiation at all times.
Objects in the path of the X-ray beam may produce scattered radiation. The
intensity depends on the energy and intensity of the X-ray exposure and the
material of the object. Protective measures have to be taken to prevent
exposure through scattered radiation.
Protective measures include:
• structural configuration of the X-ray room (e.g. lead shielded rooms)
• radiation protection for the operators (e.g. personal radiation dosimeters,
lead aprons, keep maximum distance from X-ray source, regular training,
etc.)
• protection of patients against unnecessary radiation (e.g. limitation of X-
ray field by collimation, lead shielding, lead aprons, etc.)
Topics:
• Monitoring of Personnel
• Protected area and significant zones of occupancy
Monitoring of Personnel
The monitoring checks the amount of X-ray radiation the personnel has been
exposed to. It determines safety of the operators and it helps checking if safety
measures of the X-ray environment are adequate. Inadequate or improper
protection can lead to serious damage to the health.
To measure radiation, personal radiation dosimeters are typically used. They
are worn on the body at all times during working in an environment where X-
ray radiation is applied. They provide an indication for the amount of
radiation the operator was exposed to.
1. X-ray room
2. Patient environment
3. Workstation
4. Operator room: protected area
Figure 14: Protected area and significant zones of occupancy
If operator or staff needs to be close to the patient during normal use (e.g.
some pediatric examinations or types of examinations for which the patient
requires assistance), the significant zone of occupancy applies for operator
and staff.
Warning: The radiation protection has to be applied to the
patient and to the operator.
Related Links
Radiation Protection on page 35
Topics:
SID 100 cm
3 S
4 2
50 cm
S4 6
S3
2
1
7
S5 8
1. X-ray tube
2. Focal spot label [—]
3. Significant zone of occupancy.
Minimum area 60x60 cm.
Minimum height above the floor 200 cm.
4. Dose meter
5. DR Detector or cassette
6. Significant zone of occupancy at the left side of the RAD Table
7. Significant zone of occupancy in front of the RAD Table
8. Significant zone of occupancy at the right side of the RAD Table
Figure 15: Significant zones of occupancy at the RAD Table
Related Links
1
2
3 S 140 cm
4 2
5
50 cm 6
7
S1 Phantom S2
8
9
SID115 cm
2
1
1. X-ray tube
2. Focal spot label [—]
3. Significant zone of occupancy.
Minimum area 60x60 cm.
Minimum height above the floor 200 cm.
4. Dose meter
5. Protective device
6. Wall
7. DR Detector or cassette
8. Significant zone of occupancy at the right side of the RAD Table
Related Links
Radiation Protection on page 35
Stray Radiation on page 186
Labels
Mark Meaning
Serial number
Manufacturer
Date of manufacture
Label Meaning
Dangerous voltage
Ionizing radiation
Gaseous disinfectant.
If a disinfectant is used that can form an explosive gaseous
mixture, they must have evaporated and the system must be
aerated before it is switched on again.
Pinch Points.
Risk of stumbling.
Further labels are listed and explained in the relevant modules of the System
Documentation.
Topics:
• Warning labels on the RAD Table
Type label
Mark Meaning
Related Links
DR 400 Technical Data on page 153
Related Links
RAD Table and X-Ray Tube Stand Technical Data on page 157
(Sample of subtype
5522/100)
Functional earth
Related Links
RAD Wall Stand Technical Data on page 160
Class II equipment.
Pinch Points.
The label is positioned on the lateral cover
of the bucky or on the rotating platform.
10kg
Maximum load capacity is 10 kg on the
bucky drawer when it is pulled out. Do not
lean or sit on the bucky.
The label is positioned on the lateral cover
of the bucky or on the rotating platform.
Related Links
Bucky Unit Technical Data on page 164
Functional earth
Medical equipotential
• Cleaning
• Disinfecting
• Disinfecting safety directions
• Approved disinfectants
Cleaning
To clean the exterior of the equipment:
A black screen hides the screen and shows a number counting down.
3. Clean the display.
The operation is not affected.
4. The display can be used again after the countdown has finished.
Disinfecting
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.
the accessories and connection cables by just wiping them. Switch off the
system and cover the cooled system carefully before performing a room
disinfection using nebuliser.
• Using unsuitable disinfectants can cause discoloration and damage of the
surface of the equipment.
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/main/products_services/
product-info/technology/disinfectants_dx_d_systems.jsp
Maintenance
Always consult the Agfa Service documentation and an AGFA trained and
authorized Service engineer for complete maintenance schedules.
Topics:
• Maintenance
• Maintenance of the RAD Table, RAD Wall Stand and X-Ray Tube Stand
Maintenance
Always consult the Agfa Service documentation and an Agfa trained and
authorized Service engineer for complete maintenance schedules.
Maintenance of the RAD Table, RAD Wall Stand and X-Ray Tube
Stand
The X-ray unit and all components require regular maintenance to ensure the
equipment is safe and reliable for operation.
Warning: Operation in unsafe condition includes the risk of
radiological exposure and injury of the patient and/or the
operator. The customer is responsible to ensure the fault-
free condition of the equipment.
Lifetime
Periodic maintenance
All steel cables of X-ray tube stand and RAD Wall Stand Every 12 months
shall be checked
All steel cables of X-ray tube stand and RAD Wall Stand Every 36 months
shall be exchanged to maintain fault-free operation and
ensure safety for patient and operator
This procedure is used for a typical X-ray tube. Consult the X-ray tube
manufacturer instructions for the actual X-ray tube in use and comply with the
instructions if there is conflict with this procedure.
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
Topics:
Caution: Make sure that the patient hand grips are securely
mounted.
Getting started
Topics:
1. When a new patient comes in, define the patient info for the exam.
2. Start the exam.
At the NX workstation, select the thumbnail for the exposure in the Image
Overview pane of the Examination window.
The default X-Ray exposure parameters for the selected exposure are sent
to the modality and displayed on the Software Console.
The selected DR Detector is activated.
The RAD Table or RAD Wall Stand lights up in blue, indicating the
selected modality position.
The DR Detector Switch shows which DR Detector is active and shows its
status.
• Red (flashing): starting up
• Green (constant): ready for exposure
On the NX application:
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.
2. Select CR in the Detector Switch.
3. Select the Modality Position (RAD Table, RAD Wall Stand, Free exposure)
in the Software Console.
The default X-Ray exposure parameters for the selected exposure are sent
to the modality and displayed on the software console.
The RAD Table or RAD Wall Stand lights up in blue, indicating the
selected modality position.
4. Select the subexposure if more than one image is required for the same
cassette.
If an image thumbnail is configured for multiple exposures on a single
cassette, another set of thumbnails is shown in the image detail pane. Now
you have to select one of these thumbnails to send the proper default X-
Ray exposure parameters to the modality for each exposure.
1. Check if the exposure settings displayed on the console are suitable for the
exposure.
2. Check the Ready for Exposure status.
• The actual X-Ray exposure parameters are sent back from the generator to
the NX workstation and are shown in the Image Detail pane.
• The actual X-Ray exposure parameters and the Exposure Index (EI) value
on the NX workstation can be used to monitor the performance of the
Automatic Exposure Control of the X-Ray system.
• A green OK mark appears on all thumbnails for which the exposures are
made and for which exposure settings are sent back to the NX workstation.
The image will appear in the image overview pane of the examination
window.
Oblique Exposures
1. Position the patient on the RAD Table.
2. Move the X-ray tube stand out of the coupling range of the bucky.
3. Position the bucky under the patient.
4. Set the required angle of the X-ray tube.
5. Adjust the position of the X-ray tube stand to align the X-ray exposure field
to the center of the bucky using the collimator light and the bucky markers
for orientation.
Lateral Exposures
1. Unlock the X-ray tube arm and rotate 90° around.
2. Rotate the X-Ray tube 90° around.
Check the angle on the angle display.
3. Mount the lateral cassette holder on the side rail of the tabletop. Fix it
using the two lower screws. Take care to lift the holders slightly up when
moving it, to protect the tabletop from scratching.
4. Insert a cassette or a DR detector. Fix it using the upper screw.
5. Position the patient on the table between the X-ray tube and the lateral
cassette holder. Adjust the lateral cassette holder to position the cassette
as close as possible to the patient. Fix the position using the middle screw.
Please review the following link and reduce pediatric technique factors
accordingly: http://www.pedrad.org/associations/5364/ig/
As a general rule, next recommendations shall be observed in pediatrics:
• X-Ray Generator must have short exposures times.
• ΑΕC must be used carefully, preferably use manual technique setting,
applying lower doses.
• If possible, use high kVp techniques.
Positioning the pediatric patient: Pediatric patients are not as likely as adults
to understand the need to remain still during the procedure. Therefore it
makes sense to provide aids to maintaining stable positioning. It is strongly
recommended the use of immobilizing devices such as bean bags and restraint
systems (foam wedges, adhesive tapes, etc.) to avoid the need of repeating
exposures due to the movement of the pediatric patients. Whenever possible
use techniques based on the lowest exposure times.
Shielding: We recommend you provide extra shielding of radiosensitive
organs or tissues such as eyes, gonads and thyroid glands. Applying a correct
collimation will help to protect the patient against excessive radiation as well.
Please review the following scientific literature regarding pediatric
radiosensitivity: GROSSMAN, Herman. “Radiation Protection in Diagnostic
Radiography of Children”. Pediatric Radiology, Vol. 51, (No. 1): 141--144,
January, 1973:
http://pediatrics.aappublications.org/cgi/reprint/51/1/141.
Technique factors: You should take steps to reduce technique factors to the
lowest possible levels consistent with good image acquisition.
For example if your adult abdomen settings are: 70--85 kVp, 200--400 mA,
15--80 mAs, consider starting at 65--75 kVp, 100--160 mA, 2.5--10 mAs for a
pediatric patient. Whenever possible use high kVp techniques and large SID
(Source Image Distance).
Summary:
• Image only when there is a clear medical benefit.
• Image only the indicated area.
• Use the lowest amount of radiation for adequate imaging based on size of
the child (reducing tube output -- kVp and mAs).
• Try to use always short exposure times, large SID values and immobilizing
devices.
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.
Operation
Topics:
2 Chest PA
7 9
113 cm 35°
8
10 114 kV +2
11 12
1. Patient information
2. Status bar with exam type
3. Modality position
4. DR Detector Switch
5. Grid status
6. Filter status
7. Source Image Distance (SID)
8. X-ray tube angle
9. Position tracking status
10. Radiographic parameters
11. Image preview
12. Tools
For detailed information, refer to the DR Software Console and Tube Head
Display User Manual (document 0389).
11
10
9
8
1 2 3 4 5 6 7
1. Rail system
2. X-ray tube stand with SID ruler
3. Bucky
4. Tabletop movement pedals,
Blue LED indicator light for active workstation
5. Table covers with standard exposure height marker
6. Emergency stop button
7. Tabletop
8. Collimator
9. X-ray tube arm
10. X-ray tube
1 2 3
1 2 3
Topics:
120
115
110
105
100
95
Beta axis rotation (swivel of the X-ray tube arm around the
tube stand axis)
The standard position of the X-ray tube arm is indicated by markers. When the
tube arm is in standard position it is centered in transversal direction on the
bucky.
Note: To avoid shock and damage, move the column with
normal speed and slow down when reaching the mechanical
end stops.
Related Links
Movement ranges on page 158
Ralco R221 Collimator Technical Data on page 167
Ralco R225 ACS Collimator Technical Data on page 168
Positioning the Bucky on page 93
Topics:
• Stop positions
• Collision indicator
Stop positions
The system includes stop positions.
• On the longitudinal axis movement, to position the X-ray tube in regularly
used exposure distances to the RAD Wall Stand, e.g. 150 cm and 180 cm.
• On the vertical axis movement, to position the X-ray tube stand in
regularly used exposure distances to the RAD Table, e.g. 115 cm.
The preferred positions of the stops are defined during installation.
The vertical stop on the tube stand is always active. The two transversal stops
are active when the X-ray tube is rotated towards the wall stand (90°+/- 10°).
To enter a stop position, move the X-ray tube stand or the X-ray tube arm in
longitudinal or vertical direction. The movement is stopped when the stop
position is reached. Moving too fast may cause the X-ray tube stand to skip the
stop position.
To leave a stop position, release and press again the according movement
control button.
Collision indicator
Systems with motorized movement have a collision indicator. The collision
indicator avoids collision of the X-ray tube head with the table.
The collision indicator will give a signal in following situations:
• The X-ray tube head is moved manually close than 30 cm to the table top
when performing an examination using the table.
• The X-ray tube head is moved manually closer than 15 cm to the table top
when performing an examination using the wall stand and the X-ray tube
head is rotated toward the wall stand.
The brake is activated and a single beep indicates the collision warning.
To further adjust the position, release the brake button and press it again.
Related Links
X-ray tube stand tracks wall stand height on page 99
Foot pedal to release the brake for the floating table top.
The RAD table is designed for a maximum patient load of 320 kg.
Adjusting height
To adjust the height, double click and hold the foot pedal.
Related Links
Collision protection on page 94
Collision indicator on page 90
Emergency stop button on page 25
1. Set the required SID by adjusting the position of the X-ray tube stand.
The distance between the X-ray tube head and the table top must not be
less than 50 cm.
2. On the tube head display, press the position tracking button.
Note: The movement of the X-ray tube stand has a small delay
compared to the movement of the table. The movement of the
X-ray tube is automatically stopped if the distance between the
X-ray tube head and the table would become too small (SID
lower than 45 cm).
1. Move the X-ray tube stand on the longitudinal axis outside the travel range
of the bucky.
The mechanical coupling is released.
2. Press and hold the bucky lock switch.
Topics:
1
1. Hand screw
Figure 34: Hand grip
Note: The hand grips are not intended to support the weight of
the patient.
Collision protection
Collision protection is only available on the elevating RAD Table.
The collision protection accessories are mounted on the frame of the RAD
Table. They protect the tabletop from damage when colliding with objects
below.
When the collision protection stops downward movement of the RAD table,
raise the table height and remove the object before lowering the table again.
123
Figure 36: Lateral cassette holder
• Compression belt
The compression belt provides additional fixation for the patient on the
table. It can be adjusted to patient thickness.
3
4
5
6
78
1. Wall Stand column
2. Active workstation indicator
3. Bucky
4. Button to switch on the collimator light
5. Front panel
1 2 3
Vertical movement
To release the brake for vertical movement, press the switch that is integrated
at the upper side of the handle located at the left and right side of the RAD
Wall Stand. The bucky can be moved up and down.
To stop movement and lock the bucky into position, release the switch.
Note: Do not move the bucky with excessive force to the end
stop positions.
Tilting
To tilt the bucky, press and hold the button on the tilting handle and move the
bucky. The scale for the angle is visible at the mounting point of the bucky.
To lock the bucky into position, release the button on the tilting handle.
Note: The bucky can be tilted to horizontal position. Do not use
the bucky as a seat.
Related Links
Collision indicator on page 90
Emergency stop button on page 25
Topics:
Caution: Take care that the overhead handle does not collide
with the ceiling when moving the bucky upward manually. For
automatic movement, a sensor detects if the overhead handle is
inserted and the movement is coordinated accordingly.
1. Insert the handle on the left or on the right side of the bucky frame.
2. Grip the lower part of the handle.
3. Pull the handle forward
4. Adjust the angle.
5. Move the handle back to fix the position.
4
1
2
5
3
Spacer
The spacer allows examination of sitting patients by offering additional space
to position legs and feed under the bucky.
Stand under the head cover and then fixed to a wall. It has to be installed by
service.
Bucky
The bucky is installed in RAD table and RAD wall stand.
The bucky clamps the cassette or detector during exposure and centers them
relative to the Automatic Exposure Control (AEC) and the grid.
The bucky supports cassettes in standard formats as well as DR Detectors with
cassette size format.
The bucky functionalities can be configured according the customer needs.
7
2 3 45
1. Bucky drawer
2. Button to release the brake
3. Bucky drawer handle
4. Carrier for the cassette or detector
5. Knob for rotating the cassette or detector
6. Clamps
7. Side clamps
Figure 44: Bucky
1 2 3 4 5
1. Tabletop
2. Removable grid
3. Automatic exposure control (AEC)
4. Carrier for cassette or detector
5. Bucky drawer with rotation mechanism
Figure 45: Bucky front view
Topics:
• Bucky configuration
• Rotating the bucky
• Loading of the bucky in the RAD Table
• Loading of the bucky in the RAD Wall Stand
• Unloading of the bucky in the RAD Table
• Unloading of the bucky in the RAD Wall Stand
• Centering and collimating
• Orientation of DX-D 10C, DX-D 10G in the bucky
Bucky configuration
• Bucky types
• Cassette and detector formats
• Standard cassette formats
Bucky types
The type of bucky installed in the system defines which functionality is
available.
2 1
1. Indicators for large format cassette or detector position to the top of the
bucky
2. Large format detector positioned to the top of the bucky
Figure 46: Wall stand bucky with large format detector positioned to the top
of the bucky
1. Indicators for large format cassette or detector position to the top of the
bucky
Figure 47: Indicators on bucky tray
Make sure the rotation is complete before closing the bucky drawer.
3. Close the bucky drawer using the front handle and pushing the button to
release the brake.
Make sure the bucky drawer is pushed up to the end to close completely.
4. Align the cassette or detector center indication to the center mark on the
clamp.
Warning:
When positioning the cassette or detector out of center:
• The alignment to the X-ray tube must be controlled
manually.
• The AEC sensors might not be covered or not covered
completely, causing wrong exposure dose. Make sure
that AEC sensors are covered.
5. Close the bucky drawer using the front handle and pushing the button to
release the brake.
Make sure the bucky drawer is pushed up to the end to close completely.
Related Links
Orientation of DX-D 10C, DX-D 10G in the bucky on page 116
4. Push the cassette or detector towards the lower slider to open the
clamping mechanism wide enough to contain the cassette or detector.
5. Let the cassette or detector slip into the clamping.
Warning: Make sure your fingers are not between slider
and cassette. The clamping mechanism may hurt your
fingers, therefore take special care.
6. Rotate the cassette or detector if needed to get the correct position for next
exposure.
7. Align the cassette or detector. The alignment can be centered or out of
center.
Warning:
When positioning the cassette or detector out of center:
• The alignment to the X-ray tube must be controlled
manually.
• The AEC sensors might not be covered or not covered
completely, causing wrong exposure dose. Make sure
that AEC sensors are covered.
8. Close the bucky drawer using the front handle and pushing the button to
release the brake.
Make sure the bucky drawer is pushed up to the end to close completely.
3. Lift the cassette or detector and remove it from the clamping. The
openings in the carrier allow your fingers to grip the detector or cassette.
4. Load the bucky with another cassette or detector.
• Alternatively, close the bucky drawer using the front handle and
pushing the button to release the brake.
4. Remove the cassette or detector from the clamping. The openings in the
carrier allow your fingers to grip the detector or cassette.
5. Load the bucky with another cassette or detector.
• Alternatively, close the bucky drawer using the front handle and
pushing the button to release the brake.
Centering
The bucky center position is automatically aligned to the position of the X-ray
tube stand.
The bucky provides center marks to check for correct alignment:
The collimator light field contains center lines to check the alignment of the X-
ray field to the bucky.
To align the X-ray field, adjust the position of the X-ray tube.
Collimating
To set the X-ray collimation area, pull out the bucky drawer until the cassette
or detector edge is visible. Align the X-ray collimation field to the size of the
cassette or detector.
The ACSS functionality of the bucky is only available in combination with the
automatic collimator Ralco 225 ACS. The ACCS functionality is not available
when the collimator is in manual mode.
Related Links
Automatic collimator on page 23
Topics:
Figure 51: Landscape orientation in the RAD Wall Stand left loading
Figure 52: Portrait orientation in the RAD Wall Stand right loading
Grids
Anti-scatter grids are used to reduce scattered radiation and improve image
quality. Grids are available as an option.
For DR Detectors focused grids are used. Focused grids require centering of
the X-ray source to the detector and a specific distance range between X-ray
source and detector. The color of the handle of the grid indicates which
distance the grid is used for.
To change the grid in the RAD Table or RAD Wall Stand:
Caution: Using a focused grid with the X-ray source not centered
or on a wrong distance may cause reduced image quality.
Caution: Handle grids with care and store them in a safe place
when not in use. Dropping the grid can cause damage and create
visible image artifacts or reduce image quality.
Related Links
Bucky Unit Technical Data on page 164
Topics:
150 cm green
180 cm blue
Grid detection
The grid detection functionality of the bucky detects the type and position of
the inserted grid.
The grid status is shown on the tube head display and on the Software
Console.
1 2
Related Links
Automatic Exposure Control (AEC) Technical Data on page 166
Manual Collimator
The Collimator can rotate ± 90° on its vertical axis while the X-ray tube
remains in the same position. This movement is performed by manually
turning the collimator and has detents every 90°.
1
2
3
4
1. Filter indicator
2. Filter selection wheel
3. Knobs to adjust the internal blades
The table on the front panel shows the number to set with the knobs for
each combination of SID and image size.
4. Button to switch on the light field.
After pressing the button, the lamp remains lit for a few seconds before
automatically switching off.
5. Measurement tape to measure the distance between the focal spot of X-ray
tube and the tabletop
Figure 54: Ralco 221 collimator controls
Another button to switch on the light field is available on the RAD Wall Stand.
Related Links
RAD Wall Stand on page 96
Automatic Collimator
The collimator can limit the collimated area to the size of the cassette or DR
Detector inserted in the bucky.
7
1
2
3
6 4 5
1. Display
• Size of the collimated area
• Active filter
2. Operation mode indicators
• Green: automatic mode
• Red: error mode
• Yellow: manual mode
3. Knobs to adjust the internal blades
4. Button to change the filter
5. Button to switch on or off the light field.
After pressing the button, the lamp remains lit for a few seconds before
automatically switching off.
6. Measurement tape to measure the distance between the focal spot of X-ray
tube and the tabletop
7. Key to switch to manual mode
The key is located on the backside of the collimator.
Figure 55: Ralco 225 ACS collimator controls
Another button to switch on the light field is available on both sides of the
RAD Wall Stand.
The collimator operates in full automatic mode normally. Other operation
modes are manual collimation mode and semi-automatic collimation mode.
Topics:
• Semi-automatic collimation mode
• Manual collimation mode
Figure 56: Indication on the tube head display for semi-automatic collimation
mode
Figure 57: Indication on the tube head display for manual collimation mode
Topics:
Press the Power ON button on the X-ray generator control box to switch
on the generator.
Press the Power OFF button on the X-ray generator control box to
switch off the generator.
Related Links
X-ray generator mini console on page 22
Acoustic signals
The generator indicates particular states with acoustic signals:
Visual signals
The generator indicates particular states with visual signals:
Exposure termination
In normal operation the exposure is terminated by the generator when:
• AEC faulty
• Initial dose too high or too low with AEC (if function is activated)
• Maximum exposure time of 3.2 sec reached in 1-point technique with AEC
• mAs product of 600 mAs is reached
• Maximum permissible exposure time of 6.3 sec is reached (safety switch
off)
• Door contact is opened
Related Links
System messages on page 143
X-ray generator mini console on page 22
Topics:
1 Notify service
2 Notify service on frequent occurrence
3 Can be eliminated by operator
Error numbers
Error Display Explanation Action
number
1 tube kV max Tube voltage too high (>166 2
kV/132 kV)
2 control A max Load current too high (> 250 2
A)
3 tube mA max Tube current too high (> 900 2
A)
4 tube +-kV diff Tube voltage difference 2
between +URist and-
URist>15kV
5 tube +-mA diff Tube current difference 2
between +IRist and -IRist
>100mA
6 ROM test ROM test checksum error 1
7 RAM test RAM test error 1
8 unknown unknown error 2
9 no Tube kV Tube voltage < 10kV after 2
1ms or < 50% after 30ms
10 tube kV too high Tube voltage > rated voltage 2
+ 25%
11 inverter overload Converter overload ( > 2
150000WS)
12 send timeout Serial interface transmit 2
timeout
13 E²Prom checksum E2PROM checksum error 1
14 watchdog Watchdog error 2
Exposure parameters
Tube Voltage
The tube voltage can be selected in steps of 1 kV in the range of 40 to 150 kV.
mAs Product
2 0.8 12 8.0 22 80
3 1.0 13 10 23 100
4 1.3 14 13 24 125
5 1.6 15 16 25 160
6 2.0 16 20 26 200
7 2.5 17 25 27 250
8 3.2 18 32 28 320
9 4.0 19 40 29 400
Step mA Step mA
0 10 10 100
1 13 11 125
2 16 12 160
3 20 13 200
4 25 14 250
5 32 15 320
6 40 16 400
7 50 17 500
8 63 18 650
Step mA Step mA
9 80 19 800
(only for generator with 65 kW power or higher)
0 1 10 13 20 130 30 1250
1 2 11 16 21 160 31 1600
2 3 12 20 22 200 32 2000
3 4 13 25 23 250 33 2500
4 5 14 32 24 320 34 3200
5 6 15 40 25 400 35 4000
6 7 16 50 26 500 36 5000
7 8 17 63 27 630 37 6300
8 10 18 80 28 800
9 11 19 100 29 1000
All Values are valid for 3-phase generator power line and large focal spot.
Values for other exposure conditions can be determined using the technical
data of the generator and the data sheets of the X-ray tubes.
In regular use these maximum exposure settings will not create doses that can
cause deterministic effects. Effective patient doses for typical exposures are
listed in Test Report for IEC 60601-1-3.
Switching between small focus and large focus may have a delay of a few
seconds. The focus is controlled by a relais and it requires the filament to cool
down before switching.
The settings of kV and mAs or of mA and ms are defined by an algorithm. The
highest mA setting is used for which the kV can be reached by the system and
the exposure time is not lower than 4 ms. When the kV setting is changed, the
value of mA and ms are adjusted automatically to keep the mAs value
constant, within the boundaries of generator or X-ray tube limitations.
Note: The accuracy for exposure parameter settings complies to
EN IEC 60601-2-54 with absolute maximum of 10% for kV and
an absolute maximum of 20% for mA.
Related Links
System Documentation on page 27
Problem solving
Topics:
• System messages
• Restoring connection between generator and NX after generator failure
• Automatic collimation always too wide or too narrow
• Empty Bucky Failure, Double Exposure Failure
• NX does not connect to the generator due to ID tablet
• No table movement
• DR Detector is Exceeding the Maximum Working Temperature
• DR Detector must be Recalibrated
System messages
The system can display messages to the user on the screen.
• Software Console
• Message frame
Click the message frame to view older messages.
• Dialog box
The software console displays a dialog box in the middle of the screen.
The dialog box can contain a title, a status description, an instruction
for the user and a button.
• Tube head display
• Message frame
Click the right half of the device status frame to display the message
frame. To hide the message frame, click anywhere in the display.
OK
1. Message frame
2. Dialog box
3. Device status frame
Figure 58: Messages
Messages can appear on the software console, on the tube head display, or on
both.
There are different types of messages.
Cause The sensors in the bucky that detect the size of the
cassette or DR Detector are dirty or have become weak.
Brief Solution Wipe the sensors in the bucky with a lint-free cloth. If
needed, moisten the cloth with a neutral detergent.
No table movement
Details The table is not moving up or down when pressing the
foot pedals with double click. No error is shown.
Brief Solution 1. Press the Power OFF button on the X-ray generator
control box to switch off the generator.
2. Switch off the electrical room switch.
3. Wait for 30 seconds.
4. Switch on the electrical room switch.
5. Press the Power ON button on the X-ray generator
control box to switch on the system.
Technical Data
Topics:
Type 5520/XXX
Permanent filtration
Environmental conditions
Environmental Conditions (during storage and transport)
Max. Power 40 kW 50 kW 65 kW 80 kW
Dimensions 89 cm x 43 cm x 29 cm (WxDxH)
Weight 78 kg (400V)
90 kg (400/480V)
Duty cycle The Generator duty cycle is continuous, but limits should
be set during installation depending on the capacity of the
X-ray tube.
The values for Power Output represent the maximum power output of the X-
ray generator. These values do not represent the available exposure
parameter settings on the Software Console.
Related Links
Exposure parameters on page 139
Type
TS-Fix-L-001 5521/100
TS-Fix-R-001 5521/110
TS-Elev-L-001 5521/200
TS-Elev-R-001 5521/210
TS-Fix-L-002 5521/300
TS-Fix-R-002 5521/310
TS-Elev-L-002 5521/400
TS-Elev-R-002 5521/410
Dimensions
Weight
Movement ranges
Transversal axis or y-axis ± 7 cm
movement (back & front)
Vertical axis or z-axis movement 33.5 cm to 180 cm from the floor
(up & down)
The movement range may vary
depending on the type of X-ray tube.
Longitudinal axis (x-axis) 131 cm
movement (right & left)
Alpha axis rotation (Angle of the ±110° with mechanical detents at 0°,
X-ray tube) ±45°, ±90°
Beta axis rotation (swivel of the ±90° with mechanical detents at 0°,
X-ray tube arm around the tube ±45°, ±90°
stand axis)
Bucky horizontal movement in 50 cm
the table
Type
WS-Manual-001 5522/100
WS-Manual-T-001 5522/200
WS-Manual-002 5522/300
WS-Manual-T-002 5522/400
Dimensions
Weight
(*) specific values do not apply as technical data of the system in China
150 kVp
dual focal spots 0.6 and 1.2 mm
600 KHU
LS 21/53 kW (50Hz) 23/58 kW (60Hz)
HS 40/100 kW (180Hz)
14,49x106 mAh@150kVp maximum
load
Type
BT-Cassette-T-001 5523/100
BT-Cassette-T-ACSS-001 5523/120
BT-Cassette-WS-L-001 5523/200
BT-Cassette-WS-ACSS-L-001 5523/220
BT-Cassette-WS-R-001 5523/250
BT-Cassette-WS-ACSS-R-001 5523/270
BT-Fixed-T-001 5523/300
BT-Fixed-WS-L-001 5523/310
BT-Fixed-WS-R-001 5523/320
Dimensions
Electrical connection
Operating current 80 mA
Electrical connection
(type 5523/120, 5523/220, 5523/270)
Supported sizes
Lifetime
Grid
Type
100 cm 5523/600
150 cm 5523/610
180 cm 5523/620
Dimensions
Weight 1.6 kg
Weight 7.7 kg
Weight 11 kg
Weight 255 g
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
The use of accessories, transducers and cables other than those specified, with
the exception of transducers and cables sold by the manufacturer of the DR
400 system (refer to the section Cables, transducers and accessories) as
replacement parts for internal components, may result in increased HF-
emission or decreased HF-immunity of the DR 400 system.
Warning: The DR detectors might be interfered with by
other equipment.
• REMARK 1: At 80 MHz and 800 MHz the separation distance for the
higher frequency range applies.
• 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.
power of
transmitter
W
100 12 12 23
For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in metres (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
• NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher
frequency range applies.
• NOTE 2 These guidelines may not apply in all situations.
Electromagnetic propagation is affected by absorption and reflection
from structures, objects and people.
Related Links
Cables, transducers and accessories on page 183
Essential performance
EUT-specific compliance criteria considering Essential Performance of
Equipment under Test:
• No error messages on panel and on display of EUT
• No unintended move of table, wall stand and tube-head during mode X-
Ray and Standby / no interruption during “Move” mode
• No unintended X-Ray triggering
Topics:
Optional
from to type maximum remark
length
table output control room NX Cat 5e 15 m shielded
terminal Workstation
Aux.
table output wired hand 01090350F 1.8 m unshielded,
terminal control optional
Stray Radiation
200
180
160
S1,S2
140 S3
S4,S5
Distance to floor [cm]
120
100
80
60
40
20
0
0 0,1 0,2 0,3 0,4 0,5
Kerma [uGy]
• S1,S2: 100 kV; SID 110 cm; tube/detector centre height 140cm over floor
• S3: 100 kV; SID 100 cm; table height of 70 cm (standard working height)
• S4,S5: 100 kV; SID 100 cm; table height of 70 cm (standard working
height)
Figure 60: Measurement of stray radiation in zones of occupancy (Sx)