DR 800
DR 800
DR 800
6010/200
User Manual
Contents
Legal Notice .......................................................................... 8
Introduction to this Manual ................................................... 9
Scope of this Manual ................................................10
About the safety notices in this document ................ 11
Disclaimer ............................................................... 12
Introduction ........................................................................ 13
Intended Use ............................................................14
Indications for Use ................................................... 15
Intended User .......................................................... 16
DR 800 System Overview .........................................17
Radiographic Table ...................................... 19
Position Controls ..........................................21
Worklist window ..........................................25
Software Console .........................................26
Exposure Controls ........................................28
Examination window ...................................30
Acquisition window ..................................... 31
Editing window ........................................... 32
Main Menu window ..................................... 33
Monitor for reference images ....................... 34
DR detector switch .......................................35
Collimator ................................................... 36
Portable DR Detector ................................... 38
Compressor ................................................. 39
FLFS overlay ................................................ 40
Emergency stop button .................................41
Emergency shutdown power switch ............. 42
Cabinets and power switch .......................... 43
Radiographic wall stand .............................. 44
Ceiling Suspension ...................................... 49
Messages ................................................................. 52
Labels ...................................................................... 53
Additional labeling of the radiographic table ...
56
Additional labeling of the positioning console ..
58
Additional labeling of the wireless console ...59
Additional labeling of the DR 800 sync cabinet
60
Additional labeling of the positioner cabinet ....
61
Additional labeling of the radiographic wall stand
..........................................................................62
Additional labeling of the collimator ............ 63
Legal Notice
0413
Published by Agfa NV
WARNING:
A warning safety notice indicates a hazardous situation which
can lead to a potential serious injury to a user, engineer, patient
or any other person.
CAUTION:
A caution safety notice indicates a hazardous situation which
can lead to a potential minor injury to a user, engineer, patient
or any other person.
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 on order
of a physician for prescription use only.
Introduction
Topics:
• Intended Use
• Indications for Use
• Intended User
• DR 800 System Overview
• Messages
• Labels
• Installation
• Radiation Protection
• Maintenance
Intended Use
The DR 800 is an X-ray modality. It is designed for general radiography and
dynamic (fluoroscopy and/or rapid sequence) applications. The DR 800 will
be used in a radiological environment by qualified staff to capture and route
static and dynamic X-ray images.
The DR 800 is not intended for cardiovascular and cerebrovascular contrast
studies and mammography applications.
Intended User
This manual is written for trained users of Agfa products. Users are considered
as the persons who actually handle the equipment as well as the persons
having authority over the equipment. Before attempting to work with this
equipment, the user must read, understand, note and strictly observe all
warnings, cautions and safety markings on the equipment.
Only a physician or a legally certified operator should use this product.
4 7 8
1 2 5 6 5
1. Radiographic table
2. Position controls on the table
3. Collimator
4. X-ray tube
5. Exposure controls
6. Position controls
7. NX workstation software
8. Software console
• Examination overview
• Generator controls for static image or rapid sequence
• Generator controls for fluoroscopy
• X-ray modality controls
• Positioning controls
• Messages
Figure 1: DR 800 configuration
Topics:
• Radiographic Table
• Position Controls
• Worklist window
• Software Console
• Exposure Controls
• Examination window
• Acquisition window
• Editing window
• Main Menu window
• Monitor for reference images
• DR detector switch
• Collimator
• Portable DR Detector
• Compressor
• FLFS overlay
• Emergency stop button
• Emergency shutdown power switch
• Cabinets and power switch
• Radiographic wall stand
• Ceiling Suspension
Radiographic Table
The radiographic table is used for positioning of the patient lying, sitting or
standing in front of the detector for exposure.
The radiographic table has various degrees of freedom to allow different
examinations.
The radiographic table contains a built-in DR detector to acquire radiography
or fluoroscopy images.
The radiographic table has two variants:
• Radiographic table with a built-in set of focused grids. Exposures can be
made with or without a grid. The grid is automatically selected based on
the SID.
• Radiographic table with removable grids. The focal distance of the grid is
detected in the bucky.
1. Table height
2. Table tilting angle
3. Source image distance (SID)
4. X-ray tube tilting angle, coupled to a displacement of the DR detector (for
oblique exposures)
X-ray tube rotation (to direct the X-ray tube away from the radiographic
table)
Position Controls
The position controls are available in the operator room. Optionally a wireless
console with position controls is available in the examination room.
1 2 3 4
8 7 6 5
1. Emergency stop button for motor driven movements of the radiographic
table
2. Indicator light is blinking if an automatic position is selected, until the
automatic movement has finished
3. Move to the selected automatic position, while the indicator light is
blinking
While the indicator light is off:
• Longitudinal displacement of the tabletop
• Operation of the compressor
4. Exposure button
5. • Transversal displacement of the tabletop
• Longitudinal displacement of the DR detector
6. • Table tilting angle
• Table height
7. • X-ray tube tilting angle
• Source image distance (SID)
8. Collimator
Figure 3: Position controls
To allow movement using one of the joysticks, keep the button on the joystick
pressed while operating the joystick. Movement may stop on preconfigured
threshold positions and can be continued by releasing the joystick and
operating it again.
The tilting angle to which the joystick lever is pushed controls the speed of the
movement.
The direction in which the joystick is pushed, corresponds to the direction in
which the region of interest is moved on the image as it is visible on the
monitor.
1 2 3 4 5 6 7
1. Emergency stop button for motor driven movements of the radiographic
table
2. Release position control. Keep the button pressed to allow movement.
3. Source image distance (SID)
4. Table tilting angle
Table height
5. X-ray tube tilting angle
6. Longitudinal displacement of the tabletop
7. Transversal displacement of the tabletop
Longitudinal displacement of the DR detector
Figure 4: Position controls on the radiographic table
1
1. Transversal displacement of the tabletop
2. Longitudinal displacement of the DR detector
Figure 5: Optional joystick on the radiographic table
WARNING:
Incorrect installation of the joystick can cause damage to
patients, operators and equipment.
WARNING:
All position controls are enabled simultaneously. Do not run
controls on different consoles simultaneously.
Related Links
Topics:
1
2
1 2
At the foot of the wireless console, a power socket and a main power switch
are available to connect the console to the mains power and charge the
battery.
Related Links
Wireless console status on page 234
Wireless console with position controls cannot restore connection on page 272
Worklist window
In the Worklist window, you can view and manage the exams that are
scheduled and that have been performed.
Software Console
The software console is available to support X-ray exposure and position
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 is used to adapt the parameters for automatic
positioning on the full automatic configuration.
The software console contains the DR detector switch.
Related Links
Software Console on page 187
Exposure Controls
1
2 2 3
1. The exposure button is used to obtain a static image, to acquire a rapid
sequence or to acquire a tomosynthesis sequence, depending on the mode
that is selected in the software console.
The exposure button is available on the console with the position controls.
The console is located in the operator room and another console can be
located in the examination room.
The exposure button can be pressed and hold down to the first pressure
point to prepare the X-ray tube for exposure.
The exposure button is pressed and hold down fully to make the exposure
or during acquisition of the rapid sequence.
2. The fluoroscopy pedal is used to acquire a fluo sequence.
The fluoroscopy pedal is available in the operator room as a single pedal
or together with a radiography pedal. Another fluoroscopy pedal can be
located in the examination room together with a radiography pedal.
The fluoroscopy pedal is pressed during acquisition of the fluo sequence.
3. The radiography pedal is used to obtain a static image or to acquire a rapid
sequence, depending on the mode that is selected in the software console.
The radiography pedal can be available in the examination room together
with a fluoroscopy pedal.
The radiography pedal is pressed to make the exposure or during
acquisition of the rapid sequence.
Figure 12: Exposure controls
The sound signals that are heard when pressing the pedals are different for
fluoroscopy and for radiography.
Depending on the configuration, the exposure button on the wireless console
and the footswitch in the examination room are disabled when an
examination for the ceiling suspension is selected.
Related Links
Radiography imaging modes on page 206
Fluoroscopy imaging modes on page 220
Exposure control pedals on page 261
Examination window
In the Examination window, you can view and manage the details of a
specific examination. The drop-down list in the title bar of the window shows
the name of the patient for which the examination is performed. You can
select another name from the list to display the examination of the patient.
Also the most important tools to prepare the images for diagnosis are available
here.
Acquisition window
In the Acquisition window, you can manage the image acquisition for
radiography and fluoroscopy examinations.
A fluo group supports a DR workflow with fluoroscopy for positioning and
contains a set of fluo sequences and a single static image.
A dynamic group supports a DR workflow for dynamic images and can contain
fluo sequences, rapid sequences and static images.
Fluo sequences and rapid sequences can be reviewed in a dynamic image
viewer or a mosaic view and prepared for diagnosis.
Editing window
In the Editing window, you can prepare the image for printing.
In the Main Menu window, you can manage certain aspects of the NX
Workflow which do not belong to the daily workflow.
DR detector switch
The DR detector switch is available in the X-ray modality 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.
Collimator
The collimator controls consist of a button to switch on the collimator lamp
and two knobs to open or close the internal blades of the collimator.
When pressing the collimator lamp push-button, the collimator light turns on.
It remains lit for 30 seconds before it switches off automatically (lighting time
can be configured).
Exposure field on the receptor is adjusted by setting the two knobs. The table
on the front panel shows the number to set with the knobs to open the blades
according to the SID and X-ray field to be used.
1
Topics:
• Collimator camera
• Collimator rotation
Collimator camera
The collimator has a built-in camera to visualize the anatomical region of
interest on the software console while adjusting the patient position remotely.
To hide the camera image on the software console, push the image. To display
the camera image, push the camera icon.
Collimator rotation
Depending on the configuration, the collimator can be rotated around the axis
of the X-ray beam.
Note: Black borders are not applied to dynamic images if the
collimator is rotated. Put the collimator in the default position
for performing dynamic imaging examinations.
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.
Compressor
The remote controlled compressor allows an effective though not traumatic
palpation. The default compression force is 150 N. The compressor is designed
for mechanical and electrical safety, as well as safety against wrong
manoeuvres.
The compressor has a parking position from which it automatically moves in
and out.
FLFS overlay
The FLFS overlay consists of a stitching grid and a mounting unit. The
stitching grid must be attached to the radiographic table using the mounting
unit.
The partial images of the FLFS examination are automatically stitched to
create the DR Full Leg Full Spine image. Stitching is applied based on a grid of
markers inside the stitching grid and a correction is applied based on the
alignment of the anatomical information in the image.
1
1. Mounting unit
2. Stitching grid
Figure 22: FLFS overlay
The emergency stop buttons are red with the word "STOP" for easy
recognition.
By pressing an emergency stop button, electric power to the remote controlled
tabletop is shut off, thus stopping all table movements.
WARNING:
The emergency stop button must be unlocked (pull the red
button) only after the cause of the hazard has been clearly
identified and eliminated.
2
3
4
5
6
The bucky has two variants, depending on the orientation for loading a
detector or cassette:
• Right hand side loading
• Left hand side loading
Related Links
Ceiling suspension and radiographic wall stand on page 106
Topics:
1. Release the mechanical brake for vertical movement, by turning the knob
of the vertical movement brake counterclockwise.
The bucky can be moved up and down.
2. Lock the bucky into position, by turning the knob clockwise.
WARNING:
When the brakes are released, the carriage tends to lift upward
with the bucky. This balancing helps the user to vertically
position the bucky. With empty bucky and no additional
accessories mounted, it is necessary to accompany the bucky
along its vertical movement and to avoid violent collision when
reaching the bumper at the upper end of the travel range.
WARNING:
Do not move the bucky with excessive force to the end stop
positions.
1. Relesae the tilting brake, turning the knob of the tilting brake
counterclockwise.
2. Adjust the tilting angle.
3. Lock the bucky into position, turning the knob clockwise.
To rotate the bucky:
1
2
3
1. Make sure the detector tray is locked, to protect the DR detector from
falling.
2. Hold the bucky with one hand and with the other hand release the lever
that locks the rotation.
3. Rotate the bucky to the right orientation and release the lever.
4. Continue the rotation until the lock closes.
WARNING:
Verify that the bucky tray has been blocked firmly into position
when making rotations! If the device has not been locked down,
it may be ejected from the rotation movement and fall to the
ground causing damage to it or injury to the patient and/or the
operators!
WARNING:
Never extract bucky tray when the loading position is pointed
towards the ground! It can easily fall to the ground causing
damage to it or injury to the patient and/or the operators!
WARNING:
Always keep the rotation of the bucky under control. Do not
rotate the bucky in an uncontrolled manner or allow it to
forcefully strike the mechanical stops. This could damage the
components or cause premature failures.
1
2
3
6
7
8
1. Bucky
2. Bucky drawer
3. DR Detector or CR cassette
4. Lever to lock the clamps
5. Bucky drawer handle
6. Clamp
7. Vertical center indicator
8. Vertical stop
Figure 29: Bucky
CAUTION:
Make sure your fingers are not crushed by components inside
the bucky drawer. Use the bucky drawer handle when opening
or closing the drawer.
To secure the lock for earthquake resistance, first turn the knob on the lever
counterclockwise to allow the lock to be released.
Press the lever to release the lock for the removable grid.
Ceiling Suspension
1
2
3
1. Transversal rails
2. Carriage
3. Longitudinal rails
4. Telescopic column
5. X-ray tube head unit
6. Collimator
Figure 33: Ceiling Suspension
Topics:
• Positioning the X-ray tube of the ceiling suspension
• Collimator of the ceiling suspension
The operation controls of the X-ray tube head unit are located at the control
panel. The X-ray tube can be positioned by the operator manually.
To release the brake for the selected movement direction or rotation, press
and hold the button and move the X-ray tube head unit. To improve the ease of
performing the movement, the movement is supported by motors.
To stop the movement and activate the brake, release the button.
The display of the control panel shows the rotation angle of the X-ray tube and
the SID value. The SID value can only be calculated correctly when the X-ray
tube is perpendicular to the bucky of the radiographic wall stand. This
function does not account for physical alignment of the X-ray source to the DR
detector. Always visually verify that the X-ray source is aligned to the DR
detector before taking exposures!
To avoid collisions, the movement of the radiographic table is blocked until
the X-ray tube of the ceiling suspension is moved back into the parking
position. The parking position of the ceiling suspension can be detected by
detents on the rails.
WARNING:
If movement in any direction blocks, do not apply force to
overcome the blocking. Contact your local service organization.
Note: To avoid shock and damage, move the tube head unit with
normal speed and slow down when reaching the mechanical
end stops.
CAUTION:
Rotation may be limited by cables. Avoid strain on the cables
during rotation.
Related Links
Ceiling suspension and radiographic wall stand on page 106
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.
Related Links
System messages on page 239
Labels
Do not remove the labels applied to the equipment, they are an integral part of
the instructions and documentation that accompany it.
Symbol Explanation
Ionizing radiation
Dangerous voltage
Laser Warning
Indicates the presence of a laser device.
Don't push the unit, except during movement with breaks re-
leased.
Symbol Explanation
On - off (push-push)
Functional earth
Symbol of filtration.
Manufacturer
Date of manufacture
Serial number
Symbol Explanation
Topics:
Related Links
Radiographic table on page 290
2
3
Laser power.
Label Meaning
Tube side
Installation
Installation and configuration is performed by an Agfa trained and authorized
service engineer. Contact your local support organization for more
information.
The unit shall not be installed in wet enviroments like emergency operation
rooms and operating theatre.
This unit shall not be installed in environments where there are explosion
risks.
Topics:
• Mains supply
• Radiation protection
Mains supply
All the components of the X-ray installation must be connected to the
electrical mains by means of a socket or another multi-polar connector that
must be installed by the customer. The room of the installation must be in
compliance with the IEC/CEI or UL/CSA prescriptions in force (where
requested).
The relevant national regulations must be applied in all countries.
Nonetheless, compliance with the abovementioned standards is strongly
recommended, when they do not contradict the national regulations in force,
to ensure safety for the operator, the patient and third parties.
Radiation protection
The system is intended to be used in X-ray rooms with appropriate shielding.
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, radiation protection glasses, mobile lead screens, 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:
• Fluoroscopy
• Monitoring of Personnel
• Protected area and significant zones of occupancy
Fluoroscopy
Fluoroscopy is a radiological technique used to obtain real time images of a
patient's internal anatomy, with the possibility of registering and reproducing
the obtained images on monitor.
The use of X-rays and subsequently fluoroscopy, requires that potential risks
of exposure be carefully balanced by the benefits in terms of diagnosis, that
the examination is able to offer. Despite trying to use reduced doses of
radiation, fluoroscopy sequence time can be rather long and the absorbed
dose can be relatively high.
WARNING:
Repetitive or prolonged exposures may result in local skin dose
levels that cause adverse tissue reactions.
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.
3
6
4
1. X-ray room
2. Patient environment
3. Workstation
4. Operator room: protected area
Figure 52: Protected area and significant zones of occupancy
to the patient), 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.
200 cm
0 cm
1
Workflow Fluoroscopy
Object Anthropomorphic abdomen phantom
SID 115 cm
Exposure parameters 100 kV, 50 mA, 10 frames per second, 10 ms pulse
width
Total exposure time 100 s
Inherent filtration 2.9 mm Al equivalent
4
200 cm
0 cm
2 1
1. Vertical axis indicating operator position at the right side of the table (at
15 cm from the right side of the tabletop and at 50 cm distance from
central X-ray beam) and height range of stray radiation measurement (0
cm - 200 cm)
2. Vertical axis indicating operator position at the left side of the table
3. Horizontal axis indicating the position of the X-ray tube
4. Stray radiation in mGy measured at the operator position [1]
Figure 54: Significant zone of occupancy and stray radiation during
examination with vertical table
Workflow Fluoroscopy
Object PMMA phantom measuring 25 x 25 x 25 cm3
Collimation 10 cm x 10 cm
Exposure parameters 125 kV, 80 mA, 10 frames per second, 10 ms pulse
width
Maintenance
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.
WARNING:
Improper, irregular or lack of maintenance of the equipment can
lead to injuries to persons (e.g. by radiation hazard) and
property damage as a result of malfunctions and defects of the
equipment.
WARNING:
Wear of equipment due to excessively long intervals between
service may lead to personal injury and property damage due to
worn and unsafe parts.
WARNING:
Incorrect or defective spare parts may adversely affect the safety
of the system and lead to damages, malfunctions or total failure.
Use only original spare parts provided by the manufacturer.
WARNING:
Improper changes, additions, maintenance or repair of the
equipment or the software can lead to personal injury, electrical
shock and damage to the equipment. Safety is only guaranteed
when changes, additions, maintenance or repairs are carried out
by an Agfa certified field service engineer. A non certified
engineer performing a modification or service intervention on a
medical device, acts on his own responsibility and makes the
warranty void.
WARNING:
During all functional tests requiring the activation of the
radiological generator, protective garments must be worn,
maintaining an adequate distance and, if necessary, a pen
dosimeter for checking personal X-ray exposure must be used.
WARNING:
Before starting the maintenance procedures, it is recommended
to read the safety directions in this manual.
CAUTION:
In case of functional defects or other deviations from normal
operation behavior the unit has to be switched off immediately
and the service to be informed. The equipment must only be put
back into operation when the fault has been repaired.
CAUTION:
The use of spare parts from third party suppliers can affect the
safety of the equipment. If components fail, use only original
spare parts.
Table 5: Maintenance
Lifetime
Expected lifetime for the X-ray system 10 years
Periodic maintenance
In order to ensure good and safe functioning conditions Every 12 months
of the equipment, preventive maintenance must be car-
ried out. If you have not signed a maintenance contract,
please contact the manufacturer’s service department or
its agent.
Maintenance by the user
Clean any residual contrast mediums from the tabletop. Daily
Do a visual check of the equipment movement, the dis- Daily
plays and the luminous signals.
Make sure that the necessary accessories for immobiliz- Daily
ing the patient are properly fixed to the equipment, and
particularly the handgrips.
Check that the movement stop buttons function proper- Every 6 months
ly.
Check the dimensions of the luminous field delimited by Every 6 months
the collimator by following the procedure included in
the technical manuals.
Check the cables. Ensure that cables are not damaged Every 6 months
and cable jackets are not torn.
Check the automatic collimation Every 6 months
Replace the batteries in the wireless pedal Every 12 months
The DR detector requires regular calibration. Calibra- A message is dis-
tion instructions are described in the DR Detector Cali- played on MUSI-
bration Key User Manual (doc 0134). CA Acquisition
Workstation indi-
cating that the DR
detector must be
recalibrated.
Topics:
Table 6: Maintenance
Periodic maintenance
All steel cables, winding drums, pulleys and Every 12 months
safety devices of the ceiling suspension and
the radiographic wall stand shall be checked
Condition of the tension springs of the ceil- Every 12 months
ing suspension.
Replacement of steel cables of the ceiling Every 5 years, indicated on
suspension the label that is placed on the
equipment
Replacement of steel cables of the wall stand Every 10 years, indicated on
the label that is placed on the
equipment
Replacement of tension springs of the ceiling As needed
suspension
Offset calibration
The integrated DR detector is set up to automatically perform an offset
calibration every minute. The user can manually trigger the offset calibration
by pushing the Offset Calibration button on the software console.
The DR Detector switch indicates when the offset calibration is ongoing.
WARNING:
Image artifacts after exposure of the system to foreign X-ray
radiation. If another X-ray device (X-ray tubes not connected to
the DR 800 generator) has been used nearby the system and you
are not sure that automatic offset calibration has been
performed (e.g. because a thumbnail on the NX was selected all
the time), perform a manual offset calibration before making
new exposures on the system.
Related Links
X-ray modality controls on page 228
DR Detector Status on page 194
• Cleaning
• Use of protective covers and sheaths
• Disinfecting
• Disinfecting safety directions
• Approved disinfectants
• FLFS Overlay
Cleaning
To clean the exterior of the equipment:
CAUTION:
Clean the equipment with only a little moisture. Do not
spray disinfectants or detergents directly on the equipment.
Do not pour liquid directly on 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).
Avoid to spray degreasing agent at the blue rail, because it
will cause rust.
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
FLFS Overlay
All appropriate policies and procedures should be followed to avoid
contamination of the user/staff, patients and other equipment. All existing
universal precautions should be extended to avoid coming into contact with
patient or close contact with patient or potential contaminations. The user is
responsible for selecting a disinfection procedure.
• If required, wipe the patient contact surfaces of the FLFS overlay using
disinfectants such as ethanol (70%), to prevent the risk of infection.
• Do not spray the equipment directly with disinfectants or detergents.
• Wipe it with a cloth slightly damped with a neutral detergent. Do not use
solvents such as anhydrous or high solvency alcohols, thinner or benzine.
Doing so may damage the surface of the equipment.
• Take care that by using disinfectants, the skin of the user or of the patient
cannot be irritated.
Safety Directions
WARNING:
Safety is only guaranteed when an Agfa certified field service
engineer has installed the product.
WARNING:
The product must only be installed using released components
and in released configurations.
WARNING:
To avoid risk of electric shock, this equipment must only be
connected to a supply mains with protective earth.
WARNING:
Do not connect additional extensions cords or multiple power
socket outlets to the system.
WARNING:
Do not connect the equipment with anything other than
specified. Doing so may result in fire or electric shock.
WARNING:
To avoid risk of electric shock, do not remove any covers.
Changes, additions, maintenance or repairs must be carried out
by an Agfa certified field service engineer.
WARNING:
The user must not touch part of the console or the X-ray
generator, and patient simultaneously.
WARNING:
Ionizing radiation can lead to radiation injuries if handled
incorrectly. When radiation is applied, the required protective
measures must be complied with.
WARNING:
The operator and end-user must take precautions to protect
themselves against dangerous X-ray exposure when using the
DR Detector in the X-ray beam path of an X-ray source.
WARNING:
The DR Detector is not intended to be used as a primary barrier
to X-rays. The user is responsible for ensuring the safety of the
operator, bystanders, and the subjects being radiographed.
WARNING:
X-ray radiation will extend beyond the primary protective
shielding when rotating the X-ray tube away from the
radiographic table or when manually adjusting the collimator
up to its mechanical limits and making free exposures.
WARNING:
Operating the equipment when it is faulty includes the risk of
radiological exposure and injury to the patient and to the
operator. Operate the equipment only in safe and fault-free
conditions.
WARNING:
The accessories for the radiographic table may slide off the
radiographic table if they are not properly mounted, causing
injury or damage to the equipment. Always tightly fasten the
accessories on the tabletop guides.
WARNING:
Do not subject the unit to dangerous stresses, eg. violently
stopping the moving parts at the end of the movement range,
twisting the electrical cables excessively or forcing movements
without having released the brakes.
WARNING:
The table can tilt in negative position (head down). This can
create a hazardous situation where the patient can slip from the
table. Always verify the automatic position before activating the
automatic movement and observe the patient during
movements.
WARNING:
Check upfront, before starting the digital subtraction
angiography or roadmapping procedure, that the setting of the
maximum mAs is appropriate for the targeted body part of that
specific patient.
WARNING:
System unavailability due to hardware or software failure. If the
product is used in critical clinical workflows, a backup system
has to be foreseen.
WARNING:
All the necessary precautions must be taken to prevent
unauthorized or unskilled personnel from operating this
equipment, thus jeopardizing themselves and other people.
WARNING:
Incorrect and inappropriate use of the machine by poorly
qualified personnel who are unsuitable and insufficiently
trained can cause fatal accidents.
WARNING:
This unit must be disposed by qualified personnel in order to
prevent the occurrence of danger.
WARNING:
When disposing of the collimator, X-ray tube, generator or other
significant system devices, refer to the technical manuals that
comes with them.
CAUTION:
Damaged grid. Reduced image quality. Please handle the grids
with special care.
CAUTION:
When inserting the scattered radiation grids, it is essential that
the grid corresponds to the intended source-image-distance
(SID) to which the grid is focussed. Because of the focussing of
the grids, the tube unit must be centered onto the bucky.
CAUTION:
Laser radiation is potentially dangerous for skin and eyes. Do
not stare directly or through optical instruments at the laser
beam. Do not point the laser beam on the face or the eyes of the
patient.
CAUTION:
Do not stare at the collimator light for prolonged time because it
could be dangerous for the eyes.
CAUTION:
Strictly observe all warnings, cautions, notes and safety
markings within this document and on the product.
CAUTION:
All Agfa medical products must be used by trained and qualified
personnel.
Topics:
• Dangerous areas
• Patient visibility
• Wireless console
Dangerous areas
During movement of the X-ray system, dangerous areas can be identified in
the surrounding space. It is necessary to pay special attention to such areas, in
order to prevent collisions or crushing.
Before switching on the equipment, check for:
• dangerous areas on the system, where there are potential risks of collision
or crushing
• dangerous areas on the system where the patient or operator could get
injured
• dangerous movements that might damage the equipment
Collisions may occur between the moving system and objects in the room
positioned within the movement range of the system, such as: stretchers,
chairs, mobile tables with instruments aboard, baskets, stands, pedals,
suspended devices, etc.
WARNING:
Collision with objects within the movement area of the system.
Do not activate automatic movement if extraneous objects are in
the allowed movement area of the system.
Crushing may occur between the moving system and the operator, the patient
or other persons within the movement range of the system.
WARNING:
Before activating any movement of the system, verify that no
one but the patient is present within the machine moving area
and that the patient is properly positioned and secured on the
tabletop. While controlling the position of the system, do not
remain standing close to the machine. While controlling the
position of the system, do not assume a working position seated
directly on the equipment. Be particularly wary of the risk of
crushing feet when the radiographic table tilts.
WARNING:
When the equipment is moving or the patient is being
positioned, personnel and patient may only grasp the grips that
have been provided specifically for this purpose.
WARNING:
The operator must keep hands, feet, clothing, jewelry and hair
away from moving parts to avoid that they get tangled in the
moving mechanisms.
Figure 56: The cross-hatched area indicates where there is a risk of collision or
crushing depending on the position of the system
Figure 57: The black arrows indicate where there is a risk of collision and the
white arrows indicate where there is a risk of crushing
A pair of handgrips is a standard accessory of the system. Make sure that these
handgrips are always installed.
If the handgrips cannot be used:
• pay particular attention to the potential threat of crushing between mobile
parts and openings
• during the examination, make sure the patient does not grasp the edge of
the tabletop
Patient visibility
The room layout must allow the operator to keep complete visual contact with
the moving tabletop and monitor the patient even from the operator room.
If the positioning console is installed in other positions (for instance laterally
with respect to the tabletop), the operator and the patient are both exposed to
risks caused by lack of visibility when the machine is moving.
To give the operator complete control of all movement activities, following
measures can be taken:
• Remove the patient footrest when working in a horizontal direction with
the patient on the tabletop.
• If necessary, arrange some mirrors which ensure the patient can be
monitored even in positions where the tabletop hides the patient from
view.
• Always watch the machine and the patient when performing all
movements.
Wireless console
WARNING:
Bluetooth communication works up to a maximum distance of
10 metres. For proper operation of the system, use the wireless
console exclusively within the operating room.
WARNING:
To conserve battery power, the wireless console automatically
turns off 3 minutes after the equipment has been turned off.
WARNING:
When the charge of the battery is less than 10%, it is necessary
to recharge the battery by connecting the power cord and
turning on the mains network switch.
WARNING:
The wireless console should not be left unattended when active.
Failure to do so may result in unintended movement of table.
WARNING:
When the wireless console is not in use, turn it off and park it
outside the movement range of the radiographic table.
2 3 2
1 1
For patient weights higher than 265 kg (up to max. 320 kg) it is necessary to
place the table at its minimum height, to position the mobile area based on
the area to be examined and, only later, to allow the patient on the tabletop.
Related Links
Positioning the patient on the examination table on page 143
WARNING:
Handle the FLFS overlay and the mounting unit with care to
avoid damage.
WARNING:
The FLFS overlay may slide off the radiographic table when
tilting the table if it is not properly mounted, causing injury or
damage to the equipment. Always consider the patient
orientation (head left or head right) when mounting the FLFS
overlay.
Digital tomosynthesis
WARNING:
Metal structures in the image might affect the image quality of
the tomosynthesis reconstruction.
WARNING:
Use the brakes correctly. Activate the positioning controls to
move the equipment. Release the positioning controls only after
the equipment is set in place.
WARNING:
In the bucky and in the bucky drawer there are metal
protrusions and pinch points that can cause damage to the
user’s hands. So use only the proper handle to pull out and
insert the cassette tray from the bucky.
WARNING:
Do not try to force the X-ray tube towards the bottom when the
main rope is broken! Never use the ceiling suspension after the
safety device intervention. Immediately contact service and
replace the broken rope.
WARNING:
If the wall stand unit is used with a mobile table or stretcher, it is
important that the operator must block the wheels to firmly
position the stretcher while helping the patient on or off the
table.
CAUTION:
Do not use the wallstand if it shows damage to one of the two
ropes or obvious signs of breakage or wear. Contact service to
replace broken ropes.
Basic Workflow
Topics:
Topics:
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.
2 3
1 2
Table 7: Buttons in the dynamic image screen after stopping the exposure
Button Function
Display the dynamic image in full screen mode for further edit-
ing.
2
3
After making the exposure, no more fluo sequences or static images can be
added to the fluo group.
7. Perform quality control.
8. If all images in the examination are OK, click Close and Send All.
If configured, the image is sent to the printer and/or PACS archive. The
exam is placed in the Closed Exams pane.
Fluo sequences are by default deleted after the examination is closed and
not stored and not sent to a PACS archive. This is indicated by the yellow
icon in the top right corner of the fluo sequence thumbnail. To store and
archive a selected fluo sequence, click the Store Sequence button before
clicking Close and Send All.
Figure 74: Icon indicating that the fluo sequence will not be saved
Related Links
2 3
Figure 80: Generator controls for static images and for rapid sequence
exposures
3. Move the X-ray system to the right position.
a) Check if a correct automatic position is selected.
Rapid se-
quence
exposure button
or radiography
pedal
Static im-
age
exposure button
or radiography
pedal
c) Release the exposure button or the radiography pedal to stop the rapid
sequence.
The rapid sequence is stored and displayed as a rapid sequence
thumbnail in the lower half of the Image Overview pane. The last
image of the sequence is visible in the thumbnail.
A rapid sequence thumbnail is indicated with a white Play icon in the
center.
WARNING:
In exceptional occasions the last image of a rapid
sequence may not be of appropriate quality due to an
uncompleted exposure. In this case the user can choose
to keep or or disregard this image on the NX workstation
and use the second last image instead.
8. After stopping a dynamic exposure, the dynamic image screen remains
visible and the acquired sequence is played continuously.
Table 9: Buttons in the dynamic image screen after stopping the exposure
Button Function
Display the dynamic image in full screen mode for further edit-
ing.
Related Links
Resetting the fluo timer on page 203
2
1. Digital tomosynthesis screen of the software console
2. Button to start the digital tomosynthesis workflow
Figure 97: Button to start the digital tomosynthesis workflow
If the X-ray system position is not suitable to perform the examination, the
button is disabled. Try adjusting the X-ray system to enable the button.
8. Position the X-ray tube vertically with respect to the table.
If the X-ray tube tilting angle is not at 0°, use the automatic position
controls to change the X-ray tube tilting angle to the required position.
9. Press and hold down the exposure button in prep mode.
The X-ray tube is moved to the start position of the digital tomosynthesis
exposure.
10. Press and hold down the exposure button to make a digital tomosynthesis
acquisition sequence.
Hold the exposure button pressed until three beeps are heard to indicate
that the examination has finished.
Together with the auditory signal, messages are displayed on the software
console to indicate that the examination has finished.
When the exposure button is released before the movement has finished,
the exposure sequence is aborted and the reconstruction may fail.
The acquisition sequence is stored and displayed as an acquisition
sequence thumbnail in the lower half of the Image Overview pane.
The last image of the sequence is visible in the thumbnail. An acquisition
sequence thumbnail is indicated with a white Play icon in the center.
Figure 99: Progress indicator for the image processing to create the
reconstruction sequence
2 3
2 3
Figure 106: Generator controls for static images and for DSA
DSA
exposure
button or ra-
diography
pedal
Static
image
exposure
button or ra-
diography
pedal
Fluoro- not needed
scopy
fluoroscopy
pedal
The workflow for acquiring a DSA sequence is explained in the next steps.
The other workflows are explained in other sections in this manual.
7. Select the DSA mode in the software console.
WARNING:
The DSA image processing relies on absence of movement.
Do not change the position of the table, X-ray tube or
collimator during the DSA examination.
8. Press and hold down the radiography pedal or the exposure button.
A first set of frames is used to compose the mask image. The subsequent
frames are displayed with the mask image subtracted. The syringe icon
indicates that the mask image has been created.
Figure 110: Icon indicating that injection of the contrast medium can start
9. Start injecting the contrast medium when the syringe icon is shown.
Blood vessels that contain the contrast medium, become clearly visible.
10. Release the radiography pedal or the exposure button to stop the
exposure.
The DSA sequence is stored and displayed as a DSA sequence thumbnail in
the lower half of the Image Overview pane. The last image of the
sequence is visible in the thumbnail
A DSA sequence thumbnail is indicated with a transparant Play icon in the
center.
2 3
2. Generator settings for DSA image acquisition (DSA is not part of this
workflow)
3. Generator settings for fluoroscopy or for roadmapping image
acquistion
4. Automatic position
Figure 114: Examination overview
Figure 116: Generator controls for static images and for DSA
DSA
exposure
button or ra-
diography
pedal
Static
image
exposure
button or ra-
diography
pedal
Fluoro- not needed
scopy
fluoroscopy
pedal
WARNING:
The roadmapping image processing relies on absence of
movement. Do not change the position of the table, X-ray
tube or collimator during the roadmapping examination.
8. Press and hold down the fluoroscopy pedal to start the fluo sequence for
generating the roadmapping mask.
Figure 120: Icon indicating that injection of the contrast medium can start
9. Start injecting the contrast medium when the syringe icon is shown.
WARNING:
Roadmapping does not work with negative contrast media.
The blood vessels gradually fill with contrast medium and become visible
on the screen. If the option max opacity is enabled, the blood vessels stay
visible, even if the contrast medium has moved on.
10. Release the fluoroscopy pedal when the blood vessels are sufficiently filled
with contrast medium.
The roadmapping mask is stored and displayed as a thumbnail in the
lower half of the Image Overview pane.
WARNING:
If the system has just been stopped, wait at least 10 seconds
before starting it again.
Application Examples
Following sections provide examples of how to use the system, considering a
patient lying or resting against the tabletop of the radiographic table,
according to the main intended use.
Topics:
A patient lying on a stretcher can be moved onto the examination table more
easily by first moving the tabletop to the left or to the right.
Related Links
Getting on and off the table on page 101
If corrections are required to the focal distance, the tilting angle, the
examination area centring and tube incidence, the operator can use the main
control console or the control panel onboard the machine.
All projections on the duodenal and small intestine are easy to perform with
the patient lying face down, face up or in an oblique position on the table top
and with the table in a horizontal position. The operator can inclinate the X-
ray tube to obtain the projections needed to provide the required examination
results. In addition, medical staff can work in the room, using the controls
onboard the table, to position the table as required.
Skeleton
The ample examination field that can be obtained, thanks to the movement of
the X-ray tube and DR detector group group, allows the operator to execute
the most thorough analysis of the patient. Examinations of the skull under any
incidence, of the back spine, and of the lower and upper limbs can be
performed with the table in both a horizontal and vertical position.
Cervical spine
Hysterosalpingography
The possibility of moving the X-ray tube and DR detector group towards the
front end (or the back end) of the table, allows the operator to easily execute
any radioscopic examinations and radiographs of the uterine cavity and
fallopian tube.
kV AEC mAs
Oesophagus 75-85 x
Stomach 90 x
Small intestine 85-95 x
Colon 100 x
Skull 70 x
Femur 70 16
Shoulder 65 x
Shoulder ar- 65 16
thrography
Cervical spine 65 x
Abdomen 80 x
Lumbar spine 80 x
Hand 50 2.5
Wrist 50 3
Wrist arthrogra- 50 4
phy
Chest 117 x
Intravenous Pye- 75 x
logram (IVP)
Hysterosalpin- 85 x
gography
kV ABS FPS
Oesophagus 75-85 x 5-10
Stomach 85-95 x 5-10
Small intestine 85-95 x 5
Colon 90-110 x 5
Shoulder ar- 65-70 x 5
thrography
Wrist arthrogra- 50-55 x 5
phy
Hysterosalpin- 75-90 x 5
gography
1. When a new patient comes in, define the patient info for the exam.
2. Start the exam.
2
3 1 4
3
4 0392C EN 20210309 1049
162 | DR 800 | Full Leg Full Spine
2
3
3
1 4
4 1
3
3
2
1. Patient orientation
2. Mounting unit
3. Tabeltop guides
4. FLFS overlay
Figure 126: FLFS overlay on radiographic table (head left, head right)
3. Use the positioning console to move the X-ray system to the automatic
position.
The X-Ray system moves to the default position for preparing the DR Full
Leg Full Spine examination.
If the radiographic table is tilted to vertical position, assure that the FLFS
overlay remains flat against the tabletop.
CAUTION:
After doing vertical FLFS exposures the grid can swing away
from the table and disturb the patient. Set the inclination of
the table to 89 instead of 90 degrees.
1. Position the patient on the radiographic table relative to the FLFS overlay
and make sure that the region of interest for the planned examination is
within the range of the overlay.
WARNING:
Monitor with special care the patient position (hands, feet,
fingers, etc.) to avoid injury to patient caused by unit
movements. Patient hands must be kept away from mobile
components of the X-Ray device.
WARNING:
Intravenous tubing, catheters and other patient connected
lines should be routed away from moving equipment.
WARNING:
Use always the hand grips to avoid injuries in patient hands
or fingers when the tabletop is in movement. Patient's hands
must be kept far away from the tabletop edges in every
moment.
2. Move the tabletop longitudinally and make sure that the region of interest
is within the travel area of the DR bucky.
3. On the collimator, switch on the light localizer.
If required, collimate in transversal direction.
Instruction: For automatic stitching, the width of the
collimated area must be more than 15 cm.
Verify the position on the image from the collimator camera that is
displayed in the software console.
Figure 128: Setting the top most position for the examination
5. Press the ROI 1 button to confirm the position.
6. Move the X-ray tube and DR detector to the position that matches the
bottom most position for the examination.
Figure 130: Setting the bottom most position for the examination
7. Press the ROI 2 button to confirm the position.
To adjust the positions, press the waste bin icon and repeat the
positioning.
8. Enter the value for the distance by using the up and down arrows at the
touch screen console.
Distance/OID: if the image is used for making length measurements in NX
or on true size printed images, estimate the distance between the FLFS
overlay and the horizontal plane in which measurements are to be made.
This distance is used for calibrating distance measurements on the image
in NX. If no calibration is required, leave the default value.
9. Confirm the positioning.
Use the positioning console to move the X-ray system to the automatic
position.
The X-Ray system moves to the starting position for the examination.
1. Check if the settings for patient size that are displayed on the console are
suitable for the examination.
1. Partial images
2. Confirmation button
Figure 133: Edit exposure settings for partial images
b) Select the partial image for which settings must be changed.
c) Modify the settings.
d) Confirm the settings.
Press the exposure button to execute the examination. Hold the exposure
button pressed until three beeps are heard from the NX Workstation to
indicate that the examination has finished.
Depending on the configuration, the system will perform the series of
exposures starting at the top most position or at the bottom most position.
Together with the auditory signal, messages are displayed on the software
console and on the X-Ray system control panel to indicate that the
examination has finished.
The partial images are sent to the NX workstation.
WARNING:
During exposure ionizing radiation is emitted by the X-ray
system. To indicate the presence of ionizing radiation, the
radiation indicator on the control console lights up.
Button Parameter
Button Parameter
CAUTION:
Patient movement can cause inaccurate alignment of the partial
images. Patient movement is not always detected by the system.
The user is responsible for observation of the movement of the
patient during the examination.
To perform quality control:
Hang the FLFS overlay on the hook on the wall or on a flat surface.
When the overlay stays askew at a wall or is not fully supported on a table, the
overlay will be bent after some time. A bent overlay cannot be used anymore
due to possible distortions in the resulting image.
Click Grid.
The anatomical structure in the partial images may not be aligned, due to
patient movement during the examination.
The values of the horizontal and vertical correction are set to zero. Next to
the stitching areas the following label is displayed.
0.0
-0.1
Click Anatomic.
0.0
-0.1
Adjusting the posi- Right click-hold the image and drag the mouse
tion of the lower im- arrow to any direction.
age
Press the SHIFT or CTRL button while dragging
the mouse arrow to adjust the vertical or horizon-
tal alignment only.
Use the arrow keys on the keyboard.
Click the arrow buttons on the screen.
Roaming over the Left click-hold the image and drag the mouse ar-
images row to any direction.
Zooming in/out on Use the scroll wheel on the mouse.
the images
0.0
-0.1
Click Accept.
The DR Full Leg Full Spine image is available in the examination.
Depending on the configuration settings, the stitching parameters are
added to the image as a text annotation.
Note: After saving, the DR Full Leg Full Spine image cannot be
adjusted. The same set of partial images can be used to create
another DR Full Leg Full Spine image.
Making measurements
Distance measurements on DR Full Leg Full Spine images in NX are calibrated
based on the Estimated Radiographic Magnification Factor. The calibration
factor is calculated based on:
1. the distance between the patient and the stitching grid. This distance is
entered during the acquisition workflow.
2. the Source Image Distance (SID). This distance is received together with
the X-Ray generator parameters.
Note: If the distance between the patient and the stitching grid is
not entered (or entered as zero), no calibration is applied on NX.
Measurements on the DR Full Leg Full Spine image are based on the
projection of the object on the stitching grid.
2 3
1 5 6 7 4
8 9
10
1. X-ray tube
2. Patient location
3. Stitching grid
4. DR Detector
5. Distance to be measured on the object, in a plane parallel to the stitching
grid
6. Projection of the object on the stitching grid. This is the measured distance
on the DR Full Leg Full Spine image on NX if no calibration is applied.
7. Projection of the object on the DR Detector. This is the measured distance
on a partial image on NX.
8. Distance between the plane in which the measurement is made and the
stitching grid. This distance is estimated by the user and entered at the
touch screen console while preparing the examination.
9. Distance between the stitching grid and the DR Detector. This distance is
configured during installation of the system.
10. Source image distance (SID). This distance is received together with the X-
Ray generator parameters.
Figure 147: Making measurements on DR Full Leg Full Spine images
Software Console
Table 18: Navigation
Examination overview
Positioning controls
System messages
Topics:
• Examination overview
• Generator controls for static image, rapid sequence or DSA
• Generator controls for fluoroscopy or roadmapping
• X-ray modality controls
• Positioning controls
• Controls for digital tomosynthesis
• System messages
Examination overview
In the examination overview the most important parameters are displayed. To
display more detailed parameters or to modify the parameters, navigate to the
screens with detailed controls by pushing the navigation buttons or the
corresponding area on the examination overview screen.
1
2 3
4 5
8
10
10. Messages
Figure 148: Examination overview screen
Related Links
Generator controls for static image, rapid sequence or DSA on page 204
Generator controls for fluoroscopy or roadmapping on page 219
Positioning controls on page 229
Topics:
2 3 4 5 6 7
1. Ready for exposure status
2. Modality position
3. DR detector switch
4. Filter status
5. Grid status
6. Heat units
7. Radiation status
Figure 149: X-ray modality status frame
Related Links
X-ray modality controls on page 228
Color Description
Green
Exposure ready. Indicates that the selected technique is properly set
and there are no interlock failures or system faults.
Red
Exposure not ready.
Check the message frame for more information. It is not possible to
perform an exposure due to an error.
The status will turn to green when problem is solved.
Blue
Exposure not ready.
No examination defined.
Modality Position
The modality position is automatically selected, based on the selected
exposure.
To modify the position on the modality where the exposure will be made,
navigate to the X-ray modality controls screen and select the modality
position.
Icon Description
DR detector switch
The DR detector switch is available in the X-ray modality 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
Battery status icon
DR detec-
tor status ?
icon
(blinking)
The Offset Calibration button reminds the user to manually trigger the offset
calibration in case the system cannot perform the offset calibration
automatically.
It is required to manually trigger the offset calibration, in order to prevent
image artifacts caused by delayed offset calibration.
Unknown status
If a status is unknown, a question mark icon is displayed:
?
Figure 152: Unknown status
Filter Status
On systems with automatic filtering, the filter is automatically set, based on
the selected exposure.
The filter setting can be modified on the software console.
Grid Status
Table 23: Grid status - removable grid
A grid is required.
Heat Units
The status of the heat units is displayed below the X-ray icon.
During exposures, the heat units are calculated and totalled. The heat units
display shows the percentage of the thermal capacity of the X-ray tube that is
used. For example, a display of “HU 0” would indicate that all the heat units
capacity of the X-ray tube remains. A display of "HU 100" would indicate that
maximum heat capacity of the X-ray tube is reached and no exposures can be
made until the tube has cooled down.
Radiation status
Table 25: Radiation status
Icon Description
This icon indicates that there is no specific radiation status to be re-
ported. By touching the icon, the exposure controls of the system are
disabled, regardless of the ready for exposure status.
The exposure controls of the system are disabled. No exposure can
be made. When this status is active, the X-ray modality status frame
is highlighted with a hatch pattern. Touch the icon to release the ex-
posure controls.
The exposure button is pressed halfway and the X-ray tube is pre-
pared.
Press the exposure button halfway (“Prep” position) to prepare the X-ray tube
for exposure. The indicator will light up when the X-ray tube is prepared and
there are no interlock failures or system faults.
After pressing the exposure button, the following functions are activated:
• Anode rotation.
• Filament current switches from stand-by to the selected mA.
DAP Value
The DAP value shows the radiation value of the last exposure. The radiation
measure is read as DAP value (Dose Area Product) in cGy*cm2 (for example:
DAP 12.22).
A new exposure resets the DAP value.
Fluo timer
The fluo timer displays the total duration up till now of all fluoroscopy
sequences in this examination.
7
1. Imaging mode
2. Patient age group
3. Radiographic working mode
4. Sensor area
5. Radiographic parameters
6. Automatic exposure control
7. Maximum rapid sequence time
Figure 154: Generator controls (example for rapid sequence)
To change a value, use the + and - buttons. The values increase or decrease
step by step each time the corresponding button is pushed. To change a value
without repeatedly pushing the buttons, push the value twice. The buttons
change into arrow up and arrow down buttons. Push and hold the button to
change the value.
After exposure all values reflect the settings actually used by the generator.
Topics:
• Sensor area
• Radiographic Parameters
• Focal Spot Indicator
• Automatic Exposure Control (AEC)
• AEC field selection
• Dose
• Density
• Patient Size
• AEC dose failure
DSA mode
Pressing the exposure button or radiography pedal will trig-
ger a DSA examination, lasting until the button is released.
DSA mode uses the same radiographic parameters as rapid
sequence mode.
Adult
Pediatric
Related Links
Dose on page 214
Sensor area
When in rapid sequence mode or in fluoroscopy mode, a smaller active area
on the DR detector can be selected to get better image resolution or more
frames per second.
Different sets of sensor area sizes are available for fluoroscopy and for rapid
sequence mode. When you select a sensor area for fluoroscopy mode, an equal
or larger sensor area is automatically activated for rapid sequence mode. The
collimation is automatically adjusted to match the smallest sensor area and
applies to both modes.
mAs mA,ms
Related Links
Dynamic imaging modes on page 293
Radiographic Parameters
You can set up following radiographic parameters:
• kV: shows the radiographic kV value (X-ray tube voltage) selected for the
exposure.
• mAs: shows the radiographic mAs value selected for the exposure.
• mA: shows the radiographic mA value (current) selected for the exposure.
• ms: shows the time value (in milliseconds) selected for the exposure.
• Max ms: shows the integration time of the DR detector. When operating
the DR detector, the calculated exposure time (ms) or manual overrides
can never exceed the integration time (detector ms) of the DR detector.
• Max mAs: shows the maximum allowed mAs value for exposures using
AEC. The highest allowed setting for max mAs depends on the mA setting
and the detector ms setting. Only available in AEC mode.
When an exposure is made, the actual exposure parameters are displayed in a
message.
When using AEC, the exposure is terminated by the detector ms or max mAs
settings or by the AEC dose failure safety device, even if the target dose is not
reached.
Related Links
System messages on page 239
Automatic Exposure Control (AEC) on page 212
AEC dose failure on page 218
Small
Large
You can change the focal spot by touching this indicator. It keeps kV and
constant mAs, whenever it is possible. The mA value available is set according
to maximum power, instantaneous power, space charge, etc.
When a focal spot is selected, it sets the highest mA value available for the
selected focal spot and the respective exposure time in order to keep constant
mAs, whenever the mA value does not exceed the maximum tube power and
the exposure time value does not exceed the maximum integration time of the
DR detector or the maximum exposure time of the generator.
mAs mA,ms
To deactivate AEC mode, select the two point or three point radiographic
working mode.
mAs mA,ms
Figure 157: Buttons to select two point or three point radiographic working
mode
Left field
Middle field
Right field
Dose
Each of these buttons allows adjustment of the AEC cut-off dose (low dose,
middle dose and high dose), depending on configuration at installation time
and on the selected patient age group. Each time a button is selected
(highlighted), the others are automatically deselected.
Dose
low dose
middle dose
high dose
Related Links
Patient age group on page 207
Density
These buttons are used to adjust the AEC cut-off dose (and patient entrance
dose accordingly).
Density can be increased and decreased in a range of -4 to +4, representing a
change of -50% to +100% in dose. When disabled, the density range number
appears in black.
Dose
(D)
-4 0.50
-3 0.63
-2 0.75
-1 0.88
0 1 (reference dose)
+1 1.25
+2 1.50
+3 1.75
+4 2.00
Patient Size
The size of the patient is classified in five categories: Extra Small, Small,
Medium, Large and Extra Large.
Touch the UP or DOWN arrows to select the desired patient size.
Patient size kV
Extra Small normal kV * 0.9
Medium normal kV
To change a value, use the + and - buttons. The values increase or decrease
step by step each time the corresponding button is pushed. To change a value
without repeatedly pushing the buttons, push the value twice. The buttons
change into arrow up and arrow down buttons. Push and hold the button to
change the value.
Topics:
Pulsed fluoroscopy
Pressing the fluoroscopy pedal will trigger a fluoroscopy ex-
amination, lasting until the button is released.
Continuous fluoroscopy
Pressing the fluoroscopy pedal will trigger a fluoroscopy ex-
amination, lasting until the button is released.
Roadmapping
Pressing the fluoroscopy pedal will start fluoroscopy expo-
sure for generating the roadmapping mask
Roadmapping mode uses the same radiographic parameters
as pulsed fluoroscopy mode.
WARNING:
Unsharpness of moving objects when using continuous
fluoroscopy can occur. Sharpness of moving objects can be
improved by switching to pulsed fluoroscopy.
Related Links
Radiography imaging modes on page 206
Adult
Pediatric
Related Links
Dose on page 214
Sensor area
When in rapid sequence mode or in fluoroscopy mode, a smaller active area
on the DR detector can be selected to get better image resolution or more
frames per second.
Different sets of sensor area sizes are available for fluoroscopy and for rapid
sequence mode. When you select a sensor area for fluoroscopy mode, an equal
or larger sensor area is automatically activated for rapid sequence mode. The
collimation is automatically adjusted to match the smallest sensor area and
applies to both modes.
mAs mA,ms
Related Links
Dynamic imaging modes on page 293
OFF ON
OFF ON
Topics:
• Lock brightness
• Brightness curve
• Region of interest
• Dose
• Fluoroscopy boost
Lock brightness
Table 37: Lock brightness
Brightness curve
The X-ray generator can be configured with a set of different curves to control
the exposure parameters when ABS is active.
To select another curve from the list of configured curves, use the + and -
buttons.
Region of interest
To optimize the image quality of the anatomatically relevant region in the
image, the automatic brightness system can be applied to a smaller region in
the center of the image. Only the brightness of the region of interest is taken
into account to control the exposure parameters.
To select another region of interest from the list of configured sizes, use the +
and - buttons. The size of the region of interest is displayed in cm.
Dose
Each of these buttons allows adjustment of the ABS dose (depending on
configuration at installation time). Each time a button is selected
(highlighted), the others are automatically deselected.
Dose
low dose
high dose
Fluoroscopy boost
To temporarily increase the dose while performing a fluoroscopy sequence,
push the BOOST button. To return to the normal level, push the button again.
Collimator camera
The collimator has a built-in camera to visualize the anatomical region of
interest on the software console while adjusting the patient position remotely.
To hide the camera image on the software console, push the image. To display
the camera image, push the camera icon.
3
4
5
Related Links
Modality Position on page 192
DR detector switch on page 35
Filter Status on page 197
Grid Status on page 198
Offset calibration on page 81
Positioning controls
1
1. Automatic position
2. Actual and target position parameters
3. Collimation controls
4. Wireless console status
Figure 166: Positioning controls
Topics:
• Automatic position
• Actual and target position parameters
• Collimation controls
• Wireless console status
Automatic position
Table 40: Automatic position
Table height
Collimation controls
Table 42: Collimation controls
Single collimation.
A The collimation is automatically adjusted to match the selected
sensor area. The same collimation is used for fluoroscopy as for
static images and rapid sequences.
The actual collimation setting is displayed on the software console.
Previewing Collimation
After acquisition of a dynamic image, collimator adjustments can be
previewed on the acquired image.
repositioning the patient. Collimation borders that exceed the frame size
of the dynamic image are drawn orange.
1
4
Topics:
Reconstruction parameters
Table 45: Reconstruction parameters
System messages
System messages are displayed at the bottom of the software console.
The color of the message indicates the importance:
Blue Information
Yellow Warning
Orange Error
Messages that require feedback from the user contain a button that can be
pressed.
More than one message can be active. The number of active messages and the
type of messages is indicated on the navigation button.
The system messages screen lists all messages since the last startup of the
software.
Topics:
1
1
1. Footrest
1 guides
1
4. Turn and press the knobs on both sides to release the locks.
5. Make the footrest slide by keeping the knobs pressed until the footrest is
3
almost completely inserted in the guides.
2 3 1
2 1
3
1
2
1. Footrest guides
2. Turning the1 knob
3. Pressing the knob 1
6. Release the knobs and make the footrest slide some cm more until you can
3hear the click 1of the locking device of the footrest.
3 2
1
2
3
1. Footrest guides
2. Footrest locking device
3. Lock positions on the table
7. Make sure that the footrest is firmly secured to the guides by bearing down
and pressing on the longitudinal direction onwards and backwards.
WARNING:
Make sure the footrest is correctly assembled on guides using
the locks. If this is not the case, it could come loose and cause
injuries to persons and objects during machine tilting or
movement.
WARNING:
Do not execute any adjustment of the footrest when the table is
in the vertical position: you would take the risk to make the
patient fall or hurt your feet.
Weight 6 kg
Topics:
1. Turn and press the knobs on both sides to release the locks.
2. Push the footrest some centimetres onwards.
3. Release the knobs and make the footrest slide some cm more until you can
hear the click of the locking device of the footrest.
4. Make sure that the footrest is firmly secured to the guides by bearing down
and pressing on the longitudinal direction onwards and backwards.
1
2
2
1. Inserting the shoulder rest
2. Fastening the shoulder rest
1 2
4
3 5
1
2
1. Inserting the lower limbs support
2. Fastening the lower limbs support
Mounting of ankle support and head contention device are done in the same
manner as for the lower limbs support.
1 2 3
1. Clamp for side rails of the radioagraphic table
2. Knob for loosening or fastening the rotation of the lateral arm rest
3. Knob for loosening or fastening the clamp on the side rails of the
radiographic table
a) Loosen the round knob while supporting the lateral arm rest with your
other hand.
b) Place the lateral arm rest in the required position.
c) Fix the position by turning the round knob thoroughly clockwise.
WARNING:
This adjustment should always be made with one hand
acting on the knob and the other hand holding the rod. The
rod has no mechanical stops, if not restrained, it may collide
with nearby objects or people.
7. After usage, remove the lateral arm rest from the radiographic table.
Loosen the knob of the clamp by turning it counter-clockwise and slide the
lateral arm rest off the side rail of the tabletop.
WARNING:
Hold the accessory firmly to prevent it from falling.
1. Insert the lateral arm rest in the mounting slot at the top of the bucky
frame.
2. Turn the knob clockwise to lock the lateral arm rest.
a) Hold the detector holder with one hand and loosen with the other
hand the knob that secures the arm.
WARNING:
The arm is not equipped with mechanical stops. If it no
held manually, it may cause the detector holder to fall
onto the tabletop.
b) Position the detector holder at the desired height.
c) Secure the position of the arm by turning the knob thoroughly
clockwise.
4. Mount the detector (or cassette) in the detector holder.
c) Insert the detector and close the clamps, making sure it is properly
secured and supported.
d) Fasten the clamps by turning the two knobs thoroughly clockwise.
Related Links
Mounting the lower limbs support, ankle support or head contention device on
page 250
WARNING:
In order to ensure proper hygienic conditions the medical staff
must make sure the parts of the device that come into contact
with the patient (such as examination tabletop, tabletop and
stretcher cushions) are protected using biocompatible material
sheet.
1
3 1
2
3
1
2
1. Special hand grips
3 2. 1
Support for the contention structure
3. Hooks for attaching the support to the hand grips
1
4.2 Tighten the belts, on both sides, keeping the support in the middle and
tighten3the safety buckles.
1. Belt
2. Safety buckle
5. Ensure it is firmly fastened, lifting the support a few centimetres from the
tabletop surface.
6. Insert the contention structure in the support, fitting the groove on the
end octagon in the support.
21
2 1
1
3
1 2
1
1. Support for
1 the contention structure
2 ocatagonal contention structure
2. Groove on the outside of the
3. Steel cable attaching the contention structure to the support
8. Ensure that the cable has enough friction to prevent it from coming out
spontaneously, otherwise the metal cable must be replaced.
2 2
WARNING:
16kg is the maximum weight allowed on the paediatric cradle
for small patients.
1
1. Footrest
2. Base of the cradle
5. Place the tabletop in vertical position.
WARNING:
Do no step on the footswitch top cover.
WARNING:
Store the wireless pedal, when not in use, in a safe area that
excludes the risk of accidental activation. Do not take the device
out of the examination room.
Related Links
Exposure Controls on page 28
Problem solving
Topics:
Brief Solution Follow the instructions in the DR System Key User Man-
ual to calibrate the DR Detector:
• DX-D DR Detector Calibration Key User Manual,
document 0134
Brief Solution Turn the power switch on the DR 800 sync cabinet off and on
again.
Brief Solution Manually adjust the DR Full Leg Full Spine image.
If the partial images cannot be manually adjusted, click
Cancel in the Stitching pane. No DR Full Leg Full Spine
image is available.
Stitching fails
Table 49: Problem: Stitching fails
Cause The stiching grid was not used for the examination.
Brief Solution Click Cancel in the Stitching pane. No DR Full Leg Full
Spine image is available.
Details The DR Full Leg Full Spine examination is aborted before it has
completely finished.
Cause The exposure button is released by the user before the complete
examination has finished.
Brief Sol- If you release the exposure button by accident, you can press it
ution again to continue the examination.
If the exposure button remains released for more than 2 seconds,
the examination is aborted. You can use the available partial im-
ages to create a DR Full Leg Full Spine image.
Product Information
Topics:
• Compatibility
• Compliance
• Equipment Classification
• Patient data security
• Product Complaints
• Environmental protection
• System Documentation
• Training
• Performance
• Technical Data
• Remarks for HF-emission and immunity (radiographic table)
• Remarks for HF-emission and immunity (radiographic wall stand)
• Remarks for HF-emission and immunity (radiographic wall stand bucky
with moving grid)
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
Topics:
• General
• Safety
• X-Ray Safety
• Electromagnetic Compatibility
• Earthquake resistance
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
Directive93/42/EEC on Medical Devices).
• IEC 62366
Safety
• IEC 60601-1
• IEC 60601-1-6
X-Ray Safety
• IEC 60601-2-54
• IEC 60601‐1‐3
Electromagnetic Compatibility
• IEC 60601-1-2
Earthquake resistance
Earthquake resistance is available on system configurations containing the
earthquake kit.
Equipment Classification
Per EN/IEC60601-1, Medical Electrical Equipment, General Requirements for
Safety 3rd Edition, this device is classified as following:
Topics:
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. The tabletop is the applied part of this system.
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
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.
System Documentation
The documentation shall be kept with the system for easy reference.
The most extensive configuration is described within this manual, including
the maximum number of options and accessories. Not every function, option
or accessory described may have been purchased or licensed on a particular
piece of equipment.
Technical documentation is available in the product service documentation
which is available from your local support organization.
The most recent version of this document is available on http://
www.agfahealthcare.com/global/en/library/index.jsp
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 representative can provide further information on training.
The user must note the following information in the system documentation:
• System overview
• Radiation protection
• Safety directions
• Application examples
Performance
Note: For specific information on performance with regard to
particular digitizers, refer to the respective digitizer (system)
User Manuals.
The composite, stitched image which results from the image stitching process
of the Full Leg Full Spine application is compressed. Furthermore, technical
acquisition factors vary greatly with Full Leg Full Spine imaging; for example,
a Full Leg Full Spine image may be intentionally acquired with low dose or no
anti-scatter grid to reduce exposure to a pediatric patient.
The resulting image quality is generally suboptimal for most skeletal studies
when compared to normal computed radiographic techniques.
The composite, stitched image is created to allow accurate softcopy
measurement of distances and angles by qualified medical practitioners.
WARNING:
Any incidental clinical findings that are seen on the original or
stitched images, beyond the scope of measurements of angles
and distances between skeletal entities, should be verified or
further evaluated by additional diagnostic methods.
Technical Data
Topics:
Type 6010/200
Electrical connection
Weight
Environmental conditions
Radiographic table
Type 6010/050
Manufacturer Agfa NV
Septestraat 27
2640 Mortsel, Belgium
Dimensions
Tabletop height between 50 cm and 100 cm
Tabletop dimensions 240 cm x 80 cm (long tabletop)
210 cm x 80 cm (short tabletop)
Distance between the tab- 78 mm (concave surface)
letop surface and the de-
tector 95 mm (flat surface)
Movement
Tilting range between -90° and +90°
Supported model
Pixium RF4343 FL
Warming-up time
270 minutes
Reliability
Pixel Matrix
Topics:
Pixium RF4343 FL
Maximum altitude
minimum maximum
43 cm x 43 cm sensor area
43 cm x 43 cm sensor area
Frame rate 20 10 5
43 cm x 43 cm sensor area
Wireless console
Type 6010/050
Manufacturer Agfa NV
Septestraat 27
2640 Mortsel, Belgium
Electrical connection
Weight 9.5 kg
(tilting bucky)
(tilting bucky)
Movement controls Manual movement, balanced by counter-
weights and with mechanical brakes.
Weight 130 kg (vertical bucky)
190 kg (tilting bucky)
Wall stand X-ray absorption 0.6 mm Al eq.
Anti-scatter grids 180 cm (71 inch), 79 lines/cm (200 lines/
inch), 12:1
180 cm (71 inch), 35 lines/cm (90 lines/
inch), 12:1
Ceiling suspension
Model MSP150
Manufacturer GENERAL MEDICAL MERATE S.p.A.
Via Partigiani, 25 - 24068 - Seriate (BG) -
ITALY
Dimensions
Longitudinal rails 440 cm
Transversal rails 300 cm
Weight ~270 kg
Movement
Manufacturer Ralco
Via dei Tigli 13/G
20853 Biassono (MB), Italy
Weight 9.4 kg
IEC 62368-1
NX software must only be used on PC models that have been tested and
released by Agfa.
Equivalent filtration
Equivalent filtration at 75 kV.
FFD
115/180 cm
DOSIMETER
20 cm
PMMA
20 cm
The measured values have been recalculated by relating them to the patient
entrance reference point (30 cm above patient support).
The values thus obtained have been then compared with those measured by
the system in the same operating conditions.
The variance between the values measured by the system and the values
obtained with the test is included within the limit range defined by the
standard.
Upon customer request the company can provide further dosimetric
ADDED FILTERS
information referred to specific
0Al and1Alpeculiar
- 0,1 Cu work techniques.
1Al - 0,2 Cu 2 Al
Ak rate Ak rate Ak rate Ak rate
RADIOSCOPY (*) Dose level kV mA mGy/min kV mA mGy/min kV mA mGy/min kV mA mGy/min
The
maximumfollowing
field size Level table
1 summarizes
58 1,5 7,89 doses
61 1,7 expressed
3,21 62 1,8 as Air
2,10 kerma
59 1,6 rate
4,44(Ak rate,
zoom 20x20 Level 1 67 2,3 15,54 70 2,6 6,91 71 2,7 4,93 69 2,5 9,62
mGy
maximum /fieldmin)
size or2Air kerma
Level 62 1,8 (AK
11,59 mGy)
65 2,1considering
4,98 66 a set3,29of typical
2,2 64 2,0 modes
6,91 of
zoom 20x20 Level 2 73 3,0 24,67 75 3,3 11,22 77 2,8 8,16 74 3,1 14,80
operation.
maximum field size Level 3 68 2,4 17,32 67 2,3 7,67 72 2,8 5,55 69 2,5 10,69
zoom 20x20 Level 3 73 3,0 37,00 79 3,8 18,13 85 4,2 13,44 81 4,0 23,68
ADDED FILTERS
0Al 1Al - 0,1 Cu 1Al - 0,2 Cu 2 Al
Ak rate Ak rate Ak rate Ak rate
RADIOSCOPY (*) Dose level kV mA mGy/min kV mA mGy/min kV mA mGy/min kV mA mGy/min
maximum field size Level 1 58 1,5 7,89 61 1,7 3,21 62 1,8 2,10 59 1,6 4,44
zoom 20x20 Level 1 67 2,3 15,54 70 2,6 6,91 71 2,7 4,93 69 2,5 9,62
maximum field size Level 2 62 1,8 11,59 65 2,1 4,98 66 2,2 3,29 64 2,0 6,91
zoom 20x20 Level 2 73 3,0 24,67 75 3,3 11,22 77 2,8 8,16 74 3,1 14,80
maximum field size Level 3 68 2,4 17,32 67 2,3 7,67 72 2,8 5,55 69 2,5 10,69
zoom 20x20 Level 3 73 3,0 37,00 79 3,8 18,13 85 4,2 13,44 81 4,0 23,68
ADDED FILTERS
0Al 1Al - 0,1 Cu 1Al - 0,2 Cu 2 Al
PULSED
RADIOSCOPY Ak rate Ak rate Ak rate Ak rate
4 frame/sec (*) Dose level kV mA mGy/min kV mA mGy/min kV mA mGy/min kV mA mGy/min
maximum field size Level 1 49 37,7 10,44 53 38,9 3,74 55 39,5 1,88 51 38,3 4,15
zoom 20x20 Level 1 56 40,0 16,06 60 41,0 5,24 63 42,4 3,49 59 40,7 7,61
maximum field size Level 2 54 39,2 12,34 58 40,4 4,88 60 41,0 3,37 56 39,8 5,82
zoom 20x20 Level 2 63 43,1 20,11 67 45,2 8,04 69 47,3 5,24 66 44,5 11,00
maximum field size Level 3 60 41,0 18,92 64 43,8 4,98 66 45,2 3,57 62 42,4 7,10
zoom 20x20 Level 3 71 48,8 28,34 75 50,0 ADDED FILTERS
8,21 78 50,8 5,42 73 49,2 11,19
0Al 1Al - 0,1 Cu 1Al - 0,2 Cu 2 Al
PULSED
RADIOGRAPHY FFD 115 cm (**)
RADIOSCOPY Ak rate Ak rate Ak rate Ak rate
4 frame/sec (*) Dose level kV mA 0AlmGy/min kV mA mGy/min kV mA mGy/min 1AlkV- 0,2mA
Cu mGy/min
maximum field size Level 1 49 37,7 10,44 53 38,9 3,74 55 39,5 1,88 51 38,3 4,15
Collimation
zoom 20x20 Level 1 56 40,0 16,06 Ak 41,0
60 Collimation
5,24 63 42,4 3,49 59 40,7 Ak
7,61
cmsize
maximum field Level 2 kV 54 39,2mAs 12,34 mGy
58 40,4 4,88 cm 60 41,0 kV
3,37 56mAs39,8 mGy5,82
zoom 20x20
25x20 Level 2 45 63 43,1 5 20,11 67 45,2
0,255 8,0415x2069 47,3 5,24
40 663,2 44,5 11,00
0,009
maximum field size Level 3 60 41,0 18,92 64 43,8 4,98 66 45,2 3,57 62 42,4 7,10
30x20
zoom 20x20 Level 3 58 71 48,8 2 28,34 0,180
75 50,0 8,2115x1078 50,8 50
5,42 73 5 49,2 0,110
11,19
30x20 58 32 2,546 20x20 50 10 0,062
30x30 68 2 0,278 15x10 55 10 0,093
30x30 68 5,0 0,644 25x25 60 3,2 0,070
30x30 68 10 1,627 10x30 60 5 0,078
30x30 68 32,0 4,144 20x20 60 10 0,025
25x20 70 2,5 0,287 43x43 60 10 0,026
43x30 70 5 0,619 25x30 70 1,6 0,050
25x20 70 8 0,767 25x30 70 5 0,170
25x20 70 10 0,952 20x20 70 10 0,214
43x30 70 32 2,940 43x43 70 20 0,441
25x20 70 32 2,830 20x20 75 10 0,268
20x20 75 32 3,186 43x43 75 10 0,281
43x43 75 32 3,340 20x20 75 20 0,526
20x20 75 63 6,230 43x43 75 20 0,552
43x43 75 63 6,512 20x20 75 32 0,805
43x43 80 2 0,418 43x43 75 32 0,843
43x43 80 10 2,553 20x20 75 63 1,570
20x43 85 2,5 0,486 43x43 75 63 1,638
20x43 85 10 2,220 43x43 80 2 0,076
20x20 85 32 4,084 43x43 80 10 0,345
43x43 85 32 4,300 20x20 85 32 1,195
20x20 85 63 7,930 43x43 85 32 1,253
43x43 85 63 8,290 20x20 85 63 2,322
30x30 90 1 0,050 43x43 85 63 2,420
30x30 90 2 0,124 30x30 90 1 0,022
43x43 100 1,0 0,296 30x30 90 5 0,252
43x44 100 5,0 1,480 30x30 90 10 0,513
35x43 105 1 0,295 43x43 100 1 0,078
35x43 105 5 1,296 43x43 100 5 0,356
THRESHOLD AB-
SORBED DOSE
(Gy)
Organ/ Effect Short-term expo- Long-term
Tissue sure exposure
Single dose Yearly repea-
ted for many
years
Testicles Temporary sterility 0.15 0.4
3. Epidermal necrosis 25 -
4. Skin atrophy with 10-12 1
complications
Whole Acute radiation sickness 1.0 -
body (mild)
Mains supply
Topics:
• Radiographic table
• Ceiling suspension
• Radiographic wall stand
Radiographic table
All the equipments of any X-ray installation must be connected to the
electrical mains by means of a contact or another multi-polar sectioning
device that must be installed by the customer. The room of the installation
must be in compliance with the IEC/CEI or UL/CSA prescriptions in force
(where requested). The relative national regulations must be applied in all
countries. Nonetheless, compliance with the above- mentioned standards is
strongly recommended, when they do not contradict the national regulations
in force, to ensure safety for the operator, the patient and third parties.
WARNING:
To avoid risk of electric shock, this equipment must only be
connected to a grounded electrical network.
Ceiling suspension
The system is not supplied with any type of ON/OFF switch control or related
circuitry. It is required of the installer to complete this external circuit and
instruct the operators on its use and operation once installation is complete.
The stand should be incorporated into the examination room general
emergency shutdown system.
The equipment is factory set for using single-phase mains rated at 230 VAC
50/60 Hz with a maximum power consumption of 300 VA. The system is also
prepared to accept a load from the manual or automatic collimation system
with lamp ratings up to 150 W maximum.
The stand must be connected to a stable power source to obtain the
performances for which it is designed.
Located on the main electrical plate is power strip terminal [ST2]. This is
provided for aftermarket connection to various collimation systems. The
circuit feeds 24 VAC and is able to power various collimation systems,
including lamps, rated up to 150 watts. Verify that the collimation system or
accessory does not overdraw the current rating on the circuit.
The manufacturer reserves the right to make changes to T1, fuse type, and
ratings (for optimization, enhancements, and in accordance to government
regulations regarding components used in medical devices). For the latest
information regarding voltages and ratings, always refer to the electrical
schematics that come with the equipment.
All the power connections and earth cables must be in compliance with the
national rules related or equivalent.
Located on the electrical rack is an auxiliary output for compatible client
devices requiring 24 VDC. Check the electrical diagrams that come with the
unit for more information.
WARNING:
See the accompanying electrical schematics for the protection
devices foreseen on the secondary windings of the transformer.
Annex B
Guidance and manufacturer’s declaration – Electromagnetic immunity
The system is intended for use in the electromagnetic environment specified
below. The customer or the user of the system should assure that it is used in
such an environment.
Immunity Test IEC 60601-1-2 Compliance Electromagnetic
Test level level Environment
Discharge of stat- 8 kV contact IEC 60601-1-2 Floors should consist
ic electricity in ac- Test level of wood, concrete or
cordance with IEC 2/4/8/15 kV air ceramic tiles. The
61000-4-2 relative humidity
must be at least
Voltage dips, 0% Un for 0.5 cy- IEC 60601-1-2 Mains power quality
short interrup- cle Test level should be that of a
tions and voltage typical commercial
0% Un for 1 cycle
variations on or hospital environ-
power supply iput 70% Un for 25 ment. If the user of
lines in accord- cycles the system requires
ance with IEC continued operation
0% Un for 5 s
61000-4-11 during power mains
interruptions, it is
recommended that
the system be pow-
ered from an unin-
terruptible power
supply or a battery.
Annex B
Guidance and manufacturer’s declaration – Electromagnetic immunity
The system is intended for use in the electromagnetic environment specified
below. The customer or the user of the system should assure that it is used in
such an environment.
Immunity Test IEC 60601-1-2 Compliance Electromagnetic
Test level level Environment
Discharge of static 6 kV contact IEC 60601-1-2 Floors should con-
electricity in ac- Test level sist of wood, con-
cordance with IEC 8 kV air crete or ceramic
61000-4-2 tiles. The relative
humidity must be
Voltage dips, short 0% Un for 0.5 cy- IEC 60601-1-2 Mains power qual-
interruptions and cle Test level ity should be that
voltage variations of a typical com-
40% Un for 5 cy-
on power supply mercial or hospital
cles
iput lines in ac- environment. If
cordance with IEC 70% Un for 25 cy- the user of the sys-
61000-4-11 cles tem requires con-
tinued operation
0% Un for 5 s
during power
mains interrup-
tions, it is recom-
mended that the
system be pow-
ered from an unin-
terruptible power
supply or a bat-
tery.
Recommended separation
distance:
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.
• REMARK 1: At 80MHz and 800MHz, the separation distance for the
higher frequency range applies.
• REMARK 2: These Guidelines may not be relevant in all situations. The
dispersion of electromagnetic waves is influenced by absorption and re-
flections from buildings, objects and people.
Annex B
Guidance and manufacturer’s declaration – Electromagnetic immunity
The system is intended for use in the electromagnetic environment specified
below. The customer or the user of the system should assure that it is used in
such an environment.
Immunity Test IEC 60601-1-2 Compliance Electromagnetic
Test level level Environment
Discharge of static 6 kV contact IEC 60601-1-2 Floors should con-
electricity in ac- Test level sist of wood, con-
cordance with IEC 8 kV air crete or ceramic
61000-4-2 tiles. The relative
humidity must be
Voltage dips, short < 5% UT for 0.5 IEC 60601-1-2 Mains power qual-
interruptions and cycle Test level ity should be that
voltage variations of a typical com-
(> 95% voltage
on power supply mercial or hospi-
dip in UT
iput lines in ac- tal environment.
cordance with IEC 40% UT for 5 cy- If the user of the
61000-4-11 cles system requires
continued opera-
(60% voltage dip
tion during power
in UT
mains interrup-
70% UT for 25 cy- tions, it is recom-
cles mended that the
system be pow-
(30% voltage dip
ered from an un-
in UT
interruptible pow-
< 5% UT for 5 s er supply or a bat-
tery.
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.
• REMARK 1: At 80MHz and 800MHz, the separation distance for the
higher frequency range applies.
• REMARK 2: These Guidelines may not be relevant in all situations. The
dispersion of electromagnetic waves is influenced by absorption and re-
flections from buildings, objects and people.