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DR - 100e User Mnaual
DR - 100e User Mnaual
DR - 100e User Mnaual
6012/001
6012/002
6012/003
6012/004
User Manual
Contents
Legal Notice .......................................................................... 5
Getting started .......................................................................6
Introduction to this Manual ................................................... 7
Scope of this Manual ..................................................8
About the safety notices in this document .................. 9
System Documentation ............................................ 10
Disclaimer ................................................................11
Introduction ........................................................................ 12
Intended Use ........................................................... 13
Intended User .......................................................... 14
Configuration .......................................................... 15
Operation Controls .................................................. 17
NX Workstation (all-in-one PC) ....................20
NX Application on the NX Workstation .........21
DR Detector Switch ......................................22
Portable DR Detector ................................... 23
Circuit breaker .............................................24
X-ray generator control panel .......................25
Manual Collimator .......................................26
Exposure button ...........................................27
Infrared remote control ................................28
Connectors for the hospital network and for
registering a DR Detector ............................ 29
Led beacon light .......................................... 30
Messages ................................................................. 31
Sound signals .............................................. 32
Status messages ........................................... 32
Warning messages ....................................... 33
Error messages ............................................ 35
Labels ...................................................................... 37
General ........................................................38
Type label .................................................... 41
Labeling of the collimator ............................ 42
Installation .............................................................. 43
Labeling the DR Detectors ............................44
Equipotential earth connection .................... 45
Electrostatic discharge ................................. 46
Radiation Protection ................................................ 47
Monitoring of Personnel ...............................47
Cleaning and Disinfecting ........................................ 48
Cleaning ...................................................... 49
Disinfecting ................................................. 51
Disinfecting safety directions ....................... 52
Approved disinfectants ................................ 53
Patient data security ................................................ 54
Maintenance ............................................................55
Preventive maintenance schedule ................ 55
Training ...............................................................................57
Safety Directions ..................................................................58
Basic Workflow ....................................................................62
Starting the NX workstation and the DR Detector .....63
Retrieving the patient info ...................................... 64
Moving the unit ....................................................... 65
Starting the device ...................................................68
Positioning .............................................................. 69
Selecting the exposure ............................................. 71
Preparing the exposure ............................................ 72
Checking the exposure settings ................................ 73
On the NX application .................................. 74
On a DR Detector that has a status indicator ....
74
On the X-ray generator control panel ............74
On the control panel .................................... 74
Executing the exposure ............................................75
Using the wired exposure button ..................77
Using the remote control exposure button ....78
Performing a quality control .................................... 79
Stopping the device ................................................. 80
Using the NX workstation with the X-ray system switched
off ............................................................................81
Stopping the NX workstation and the DR Detector ... 82
Using the ‘virtual keyboard’ ..................................... 83
Restriction on the use of virtual keyboard software
..........................................................................84
Advanced Operation ............................................................ 85
Using a moving grid .................................................86
Using a DAP meter ................................................... 87
DAP value on the NX workstation .................87
Hanging a leaded apron ...........................................88
Making an exposure using a cassette ........................ 89
Setting the exposure parameters on the X-ray
generator control panel ................................89
Modifying the exposure parameters of an anatomic
program .................................................................. 92
Product Information ............................................................ 94
Options and Accessories ...........................................95
Compatibility ...........................................................95
Compliance ............................................................. 95
General ........................................................96
Safety .......................................................... 96
Electromagnetic Compatibility .....................96
Laser Safety ................................................. 96
Connectivity ............................................................ 97
Connecting DR 100e to a wired network ...... 97
Equipment Classification ......................................... 98
Legal Notice
0413
Published by Agfa NV
Getting started
Related Links
Intended Use on page 13
Operation Controls on page 17
Safety Directions on page 58
Basic Workflow on page 62
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.
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
Disclaimer
Agfa assumes no liability for use of this document if any unauthorized
changes to the content or format have been made.
Every care has been taken to ensure the accuracy of the information in this
document. However, Agfa assumes no responsibility or liability for errors,
inaccuracies or omissions that may appear in this document. To improve
reliability, function or design Agfa reserves the right to change the product
without further notice. This manual is provided without warranty of any kind,
implied or expressed, including, but not limited to, the implied warranties of
merchantability and fitness for a particular purpose.
Note: In the United States, Federal law restricts this device to sale
by or on the order of a physician.
Introduction
Topics:
• Intended Use
• Intended User
• Configuration
• Operation Controls
• Messages
• Labels
• Installation
• Radiation Protection
• Cleaning and Disinfecting
• Patient data security
• Maintenance
Intended Use
The DR 100e digital system is a mobile X-ray imaging system used in hospitals,
clinics and medical practices by physicists, radiographers and radiologists to
make, process and view static X-ray radiographic images of the skeleton
(including skull, spinal column and extremities), chest, abdomen and other
body parts on adult, pediatric or neonatal patients.
Applications can be performed with the patient in the sitting, standing or
lying position.
This device is not intended for mammography applications.
Intended User
This manual has been written for trained users of Agfa products and trained
diagnostic X–Ray clinical personnel who have received proper training.
Users are those persons who actually handle the equipment and those who
have authority over the equipment.
Before attempting to work with this equipment, the user must read,
understand, note and strictly observe all warnings, cautions and safety
markings on the equipment.
Configuration
DR 100e is an integrated mobile Digital Radiography X-Ray System.
Figure 1: DR 100e mobile X-Ray System with rotating column (type 6012/004
or 6012/002)
Figure 2: DR 100e mobile X-Ray System with fixed column (type 6012/003 or
6012/001)
Operation Controls
6
7
1
2 8
3
9
4
1. Exposure button
2. Circuit breaker and equipotential node
3. Power supply cable reel
4. Rotating column
5. Lock of the arm movement during transport
6. X-ray generator and X-ray tube assembly
7. Goniometer
8. Collimator
9. X-ray tube handle
1
2
3
4
5
6
7
8
1. Brake pedals
Topics:
1 2 34
1. Speaker volume
2. Display on/off
3. Display brightness
4. Power button
Figure 3: Control buttons
Figure 4: NX application
DR Detector Switch
The DR Detector Switch is available in the title bar of the NX application.
The DR Detector Switch shows which DR Detector is active and shows its
status. The DR Detector Switch can be used to activate another DR Detector.
DR Detector Status
(blinking) (blinking)
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.
Circuit breaker
15 6
14
13 7
12
11 10 9 8
1. Mains power indicator light.
The indicator lights up when the device is connected to the mains and
powered.
2. Turn the device on.
3. Control panel display for device status, X-ray parameters and messages.
4. The indicator lights up when the device is ready for exposure.
5. The indicator lights up when exposure is ongoing.
6. Reset the alarm.
Return to the upper menu.
7. Function buttons for selecting a line on the display.
8. Modify the exposure settings for mAs.
9. Modify the exposure settings for kV.
10. Switch to manual exposure mode and open the list of anatomical
programs.
Scroll down.
11. Activate remote control.
The indicator lights up when the remote control is enabled.
12. Small focus and large focus.
The indicator light shows the active setting.
13. Moving grid.
The indicator lights up when the signal for the moving grid is enabled.
14. Collimator light.
After pressing the button, the light field indicating the collimated area and
the laser light indicating the center position remain lit for a few seconds
before automatically switching off.
15. Turn the device off.
Manual Collimator
6
5 1
4 2
3
1. Longitudinal collimation
2. Button to switch on the light field indicating the collimated area and the
laser light indicating the center position.
After pressing the button, they remain lit for a few seconds before
automatically switching off.
3. Rails to insert a DAP meter or a filter.
4. Measurement tape to measure the distance between the focal spot of X-ray
tube and the tabletop.
The measurement tape is at the rear side of the collimator.
5. Transversal collimation
6. Filter selection.
Another button to switch on the light field is available on the X-ray generator
control panel.
Exposure button
1 2
3 1
4 2
The battery status indicator flashes once per second when the battery is near
the end of life and twice per second when the battery must be replaced.
The transmission indicator lights up when one of the two buttons is pressed.
1
2
1
2
Color Meaning
Green The wireless DR Detector and the X-ray generator are ready for mak-
ing an exposure.
Yellow X-ray radiation is ongoing.
Messages
Under certain conditions the system sounds a signal or shows a message on
the display.
Topics:
• Sound signals
• Status messages
• Warning messages
• Error messages
Sound signals
Signal Description
2 beeps Successful storage of exposure parameters in an ana-
tomic program.
3 beeps X-ray exposure finished successfully
1 long beep (1 sec) Alarm or malfunction
Status messages
Message Description Action
READY The device is ready to
perform an exposure
WAITING Preparation phase Wait for the message in-
dicating that the device
is ready.
MANUAL
DAP READY Dosimeter ready
Warning messages
Warning messages must be reset using the reset button in order to continue
working.
Error messages
Details on the contents of messages can be found in the service
documentation which is available to service personnel.
The device must be restarted in order to continue working.
Labels
Topics:
• General
• Type label
• Labeling of the collimator
General
Always take into account the markings and labels provided on the inside and
outside of the machine. A brief overview of these markings and labels and
their meaning is given below.
Figure 14: Position of the labels, illustrated on a system with rotating column
Figure 15: Position of labels specific for system with fixed column
A
Information label for the handlebar op-
eration.
B
Overcoming of obstacles.
C
Transport position.
D
Exposure hand switch
E
Circuit breaker on and off positions.
F
Equipotential connector.
G
Connector for moving grid.
H
Left pedal brake lock.
Right pedal brake lock.
X-ray tube rotation lock.
By turning the knob clockwise, the rota-
tion unlocks.
I
USB connector.
L
Wired network connector.
This connector is used to connect to the
hospital network.
Type label
X-ray system
Installation
Installation and configuration is performed by an Agfa trained and authorized
service engineer. Contact your local support organization for more
information.
Do not use the device in areas where there is a risk of fire.
Topics:
Electrostatic discharge
CAUTION:
Always resort to static procedures, protections and appropriate
products before opening or during the handling of the
equipment. This equipment includes electrostatically sensitive
components. Non-compliance with electrostatic discharge
procedures may cause damages to the components. Such
damages to the components are not covered by any warranty.
The electrostatic discharge can cause a remarkable voltage that could cause
damages to printed circuit boards or to other equipment components.
Electrostatic discharge damages can accumulate and can initially not be
visible, such as a hardware failure, but can reduce performances. Therefore, it
is recommended to use proper electrostatic discharge handling procedures.
Electrostatic discharge can be due to low humidity or to the use of electrical
equipment on carpets, bedding and clothes.
Radiation Protection
X-ray radiation can cause serious damage to the health, therefore observe
great care and ensure that protection against X-ray exposure is always applied.
Some of the effects of X-ray radiation are cumulative and may extend over a
period of time. Therefore the X-ray operator should avoid exposure by X-ray
radiation at all times.
Objects in the path of the X-ray beam may produce scattered radiation. The
intensity depends on the energy and intensity of the X-ray exposure and the
material of the object. Protective measures have to be taken to prevent
exposure through scattered radiation.
Protective measures include:
• structural configuration of the X-ray room (e.g. lead shielded rooms)
• radiation protection for the operators (e.g. personal radiation dosimeters,
lead aprons, keep maximum distance from X-ray source, regular training,
etc.)
• protection of patients against unnecessary radiation (e.g. limitation of X-
ray field by collimation, lead shielding, lead aprons, etc.)
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.
• Cleaning
• Disinfecting
• Disinfecting safety directions
• Approved disinfectants
Cleaning
To clean the exterior of the equipment:
Topics:
• Cleaning chromed parts
• Cleaning plastic surfaces
• Cleaning enemaled or aliminum parts
Disinfecting
To disinfect the device, use only disinfectants and disinfection methods that
are approved by Agfa and that correspond to the national regulation and
guidelines as well as explosion protection. If you plan to use other
disinfectants, approval of Agfa is needed before use, as most disinfectants can
damage the device. UV disinfection is also not allowed.
Perform the procedure following the instructions for use, the disposal
instructions and the safety instructions of the selected disinfectants and tools
and of the hospital.
Approved disinfectants
Refer to the Agfa website for specifications on the disinfectants that have been
found compatible with the cover material of the device and can be used on the
outer surface of the device.
http://www.agfahealthcare.com/global/en/library/overview.jsp?ID=41651138
Maintenance
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.
Check for lack of oil and unusual noises in high voltage generator.
Training
The user must have received adequate training on the safe and effective use of
the system before attempting to work with it. Training requirements may vary
from country to country. The user must make sure that training is received in
accordance with local laws or regulations that have the force of law. Your local
Agfa or dealer representative can provide further information on training.
The user must note the following information in the system documentation:
• Intended Use.
• Intended User.
• Safety Directions.
Safety Directions
WARNING:
Only qualified and authorized personnel shall operate this
system. In this context ‘qualified’ means those persons legally
permitted to operate this equipment in the jurisdiction in which
the equipment is being used, and ‘authorized’ means those
persons authorized by the authority controlling the use of the
equipment. Full use must be made of all radiation protection
features, devices, systems, procedures and accessories.
WARNING:
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:
Do not use the device for any application before correctly
performing all regular checks and updating the periodical
maintenance. If it is sure or probable that any part of the device
is defective or wrongly adjusted, don't use it before performing
all repairs. The use of a device with defective parts or adjusted
in a wrong way, can expose the user or the patient to ionizing
radiations or to other dangers concerning safety. This can cause
serious or mortal physical injuries, or wrong diagnosis or
therapies.
WARNING:
Do not use the device for any application before reading,
understanding and assimilating all information about safety,
safety and emergency procedures specified in the current
chapter about Safety. The use of the equipment without a proper
knowledge of safety rules can cause serious or mortal physical
injuries, or wrong diagnosis or therapies.
WARNING:
If you are not sure to be able to use this device in a safe and
efficient way, don't use it. The use of this device without proper
and adequate training can cause serious or mortal physical
injuries or wrong diagnosis or therapies.
WARNING:
Do not use the device with patients if there is no adequate
understanding of its capabilities and functions. Using the device
without an adequate knowledge of its functioning can
compromise the efficacy and/or reduce the safety of the patient,
the user and other people nearby.
WARNING:
This equipment must be used only in compliance with the safety
instructions specified in this User Manual and exclusively for
intended purposes. Do not use the device for purpose other than
those for which it is intended. Do not use the device with other
products than the ones whose compatibility has been recognized
by the Manufacturer. The use of the device for purposes other
than the ones expected or with an incompatible product, can
cause serious or mortal physical injuries or wrong diagnosis or
therapies.
WARNING:
The device should not be used adjacent to other equipment and
if adjacent use is necessary, the device should be observed to
verify normal operation in the configuration in which it will be
used.
WARNING:
If the device doesn't work as usual or shows symptoms of a fault,
even if no error messages are displayed, contact your local
service organization for assistance.
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:
To avoid electric shocks and burns caused by use of the wrong
type of fire extinguisher, make sure that the fire extinguisher at
the site has been approved for use on electrical fires.
WARNING:
Before trying to extinguish the fire, the safety measure to be
taken is to separate the equipment from other electric power
sources and from all other sources in order to reduce the risk of
electrical shock.
WARNING:
Never try to remove, modify, exclude or obstruct any safety
feature on the device. An intervention on safety features can
cause serious physical injuries or even death.
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:
Do not remove protections or cables from the device, unless it is
expressly required in this User Manual, because inside are
dangerous electrical voltages. The removal of protections or
cables can cause mortal injuries or serious damages to the
people.
WARNING:
The device includes moving parts. The removal of protections
can cause serious or mortal physical injuries to people.
WARNING:
Do not block the ventilation ports to prevent overheating.
Overheating can cause system malfunction and damages.
WARNING:
Always double check your exposure parameter settings prior to
exposing the patient.
CAUTION:
Avoid unnecessary dose by checking before exposure if the DR
Detector Switch displays the name of the DR Detector that is
being used and if the status of the DR Detector is ready for
exposure.
CAUTION:
Avoid unnecessary dose by checking before exposure if the
beacon light lights up green.
CAUTION:
Excessive ambient temperature may impact the performance
and cause permanent damage to the device. If ambient
temperature and humidity is outside the range of 10 - 40 °C and
30 - 75% RH, do not operate the system or use air conditioning.
Warranty will be void if it is obvious that operating conditions
are not met.
CAUTION:
Damaged grid. Reduced image quality. Please handle the grids
with special care.
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:
Strictly observe all warnings, cautions, notes and safety
markings within this document and on the product.
Basic Workflow
Topics:
1. Switch on the all-in-one PC by pressing and holding the power button for 2
seconds.
For detailed information about starting up NX, refer to the NX User
Manual, document 4420.
2. Power on the DR Detector.
a) Attach a fully charged battery pack to the DR Detector.
b) Turn on the DR Detector.
c) If needed, register the DR Detector to the DR 100e system.
For detailed information about powering on the DR Detector, refer to the
DR Detector user manual.
Related Links
Connectors for the hospital network and for registering a DR Detector on page 29
NX Workstation (all-in-one PC) on page 20
Note: If the patient cannot be retrieved from the RIS you should
enter patient data manually. In that case, you can use the ‘virtual
keyboard’.
Related Links
Connecting DR 100e to a wired network on page 97
The two arrows (A) on the foot of the column are aligned.
The lock (B) activates with a click. To assert that the arm is locked, turn
the knob with the arrow towards the red dot.
4. Put the X-ray tube (A) in vertical position on both rotation axes (B and C).
During the startup sequence, a sound signal is heard and the display and
indicator lights light up.
If a DAP meter is present, the status of the DAP meter is displayed.
If the DAP meter is not present or not working properly, an error message
is dispayed. To continue the startup, press the reset button. The DAP meter
is inactive.
While the device prepares, the busy status is displayed. It may take up to two
minutes for the ready status to appear.
Positioning
WARNING:
Monitor the patient position (hands, feet, fingers, etc.) with
special care to avoid injury to the patient caused by unit
movements. Patient hands must be kept away from mobile
components of the unit. Intravenous tubing, catheters and other
patient connected lines should be routed away from moving
equipment.
1. Pull and rotate the knob (A) with the arrow towards the green dot to
unlock the arm.
The collimator can be rotated on its vertical axis up to 120 degrees in each
direction. To rotate the collimator, grip it with both hands and rotate in
the desired direction.
Related Links
X-ray generator control panel on page 25
If there is a chance that the detector comes in contact with liquids (bodily
fluids, disinfectants,...), the DR Detector must be wrapped in a protective
plastic bag while performing the examination.
• If a filter is used, mount the filter to the collimator.
• If a grid is used, attach the grid to the detector.
2. Switch on the light localizer on the collimator. Adapt collimation if
required.
CAUTION:
Misalignment of the DR Detector and the X-ray tube causes
unnecessary exposure of the patient to radiation.
• On the NX application
• On a DR Detector that has a status indicator
• On the X-ray generator control panel
• On the control panel
On the NX application
1. Check if the DR Detector Switch displays the name of the DR Detector
that's being used
2. If a wrong DR Detector is displayed, select the right DR Detector by
clicking the drop down arrow on the DR Detector Switch.
Related Links
DR Detector Switch on page 22
Related Links
X-ray generator control panel on page 25
This indicates that the wireless DR Detector and the X-ray generator are
ready for making an exposure.
Related Links
Led beacon light on page 30
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.
CAUTION:
Do not select another thumbnail until the preview image is
visible in the active thumbnail. The acquired image may be
linked to the wrong exposure.
Topics:
1. Press and hold the exposure button down to the first pressure point.
The X-ray tube is prepared for performing an exposure.
To start the exposure directly after preparation of the X-ray tube has
ended, immediately press the exposure button down fully.
2. Press the exposure button down fully and keep it pressed until the
exposure has ended.
When the X-ray exposure is finished successfully, three beeps are heard.
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.
Related Links
Exposure button on page 27
1. Point the remote control towards the remote control receiver on the
device.
2. Press and release the exposure button on the remote control.
The X-ray tube is prepared for performing an exposure.
3. Press the exposure button withing 15 seconds and keep it pressed until the
exposure has ended.
When the X-ray exposure is finished successfully, three beeps are heard.
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.
4. Return the remote control to its cradle.
The remote control produces a sound signal if it is not returned to its
cradle after three minutes.
Related Links
Infrared remote control on page 28
Related Links
Connecting DR 100e to a wired network on page 97
Related Links
NX Workstation (all-in-one PC) on page 20
Button Function
Enter button
Close button
After entering text, select another text field to continue typing or hide the
virtual keyboard by clicking the Enter button.
If the virtual keyboard is not displayed automatically or if the virtual keyboard
is in the way, click the floating virtual keyboard button.
Note: Clicking the Close button may cause the virtual keyboard
to remain hidden when entering the text field again.
Advanced Operation
Topics:
Figure 27: Connector for moving grid on a system with rotating column
Figure 28: Connector for moving grid on a system with fixed column
2. Activate the moving grid.
The indicator lights up when the signal for the moving grid is enabled.
3. Prepare the exposure.
4. Execute the exposure.
If exposure is blocked, check the error messages and the connection to the
bucky.
The function of the DAP meter is to measure the dose-area product (μGy.m2)
that is going out towards the patient, accumulated over all exposures.
1
2
1. Apron hanger.
2. Leaded apron.
Figure 32: Switch to manual exposure mode and open the list of anatomical
programs
An anatomic group is displayed on the first line of the display, with the
anatomic programs listed below.
b) To switch to another anatomic group, press the F1 button on the
console repeatedly.
Related Links
Anatomic program exposure parameters on page 108
Modifying the exposure parameters of an anatomic program on page 92
X-ray generator control panel on page 25
An anatomic group is displayed on the first line of the display, with the
anatomic programs listed below.
2. Select the anatomic program for which new exposure parameters are
required.
Product Information
Topics:
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
• Electromagnetic Compatibility
• Laser Safety
General
• The product has been designed in accordance with the MEDDEV
Guidelines relating to the application of Medical Devices and have been
tested as part of the conformity assessment procedures required by
93/42/EEC Medical Device Directive (European Council Directive
93/42/EEC on Medical Devices).
Safety
• IEC 60601-1
Electromagnetic Compatibility
• IEC 60601-1-2
Laser Safety
• IEC 60825-1
Connectivity
DR 100e requires a TCP/IP network to exchange information with a number of
other devices. The recommended minimum network performance is 100 Mbit
for wired ethernet and IEEE 802.11 g for wireless network.
Note: A wireless network operating on variable speed or subject to
interruptions will cause delays on the NX workstation.
DR 100e communicates with other devices in the hospital network using one
of the following protocols:
• DICOM
• IHE
DR 100e can be connected to a RIS system (input scheduling), a PACS system
(output image/data management) and to a hardcopy device (output image).
Related Links
Connectors for the hospital network and for registering a DR Detector on page 29
Equipment Classification
Per EN/IEC60601-1, Medical Electrical Equipment, General Requirements for
Safety 3rd Edition, this device is classified as following:
Product Complaints
Any health care professional (for example a customer or a user) who has any
complaints or has experienced any dissatisfaction with the quality, durability,
reliability, safety, effectiveness, or performance of this product must notify
Agfa.
If the device malfunctions and may have caused or contributed to a serious
injury, Agfa must be notified immediately by telephone, fax or written
correspondence to the following address:
Agfa Service Support - local support addresses and phone numbers are listed
on www.agfa.com
Agfa - Septestraat 27, 2640 Mortsel, Belgium
Agfa - Fax +32 3 444 7094
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.
Technical Data
Topics:
• DR 100e
• Anatomic program exposure parameters
• DAP meter
• Collimator
• X-ray generator and X-ray tube assembly
DR 100e
Electrical connection
Topics:
• Dimensions
• Environmental conditions
Dimensions
Table 4: Dimensions of the system with rotating column
Dimensions
Weight 240 kg
(without DR detector)
Dimensions
Weight 170 kg
(without DR detector)
Rotation of the monobloc around its 151° (102° ahead, 49° back)
axis (γ swivel)
Movement manual
Environmental conditions
Table 6: Environmental conditions of the mobile X-ray unit
DAP meter
Model Diamentor CI-P
Type Device for the dose area product meas-
urement in X-ray diagnostics according
to IEC 60580 standard.
Principle of measurement Radiation measure with ionization
chamber
Measured quantity Dose area product
Digital resolution 0.01 μGym2
Max linearity error < 2.5%
Nominal range of dose-area prod- (0.01 - 2500) μGym2/s
uct rate
Equivalent filtration of the cham- 0.3 mm Al
ber @75kV
Max measurement field 118 mm x 118 mm
Dimensions (W x D x H) 152 mm x 234 mm x 23 mm
Weight 455 g
Collimator
Model R108 F
Collimation Manual with internal light source,
multilayer, squared field.
Assembly plan from focus 80 mm (3.14")
Coverage of the field at 100cm FFD minimum 0 cm x 0 cm
(SID)
maximum 43 cm x 43 cm
Lighting source Clusters of high-brightness LED pow-
er
Lamp lighting time 30 s
Light intensity (IEC 60601-2-54) > 160 lux
Minimum contrast ratio (IEC 4:1
60601-2-54)
Focal distance measurement Retractable tape measure (maximum
extension 3 m)
Inherent filtration 2 mm equivalent Al at 75kV
Additional filtration Manual selection
• 0 mm Al
• 1 mm Al + 0.1 mm Cu
• 1 mm Al + 0.2 mm Cu
• 2 mm Al
Rotation ± 120°
Weight 5.5 kg
Laser field to determine the focal dis-
tance at 1 m
Model name
Rotating anode monobloc MHF2030
High voltage generator
Thermo-tinned structure
Max. power (100 kV - 320 32 kW
mA)
Max. voltage to the tube 125 kV
Max. current to the tube 450 mA
Ripple to the max. power < 1%
Rise time to the max. < 2 ms
power
Performance
According to the load curves of the x-ray tube
Housing
Min. inherent filtration 1.1 mm Al
@75 kV
Dimensions (W x D x H) 320 mm x 140 mm x 324.5 mm x 145 mm x
241 mm 244.5 mm
Weight 19.4 kg 18.7 kg
Thermal features
Thermal capacity 500 kJ 600 kJ
Thermal safety 60 °C ± 5° C
Thermal switch normally closed
Lung 0.16 dm3 0.2 dm3
Continuous thermal dissi- 55 W 60 W
pation
Max. housing tempera- 60 °C
ture
Heating curves (50 W, 100 W, 200 W, 300 W) and cooling curve (***)
Model name
Rotating anode X22 0.8/1.3 X22 0.6/1.3
Specifications
X-ray tube X22
Rotation speed 3000 min‾¹
Nominal High voltage 130 kVp
Nominal focus dim. (IEC 0.8 mm small focus 0.6 mm small focus
60336)
CURVE DI CARICO SINGOLO - SINGLE LOAD RATING - ABAQUE DE CHARGE UNIQUE CURVE DI CARICO SINGOLO - SINGLE LOAD RATING - ABAQUE DE CHARGE UNIQUE
0.6 - 3 ~ - 3000 min-1 1.3 - 3 ~ - 3000 min-1
250 700
500
50 kV 50 kV
60 kV 60 kV
150
70 kV 400 70 kV
80 kV 80 kV
(mA)
(mA)
90 kV 90 kV
100 kV 300 100 kV
100 110 kV 110 kV
120 kV 120 kV
130 kV 200 130 kV
50
100
0 0
0.01 0.1 1 10 0.01 0.1 1 10
Tempo di esposizione - Time - Temps (sec) Tempo di esposizione - Time - Temps (sec)
High frequency Group 1 The device uses high frequency energy exclu-
RF emissions in sively for its internal functions. For this reason,
accordance with its high frequency RF emission is very low and
CISPR 11 it is improbable that neighboring electronic
equipment will be disrupted.
accordance with IEC Ur) for 25 peri- If the user wants the device
61000-4-11 ods at 0° to work continuously, even
• 0% Ur for 250 pe- when the energy supply is
riods interrupted, it is recommen-
ded to use an energy supply
free of interruptions or a
battery.
RF communication 28 V/m
The distance can be determined through the equation for each respective
column.
P is the rated power of the transmitter in watts (W) according to the manu-
facturer information on the transmitter, only for transmitters where the rat-
ed power is not mentioned in the above table.
REMARK : These Guidelines may not be relevant in all situations. The dis-
persion of electromagnetic waves is influenced by absorption and reflections
from buildings, objects and people.
Topics:
• Precautions on EMC
• Cables, transducers and accessories
Precautions on EMC
WARNING:
The system should not be used adjacent to or stacked with other
equipment and if adjacent or stacked use is necessary, the
system should be observed to verify normal operation in the
configuration in which it will be used.
CAUTION:
Portable RF communications equipment (including peripherals
such as antenna cables and external antennas) should be used
no closer than 30 cm (12 inches) to any part of the system,
including cables specified by the manufacturer. Otherwise,
degradation of the performance of this equipment could result.
maximum length
network con- Network cable CAT5e F/UTP (shielded end) with shielded
nection RJ45;
10 m
(or original Agfa cable F7.0477.1052; 5m)