AGFA D2RS User manual

OM-RCTDRDyn.R0a Release in January 2015
Digital Remote Controlled Table with dynamic flat panel detector
User’s Manual

Digital Remote Controlled Table with dynamic flat panel detector
User’s Manual
1
REVISIONS HISTORY
Revision Date Reason for change
0 30 January 2015 First edition Of reorganisation of the
manuals

Digital Remote Controlled Table with dynamic flat panel detector
User’s Manual
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Please read the whole documentation before using the medical device

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User’s Manual
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TABLE OF CONTENTS
Note to the user ..................................................................................................................................................6
Guarantee conditions..........................................................................................................................................7
Environmental protection....................................................................................................................................8
Safety and protection..........................................................................................................................................9
1. DESCRIPTION.............................................................................................................13
1.1. Generalities........................................................................................................................................13
1.2. Table control console........................................................................................................................14
1.2.1. Table switching on .............................................................................................................14
1.2.2. Table switching off.............................................................................................................14
1.2.3. Tube movements controls with joystick .............................................................................15
1.2.4. Column reset button...........................................................................................................15
1.2.5. Collimator shutters controls with joystick...........................................................................15
1.2.6. Automatic collimation mode...............................................................................................15
1.2.7. Light beam switching on ....................................................................................................15
1.2.8. Compression controls (option)...........................................................................................16
1.2.9. Unique control for autopositioning .....................................................................................16
1.2.10. Detector IN / OUT (for version with removable detector) ..................................................16
1.2.11. Centring controls with joystick............................................................................................16
1.2.12. Tabletop longitudinal movement........................................................................................17
1.2.13. Tabletop height and tilting with joystick .............................................................................17
1.2.14. Tabletop reset button.........................................................................................................17
1.2.15. Exposure controls ..............................................................................................................17
1.2.16. Touch screen display.........................................................................................................18
1.3. Automatic collimator.........................................................................................................................19
1.4. Remote handswitch...........................................................................................................................20

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2. OPERATION ................................................................................................................21
2.1. Switching on ......................................................................................................................................21
2.2. Detector positionning (for version with removable detector).......................................................22
2.3. Patient positioning ............................................................................................................................23
2.3.1. Accessories Installation .......................................................................................................23
2.3.2. Patient Installation................................................................................................................23
2.3.3. Patient positioning................................................................................................................24
2.4. Table autopositioning .......................................................................................................................25
2.5. Preparation for exposure..................................................................................................................26
2.6. Generator interface use ....................................................................................................................27
Refer to Generator interface User Manual
2.7. Digital system control console use.................................................................................................27
Refer to Digital System User Manual
2.8. Detector use (for version with removable detector) ......................................................................27
2.9. Tomography use................................................................................................................................28
2.10. Stitching use (option)........................................................................................................................30
2.11. Motorised compression system use (option).................................................................................31
3. TABLE MAINTENANCE ..............................................................................................32
3.1. Cleaning and disinfecting...............................................................................................................32
3.2. Preventive maintenance .................................................................................................................33
4. ERROR MESSAGES ...................................................................................................34
4.1. Information messages.......................................................................................................................34
4.2. Operation messages .........................................................................................................................36
4.3. Failure messages...............................................................................................................................37
4.4. Service messages..............................................................................................................................39

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IMPORTANT ! ... X-ray Protection
X-RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND OPERATOR
UNLESS MEASURES OF PROTECTION ARE STRICTLY OBSERVED
X-ray equipment if not properly used may cause injury. Accordingly, the instructions herein should be thoroughly
read and understood before attempting to place this equipment in operation. We will be glad to assist and
cooperate in placing this equipment in use.
Although this apparatus is built to the highest safety standards and incorporates a high degree of protection against
X-radiation other than the useful beam, no practical design of equipment can provide complete protection. Nor can
any practical design compel the operator to take adequate precautions to prevent the possibility of any persons
carelessly, unwisely, or unknowingly exposing themselves or others to X-radiation.
It is important that everyone working with X-radiation be properly trained and take adequate steps to insure
protection against injury.
The manufacturer assumes that all operator and service personnel authorized to use, install, calibrate and maintain
this equipment is cognizant of the danger of excessive exposure to X-radiation, is sufficiently trained and has the
required knowledges for it. The equipment herein described is sold with the understanding that the manufacturer,
its agents, and representatives are not liable for injury or damage which may result from exposure to X-radiation.
Various protective material and devices are available. It is recommended that such materials and devices be used.

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In normal use, (detector integrated into the table as image receptor) the reference axis of the X-ray beam must
form an angle of 90 ° with the surface of the tabletop, so that the X-ray beam corresponds to the image area. There
is an indexing system, activated by the buttons on the tube cover that automatically positions the X-ray tube
assembly at 0°, + / -90° and 180°.
Be sure that in normal use (detector in the table) the X-ray tube assembly is well positioned at 0 ° with the indexing
system.
NOTE TO THE USER
Your X-ray department has just purchased a Digital Dynamic Remote System with flat panel detector.
We congratulate you on this choice, and are sure you will be fully satisfied with its use and diagnostic capabilities.
These radiology units offer high quality and advanced technology.
To become familiar with its operation and make the most of its performance, the use of this equipment is conditioned
by the initial training received during approximately 5 days, depending on the X-ray service requirements, provided
during entry into service as well as the careful reading and understanding of the full user manual.
Read all documentation before using the medical device.
Keep this manual with the others in a safe place so that you can easily refer to it in the future.
Thank you for your confidence.

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GUARANTEE CONDITIONS
It is the responsibility of the user to ensure that the government regulations respecting installation and operation of
the equipment are observed.
Incorrect operation or failure of the user to maintain the equipment in accordance with the schedule of maintenance
relieves the manufacturer or his agent from all responsibility for consequent non-compliance, damage, injury,
defects and/or other malfunction.
In normal use, the table must be fixed to floor by eight screws M8x120. Refer to Service manual, in « Mounting »
chapter in paragraph « Implementation to floor ». No specific foot exists for the control console: it must be layed on
the shelf behind the shield but it is not necessary to fix it.
Refer to Service manual for any question related to the installation of the remote controlled table.
In any case of trouble, please contact the authorized company in charge with the equipment.
Refer to Service Manual to obtain pieces of information retated to:
- functioning, transport, and to storage of the equipment,
- the conditions necessary for installation of the equipment,
- the preparation for use of the equipment,
- the replacement of fuses, power supply cords and other parts,
- the circuits diagrams, and to the list of components,
- mains isolation.
The installation and equipment must not be used if any mechanical, electrical or radiation-emitting component is
defective, or if the procedures described in the schedule of maintenance have not been carried out.
Changes and additions to the equipment may only be carried out by the manufacturer or by third parties expressly
authorized by the manufacturer to do so. Such changes must comply with local regulations and accepted standards
of good practice.
In case the power lines do not meet the specifications given in section A "Preinstallation" of the Service Manual, the
table cannot reach its maximum performance and the standard use cannot be guaranteed.
Technical files (diagrams, parts list, measurement procedure and so on...) are available on request to the
manufacturer.

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ENVIRONMENTAL PROTECTION
This equipment or system contains environmentally dangerous components and materials (electronic boards,
electronic components, lead, transformers, etc…) that, once the life-cycle of the equipment or system comes to
end, becomes dangerous and need to be considered as harmful waste according to the international, domestic and
local regulations.
Please, contact the manufacturer once the life-cycle of the equipment or system comes to end and before remove
this equipment or system.
Label in compliance with 2002 / 96 / EC European Directive

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SAFETY AND PROTECTION
X-rays are not innocuous and can be dangerous if used badly. You must, therefore, take precautions even when
following the instructions in this manual.
Are entitled to use the remote controlled table physicians specialized in radiology and medical imaging as well as
medical electroradiology operators, these users receive initial and ongoing training in radiation protection to
implement these measures.
X-rays units manufactured by the manufacturer comply with the strictest safety standards in force throughout the
world. They guarantee optimum protection against radiation risks.
Nonetheless, you are handling a unit specifically designed to generate X-rays to allow medical diagnosis on a film
or using a digital imaging system. Consequently, despite the inherent safety of our equipment, we recommend
using conventional commercially available equipment to protect yourself and your patient against scattered
radiation risks.
The following instructions must be strictly observed:
1- Safety:
Use only the following accessories supplied by the manufacturer:
- Remote control
- Compression band and compression winches
- Footrest
- Stool
- Handles
- Double pedal
OPTIONAL ACCESSORIES:
- Triple pedal
- Cup holder
- Pair of shoulder rests
- Pair of gynaecological stirrups
- Retaining bar
- Compression ladle
- Compression plexi
- IV-Pole
- Multi FPD lateral support
- 1m ruler for stitching
- Ruler support for stitching
- 10cm ruler for measuring
- Ruler support for measuring
- Secondary console
Note: applied parts, as defined in the general requirements for basic safety and essential performance are
tabletop, footrest, stool, handles, compression band, pair of shoulder rests, pair of gynaecological stirrups,
retaining bar, compression ladle, compression plexi.
Reminder: the applied part is defined as the part of the electromedical device (EM) which in normal use is
necessarily in physical contact with the patient so that the EM device or EM system performs its function.

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Equipment described herein is unsuitable for operation where and when flammable gasses or vapours
are present.
It is vital that an authorized distributor carries out the assembly, extensions, adjustments, modifications
and repairs. Also, your radiology unit must be installed in premises that comply with IEC provisions and
the standards in force.
Any modification, not recommended or not approved by the manufacturer, is prohibited
Due care must be taken to prevent injury to the patient. Ensure that patient's clothing cannot be trapped
in the equipment. The user must ensure that the patient remains to the specified handgrips.
For examinations without using the detector inside support, that is to say for direct exposure in the
room, for example with one additional portable detector put on the tabletop (elbow, hand …), the user
must position the patient at the head of the table and not on lateral side.
The normal load of patients should be done when the tabletop is in the central position
The system « 120 cm tabletop movement » works only for patient loading in lying position, from
stretcher to tabletop. In this case, the heights of the stretcher and the table must be identical. Never let
the patient at the end of the tabletop. When the tabletop is out, do not sit or exert pressure on the
tabletop.
The patient must be correctly and securely positioned (using handgrips, footrest...), before moving or
tilting the table.
The user must always ensure that there are no obstacles that would interfere with the table. Ensure that
accessories such as shoulder supports, leg supports or footrest are correctly fixed to the table.
When the table is switched on, an operator must be in the exam room while a patient is on or close to the table.
In the event of mains supply microcuts, control inverter fault may happen for the motor of carriage,
column, tilting or longitudinal tabletop movement (120cm one). Then you have to switch off the table
with the general ON /OFF and switch it on again two minutes later.
Safety signs:
General warning sign
Warning: dangerous voltage
Follow operating instructions
CAUTION : X-RAYS

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2- X-ray protection:
Use the smallest possible X-ray field
Use the shortest possible fluoroscopy time
Use the highest possible Skin-Focus distance, in order that the patient dose is the lowest possible
Check the good condition of working for the X-ray tube and detector
Keep as far away from the beam as possible
During exposure, personnel not directly involved with the patient must go behind lead or lead-glass
shielding
Should the collimator be damaged, it must be repaired or replaced before the equipment is returned to
service
It is important that all procedures dealing with X-ray radiation must be made by personnel that is qualified
and fully acquainted with the radiation protection
3- Ionizing radiation
Risks
Risks associated with ionizing radiation depend on the dose delivered during an examination but also the
accumulation of dose during several successive examinations. The purpose of radiation protection is to
prevent or reduce these risks.
Nature of hazard
The user is faced with the risks associated with ionizing radiation. Therefore, if the user does not respect
safety regulations put in place, he can be exposed to a radiation hazard
Precautions
Two main rules regarding radiation protection are daily implemented: justification and optimization.
The justification lies in the fact that, as with any medical procedure, the benefit must be greater than the
risk. Although the risk of low doses is not demonstrated, caution is to consider that they can be responsible.
Therefore the achievement of examination with ionizing radiation is well thought out and weighed.
The optimization of doses is the role of the users who need the least radiation necessary to obtain an
examination to answer questions.
Contraindications
There are no contraindications to the achievement of a radiographic examination except for pregnant women.
The case of examination requiring the injection of contrast product, for patients suffering from a particular
disease or have allergies, should be studied and requires taking certain precautions before intervention.
Refer to the chapter "Radiation protection and imaging performance".
Also note that the use of a second console in room should be done within the significant zone of
occupancy, or a greater distance from the x-ray beam.

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4- Electromagnetic risks:
Emission:
This equipment can cause electromagnetic inteferences to other apparatuses, medical or not. For
adapted protection against interferences, the equipment is in compliance with the criteria of
CEI 60601-1-2 medical standard and EN 55011 emission standard, class A
Immunity:
In order to avoid disturbances risks for the table, it is recommended not to use apparatuses that
generate Radio Frequency energy intentionally, in the vicinity.
Switch off these apparatuses when they are close to the remote controlled table.
Equipments or instruments operating in the vicinity of table must be in compliance with the
ElectroMagnetic Compatibility standards.
5- Electrical Hazards
The remote controlled table may cause electrical hazards in very rare cases.
In order to provide the most effective protection possible, it has been designed to meet the requirements of
Article 8 of IEC 60601-1 "Protection against electrical hazards from electromedical equipments."
It is recommended to refer to the manuals before any maintenance on this device.
No additional multiple portable socket outlet or extension cord shall be connected to the system.
Do not connect items which are not specified as part of the system.
When a non medical electrical equipment, which has been supplied as a part of the system, is directly
connected to the wall outlet, the user does not benefit from the specific protections of the system power
supply, notably concerning the leakage currents.
When an electric equipment, which has not been supplied as a part of the system is connected to a socket
outlet dedicated to the system, it can be prejudicial to the safety of the system.
WARNING: To avoid electric shock, this unit must be connected only to a mains supply with a protective ground.
6- Cleaning:
Always disconnect the equipment from the general mains supply before cleaning or disinfecting.
Avoid water or other liquid to enter the equipment, as such liquid may cause short circuits and/or some
corrosion.
It must be noted that some disinfectants vaporise, forming potentially explosive mixtures.
Should such disinfectants be used, the vapours must first be allowed to disperse before the equipment
is returned to use.
In the event of failure to comply with these instructions, the manufacturer shall not be held responsible for the
safety, reliability and characteristics of the machine.
Your distributor will be pleased to help you with the initial use of your unit and to answer any subsequent questions
you may have.

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1. DESCRIPTION
1.1. GENERALITIES
This remote control table is a universal X-ray examination table with variable height fully digitized &
microprocessor controlled and developed for easy and fast examinations in fluoroscopy and radiography.
The table is suited for functional and for anatomical examinations with the patient in any position.
This multipurpose table is designed for performing following examination on adults, children and babies:
Radiography exams:
- General x-ray procedures: skull, chest, abdomen, pelvis, spine, extremities …
- Tomography
- Extremities (skyline patella, weight bearing exams …)
- Paediatrics (baby pelvis …)
- Stitching (option)
Dynamic exams:
- Full digestive tract
- Uro-genital system
- Endoscopy
- Arthrography
- Myelography
- Paediatrics
- DSA (option)
This list of procedures is not an exhaustive one, but gives an idea of the wide range of possibilities that the system offers.

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1.2TABLE CONTROL CONSOLE
Note: a seconday console is optional. The way to use it is almost the same as for the main console.
On secondary console, a locking key activates the main console (and thus activates the infrared control
handswitch and inactivates the secondary console) OR activates the secondary console (and thus
inactivates the infrared control handswitch and inactivates the main console).
The controls of axes as collimator shutters, detector rotation (for version with removable detector), or
zoom change can be done on the two consoles whatever locking system position is.
The secondary console allows triggering the emission of X-rays, but it is not possible to perform parameter
settings, Generator interface is not available.
WARNING: The secondary console should only be connected to the power cable located in the table output
1.2.1. TABLE SWITCHING ON
1 (I) button on the back of the control console switches on the table.
1.2.2. TABLE SWITCHING OFF
(O) button on the back of the control console switches off the table.
(O) button on the back of the control console swicthes off the generator
One emergency stop button on the main control console (n°2)
Two other emergency stop buttons are located on the table, one on each side of detector support.
Note: these emergency stop buttons only stop the table movements.
2
1

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1.2.3. TUBE MOVEMENTS CONTROLS WITH JOYSTICK
3 Increase SID
4 Decrease SID
5 Head side (to the left) column movement
6 Foot side (to the right) column movement
1.2.4. COLUMN RESET BUTTON
7 Column perpendicular stop
1.2.5. COLLIMATOR SHUTTERS CONTROLS WITH JOYSTICK
8 shutter longitudinal opening
9 shutter longitudinal closing
10 shutter lateral opening
11 shutter lateral closing
1.2.6. AUTOMATIC COLLIMATION MODE
12 selection of automatic
collimation mode
1.2.7. LIGHT BEAM SWITCHING ON
13 lighting of beam
3
4
5
6
7
8
9
10
11
12
13
AUTO

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1.2.8. COMPRESSION CONTROLS (OPTION)
14 Raise compression device to parking position
15 Lower compression device
1.2.9. UNIQUE CONTROL FOR AUTOPOSITIONING
16 “Move” button allows table autopositioning
through anatomical programming
1.2.10. DETECTOR IN / OUT
(for version with removable detector)
17 Detector IN
18 Detector OUT
1.2.11. CENTRING CONTROLS WITH JOYSTICK
19 Carriage movement on foot side or head side
20 Tabletop lateral movement on column side
or opposite
1.2.12. TABLETOP LONGITUDINAL MOVEMENT
21 Head side (to the left) movement
22 Foot side (to the right) movement
14
15
16
21
22
19
19
20
20
17
18

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1.2.13. TABLETOP HEIGHT AND TILTING WITH JOYSTICK
23 Table height UP movement
24 Table height DOWN movement
25 Trendelenburg (negative) tilting
26 Positive (to vertical position) tilting
1.2.14. TABLETOP RESET BUTTON
27 Table horizontal stop
1.2.15. EXPOSURE CONTROLS
28 Preparation (1st trigger) control
29 X-ray emission (2nd trigger) control
Radiography can be also performed by pressing the pedal indicated by the symbol with preparation control
(1st trigger) and X-ray emission control (2nd trigger) as for standard protocols with two buttons on the table console.
Fluoroscopy is performed by pressing the pedal indicated by the symbol .
Cine mode is performed by pressing the pedal indicated by the symbol (for versions with this functionality,
please refer to the user manual of digital system).
IMPORTANT ! ... X-ray Protection
X-RAY EQUIPMENT IS DANGEROUS TO BOTH PATIENT AND OPERATOR UNLESS MEASURES OF PROTECTION ARE STRICTLY
OBSERVED
X-ray equipment if not properly used may cause injury. Accordingly, the instructions herein should be thoroughly read and understood
before attempting to place this equipment in operation. We will be glad to assist and cooperate in placing this equipment in use.
Although this apparatus is built to the highest safety standards and incorporates a high degree of protection against X-radiation other than the useful
beam, no practical design of equipment can provide complete protection. Nor can any practical design compel the operator to take adequate
precautions to prevent the possibility of any persons carelessly, unwisely, or unknowingly exposing themselves or others to X-radiation.
It is important that everyone working with X-radiation be properly trained and take adequate steps to insure protection against injury. The manufacturer
assumes that all operator and service personnel authorized to use, install, calibrate and maintain this equipment is cognizant of the danger of
excessive exposure to X-radiation, is sufficiently trained and has the required knowledges for it. The equipment herein described is sold with the
understanding that the manufacturer, its agents, and representatives are not liable for injury or damage which may result from exposure to X-radiation.
Various protective material and devices are available. It is recommended that such materials and devices be used.
23
24
25
26
27
28
29

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1.2.16. TOUCH SCREEN DISPLAY
30 LCD screen to display parameters (example below)
This screen shows the parameters according to the anatomical programming for table, generator and can
display images from video camera for centring without fluoroscopy.
It indicates the name of position in anatomical programming (if not, it indicates “manual positioning”), with
values of SID, column and tilting angles, height of tabletop regarding floor, height of detector centre
regarding table foot border, shutters opening, zoom if selected.
For the video camera, it displays the parameters of table and the image filmed by the camera in real time.
Refer to the following chapter “2. OPERATION”
For the generator, it displays the interface to modify exposure parameters as kV, mA, s, mAs, AEC
selection … Refer to the following chapter “2. OPERATION”
It also displays error or warning message, or messages asking the user to input information.
For more details and explanations, refer to the following chapter “2. OPERATION”

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1.3 AUTOMATIC COLLIMATOR
The LCD screen indicates SID value, lateral and longitudinal blades openings in cm.
The knobs that disengage the motor driving of blades permit to collimate manually.
8 shutter longitudinal opening
9 shutter longitudinal closing
10 shutter lateral opening
11 shutter lateral closing
These soft keys control the opening or closing of the collimator motorised blades in order to limit the X-ray
beam. The final image field can be checked by switch on the collimator lamp. These controls can be used in
both Automatic and Manual modes.
13 This soft key is used to switch on the collimator lamp. It is on for approximately 20 seconds.
When green LED turns On, automatic collimation mode is ready.
The red LED turns momentarily On when the blades are moving and/or the system is NOT ready.
X-rays are inhibited.
Not used.

Soft key to select the filtres manually, choice between no filtration, 0.1mm Cu added to 1mm Al,
0.2mm Cu added to 1mm Al, 1mm Al added to 1mm Al. This selection is made automatically with
anatomical progamming from the main console. It is possible to set different filtres between fluoro
and graphy. The current used filtre is displayed in front of the corresponding icon. You can select the
filtre using + and – keys.
8
9
11
10
13