Eurocolumbus Alien X Alien e User Manual Rev1.7.23

alien X / alien e
USER MANUAL
0051
alien X / alien e
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User manual
Revision: 1.7.24 - 25.02.2021
DISCLAIMER
This document is the exclusive property of Eurocolumbus S.r.l., all rights are reserved. Any disclosure,
reproduction or transfer of the content to third parties is forbidden without the prior authorization of the
Company. It is also forbidden to use this documentation for purposes other than learning the characteristics
and operating procedures of the unit.
Eurocolumbus S.r.l. declines all responsibility for damage to persons or property due to improper use of this
product and failure to follow the instructions, warnings, instructions and precautions in this user manual.
This user manual is provided only in paper format and must always accompany the device.
Eurocolumbus pursue a policy of continuous improvement of its products. Even though it has been made the
greatest attention updating the documentation, this document should not be regarded as infallible guide to
the features and functionality of the product.
The information contained in this document may change without notice and do not represent a commitment
for Eurocolumbus S.r.l..
Notice will be provided only in case of modification to characteristics or functions which affect the safety.
No parts of this document can be reproduced in any way, included photocopy and digital recording, without
the wrote authorization of Eurocolumbus S.r.l..
The device is manufactured by:
Eurocolumbus S.r.l.
Via Filargo 36 Milano 20143
P.IVA: 00840200158
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SOMMARIO
DISCLAIMER .................................................................................................................... 2
1 GENERAL INFORMATION .......................................................................................... 7
1.1. INTENDED USE....................................................................................................................................... 8
1.2. CLASSIFICATION ......................................................................................................................................... 8
2 SIMBOLOGY ............................................................................................................. 9
2.1 INTERNATIONAL CLASSIFICATION OF THE ENCLOSURES PROTECTION (IPXX) .......................................................... 9
3 PRELIMINAR WARNINGS ........................................................................................ 10
4 ENVIROMENTAL CONDITIONS................................................................................. 10
5 SYSTEM DESCRIPTION ............................................................................................ 11
5.1 STAND ................................................................................................................................................... 11
5.2 TROLLEY ................................................................................................................................................. 13
5.3 TOUCHSCREEN CONTROL PANEL ETS15 ........................................................................................................ 14
5.4 WIRELESS PEDAL .................................................................................................................................... 17
5.5 WIRELESS CONTROL CONSOLE ............................................................................................................... 18
5.6 MINI TROLLEY ETS15 ........................................................................................................................... 20
5.7 EMERGENCY BUTTON ......................................................................................................................... 21
5.8 EXPOSURE HANDSWITCH .................................................................................................................... 21
5.9 LASER CENTERING DEVICE................................................................................................................... 21
5.10 FIELD ILLUMINATION LAMP .................................................................................................................... 22
5.11 AUTOMATIC INJECTOR CONTROL (OPTIONAL) ............................................................................................ 22
5.12 DOOR INTERLOCK (OPTIONAL) ........................................................................................................... 22
5.13 EXTERNAL EXPOSURE LAMP (OPTIONAL) ........................................................................................... 23
6 TURNING ON .......................................................................................................... 23
7 UNIT MOBILITY ...................................................................................................... 26
7.1 USE OF THE STEERING ............................................................................................................................... 26
7.2 USE OF THE BRAKE ................................................................................................................................... 27
7.3 TROLLEY MOVEMENT ............................................................................................................................... 27
7.4 STAND PARKING POSITION AND MOVEMENT..................................................................................... 28
8 MOTORIZED MOVEMENT AND C-ARM POSITION .................................................... 28
8.1 C-ARM MOTION ...................................................................................................................................... 28
8.1.1 Horizontal movement (manual) ...........................................................................29
8.1.2 WIG-WAG MOVEMENT (manual) ........................................................................30
8.1.3 Motorized movements .........................................................................................32
8.1.4 Circumferential movement ..................................................................................33
8.1.5 Orbital movement ................................................................................................35
8.1.6 Vertical movement...............................................................................................37
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8.1.7 Horizontal movement (optional)..........................................................................38

8.1.8 SID movement ......................................................................................................39
8.1.9 Notable positions movement ...............................................................................40
8.1.10 projection positions movement ...........................................................................40
8.1.11 Position memories ...............................................................................................41
8.1.12 Easy anti-collision system ....................................................................................44
9 TURNING OFF ......................................................................................................... 46
9.1 EMERGENCY SWITCH OFF .......................................................................................................................... 46
9.2 EMERGENCY RESTART ............................................................................................................................... 47
9.3 X-RAY EMISSION INTERLOCK ...................................................................................................................... 48
10 FLY SOFTWARE ................................................................................................... 48
10.1 USER ACCOUNT MANAGEMENT .............................................................................................................. 48
10.1.1 User login .............................................................................................................49
10.2 GRAPHIC USER INTERFACE (GUI) ........................................................................................................... 50
10.2.1 Home Page...........................................................................................................50
10.2.2 Database page .....................................................................................................53
10.2.3 Viewers page........................................................................................................59
10.2.4 System control page ............................................................................................82
10.2.5 System setting page .............................................................................................89
10.2.6 System monitor page ...........................................................................................90
11 PROCEDURES ...................................................................................................... 93
11.1 SOFTWARE START-UP............................................................................................................................ 93
11.2 OPEN AN EXAM ................................................................................................................................... 93
11.2.1 Load exam data from a remote work list ............................................................95
11.2.2 Load exam data from a local work list.................................................................95
11.3 IMAGE ACQUISITION ............................................................................................................................. 96
11.4 LOAD EXAM FROM DATABASE ................................................................................................................. 97
11.5 IMPORT EXAM ..................................................................................................................................... 99
11.6 EXPORT EXAM ................................................................................................................................... 102
11.7 ALLARM POPUPS ........................................................................................................................... 103
11.8 MEMORY MANAGEMENT ..................................................................................................................... 105
11.9 REMOVABLE ANTI-SCATTERING GRID ..................................................................................................... 105
11.9.1 Removable grid on c-arm with only motorized movement ...............................105
11.9.2 Removable grid on c-arm with manual/motorized movement .........................106
11.10 USE OF THE PRINTER ................................................................................................................ 108
11.10.1 LOADING PAPER IN THE UNIT .....................................................................110
11.10.2 CLEANING THE THERMAL HEAD ..................................................................113
12 RADIOPROTECTION ............................................................................................115
12.1 SKIN DOSE MANAGEMENT ................................................................................................................... 118
12.2 EMISSION LEVEL ................................................................................................................................. 119
12.2.1 DosimetrY...........................................................................................................121
12.3 SIGNIFICANT ZONES OF OCCUPANCY ...................................................................................................... 121
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12.3.1 Stray radiation ...................................................................................................121

12.4 ISOKERMA MAPS ............................................................................................................................. 125
13 EMISSION ..........................................................................................................127
13.1 ACQUISITION MODES .......................................................................................................................... 127
13.1.1 Scopy: pulsed fluoroscopy ..................................................................................128
13.1.2 HQ: high quality pulsed fluoroscopy ..................................................................128
13.1.3 Graphy DR: direct radiography ..........................................................................128
13.1.4 Scopy SS: single shot emission ...........................................................................128
13.1.5 HQ SS: high quality single shot emission ...........................................................129
13.1.6 Scopy HQ DSA: high quality pulsed fluoroscopy DSA .........................................129
13.1.7 Scopy HQ DSA CO2: high quality pulsed fluoroscopy DSA for CO2 ....................129
13.1.8 Scopy DSA roadmap: pulsed fluoroscopy roadmap ...........................................129
13.1.9 Scopy Cont: continuous fluoroscopy ..................................................................130
13.2 DOSE LEVEL....................................................................................................................................... 130
13.3 EXPOSED FIELD AND COLLIMATION SYSTEM ............................................................................................. 131
13.3.1 Collimator: iris ....................................................................................................131
13.3.2 Collimator: blades ..............................................................................................131
13.3.3 Collimator: additional filters ..............................................................................132
13.3.4 Irradiated field dimensions ................................................................................133
13.4 AUTOMATIC EXPOSURE CONTROL AEC ......................................................................................... 133
13.4.1 Dose regulation and gray scale management ...................................................133
13.4.2 Motion detection ...............................................................................................134
13.5 SKIN DOSE MANAGEMENT ................................................................................................................... 134
13.6 THERMAL MANAGEMENT .................................................................................................................... 134
13.6.1 THERMAL PROBLEM ..........................................................................................134
13.6.2 Thermal control..................................................................................................134
13.6.3 Thermal locK ......................................................................................................136
13.6.4 Notes on the thermal behavior of the detector .................................................137
13.6.5 Effects of the use of the sterile protections .......................................................137
14 MAINTENANCE ..................................................................................................138
14.1 DAILY MAINTENANCE .......................................................................................................................... 138
14.2 ORDINARY MAINTENANCE ................................................................................................................... 138
14.3 CLEANING ......................................................................................................................................... 138
14.4 DYNAMIC FLAT PANEL SAFETY RULES...................................................................................................... 139
14.4.1 Mechanical Shock ..............................................................................................139
14.4.2 Thermal dissipation............................................................................................140
14.1 TUBE HEAD SAFETY RULES .................................................................................................................... 140
15 TROUBLESHOOTING ...........................................................................................141
16 DISMANTLING....................................................................................................143
17 TECHNICAL CHARACTERISTICS ............................................................................144
17.1 GENERATOR CHARACTERISTICS ............................................................................................................. 144
17.2 TUBE, FLAT PANEL E MONITOR AVAILABLE ............................................................................................. 145
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17.3 X-RAY TUBE ASSEMBLY CHARACTERISTICS ............................................................................................... 146

C33-RTM80HS Characteristics ..........................................................................................146
B146H-G689 Characteristics ............................................................................................147
17.4 OPERATING MODE ........................................................................................................................ 148
17.5 APPLIED PARTS .............................................................................................................................. 148
18 LABELING...........................................................................................................149
18.1 DEVICE IDENTIFICATION LABEL...................................................................................................... 149
18.2 SAFETY SYMBOLS AND LABELING .................................................................................................. 149
19 ELECTROMAGNETIC COMPATIBILITY ...................................................................151
19.1 EMC DISCLAMER ............................................................................................................................ 151
19.2 TABLES 60601-1-2 ........................................................................................................................... 151
19.2.1 Table 1 (60601-1-2 numeration) ........................................................................152
19.2.2 Table 2 (60601-1-2 numeration) ........................................................................152
APPENDIX A ..................................................................................................................... I
DOSIMETRY FLY 5 - VAREX 3030 ............................................................................................................................... I
APPENDIX B .................................................................................................................. VII

DOSIMETRY FLY 5 - VW1212 ................................................................................................................................ VII
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1 GENERAL INFORMATION
The medical device described in this user manual can be supplied in different configurations:
X XX XX X X X X X X X X
0
1
Touch Screen ETS15
2
3
1
Computer
2
1
2
3
Monitor
4
5
6
1
2
3
4
Trolley
5
6
7
8
0
DFF
1
1
Movements 2
3
1
2
Generator
3
4
1
Collimator 2
3
I1
I2
Housing I3
V1
V2
V1
V2
V3
Detector D1
D2
W1
W2
1
2
C-arm depth
3
4
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The REF coding made of 11 digits is formed by the association of the above components.
Please refer to the information on the label containing the nameplate data.
This user manual is dedicated to the following devices:
Brand EUROCOLUMBUS
Commercial name alien X alien e

alien 3030
alien 303075
alien 3030 cardio
alien 2020
Versions -- alien 202075
alien 2020 cardio
alien 2121
alien 212175
alien 2121 cardio
1.1. INTENDED USE
The system described in this user manual is an active radiological interventional medical device having
functions of INDIRECT RADIOSCOPY, intended to be used in guided interventions in the fields of cardiology,
gastroenterology, neurology, orthopaedics, urology, vascular and paediatrics.
Although all acquisition modalities are defined as indirect radioscopy, the software uses different names to
indicate particular usage, as described here following:
SCOPY: permanent or non-permanent acquisitions, carried out indirectly, definable as low dose radioscopy, to
be used for any application where it is not required a high level of dose.
SCOPY HQ: permanent acquisitions, carried out indirectly, otherwise definable as high-dose radioscopy, to be
used in any application where it is required a high level of dose.
The unit is also capable to make exposure in manual radiography, using the so called three-point technique,
but only for testing or calibration purposes.
1.2. CLASSIFICATION
The device described in this manual, regardless of the configuration, is a Class IIb Medical Device, rule 10
according to the classification criteria expressed in Annex IX of the Medical Devices Directive 93/42 / EEC and
s.m.i.
THIS MEDICAL DEVICE SHALL ONLY BE USED BY PERSONNEL WH O HAVE BEEN QUALIFIED FOR
THE USE OF RADIOLOGICAL EQUIPMENT
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2 SIMBOLOGY
To make the reading of the manual comfortable and clear, the following symbols are used to manage the
important warnings for correct and safe use of the device.
Information for a safe use

This symbol is used close to any statement related to a safe use of the system.
Useful information
This symbol identifies useful and general which may help the operator to use the system
in a conscious and informed way, or in case of request of particular actions.
It identifies that the product is manufactured, designed and produced in compliance with
the safety requirements (RES) of the Medical Devices Directive 93/42 / EEC and the
conformity assessment involved a Notified Body.
2.1 INTERNATIONAL CLASSIFICATION OF THE ENCLOSURES PROTECTION (IPXX)
This chapter describes the international classification protection degrees of the enclosures according to the
IEC 60529 norm. The code is indicated by “IP” followed by two digits. The first one indicates the protection
level with regard to solids and the second one the protection level with regard to liquids.
First number meanings:
IPnX Description
IP0X No protection
IP1X Protection with regard to objects with diameter more than 50mm
IP3X Protection with regard to objects with diameter more than 2.5mm
IP5X Protection with regard to powders
IP6X Totally protected with regard to the entry of powders
Second number meanings:
IPXn Description
IPX0 No protection
IPX1 Protected with regard to vertical drops
IPX2 Protected with regard to drops coming with a maximum inclination of 15°
IPX3 Protected with regard to rain
IPX4 Protected with regard to sprays
IPX5 Protected with regard to water jet
IPX6 Protected with regard to water waves
IPX7 Protected with regard to possible immersion
IPX8 Protected with regard to possible submersion
SOME PARTS OR ACCESSORIES COULD BE LABELED WITH THE IPXX PROTECTION CODE.
PLEASE REFER TO THE ABOVE TABLES TO UNDERSTAND THE MEANING OF THE CODE
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3 PRELIMINAR WARNINGS
Failure to comply with the following warnings as well as the rules and precautions described in this user
manual will result in the immediate invalidation of any warranty on the device.
Eurocolumbus S.r.l. is not responsible for any damage to persons or property because of failure to comply
with the rules or precautions listed below and reported in general in this user manual.
MISSING OR NEGLIGENCE IN THE FILLING OF THE FOLLOWING INDICATIONS MAY CAUSE

MALFUNCTION OF THE DEVICE, DAMAGE AND INJURY TO THE USER
IN ORDER OF PREVENTING ELECTRIC SHOCK HAZARDS, CONNECT THE DEVICE ONLY TO

SOCKETS WITH PROTECTIVE GROUNDING
DO NOT USE THIS DEVICE BEFORE READING AND FULLY UNDERSTANDING OF THIS
MANUAL
NO MODIFICATION OF THE DEVICE AND / OR OF ITS PARTS IS ADMITTED
THE USE OF THE DEVICE FOR DIFFERENT USES FROM THOSE INDICATED IN THIS USER'S
MANUAL, MAY EXPOSE THE PATIENT AND THE OPERATOR TO DANGER
IT IS NECESSARY TO RESTRICT ACCESS TO THE DEVICE ACCORDING TO LOCAL

REGULATIONS IN TERMS OF RADIATION PROTECTION
BEFORE USING, VERIFY THE PRESENCE AND INTEGRITY OF ALL INDIVIDUAL PROTECTIVE
DEVICES REQUIRED FOR ITS USE
THE CONNECTION OF EXTERNAL DEVICES OR THE INSTALLATION OF SOFTWARES WHICH

ARE NOT PROVIDED BY THIS MANUAL ARE FORBIDEN, BECAUSE THEY MAY PRODUCE A
SOURCE OF DANGER.
THE UNIT IS EQUIPPED WITH A INTERLOCK KEY SWITCH WHICH DISABLE ANY EMISSION IF
ACTIVE. CHECK THE STATUS OF THE INTERLOCK KEY SWITCH BEFORE TO START A
PROCEDURE.
4 ENVIROMENTAL CONDITIONS
The temperature of the room where the unit is used must be between 10 ° C and 35 ° C and a humidity
between 20% and 80% non-condensing.
The place where the unit is used must guarantee the necessary operating spaces in order to allow easy
access to the control panel and to the access panels to the internal parts of the unit, this to ensure full
operation and safety.
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DO NOT USE THE DEVICE IN THE ENVIRONMENT WITH THE PRESENCE OF FLAMMABLE
ANESTHETIC MIXTURES WITH AIR, OXYGEN OR NITROGEN PROTOSSIDE
THE UNIT IS NOT PROVIDED FOR OUTDOOR OPERATION, OR TO EXPOSE TO

ATMOSPHERIC AGENTS.
5 SYSTEM DESCRIPTION
The unit is composed of two main parts, the C-arm stand and the trolley monitor console:
The images in this chapter may differ in some accessories or parts with respect to the
configuration of the unit to which this documentation was enclosed.
The device can be provided with the CT70T EVOLUTION table
The device can be provided with the MINI TROLLEY ETS15 for remote control
5.1 STAND
The stand is movable on four wheels: two rear wheels can be oriented via the steering command, the two
front ones are swiveling wheels, all equipped with cable sweeper. When necessary, the brake command acts
on the rear wheels locking them in position.
The stand is equipped with one of control touch screens interface ETS15, with which the user can access all
the functions of the unit.
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The circumferential and orbital rotations as well as the in/out movement may be manual or actuated by the
use of electrical motors or actuators, depending on the system version. The column lift and the DFF
(movable detector), when present, are only motorized. The wig-wag movement, which is the oscillation on
the horizontal plane, is performed only manually after the unbrake of the wig-wag lever and the wig-wag
locking pin. The stand is connected to the trolley via an umbilical cable mounting a multifunction quick
release connector.
THE EMERGENCY BUTTONS ARE LOCATED ON THE BACK OF THE MONITOR TROLLEY, ON
THE TOP OF THE STAND TOUCH SCREEN PANEL ETS15 AND, IF PRESENT AND CONNECTED,
EVEN ON THE SIDE OF THE MINI TROLLEY ETS15
1. C-arm
2. Image detector group
3. X-ray emission group. It
includes:
• Collimator
• Tube head
4. Front swivelling wheels
with cable sweeper
5. Rear steering and
breaking wheels with
cable sweeper.
6. Stand moving handle
7. Touch screen control
panel ETS15 +
emergency stop button
8. Umbilical connection
9. Wig-wag brake lever,
wheels brakes, manual
exposure control
1. Wig-wag centering
knob
2. Steering control handle
3. Umbilical connection
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WHEN OPERATED INTO CONTAMINATION CONTROLLED ENVIRONMENT, THE USE OF

PROTECTIVE SLEEVE FOR C_ARM, TUBE, AND DETECTOR IS HIGHLY SUGGESTED
IN CASE OF USE OF PROTECTIVE SLEEVES, REMOVE THEM AS SOON AS POSSIBLE IN

ORDER TO ASSURE A BETTER AND FAST COOLING OF THE WARM PART AFTER THE USE.
FOR INFORMATION ON THE FIXING OF STERILE PROTECTION, REFER TO THE CLEANING

SECTION OF THIS MANUAL.
5.2 TROLLEY
The trolley is easily movable thanks to its four turning wheels equipped with position brakes and cable
sweeper, and via comfortable handles.
The trolley contains the computer, the control console and the monitors used for the diagnosis. It groups the
controls for the digital memory and eventually for the local printer. Its components may change depending
on the custom system’s configuration.
The trolley is connected to the stand via an umbilical cable mounting a multifunction quick release
connector.
THE EMERGENCY BUTTONS ARE LOCATED ON THE BACK OF THE MONITOR TROLLEY, ON
THE TOP OF THE STAND TOUCH SCREEN PANEL AND, IF PRESENT AND CONNECTED, EVEN
ON THE SIDE OF THE MINI TROLLEY ETS15
1. Image display
2. Touch control panel ETS15, trolley side
3. Xray emission blinking light (yellow)
4. Displays lift column
5. Handgrip
6. Printer (optional)
7. CD/DVD writer/reader
8. Swivel wheels with brakes
and cable sweeper
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1. Emergency button
2. Connection panel
3. Ventilation grids
4. Main power switch, current braker
5. Functional ground terminal
6. Umbilical cabling and power cable
1. Display lifter control switch

2. Xray interlock key switch
3. Multifunctional connector ROOM IN USE
4. Turn on button
5. Automatic injecto connector (opzionale)
6. Ethernet connection for DICOM purposes.
7. USB
8. Wired footswitch connector or table
connection (optional)
9. DVI OUTPUTs (optional)
5.3 TOUCHSCREEN CONTROL PANEL ETS15
The main ETS15 control panel consists of a touch screen user interface from which it is possible to control all
the functions of the unit. The touch screen panels are placed on the stand, on the main trolley and, if
equipped, also on the mini trolley ETS15.
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On the stand, the touchscreen panel can be rotated in all directions and oriented slightly upwards or
downwards.
On the trolley the touchscreen panel can be tilted completely up or down but cannot be rotated.
The graphical user interface has multiple controls and different commands depending on the function
performed, some of which correspond to the commands of the wireless console. The Fly software graphical
interface is basically composed by 6 pages and the user can navigate through them selecting the correct icon
from the top toolbar. As shown in the figure below, each page is identified by an appropriate icon, and each
one is committed to a proper functionality.
Here is a brief description (for a detailed characterization please refer to the following paragraphs):
Home page: allows to configure a new exam and eventually recall the patient data form the
DICOM work list.
Database page: for the management of exams database.
Viewers page: allows to view open exams.
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System control page: this key is used to monitor and set, in the case of manual control, the
emission parameters. It allows to control the movements of the arc.
System settings page: this key is used for system settings, such as monitor management,
network management or DICOM functions. It is organized in sub-pages accessible according to
the level of access.
System monitor page: this key is used to monitor the entire system, providing access to logs and
error logs, when present.
To be noted that an icon of the GUI (graphical user interface ) will be represented differently
depending on weather it is enabled, disabled or selected. If the icon is slightly visible and nor
the contour nor the icon is lighted up, then the button is disabled, and its functionality will not
be available to use. If the icon and its contour are visible and lighted up, then the icon is
enabled and its function as well. Lastly, if the icon highlighted the icon is actually selected and
the associate function is currently active.
For example, the system control page shown below, provides the different control commands for the
movements of C-arm and displays the angular position for the circumferential and orbital movements
(degrees), the DFF / SID positions, column and horizontal potitions (mm) and the irradiating area (cmxcm).
The ETS15 touch screen panel also displays the icon corresponding to the physical interlock system of the
emission with which the system is equipped. Whenever such interlock is active the emission will be inhibited
and the x-rays icon will turn red, as shown below:
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From the touch screen control panel it is also possible to switch off the entire system by pressing the
following button on the home page:
As a consequence, the software will ask to confirm the choice showing the following pop-up:
For a detailed description of all the functions that can be activated from the different pages of the ETS15
touch screen panel, please refer to the dedicated paragraphs.
5.4 WIRELESS PEDAL
The wireless pedal has two pedals and two buttons. All of them may be configured for different uses by
software. The main pedals are used to start an exposure in the modality for which they have been
configured. The two buttons are used to select software functions as: FOV selection, dose level change,
recording start, and others, depending on their configuration over a defined set of options.
1. Exposure pedal
2. Exposure pedal
3. Configurable button
4. Configurable button
In the event that the device configuration does not provide for wireless, the wired pedal will
be connected to a special connector located on the back of the cart.
The functions are the same.
If there are several wireless pedals, check that the serial number of the pedal matches the
serial number of the device.
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The battery has an autonomy of about 2 years, if you should detect the low battery signal,
issued by the control unit, contact the manufacturer.
From the first signal the pedal will guarantee its functioning for no more than 2 months.
It is recommended not to move the pedal away when pressed and in any case not to attempt
to use it for more than 6 meters away from the device.
The use of the wireless peal at distance greater than 6 metres from the unit may result in
missing commands due to the loss of the wireless connection.
The wireless pedal guarantees an IP X8 degree
5.5 WIRELESS CONTROL CONSOLE
The wireless control console has multiple controls that correspond to the commands that can be activated
by the control touch screen ETS15 located on the stand and on the trolley, with the exception of the
exposure start command.
3 6
5 9
1
2
4 8 7 10
11
1. Rotation joystick. It allows moving the C-arm in any position and is equipped with a
safety lock. To unlock the command, move its upper circular part upward before
moving the joystick:
2. Collimation filter blade control joystick. Control the filter blade inlet / outlet (right /
left) and its angular position (forward / backward). Depending on the versions, the
mobile filtration can consist of: double copper blades, single cardiological moon
shape copper blade, double lead blades.
3. SID positioning keys (if present). They move the detector along the x-ray beam,
bringing it closer or away from the x-ray tube..
4. C-arm lift column controls. Allows to lift the C-arm up or down by motor.
5. Memory open button. Opens the storage memory to store the desired position in
one of the two available memory position recall button (M1, M2).
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6. Position recall memories M1 and M2. Buttons for the movement into pre-stored
positions.
7. Unlock button. Activate the unlocking of the motion controls. Can be used, for
example, to exit a blocking position following a collision alarm. The lit LED indicates
that the key is active (anti-collision control active). ATTENTION: by pressing this
button, the movements are not controlled by an anti-collision system.
8. Laser centering trigger button. Allows the laser centering device to be turned on.
Pressing again, the centering device switches off automatically, which will switch off
automatically after a few seconds.
9. FOV control. Those button allows to select the desired FOV (Field Of View)
10. Field limit partializaztion. Pushing this button is possible to select one of
the operative modes of the square iris, controlling vertical or horizontal or both
direction field limits. The leds agains each mode indicates which one is actually
selected. Attention! the button acts pushing it exactly in the middle.
11. Horizontal motion. Those buttons allow to move the horizontal cariage forward or
backward by motor, in the unit equibbed with this function.
In case the configuration of the device does not provide for wireless, the wired console will be
connected to a special connector located on the back of the cart.
The functions are the same.
The battery has an autonomy of about 2 years, if you should detect the low battery signal,
issued by the control unit, contact the manufacturer.
From the first report the console will guarantee its operation for no more than 2 months.
The use of the wireless console at distance greater than 6 metres from the unit may result in
missing commands due to the loss of wireless connection.
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5.6 MINI TROLLEY ETS15
The unit can be supplied with the MINI TROLLEY ETS15 which through the touch screen interface ETS15
allows the remote control of the functions of the unit. The touch screen panel ETS15 on the MINI TROLLEY
ETS15 is the same as the one on the C-arm and on the main trolley.
1. Touch control panel ETS15

2. Handgrip
3. Emergency button
4. Trolley connection cable
5. Swivel wheels with
5
cable sweeper, two with brakes
The Mini Trolley ETS15 must be connected to the trolley before each use
through the connector on the panel located on the back of the main trolley.
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5.7 EMERGENCY BUTTON
The system is equipped with emergency buttons: one is located on the back of the C-arm control
touch screen ETS15, one on the back of the monitor trolley, and one, if present and connected,
on the side of the MINI TROLLEY ETS15. The pushing of any emergency button results into an
immediate C-arm switch off. Only the unit elaborator, the image displays, and the trolley touch control panel
will remain active in order to allow the management of the exam image data. When one of the emergency
buttons is pushed, the stand remains completely out of power and there are no possibilities that the C-arm
restart itself. Because of safety reason, any emergency button requires a manual arming once have been
pushed. This mean that it will remain in the off state until somebody will act over it turning clockwise and
pulling it out. The red light indicates that the unit is in the active state. When one any of the emergency
button is pushed, the red light is off on all buttons.
5.8 EXPOSURE HANDSWITCH
The exposure handswitch can be used to manually control the X-ray emission. Its function changes
depending on how it has been configured.
The length of its cable is such as to allow the exposure control from two meters away from the unit.
The button can be configured, by software, to perform any of the exposure modes.
5.9 LASER CENTERING DEVICE
The laser centering device consists of two red laser emitters that create two light planes crossed and aligned
with the x-ray beam. In this way the reference cross is visible at any distance between the X-ray cuff and the
detector.
It is identified by the label on the detector near the laser diodes.
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This icon represents the key to turn on the laser centering device on the touch screen console.
Pushing the button a second time, the lasers turns off. The lasers turns off anyway after 10 seconds
since they have been turned on.
The laser centering tool has the following characteristics:
• wavelenght 655 nm
• max output power < 1mW
• Classified Class 2 by the directive UNI EN 60825-1
Although the laser centering tool uses very low power laser beams, the laser beam may be
dangerous for eyes.
Never point the laser beam towards eyes.
Never stare into the direct laser beam.
Never point the laser beam against reflective surfaces.
5.10 FIELD ILLUMINATION LAMP
This option, available only in devices equipped with a Dynamic Flat panel. The field illumination
lamp consists of a with light led lamp which can be used to illuminate the field below the flat panel
detector. The lamp can be turned on using the button on the touch control panel ETS15. To
switch off the lamp, push the button again.
5.11 AUTOMATIC INJECTOR CONTROL (OPTIONAL)
The control function of the automatic injector allows the synchronization of the injection of the contrast
medium at the correct time, according to the provisions of the selected acquisition program, without the
operator having to deal with it.
This function provides only the "start injection" command and not commands related to the quantity or
intensity of the flow, which must however be set to the same urgency according to what is indicated in its
accompanying manual.
To use this function, connect the automatic injector to the "INJECTOR" connector on the rear panel of the
monitor trolley. The connection requires an appropriately prepared cable depending on the model and
brand of the automatic injector to be connected.
Please refer to Technical Manual for information regarding the connection of an external
automatic injection system.
5.12 DOOR INTERLOCK (OPTIONAL)
The interlock function, if previously activated during installation, allows to inhibit the emission when
somebody opens the door of the room where the system is located. This option is an effective method of
radiation protection for operators placed in the immediate vicinity of the room.
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The door interlock connection is available within the "ROOM IN USE" connector signals, available on the rear
panel of the cart.
Please refer to Technical Manual for information regarding the connection of the door
interlock.
5.13 EXTERNAL EXPOSURE LAMP (OPTIONAL)
The lamp signalling function allows the control of a lamp with two lights ("MACHINE ON" and "EXPOSURE IN
PROGRESS"). This function is an effective method of radiation protection for operators placed in the
immediate vicinity of the hall.
To use this function, the signal lamp must be connected to the "ROOM IN USE" connector on the rear panel
of the monitor trolley using a cable and a special control circuit.
Please refer to Technical Manual for information regarding the connection of the external
exposure lamp.
6 TURNING ON
THE FIRST START-UP OF THE DEVICE SHOULD BE MADE ONLY BY TECHNICAL PERSONNEL
Eurocolumbus S.r.l. SPECIALIZED AND SPECIALLY FORMED OR EXPRESSLY AUTHORIZED
BEFORE TURN ON THE UNIT, CHECK THAT THE ELECTRICAL SYSTEM COMPLIES WITH THE
REQUIREMENTS OF STANDARD CEI 64-8 / 7 AND THAT THE SOURCE OF POWER COMPLY TO
THE DATA REPORTED ON THE UNIT IDENTIFICATION LABEL
BEFORE EVERY START UP, CHECK THE FULL INTEGRITY OF THE DEVICE
DO NOT POSITION THE DEVICE SO THAT IT IS DIFFICULT TO DISCONNECT THE PLUG FROM THE
POWER SUPPLY OUTLET
CONSIDER THAT MOBILE PHONES OR OTHER DEVICES USING RADIO FREQUENCIES MAY
PRODUCE DISTURBANCE TO THE SYSTEM
DO NOT LOCATE THE ACTIVE UNIT TO CLOSED TO OTHER ACTIVE MEDICAL DEVICES
VERIFY THAT THE ENVIRONMENT OF USE IS IN ACCORDANCE WITH THE REQUIREMENTS OF

THE CHAPTER "ELECTROMAGNETIC COMPATIBILITY"
The unit fully satisfy the requirements of the IEC/EN 60601-1/A1
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The unit is equipped with a single-phase power cable with ground wire (P + N + G), having a single phase
plug.
The unit is supplied, at the rear base of the trolley, with a differential magneto-thermal switch and a
functional earth terminal indicated by the symbol.
To switch the device on, follow the steps described below:

1. Unclip and unroll the umbilical cord (stand-to-trolley connecting cable) and the power cord from the
bracket at the rear of the cart.
2. Connect the umbilical connector to the plug at the side of the C-arm, pushing it gently inside in a
perpendicular way. Meantime, grab the metal locker and pull it toward you, in order to lock the
connector in position:
3. Connect the power supply cord to the wall socket. The wall socket shall comply to the following
requirements:
Units having BOOSTER system:

- Voltage 220-240 Vac
- Frequency 50/60 Hz
- Output nominal current 16A
- Single phase power plug IEC309 P+N+T 16A. Here following a sample image:
- Circuit breaker 16A curve C

Units without BOOSTER system:
- Voltage 220-240 Vac
- Frequency 50/60 Hz
- Output nominal current 25A
- Single phase power plug IEC309 P+N+T 32A. Here following a sample image:
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- Circuit breaker 25A curve C

4. Check that both the emergency button is armed (pulled out, not pushed).
5. If present, check if the wall switch is on.
6. Turn on the main unit switch located at the bottom of the rear side of the monitor trolley.
7. Push the button Turn On located on the connection panel on the rear side of the monitor
trolley. The unit will start the turning on procedure.
8. Wait the complete turn on of the unit, until you will see the control interface appearing of each one
of the touch control panels.
FOR INDIVIDUAL DEVICES (OPTIONAL OR STANDARD) AS A PRINTER ECC. MAKE SURE THAT THE
RELEVANT POWER SWITCHES ARE IN THE INPUT POSITION. REFER TO THE RELEVANT
MANUALS.
THE STARTING PROCEDURE ABOUT A MINUTE.
TO USE THE MACHINE AND TO ACCESS ALL DATA SENSITIVE FROM THE DATABASE IT IS
NECESSARY TO PROCEED WITH THE USER LOGIN FROM THE SCREEN ON THE TOUCH SCREEN
ETS15 OF THE CART.
THE LOGIN IS NOT NECESSARY WHEN YOU INTEND TO OPEN AN EMERGENCY EXAM.
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7 UNIT MOBILITY
THE UNIT IS EQUIPPED WITH WHEELS WITHOUT MOTORS.
IN CASE OF TOTAL OR PARTIAL BLOCK OF ELECTRO-ACTUATED MOVEMENTS DO NOT ATTEMPT

TO ACT MANUALLY ON THE SAME.
IN CASE OF NECESSITY FOR EXAMPLE OF CPR (CARDIOPULMONARY RESUSCITATION) THE
PATIENT'S RELEASE IS CARRIED OUT THROUGH THE MOVEMENT OF THE ENTIRE STATION WITH
THE GUIDE HANDLES LISTED IN THE PREVIOUS CHAPTERS
IN CASE OF MOVEMENT OF THE UNIT TOWARDS DIFFERENT DEPARTMENTS AND FOR LONG
DISTANCE, PUT THE C-ARM INTO THE PARCKING POSITION AS EXPLANED LATER IN THIS
MANUAL
THE TRANSPORTATION MUST ALWAYS BE CARRIED OUT ON FLAT AND NON-ACCIDENTED

SURFACES, TO GUARANTEE THE STABILITY AND OPERATION OF WHEELS, STEERING AND
BRAKES. IF IT MOVES ON A TILTED FLOOR, THIS TILTING MUST NOT BE MORE THAN 10 ° AND
REQUIRES ANOTHER ATTENTION IN EVERY CASE
WHEN SHOULD BE MOVED, MAKE SURE THAT THE BRAKE IS DISENGAGED. NO OBSERVANCE OF
THIS POINT MAY CAUSE DAMAGE TO THE BRAKE
MOVE THE STAND AND THE TROLLEY SEPARATELY, PAYNG ATTENTION TO AVOID COLLISIONS
WITH PEOPLE OR OTHER OBJECTS ALONG THE WAY
REMEMBER TO BRAKE THE STAND AND THE TROLLEY EVERY TIME YOU LEAVE THE UNIT
ABBANDONED (ORANGE HANDLE)
THE DEVICE MUST ALWAYS BE MOVED BY TWO PEOPLE
7.1 USE OF THE STEERING
Move the stand using the handgrip only. Eventually act on steering to drive the stand in the desired
direction.
The steering can be controlled using the steering handle on the left side of the unit. The rear steering wheels
will be oriented along the handle direction. In order to rotate the handle, first press it down.
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7.2 USE OF THE BRAKE
Every time the unit is leaved unattended it must be braked (orange knob). Indeed, the brake command is
used to block the wheels preventing accidental movement of the unit. To activate the brake command,
rotate anti-clockwise the knob on the right side of the control panel until it reaches a transversal position
with respect to the unit and a mechanical click is heard. To unlock the brake, rotate clockwise the lever. The
“locked” and “unlocked” positions are clearly indicated by the padlock icons (closed and open respectively).
The use of the brake is suggested also during the intervention to give to the C-arm more stability
7.3 TROLLEY MOVEMENT
In case of movement along long sentences, it is necessary to put the trolley in parking position as described
here following:
1. Lift down the display to the minimal highness using the two controls on the
touchscreen.
2. Unlock all the wheels pulling up the red brake lever on each of them.
3. Once the movement is finished, push down the red brake lever to brake each wheel.
4. Move the trolley acting on the handgrip only. Do not pull it from the cable or other parts.
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7.4 STAND PARKING POSITION AND MOVEMENT
Before proceeding with the following steps, we recommend reading the following paragraph
"MOTORIZED MOVEMENT AND C-ARM POSITION"
1. Move the C-arc to a perfectly vertical position, and with the detector in the upper position, using the
controls .
2. Lift the C-Arm downwards using the button

3. Slightly lift up the C-Arm in order to have a little gap from its lower position, using the button
4. Unlock the horizontal brake and pull the horixontal cariage backward until its maximum.
Then brake the hozicontal cariage pushing again the same button.
5. Centre and lock the wig-wag position using the wig-wag centring knob on left side of the horizontal
carriage and the brake lever on the right side of the horizontal carriage.
6. Turn off the unit pushing the button .

7. Switch off the main switch on the lower back part of the trolley.
8. Switch off the wall switch, if present.
9. Pull out the power plug.
10. Disconnect the umbilical tube from the stand, acting gently on its retaining lever.
11. Roll both the umbilical tube and power cord and attach them on the support on the back of the
trolley.
8 MOTORIZED MOVEMENT AND C-ARM POSITION
8.1 C-ARM MOTION
MOTORIZED MOTIONS OF THE C-ARM ARE MANAGED WITH AN APPROPRIATE ALGORITHM

THAT, IN CASE OF FAILURE IN THE TRANSMISSION OF CONTROLS COMING FROM THE CONTROL
CONSOLE, PUTS ALL MNOTORS IN "OFF" AND SAFE STOP CONDITION
TO PREVENT ACCIDENTAL ACTIVATION OF THE ROTATION OF THE ARC DURING USE, THE
REMOTE-CONTROL CONSOLE OF MOVEMENTS IS EQUIPPED WITH A DOUBLE COMMAND
CAREFULLY CHECK THE UNIT DURING ANY MOTION IN ORDER TO PERFORM ALWAYS A SAFE
ACTION
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DURING MOVEMENTS DO NOT TOUCH THE C-ARM, IN PARTICULAR IN THE INTERCONNECTION

POINTS BETWEEN THE MOVABLE PART AND THE FIXED PART OF THE STATION
ABSOLUTELLY AVOID PULLING CABLES
DO NOT SIT DOWN OVER THE UNIT, ON ANY PART
DO NOT PLACE OBJECTS ON THE UNIT, EXPECIALLY CONTAINERS INCLUDING LIQUIDS OF ANY
KIND
IN CASE OF A TOTAL OR PARTIAL BLOCK OF ELECTRO-ACTUATED MOVEMENTS, DO NOT

ATTEMPT TO ACTUALLY ACT ON THE SAME.
IN CASE OF NEED FOR EXAMPLE OF CPR (CARDIOPULMONARY RENIMATION) THE PATIENT
RELEASE IS CARRIED THROUGH THE MOVEMENT OF THE ENTIRE STATUE WITH THE DRIVING
HANDS RETURNED IN THE PREVIOUS CHAPTERS
IN CASE OF UNCONTROLLED MOVEMENTS OR PANIC SITUATIONS, ACT BY PRESSING THE

EMERGENCY BUTTON
8.1.1 HORIZONTAL MOVEMENT (MANUAL)
DURING HORIZONTAL HANDLING OF THE ARC, BRING HANDS EXCLUSIVELY ON THE SPECIFIC
HANDLING HANDLE
Horizontal movement can be performed manually as follows:
1. Push the horizontal brake unlock button available on the C-arm touch control panel the button.
the yellow flag will turn on indicating its active state.
2. Use the horizontal carriage handgrip to push or pull the horizontal carriage in the desired position
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3. Push again the horizontal brake button . the yellow flag will turn off.
In order to give maximum safety, the horizontal brake turns automatically off (locked) after 30
seconds its unlocking.
8.1.2 WIG-WAG MOVEMENT (MANUAL)
Wig-wag movement (horizontal oscillation) can be manually performed as following:

1. Check if the wig-wag unlocking knob is unlocked. The unlocking knob is unlocked when pulled out
and rotated.
2. Unlock the wig-wag brake rotating the wig-wag brake lever counter clockwise until the position
indicated by . The wig-wag is now free to move.
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3. Using the horizontal carriage handgrip, rotate the wig-wag into desired position:
4. Once into the desired position, rotate the brake lever clockwise till the locked position .
In case of necessity, to centre again the wig-wag position:

- unbrake the braking lever
- unlock first the wig-wag locking knob in order to make it free to move
- oscillate the wig-wag until the knob finds the locking path
- brake again the wig-wag using the brake lever
NEVER LEAVE THE WIG WAG UNBRAKE
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8.1.3 MOTORIZED MOVEMENTS
The circumferential movement, the orbital movement and the SID movement (if available) are motorized.
The C-Arm positioning controls has the following characteristics:
• Motorized positioning, using continuous operator activation, along any degree of inclination within
its maximum excursions
• Automatic stop at the pre-set positions of 0°, +/- 30°, +/- 45°, +/- 90° (if available for the considered
movement).
• Automatic position search, using continuous operator activation, to one of the four previously stored
custom positions.
The movement commands are available in the system control page, which also visualizes the angular
position (degrees) of the rotational and circumferential C-arm positions, as well as the SID column, and
horizontal positions (mm) and the irradiating area (cmxcm).
The system control page, shown above, provides several subpanels which displays all the control commands
for the C-arm movements. Each one of these subpanels will be displayed enabling a specific key. In
particular:
will show control buttons to “manually” position the C-arm:
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SID movement
Vertical movement
Circumferential movement Orbital movement
Notable positions movement

Movimento verso posizioni prefissate
Orbital and circumferential Brake release
movement speed reduction
Horizontal movement
will show control buttons to move the C-arm towards notable positions.
will show the buttons to memorize the C-arm position using one of the four memory positions or
move the C-arm towards a required one.
will show the control buttons to move the C-arm position to the available projection positions.
8.1.4 CIRCUMFERENTIAL MOVEMENT
The circumferential movement may be motorized or also manual, depending on versions.

If available, the manual movement can be done after the circumferential brake have been disabled acting on
its control lever.
AFTER UNLOCKING THE BRAKE, THE MOVEMENT MUST BE CONTROLLED THROUGH THE
APPROPRIATE IDENTIFIED HANDLE.
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IMMEDIATELLY AFTER ANY MANUAL MOVEMENT PUT THE BRAKE IN LOCKING POSITION
BEFORE TO LEAVE THE C-ARM UNCONTOLLED
The circumferential movement, if motorized, can be operated using the and keys. The rotation
occurs along the circumference of the C-arm.
The negative circumferential movement is defined as the one where the C-ARM flows from top to bottom of
its support, while the positive circumferential movement is defined as the one where the C-ARM flows from
the bottom to the top of its support.
The motor moves continuously as long as the key is pressed. Whenever the key is released the movement
stops immediately. The movement ends as soon as the C-arm circumferential position reaches the upper and
lower stroke limits, such positions are identified by two limit proximity sensors. Moreover, the
circumferential movement is monitored by the anti-collision control system, whenever the unit is equipped
with it. this option and properly configured. For more information.
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The reading of the angular positions has a precision which is limited by the flexibility of the C-
arm. The precision is +/- 2°.
The anti-collision system is to be considered a tool to support the operator's supervision. This
system does not perform security functions.
The anti-collision system must be deactivated only in particular conditions, in case of real
necessity and always with the full supervision of the technician who must visually check the
movement of the C-arm. Eurocolumbus S.r.l. is not responsible for any damage related to the
use of the instrument in the event of deactivation.
The intervention of the anti-collision system does not affect radiological functions. Even during
the collision warning, the unit can emit x-rays.
8.1.5 ORBITAL MOVEMENT
The orbital movement may be motorized or also manual, depending on versions. If available, the manual
movement can be done after the orbital brake have been disabled acting on its control lever.
AFTER UNLOCKING THE BRAKE, THE MOVEMENT MUST BE CONTROLLED THROUGH THE
APPROPRIATE IDENTIFIED HANDLE.
IMMEDIATELLY AFTER ANY MANUAL MOVEMENT PUT THE BRAKE IN LOCKING POSITION
BEFORE TO LEAVE THE C-ARM UNCONTROLLED
The orbital movement can be operated using the and keys. During such a rotation, the C-arm
changes its inclination along the lateral direction. For safety reasons, the range is limited up to +/- 210°.
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As for the circumferential movement, the C-arm moves as long as the proper key is pressed. Whenever such
a key is released the movement ends. In addition, such a movement is monitored by the anti-collision
control system, whenever the unit is equipped with it, and the control is active.
The reading of the angular positions has a precision which is limited by the flexibility of the C-
arm. The precision is +/- 2°.
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8.1.6 VERTICAL MOVEMENT
The C-arm vertical positioning is controlled using the and keys.

The C-arm positioning along the vertical position can be regulated from the minimum height to the
maximum one according to the needs.
In addition, such a movement is subject to the anti-collision control system, whenever the unit is equipped
with it, and the control is active
The precision of the up down position reading is +/-1mm.
If, during the vertical movement, the user sets a sudden change of direction, the
electromechanical vertical switch could deny the command without providing the movement.
This is normal: the switch itself comes with a protection control which requires a 1 second
minimum pause whenever a change from one direction to the other is set.
BEFORE THE UNIT NEEDS TO BE MOVED OR TRANSPORTED, IT’S HIGHLY RECOMMENDED TO

SET THE LOWEST VERTICAL POSITION IN ORDER TO PRESERVE THE INTEGRITY OF THE
MECHANICAL ELEMENTS.
In case of connection with the CT70T Evolution device, it is possible to obtain the vertical
movement of the table with the buttons on the side.
The table positioning along the vertical position can be regulated from the minimum height to the maximum
height according to the needs. In addition, the movement is monitored by the anti-collision control system,
whenever the unit is equipped with it, and the control is active.
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The movement stops at the limit of the stroke
In case of connection with the CT70T Evolution device, it is possible to obtain the contemporary
vertical movement of the C-arm and the table with the button on the side.
The contemporary movement can be controlled only by the C-arm control system. The
activation of movements performed through console of the table does not generate C-arm
movement.
In case of contemporary movement, the positioning deviation between the two elements is
max +/- 1cm.
When one of the two devices reaches the end of the stroke, also the other stops the
movement.
IN CASE OF CONNECTION WITH THE CT70T EVOLUTION MEDICAL DEVICE, THE SAFETY DEVICES
DESCRIBED UNITIL NOW WORK IN THE SAME MODES.
THE LOSS OF CONNECTION BETWEEN C-ARM AND TABLE GENERATES THE INTERRUPTION OF
ANY COMMAND GIVEN BY THE C-ARM INTERFACE. WHEN THE C-ARM ANTI-COLLISION
SYSTEM OR THE IMPACT WITH EXTERNAL ELEMENTS INTERRUPTS THE MOVEMENT, THE NON-
IMPACTED MOVEMENT IS ALSO INTERRUPTED.
IN CASE OF CONNECTION WITH THE MEDICAL DEVICE CT70T EVOLUTION BOTH THE DEVICES
MUST BE CONTINUOUSLY KEPT UNDER CONTROL IN ORDER TO CHECK THE MOVEMENTS IN
EVERY INSTANT.
8.1.7 HORIZONTAL MOVEMENT (OPTIONAL)
The C-arm horizontal positioning is controlled using the and keys. The range of the
horizontal movement depends on the unit model. For details on the various models please refer to the table
in the chapter 17.
The C-arm positioning along the horizontal position can be regulated from the minimum extension to the
maximum one according to the needs.
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To be noted that, in case the unit is not equipped with horizontal movement, the two keys shown above will
not be visible. In addition, the automatic movement is not allowed when the movement is unbraked.
The precision of the horizontal position reading is +/-1mm.
If, during the horizontal movement, the user sets a sudden change of direction, the
electromechanical switch could deny the command without providing the movement. This is
normal: the switch itself comes with a protection control which requires a 1 second minimum
pause whenever a change from one direction to the other is set.
BEFORE THE UNIT NEEDS TO BE MOVED OR TRANSPORTED, IT’S HIGHLY RECOMMENDED TO

SET THE C-ARM POSITION CLOSEST TO THE MACHINE IN ORDER TO PRESERVE THE INTEGRITY
OF THE MECHANICAL ELEMENTS.
THE HORIZONTAL MOVIMENT MUST BE CONSTANTLY MONITORED BY AN OPERATOR
8.1.8 SID MOVEMENT
The SID (variable Source Image Distance) movement is available only if provided in the
configuration provided. The SID movement is controlled using the two keys, and at
maximum of about 130 mm.
Please note that along with the SID movement also the collimator blades will adjust so to
ensure a self-collimated x-rays beam, always centered and limited to the sensitive area of the
detector.
The SID movement does not allow to set custom movements limits.
Again, as for the other motorized movements, such a movement is under the control of the anti-collision
system, whenever the unit is equipped with it, and the control is active.
The SID position indication has a precision of +/-1mm.
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8.1.9 NOTABLE POSITIONS MOVEMENT
Both for the circumferential and orbital movement, the C-arm can be positioned at notable angles, such as
+/- 30°, +/- 90°, +/-45°, 0°, pressing the proper keys among the ones shown below:
In order to move the C-arm to the desired circumferential/orbital position the user must keep the key
pressed otherwise the motor will stop as soon as the key is released.
In addition, such a movement is under the control of the anti-collision system, whenever the unit is
equipped with it, and the control is active.
8.1.10 PROJECTION POSITIONS MOVEMENT
The projection positions can be configured and saved for each anatomical program and for each consequent
body area using the web interface.
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Once those notable projections have been configured, the user can eventually visualize them
pressing the key, and if needed move the C-arm to the position that results in the configured
projection position by selecting the proper one among the seven available:
Where the C-arm position is expressed with respect to the patient position, according to the following
nomenclature:
• CRA: Cranial, meaning towards the patient’s head
• CAU: Caudal, meaning towards the patient’s feet
• LAO: Left-Anterior Oblique
• RAO: Right-Anterior Oblique
The configuration of the projection positions can only be carried out by operators with a
privileged access level, so in case of necessity contact the technical assistance.
8.1.11 POSITION MEMORIES
The unit is provided with four position memories. The user can quickly and easily store a position in each
one, as a combination of circumferential, orbital movements and sid position.
The movements toward the previously stored positions are performed in a semi-automatic way, meaning
that unit automatically control that the target position has been reached and stops at it. However, the user
must keep the command key pressed in order to perform the movement. In this way, maximum safety is
guaranteed during the procedure.
In addition, such a movement is under the control of the anti-collision system, whenever the unit is
equipped with it, and the control is active.
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8.1.11.1 STORING C-ARM POSITIONS IN THE MEMORY
In order to move the C-arm towards one of the memory keys M1, M2, M3, M4 the user must associate at
least one C-arm position to one of the previous keys. In order to do so, the following steps must be followed:
1. Move the C-arm to the desired position using the normal circumferential and orbital movement
commands, previously mentioned.
2. As soon as the desired C-arm configuration position has been reached, press the
“memorizing” positions key in order to open the following sub-panel:
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3. Choose one of the four memory key provided (M1, M2, M3, M4), and press the
memorizing program key associated.
4. Check if the memorizing process has been completed by looking at the circumferential and orbital
angles and SID position displayed just below the selected memory key (see the figure above). The
latter should now match the current ones.
5. In order to save another position, start again from point 1.
8.1.11.2 MOVEMENT USING THE POSITION MEMORIES
To use one of the position memories (M1, M2, M3, M4) follow the steps described below:
1. Make sure that at least one among the four keys contains a stored position, as explained in the
previous paragraph.
2. Press the “memorizing” positions key in order to open the proper sub-panel, as
described in point 2 of the previous paragraph.
3. Choose the proper one among the available keys, according to the desired C-arm position. Keep
pressed one of the M# key.
4. When the position has been reached, the C-arm automatically stops moving, thus the user can
release the key.
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8.1.12 EASY ANTI-COLLISION SYSTEM
The units can be equipped, as optional, with the Easy Anti-collision System by Eurocolumbus. This system is
able to detect the proximity of any object within a predefined range in the proximity of the sensitive
surfaces. Such a system detects any collision around the detector and the tube head.
The operating distance set in the factory is about 3cm.
Any conductive object (such as the patient body, the operators body, the structure of the operating table,
surgical lights, carts and floor lamps, etc..) that comes close to the sensible area and below the minimum
distance will result in an immediate arrest of any movements in progress. Moreover, the collision will be
notified both on the system control page and the monitors, which will become red as soon as the limit is
overcome.
Moreover, any further movement will be prohibited. Indeed, any movement control button will be disabled.
In order to ignore the collission signal and so move the C-arm the following key must be pressed .
Whenever, the latter is “turned off” the anti-collision control system will be disabled. In addition, both the
system control page and the monitor will notify that the anti-collision system has being ignored by turning
orange.
If the anti-collision system includes sensors divided into the right and left side of the panel and the tube, the
relative orbital and column movements will in any case be inhibited.
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WHEN THE KEY IS PRESSED, THE MOVEMENT IS FULLY UNDER MANUAL CONTROL.
ONLY THE MECHANICAL SAFETY LIMITS WILL BE ENABLED. PAY CLOSE ATTENTION TO THE
MOVEMENT AS THE ANTI-COLLISION CONTROL ARE DISABLED. PLEASE NOTE THAT, FOR
SAFETY REASONS, THE ELECTROMECHANICAL LIMIT SWITCHES WILL REMAIN ACTIVE.
TO COMPLETELY DISABLE THE ANTI-COLLISION SYSTEM, PRESS THE APPROPRIATE BUTTON
REPORTED ABOVE AND ALSO PRESS THE COMPLETE ANTICOLLISION DISABLING BUTTON
LOCATED ON THE SYSTEM SETTINGS PAGE.
The deactivation of the anti-collision system must only take place under special conditions, in
case of actual necessity and always with the full supervision of the technician who must
visually check the movement of the C-arm. Eurocolumbus S.r.l. is not responsible for any
damage related to the use of the instrument in case of deactivation.
The operation of the anti-collision system does not affect the radiological functions. Even
during the collision warning, the unit is capable of emitting X-rays in any of the provided
procedures.
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9 TURNING OFF
Before switching off the stand, move the unit to the parking position, as this is not possible
when the machine is off because it is the motorized C-arm.
The unit switch off procedure requires only one step, since the processing unit will automatically switch off
the stand as well. Therefore, before turning everything off, make sure the unit is in parking position.
The whole system can be turned off pressing the key in the touch screen console home page. As a
consequence, the software will ask to confirm the choice showing the following pop-up:
If the unit is equipped with UPS and this detects a power failure, the unit will show the following warning pop-
up on the doctor's monitor and on the touch screens and will turn off in the indicated time, closing any open
exams:
9.1 EMERGENCY SWITCH OFF
The unit is provided with two red emergency buttons and an optional button on the side of the
MINI TROLLEY ETS15, that can be used to immediately switch the whole unit off, if needed. These
emergency buttons are available at the back of the trolley, on the touch screen ETS15 and on the
side of the MINI TROLLEY ETS15.
These emergency buttons are manual rearmable push button switches. Therefore, after been pressed, they
will stay pressed if not intentionally re-armed.
The emergency shutdown cuts off the power supply from the generator and the C-arm (the touch screen
console ETS15 and all the functions it controls are disabled, including movements). The processing unit
(computer) mounted in the trolley stays active in order to avoid data loss.
To reactivate the system, re-arm the emergency button before repeating the unit turning on procedure. To
rearm the emergency button turn it clockwise until it snaps back into its operating position.
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9.2 EMERGENCY RESTART
The unit, due to its characteristics and its normal use, does not provide any emergency operation status,
meant as a working condition with limited functions.
The unit, considering its peculiarities and its normal way of use and intended use, does not provide a
functioning in a state of emergency as a partial or limited operating status.
In case of accidental switch off, or temporary blackout that causes a unit switch off, the user will need to
normally turn the whole system on.
IN CASE OF A SUSPECTED POSSIBLE FAULT, THE RESTART MUST BE PERFORMED WITH THE
MAXIMUM ATTENTION.
Below is shown a flow chart describing the actions to be undertaken when an emergency re-activation is
required.
START
The supply NO
Verify the power line
voltage is present?
YES
NO
The emergency buttons Rearm the emergency button
are all armed?
YES
Is the main
NO Switch on the main power
switch on? switch on the lower back part of
the trolley
YES
Push the start button to try a

restart
Wait for the complete start-up of

the unit (about 2 minutes)
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IN CASE OF A SUSPECTED POSSIBLE FAULT, THE RESTART MUST BE IMMEDIATELY STOPPED

AND THE UNIT MUST BE DISCONNECTED FROM THE MAINS.
In the event that the shutdown should occur by means of the emergency button, reactivation
takes 30 seconds.
9.3 X-RAY EMISSION INTERLOCK
For security reason, the unit is equipped with a physical interlock switch, placed on the trolley. Whenever
such interlock is active the emission will be inhibited and the x-rays icon will turn red, as shown below:
10 FLY SOFTWARE
This chapter describes the main features of the Fly software, with particular attention to the graphical user
interface (GUI).
10.1 USER ACCOUNT MANAGEMENT
The Fly software requires a user login in order to access any sensible data from the database. However, a
user login is not required when an emergency exam is intended to be opened. When such a condition is
verified, press the “CANCEL” key on the login pop-up which appears at the software start-up:
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10.1.1 USER LOGIN
In order to login, the software requires each user to have an account previously configured by the system
administrator. If such a requirement is met, then the user will be able to login into the Fly software providing
proper “user-name” and “password”.
Each account configuration requires a specific access level. Indeed, users can have different level of access
to the system and the access level is a property of each user. Here is a list of the different access levels
configurable and their respective privileges:
• Anonymous: the user will have partial privileges. It does not allow access to the system database
nor the system settings page. A user may need to log in as “Anonymous” in case of emergency so
that it will have easily access to the images.
• Operator: the user will have regular privileges, except management functions or administrator
privileges.
• Database manager: the user will have privileges concerning the database management, i.e delete
the exams from the database or modify the patient data.
• Administrator: the user will have all the administration privileges, therefore it allows to add, delete
and configure other users. For more information on the functions of this access see the technical
manual.
As soon as the user is logged in the system will make available all the functionalities in accordance with the
user access level. During the its operation, the system will register all the user’s login and logout on a proper
log file, together with the login/logout date and time. Moreover, the user logout is allowed exclusively when
the exam has been closed and pressing the key in the home page.
To sum up, assuming that the software functions can be classified as follows:
• acquisition, ability to open an emergency exam, insert patient data and start acquisition procedure.
• Elaboration, ability to elaborate images once acquired
• delete, ability to delete runs from an exam or exam as a whole from the database
• modify patient data, ability to modify patient data and exam in the database
• system configuration, ability to configure the system network and basic functions and modify users
account
Here is a table that summarizes all the access level and their privileges:
Acquisition Elaboration Delete Modify patient data System configuration

Anonymous X
Operator X X
Database manger X X X X
Administrator X X X X
To be noted that there are further access level which enables further functionalities, however those will be
discussed in the technical manual.
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10.2 GRAPHIC USER INTERFACE (GUI)
The graphical user interface (GUI) is a type of user interface through which the user interacts with the
software by means of graphical icons and visual indicators. The Fly software graphical interface is basically
composed by 6 pages and the user can navigate through them selecting the correct icon from the top tool-
bar. As shown in the figure below, each page is identified by an appropriate icon, and each one is committed
to a proper functionality.
Here is a brief description (for a detailed characterization please refer to the following paragraphs):
Home page: allows to configure a new exam and eventually recall the patient data form the
DICOM work list.
Database page: for the management of exams database.
Viewers page: allows to view open exams.
System control page: this key is used to monitor and set, in the case of manual control, the
emission parameters. It allows to control the movements of the arc.
System settings page: this key is used for system settings, such as monitor management,
network management or DICOM functions. It is organized in sub-pages accessible according to
the level of access.
System monitor page: this key is used to monitor the entire system, providing access to logs and
error logs, when present.
To be noted that an icon of the GUI will be represented differently depending on weather it is
enabled, disabled or selected. If the icon is slightly visible and nor the contour nor the icon is
lighted up, then the button is disabled, and its functionality will not be available to use. If the
icon and its contour are visible and lighted up, then the icon is enabled and its function as well.
Lastly, if the icon highlighted the icon is actually selected and the associate function is
currently active.
10.2.1 HOME PAGE
The home page is the initial page of the GUI. From it the work list can be downloaded, and the exam can be
configured. As shown in the figure below the home page can be seen as composed by 3 sub-panels; one for
loading of the work list (1), one for the addition of the exam data (2) and one for the selection of the
procedure (3).
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1.
2.
3.
Moreover, compared to the other pages, three more buttons are present on the top tool-bar, those are:
User button: opens the “user login”.
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Text label button: is used to switch between text mode and icon mode. In the first case, the
button consists of a brief description of the functionality, in the second of a graphical
representation of it.
Switch off button: used to switch off the software.
When the trolley is disconnected from the arc the following disconnect icon appears at the top
right. In case of disconnection the exam will be closed.
When the panel is disconnected but the trolley is connected to the C-arm, the following icon
appears. Similarly, in the event of disconnection, the current exam will be closed.
10.2.1.1 WORK LIST
The DICOM work list can be either downloaded from a remote PACS server or loaded from a local
file, where such a file has been created locally as a copy of the last work list downloaded remotely.
Therefore, when no Internet connection is available, selecting the “Remote” tab, the work list can
be downloaded locally (pressing the button synchronize button) and when needed, selecting the tab “Local”,
the work list can be loaded from the file saved locally.
Moreover, the research on the remote server may be filtered using some patient information, such as
Surname, Name, Sex, Birth date, ID of the patient, or using exams data, such as date start, date end, Station
AET, and modality. By default, the dates are set to the current one.
In order to exploit the Work list function, the system should be properly configured for the
connection to the srever. This configuration should be performed by technical assistance.
10.2.1.2 EXAM DATA
As soon as the work list has been loaded from a local or remote database, the selection of the proper patient
information within the list will automatically fill out the exam data. To be noted that all the fields marked
with a yellow asterisk (*) are mandatory. Moreover, if any incorrect entry may occur the “X” button allows
to clear all the fields.
THE "X" BUTTON DO NOT DELETE THE PATIENT FROM THE MEMORY BUT SIMPLY CLEARS THE
PATIENT DATA FIELDS.
If all the mandatory fields have been completed and the anatomical program has been selected
then the exam can be regularly initialized clicking on the flag button.
However, in case of emergency, in order to speed up the access to the image acquisition system in
case of emergency procedure, the exam can be initialized by simply pressing at the emergency
button.
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10.2.1.3 EXAM PROCEDURE
The exam procedure can be selected from the list of available anatomical optimized programs. As explained
below, each of them is identified by a suitable icon and is coupled with a pre-set of default acquisition and
setup parameters. However, all the system parameters might be changed through the proper function in the
GUI.
CARDIOLOGY programs: Two are the cardiology programs available, Electrophysiology,
and Hemodynamic. Both offers optimization procedures, such as pacemaker placement,
coronary angiography, catherization and spider position.
GASTROENTEROLOGY program: it involves subprograms such as PCR, endoscopy.
NEUROLOGY program: it involves pre-set configurations for neurosurgery procedure on-spine.
ORTHOPEDIC program: it involves an optimized procedure for each body district.
UROLOGY program: it includes default optimized configurations for kidney and urinary tract.
VASCULAR program: for each region of the vascular system a proper optimized procedure is made
available. It may include also optional programs such as DSA and Roadmap.
PEDIATRIC program: it enables functions for pediatric purposes, i.e. additional filters and dose
reductions.
In pediatric procedures or if necessary, the grid can be removed manually, without the use of
tools or instruments.
10.2.2 DATABASE PAGE
This page is committed to the management of the exams archive. The database page can be seen as divided
into three sub-panels. The “Exams selection” sub-panel contains the fields from which to filter the research
within database: local, imported, external or from the PACS server. Those are mainly, the patient data and
the exam info.
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The "Exam List" sub-panel shows the exams selected and loaded from the system database.
While the “Runs view” sub-panel visualizes the list of runs present in the selected exams.
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10.2.2.1 EXAMS SELECTION
The exams can be loaded from four different units. The source can be specified selecting one of the
following tabs at the top of the Exams selection sub-panel:
which identifies the local archive.
which identifies the imported archive. It includes the data previously downloaded from the
PACS server by means of the “Query-Retrieve” tab.
it allows to upload the exam from an external unit, such a hard-drive. It is an optional
function therefore it may be not present in the software GUI.
Using the buttons on the side, the external unit can be accessed or removed.
If the external unit contains local exams, obtained with the same instrumentation, they are
loaded into the corresponding subpage, after setting the filtering data with the corresponding
button.
Exams obtained with other devices can be loaded only if
in DICOM format from USB or CD
To select / deselect all exams, hide them and load them the
corresponding buttons are shown on the side.
“Q/R”: The DICOM Query/Retrieve function is used to download data coming from a
configured PACS server. As previously mentioned, before sending a query command to
the external database, some filtering information may be added in order to speed up the
searching process.
Query command: Therefore, once the filtering data have been set, a query command can be
send. The "Query results" panel will be displayed on the right side of the page, showing all the
studies in the database compatible with the data entered.
Being the query/retrieve mechanism based on the hierarchic structure of each individual SOP instance in the
DICOM standard, the data retrieved will be structured as follows:
Studies → Series → Images
As a result of the first query the software GUI will show all the available Studies in the PACS server.
"retrieval / download of studies" button: the user will be able to retrieve/download the whole
available studies for each patient, or send another query command, pressing the "query command"
button.
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The result of the second query will be a list of all the available Series (for the selected Study) which again can
be further queried , or retrieved/downloaded locally. Similarly, the result of a second query will
be a list of all the Images with the same Series which can finally be selected and retrieved/downloaded
individually or as a whole. During the operations mentioned above the following sub-panels will be visible:
In order to simplify and optimize the research, the exams can be filtered by means of one or more patient
info (Surname, Name, Patient ID, Acc. Number, etc) or through the exams data, such as specialty,
department, operator or doctor. If any incorrect entry occurs all the fields can be cleared selecting the “X”
button.
To be noted that each Study/Series/Image may be individually selected selecting the left column
corresponding to the proper line and the appropriate key.
It is also possible to select/deselect all the exams the exams using the appropriate keys.
The results can be deleted using this button.
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As shown in the figure above, a selected exam can be exported on a USB unit selecting the proper tab. In
addition, depending on the user access level it may be possible to modify the patient data from the
equivalent tab. When the latter function is available, the following panel will open:
To be noted that some or all the exams appearing in the sub-panel can be hidden pressing on this
button.
10.2.2.2 EXAMS VIEW

The Exams view sub-panel visualizes the list of exams previously loaded form the database. As in the
previous case, from such a list an exam may be selected individually or altogether through appropriate
buttons. For any selected exam, as shown in the figure below, the images, information and dose statistics
can be visualized, exported and printed.
The "Dose Report" button allows the view, and eventually print, the dose level report of the exam
highlighted on a new page.
The “Statistics” tab, will visualize a new page containing a copious amount of data about the
patient and the exam which may be printed as well.
From this sub-panel also, a Radiation Dose Structured Reports (RSDR) may be exported on a
USB device or to a PACS storing service.
Similarly, a Dose level report or a DICOM file may be exported to a PACS storage system
One or more dose level reports can be directly printed pressing this button.
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In addition, the image may be exported on a USB unit as a Raw or TIFF format and
after on CD.
Lastly, the exam list can be unloaded pressing the “Unload” button.
To be noted that the “delete” button will be enabled only if the access level is appropriate.
10.2.2.3 RUNS VIEW
The images included in the selected exams are visualized as a list in the current panel, as depicted in the
figure below.
As for the previews paragraphs, the selected run is indicated by a check sign on the left column.
In addition, the operator can check exclusively the runs marked as important (▲) pressing the
proper button.
In order to visualize the appropriate image in the monitor page, select the desired run and then select the
row. As soon as the row is highlighted in yellow, which means that it has been selected, the image will be
visible. As shown in the figure above, for each run other than its Id, its acquisition time, its program and sub-
program, the acquisition mode, Dose Level and Recording Mode are shown:
Each run may be exported as a DICOM format to an external USB device connected to one of the USB port
available, CD/DVD or PACS storage system. In addition, an image can be converted or not (Raw format) to
TIFF format and loaded on a USB device or CD.
Each of these procedures is completed by selecting (✓) near the line of interest and clicking the button for
the desired export. During the procedure the software returns feedback to the user and confirms the success
/ failure of the procedure.
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10.2.3 VIEWERS PAGE

1
The viewer page is committed to the visualization of the images that are acquired during the exam or
present in the system database. As shown in the figure above, this page is made up by two viewers monitors
and for each one of this monitor it is possible to switch among six different pages or panels, navigating
through the tool-bars (1) at the top page.
Each tab of the tool-bars will open a different panel among those listed below:
Panel acquire: visualizes the panel which includes the main acquisition settings, such as the
selection f body district, acquisition mode, AEC etc.
Panel play/preview: visualizes the panel which includes the controls for the digital video player.
Panel analyse: visualizes the panel which includes the control and functions for the image
analyses.
Panel preview: visualizes the panel that includes all the previews of the current run.
Panel information: visualizes the panel that reports all the information about the current exam,
run and frame.
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Panel C-arm: visualizes the panel that includes all the information about the C-arm and the buttons
for its control. To be noted that only the C-arm panel is available at the time that no examination is
open or loaded.
Monitor panel: displays the image corresponding to the icon represented, as explained below.
To configure the type of monitor to be displayed, the user can use the buttons in the left
and right corners, respectively.
The user can select the monitor of interest from the list of monitors shown, as shown in the following
example:
To be noted that the icons may differ from those shown above depending on the types of configured and
active monitors.
Namely, both monitors can be configured as:
Real-time monitor: visualizes live images as they are acquired. Where the number at the bottom
right corner refers to the left (1) or right (2) monitor.
Dvp monitor: visualizes recorded images previously loaded from the database and selected from
the list of runs. In the case of subtracted images or roadmaps the number at the bottom right
differentiates the image reproduction modes.
Monitor of the last image acquired: it automatically updates and displays the last image acquired
during the exam. This monitor is only available for the left monitor.
Fixed reference monitor: shows a fixed image, which is maintained as a fixed reference image. This
monitor is only available for the left monitor.
Monitor with DICOM image: shows an image in DICOM format previously imported into the
system via USB and / or CD device.
Monitor with 3D DICOM image: shows an image in DICOM format previously imported into the
system via USB and / or CD device. This type of display is possible if the 3D image reconstruction
(also MRI) is possible from the DICOM study.
From both panels, the displayed images can be:
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set as a reference and transferred on the right monitor, through the “Transfer Image” button. To
be noted that the reference image will always be moved to the right monitor since it is the only
one equipped with the reference image functionality.
Saved on an external support, through the “Export” button.
If one or more individual frames have been marked (▲), at the click on the button the following message
will appear allowing you to choose the format and export target between DICOM PACS, DICOM USB, DICOM
CD and PNG format. If no frame is selected as imported, the images are automatically saved in PNG format
without any message appearing.
Printed on the local configured thermal printer, if present, pressing the “Print” button.
It is possible to adjust the opening/closing the collimator directly on the image: selecting the button
and touching the image the blade will be positioned at the indicated point. To adjust the position,
simply slide your finger on the touchscreen ETS15 to the desired position: the blade will follow the
finger movement until it is released. The button automatically deselects on release. In order to
continue moving the collimator in this way it is necessary to re-select it. This button is visible only with
the monitor in real-time.
Select an image analysis tool. By default it is set to the gestural mode of scrolling between frames
and run. When the gesture mode is active, it is possible hold down any point in the image to display
of instructions on how to use gestures, as shown in the following image:
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To select the desired analysis tool press this button. Will appear the following popup message:
Each analysis tool with the corresponding icon is also briefly described. The selected instrument will become
the current one only after confirmation.
When a tool different by the default tool is selected, the selection button will change color and show
the icon of the current tool.
The available tools, besides the gesture mode, are the following:
Manual movement of the frame
Image rotation
Pointer tool to view a red laser when a point is pressed on the image.
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Drawing tool
Text annotation
Measuring tool
Stenosis tool
Redraw the ROIN of the processed image
The last four tools, if selected, cause the opening of the Analysis Panel, where there are additional features.
Please refer to the chapter Panel Analyze (10.2.3.4) for further explanations.
10.2.3.1 GENERAL INFO
1 2 3 4 5 6 7
The figure above illustrates the bottom section of the viewer page which is always visualized, independently
from the active panel in the two monitor pages. It gives information about:
1. the space left in the working and storing database,
2. the effective exposition time, total time and dosimetry
3. Information about the material used as a filter and its thickness (3), the anode and housing
temperatures as they approach their limits
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4. The acquisition and exposure levels such as kV, mA, pulse length and frame-rate.
The “x-ray” symbol indicates the system status: it turns blue when the exposure is disabled, the
interlock is active, or the detector is not ready; it is green when the exposure is enabled, yellow if
under exposure and red if there is any exposure error, generator error or of any other kind.
5. Among the general information, the sub-panel shows when:
the AEC mode is enabled,
which Dose Level is used,
if the “Hard Metal” function is applied,
which kind of recording mode is active.
The software also shows the following icon if the offsets with which the panel is working are
in the range of +/-3 ° compared to the measured temperature, otherwise in the place of ✓
will be shown the following !, in yellow.
6. It also visualizes the acquisition modes and commands configured on the pedal
Below are listed all the icons representing the control actions that can be associated to the pedal:
Change mode x-rays command 0
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Change mode x-rays command 1
Fov up: increase the Fov dimensions
Fov down : decrease the Fov dimensions
Fov change: switch FOV
Dose up: increase the Dose level
Dose down: decrease the dose level
Dose change: change dose level
Save last run
Fix image
Re-mask
Voice control
Saving the last run may take a few seconds. A popup is shown during this operation (below on the
left) and at the end (below on the right).
Voice control, when activated by pedal, allows the following commands:

• "show run #": shows the desired run
• "mark run #": marks the desired run
• "play": reproduces the current run
• "stop": stops the current run
• "fov in": closes the collimator of a step
• "fov out": opens the collimator of a step
• "next": shows the next run
• "reference": sets the current run as a fix image.
7. Lastly, the sub-panel indicates the FOV dimensions (6), in mm, and the c-arm angular positions (6),
in degrees.
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This icon appears instead if it is recommended to use the high dose program.
10.2.3.2 PANEL ACQUIRE
By default, when an exam is open the monitor “2” will show the acquire panel so that the user will be able to
modify the default acquisition settings, while the monitor “1” shows the live image. First of all, the user will
need to select the proper body district from the “Program Selection” sub-panel (1) by selecting on the
desired body area. Moreover, for each body district a proper sub-program may be loaded from the
“Programs Selection Menu” below (2). To be noted that the available body districts and associated sub-
program depends on the anatomical program previously selected while opening the exam.
Using the “Patient Orientation” drop-down menu it is possible to select the patient's position between
prone, semi-prone, supine, standing, kneeling, frog, sitting and right or left lateral decubitus. On the basis of
the selected district, it is possible to choose the current laterality.
Subsequently, the operator can modify the default settings for the analytical sub-program in use as well as
the functions associated to each pedal (identified as Xrays Cmds).
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1 2
In particular, for what concerns the pedal commands, knowing that the left pedal is referred as number 0
and the right one as number 1, the buttons in the section "Cfg Cmds" (1) allows to configure the control
action associated to each pedal button choosing from the list previously explained. In addition, the operator
can select from the “X-rays” command menu (2) the acquisition mode associated to each pedal button,
choosing among the followings:
Scopy
Scopy SS
Scopy HQ
Scopy HQ SS
Scopy HQ DSA
Scopy HQ DSA CO2
Scopy DSA Roadmap
Graphy DR
The available image acquisition modalities depend on the main program selected.
The recording modality can be specified individually for the “Scopy” and for the Scopy “HQ” selecting the
proper one among the following list:
Record only last image
Record all frames
Save the last run
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Furthermore, the operator can modify the Dose Level, selecting the desired
one among “High”, “Normal” and “Low” dose level, from the “Dose Control”
sub-panel.
In addition, for acquisition modality present for the sub-program chosen, it is

possible to vary the “Noise” and the frame-rate, as shown below. For each one
of those values, two buttons are available in order to decrease (-) or increase
(+) the quantity.
The default settings may be restored pressing on the “Defaults” button.

Additional options are the automatic exposure control mode (AEC), which can be disabled/enabled, as well
as the Hard metal function.
When the “Roadmap DSA Scopy” is enabled (depending on the sub-program previously selected)
also the subtraction mask may be changed using the button.
Lastly, among the acquisition settings, from the “Anatomic Filters” sub-panel, the operator can vary the
filters quantity used for the image processing. In particular, those filters are:
Gray compression level
Median filter
Contrast level
Edge level
Latitude level
Windowing
If the “DSA “acquisition modality is enabled a further sub-panel “DSA Filters” will be displayed, allowing to
adjust:
Brightness level
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Contrast level
Land marking: It allows to regulate the percentage of anatomic view below the Road-map view.
DSA noise correction factor: check the image opacity
For each one, the left button is used to decrease the filter value, while the right one to increase it. In order
to restore the default values, press the “Defaults” button.
10.2.3.3 PANEL PLAY/PREVIEW
The following description of the play / preview panel refers to the images reproduced if a DICOM image is
not shown in the monitor of the side panel.
2 3
This page provides all controls for the review and navigation of the acquired exam runs. Through the
“Options” sub-panel (1) the user can enable the auto-play function for the “Scopy” or “Scopy HQ”.
Therefore, the run will be played automatically for the selected acquisition modality as soon as it is selected.
The Runs Tools sub-panel (2) provides:
the button that allows to view all the runs of the exam (as a sequence) or only the selected run
filtered by the user;
the control buttons that allows to navigate through the exam runs and select eventually the previous run (←)
or the next one (→).
The “Play Tools” sub-panel buttons (3) provides the possibility to play, slide through the different
frames using the sliding bar.
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Finally set up the reproduction speed of the run.

Where 100% means the same speed of the original acquisition frame-rate.
The secondary panel "Image Tools", as well as the secondary panel "Review tools", includes command
buttons to: navigate within the frames selecting the previous (←) or next frame (→), to mark the frame as
important using (▲).
This button instead allows you to deselect all the frames marked as important (▲).
It is even possible to select the first or the last frame.
This button allows to view useful tools in the secondary panel below:
1 2 3
The secondary panels “Cfg Views Left” and “Cfg Views Right” (1) show and allow the choice of the
reproduction mode in the case of subtracted images and roadmaps. It corresponds to the same functionality
of the display panel as selecting the DVP Monitor.
The button matches are as follows:
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The DVP1 monitor shows the subtracted image.
The DVP2 monitor shows the trace of the subtracted image.
The DVP3 monitor shows the anatomical image.
The buttons on the secondary panel (2) respectively allow to recalculate the mask, set the entire stack or the
image as a trace for the roadmap.
The pixel shift panel (3) allows to move / reset the image with respect to the mask.
This button allows to view the "Anatomic filters" and / or "DSA Filters" secondary
panel visible if the one shown above is visible. This new panel provides controls
for the filters to be applied during image processing
Finally, the preview panel contains a preview list of all the runs in the current exam on the right side sub-
panel (). From it the user can directly select the run and mark them as important. The navigation buttons
allows to navigate through the pages if the runs occupy more than one page. The list then can also be
filtered by the runs selected or marked.
If instead a DICOM image is shown, this panel will be divided into a Settings section (1), several sub-panels
that allow scrolling between the different instances, series and, in the case of DICOM multiframes, video
playing (2) and a section with zoom and measurement tools (3).
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The setting sub-panel (1) allows the adjustment of the DICOM image by acting on the WindowLevel e
WindowCenter parameters, by default set to the values read by the selected series or by the instances.
This button allows to set these parameters between the different instances and series that are part
of the same study.
If a study contains more series or instances, the start / stop buttons of the overview (1), which allows
automatic scrolling between the different images, and the manual scroll buttons (2) will be enabled in the
Runs Tools sub-panel.
In the case of DICOM multiframes, the subpanels containing the reproduction and scrolling tools between
frames allow the following functions:
• manual scrolling between frames (1),

• selection of the first or last frame (2),
• setting the playback speed (3),
• start / stop video playback (4).
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1
3
These buttons show, in the Tools subpanel, which of the interaction modes with the DICOM image is
set and its selection. If the Panoramic interaction mode is enabled (in the top),it is possible to move
image by touching it . If the Measures interaction mode is enabled, it is possible to add measures or
modify existing ones.
The zoom buttons allow to increase, decrease or reset the zoom of the image. The
reset button also allows you to return to the default image position.
Using this button it is possible to make the zoom parameters and image position permanent between
the different instances and the different series.
If the Measure interaction mode is enabled, you can add measures using the appropriate button.
Pressing the button adds a measurement object (as shown in the following figure), containing
information on the length of the measurement, color and with the possibility of hiding / showing the
measurement or deleting it.
It is possible to create the measurement by touching the image and dragging a finger on it.
It is possible to modify the image only if the relative interaction mode is enabled and the desired
measurement is selected.
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10.2.3.4 PANEL ANALYZE
The "Stopwatch" panel (1) acts as a stopwatch with the respective "stop", "play" and "reset" buttons.
The stopwatch is also visible on the doctor monitor, when it has a different value than the
"reset" status
For what concerns the “View tools” sub-panel (2), the user can zoom in (+) or out (-
) or restore the image dimensions through this button.
These buttons allow to mirror the image horizontally and vertically, or to swap
blacks and whites.
Furthermore, the sub-panel provides control buttons to rotate clockwise or

counterclockwise the image, as well as restore the default orientation.
Further functionality of the selected instruments are displayed here:

It provides also, the tools to draw on the image by pushing the following button, which will enable
and open the “Draw “sub-panel, as shown in figure below:
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From it, it is possible to choose between the writing or deleting tools
and tract widths.
It is possible to select the desired color by pressing the button.
Finally, the drawing may be hide or deleted.
The text box, through which the user enter text on the image. Selecting a point on the image
displays the following window:
which requires the user to enter an annotation. Press "OK" to save the text on the image.
Each annotation can be deleted by pressing the button in the "Overlay Tools" panel:
Measure tool
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When pressing the “Measurement” button the following control buttons will be shown:
Each measurement refers to a known reference measurement, with which the measurement system is
previously calibrated.
To calibrate the measurement it is necessary to acquire the image of an object with a known size (for
example a radio-opaque disk) placed in the field of vision according to a suitable inclination, thus arranging
the known dimension in a direction orthogonal to the beam.
Next, add on the image containing the known object in millimeters (mm), a measurement
indication: select the icon and click on the start and end point of the note dimension on the object.
Press the button that opens the following window:
and enter the actual measurement. Any other measurement made will be scaled using the known size. Note
that the measurements on the image are not affected by the zoom on the image.
In order to add a measurement indication on the image, such as a distance or length measure, the
user will need to select the button and then select on the image the measurement starting point
and final point (both are identified by a red dot when marked), as a consequence a segment
indicating the measure (mm) will appear.
Similarly, an angular measurement can be added selecting, where in this case three points need to
be identified in order for the measurement to appear on the image.
In addition, the measure indication can be moved on the image pressing the button and
then moving the start/end point along the image or deleted through the proper button.
Lastly, all the measurements can be deleted or hidden through the proper buttons.
The measurement limits of the system are given by the pixel size of the panel used (for example, if the panel
has a pixel size of 0.2 mm, the accuracy will be 0.2 mm), then refer to the panel technical sheet.
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It is necessary to recalibrate the measurement system, and then repeat the calibration procedure with a
known object (see above) every time the patient or the C-arm is moved.
Stenosis Tool
The viewfinder icon should be selected first in order to be able to draw on the image the reference
dimension (as for the measurements, click on the image to select the starting point and then click
again to select the last point).
As soon as the reference green segment has been draw, mark the start and end point on the image and a
segment will appear showing the dimension in percentage with respect to the reference, as shown in the
figure below:
As for the functions explained previously in this paragraph, the segment can be moved and
deleted (as well as the reference) through the proper buttons.
Image reprocessing based on the selected ROIN
Through the central button it is possible to restore the considered ROIN to the whole one, while
through the arrows it is possible to resize it as desired. In this way, the image considered will be reworked at
runtime.
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10.2.3.5 PANEL PREVIEW
The “Preview” panel displays all the runs of the current exam as a preview list so that the user can easily
identify and select the proper one.
As shown in the figure above, the list is disposed in the form of a grid and its
dimensions can be adjusted choosing among the following buttons. From left to
right, the icons show that the grid dimensions (number of previews per
row/column) can vary from lower to larger dimensions.
If the number of previews exceeds the maximum number for a single page, the up and
down arrows should be used to change them.
In addition, the previews list can be filtered so that it shows only the runs marked
as important (▲), checked (✓) or marked as single frame “fluoroscopy”, using the
proper buttons.
Indeed, as previously explained in this section, the buttons shown below may be
used to select one single run as important or select/deselect all the runs together
(from right to left)
Sam holds for the check sign.
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10.2.3.6 PANEL INFORMATION
The panel visualizes all the information about the selected exam, run and frame, dividing them into three
sub-panels (exam info, run info and frame info). All the information is referred to the image displayed in the
opposite viewer.
As shown in the figure above, the patient details and exams info are listed among the “Exam Info”, while
anatomical program and sub-program is displayed in the “Run Info”, together with data about the options
used (such as metal function). Lastly, the “Frame Info” contains data about the exposure and dose levels
while acquiring the frames.
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10.2.3.7 PANEL C-ARM
1 2
The “C-arm “panel provides the control buttons to move the C-arm along the principal directions, eventually
store the positions in memory in order to facilitate the c-arm positioning later on, and finally move the C-arm
in the Angle Positions.
The “Jogs” sub-panel (1) contains the buttons to control the C-arm movement along the vertical direction:
along the vertical direction
along the orbital direction
circumferential direction
horizontal direction.
In addition, it allows to brake/unbrake the horizontal carriage, in order to move the C-arm in
horizontal direction manually; in this case the automatic movements are blocked.
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The buttons allows to rotate the C-arm in any direction up to the 0° position, into
circumferential direction (green) or orbital direction (blue).
Whenever, the button is pressed, all the movements are slower.

To be noted that if the “radar” button is enabled, meaning that the anti-collision system is active,
all the movements which will inevitably lead to a collision will be disabled (impossible to control).
The secondary panel “Collimator” (2), provides the command button to be used to control
the horizontal opening of the collimation blades
vertical openings of the collimation blades.
and command button to decrease or increase the FOV (field of view).

This panel also provides other command button like:
the laser centering tool,
the field illumination lamp
the exposure time reset,
the enabling/disabling of the anti-collision system
and DFF movement

The “Mems” sub-panel (3) allows to store four C-arm positions described as a combination of the
circumferential, orbital and SID movement.
Therefore, in order to memorize the position, first position the C-arm at the proper location, using
the control buttons previously described, and then press the button associated to the proper
memory key (M1, M2, M3, M4). As a consequence, the description below will be updated showing
the new memorized position, as shown below:
Thus, C-arm will automatically move towards the memorized “M#” position whenever the “M#” button is
pressed. To be noted that such a movement is semi-automatic, meaning that the C-arm will automatically
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stop as soon as the target position is reached but in order to do so the user must keep the button pressed
for the while procedure.
The secondary panel "Isocentrism" (4) allows to activate this feature for circumferential
movements.
The following buttons allow you to move the isocenter in a vertical direction respectively
upwards and downwards.
10.2.4 SYSTEM CONTROL PAGE
1 2 3
The “System Control Page” provides all the information about the C-arm positioning and x-rays settings.
Those information are indeed updated constantly and shown in the central section (2) of the page, as shown
in the figure above. As previously mentioned, the “x-rays” symbol shows weather the x-rays emission is
active(yellow) or not (blue).
In addition to the general information, this page provides two main sub-panels which are equipped with
buttons for the control of the C-arm, the collimation system and other additional system services.
Starting from the left sub-panel (1), here is a list describing each control button and their related control
commands:
from which it is possible to access the list of positions with which to define the position of the unit
with respect to the patient and thus allowing the movement of the arc in pre-memorized
projections.
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Based on the figure shown above, the C-shaped bow is positioned relative to the patient in position;
indefinite, at the patient's head, at the patient's feet, on the left and right side (on the other side
downwards).
X-rays collimator control commands : the user can choose the filtering component along with its
thickness selecting the proper one from the “Selection Menu”, as shown below:
It provides the control buttons for the opening and closing movement of the collimator
along the horizontal direction
vertical direction
for the widening and narrowing of the field of view (FOV),
for the rotation of the blades
and their movement along the radial direction
Service function control commands: from it can be enabled:
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The centering laser il laser di centraggio,
The C-arm light
Trolley image display lift,
table movimentation,
reset the collimator to a max opening
button to release orbital movement brake. Note that this automatic brake release precludes
the possibility of automatic motor movement, therefore the icons relating to the orbital
movement will be switched off as soon as the brake is deactivated and reactivated otherwise.
anchor the movement of the C-arm to the bed.
In case of connection with the CT70T Evolution device, it is possible to obtain the vertical
movement of the table with the buttons above described. The contemporary movement can
be controlled only by the C-arm control system. The activation of movements performed
through console of the table does not generate C-arm movement.
Xrays commands configuration:
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From the right sub-panel (3) instead, the following control buttons are provided:
which opens a further sub-panel containing seven saved “projection” c-arm configurations.
Therefore, selecting the proper one, the C-arm will reach the memorized positions so that the
resulting projection matches the required one.
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Similarly, to the above command, this control button will open a further sub-panel showing the
four (M1, M2, M3, M4) c-arm positions saved. As shown in the figure below, for each one the fly
software saves the rotation angle, the orbital angle and the sid position:
which provides all the control buttons that allow to move the c-arm to known angular positions
along the circumferential and orbital direction, as shown below:
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which shows the commands that control the continuous rotation of the arc along the orbital and
circumferential direction, and the monitor vertical movement as well. If the system is equipped
with the DFF (Dynamic Field to Focal), the panel also include the button to modify the sid up or
down.
Unlike the previous commands, those here mentioned enable the “jog” movement, meaning that the c-arm
will move according to the specific requirement as long as the button is pressed, and will stop only if the user
releases the button or the c-arm reaches the limit or sees an obstacle in the way.
which opens the sub-panel containing the general settings. In particular, from it the user will be
able to enable/disable the automatic exposure control, select the required dose level among the
three available (low, normal, high), select the recording system for “Scopy” and “Scopy HQ”.
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which opens the “dose regulation” sub-panel. From it the user will be able to adjust manually the
dose parameter as well as the frame rate, according to selected acquisition mode. To be noted
that the manual configuration will be available only when the automatic exposure control is
disabled, otherwise the software will not use the required exposure level set.
If the pulsed exposure modality is active, the selection of the length of the pulse will be not available.
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10.2.5 SYSTEM SETTING PAGE
The System Settings page allows the configuration of the system, including the network, the monitors and
the channels associated with them.
Depending on the access level some settings are not configurable. In
particular, this page is divided into 3 sub-pages which can be accessed through
the corresponding buttons.
The required access levels are, from left to right, "Operator", "Administrator" and "Assistance" respectively.
Obviously, each page that is accessible to users with less privileges, as an operator, is accessible to users with
greater privileges, such as administrator or assistance.
The following chapter will deal with the "Operator" account, while the "Administrator" and "Assistance" will
only be described in the Technical Manual.
10.2.5.1 SYSTEM SETTINGS PAGE - OPERATOR
As shown in the figure above, from the “Operator” account page, the user may configure all the basic (1)
system functionalities such as:
• connect the external database
• choose the desired language among the listed ones
• enable/disable the mouse pointer and keyboard auto-hide
• enable more printed pages
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• take a screen-shot
• if the anti-collision system is disabled from the system control page, the button for completely
disabling the proximity sensor, allows to have no restrictions on the possible movements of the
machine
• configure the screens and monitor in which the FlyWiki tool is shown.
• configure the network, enabling either the wired or wireless Internet connection
In addition, this page provides the DICOM services configuration buttons. In particular, enable the MPPS
(Modality Performed Procedure Step Service)
In addition, the operator can select the desired server for the 3 modes of store / work list and Query /
retrieve and subsequently verify the operation of the connection through the "ping" and "c-echo" buttons.
10.2.6 SYSTEM MONITOR PAGE
10.2.6.1 FLYWIKI
FlyWiki is a visible help tool, if the license is enabled, which allows the search and display of content useful to
the user regarding the use of the machine such as procedures and features.
Through the search bar (1) it is possible to search for the desired content using keywords. If the search bar is
left empty, pressing the search button (2) will display all the available contents. The FAQs show the most
commonly used content (3).
1 2 3
Each content shows a title and a short description. When a content is selected, images are shown to explain
the procedure or functionality.
If there are several images, these buttons allow scrolling between these images
If there are several images, these buttons allow scrolling between these images
By pressing the return button, it is possible return to the search page and stop playing the video.
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10.2.6.2 ERROR MONITORING
If a hardware or software error is revealed, the icon of the System Control page will start to blink
indicating the error event.
Icon stop blinking only after the user opens this page and deletes the errors listed using
the "clear" button at the bottom of the page.
A description of the error may be evaluated pushing the icon and getting access to the system control page,
where the erro is usually reported by code and description in red color. The error list may be deleted acting
on the "clear" button at the end of the page.
Example:
An
error popup will be also displayed to a brief period.
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10.2.6.3 LOG MONITORING
The events occurring in the fly software are regularly recorded as messages or logs which can be visualized in
the System Monitor page, selecting the “Logs” tab. Those messages are commonly used to understand and
track down the activity of the system and eventually diagnose a problem. As shown in the figure above, the
“Logs” page provides two lateral bars each one composed by several tabs representing a specific module
(left bar) or function (right bar) of the software. Therefore, selecting the proper one the user will visualize
the messages coming from that module/function. To be noted that irregular behavior of the software will be
displayed in yellow, while errors will be shown in red. The latter will be finally shown in the page opened
from the “Errors” tab.
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11 PROCEDURES
This chapter is meant to identify and describe the main procedure of the fly software.
11.1 SOFTWARE START-UP
The fly software starts-up automatically at the unit start-up. Indeed, pushing the power-on button at the
rear of the trolley, turns on the computer which gives the boot command to the fly software. The software
start-up procedure ends as soon as the GUI is “on-line”., meaning as soon as the anatomical programs key
are enabled, and the emergency button is shown, as described in the figure below:
The software immediately requires a system login and automatically asks for it, showing the following login
window:
It is mandatory, for the user to login in order to access any sensible data within the system database.
Therefore, it is always recommended to login, except if an emergency procedure is required. In the
latter case, select “CANCEL” and open the exam as “emergency” as soon as the GUI is “on-line”.
In order to login into the system enter a valid “user-name” and “password”, which should have been
provided by the system administrator and proceed with the exam configuration.
If no “user-name” nor “password” have been provided, please contact the system administrator or
eventually the assistance.
11.2 OPEN AN EXAM
In order to open an exam, the software requires either to fill in the patient exam data, or to open the exam
as an emergency procedure.
To open an exam as a regular procedure, the user must complete all the mandatory fields in the exam data
section, which involves, patient:
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• surname and name

• ID and acceptance number
• Sex and birth date
All that mandatory information is marked with an asterisk.
Further information, which are not mandatory to open a regular procedure are: the department, doctor and
operator name and the study ID.
In order to fill in the exam patient data the user can download the patient info from the remote work list,
from the local work list, or inserting each data singularly.
In the latter case, select the rectangular area next to each singular mandatory field and type in the data
using the keyboard that will appear. To move from one field to the one immediately below, use the “tab”
key of the keyboard:
As soon as all the mandatory information have been given, the “open procedure” button will turn into a flag,
as shown in the figure below:
Therefore, select the proper anatomical program among those available and open the exam
using the key.
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11.2.1 LOAD EXAM DATA FROM A REMOTE WORK LIST
This paragraph assumes that all the remote work list connection has been correctly configured and checked.
Before retrieving the data from the remote work list make sure that all the filters are consistent with the
requirements. As default, those filters are set to the configured AET station name and modality, and to the
current date.
Download the work list from the remote server by pressing the key. As a result, the table will fill
up with the patient data, as shown below:
Select the patient data, by clicking the proper row. In this way, the exam data will automatically fill up.
In order to delete all the patient data and select another patient from the work list, first clear all
the data inserted using the key, confirm the choice and subsequently click the proper row.
To be noted that if no connection was correctly established by the system the following window will be
shown:
If such a case occurs, please check the Internet connection or contact the assistance for the work list
configuration.
11.2.2 LOAD EXAM DATA FROM A LOCAL WORK LIST
If no Internet connection is available but the work list has been previously downloaded from the
server, select the local work list and the load key. As a result, the local work list table will fill in.
Again, select the proper patient and the exam data will automatically fill in.
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11.3 IMAGE ACQUISITION
At this point the unit is ready to acquire images. However, the emission will still be inhibited if the emission
interlock key is locked. Therefore, check that the interlock is unlocked.
Whenever the exam is opened, the software automatically opens the viewers pages on the touch screens
ETS15, which displays the viewer “Live” on the left side and the “Panel acquire” with all the acquisition
settings, on the right side. The doctor monitors, instead, will display the 2 configured default viewers.
From the “Panel acquire” the user should setup the:
• desired body strict, selecting the correct body part and choosing among the available programs from
the program list (which usually only contains a default program).
if no body part has been selected and the emergency program is available, the software starts from
the latter.
desired recording mode among “last frame” only, meaning that only the last frame of
each run will be saved, or “all frames”, which produce a multi frame run.
desired dose control: if low, medium, or high level dose.
desired field of view: which is the viewing area of the detector. It can reduce or
increased by a fixed percentage depending on what is the minimum and how many
steps were configured. Or It can be adjusted moving the horizontal or vertical blades.
Desired x-ray commands configured for each pedal: selecting the desired acquisition mode from the lists, as
follows:
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the available acquisition modes depend on the anatomical program previously selected when opening the
exam.
Desired x-ray commands configured for each pedal button: selecting the desired one from the command
lists, as follows:
check the acquisition settings: increasing or decreasing the noise level, the frame rate for each available
acquisition mode. First choose the acquisition mode from the acquisition mode list and then adjust its
settings:
As default the software automatically set the AEC as active. Therefore, the software is ready to start the
acquisition as soon as the pedal is pressed, and automatically regulates the exposure parameters in order to
meet the program settings configured.
Once the x-ray commands have been correctly selected from the list, start the acquisition by pressing one of
the two available pedals. The real-time image will immediately appear on the viewers touch screens ETS15
and doctor monitors, together with the exposure parameters computed by the software during the
automatic exposure control (AEC).
The system also constantly monitors the anode and housing temperatures and displays all the relevant
information in the lower sub-panel on the touch screens ETS15 as well as on the doctor monitors:
In order to change the projection, move the C-arm, following the instruction listed above.
If the body district has to be changed the user should newly setup the acquisition settings starting from the
top of the dotted list above described.
11.4 LOAD EXAM FROM DATABASE
An exam might be loaded from local, extern or imported database. For a detailed description of how to use
the Q/R command please refer to the appropriate paragraph.
In order to load an exam, follow the instructions described below:
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1. select the unit from which to retrieve the exams, choosing between local, imported or extern
(optional – therefore not necessarily present).
2. insert patient information in order to speed up the searching process. Eventually delete
all the patient information inserted and re-search results, if you entered wrong
information, using the button.
3. press the query key and select the right exam/s from the list resulting in the “Query
results”.
To select the exam, click on the first column of the row corresponding to the desired
exam/s and it will be marked as checked (✓).
To select/unselect all use the buttons on the sides.
4. once at least one exam has been selected, the software will enable the import button.
Therefore, click it in order to load it
5. at the end of the loading process, all the exams loaded are shown in the “Exams” list. Therefore,
select the desired exam by clicking anywhere on the proper row. The selection is represented as an
highlighted row.
6. choose the desired run among the ones shown in the “Run” list. In this way the selected ones will be
shown in the DVP viewers.
7. In order to unload an exam check (✓) the right row and use the unload key.
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8. If another exam is needed to be loaded, start again from point 1.
11.5 IMPORT EXAM
To import Raw images from USB device it is possible:

1. Select the external unit from which to retrieve the exam.
2. Select local images to upload images in Raw format (only if exported from other Eurocolumbus
machines).
3. Insert the USB device so that the desired images are accessible through the search button.
4. Select the desired exam and import it with the appropriate import button.
5. Then select the unit containing the imported exams, choose the exam just imported and load it
using the appropriate button.
6. The imported series will be visible. Just select one to view it.
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The steps to import DICOM images are:

1. Select the external drive from which to recover the images.
2. Select to obtain DICOM images from a USB device.
3. Select the desired exam. Using the appropriate button it is possible to access the contents of the
folder.
4. Using the same button in the DICOMDIR folder, you can access the DICOM images. To import the
images, select them and press the import button.
5. Then select the unit containing the imported exams, choose the exam just imported and load it using
the appropriate button.
6. The selection of the desired series allows its display.
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The steps to import images from PACS are:

1. Select the import method as Q / R using the appropriate button.
2. Get the list of exams through the search button.
3. Select the desired exam and import it using the import button.
4. Confirm the studies import request message.
5. Search among the imported exams the one just imported and download the exam with the
appropriate button.
6. The series will be visible. Just select one to view it.
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11.6 EXPORT EXAM
From the database page, each exam that can be retrieved and loaded can be also exported on
different devices/services, such as USB, PACS or CD.
From the “Query results” list, which can be accessed as described in the previous paragraphs, the user can
select the proper exam, marking it as checked (click first column of the desired row) and press the key. If the
following window opens:
make sure that the usb device is correctly attached to the system and eventually that the usb device is not
corrupted in any way. Using the “EXPORT USB” command, the marked exam is copied from the local device
to the USB unit. In addition, the user can use the same functionality and export the exam from the “Exam”
list, rather than the “Query results” list, as shown in the figure below:
In addition, from the exam list the following export functions are available:
• RDSR USB, a RDSR report is saved on an external USB device connected to one of the available USB
port.
• RDSR PACS, a RDSR report is saved to a remote PACS server. Therefore, make sure that the
connection is correctly established, if not contact the assistance.
• DOSE PACS, a dose report is saved to a remote PACS server. Therefore, make sure that the
connection is correctly established, if not contact the assistance.
• DICOM PACS, the whole exam is saved as a DICOM format to a remote PACS storage system.
Therefore, make sure that the connection is correctly established, if not contact the assistance.
• EXPORT USB, the whole exam folder is copied to an external USB device connected to one of the
available USB port.
• TIFF USB, all the runs within the exam are exported in TIFF format to an external USB device
connected to one of the available USB port.
Finally, from the runs list, the user can select one or multiple runs from an exam an export them using the
following functions:
• DICOM USB, the selected runs are saved in DICOM format to an external USB device connected to
one of the available USB port.
• DICOM CD, the selected runs are saved in DICOM format on a CD correctly mounted in the system.
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• DICOM PACS, the selected runs are saved as a DICOM format to a remote PACS server. Therefore,
make sure that the connection is correctly established, if not contact the assistance.
• RAW USB, the selected runs are saved in RAW format to an external USB device connected to one of
the available USB port.
• TIFF USB, the selected runs are saved in TIFF format to an external USB device connected to one of
the available USB port.
To be noted that the user should use the exams export functions rather than the runs ones, when the whole
exam has to be exported. Otherwise, if only single runs are needed use the export functions from the run
list.
During the export it is not allowed to open / close exams
Please note that for image quality control procedures on the X-ray machine it is advisable to export the
desired images in RAW format, verifying that the administrator has set up the export functions with full
resolution and 16 bit. These images are affected exclusively by panel calibration, defective pixel correction
and compensation to ensure panel linearity.
11.7 ALLARM POPUPS
The software reports any system errors or special conditions through pop-ups. Below is a list of possible
reports from the software with a brief description of the conditions in which they can be presented:
• Server connection failed:
Appears any time a server connection is missing or not set up, and the operator tries to use a
function which require it, for example a DICOM export or the sending of the dose structured report.
• USB device not found:
Appears when the operator tries to export on an external USB device, but this device is not found
connected.
• Insufficient data for the panel detector calibration:
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This popup may show up at the starting of the software. As stated in the description, wait few
seconds.
• Maximum exposure time reached:
The x-ray emission has exceeded the limit configured in the machine. If the message is particularly
critical, further notification is made by the software in the system monitoring page, "Errors" section.
The message is reported with the addition of an error code.
The administrator can enable / disable the acoustic signal during x-ray emission from the "Administrator"
panel of the system setting page. Refer to the technical manual for a description of how to change these
settings.
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11.8 MEMORY MANAGEMENT
The software constantly monitors the actual memory available in the system, making it visible on the display
page, in particular in the system monitoring bar:
The "work db" bar shows the percentage of available memory remaining on the solid state memory,
containing the current exam and any loaded exams, while the "store db" bar indicates the percentage of
memory remaining on the hard disk.
The software manages the "work" memory by moving the data on the "store" memory, and therefore on the
hard disk, whenever the percentage of free "work" memory falls below 20%.
In the event that both memories are full and therefore the percentage of memory "store" is full and the
"work" memory falls below 5%, the software prevents the storage of frames by setting the registration to no
frame and preventing the change. This event is reported to the operator with a suitable explanatory pop-up.
It follows that in order to continue saving images, it is necessary to free up memory on the hard disk.
IT IS NECESSARY TO CHECK THE MEMORY AVAILABLE ON THE RIGID DISC (INDICATED BY THE
SOFTWARE ON THE DOCTOR'S MONITOR) IN ORDER TO AVOID THAT THE SOFTWARE STOPS TO
REGISTER IMAGES DOES NOT JUST THE FREE PERCENTAGE BECOMES CRITICAL
11.9 REMOVABLE ANTI-SCATTERING GRID
The unit is equipped with a device to remove manually the anti-scattering grid as required by some
procedures, typically in pediatric procedures.
The grid can be removed without using tools or instruments.
11.9.1 REMOVABLE GRID ON C -ARM WITH ONLY MOTORIZED MOVEMENT
In C-arm with only motorized movement, the anti-scattering grid looks like this:
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If necessary, the grid can be removed unscrewing manually the four locking knobs manually, without using
any tools.
To reassemble the grid, it is necessary positioning it in the same originally direction. In addition, the grid
must be positioned by aligning the two notches of the grid with the notches of the support.
IF AFTER REPOSITIONING THE GRID, THE IMAGE OBTAINED HAS SHADOWS, THE CAUSE COULD
BE INCORRECT POSITIONING OF THE GRID. PLEASE PULL OUT THE GRID AND REPOSITION IT
UPSIDE DOWN.
11.9.2 REMOVABLE GRID ON C -ARM WITH MANUAL/MOTORIZED MOVEMENT
In C-arm with manual/motorized movement, the anti-scattering grid looks like this:
If necessary, the grid can be extracted manually, without using any tools according the following procedure:
1. Place the locking pin in the "UNLOCKED" position by pulling it outwards and rotating it 90 degrees.
2
3
1
2. Remove the grill by pulling it out with a little force
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3. To reinsert the grid, proceed in reverse order. Insert the grid in the seat, taking care to position it with
the label outwards (tube side), then reposition the pin in the locked position, turning it manually unitil it
snaps shortening.
IF AFTER REPOSITIONING THE GRID, THE IMAGE OBTAINED HAS SHADOWS, THE CAUSE COULD
BE INCORRECT POSITIONING OF THE GRID. PLEASE PULL OUT THE GRID AND REPOSITION IT
UPSIDE DOWN.
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11.10 USE OF THE PRINTER
DO NOT USE THE IMAGES OF THE LASER PRINTER FOR DIAGNOSTIC PURPOSES
The unit can be equipped with a thermal laser printer installed inside the trolley. The position of the printer
is on the side of the trolley (1) to be easily accessible
The printer uses the heating of a thermal head in contact with a special thermal paper to print images based
on the image data received at the input.
The printer's power switch, located in the lower left corner of the front panel, should always remain in the
"on" state in order to allow the printer to automatically turn on during the general machine start-up phases.
If it is not in the “on” state, press the following button to turn on the printer:
The printer is set to work correctly with the fly software system and the prints can be made directly using
the print commands available on the fly user interface:
Print button available in the fly software interface.
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However, the buttons available on the front panel of the printer are listed below:
UP991AD MODEL
7. Power ON/OFF switch. It should always remain in the on position.

8. Printer window display. Gives information during use.
9. Menu lever. Navigate menus by tilting up, down, left or right. Also, by pressing the center of the
lever, you can change the standby status to menu mode, or select menu setting items.
10. CONTRAST dial. Adjusts the contrast of printouts.
11. BRIGHT dial. Adjusts the brightness of the printouts.
12. CUT button (optional). Press to cut the paper at the end of a print job using the internal paper
cutter
13. FEED button. Hold down to feed paper.
14. MULTI PICTURE button. Toggles between the multi-picture mode and single-picture mode.
NOTE: this function is specific to the printer and different from the similar function made
available by the fly software to print multiple images on a single sheet.
15. CAPTURE button. Not available as a printer function for direct video sources, not used on the
machine.
16. COPY button. Press to print a copy of the last printed image. NOTE: subsequent print can also be
done with the fly software function.
17. PRINT button. Print command of the image from a video source. Not used in the machine.
18. OPEN/CLOSE button. Press to open or close the paper door. While printing, press to cancel the
print job.
19. Paper door. Open to install or replace printing paper, and to clean the thermal head and platen
roller.
20. 15. USB Flash Drive terminal and USB Flash Drive access lamp. Not used in the machine.
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UP971AD MODEL
1. Power ON/OFF switch. It should always remain in the on position.

2. Printer window display. Gives information during use.
3. Menu lever. Navigate menus by tilting up, down, left or right. Also, by pressing the center of the
lever, you can change the standby status to menu mode, or select menu setting items.
4. CONTRAST dial. Adjusts the contrast of printouts.
5. BRIGHT dial. Adjusts the brightness of the printouts.
6. FEED button. Hold down to feed paper.
7. MULTI PICTURE button. Toggles between the multi-picture mode and single-picture mode.
NOTE: this function is specific to the printer and different from the similar function made
available by the fly software to print multiple images on a single sheet.
8. CAPTURE button. Not available as a printer function for direct video sources, not used on the
machine.
9. COPY button. Press to print a copy of the last printed image. NOTE: subsequent print can also be
done with the fly software function.
10. PRINT button. Print command of the image from a video source. Not used in the machine.
11. OPEN/CLOSE button. Press to open or close the paper door. While printing, press to cancel the
print job.
12. Paper Cutter. Cut the paper as each image is printed.
13. Paper door. Open to install or replace printing paper, and to clean the thermal head and platen
roller.
11.10.1 LOADING PAPER IN THE UNIT
USE ORIGINAL THERMAL PAPER ONLY. USING NON-ORIGINAL PAPER MAY RESULT WILL
UNSATISFACTORY PRINTS OR DAMAGE TO THE PRINTER.
WHEN LOADING A NEW ROLL OF THERMAL PAPER, PAY MAXIMUM ATTENTION NOT TO
DAMAGE THE INTERNAL PARTS OF THE PRINTER
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DO NOT TOUCH THE PRINT SURFACE OF THERMAL PRINTING PAPER WHEN LOADING IT.
FINGERPRINTS, PERSPIRATION AND CREASES THAT MAY RESULT WILL LOWER THE PRINT
QUALITY.
The printer uses rolls of thermal paper to be loaded into the appropriate internal tray using the following
procedure:
1. Press the power on/off switch to turn the unit on:
The LCD display backlight lights in amber and shows the message “EMPTY”
when no printing paper is loaded.
The LCD display backlight lights in amber and shows the message “DOOR”
when the paper door is open.
2. Press the OPEN/CLOSE button to open the paper door.
3. Place the printing paper roll on the tray.

Using UPP-210SE/UPP-210HD
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Using UPT-210BL thermal film (only UP991AD model)
Place the paper with the heat sensitive side facing up. The printer will not print if the paper is
reversed.
4. Insert the paper into the groove of the paper tray and pull it out through the paper exit.
Place the paper near the center of the groove of the paper tray (inside of the guide). Note that
paper jams may occur if the paper is placed at the edge of the groove of the paper tray.
Pull out the printing paper to remove any slack and possible creases.
5. Press the OPEN/CLOSE button to close the paper door. You can also push the paper door to close it.
6. Remove the paper leading edge.
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UP991AD MODEL
After loading paper, press the FEED button to feed out 15 to 20 cm (6 to 8 inches) of paper and press the
CUT button to remove it.
UP971AD MODEL
After loading paper, press the FEED button to feed out 15 to 20 cm (6 to 8 inches) of paper. Then use the
paper cutter to remove it.
To use the UPT-210BL after printing with UPP-210SE/UPP-210HD, clean the thermal head
before printing. Otherwise, fine stripes may appear on printouts.
11.10.2 CLEANING THE THERMAL HEAD
If white stripes appear on the printouts, clean the thermal head using the cleaning sheet supplied.
Carry out the thermal head cleaning operation using the menu.
1. Press the power on/off switch to turn the unit on.
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2. Press the OPEN/CLOSE button to open the paper door.
3. Insert the supplied cleaning sheet, with the black surface facing down, into the groove of the paper
tray so that a small portion of the front edge of the sheet protrudes from the paper exit.
4. Press the OPEN/CLOSE button to close the paper door.

5. Press the menu lever. The first menu item “HISTORY” is displayed on the LCD.
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6. Display “CLEAN.TH” by turning the menu lever up or down, and then press the menu lever.
7. Confirm that “CLEAN:OK” is displayed, and then press the menu lever. The unit starts cleaning the
thermal head. “CLEAN.TH” is displayed on the LCD. The cleaning sheet stops, and the cleaning is
completed.
8. Press the OPEN/CLOSE button to open the paper door and remove the cleaning sheet.
12 RADIOPROTECTION
The unit is radiologic equipment emitting X-rays during the active phase (load applied).
Exposure to ionizing radiation, as X-ray, is dangerous and can have serious health consequences for any
person present in the proximity of the emitter if the specific safety rules in terms of radioprotection are not
complied. (Both in the event of exposure to the direct radiation of the useful beam, or in the event of
exposure to diffuse radiation).
The personnel using such equipment shall be trained and informed by the safety, prevention and protection
supervisors regarding:
• The risks deriving from the exposure to ionizing emissions;

• The correct working procedures to minimize the exposure to the ionizing emissions of himself, of the
patient and the other people;
• The radioprotection rules to be followed in order to minimize the effect of the exposure to the
ionizing emissions.
• personal protective equipment and the patient, designed to minimize exposure to ionizing radiation
THE OWNING AND THE USE OF THE UNIT MUST COMPLY WITH THE LAWS, DIRECTIVES AND
LOCAL REGULATIONS RELEVANT TO POSSESSION AND USE OF EQUIPMENT EMITTING IONIZING
RADIATION FOR MEDICAL USE
DO NOT APPLY X-RAY EMISSION IF NOT STRICTLY NECESSARY AND FOR THE MINIMAL
NECESSARY TIME
USE THE UNIT COLLIMATOR IN ORDER TO MINIMIZE THE AREA WHERE THE X-RAY EMISSION
WILL BE APPLIED (BEAM LIMITING) AND REMOVE ALL NOT NECESSARY OBJECTS WITHIN THE X-
RAY BEAM
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IN ORDER TO ASSURE THE MAXIMUM SAFETY TO THE PRESENT PEOPLE, USE THE UNIT WITH
THE TUBE HEAD IN THE LOWER SIDE (EMISSION DIRECTION DOWN TO TOP)
USE THE AUTOMATIC REGULATION OF THE EXPOSURE PARAMETERS OR THE PARAMETERS

THAT WILL ENSURE THE MINIMUM DOSE FOR THE PURPOSES OF THE EXAMINATION
MAINTAIN THE MAXIMUM FOCUS-TO-SKIN DISTANCE AS REASONABLE POSSIBLE, IN ORDER TO

MAINTAIN THE DOSE ABSORBED BY THE PATIENT AS LOWER AS REASONABLY POSSIBLE, AND
THEREFORE REDUCING THE SCATTERED RADIATION HARMFUL TO THE OPERATOR AND
DELETERIOUS FOR THE QUALITY OF THE OBTAINED IMAGE.
PAY ATTENTION TO THE QUALITY OF THE MATERIAL (E.G. THE SURGICAL TABLE) THAT ARE IN
THE RADIATION BEAM WHICH COULD CAUSE ADVERSE EFFECTS BOTH IN TERM OF DOSE TO
THE PATIENT, AND OF THE QUALITY OF THE ACHIEVED IMAGE
MAKE SURE THAT THE RADIOLOGIC EXAMINATION STAFF USES THE PERSONAL PROTECTIVE
EQUIPMENT (LEAD PROTECTIVE CLOTHING, THYROID COLLAR PROTECTION, RADIOLOGICAL
GLASSES, ETC.) WHEN OPERATING NEAR THE X-RAY SOURCE, ACCORDING TO THE
INFORMATION PROVIDED BY THE EMPLOYER AND THE QUALIFIED EXPERT
DURING THE EXECUTION OF RADIOLOGICAL EXAMINATIONS, THE STAFF MUST STAY IN THE
CONTROL ROOM OR SHELTERED BEHIND PROTECTIVE BARRIERS, FIXED OR MOBILE. IF THERE
ARE NO PROTECTIVE BULKHEADS, THEY MUST STAY AT THE MAXIMUM DISTANCE FROM X-RAY
SOURCE AND THE IRRADIATED OBJECT
DURING THE USE, PAY ATTENTION TO THE EXPOSURE LEVEL INDICATORS AVAILABLE ON THE
MONITORS AND ON THE TOUCH SCREEN CONTROL CONSOLE ETS15
THE ROOM WHERE THE UNIT IS USED MAY REQUIRE PARTICULAR RADIOPROTECTION
SOLUTIONS SUCH AS LEAD SHIELD, TO BE CARRIED OUT ACCORDING TO PRECISE
CALCULATIONS OF THE QUALIFIED EXPERT RESPONSIBLE FOR
FOLLOW CAREFULLY THE INDICATION OF THE RADIOLOGIST REGARDING THE PROTECTION OF

THE PATIENT IN ORDER TO PREVENT DAMAGE FROM EXPOSURE TO X-RAYS. THIS IS MORE
IMPORTANT WITH “HIGH RISK CLASS” PATIENTS SUCH AS PREGNANT WOMEN (THEY ARE
REQUIRED TO INFORM THE DOCTOR RESPONSIBLE FOR THE CONDUCT OF THE EXAMINATION
OF THEIR STATE) AND CHILDREN
The maximum dose emitted corresponds to the emission parameters of 63kV, 100 mA, 60 msec for a dose
rate of 495.1 mGy / min, obtainable in automatic emission mode, high dose, for the chest vascular program
in Scopia HQ DSA acquisition mode. During an exam, the operator can modify the x-ray field through the
following buttons, present in the acquisition panel:
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As shown in the following figures, the collimation area is always displayed on the image as an area delimited
by yellow dotted lines:
As soon as the collimation area is modified, for example restricted to an area (14x25), the image is
collimated in advance so as to make the actual irradiated area visible to the operator.
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Similarly, if the collimated area increases, the operator can determine before the application of the load, the
extension of the x-ray field:
12.1 SKIN DOSE MANAGEMENT
In case of long procedures, the skin dose level can exceed levels which can cause deterministic damages.
The unit offers many exposure modes, each one having different levels of emitted dose for time unit (called
Kerma Ratio or Dose Ratio).
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On the touchscreen control console ETS15 and on the doctor screens are reported the Kerma rate and the
cumulative Kerma related to the current exposure. Those values are continuously calculated by the unit in
reference with the current exposure level and parameters.
The indicated values are referred to system reference point which is described in terms of the distance (in
“mm”) form the x-rays tube focal spot towards the detector. The reference point definition is explicitly
defined in the structured dose report (RDSR “Radiation Dose Structured Report”) according to the DICOM
standard.
If the unit is equipped with movable detector, the reference point is assumed as the middle point of the
maximum focal to detector distance. If the unit has a fixed detector, the reference point is assumed as the
middle point of the focal to detector distance.
The automatic exposure control aims to give the lowest possible dose compatible with the required image
quality level of the protocol under use.
12.2 EMISSION LEVEL
The unit provide different anatomical programs, which may have an indefinite number of subprograms, all
selectable from the FLY elaborator user interface. To each functioning program is associated a different
setup resulting from the combination of the factory defined parameters.
In order to provide a reference, this chapter gives a reading of the dose levels which can be obtained using
the defaults configuration for each one of the anatomic program, and it is provided an indication of the dose
variation depending on each one of the user available settings.
To select each of the configuration, choose the desired anatomical
program the press the emergency button
Real-time dosimetric readers are constantly shown on the display page and on the doctor's monitor, as
shown in the following figure:
Furthermore, these indications are also made visible on the system control page:
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These values are updated in real time during the acquisition.

The dose measurement system is based on the use of 4 dose measurements made during machine
calibration and normalized on the mas value. These measures are used by the system that calculates the
real-time value by interpolating on these points and using the calculated mas value.
The accuracy of the real-time measurement is equal to the accuracy of the probe used to calibrate the
reference points, ie +/- 5%.
To ensure that the accuracy remains the one previously declared, it is necessary to periodically monitor and
verify that the measurement is correct, if this is not the case, it will be necessary to perform the reference
dose measurements again and calibrate the real-time measurement system of the Fly software.
TO DO THAT THE PRECISION REMAINS THAT PREVIOUSLY DECLARED, IT IS NECESSARY TO MAKE

CALIBRATION DURING THE ROUTINE MAINTENANCE PROCEDURES.
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12.2.1 DOSIMETRY
This chapter reports detailed indication related to the reference air Kerma Rates (instantaneous dose
emission) for each exposure program, as well as the maximum emitted dose levels.
All dose levels are shown in APPENDIX A and APPENDIX B of this manual and are referred to a standard
phantom made of PMMA layer having dimension 35 x 35cm and 20cm total thickness, which have been
positioned in contact of the detector. The measurement probe have been located ad middle point of the
focal-to-detector distance:
For each program and modality the tables reports the exposure factors and the obtained Kerma Rate and
the filter used. The stated kerma rate is expressed in mGy/min if not differently specified.
By varying only, the acquisition framerate, the resulting dose rate can be calculated summarily by
multiplying the dose rate shown in the table for the new framerate set, divided by the framerate in the
table.
It should be noted that during operation, the automatic adjustment varies several parameters at the same
time and therefore the above table is to be considered only a roughly quantitative reference to the variation
of the dose with respect to the change of the acquisition framerate.
Remember that doubling the level of the mA, or doubling the framerate, or doubling the length of the single
pulse, produces on average the doubling of the dose rate applied.
12.3 SIGNIFICANT ZONES OF OCCUPANCY
The following maps show the distribution of the radiation diffused by a PMMA phantom, both in the position
of normal use and in a 3-meters radius around the unit.
12.3.1 STRAY RADIATION
The following map shows the values of the radiation diffused by a PMMA phantom (20x50x15 cm) placed in
order to obtain the entry point of the beam at 25 cm distance from the detector, radiated with a beam
having the following features: 120Kv and 70kV at 7,2mAs. The map is shown both for the front position (left)
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and the side one (right). The stated dose values are to be considered to be measured at 75 cm from the
beam centre, with the c-arm positioned vertically in order to have the tube head in the bottom side.
Measurement assets:
Phantom
Measuring point
Support
X beam axle
12.3.1.1 MEASURED VALUES

Flat panel 30x30
Collimation area 30x30
Manual exposure at 70/120 Kv – 30mA – 25ms - 9 fps – equal to 6,75 mAs.
Lateral Front Lateral Front

Height from floor
70 kV dose 70 kV dose 120 kV 120 kV dose
(cm)
(mSv/h) (mSv/h) dose (mSv/h) (mSv/h)
190 0,5 0,5 5 5
170 0,7 0,7 8 8
150 1,2 1,2 11 10
112 1,7 1,7 15 13 * height of phantom
100 1,5 1,8 14 15
80 1,5 1,7 13 15
35 1,6 1,6 14 14
15 1,2 1,2 11 12 ** height of tube focus
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20x20 field
Lateral Front Lateral Front

Height from floor
70 kV dose 70 kV dose 120 kV dose 120 kV dose
(cm)
(mSv/h) (mSv/h) (mSv/h) (mSv/h)
190 0,15 0,15 1,3 1,4
170 0,25 0,25 2,2 2
150 0,45 0,5 3,3 3,5 * height of

phantom
112 1 0,8 6 7
100 1 0,9 6 8
80 1,1 1 5,5 10
35 0,9 0,8 7 8
** height of
15 0,55 0,6 5 5 tube focus
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No PMMA
Air only
20x20 collimation
Front Front
Height from floor
70 kV dose 120 kV dose
(cm)
(mSv/h) (mSv/h)
190 0,025 0,25
170 0,035 0,3
150 0,05 0,3
112 0,1 0,8 * height of phantom
100 0,11 1
80 0,15 1,2
35 0,1 0,9
15 0,05 0,5 ** height of tube focus
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12.4 ISOKERMA MAPS
In order to make known to the user which are the safe areas, i.e. those in which the diffuse dose is minimal,
please find below the isokerma maps determined at 1mt and 1.5 m from the ground, and with the C-Arm
positioned vertically and horizontally. The maps are expressed with reference to the patient entry point
(defined as the point at 15 cm from the isocenter, toward the direction of the X-ray tube). A cubic PMMA
phantom with 20 mm side was used. Doses are measured in uGy and are normalized to the dose of 1
Gy*cm2.
C-ARM VERTICAL POSITION, 1m from ground
C-ARM VERTICAL POSITION, 1,5 m from ground
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C-ARM HORIZONTAL POSITION, 1m from ground
C-ARM HORIZONTAL POSITION, 1,5 m from ground
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The load factors are visible in the monitoring panel on the display page and on the doctor's monitor:
In addition to the system control page:
These parameters are updated in real-time.
13 EMISSION
13.1 ACQUISITION MODES
The unit is equipped with a rotating bi-focal anode tube head.

The device has been designed to provide the following exposure modes:
• Scopy: pulsed fluoroscopy
• Scopy HQ: high quality pulsed fluoroscopy
• Graphy DR: digital manual radiography
• Scopy SS: single shot emission
• Scopy HQ SS: high quality single shot simulation
• Scopy HQ DSA: high quality pulsed fluoroscopy with digital subtraction (DSA)
• Scopy HQ DSA CO2: high quality pulsed fluoroscopy with digital subtraction (DSA) for Carbon-Dioxide
based contrast medium injection
• Scopy DSA Roadmap: pulsed fluoroscopy with digital subtraction and vessels roadmap
• Scopy Cont: continuous fluoroscopy
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The available image acquisition modalities depends on the main program selected. Please refer to section 6
for further details. Except fot the “Graphy DR” all the acquisition modes provide an automatic exposure
control which calculates the minimum emission levels which guarantee the target image quality for the
specific procedure.
Exposure modes are available depending on the selected anatomical program.
13.1.1 SCOPY: PULSED FLUOROSCOPY
The “Scopy” acquisition mode is the standard pulsed fluoroscopy where the xrays are emitted in pulses,
synchronized with the frame acquisition from the detector. The result is a dynamic image flux on the screen.
The acquisition frame rate can be varied according to the detector model and acquisition program under
use.
When the automatic exposure control (AEC) is active, the emission parameters (emission current [mA],
beam energy [kV] and pulses length [ms]) are automatically adapted to the current imaging scenario and
keep the dose to the minimum possible values.
The “Scopy” acquisition mode employs low dose levels, and for this reason it is mainly used in all cases
where the procedure requires long exposures (for example for the catheters routing).
13.1.2 HQ: HIGH QUALITY PULSED FLUOROSCOPY
The “Scopy HQ” acquisition mode is still a pulsed fluoroscopy mode similar to “Scopy”, however it produces
higher quality images, and therefore employs higher dose levels. As for the “Scopy” acquisition mode, the
AEC controls the emission parameters to adapt to the current scenario, and the frame rate can be varied
along a set of available values according to the program under use.
The “Scopy HQ” acquisition mode is intended to be used when a better image quality is required, for
example in procedures which include the injection of contrast liquid for diagnostic purposes.
13.1.3 GRAPHY DR: DIRECT RADIOGRAPHY
The “Graphy DR” acquisition mode allows using the unit as a normal portable X-ray system. The emission is
controlled at single shot and it is possible setting kV, mA and ms manually.
The “Graphy DR” acquisition mode allows the completely manual use of the unit and is usually used for
single exposures for equipment testing purposes (e.g. periodic checks, calibration).
When used together with automatic exposure control (AEC), this mode produces a single image similar to
the " Scopy SS”.
13.1.4 SCOPY SS: SINGLE SHOT EMISSION
The “Scopy SS” acquisition mode produces a single image when the emission is triggered. The AEC
automatically calculates the emission parameters. The image quality of the “Scopy SS” acquisitions is higher
than the images acquired with the standard “Scopy” acquisition mode, but it is still a low-dose mode.
The “Scopy SS” acquisition mode is suggested to be used for procedures where thers is no need for a
continuous image stream, such as orthopedic procedures, or when a more detailed view is required with
respect to a “Scopy” acquisition.
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13.1.5 HQ SS: HIGH QUALITY SINGLE SHOT EM ISSION
The “Scopy HQ SS” acquisition mode, as the “Scopy SS”, produces a single image when the emission is
triggered. The AEC automatically calculates the emission parameters. The image quality of the “Scopy HQ
SS” acquisitions is higher than the images acquired with the“Scopy SS” acquisition mode and more dose is
delivered to the patient.
The “Scopy HQ SS” acquisition mode is intended to be used whenever a single high quality image is required
during the surgery, for example to check the correct position of a stent or prothesis.
13.1.6 SCOPY HQ DSA: HIGH QUALITY PULSED FLUOROSCOPY DSA
The “Scopy HQ DSA” is a particuar “Scopy HQ” acquisition which employs a digital subtraction. The first
frames of the “Scopy HQ DSA” create a mask image, which will be subtracted to every following frame. As a
result of the subtraction, only the density differences with respect to the previous frames arise as
darker/lighter features in the image, as explained in the sequence pictures below:
During the “Scopy HQ DSA” acquisition. Te AEC works as for the normal “Scopy HQ” mode, until the mask is
acquired. After the subtraction the dose is locked in order to avoid artifacts in the density change displaying.
The positive density variations are displayed as darker points, while the negative ones in whiter points. In
case injection of a Iodine-based contrast medium, there is a positive density variation along the blood
vessels, which are then displayed as a dark trace.
The “Scopy HQ DSA” is intended to be used for the blood vessels analysis through the injection of a contrast
medium (Iodine based).
13.1.7 SCOPY HQ DSA CO2: HIGH QUALITY PULSED FLUOROSCOPY DSA FOR CO2
The “Scopy HQ DSA CO2” acquisition mode is similar to the “Scopy HQ DSA” one, but it is optimized for CO2
based DSA procedures. CO2 can be injected inside blood vessels instead of Iodine based media, with the aim
of reducing the side-effects to the patient.
In case of a CO2 injection, there is a negative density variation along the blood vessels, but in this protocol
the subtraction process is inverted with respect to the standard “Scopy HQ DSA”, and thus the vessels are
still displayed as a darker trace.
13.1.8 SCOPY DSA ROADMAP: PULSED FLUOROSCOPY ROADMAP
The “Scopy DSA Roadmap” acquisition mode is a particuar “Scopy” acquisition wich employs a digital
subtraction and in image fusion at the same time. The digital subtraction works in the very same way as for
the “Scopy HQ DSA”, but with lower dose involved. Moreover, a third image is involved in the image
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processing, together with the current frame and the mask, and it is a selectable darker trace image from a
previously acquired “Scopy HQ DSA” acquisition.
By default, the darker trace of the last acquired “ Scopy HQ DSA CO2” is selected as trace image, and it is
fused as a white trace on the Roadmap subtraction. In this way the white trace acts as a guide for the
catheter insertion in the blood vessels: the moving caterer is indeed seen as a positive density variation in
the subtraction, and is displayed as a high contrast dark feature, which moves along the white trace of the
blood vessel.
13.1.9 SCOPY CONT: CONTINUOUS FLUOROSCOPY
The “Scopy Cont” acquisition mode is a standard continuous fluoroscopy acquisition where the xrays
emission is switched on at the acquisition start, until the command is released, and the flat panel detector is
triggered at its highest possible frame rate. Due to the fact that the flat panels have a readout time during
which radiation signal is not collected, it is strongly recommended to used pulsed fluoroscopy modes only
for dose reduction purposes.
13.2 DOSE LEVEL
The Fly software in the unit provides three different dose levels for each acquisition protocol. The three dose
levels are called “Low”, “Normal” and “High”. By default, the dose level is set to “Normal”, but it can be set
by the user from the dedicated buttons in the Acquisition subpanel in touchscreen control console ETS15.
According to the normative the air kerma rate in radioscopy (CEI EN 60601-2-43, 203.6.101):
203.6.101 Range of AIR KERMA RATES in RADIOSCOPY
For RADIOSCOPY the MODES OF OPERATION provided for NORMAL USE shall include two modes,
designated normal and low respectively, producing different REFERENCE AIR KERMA RATES, such that
the value for the low mode does not exceed 50 % of the value for the normal mode. Additional MODES
OF OPERATION may be provided, with REFERENCE AIR KERMA RATES less or greater than the values
for the normal and low modes.
The fly software follows the normative, providing the “Low” dose level protocol with less than 50% of the air
kerma rate of the “Normal” dose level. Each acquisition mode can be configured to three dose levels (Low –
Normal - High) which result in different Kerma rates during the acquisition. The “Normal” dose level is the
default, and it is programmed to give the desired image quality according to the protocol under use. The
“High” dose level is intended to be used only when, due to hard imaging scenarios (thick patients or oblique
views) the “Normal” dose level does not guarantee the required image quality and reaches its emission
limits.
The “High” dose level protocol employs a higher dose per frame during the acquisition, with the aim of
reaching the desired image quality. In order to do so, due to system hardware limitations, the acquisition
frame rate (fps) may be lower than the one of the “Normal” dose level protocol. As a result, the “High” dose
level protocol, which has a higher dose per frame delivery, may result in an average air kerma rate lower
than the “Normal” dose level one.
The unit is equipped with a generator that can deliver up to 25kW.
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FOR DETAILED INFORMATION REGARDING THE MAXIMUM EXPOSURE LEVELS, PLEASE REFER
TO THE GENERAL CHARACTERISTICS TABLE ABOVE
THE INDICATION OF THE EMITTED DOSE LEVEL (KERMA), ARE REFERRED TO SYSTEM
REFERENCE POINT AS DESCRIBED ABOVE
THE UNIT EMITS IONIZING RADIATION. FOR THIS REASON IT IS IMPORTANT TO BE EQUIPPED
WITH THE PROPER PROTECTIONS DURING THE USE, ACCORDING TO THE LCOAL
RADIOPROTECTION LAWS.
13.3 EXPOSED FIELD AND COLLIMATION SYSTEM
The unit is equipped with a motorized collimator that can freely be controlled by the operator. The
collimator is equipped with:
• Lead blades iris for total filtering (4mm Pb)
• Parallel blades or cardiology blade (1mmCu) for partial filtering
• Additional filters: Air, 0.05 mm Cu, 0.1 mm Cu, 1 mm Al
The Fly AEC makes wide use of the additional filtrations in order to optimize the image quality / dose
delivery ratio.
13.3.1 COLLIMATOR: IRIS
The collimator is equipped with a round iris, in the units with the image intensifier detector, or square field
for the units having the flat panel detectors.
The iris maximum aperture, whatever it is, always corresponds to the maximum field used in that moment,
in other words it is always such to ensure the precise coverage of the active acquisition surface. This
maximum opening limit is automatically adjusted whenever the acquisition FOV (Field Of View) or the
variable DFF (Dynamic Focus to Detector distance) are changed.
The round iris can be closed up to 10% of its maximum aperture.
The square field iris can be completely closed (residual opening less than 1%). The square field iris can be set
to work with a rectangular field and also to close only on two of the four sides of the image. This operation
mode is typical in the case of units with rectangular field flat panel and for the applications of peripheral
vascular surgery.
The initial opening of the iris is always set to the maximum allowable opening for the selected field.
13.3.2 COLLIMATOR: BLADES
The collimator is equipped with blades for the partial filtering of the beam (1 mm Cu).
It is possible adjusting two movements of the blades:
• Rotation: angular position, clockwise or counter clockwise, with reference to the center of the image.
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• Open/close: closing/opening movement

The initial position of the blades corresponds to the edge of the visible image for the selected field.
The blades can be two parallel ones, closing toward the centre of the image, or only one with semi-concave
shape for cardiac filter).
13.3.3 COLLIMATOR: ADDITIONAL FILTERS
The collimator is equipped with additional filters which may be used according to the user needs. The Fly
AEC makes wide use of the additional filtrations in order to optimize the image quality / dose delivery ratio
according to the protocol under use.
These filters are available in four selections:
• Open field (air)
• 0.05 mm Cu (Copper)
• 0.1 mmCu (Copper)
• 1 mm Al (Aluminium)
All filters different from air, have as also an additional filtration of 1mm Al.
For all programs, the selected filter is indicated on the system control page by clicking the button:
From this secondary panel it is possible to display the filter in use, for example AL: 1.0 mm. By opening the
filter user you can then view all the filters available for this anatomical program and body area:
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13.3.4 IRRADIATED FIELD DIMENSIONS
The unit is equipped with an isocentric C-arm. Moreover, the reference axis of the x-ray beam is aligned in a
perpendicular mode with the center of the detector.
The detector - focal distance is 1050 mm +/-3% depending on the C-arm type and the type of the installed
detector.
Only on the units equipped with flat panel detector, and when the dynamic field to focal distance system is
installed, it is possible to change the SID (focal – detector distance) within a range of 13cm.
In all situations, the radiated field corresponds to the active area of the detector, or better to the area
displayed during the acquisition. The unit automatically adjusts the iris of the collimator maximum aperture
taking into account the selected field, the selected area of the image, the position of the SID (if present).
13.4 AUTOMATIC EXPOSURE CONTROL AEC
The automatic control system guarantees the best ratio between dose level and image quality under all
conditions. For this purpose, the exposure parameters are continuously regulated by the software, which
controls minimum variations of kV, mA and duration of the radiation pulse (ms).
The operator can check correct operation by checking that the parameters vary continuously until the
optimal dose is reached.
The automatic exposure adjustment parameters can be enabled pressing the key. As a default,
the automatic adjustment function is always enabled for both “SCP” and “SCP-HQ” modes
(enabled means that the icon is “lighted-up” and so turns yellow).
In case of particular needs it is possible to switch off the automatic exposure mode and turn on the manual
mode pressing the same key, which in this case “turns off ” and so disables the automatic mode. In manual
mode the kV and mA may be regulated from the C-Arm control panel ETS15.
13.4.1 DOSE REGULATION AND GRAY SCALE MANAGEMENT
The automatic control applies the dose regulation frame by frame. At each time the emitted dose is set in
order to allow the better view of the image gray scale depending on target density as well as the procedure
performed (image analysis). Therefore, it is important to always select the correct anatomical program while
performing an exam.
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13.4.2 MOTION DETECTION
The automatic control is also equipped with a motion detection function. Such a control of the image
regulates the recursive filtering correction applied which acts on the shadows of the moving objects.
This function is fully automatic and active when the automatic exposition adjustment is active. Its purpose is
to reduce the noise, improve image quality and reduce the dose.
13.5 SKIN DOSE MANAGEMENT
It is widely proven that the excess of x-ray dose may cause deterministic damage to the patient. This chapter
gives information on the dose levels for each working mode.
The units can basically work in two main modes, SCP and SCP HQ. This two modes classify the level of the
used emitted dose. The SCP (pulsed fluoroscopy) and the SCP HQ (high quality pulsed fluoroscopy) gives
different setting and dose level depending on the anatomical program, on the body district and on the dose
level selection.
13.6 THERMAL MANAGEMENT
The unit is designed for a continuous use, but the technical characteristics of some of their components
bring up some limits to length of the exposures. The main constrain related to the continuous exposure is
given by the thermal condition of the x-rays tube as explained in the sections below.
13.6.1 THERMAL PROBLEM
The X-ray tube can emit radiation until the anode and cuff temperatures are kept below certain values.
During the X-ray emission the rotary anode heats up due to the physical process. In order to restore thermal
equilibrium, part of the anode heat is transferred through the irradiation to the tube housing. However, this
brings the body of the tube itself to heat up.
There are two main physical limits beyond which the tube cannot function properly:
• The first is the evaporation temperature of the anode, ie the temperature at which the anode begins
to evaporate inside the X-ray tube, influencing the level of vacuum required for the emission of X-
rays.
• The second is a safety temperature for the headset, above which the cooling oil pressure inside the
cuff can become dangerous.
13.6.2 THERMAL CONTROL
The Fly software which controls unit constantly evaluates both the anode and housing temperatures, in
order to keep the tube always below the safety limits and guarantee that the x-rays emission is always
available.
The indication of anode temperature and housing temperature (in °C degrees) is available on the graphic
interface, both on the doctor screen and on the touchscreen control console ETS15 in more than one page.
In such a way, the user always has access to the status of the unit, as shown in the pictures below.
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The status bars which indicate both the anode and the housing temperature change color according to the
current status: when the indicator is green, the system is under optimal conditions; when the indicator is
orange, the system is in a warning status; when the indicator is red, the system is in a critical status, and it is
recommended to let the system cool down before continuing.
X-Rays tubes rotating anode work properly until they reach a temperature of 1000 °C, above this
temperature, the anode starts releasing particles in the vacuum tube which will affect its life-time. When the
anode temperature overcomes 1000 °C the indicator becomes red and it is strongly suggested to wait few
minutes for the anode to cool down. When the anode temperature is above 900 °C the indicator becomes
orange, indicating a warning situation, but it is still safe to go on with the exposures. The tube anode
equilibrium temperature during an operation may be around 800 °C. Indeed, the more the temperature is
high, the more the tube cools down fast and reaches an equilibrium between the exposures.
The temperature indicator for the housing becomes orange above 60 °C, and red above 70 °C. While the
cooling of the anode is fast, and it only takes few seconds to reach again a safety zone, the housing thermal
dynamic is much slower and the housing may take some hours to return to ambient temperature from high
values.
According to the program under use and the thermal status of the unit, the Fly software may disable some
acquisition modes which would cause an overheating of the x rays tube. When this happens, the acquisition
mode indicator becomes red as in the following picture, and the corresponding x rays command (pedal)
becomes ineffective. The normal “Scopy” acquisition mode is never disabled.
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As an alternative, the Fly software can react to prevent the system overheating by dynamically modifying the
emission parameters, in order to reduce the heat transfer to the tube and keep the status under control.
There are three control thresholds which may be triggered during the use from the temperature increase.
When a threshold is overcome, the system changes the emission parameters (image quality or frame rate
will be lowered), and the change is notified to the use by changing the color of the emission signal, both on
the doctor screens and on the touchscreen control consoles ETS15. The figure below shows how the
emission signals looks like after the overcome of the three temperature thresholds, indicating that the
thermal control is operative:
13.6.3 THERMAL LOCK
Together with the software control, there is a hardware temperature switch on the tube, which may disable
the emission, as a safety feature.
IN THE CASE OF EXTERNAL CAUSES (SUCH AS TOO HIGH AMBIENT TEMPERATURE) OR

INTERNAL FAILURES (BREAKS OR BLOCKAGE OF THE COOLING SYSTEM INSIDE THE UNIT), THE
INTERVENTION OF THE THERMAL SWITCH ON THE TUBE HEAD MAY OCCUR PRIOR TO
SHOWING OF THE RED ICON.
The hardware thermal switch is activated when the tube head body external temperature reaches the
maximum allowed value (about 75°C). When in thermal block condition, the unit blocks the X-ray emission,
but keeps working all other functions.
The thermal lock is a self-recovering status. In the case of lock, do not switch off the equipment. Keeping the
unit in operation will ensure the functioning of the internal cooling system and then automatically recovery
of all the functions within a time reasonably low. The actual thermal recovery time, from the lock
intervention to the condition of full operation, depends on the heat dissipation capacity of the environment.
With an ambient temperature of 20°C, the thermal recovery time takes place in about 5 min from the lock.
THE THERMAL RECOVERY OCCURS WHEN THE TEMPERATURE OF THE EXTERNAL TUBE HEAD
BECOMES LOWER THAN THE HYSTERESIS OF THE THERMAL SWITCH (TYPICALLY AROUND 65°C).
THIS CONDITION DOES NOT CORRESPOND TO THE CONDITION OF TUBE HEAD COMPLETELY
COLD. THE SUBSEQUENT PERIOD OF OPERATION BEFORE GETTING BACK TO THERMAL
SHUTDOWN CONDITION DOES NOT CORRESPOND TO THE MAXIMUM ONE.
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THE THERMAL LOCK CONDITION DO NOT CAUSE A RISKY SITUATION FOR THE PATIENT, THE
USER OR OTHER PEOPLE IN THE VICINITY OF THE UNIT. HOWEVER, THE TEMPORARY INABILITY
TO PERFORM AN X-RAY EMISSION DURING THERMAL SHUTDOWN CONDITION COULD RESULT
IN A PROBLEM FOR THE EXECUTION OF THE PROCEDURE. FOR THIS REASON, ATTENTION
SHOULD BE PAID TO THE INDICATORS OF THE THERMAL CONDITION OF THE UNIT ANY TIME
FOR THE DURATION OF ITS USE.
13.6.4 NOTES ON THE THERMAL BEHAVIOR OF THE DETECTOR
Whilst for the units equipped with image intensifier detector the problem of thermal management does not
arise, in the case of flat panel detectors the temperature of the detector is not a negligible problem.
The calibration of the flat panel detector is normally performed at an average working temperature
approximately 30°C. If the detector is at a very low temperature (<15°C) or at a very high one (>50°C), the
quality of the obtained images may not be optimal, with a background noise.
For the above reason, and as far as reasonably possible, it is recommended to perform the exam when the
panel has reached its optimum working temperature (about 30°C).
13.6.5 EFFECTS OF THE USE OF THE STERILE PROTECTIONS
As shown in the previous paragraphs, the ventilation of the parts of the unit that produce heat during the
use is particularly important, because it guarantees a longer time of continuous use.
The use of sterile protections such as sterile plastic bags or other materials, may decrease the aeration of
both the detector and the tube head, not allowing a correct heat dissipation. Although this condition does
not lead to a malfunction, it could significantly reduce the time of continuous use, making the thermal block
systems to intervene in advance (remember, however, that they are automatically reversible).
For this reason, it is appropriate to remove the sterile protections at the end of the procedure and as soon as
possible, so that to let to the tube head and to the detector the maximum ventilation required to quickly
dissipate the accumulated heat.
For units with liquid cooling of the tube head, the heat exchanger is located under the foot of unit. In this
case, therefore, the use of sterile covers on the tube head does not affect the heat exchange.
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14 MAINTENANCE
ALWAYS CHECK THAT THE DEVICE IS DISCONNECTED FROM THE POWER SUPPLY BEFORE
PERFORMING ANY OPERATION UNDER DESCRIBED
The useful life of the device if correctly maintained and used is equal to 10 years
14.1 DAILY MAINTENANCE
Daily maintenance is the responsibility of the user or the person in charge of the equipment as identified by
the owner of the equipment.
Daily maintenance procedures include:
- visual verification of the integrity status of the unit in all its parts
- verification of the correct functioning of the equipment as far as it is for the user: check of
functioning of the normal functions of use. Report in detail the cases of malfunction to the person in
charge of managing the equipment indicated by the entity holding the equipment.
- cleaning and parking the unit: as described in this manual.
The above procedures are to be considered as minimum indispensable.
14.2 ORDINARY MAINTENANCE
To guarantee the integrity of the machine and its characteristics as stated in this manual, the machine must
be subjected to ordinary maintenance with cadence and modality as specified in the technical manual.
14.3 CLEANING
It is advisable to adequately clean the parts of the unit that may accidentally come in contact with the
patient. Furthermore in order to guarantee the sterility of the unit parts which can came in contact with the
patient, the use of sterile covers is highly recommended, when operating in sterile environments.
IN CONTROLLED CONTAMINATION ENVIRONMENTS IT IS ALWAYS APPROPRIATE TO USE

STERILE PROTECTIONS ON THE ARCH A C, ON THE DETECTOR ASSEMBLY AND ON THE
TUBE HEAD BY CARING NOT TO LIMIT THE MOVEMENTS
THE COVERS ON THE DETECTOR UNIT AND ON THE TUBE HEAD MAY BE FIXED WITH
APPROPRIATE ELASTIC. THE PROTECTIONS ON THE C-ARM MAY BE FIXED WITH
ADJUSTABLE FIXING CLIPS, PROVIDED TOGETHER WITH THE ROOFS.
IMPROPER APPLICATION OF THE STERILE COVERS ON C-ARM INCLUDES RISK OF

INFECTION.
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THE UNIT MUST BE OFF BEFORE PERFORMING ANY CLEANING ACTION
CLEAN USING SOFT TISSUE AND NON-ABRASIVE DETERGENTS
NEVER SPRAY THE CLEANING AGENT DIRECTLY ON THE UNIT SURFACES
AVOID LIQUID DROPS DIRECTLY ON THE UNIT SURFACES
WE HIGHLY SUGGEST USING CLEANING AGENTS BASED ON QUATERNARY AMMONIUM
DUE TO THEIR AGRESSIVITY AGAINST THE UNIT EXTERNAL MATERIALS AND PAINTINGS,
NEVER USE CLEANING AGENTS CONTAINING: ALCHOOL, ORGANIC SOLVENT OF ANY
KIND, HYDROGEN PEROXIDE, CHLORIDE.
THE UNIT CAN BE CLEANED USING DISINFECTANTS +45 LIV PREVIOUSLY SPRAYED ON A
SOFT TISSUE. NEVER SPRAY THE CLEANING AGENT DIRECTLY TO THE UNIT SURFACES
PAY ATTENTION NOT TO TROW LIQUID AGAINST THE UNIT DURING THE CLEANING
PROCEDURES.
14.4 DYNAMIC FLAT PANEL SAFETY RULES
The dynamic flat panels are high technology and high integration devices. They are made by an amorphous
silicon panel and by a proper signal encoding circuitry. Their structure is quite delicate, but they are well
protected against mechanical damages by the external detector group carters.
14.4.1 MECHANICAL SHOCK
The flat panel has to be protected against mechanical shocks. Direct or indirect hits may definitively damage
the flat panel. Pay maximum attention to side exposed to X-rays as it is not protected by additional
mechanical structure of the detection group. These precautions should be taken during use, during
transportation and storage of the unit.
On both sides of the detector based on dynamic flat panel should not be put objects of any kind, neither
during normal use, nor during transport or storage of the unit.
THE SURFACE OF THE FLAT PANEL DETECTOR IS NOT DESIGNED TO BE USED AS A WORK
SURFACE. USING THE SURFACE OF THE DETECTOR IN THESE TERMS MAY CAUSE DAMAGE
TO THE APPLIANCE. THERE IS NO EVIDENCE OF RISKS FOR THE PATIENT OR THE
OPERATOR
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ON BOTH THE SURFACES OF THE DETECTOR BASED ON THE DYNAMIC FLAT PANEL, IT
DOES NOT NEED TO APPLY ITEMS OF ANY KIND
14.4.2 THERMAL DISSIPATION
During normal operation, the flat panel produces heat. The external structure of the detector unit ensures
sufficient dissipation of the generated heat provided there is sufficient circulation of air around it. In the uses
in which the detector cover is provided with protective plastic caps, these must however be installed in such
a way as to guarantee a sufficient amount of air around the flat panel, or at least removed at the end of the
procedure in order to allow the necessary cooling of the detector.
The quality of the images acquired is also a function of the detector temperature. In fact,
the gain calibration is performed at a temperature equal to the average working
temperature. Cold-acquired images, as well as images taken with the detector that is too
hot, may have a higher percentage of background noise than optimal quality. However,
the loss of quality is not such as to generate a possible risk. Remember that the average
operating temperature is around 30 ° C.
14.1 TUBE HEAD SAFETY RULES
For additional technical information, refer to the attached technical documentation
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15 TROUBLESHOOTING
The table below is intended to identify the most common problems encountered when using the machine,
and to offer solutions. In the event that the problem found is not present such a list or the solution provided
is not effective, refer to the technical manual
Problem Possible cause Possible solution
TURNING ON
The device does not Missing mains Verify that the wall plug receive supply from the line
turn on
Power cord not Verify that the power cord is well connected into the wall socket.
connected or not
properly connected
Wall switch not active Activate the wall switch (if present).
Umbilical cabling is not Check if the umbilical cabling has been properly connected to the
connected or not C-arm stand socket
properly connected
General switch not Turn on the general switch located on the lower back side of the
active monitor trolley.
One of the emergency Disable all emergency buttons (they shall be all pulled out)
buttons is pushed
Monitor
The monitors remain Power to the monitors Check if the monitors are turned on.
black is missing or the
Eventually check if the power correctly come to the monitors and
monitors are turned
if the signal plug is properly connected to them.
off
Movement
The s-arm stand brake Disable the c-arm stand acting on the brake lever
is active
The c-arm stand do
not move
The steering is not on Rotate the steering in the proper desired direction
the correct position
respect the desired
direction
The c-arm stand do The steering is not Rotate the steering in the proper desired direction
not move through directed into the
the desired direction desired movement
direction
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Monitor trolley do Wheel brake are active Unbrake all wheels pulling up each brake lever
not move
Wig Wag do not The wig -wag locking Unlock the wig-wag locking pin and the wig-wag brake lever
rotate knob or the wig-wag
lever brake are locked
One or more of the One or more fuses are Call technical assistance for checking and repairing
motorized motions blown.
of the c-arm do not
work in
Xray emission
Xray interlock key is Check the status of the xray interlock key and eventually turn it
active into the unlocked position
The beam emission Reset the max exposure time timer on the software interface
time has reached the
limit configured in the
No xray emission system
The tubehead thermal Do not use xray emission (exposures) and wait the cooling by the
switch opened due to cooling system. All other functions may be used. DO NOT SWITCH
high temperature OFF.
Error in the emission Try to fully restart the unit. If the problem persists, contact
system technical assistance
Software
Software seems not Possible error on Check that into the FLY software system log there are no displayed
answering to the software system errors (red lines). The error generally supplies also information
user controls regarding a possible solution. In case of needs, download the full
log file into a USB memory key and transmit it to Eurocolumbus
technical assistance for further investigation.
Printer
The printer doesn’t Missing paper or paper Open the printer front panel and check the presence of paper into
print jam the paper roll. Also check if the paper is correctly inserted into the
front paper feed mechanism.
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16 DISMANTLING
The unit includes materials which may be recycled and materials which requires disposal. Follow the local
rules for the dismantling and disposal, or even recycling, of the unit.
Eurocolumbus is not directly responsible for the disposal of the equipment, so it is strongly recommended to
always refer to authorized disposal companies able to dispose of the device according to local legal rules.
The following table provides general indications, but does not constitute an exhaustive list, relating to the
materials that make up the device and the type of classification in terms of disposal.
Hazardous waste
Part Material type Recyclable material Waste disposal
(separate collection)
Unit structure Alluminium X
- metallic pars Steel X
Unit covers ABS X
- plastic other X
Electric motors and
(X)
actuators
Component PCB (X)
Power supplies (X)
Detector (X)
Xray housing and Mainly
tube containing
aluminium,
copper, X XX
tungsten, glass,
lead and
dielectric oil
Generator Mainly
containing
aluminium, X XX
copper, and
dielectric oil
Inverter (X)
Computer (X)
Displays XX
Cabling (X)
Cooling system XX
Packaging wood (X)
cardboard (X)
paper (X)
poliethilene (X)
other (X)
Other (X)
X: disposal action
(X): some parts may be recycled following particular dismalting procedures and processes.
XX: some parts may be dangerous for the environment, so they shall be stocked following local rules for
dangerous materials and substances.
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17 TECHNICAL CHARACTERISTICS
Stand:
Width: 800 mm
Lenght: 1960 -2100 mm depending on the version
Height: 1710 - 1840 mm depending on the version
Dimensions
Trolley:
Width: 550 mm
Lenght: 550 mm
Height: 1600 -1900 mm
Stand (without monitor trolley ): from 360 Kg to 400 Kg depending on the version
Weight
Trolley: 165 Kg (depending on the configuration)
Free space within tubehead and detector: without DFF/SID 850 mm. With DFF/SID 850-
C-Arm geomertry 730 mm /920-800 mm depending on the version
C-arm depth: 690/730/750 mm depending on configurations
Horizontal excursion: 200/250/280 mm depending on configuration
Orbital: +/- 210°, +/- 225° depending on the version
Rotational: 180°, 150°, 140° depending on the version
Lift: 500 mm
Movement range
DFF/SID: 1050 for alien e version alien (2020/2121/3030) and alien X
Variable DFF/SID: 1050/930 for alien e version alien (2020/2121/3030) cardio;
1120 -1108 for alien e version alien (202075/212175/303075)
Wig-wag (horizontal oscillation): +/- 8° or +/- 12° depending on configuration
220-240 Vac - 50/60 Hz
Nominal power: 3680VA or 5750 VA depending on configurations
Working current: 16/25 A depending on configurations
Requires following socket and protections
With BOOSTER (25kW)
Supply
• IEC309 single phase interlocked socket, 16 A, P+N+PE
• Circuit braker not less than 16A curve C
Without BOOSTER:
• IEC309 single phase interlocked socket, 32 A, P+N+PE
• Circuit brakernot less than 25A curve C
During use +10 / +35°C

Ambient
temperature: Stocking / transport -25 / +70°C
Environmental During use 20 / 80% Ur not condensing
conditions Umidity:
Stocking / transport 5 / 95% Ur not condensing
Atmosferic During use 700 a 1020 hPa
pressure: Stocking / transport 500 a 1060 hPa (375 - 795 mm Hg)
17.1 GENERATOR CHARACTERISTICS
Inverter frequency 40 KHz

12 KW - 100 kV - 120 mA - 0.1 sec
Output nominal power depending on versions 15 KW - 90 kV - 160 mA - 0.1 sec
25 KW - 100 kV - 250 mA - 0.1 sec
From 120mA to 250mA depending on
Max output tube current
configurations
Max tube voltage 125 KV
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Scopy Cont subordinated to the will of the operator Yes
Scopy Yes
Version 12kW: 90 mA a 125kV
Scopy: current settable at the maximum voltage Version 15kW: 120 mA a 125kV
Version 12kW: 100 kV a 120mA
Scopy: voltage settable at the maximum current Version 15kW: 60 kV a 250mA
Scopy HQ: current settable at the maximum voltage Version 15kW: 120 mA a 125kV
Scopy HQ: voltage settable at the maximum current Version 15kW: 60 kV a 250mA
12kW a 120mA
Scopy - mA max 15kW a 250mA
25KW a 250mA
Scopy - KV range from 40 kV to 125 kV
12kW at 120mA
Scopy HQ - mA max 15kW at 250mA
25KW at 250mA
Scopy HQ - KV range from 40 to 125 kV
12kW at 120mA
Graphy DR - mA max 15kW at 250mA
25KW at 250mA
Graphy DR- kV range from 40 to 125 kV
Pulsed exposure framerates Up to 30 frame/sec
17.2 TUBE, FLAT PANEL E MONITOR AVAILABLE
RTM 80HS - 400KHU on housing C33 - 1.200 W dissipation Focal Spots - mm 0.3 x 0.5 low - high speed
G689 - 600KHU on housing B146H - 1.200 W dissipation Focal Spots - mm 0.3 x 0.6 low - high speed
TUBE G896 - 857KHU on housing B146H - 1.200 W dissipation Focal Spots - mm 0.6 x 1.0 low - high speed
RTM 70HS - 300KHU on housing C30 - C32 600 - 1.000 W
Focal Spots - mm 0.3x0.6 low - high speed
dissipation
RAD 99B - 300KHU on housing B145W 600 W dissipation Focal Spots - mm 0.3 x 0.6 low speed
PS 2020 1024x1024x16bit
PS 2121 1024x1024x16bit
FLAT PANEL
PS 3030 1536x1536x16bit
VW1212ga 2048x2048x16bit
MVCD1619 1280x1024
MVGD1619 1280x1024
MONITOR
MVCD-4127 HBT 2560x1440
MDAC 8331 HPEW 3860x2160 – 4096x2160
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17.3 X-RAY TUBE ASSEMBLY CHARACTERISTICS
C33-RTM80HS CHARACTERISTICS
Focal spots 03/05 mm
Rotating anode speed 3000 rpm 9000 rpm
Small focal spot 6kW Small focal spot 10kW
Nominal anode power
Tube Large focal spot 25kW Large focal spot 45kW
Anode angle 10°
Anode heat storage capacity 300 KJ (400 kHU)
Maximum anode dissipation 1300 W (104 kHU/min)
Heat Storage Capacity with WAD 7.000.000HU o 8.000.000HU
Maximum continuous heat
1200 W
dissipation
Tube assembly
Min. tube assembly inherent
1.2 mm Al
filtration
Total filtration >5 mm Al
Filament emission charts:
Filament emission (0,3) Filament emission(0,5)

200 450
400
Tube current (mA)
Tube current (mA)
160 350
300
120 250
80 100kV 200 100kV
150
40 50kV 100 50kV
50
0 0
3 3,4 3,8 4,2 4,6 5 3,4 3,8 4,2 4,6 5
Filament current (A) Filament current (A)
Anode Heating & Cooling Chart:
Anode heating and cooling curves

350
300
Stored energy (kJ)
250
200 1200 W
150 1000 W
100 500 W
COOLING
50
0
-1 1 3 5 7 9 11 13 15
Time (min)
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Tube assembly heating and cooling curves:
C33 - Heating and cooling

500
450
400
350
300
250
200
150
100
50
0
0 10 20 30 40 50 60 70
1200W 800W 500W COOLING
B146H-G689 CHARACTERISTICS
Focal spots 03/06 mm
Rotating anode speed 3000 rpm 9000 rpm
Nominal anode power Small focal spot 8kW Small focal spot 17kW
Tube Large focal spot 25kW Large focal spot 47kW
Anode angle 10°
Anode heat storage capacity 452KJ (600 kHU)
Maximum anode dissipation 1832 W (154 kHU/min)
Heat Storage Capacity with WAD 8.000.000HU
Maximum continuous heat dissipation 1200 W
Tube assembly
Min. tube assembly inherent filtration 1.2 mm Al
Total filtration >4 mm Al
Filament emission charts:
Filament emission(0,3) Filament emission(0,6)

200 500
460
420
Tube current (mA)
160
Tube current (mA)
380
340
120 300
120kV 260 120kV
80 220
80kV 180 80kV
140
40 40kV 100 40kV
60
0 20
-20
3 3,4 3,8 4,2 3,8 4 4,2 4,4 4,6 4,8 5
Filament current (A) Filament current (A)
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Anode Heating & Cooling Chart:
Anode heating and cooling chart

500
450
400
350
Stored energy (kJ)
300
1,8kW
250
0,7kW
200
0,2kW
150
COOLING
100
50
0
0 10 20 30 40 50 60 70 80
Time (min)
Tube assembly heating and cooling curves:
B146H - Heating and coooling

1800
1600
1400
1200
1000
800
600
400
200
0
0 10 20 30 40 50 60 70 80 90
1200W 800W 500W COOLING
17.4 OPERATING MODE
The normal use of the device shall be considered as continuous functioning, due to its characteristics.
(60601-1 3rd ed. - par. 7.2.11) . Anyway, as most of equipement of same type, the normal use of this device
includes alternated peiords of stand-by and active working.
17.5 APPLIED PARTS
The device does not have any applied parts as defined by the 60601-1 third edition standard in par. 7.2.10.
However, it has parts that are potentially accessible to the patient, that is, the internal parts of the arch
which, for safety purposes, must therefore be considered as an applied part of type B.
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18 LABELING
18.1 DEVICE IDENTIFICATION LABEL
The unit is identified by the label applied on the rear panel of the monitor trolley. The label includes the
following data:
• Brand, product name and nomenclature classification (according to IEC 60601-2-43)
• Name and address of the manufacturer
• Year of manufacturing
• Serial number
• Class and type identification according to IEC 60601-1 and latest updates
• Power supply data
The following images shows an example of the label used for the unit identification.
The identification plate shown here is to be considered an example. The model of the
equipment to which this manual was attached may be different.
18.2 SAFETY SYMBOLS AND LABELING
Attention, refer to the user manual. Safety information
Insulation class I and applied part of type B
Do not dispose of this product and its accessories as general waste. Prepare the
product for recycling or recycling as indicated by the Legislative Decree of March
14, 2014, n. 49 "Implementation of Directive 2012/19 / EU on waste electrical
and electronic equipment (WEEE)".
Complies with Council Directive 93/42 / EEC and s.m.i., DM Class IIb.
The 4-digit code indicates the certifying body of the device.
SWITCH OFF
Before any intervention on parts marked with this label, it is mandatory to
switch off the power supply to the machine.
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ATTENTION TO HANDS
This symbol calls attention to a possible source of danger specifically to the
position of the hands.
ELECTRICAL SHOCK DANGER
This symbol calls attention to a possible one
danger of electric shock. Care should be taken to access and operate on parts
and areas indicated by this symbol.
LASER emission
This symbol identifies a laser light emission element. These elements can be a
source of danger for vision. Do not look at the emitter directly.
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19 ELECTROMAGNETIC COMPATIBILITY
19.1 EMC DISCLAMER
The appliance complies with the CEI EN 60601-1-2 collateral standard. Standard applicable to the product
and relative to electromagnetic compatibility.
THE APPLIANCE MUST BE INSTALLED AND STARTED ACCORDING TO THE EMC

INFORMATION PROVIDED IN THIS SECTION.
THE APPLIANCE MAY BE INFLUENCED BY COMMUNICATION EQUIPMENT AND MOBILE

PHONES.
PORTABLE AND MOBILE RADIOCOMMUNICATIONS SHOULD BE USED AT A MINIMUM

DISTANCE OF 30 CM FROM THE DEVICE
THE UNIT CAN NOT BE EQUIPPED WITH CABLE OTHER THAN THOSE SPECIFIED BY THE
MANUFACTURER
USE OF ACCESSORIES, TRANSDUCERS AND CABLES OTHER THAN THOSE SPECIFIED,

EXCEPT THOSE SOLD BY THE MANUFACTURER AS SPARE PARTS, MAY AFFECT NEGATIVELY
ON THE EMC PERFORMANCE.
THE DEVICE SHOULD NOT BE USED NEAR OR OVERLAPPING WITH OTHER EQUIPMENT IN
ORDER TO AVOID INTERFERENCE IN THE NORMAL OPERATING CONDITION.
IN CASE OF ELECTROSTATIC DISCHARGES, THE TEMPORARY SHUTDOWN OF THE

MONITORS COULD MAKE IT POSSIBLE.IN THIS CASE IT WILL BE SUFFICIENT TO PROVIDE
FOR THE RESTARTING OF THE SAME.
19.2 TABLES 60601-1-2
THE EMISSIONS CHARACTERISTICS OF THIS EQUIPMENT MAKE IT SUITABLE

FOR USE IN INDUSTRIAL CONTEXTS AND HOSPITALS (CISPR 11 CLASS A).
IF USED IN A RESIDENTIAL ENVIRONMENT (FOR WHICH IT IS IN GENERAL REQUESTED

COMPLIANCE WITH CISPR 11 CLASS B), THIS EQUIPMENT
COULD NOT OFFER AN ADEQUATE PROTECTION TO COMMUNICATION SERVICES IN
RADIO FREQUENCY. IT MAY BE NECESSARY TO ADOPT MEASURES FOR
ATTEMPT THE PROBLEM, FOR EXAMPLE MOVING THE APPLIANCE OR ORIENTING IT
OTHERWISE.
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19.2.1 TABLE 1 (60601-1-2 NUMERATION)
The device is intended for use only in the electromagnetic environment specified below. The customer or user of the device must
ensure that it is used in that environment.
Emissions test Compliance Electromagnetic Environment
The device uses RF energy only for its internal
operation. For this reason, its RF emissions are very
RF emissions CISPR 11 Group 1
low and probably do not cause interference in nearby
electronic devices.
RF emissions CISPR 11 Class A The device is suitable for use in all buildings other than
domestic and those directly connected to a low-
Harmonic emissions EN 61000-3-2 Class A
voltage power supply network that supplies buildings
Voltage fluctuations/flicker emissions EN 61000-3-3 Conforme for domestic use.
CISPR 14 Non applicabile
CISPR 15 Non applicabile
19.2.2 TABLE 2 (60601-1-2 NUMERATION)
The device is intended for use only in the electromagnetic environment specified below. The customer or user of the device must
ensure that it is used in that environment.
Immunity Test EN 60601-1-2 Test level Compliance level Electromagnetic Environment - guidance
Floors should be wood, concrete or ceramic. If the
Electrostatic discharge (ESD) 8 kV contact EN 60601-1-2
floors are covered with synthetic material, the
EN 61000-4-2 2/4/8/15 kV air Test level
relative humidity should be at least 30%
Portable and mobile RF communications equipment
Radiated electromagnetic
3 V/m EN 60601-1-2 should be used no closer to any part of the EUT.
field
80 MHz to 2.7 GHz Test level Including cables.
IEC 61000-4-3
Minimum distance 30 cm.
2 kV for power The quality of the mains voltage should be that of a
Electrical fast transient/burst supply lines EN 60601-1-2 typical commercial or hospital environment
EN 61000-4-4 1 kV for input/output Test level
lines > 3 m
0.5/1 kV differential The quality of the mains voltage should be that of a
Surge mode EN 60601-1-2 typical commercial or hospital environment
EN 61000-4-5 0.5/1/2 kV common Test level
mode
3V Portable and mobile RF communications equipment
Conducted disturbances
150 kHz to 80 MHz IEC 60601-1-2 should be used no closer to any part of the EUT.
induced by RF fields
6V Test level including cables.
IEC 61000-4-6
ISM frequencies Minimum distance 30 cm
The quality of the mains voltage should be that of a
10 ms – 0% a 0°, 45°, 90°,
Voltage dips, short typical commercial or hospital environment. If the
135°, 180°. 225°, 270°,
interruptions and voltage user requires continuous operation even during the
315° EN 60601-1-2
variations on power supply interruption of the mains voltage, it is
20 ms – 0% a 0° Test level
input lines recommended to power the appliance with an
500 ms – 70% a 0°
EN 61000-4-11 uninterruptible power supply (UPS) or with
5 s – 0%
batteries.
Power frequency (50/60 Hz) Network frequency magnetic fields should have
EN 60601-1-2
magnetic field 30 A/m characteristic levels of a typical location in a
Test level
EN 61000-4-8 commercial or hospital environment
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APPENDIX A
DOSIMETRY FLY 5 - VAREX 3030
CARDIOLOGY EP PROGRAM (Filter: Cu 0.05)

Dose rate Dose rate
Acq. mode Dose level Body Area kV mA FPS ms
(uGy/sec) (mGy/min)
Scopy Normal Chest 72,8 20 9 8 62,20 3.7
Scopy High Chest 82,4 30 9 8 73,43 4,4
Scopy Low Chest 72,2 20 6 8 40,61 2,4
Scopy HQ Normal Chest 74,0 80 9 11 330,3 19,8
Scopy HQ High Chest 72,0 100 9 11 377,1 22,6
Scopy HQ Low Chest 73,4 80 6 11 218,3 13,1
CARDIOLOGY HD PROGRAM (Filter: Cu 0.05)

Body Dose rate Dose rate
Acq. mode Dose level kV mA FPS ms
Area (uGy/sec) (mGy/min)
Scopy Normal Chest 70,6 25 9 8 67,48 4
Scopy High Chest 66,8 40 9 8 81,76 4,9
Scopy Low Chest 69,8 25 6 8 43,66 2,6
Scopy HQ Normal Chest 74,0 80 9 11 332,7 19,9
ENDOSCOPY PROGRAM (Filter: Cu 0.05)

Body Dose rate Dose rate Dose uGy
Area (uGy/sec) (mGy/min) (for SS)
Scopy Normal Pelvis 83,8 20 9 11 144,2 8,7 --
Scopy High Pelvis 81,8 30 9 9 153,4 9,2 --
Scopy Low Pelvis 83,8 20 4 11 66,53 4 --
Scopy S.S. Normal Pelvis 75 70 6 24 -- 0 67,48
Scopy S.S High Pelvis 69,6 70 4 40 -- 0 87,59
Scopy S.S Low Pelvis 80,8 70 6 16 -- 0 58,22
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VASCULAR PROGRAM (Filter: Cu 0.05)

Dose Dose rate Dose rate
Acq. mode Body Area kV mA FPS ms
level (uGy/sec) (mGy/min)
Scopy Normal Emergency 94,4 20 9 12 229,1 13,7
Scopy High Emergency 92,6 30 9 10 252,6 15,2
Scopy Low Emergency 93,8 20 4 12 102,8 6,2
Emergency
Scopy HQ DSA Normal 62,8 80 4 96 1005 60,3
(Filter Al 1,00)
Scopy HQ DSA Emergency
High 60,6 100 4 96 1101 66,1
(Filter Al 1,00)
Low 62,6 80 3 96 764,5 45,9
(Filter Al 1,00)
Scopy Normal Pelvis 94,6 20 9 19 364,3 21,9
Scopy High Pelvis 91,2 30 9 16 393,5 23,6
Scopy Low Pelvis 92,8 20 4 18 149,4 9
Pelvis
Scopy HQ DSA Normal 62,0 80 4 96 968,9 58,1
(Filter Al 1,00)
Scopy HQ DSA Pelvis
High 62,0 100 4 96 1203 72,2
(Filter Al 1,00)
Scopy HQ DSA Low Pelvis 62,0 80 3 96 734,5 44,1
(Filter Al 1,00)
Scopy Normal Chest 90 20 12 16 351,2 21,1
Scopy High Chest 85,8 30 12 14 376,8 22,6
Scopy Low Chest 88,2 20 6 16 168,5 10,1
Scopy HQ DSA Normal Chest 61,0 80 6 60 923,8 55,4
(Filter Al 1,00)
Scopy HQ DSA Chest
High 61,0 100 6 60 1139 68,3
(Filter Al 1,00)
Scopy HQ DSA Chest
Low 61,0 80 3 60 477,8 28,7
(Filter Al 1,00)
Scopy Normal Knee 94,0 20 9 12 226,1 13,6
Scopy High Knee 92,6 30 9 10 252,7 15,2
Scopy Low Knee 93,8 20 4 12 103,4 6,2
Knee
(Filter Al 1,00)
Scopy HQ DSA Knee
High 60,0 100 4 96 1070 64,2
(Filter Al 1,00)
Scopy HQ DSA Knee
Low 62,0 80 3 96 734,7 44,1
(Filter Al 1,00)
Scopy Normal Foot 88,2 15 9 15 181,4 10,9
Scopy High Foot 87,0 20 9 14 206,5 12,4
Scopy Low Foot 87,8 15 4 15 80,89 4,9
Foot
(Filter Al 1,00)
Scopy HQ DSA Foot
High 63,2 80 4 64 697,1 41,8
(Filter Al 1,00)
Scopy HQ DSA Foot
Low 65 60 3 64 442,8 26,6
(Filter Al 1,00)
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Scopy Normal Head 83,0 20 9 11 136,9 8,2

Scopy High Head 81,6 30 9 9 150,8 9
Scopy Low Head 82,8 20 4 11 62,82 3,8
Head
(Filter Al 1,00)
Scopy HQ DSA Head
High 61,0 100 4 80 971,1 58,3
(Filter Al 1,00)
Scopy HQ DSA Head
Low 61,0 80 3 80 592,1 35,5
(Filter Al 1,00)
NEUROLOGY PROGRAM (Filter: Cu 0.05)

Dose Dose rate Dose rate Dose uGy
level (uGy/sec) (mGy/min) (for SS)
Scopy Normal Emergency 91,0 30 9 9 215,3 12,9 --
Scopy High Emergency 89,8 40 6 8 155,9 9,4 --
Scopy Low Emergency 91,2 30 3 9 75,88 4,6 --
Scopy S.S Normal Emergency 71,0 70 3 64 -- 0 153,1
Scopy S.S High Emergency 71,0 70 3 64 -- 0 152,3
Scopy S.S Low Emergency 71,0 70 3 56 -- 0 133,1
Scopy Low Pelvis 91,4 30 3 9 102,5 6,2 --
Scopy S.S Normal Pelvis 78,8 40 4 48 -- 0 96,60
Scopy S.S Low Pelvis 40 70 4 40 -- 0 74,67
Scopy Normal Chest 85,0 30 9 12 241,9 14,5
Scopy High Chest 83,8 40 6 11 180,9 10,9 --
Scopy Low Chest 85,0 30 3 12 82,91 5 --
Scopy S.S Normal Chest 69,6 70 3 64 -- 0 142,6
Scopy S.S High Chest 69,6 70 3 64 -- 0 142,2
Scopy S.S Low Chest 9,6 70 3 56 -- 0 124,8
Scopy Normal Head 90,8 30 9 9 218,8 13,1 --
Scopy High Head 89,2 40 9 8 229,2 13,8 --
Scopy Low Head 90,8 30 4 9 99,17 6 --
Scopy S.S Normal Head 75,0 60 4 24 -- 0 59,01
Scopy S.S High Head 73,2 60 3 32 -- 0 72,73
Scopy S.S Low Head 78,4 60 4 20 -- 0 59,24
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ORTHOPEDY PROGRAM (Filter: Cu 0.05)

Scopy Low Emergency 91 30 3 9 75,81 4,5 --
Scopy High Head 89,8 40 9 8 234,1 14 --
Scopy Low Head 90,6 30 4 9 98,67 5,9 --
Scopy S.S Low Head 78,4 60 4 20 -- 0 58,99
Scopy Normal Chest 91,4 30 9 9 221,4 13,3 --
Scopy High Chest 89,6 40 9 8 231,3 13,9 --
Scopy Low Chest 91,4 30 4 9q 100,4 6 --
Scopy Normal Shoulder 89,0 20 9 13 211,2 12,7 --
Scopy High Shoulder 84,8 40 9 10 247,6 14,9 --
Scopy Low Shoulder 88,8 20 4 13 96,00 5,8 --
Scopy S.S Normal Shoulder 76,4 40 6 30 -- 0 56,04
Scopy S.S High Shoulder 72,4 60 4 48 -- 0 105,4
Scopy S.S Low Shoulder 81,2 40 6 24 -- 0 56,64
Scopy Low Pelvis 85,2 30 3 12 86,53 5,2 --
Scopy Normal Hand 80,0 15 9 15 135,5 8,1 --
Scopy High Hand 80,0 20 9 20 230,9 13,9 --
Scopy Low Hand 80,0 15 4 15 60,82 3,6 --
Scopy S.S Normal Hand 72,6 30 6 51 -- 0 65,65
Scopy S.S High Hand 71,4 40 6 48 -- 0 75,69
Scopy S.S Low Hand 75,8 30 6 36 -- 0 54,16
Scopy Normal Knee 93,2 20 9 11 204,2 12,3 --
Scopy High Knee 91,0 30 9 9 216,7 13 --
Scopy Low Knee 92,8 20 4 11 94,06 5,6 --
Scopy S.S Normal Knee 75,0 40 6 36 -- 0 65,37
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Scopy S.S High Knee 70,4 60 4 44 -- 0 92,84

Scopy S.S Low Knee 77,8 40 6 26 -- 0 53,83
Scopy Normal Foot 80,0 15 9 15 136,1 8,2 --
Scopy High Foot 80.0 15 9 15 141,7 8,5 --
Scopy Low Foot 80,0 15 4 15 61,77 3,7 --
Scopy S.S Normal Foot 70,0 40 6 48 -- 0 71,23
Scopy S.S High Foot 70,0 80 6 48 -- 0 139,7
Scopy S.S Low Foot 73,8 40 6 34 -- 0 61,03
UROLOGY PROGRAM (Filter: Cu 0.05)

Scopy Low Pelvis 100,8 20 4 9 100,4 6 --
PEDIATRIC PROGRAM (Filter: Cu 0.1)

Scopy High Head 79,06 9 9 13 61,89 3,7 --
Scopy Low Head 79,6 9 3 13 21,45 1,3 --
Scopy S.S Low Head 69,6 20 6 16 -- 0 17,42
Scopy High Chest 80,0 9 9 13 61,86 3,7
Scopy Low Chest 80,0 9 3 13 20,48 1,2 --
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Scopy Low Pelvis 80,2 9 3 13 21,22 1,3 --
Scopy Normal Hand 80 9 9 14 64,85 3,9 --
Scopy High Hand 80 9 9 14 64,51 3,9 --
Scopy Low Hand 80 9 3 14 21,87 1,3 --
Scopy S.S Low Hand 73,0 20 6 11 -- 0 14,62
Scopy Normal Knee 80 9 9 14 60,37 3,6 --
Scopy High Knee 80 9 9 14 64,86 3,9 --
Scopy Low Knee 80 9 3 14 22,02 1,3 --
Scopy S.S Low Knee 72,2 20 6 16 -- 0 19,47
Scopy Normal Foot 80 9 9 14 64,23 3,9 --
Scopy High Foot 80 9 9 14 64,94 3,9 --
Scopy Low Foot 80 9 3 14 21,75 1,3 --
Scopy S.S Low Foot 74,2 20 6 12 -- 0 17,13
This tables reports detailed indication related to the reference air Kerma Rates (instantaneous dose
For more information and for details on the test setup, refer to the “Dosimetry”
paragraph in the “Radiation protection” chapter of this manual.
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APPENDIX B
DOSIMETRY FLY 5 - VW1212
CARDIOLOGY EP PROGRAM (Filter: Cu 0.05)

Scopy High Chest 72 30 9 8 109 5,4
Scopy Low Chest 77,2 20 6 8 65,93 3,2
Scopy HQ Normal Chest 71,4 80 9 11 374,2 19
CARDIOLOGY HD PROGRAM (Filter: Cu 0.05)

Scopy High Chest 68,2 30 9 8 111,3 5,6
Scopy Low Chest 73,6 20 6 8 64,26 3,3
Scopy HQ Normal Chest 71,4 80 9 11 375,9 19
ENDOSCOPY PROGRAM (Filter: Cu 0.05)

Body Dose rate Dose rate Dose uGy
Area (uGy/sec) (mGy/min) (for SS)
Scopy High Pelvis 67 30 12 8 110,6 5,2 --
Scopy Low Pelvis 73,8 25 6 8 68,46 3,3 --
Scopy S.S. Normal Pelvis 77 70 6 24 -- 0 93,57
Scopy S.S High Pelvis 77 70 4 40 -- 0 157,6
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VASCULAR PROGRAM (Filter: Cu 0.05)

Dose Dose rate Dose rate
level (uGy/sec) (mGy/min)
Scopy Normal Emergency 86,8 20 9 8 135,6 6,9
Scopy High Emergency 81,4 30 9 8 155,7 8,6
Scopy Low Emergency 87,4 20 4 8 62,91 3,1
Emergency
Scopy HQ DSA Normal 65 80 4 96 1026 48,9
(Filter Al 1,00)
High 65 100 4 96 1268 61,2
(Filter Al 1,00)
Low 66,6 80 3 96 839,3 40
(Filter Al 1,00)
Scopy Normal Pelvis 83 20 9 8 118,1 6,1
Scopy High Pelvis 78,4 30 9 8 137,3 7,6
Scopy Low Pelvis 83,8 20 4 8 55,14 2,8
Pelvis
Scopy HQ DSA Normal 65,8 80 4 96 1065 51,1
(Filter Al 1,00)
Scopy HQ DSA Pelvis
High 63 100 4 96 1136 54,7
(Filter Al 1,00)
Scopy HQ DSA Low Pelvis 64,8 80 3 96 763,6 36,3
(Filter Al 1,00)
Scopy Normal Chest 74,4 20 12 9 123 6,2
Scopy High Chest 72,2 30 12 8 136,3 7,3
Scopy Low Chest 78,4 20 6 11 90,33 4,6
Scopy HQ DSA Normal Chest 61 80 6 60 804,9 36,4
(Filter Al 1,00)
Scopy HQ DSA Chest
High 61 100 6 60 1020 45,5
(Filter Al 1,00)
Scopy HQ DSA Chest
Low 61 80 3 60 421,7 18,2
(Filter Al 1,00)
Scopy Normal Knee 85 20 9 8 127,4 6,5
Scopy High Knee 79,8 30 9 8 144,9 8,1
Scopy Low Knee 85,2 20 4 8 57,51 2,9
Knee
Scopy HQ DSA Normal 65,4 80 4 96 1029 50
(Filter Al 1,00)
Scopy HQ DSA Knee
High 63,6 100 4 96 1129 56,6
(Filter Al 1,00)
Scopy HQ DSA Knee
Low 65,4 80 3 96 787,2 37,5
(Filter Al 1,00)
Scopy Normal Foot 84,8 15 9 13 165,2 7,9
Scopy High Foot 82,4 20 9 12 173,4 9
Scopy Low Foot 86,4 15 4 14 85,43 4
Foot
Scopy HQ DSA Normal 70 60 4 64 674,9 33,7
(Filter Al 1,00)
Scopy HQ DSA Foot
High 67,6 80 4 64 774,2 38,1
(Filter Al 1,00)
Scopy HQ DSA Low Foot 70,4 60 3 64 524,3 25,9
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(Filter Al 1,00)
Scopy Normal Head 82,4 20 9 10 145,7 7,5
Scopy High Head 80,8 30 9 8 151,6 8,5
Scopy Low Head 82,6 20 4 11 72,11 3,7
Head
(Filter Al 1,00)
Scopy HQ DSA High Head 62 100 4 80 909,8 43
(Filter Al 1,00)
Scopy HQ DSA Head
Low 63,8 80 3 80 612,5 28,7
(Filter Al 1,00)
NEUROLOGY PROGRAM (Filter: Cu 0.05)

Scopy S.S Normal Emergency 78 70 3 64 -- 0 264,8
Scopy S.S High Emergency 78 70 3 64 -- 0 264,6
Scopy S.S Low Emergency 78 70 3 56 -- 0 231,9
Scopy Low Pelvis 75,8 30 3 8 45,71 2,2 --
Scopy S.S Normal Pelvis 78 70 3 64 -- 0 265,1
Scopy S.S Low Pelvis 78 70 3 56 -- 0 232
Scopy High Chest 72,8 40 9 8 143,8 7,5 --
Scopy Low Chest 75,8 30 4 8 59,33 3 --
Scopy Normal Head 75 30 9 8 127,9 6,4 --
Scopy High Head 72,6 40 9 8 141,9 7,4 --
Scopy Low Head 76,2 30 4 8 61,38 3 --
Scopy S.S Low Head 77,6 60 4 20 -- 0 72,68
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ORTHOPEDY PROGRAM (Filter: Cu 0.05)

Scopy S.S Normal Emergency 78 70 3 64 -- 0 265,3
Scopy S.S High Emergency 78 70 3 64 -- 0 265,4
Scopy S.S Low Emergency 78 70 3 56 -- 0 231,2
Scopy High Head 73,6 40 9 8 149,8 7,9 --
Scopy Low Head 76 30 4 8 61,3 3
Scopy S.S Low Head 78,2 60 4 20 -- 0 74,39
Scopy High Chest 73,6 40 9 8 148,6 7,9 --
Scopy Low Chest 77 30 4 8 62,77 3,1 --
Scopy Normal Pelvis 78 30 9 8 134,5 7,4 --
Scopy High Pelvis 76 40 6 8 105,1 6 --
Scopy Low Pelvis 80,6 30 3 8 51,76 2,8 --
Scopy High Hand 74,6 20 9 13 138,9 6,8 --
Scopy Low Hand 79,4 15 4 14 64,65 3,1 --
Scopy S.S Low Hand 77,2 30 6 36 -- 0 64,67
Scopy Normal Knee 85,2 20 9 8 128,2 6,6 -
Scopy High Knee 80 30 9 8 146,9 8,2 --
Scopy Low Knee 86 20 4 8 59,86 3 --
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Scopy S.S Low Knee 78 40 6 26 -- 0 63,88
Scopy Normal Foot 78 15 9 13 127,7 6 --
Scopy High Foot 78 15 9 13 128,8 6 --
Scopy Low Foot 78,8 10 4 14 63,78 3 --
Scopy S.S Low Foot 74,4 40 6 34 -- 0 73,5
UROLOGY PROGRAM (Filter: Cu 0.05)

Scopy High Pelvis 79,6 30 9 8 145,6 8 --
Scopy Low Pelvis 84,8 20 4 8 57,42 2,9 --
PEDIATRIC PROGRAM (Filter: Cu 0.1)

Scopy Normal Emergency 79 9 9 13 66,45 5,8 --
Scopy High Head 83,6 9 9 13 80,58 7,3 --
Scopy Low Head 85,2 9 3 13 29,38 2,6 --
Scopy S.S Low Head 73 20 6 16 -- 0 23,29
Scopy High Chest 77,8 9 9 13 62,87 5,4 --
Scopy Low Chest 83 9 3 13 27,07 2,4 --
Scopy S.S Normal Chest 75 20 6 24 -- 0 39,68
Scopy S.S High Chest 78 30 6 24 -- 0 65,42
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Scopy High Shoulder 90,2 9 9 13 111 9,5 --
Scopy Low Shoulder 92 9 3 13 40,15 3,4 --
Scopy S.S Normal Shoulder 776 20 6 24 -- 0 45,19
Scopy Low Pelvis 79,6 9 3 13 22,85 2 --
Scopy High Hand 78,8 9 9 13 65,22 5,8 --
Scopy Low Hand 79,8 9 3 13 22,96 2 --
Scopy S.S Normal Hand 75 20 6 24 -- 0 41,73
Scopy S.S High Hand 73 30 6 22 -- 0 47,62
Scopy S.S Low Hand 74,8 20 6 12 -- 0 20,43
Scopy Normal Knee 78,8 9 9 13 65,62 5,8 --
Scopy High Knee 78,8 9 9 13 66,22 5,8 --
Scopy Low Knee 79,8 9 3 13 23,41 2 --
Scopy S.S Low Knee 71,6 20 6 16 -- 0 22,12
Scopy Normal Foot 79 9 9 13 66,79 5,8 --
Scopy High Foot 79 9 9 13 67,02 5,8 --
Scopy Low Foot 79,8 9 3 13 23,67 2 --
Scopy S.S Normal Foot 75 20 6 24 -- 0 41,9
Scopy S.S High Foot 74 30 6 24 -- 0 56,96
Scopy S.S Low Foot 74 20 6 12 -- 0 19,76
This tables reports detailed indication related to the reference air Kerma Rates (instantaneous dose
For more information and for details on the test setup, refer to the “Dosimetry”
paragraph in the “Radiation protection” chapter of this manual.
xii | P a g i n a

Eurocolumbus Alien X Alien e User Manual Rev1.7.23

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alien X / alien e

The device is manufactured by:

8.1.7 Horizontal movement (optional)..........................................................................38

12.3.1 Stray radiation ...................................................................................................121

17.3 X-RAY TUBE ASSEMBLY CHARACTERISTICS ............................................................................................... 146

APPENDIX B .................................................................................................................. VII

This user manual is dedicated to the following devices:

Commercial name alien X alien e

1.1. INTENDED USE

Information for a safe use

2.1 INTERNATIONAL CLASSIFICATION OF THE ENCLOSURES PROTECTION (IPXX)

MISSING OR NEGLIGENCE IN THE FILLING OF THE FOLLOWING INDICATIONS MAY CAUSE

IN ORDER OF PREVENTING ELECTRIC SHOCK HAZARDS, CONNECT THE DEVICE ONLY TO

NO MODIFICATION OF THE DEVICE AND / OR OF ITS PARTS IS ADMITTED

IT IS NECESSARY TO RESTRICT ACCESS TO THE DEVICE ACCORDING TO LOCAL

THE CONNECTION OF EXTERNAL DEVICES OR THE INSTALLATION OF SOFTWARES WHICH

THE UNIT IS NOT PROVIDED FOR OUTDOOR OPERATION, OR TO EXPOSE TO

The device can be provided with the CT70T EVOLUTION table

WHEN OPERATED INTO CONTAMINATION CONTROLLED ENVIRONMENT, THE USE OF

IN CASE OF USE OF PROTECTIVE SLEEVES, REMOVE THEM AS SOON AS POSSIBLE IN

FOR INFORMATION ON THE FIXING OF STERILE PROTECTION, REFER TO THE CLEANING

1. Display lifter control switch

5.3 TOUCHSCREEN CONTROL PANEL ETS15

Database page: for the management of exams database.

Viewers page: allows to view open exams.

5.4 WIRELESS PEDAL

The wireless pedal guarantees an IP X8 degree

5.5 WIRELESS CONTROL CONSOLE

5.6 MINI TROLLEY ETS15

1. Touch control panel ETS15

5.7 EMERGENCY BUTTON

5.8 EXPOSURE HANDSWITCH

5.9 LASER CENTERING DEVICE

5.10 FIELD ILLUMINATION LAMP

5.11 AUTOMATIC INJECTOR CONTROL (OPTIONAL)

5.12 DOOR INTERLOCK (OPTIONAL)

5.13 EXTERNAL EXPOSURE LAMP (OPTIONAL)

VERIFY THAT THE ENVIRONMENT OF USE IS IN ACCORDANCE WITH THE REQUIREMENTS OF

The unit fully satisfy the requirements of the IEC/EN 60601-1/A1

functional earth terminal indicated by the symbol.

To switch the device on, follow the steps described below:

Units having BOOSTER system:

- Circuit breaker 16A curve C

- Circuit breaker 25A curve C

THE UNIT IS EQUIPPED WITH WHEELS WITHOUT MOTORS.

IN CASE OF TOTAL OR PARTIAL BLOCK OF ELECTRO-ACTUATED MOVEMENTS DO NOT ATTEMPT

THE TRANSPORTATION MUST ALWAYS BE CARRIED OUT ON FLAT AND NON-ACCIDENTED

THE DEVICE MUST ALWAYS BE MOVED BY TWO PEOPLE

7.1 USE OF THE STEERING

7.2 USE OF THE BRAKE

7.3 TROLLEY MOVEMENT

7.4 STAND PARKING POSITION AND MOVEMENT

2. Lift the C-Arm downwards using the button

6. Turn off the unit pushing the button .

8 MOTORIZED MOVEMENT AND C-ARM POSITION

8.1 C-ARM MOTION

MOTORIZED MOTIONS OF THE C-ARM ARE MANAGED WITH AN APPROPRIATE ALGORITHM

DURING MOVEMENTS DO NOT TOUCH THE C-ARM, IN PARTICULAR IN THE INTERCONNECTION