09_FT_05_User manual rev1.7.24

alien X / alien e USER MANUAL 0051

alien X / alien e 2 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 2|P a g i n a

alien X / alien e 3 User manual Revision: 1.7.24 - 25.02.2021 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 3|P a g i n a

alien X / alien e 4 User manual Revision: 1.7.24 - 25.02.2021 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 4|P a g i n a

alien X / alien e 5 User manual Revision: 1.7.24 - 25.02.2021 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 5|P a g i n a

alien X / alien e 6 User manual Revision: 1.7.24 - 25.02.2021 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 6|P a g i n a

alien X / alien e 7 User manual Revision: 1.7.24 - 25.02.2021 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 Touch Screen ETS15 0 Computer 1 Monitor 2 3 Trolley DFF 1 2 Movements Generator 1 Collimator 2 Housing 3 4 Detector 5 6 C-arm depth 1 2 3 4 5 6 7 8 0 1 1 2 3 1 2 3 4 1 2 3 I1 I2 I3 V1 V2 V1 V2 V3 D1 D2 W1 W2 1 2 3 4 7|P a g i n a

alien X / alien e 8 User manual Revision: 1.7.24 - 25.02.2021 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 alien X EUROCOLUMBUS Commercial name -- alien e Versions alien 3030 alien 303075 alien 3030 cardio alien 2020 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 WHO HAVE BEEN QUALIFIED FOR THE USE OF RADIOLOGICAL EQUIPMENT 8|P a g i n a

alien X / alien e 9 User manual Revision: 1.7.24 - 25.02.2021 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 IP2X Protection with regard to objects with diameter more than 12mm IP3X Protection with regard to objects with diameter more than 2.5mm IP4X Protection with regard to objects with diameter more than 1mm 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 9|P a g i n a

alien X / alien e 10 User manual Revision: 1.7.24 - 25.02.2021 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. 10 | P a g i n a

alien X / alien e 11 User manual Revision: 1.7.24 - 25.02.2021 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. 11 | P a g i n a

alien X / alien e 12 User manual Revision: 1.7.24 - 25.02.2021 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 12 | P a g i n a

alien X / alien e 13 User manual Revision: 1.7.24 - 25.02.2021 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 13 | P a g i n a

alien X / alien e 14 User manual Revision: 1.7.24 - 25.02.2021 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. 14 | P a g i n a

alien X / alien e 15 User manual Revision: 1.7.24 - 25.02.2021 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. 15 | P a g i n a

alien X / alien e 16 User manual Revision: 1.7.24 - 25.02.2021 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: 16 | P a g i n a

alien X / alien e 17 User manual Revision: 1.7.24 - 25.02.2021 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. 17 | P a g i n a

alien X / alien e 18 User manual Revision: 1.7.24 - 25.02.2021 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. 36 59 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). 18 | P a g i n a

alien X / alien e 19 User manual Revision: 1.7.24 - 25.02.2021 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. 19 | P a g i n a

alien X / alien e 20 User manual Revision: 1.7.24 - 25.02.2021 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 3 2 4 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. 20 | P a g i n a

alien X / alien e 21 User manual Revision: 1.7.24 - 25.02.2021 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. 21 | P a g i n a

alien X / alien e 22 User manual Revision: 1.7.24 - 25.02.2021 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. 22 | P a g i n a

alien X / alien e 23 User manual Revision: 1.7.24 - 25.02.2021 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 23 | P a g i n a

alien X / alien e 24 User manual Revision: 1.7.24 - 25.02.2021 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: 24 | P a g i n a

alien X / alien e 25 User manual Revision: 1.7.24 - 25.02.2021 - 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. 25 | P a g i n a

alien X / alien e 26 User manual Revision: 1.7.24 - 25.02.2021 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. 26 | P a g i n a

alien X / alien e 27 User manual Revision: 1.7.24 - 25.02.2021 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. 27 | P a g i n a

alien X / alien e 28 User manual Revision: 1.7.24 - 25.02.2021 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 28 | P a g i n a

alien X / alien e 29 User manual Revision: 1.7.24 - 25.02.2021 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 29 | P a g i n a

alien X / alien e 30 User manual Revision: 1.7.24 - 25.02.2021 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. 30 | P a g i n a

alien X / alien e 31 User manual Revision: 1.7.24 - 25.02.2021 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 31 | P a g i n a

alien X / alien e 32 User manual Revision: 1.7.24 - 25.02.2021 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: 32 | P a g i n a

alien X / alien e 33 User manual Revision: 1.7.24 - 25.02.2021 SID movement Vertical movement Circumferential movement Orbital movement Orbital and circumferential Notable positions movement movement speed reduction Movimento verso posizioni prefissate Brake release 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. 33 | P a g i n a

alien X / alien e 34 User manual Revision: 1.7.24 - 25.02.2021 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. 34 | P a g i n a

alien X / alien e 35 User manual Revision: 1.7.24 - 25.02.2021 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°. 35 | P a g i n a

alien X / alien e 36 User manual Revision: 1.7.24 - 25.02.2021 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°. 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. 36 | P a g i n a

alien X / alien e 37 User manual Revision: 1.7.24 - 25.02.2021 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. 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. 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. 37 | P a g i n a

alien X / alien e 38 User manual Revision: 1.7.24 - 25.02.2021 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. 38 | P a g i n a

alien X / alien e 39 User manual Revision: 1.7.24 - 25.02.2021 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. The anti-collision system is to be considered a tool to support the operator's supervision. This system does not perform security functions. 39 | P a g i n a

alien X / alien e 40 User manual Revision: 1.7.24 - 25.02.2021 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. 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. 8.1.10 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. 40 | P a g i n a

alien X / alien e 41 User manual Revision: 1.7.24 - 25.02.2021 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. 41 | P a g i n a

alien X / alien e 42 User manual Revision: 1.7.24 - 25.02.2021 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. 8.1.11.1 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: 42 | P a g i n a

alien X / alien e 43 User manual Revision: 1.7.24 - 25.02.2021 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. 43 | P a g i n a

alien X / alien e 44 User manual Revision: 1.7.24 - 25.02.2021 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. 44 | P a g i n a

alien X / alien e 45 User manual Revision: 1.7.24 - 25.02.2021 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 anti-collision system is to be considered a tool to support the operator's supervision. This system does not perform security functions. 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. 45 | P a g i n a

alien X / alien e 46 User manual Revision: 1.7.24 - 25.02.2021 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. 46 | P a g i n a

alien X / alien e 47 User manual Revision: 1.7.24 - 25.02.2021 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) 47 | P a g i n a

alien X / alien e 48 User manual Revision: 1.7.24 - 25.02.2021 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: 48 | P a g i n a

alien X / alien e 49 User manual Revision: 1.7.24 - 25.02.2021 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: Anonymous Acquisition Elaboration Delete Modify patient data System configuration Operator X Database manger X X X X Administrator X X 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. 49 | P a g i n a

alien X / alien e 50 User manual Revision: 1.7.24 - 25.02.2021 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). 50 | P a g i n a