09_FT_05_User manual rev1.7.24

["alien X \/ alien e 101 User manual Revision: 1.7.24 - 25.02.2021 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. 101 | P a g i n a","alien X \/ alien e 102 User manual Revision: 1.7.24 - 25.02.2021 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 \u201cQuery results\u201d 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 \u201cEXPORT USB\u201d 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 \u201cExam\u201d list, rather than the \u201cQuery results\u201d list, as shown in the figure below: In addition, from the exam list the following export functions are available: \u2022 RDSR USB, a RDSR report is saved on an external USB device connected to one of the available USB port. \u2022 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. \u2022 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. \u2022 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. \u2022 EXPORT USB, the whole exam folder is copied to an external USB device connected to one of the available USB port. \u2022 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: \u2022 DICOM USB, the selected runs are saved in DICOM format to an external USB device connected to one of the available USB port. \u2022 DICOM CD, the selected runs are saved in DICOM format on a CD correctly mounted in the system. 102 | P a g i n a","alien X \/ alien e 103 User manual Revision: 1.7.24 - 25.02.2021 \u2022 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. \u2022 RAW USB, the selected runs are saved in RAW format to an external USB device connected to one of the available USB port. \u2022 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: \u2022 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. \u2022 USB device not found: Appears when the operator tries to export on an external USB device, but this device is not found connected. \u2022 Insufficient data for the panel detector calibration: 103 | P a g i n a","alien X \/ alien e 104 User manual Revision: 1.7.24 - 25.02.2021 This popup may show up at the starting of the software. As stated in the description, wait few seconds. \u2022 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. 104 | P a g i n a","alien X \/ alien e 105 User manual Revision: 1.7.24 - 25.02.2021 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: 105 | P a g i n a","alien X \/ alien e 106 User manual Revision: 1.7.24 - 25.02.2021 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 106 | P a g i n a","alien X \/ alien e 107 User manual Revision: 1.7.24 - 25.02.2021 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. 107 | P a g i n a","alien X \/ alien e 108 User manual Revision: 1.7.24 - 25.02.2021 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 1 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 \u201con\u201d 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. 108 | P a g i n a","alien X \/ alien e 109 User manual Revision: 1.7.24 - 25.02.2021 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. 109 | P a g i n a","alien X \/ alien e 110 User manual Revision: 1.7.24 - 25.02.2021 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. 11.10.1LOADING 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 110 | P a g i n a","alien X \/ alien e 111 User manual Revision: 1.7.24 - 25.02.2021 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 \u201cEMPTY\u201d when no printing paper is loaded. The LCD display backlight lights in amber and shows the message \u201cDOOR\u201d 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 111 | P a g i n a","alien X \/ alien e 112 User manual Revision: 1.7.24 - 25.02.2021 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. 112 | P a g i n a","alien X \/ alien e 113 User manual Revision: 1.7.24 - 25.02.2021 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. 11.10.2CLEANING 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. 113 | P a g i n a","alien X \/ alien e 114 User manual Revision: 1.7.24 - 25.02.2021 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 \u201cHISTORY\u201d is displayed on the LCD. 114 | P a g i n a","alien X \/ alien e 115 User manual Revision: 1.7.24 - 25.02.2021 6. Display \u201cCLEAN.TH\u201d by turning the menu lever up or down, and then press the menu lever. 7. Confirm that \u201cCLEAN:OK\u201d is displayed, and then press the menu lever. The unit starts cleaning the thermal head. \u201cCLEAN.TH\u201d 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: \u2022 The risks deriving from the exposure to ionizing emissions; \u2022 The correct working procedures to minimize the exposure to the ionizing emissions of himself, of the patient and the other people; \u2022 The radioprotection rules to be followed in order to minimize the effect of the exposure to the ionizing emissions. \u2022 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 115 | P a g i n a","alien X \/ alien e 116 User manual Revision: 1.7.24 - 25.02.2021 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 \u201cHIGH RISK CLASS\u201d 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: 116 | P a g i n a","alien X \/ alien e 117 User manual Revision: 1.7.24 - 25.02.2021 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. 117 | P a g i n a","alien X \/ alien e 118 User manual Revision: 1.7.24 - 25.02.2021 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). 118 | P a g i n a","alien X \/ alien e 119 User manual Revision: 1.7.24 - 25.02.2021 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 \u201cmm\u201d) form the x-rays tube focal spot towards the detector. The reference point definition is explicitly defined in the structured dose report (RDSR \u201cRadiation Dose Structured Report\u201d) 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: 119 | P a g i n a","alien X \/ alien e 120 User manual Revision: 1.7.24 - 25.02.2021 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. 120 | P a g i n a","alien X \/ alien e 121 User manual Revision: 1.7.24 - 25.02.2021 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) 121 | P a g i n a","alien X \/ alien e 122 User manual Revision: 1.7.24 - 25.02.2021 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 \u2013 30mA \u2013 25ms - 9 fps \u2013 equal to 6,75 mAs. Height from floor Lateral Front Lateral Front (cm) 70 kV dose 70 kV dose 120 kV 120 kV dose dose (mSv\/h) (mSv\/h) (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 122 | P a g i n a","alien X \/ alien e 123 User manual Revision: 1.7.24 - 25.02.2021 20x20 field Lateral Front Lateral Front 70 kV dose Height from floor 70 kV dose 120 kV dose 120 kV dose (cm) (mSv\/h) 190 0,15 (mSv\/h) (mSv\/h) (mSv\/h) 170 150 0,25 0,15 1,3 1,4 112 100 0,45 0,25 2,2 2 80 35 1 0,5 3,3 3,5 * height of 15 0,8 6 phantom 1 7 1,1 0,9 6 8 0,9 1 5,5 10 0,55 0,8 7 8 0,6 5 ** height of 5 tube focus 123 | P a g i n a","alien X \/ alien e 124 User manual Revision: 1.7.24 - 25.02.2021 No PMMA Front Front Air only 70 kV dose 120 kV dose 20x20 collimation (mSv\/h) (mSv\/h) Height from floor 0,025 0,25 (cm) 0,035 0,3 190 0,05 170 0,1 0,3 150 0,11 0,8 * height of phantom 112 0,15 100 0,1 1 80 35 0,05 1,2 15 0,9 0,5 ** height of tube focus 124 | P a g i n a","alien X \/ alien e 125 User manual Revision: 1.7.24 - 25.02.2021 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 125 | P a g i n a","alien X \/ alien e 126 User manual Revision: 1.7.24 - 25.02.2021 C-ARM HORIZONTAL POSITION, 1m from ground C-ARM HORIZONTAL POSITION, 1,5 m from ground 126 | P a g i n a","alien X \/ alien e 127 User manual Revision: 1.7.24 - 25.02.2021 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: \u2022 Scopy: pulsed fluoroscopy \u2022 Scopy HQ: high quality pulsed fluoroscopy \u2022 Graphy DR: digital manual radiography \u2022 Scopy SS: single shot emission \u2022 Scopy HQ SS: high quality single shot simulation \u2022 Scopy HQ DSA: high quality pulsed fluoroscopy with digital subtraction (DSA) \u2022 Scopy HQ DSA CO2: high quality pulsed fluoroscopy with digital subtraction (DSA) for Carbon-Dioxide based contrast medium injection \u2022 Scopy DSA Roadmap: pulsed fluoroscopy with digital subtraction and vessels roadmap \u2022 Scopy Cont: continuous fluoroscopy 127 | P a g i n a","alien X \/ alien e 128 User manual Revision: 1.7.24 - 25.02.2021 The available image acquisition modalities depends on the main program selected. Please refer to section 6 for further details. Except fot the \u201cGraphy DR\u201d 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 \u201cScopy\u201d 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 \u201cScopy\u201d 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 \u201cScopy HQ\u201d acquisition mode is still a pulsed fluoroscopy mode similar to \u201cScopy\u201d, however it produces higher quality images, and therefore employs higher dose levels. As for the \u201cScopy\u201d 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 \u201cScopy HQ\u201d 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 \u201cGraphy DR\u201d 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 \u201cGraphy DR\u201d 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\u201d. 13.1.4 SCOPY SS: SINGLE SHOT EMISSION The \u201cScopy SS\u201d acquisition mode produces a single image when the emission is triggered. The AEC automatically calculates the emission parameters. The image quality of the \u201cScopy SS\u201d acquisitions is higher than the images acquired with the standard \u201cScopy\u201d acquisition mode, but it is still a low-dose mode. The \u201cScopy SS\u201d 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 \u201cScopy\u201d acquisition. 128 | P a g i n a","alien X \/ alien e 129 User manual Revision: 1.7.24 - 25.02.2021 13.1.5 HQ SS: HIGH QUALITY SINGLE SHOT EMISSION The \u201cScopy HQ SS\u201d acquisition mode, as the \u201cScopy SS\u201d, produces a single image when the emission is triggered. The AEC automatically calculates the emission parameters. The image quality of the \u201cScopy HQ SS\u201d acquisitions is higher than the images acquired with the\u201cScopy SS\u201d acquisition mode and more dose is delivered to the patient. The \u201cScopy HQ SS\u201d 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 \u201cScopy HQ DSA\u201d is a particuar \u201cScopy HQ\u201d acquisition which employs a digital subtraction. The first frames of the \u201cScopy HQ DSA\u201d 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 \u201cScopy HQ DSA\u201d acquisition. Te AEC works as for the normal \u201cScopy HQ\u201d 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 \u201cScopy HQ DSA\u201d 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 \u201cScopy HQ DSA CO2\u201d acquisition mode is similar to the \u201cScopy HQ DSA\u201d 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 \u201cScopy HQ DSA\u201d, and thus the vessels are still displayed as a darker trace. 13.1.8 SCOPY DSA ROADMAP: PULSED FLUOROSCOPY ROADMAP The \u201cScopy DSA Roadmap\u201d acquisition mode is a particuar \u201cScopy\u201d 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 \u201cScopy HQ DSA\u201d, but with lower dose involved. Moreover, a third image is involved in the image 129 | P a g i n a","alien X \/ alien e 130 User manual Revision: 1.7.24 - 25.02.2021 processing, together with the current frame and the mask, and it is a selectable darker trace image from a previously acquired \u201cScopy HQ DSA\u201d acquisition. By default, the darker trace of the last acquired \u201c Scopy HQ DSA CO2\u201d 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 \u201cScopy Cont\u201d 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 \u201cLow\u201d, \u201cNormal\u201d and \u201cHigh\u201d. By default, the dose level is set to \u201cNormal\u201d, 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 \u201cLow\u201d dose level protocol with less than 50% of the air kerma rate of the \u201cNormal\u201d dose level. Each acquisition mode can be configured to three dose levels (Low \u2013 Normal - High) which result in different Kerma rates during the acquisition. The \u201cNormal\u201d dose level is the default, and it is programmed to give the desired image quality according to the protocol under use. The \u201cHigh\u201d dose level is intended to be used only when, due to hard imaging scenarios (thick patients or oblique views) the \u201cNormal\u201d dose level does not guarantee the required image quality and reaches its emission limits. The \u201cHigh\u201d 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 \u201cNormal\u201d dose level protocol. As a result, the \u201cHigh\u201d dose level protocol, which has a higher dose per frame delivery, may result in an average air kerma rate lower than the \u201cNormal\u201d dose level one. The unit is equipped with a generator that can deliver up to 25kW. 130 | P a g i n a","alien X \/ alien e 131 User manual Revision: 1.7.24 - 25.02.2021 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: \u2022 Lead blades iris for total filtering (4mm Pb) \u2022 Parallel blades or cardiology blade (1mmCu) for partial filtering \u2022 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: \u2022 Rotation: angular position, clockwise or counter clockwise, with reference to the center of the image. 131 | P a g i n a","alien X \/ alien e 132 User manual Revision: 1.7.24 - 25.02.2021 \u2022 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: \u2022 Open field (air) \u2022 0.05 mm Cu (Copper) \u2022 0.1 mmCu (Copper) \u2022 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: 132 | P a g i n a","alien X \/ alien e 133 User manual Revision: 1.7.24 - 25.02.2021 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 \u2013 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 \u201cSCP\u201d and \u201cSCP-HQ\u201d modes (enabled means that the icon is \u201clighted-up\u201d 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 \u201cturns off \u201d 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. 133 | P a g i n a","alien X \/ alien e 134 User manual Revision: 1.7.24 - 25.02.2021 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: \u2022 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. \u2022 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 \u00b0C 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. 134 | P a g i n a","alien X \/ alien e 135 User manual Revision: 1.7.24 - 25.02.2021 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 \u00b0C, above this temperature, the anode starts releasing particles in the vacuum tube which will affect its life-time. When the anode temperature overcomes 1000 \u00b0C 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 \u00b0C 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 \u00b0C. 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 \u00b0C, and red above 70 \u00b0C. 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 \u201cScopy\u201d acquisition mode is never disabled. 135 | P a g i n a","alien X \/ alien e 136 User manual Revision: 1.7.24 - 25.02.2021 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\u00b0C). 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\u00b0C, 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\u00b0C). 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. 136 | P a g i n a","alien X \/ alien e 137 User manual Revision: 1.7.24 - 25.02.2021 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\u00b0C. If the detector is at a very low temperature (<15\u00b0C) or at a very high one (>50\u00b0C), 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\u00b0C). 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. 137 | P a g i n a","alien X \/ alien e 138 User manual Revision: 1.7.24 - 25.02.2021 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. 138 | P a g i n a","alien X \/ alien e 139 User manual Revision: 1.7.24 - 25.02.2021 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 139 | P a g i n a","alien X \/ alien e 140 User manual Revision: 1.7.24 - 25.02.2021 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 \u00b0 C. 14.1 TUBE HEAD SAFETY RULES For additional technical information, refer to the attached technical documentation 140 | P a g i n a","alien X \/ alien e 141 User manual Revision: 1.7.24 - 25.02.2021 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 Verify that the power cord is well connected into the wall socket. Power cord not 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 monitors are turned Eventually check if the power correctly come to the monitors and off if the signal plug is properly connected to them. Movement The c-arm stand do The s-arm stand brake Disable the c-arm stand acting on the brake lever not move is active 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 141 | P a g i n a","alien X \/ alien e 142 User manual Revision: 1.7.24 - 25.02.2021 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 No xray emission limit configured in the 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\u2019t 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. 142 | P a g i n a","alien X \/ alien e 143 User manual Revision: 1.7.24 - 25.02.2021 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. Part Material type Recyclable material Waste disposal Hazardous waste Unit structure Alluminium X (separate collection) - metallic pars Steel X X Unit covers ABS X (X) XX - plastic other (X) XX Electric motors and X (X) XX actuators Mainly (X) XX Component PCB containing X Power supplies aluminium, (X) Detector copper, (X) Xray housing and tungsten, glass, (X) tube lead and (X) dielectric oil (X) Generator Mainly (X) containing (X) Inverter aluminium, (X) Computer copper, and (X) Displays dielectric oil Cabling Cooling system wood Packaging cardboard paper Other poliethilene other 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. 143 | P a g i n a","alien X \/ alien e 144 User manual Revision: 1.7.24 - 25.02.2021 17 TECHNICAL CHARACTERISTICS Dimensions Stand: Weight Width: 800 mm C-Arm geomertry Lenght: 1960 -2100 mm depending on the version Movement range Height: 1710 - 1840 mm depending on the version Trolley: Supply Width: 550 mm Lenght: 550 mm Height: 1600 -1900 mm Stand (without monitor trolley ): from 360 Kg to 400 Kg depending on the version Trolley: 165 Kg (depending on the configuration) Free space within tubehead and detector: without DFF\/SID 850 mm. With DFF\/SID 850- 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\u00b0, +\/- 225\u00b0 depending on the version Rotational: 180\u00b0, 150\u00b0, 140\u00b0 depending on the version Lift: 500 mm 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\u00b0 or +\/- 12\u00b0 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) \u2022 IEC309 single phase interlocked socket, 16 A, P+N+PE \u2022 Circuit braker not less than 16A curve C Without BOOSTER: \u2022 IEC309 single phase interlocked socket, 32 A, P+N+PE \u2022 Circuit brakernot less than 25A curve C Environmental Ambient During use +10 \/ +35\u00b0C conditions temperature: Stocking \/ transport -25 \/ +70\u00b0C Umidity: During use 20 \/ 80% Ur not condensing Atmosferic Stocking \/ transport 5 \/ 95% Ur not condensing pressure: During use 700 a 1020 hPa Stocking \/ transport 500 a 1060 hPa (375 - 795 mm Hg) 17.1 GENERATOR CHARACTERISTICS Inverter frequency 40 KHz Output nominal power depending on versions Max output tube current 12 KW - 100 kV - 120 mA - 0.1 sec Max tube voltage 15 KW - 90 kV - 160 mA - 0.1 sec 25 KW - 100 kV - 250 mA - 0.1 sec From 120mA to 250mA depending on configurations 125 KV 144 | P a g i n a","alien X \/ alien e 145 User manual Revision: 1.7.24 - 25.02.2021 Scopy Cont subordinated to the will of the operator Yes Scopy Scopy: current settable at the maximum voltage Yes Scopy: voltage settable at the maximum current Version 12kW: 90 mA a 125kV Version 15kW: 120 mA a 125kV Scopy HQ: current settable at the maximum voltage Version 25kW: 150 mA a 125kV Version 12kW: 100 kV a 120mA Scopy HQ: voltage settable at the maximum current Version 15kW: 60 kV a 250mA Version 25kW: 65 kV a 250mA Scopy - mA max Version 12kW: 90 mA a 125kV Scopy - KV range Version 15kW: 120 mA a 125kV Scopy HQ - mA max Version 25kW: 150 mA a 125kV Scopy HQ - KV range Version 12kW: 100 kV a 120mA Graphy DR - mA max Version 15kW: 60 kV a 250mA Graphy DR- kV range Version 25kW: 65 kV a 250mA Pulsed exposure framerates 12kW a 120mA 17.2 TUBE, FLAT PANEL E MONITOR AVAILABLE 15kW a 250mA 25KW a 250mA from 40 kV to 125 kV 12kW at 120mA 15kW at 250mA 25KW at 250mA from 40 to 125 kV 12kW at 120mA 15kW at 250mA 25KW at 250mA from 40 to 125 kV Up to 30 frame\/sec RTM 80HS - 400KHU on housing C33 - 1.200 W dissipation Focal Spots - mm 0.3 x 0.5 low - high speed Focal Spots - mm 0.3 x 0.6 low - high speed G689 - 600KHU on housing B146H - 1.200 W dissipation Focal Spots - mm 0.6 x 1.0 low - high speed Focal Spots - mm 0.3x0.6 low - high speed TUBE G896 - 857KHU on housing B146H - 1.200 W dissipation Focal Spots - mm 0.3 x 0.6 low speed RTM 70HS - 300KHU on housing C30 - C32 600 - 1.000 W dissipation RAD 99B - 300KHU on housing B145W 600 W dissipation FLAT PANEL PS 2020 1024x1024x16bit MONITOR PS 2121 1024x1024x16bit PS 3030 1536x1536x16bit VW1212ga 2048x2048x16bit MVCD1619 1280x1024 MVGD1619 1280x1024 MVCD-4127 HBT 2560x1440 MDAC 8331 HPEW 3860x2160 \u2013 4096x2160 145 | P a g i n a","alien X \/ alien e 146 User manual Revision: 1.7.24 - 25.02.2021 17.3 X-RAY TUBE ASSEMBLY CHARACTERISTICS C33-RTM80HS CHARACTERISTICS 03\/05 mm Focal spots 3000 rpm 9000 rpm Rotating anode speed Nominal anode power Small focal spot 6kW Small focal spot 10kW Tube Anode angle Large focal spot 25kW Large focal spot 45kW Tube assembly Anode heat storage capacity Maximum anode dissipation 10\u00b0 Heat Storage Capacity with WAD Maximum continuous heat 300 KJ (400 kHU) dissipation Min. tube assembly inherent 1300 W (104 kHU\/min) filtration Total filtration 7.000.000HU o 8.000.000HU 1200 W 1.2 mm Al >5 mm Al Filament emission charts: Filament emission (0,3) Filament emission(0,5) Tube current (mA) 200 Tube current (mA) 450 100kV 400 50kV 160 350 300 120 250 80 100kV 200 40 50kV 150 100 0 3 3,4 3,8 4,2 4,6 5 50 Filament current (A) 0 3,4 3,8 4,2 4,6 5 Filament current (A) Anode Heating & Cooling Chart: Stored energy (kJ)350 Anode heating and cooling curves 1200 W 300 1000 W 250 3 5 7 9 11 13 500 W 200 Time (min) COOLING 150 100 15 50 0 -1 1 146 | P a g i n a","alien X \/ alien e 147 User manual Revision: 1.7.24 - 25.02.2021 Tube assembly heating and cooling curves: C33 - Heating and cooling 500 10 20 30 40 50 60 70 450 400 350 300 250 200 150 100 50 0 0 1200W 800W 500W COOLING B146H-G689 CHARACTERISTICS Focal spots 03\/06 mm 9000 rpm Rotating anode speed 3000 rpm Small focal spot 17kW Small focal spot 8kW Large focal spot 47kW Tube Nominal anode power Large focal spot 25kW 10\u00b0 Anode angle 452KJ (600 kHU) Anode heat storage capacity 1832 W (154 kHU\/min) 8.000.000HU Maximum anode dissipation 1200 W Heat Storage Capacity with WAD 1.2 mm Al >4 mm Al Tube assembly Maximum continuous heat dissipation Min. tube assembly inherent filtration Total filtration Filament emission charts: Filament emission(0,3) Filament emission(0,6) 200 500 460 160 420 380 120 340 120kV 300 260 80 80kV 220 40 40kV 180 140 0 100 3 3,4 3,8 4,2 Filament current (A) 60 Tube current (mA) 20 120kV Tube current (mA) -20 80kV 40kV 3,8 4 4,2 4,4 4,6 4,8 Filament current (A) 5 147 | P a g i n a","alien X \/ alien e 148 User manual Revision: 1.7.24 - 25.02.2021 Anode Heating & Cooling Chart: Stored energy (kJ) 500 Anode heating and cooling chart 1,8kW 450 0,7kW 400 10 20 30 40 50 60 70 0,2kW 350 Time (min) COOLING 300 250 80 200 150 100 50 0 0 Tube assembly heating and cooling curves: B146H - Heating and coooling 1800 10 20 30 40 50 60 70 80 90 1600 1400 1200 1000 800 600 400 200 0 0 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. 148 | P a g i n a","alien X \/ alien e 149 User manual Revision: 1.7.24 - 25.02.2021 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: \u2022 Brand, product name and nomenclature classification (according to IEC 60601-2-43) \u2022 Name and address of the manufacturer \u2022 Year of manufacturing \u2022 Serial number \u2022 Class and type identification according to IEC 60601-1 and latest updates \u2022 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. 149 | P a g i n a","alien X \/ alien e 150 User manual Revision: 1.7.24 - 25.02.2021 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. 150 | P a g i n a"]