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FAXITRON CT USER

MANUAL

| HOLOGIC | REVISION 002

SECTION

Schedule of
Maintenance

8-13

Section 8.7.0 Failure Criteria:

The Safety Interlocks and Indicators test fails if any of the following conditions are observed:

•

Green Power LED does not illuminate when system is powered on,

•

Red X-Ray On LED does not illuminate during X-ray exposures,

•

Audible Intermittent Beep does not sound during X-ray exposures,

•

Touch Screen Display does not

show yellow and black “X

Ray On”

message. Note: Top left corner of the

screen will also display “X

Ray On” in blue text

•

X-ray exposure

does not stop within 2 seconds after “Stop X

ray” button on the display monitor, the

”Stop” button on the Touch Screen, or the physical “Stop” button on

the control panel is pressed,

•

X-ray exposure does not stop immediately when the door is open, or

•

The Touch Screen does not display “Door Open” any time the chamber door is open

Содержание Faxitron CT

Страница 1: ...User s Manual from Hologic Document 5081 9544 Revision 002 Issued March 2020...

Страница 2: ...e user on how to setup install and use the Faxitron CT hardware and the Software System both developed by Faxitron Bioptics LLC Faxitron CT was previously known as VisionCT and associated software was...

Страница 3: ...5 5 0 0 5 1 0 5 2 0 5 3 0 5 3 1 5 3 2 5 3 3 5 3 4 5 4 0 5 5 0 5 6 0 5 6 1 5 7 0 5 7 1 5 7 2 5 7 3 5 7 4 5 7 5 5 8 0 5 8 1 5 8 2 5 8 3 5 8 4 5 8 5 5 9 0 5 10 0 5 11 0 5 12 0 5 13 0 5 14 0 Faxitron CT S...

Страница 4: ...ECTION 8 8 0 0 8 1 0 8 2 0 8 3 0 8 4 0 8 5 0 8 6 0 8 7 0 8 8 0 8 9 0 8 10 0 8 11 0 Schedule of Maintenance Schedule of Maintenance Internal Cleaning External Cleaning Replaceable Parts Equipement Need...

Страница 5: ...FAXITRON CT USER MANUAL HOLOGIC REVISION 002 1 SECTION 1 Introduction...

Страница 6: ...p system Warns the reader of potential electrocution should the reader ignore the warning and deliberately use specialized tools to open a sealed electrical cabinet and handle its contents Note No too...

Страница 7: ...ndard waste Send decommissioned material to Hologic or contact your service representative Manufacturer Date of Manufacture or Caution Radiation X Rays Produced Caution Potentially infectious material...

Страница 8: ...FAXITRON CT USER MANUAL HOLOGIC REVISION 002 SECTION Introduction 1 1 4 Label A Standard and Canadian Versions Label B Label C 1 2 0 Product Labels Figure 1 3 1 Warning and Safety Labels...

Страница 9: ...FAXITRON CT USER MANUAL HOLOGIC REVISION 002 SECTION Introduction 1 1 5 Label D Standard and Canadian Version Label E Label F 1 2 0 Product Labels Figure 1 3 1 Continued Warning and Safety Labels...

Страница 10: ...FAXITRON CT USER MANUAL HOLOGIC REVISION 002 SECTION Introduction 1 1 6 Label G Label H Label K Label L 1 2 0 Product Labels Figure 1 3 1 Continued Warning and Safety Labels...

Страница 11: ...SION 002 SECTION Introduction 1 1 7 Barcode Identification and Compliance Label Mobile System 120VAC Barcode Identification and Compliance Label Mobile System 230VAC 1 2 0 Product Labels Figure 1 3 1...

Страница 12: ...8 Label G used on the inside for the Tube Camera and Lower Rear Cover Interlock 1 2 0 Cont Product Labels Figure 1 3 2 Label Locations Continued on next page Label A Label C Chamber Floor Label D Insi...

Страница 13: ...FAXITRON CT USER MANUAL HOLOGIC REVISION 002 SECTION Introduction 1 1 9 Front labels same as shown on previous page Label K Label H Label L Compliance and Identification Label...

Страница 14: ...FAXITRON CT USER MANUAL HOLOGIC REVISION 002 2 SECTION 2 Installation and Set up...

Страница 15: ...pecified herein may result in hazardous radiation exposure Interoperable Connections The Faxitron CT is capable of operating as a standalone device without any input or output to other devices Images...

Страница 16: ...it from threats related to its Internet connection Faxitron will develop updates or patches for the Faxitron software to continue to assure the product s safety as needed throughout the lifecycle of t...

Страница 17: ...porting the Crates Caution The crate weighs approximately 315 pounds 140 kg The packaged system should be kept upright as indicated on the shipping crates Unpacking and Installing the System The Faxit...

Страница 18: ...logical Health 21 CFR 1020 40 Designed to comply with standards set forth by Underwriters Laboratories in the US and Canada X RAY TUBE Focal spot size 15 um kV 15 50kV mA 1 0mA max Power Isowatt limit...

Страница 19: ...2 5 fps for best image quality max 22 fps Saturation Dose 14uGy Dynamic Range 76dB DQE 0 lp mm RQA5 70 Scintillator Medical grade columnar cesium iodide CsI Tl EXTERIOR DIMENSIONS Approximate cm inch...

Страница 20: ...FAXITRON CT USER MANUAL HOLOGIC REVISION 002 SECTION Installation and Setup 2 2 7 180cm 70 70cm 27 65cm 25...

Страница 21: ...FAXITRON CT USER MANUAL HOLOGIC REVISION 002 3 SECTION 3 Calibration...

Страница 22: ...n it is recommended that the system be re calibrated after the system is moved from one room to another room with potentially different ambient temperature humidity settings If the system has been kno...

Страница 23: ...o stop X Rays through software or touch control panel Geometric Calibration Sequence Geometric Calibration ensures the system is set up correctly to perform the highly precise reconstruction of the CT...

Страница 24: ...ng it on the CT pedestal The phantom has a location stud that will center the phantom on the pedestal Once positioned click Okay Check the box to confirm the Phantom is placed and proceed by clicking...

Страница 25: ...e calibration page and click on Uniformity Calibration This time insert the clear Uniformity Calibration phantom by placing it on the CT pedestal The phantom has a location stud that will center the p...

Страница 26: ...FAXITRON CT USER MANUAL HOLOGIC REVISION 002 4 SECTION 4 Quick Start Basic Operation of the Faxitron CT...

Страница 27: ...t of the system will all power up Ideally allow the system to warm up for 30 minutes before calibration and image acquisition From the Windows desktop double click on the Software icon then enter the...

Страница 28: ...provided The specimen must fit completely within the inner ring shown below To ensure the DICOM data is correct place the Posterior face down on the foam with the Inferior Caudal side facing the maker...

Страница 29: ...sed Manual Entry or Select from Database For this example we will use manual entry In the other options the Patient information will be imported See next section for more details Select Manual Entry T...

Страница 30: ...om right hand corner of the software shown above or press the green X Ray button on the touch panel to start the exposure In 2D mode when the exposure is complete the computer will process the data an...

Страница 31: ...le the 3D scan is happening in the background When the exposure is complete a four pane view is shown To send the CT image series to the PACS network click on the PACS Store icon assuming a PACS conne...

Страница 32: ...d hold the ON OFF button on the front of the system until a Beep is heard This will shut down the software computer and system 2 Or from the software click the Shut Down button from the main screen A...

Страница 33: ...FAXITRON CT USER MANUAL HOLOGIC REVISION 002 5 SECTION 5 Faxitron CT Software Operation...

Страница 34: ...t the beginning of every new day of system use for best image quality The system user may also perform calibration at any time to ensure optimum image quality After calibration the Home Menu will be d...

Страница 35: ...o the field s and select the Query button located in the bottom left corner The table is re populated with the entries that match the queried information The user can then single click any entry and h...

Страница 36: ...p down menu The Date must be entered as yyyy mm dd e g 1962 08 13 Failure to enter a valid date may cause errors when attempting to retrieve images The required fields may be altered or deleted depend...

Страница 37: ...the table and then clicks on the Select Patient button which opens the Patient Information editor as before Patients will be stored in the Database as the system is being used plus patient informatio...

Страница 38: ...as desired then click on The Accept button to save the changes and continue to image acquisition The Start a New Patient button which will return the user to the Patient Data Entry Screen Once the use...

Страница 39: ...the left image would be in the Medial Lateral ML and the right image the Cranial Caudal CC view After an image is acquired in 3D mode four images will appear on the screen as shown below The bottom r...

Страница 40: ...icro calcifications and small masses in the image The algorithm commonly known as Peripheral Equalization or Thickness Equalization in advanced imaging is applied to the whole image In addition to thi...

Страница 41: ...right for low high contrast Move the cursor until image is at desired levels Window Level and Contrast Adjustment The button shown will open the Window Level and Contrast adjustment tool This tool al...

Страница 42: ...oomed in it may be necessary to pan the image Use the middle mouse button to pan The Fit All button will attempt to detect and zoom in onto the specimen as to ensure that the specimen is in full view...

Страница 43: ...g Save or Cancel from this dialog box will either cancel the previous annotations or save the current annotations to the window It will also return you to normal imaging mode The tool pallet consists...

Страница 44: ...ne with an arrow at the end Mouse behavior same as Line Tool Polygon Open Line Tool Draws non straight open segmented lines Left click mouse hold button draw Release left button this sets a line segme...

Страница 45: ...y large and may take several minutes to send to the server A confirmation will appear once it is complete After an image is taken the current image properties can be viewed by pressing the i icon in t...

Страница 46: ...l rotate in the same way to help with orientation Use the right mouse button for zooming in and out The middle button for pan move left right up or down Each of the 4 views can be maximized to full sc...

Страница 47: ...re When placed correctly the DICOM tags in the image will match the orientation of the patient The posterior should be on the foam with caudal inferior pointing towards the front of the system and the...

Страница 48: ...16 Note The orientation only applies to specimens that are placed on the foam correctly View 1 is Cranial Caudal CC View 2 in Medial Lateral ML View 3 is Anterior Posterior AP 5 8 1 Cont Specimen Ori...

Страница 49: ...er of the other 3 views In this example the red face is the top of the cube Anterior and the Slice view with the red square in the corner shown below is the top down view Anterior Posterior This color...

Страница 50: ...002 SECTION Faxitron CT Software 5 5 18 Orientation Markers Can be displayed in each view to aid This will display position of the sample relative to the system 5 8 1 Cont Specimen Orientation Figure...

Страница 51: ...the blue line shown below When a slice view is selected a scroll bar will appear under the image Moving this scroll bar will adjust the position of the slice along an axis perpendicualr to the screen...

Страница 52: ...each slice view Pressing the PLAY button automatically moves the scroll bar through the slice The scroll bar will always move to the right through the end of the view frame then start at the far left...

Страница 53: ...In this example the top image is the MIP view By grabbing the line in the top view with a left click and hold the user can move to a position that disects an area of interest like a calcification cir...

Страница 54: ...e for describing radiodensity relative to water defined as 0 and air defined as 1000 It is frequently used in CT scans Simply place the mouse cursor over the area you want to measure For example below...

Страница 55: ...view Review mode can be entered by clicking the Review button in the Home Menu page The Database is basically comprised of 4 sections The Patient List at the top the Procedure List on the lower left t...

Страница 56: ...utton at the bottom of the screen Images not in the Database can be Opened Go to the Database Window and in the Top Right corner select the Browse File System This will open a standard Windows browser...

Страница 57: ...eristics that identify it to computer and software as a DICOM Standard file Once a software application recognizes the file as a DICOM Standard file it can initiate a DICOM reader and extract the data...

Страница 58: ...essible to the user unless directed by a service engineer These include the following Default directories Viewer settings Imager parameters And Image Enhancement settings 5 11 0 System Settings Figure...

Страница 59: ...your system Clicking Help brings the user to the Help page There they can Open the Quick Start Guide Review a simple animation showing how the specimen should be placed Get the contact information fo...

Страница 60: ...o shut down from the software simply click Shut Down and the entire system will shut down A message will appear to confirm the system will be shut down Click Okay to continue and let the system fully...

Страница 61: ...FAXITRON CT USER MANUAL HOLOGIC REVISION 002 6 SECTION 6 Compliance Requirements and Safety Measure...

Страница 62: ...the system doors X Ray Generation Indicators The Faxitron CT has an X Ray On indicator light on the front panel on the touch panel and graphical user interface plus it produces an audible tone when g...

Страница 63: ...FAXITRON CT USER MANUAL HOLOGIC REVISION 002 7 SECTION 7 Service and Troubleshooting...

Страница 64: ...n image If not the power could overload the UPS and shut down Check to make sure the system is connected to mains and the power inlet is switched on There appears to be another object in the image Ver...

Страница 65: ...FAXITRON CT USER MANUAL HOLOGIC REVISION 002 8 SECTION 8 Schedule of Maintenance...

Страница 66: ...tem with a cloth moistened with mild soap and water No harsh abrasives or cleaners should be used on the system to prevent scratching Do not allow any moisture whatsoever to come in contact with the e...

Страница 67: ...on surveys and image tests can be conducted by the user in accordance with the instructions in this manual Refer to local government regulations and facility procedures for further guidance and compli...

Страница 68: ...n exposure to be taken 7 Verify that the green Start X Ray software button is on 8 In 2D mode press the green X ray button on the touchscreen on the front of the Faxitron CT The system should begin ta...

Страница 69: ...ystem is fully calibrated Image Geometric and Uniformity Wax insert needs to be taken out of its acrylic holder Using tape or a small slit in the single use foam tray place the ACR phantom standing on...

Страница 70: ...beam without using any attenuator blocks 4 Still in 2D mode start X Rays and wait for all processing to be completed and the image to be displayed 5 Adjust contrast and brightness levels as needed fo...

Страница 71: ...ain that the survey meter calibration is current 2 Battery Check Check for proper battery condition Replace batteries before survey if required 3 Check Operation If check source is available Note The...

Страница 72: ...ron radiation emission limit of 0 1 milli Roentgen mR per hour 1 0 Sv h at any point 5 centimeters cm outside the external surface contact a Faxitron or Hologic representative to discuss repair option...

Страница 73: ...mp and will be the most recent file in the directory The filename format is yyyymmdd i e 20191220 101916 4 Open ImageJ from the Windows Start menu or navigate to Local Disk C Faxitron support ImageJ a...

Страница 74: ...e data of the 3D Resolution Phantom must meet certain criteria for 3D resolution by measuring a line profile through the wire in the middle of the reconstructed 3D Resolution Phantom Required Material...

Страница 75: ...intensity profile plot along the line drawn 8 Select the window with the plotted line profile through the wire It will look similar to the example above 9 On the line provided below record the width o...

Страница 76: ...l _____ Initials _____________ Date _______________ If any failed state the reason and the actions taken to correct the failure ________________________________________________________________________...

Страница 77: ...ble Intermittent Beep does not sound during X ray exposures Touch Screen Display does not show yellow and black X Ray On message Note Top left corner of the screen will also display X Ray On in blue t...

Страница 78: ...FAXITRON CT USER MANUAL HOLOGIC REVISION 002 9 SECTION 9 Revision History...

Страница 79: ...Added 3D Uniformity Resolution tests Jared Moore Eng Draft Draft 1 3 8 Oct 2017 PC Requirements added and software sections update with 3D image functionality Ciaran Purdy Mikhail Viznyuk Draft 2 0 30...

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