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MiniCAT™ User Manual v5.2

1.6 Regulatory Compliance

MiniCAT™ has been tested and/or evaluated against and found to be compliant with the following
standards/requirements:

IEC 60601-1:2003-04-25 (ED.1) with Revisions up to 2003/06/30:

IEC 60601-1-1:2000 Collateral Standard-General Requirements for Radiation Protection
for Diagnostic X-ray Equipment

IEC 60601-1-2: 2001 + A1: 2004 Class A for Emissions, Immunity for Non Life-
Supporting Equipment

IEC 60601-1-3 1994 Particular Requirements for Safety of X-ray Equipment

IEC 60601-1-4 General Requirements for Safety-Collateral Standard: Programmable
Electrical Medical Systems

IEC 60601-2-32: 1994 Particular Requirements For the Safety of X-ray Equipment for
Computed Tomography

IEC 60601-2-44: 2001 Particular Requirements For the Safety of X-ray Equipment for
Computed Tomography

CAN/CSA C22.2 No.:601.1-M90 Collateral Standard-Safety Requirements for Medical
Electrical Systems

Содержание xoran

Страница 1: ...USER MANUAL ...

Страница 2: ...erview 15 2 3 Online User Manual 15 2 4 System Hardware 16 2 5 Other Components 19 2 6 Quick Reference Guide 3 0 STARTUP AND SHUTDOWN 22 22 3 1 Emergency Shutdown 23 3 2 System Startup 27 3 3 User Management 28 3 4 System Shutdown 29 3 5 Uninterruptible Power Supply UPS 4 0 PATIENT DATABASE 31 31 4 1 Patient Database 31 4 2 Enter New Patient 32 4 3 Find Existing Patient 34 4 4 Advanced Search 36 4...

Страница 3: ...CLIENT 79 9 0 OUTPUT IMAGES 81 10 0 TECHNICAL SPECIFICATIONS 82 82 10 1 General Information 84 10 2 Imaging Properties 95 10 3 X Ray Specifications 97 10 4 Scatter Map 100 10 5 Dose Information 104 10 6 Installation Requirements 109 10 7 IGS Compatibility 11 0 QUALITY CONTROL TESTS 111 114 11 1 Laser Accuracy 115 11 2 CT Number of Reference Materials 116 11 3 Spatial Resolution 118 11 4 CT Number ...

Страница 4: ...ould utilize the Emergency Stop E Stop button to turn off the power to all moving parts in order for the patient to be safely removed from the machine Patient E Stop Operator E Stop All persons operating or occupying the area around the scanner must be properly trained on the principles of radiation safety The persons authorized to operate the equipment will be properly trained by Xoran Technologi...

Страница 5: ...n and all powered motion of the equipment in the case of an emergency Testing or calibration should never be performed while a patient is positioned in or near the scanner The operator should utilize the appropriate radiation protection devices while testing or calibrating the equipment No attempt should be made to move adjust or manipulate the scanner or patient during image acquisition This coul...

Страница 6: ...l Dosimetry The purpose of a radiation dosimetry program is to measure the radiation dose equivalent from occupationally exposed radiation workers You must check with your state radiation safety program to ascertain your state s specific radiation dosimetry requirements X Ray Warning System When the MiniCAT is in use and X rays are being emitted you will see a yellow flashing light located on top ...

Страница 7: ...el and the value of property and the community Instructions Training Use The MiniCAT shall be used supervised or directed by an individual who is competently aware of the potential hazards involved from ionizing radiation and who is capable of minimizing these hazards Xoran provides comprehensive training and support for MiniCAT users Xoran accepts no responsibility for the misuse of a MiniCAT The...

Страница 8: ...nected to an equivalent receptacle marked Hospital Only or Hospital Grade Attention Consult accompanying notices and or warnings X ray Caution These symbols indicate the presence of X ray radiation This X ray device may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed Pinch Point This symbol alerts you to the potential for injury due to movi...

Страница 9: ...es LLC Symbol Description Class II Laser This symbol alerts you to the presence of Class II laser light Do not stare into the beam Laser Alignment Symbol Electrostatic Sensitive Symbol Circuit Breaker Symbol Patient Chair Symbol Emergency Stop Symbol ...

Страница 10: ...7 MiniCAT User Manual v5 2 2014 Xoran Technologies LLC Symbol Description Chair Elevation Symbol Up Down Patient Symbol AC Power Symbol Power Symbol OFF Power Symbol ON DC Power Symbol ...

Страница 11: ...ction against harmful interference in a commercial environment The MiniCAT generates uses and can radiate electromagnetic energy If the MiniCAT is not installed and used in accordance with these instructions it may cause harmful interference to surrounding equipment MiniCAT is intended for use in an electromagnetic environment specified below The user of the MiniCAT should ensure that it is used i...

Страница 12: ...6 meters Radiated RF The MiniCAT is intended for use in an electromagnetic environment in which radiated disturbances are controlled The user can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment and the MiniCAT as recommended below according to the maximum output power of the communications equipment Maximum Output ...

Страница 13: ... workstation and server if applicable Open server front panel and gently vacuum dust accumulation if applicable Service and Maintenance It is recommended that the equipment be inspected and serviced annually Inspection and service must be performed by Xoran Technologies LLC or other technician licensed and qualified to service this equipment Circuit diagrams component parts lists descriptions and ...

Страница 14: ...eded Annually Application Maintenance Geometric Calibration Annually Shutter Calibration Annually Water Attenuation Calibration Annually Quality Control Tests CT Number of Reference Materials Annually Spatial Resolution Annually CT Number and Standard Deviation of Water Annually Artifact Test Annually Uniformity Test Annually Contrast Scale Annually Image Noise Annually Nominal Tomographic Section...

Страница 15: ...t IEC 60601 1 2 2001 A1 2004 Class A for Emissions Immunity for Non Life Supporting Equipment IEC 60601 1 3 1994 Particular Requirements for Safety of X ray Equipment IEC 60601 1 4 General Requirements for Safety Collateral Standard Programmable Electrical Medical Systems IEC 60601 2 32 1994 Particular Requirements For the Safety of X ray Equipment for Computed Tomography IEC 60601 2 44 2001 Parti...

Страница 16: ...against electric shock Class I Applied part has degree of protection against electric shock Type B Applied Part Class of equipment against ingress of liquids Ordinary Equipment IPX0 Radiated emissions Class A FDA Class 2 Mode of Operation Continuous operation with intermittent loading ...

Страница 17: ...afety instructions when using the scanner The instructions in this User Manual are meant to supplement your Xoran on site training your radiation safety training as required by your State s Radiation Safety Regulations and your own professional training and expertise Customer Service and Support is our first priority We want to do everything we can to help you use your new MiniCAT scanner in a saf...

Страница 18: ...ng of the maxillofacial complex temporal bone and sinuses 2 3 Online User Manual The most up to date version of this manual can always be viewed online at http help xorantech com MiniCAT_5 2 Navigate the online manual by clicking chapter headings in the table of contents on the left For a PDF copy click the convert to PDF button in the top right hand corner of the online manual Tip From the MiniCA...

Страница 19: ...s manual 2 5 Other Components The following is a list of other components that accompany the MiniCAT Call Xoran Customer Service for replacements as needed Part Number Description 15234 Phantom Holder 20008 Seat Cushion 20011 Workstation with Keyboard and Mouse 20132 Mouse Pad 15239 Carbon Fiber Head Holder ...

Страница 20: ...t Additional MiniCAT Software Viewing Stations A MiniCAT Viewing Station is a computer that has MiniCAT software installed and is used as an additional client workstation within a Practice or Hospital environment Viewing Stations can be used for viewing Xoran studies and generating image outputs Viewing stations are connected to a Xoran server and they retrieve patient data and studies from the Xo...

Страница 21: ... Management NOTE 1 The 3D View functionality will be assured to function with a Xoran Specified Computer System Note A Xoran Specified Computer System will require the user to limit the installation of miscellaneous third party software Additional software programs installed on your workstation could impact the efficient function of the Xoran 3D View 2 The 3D View option may not work with standard...

Страница 22: ...or press the F9 CAL key Caution X ray radiation emitted Follow radiation safety protocols 2 Enter Patient Information Enter patient information and click Save SCANNING 1 Select Patient From the Patient Database locate and highlight the patient record Click Acquire New and follow the on screen prompts 2 Select Procedure Create a study title select the procedure and choose the ordering physician 3 S...

Страница 23: ...sides of patient s head Secure patient s head with forehead strap 4 Scan Patient Caution X ray radiation emitted Follow radiation safety protocols Scout confirms patient position No Scout Needed Sinus Scan Scout Temporal Bone Scout Sinus Scan Scout with GE Headset Click Start Acquisition to initiate the scanning process and follow the on screen prompts When the scan is complete the gantry will rew...

Страница 24: ...s Axial coronal sagittal and 3D views are all visible at once Click Image Output from any image viewing window to export images if applicable 6 Initiate Scan Transfer to XoranConnect After the acquisition and reconstruction are complete click Exit in the viewer window to initiate scan transfer and allow it to be available on XoranConnect Note Press the F1 HELP key to access the online user manual ...

Страница 25: ...own the scanner cutting power to all moving parts and ceasing the emission of X rays The operator or patient should press the E Stop in case of emergency or system malfunction where the safety of the patient or operator is at risk such as Extreme patient motion during acquisition i e standing up Software malfunction i e frames do not appear during image acquisition A person or object enters the ga...

Страница 26: ... resetting the E Stop 3 2 System Startup Caution It is recommend that the scanner remain on at all times If the scanner has been shut down for any reason please allow one hour for the scanner to warm up before scanning patients to ensure the best quality images Both the MiniCAT scanner hardware and the workstation must be turned on for the system to function properly ...

Страница 27: ...ntrols the MiniCAT system hardware and software Press the power button to start the workstation Also turn on peripheral devices such as the workstation monitor printer and server if applicable at this time The Operator Control Box should be located on the operator s desk The lights on the Operator Control Box represent the following POWER The system is turned on READY The system is ready to perfor...

Страница 28: ...ht indicates a hardware initialization problem Please follow the system shutdown procedure followed by the system startup procedure If the problem persists please contact Xoran Customer Service for assistance Note The same light configuration is on the front overhead cover of the machine except the fault light The Yellow OFF button on the Operator Control Box can be used to turn off the MiniCAT sc...

Страница 29: ...iniCAT icon on the desktop if your system allows access to the Windows desktop If not proceed to step 2 below 2 Enter username and password If system has exited to Windows login type ct as your user name and ct as the password to return to MiniCAT application Upon login Patient Database window will open ...

Страница 30: ...stem is called a user User information can be managed in the User Management window To launch select the User Management option from the Tools menu in the application The most common User Management actions are listed below New User From the User menu select New User Fill in the user information into the fields ...

Страница 31: ...em and use the MiniCAT software Clearing the Active check box deactivates the user This prevents this user from using the scanner but preserves the user data for record keeping and or future reactivation purposes 3 4 System Shutdown Note It is recommended that the scanner remain on at all times If the scanner has been shut down for any reason please allow one hour for the scanner to warm up before...

Страница 32: ...ctivity Turn Off Scanner To turn off the scanner push the yellow OFF button on the Operator Control Box It is safe to leave the scanner on continuously 3 5 Uninterruptible Power Supply UPS The MiniCAT system is equipped with an Uninterruptible Power Supply UPS which contains a backup battery with enough capacity to complete one scan with reconstruction If the facility power ...

Страница 33: ...ttery The scan in progress will complete as usual No information will be lost The UPS will beep indicating that the battery is being consumed Note When the scan is complete it is recommended that the system be shut down and the main circuit breaker turned off until continuous power is restored A new scan should not be initiated on battery power ...

Страница 34: ...4 1 Patient Database The Patient Database window is automatically opened when the MiniCAT software application is launched Note The Patient Database window will close and revert back to the login screen after two hours of inactivity 4 2 Enter New Patient 1 To enter a new patient click Start Over in the lower left portion of the Patient Database window ...

Страница 35: ...t data in the fields 3 After entering the information in the required fields click Save on the bottom left of the screen 4 3 Find Existing Patient 1 To find an existing patient click Start Over The Find button will be enabled and the patient data fields will become blank ...

Страница 36: ... known information in the patient data fields For example type the first few letters of the patient s last name 3 After you enter your search criteria click Find A list of matching patients will be displayed 4 Click on the to view studies listed under this patient s name There are three types of study files They are described below ...

Страница 37: ...mographic algorithm to create 3D imagery Recon The final result is known as the Reconstruction This 3D volume imagery can be viewed as a series of coronal sagittal or axial slices as well as in many other ways 5 To open a study for viewing double click on its title Note Refer to Chapter 7 for more information on viewing patient studies 4 4 Advanced Search Patient studies may also be searched by or...

Страница 38: ...rch criteria into the Advanced Search window and click Search A list of matching patients will be displayed 3 Click on the to view studies listed under this patient s name in the Patient Database 4 To open a study for viewing double click on its title Note Refer to Chapter 7 for more information on viewing patient studies ...

Страница 39: ...he drop down menu Caution This action permanently deletes files from your system Be sure to follow any required procedures for record retention and data backup before deleting patient records 4 6 Purge Files To purge unneeded patients and studies in your system follow these steps 1 Select the Purge option from the Tools menu 2 Specify date interval to purge 3 Select study type s to purge ...

Страница 40: ... Technologies LLC 4 Press OK to remove the files permanently from your system Caution This action permanently deletes files from your system Be sure to follow any required procedures for record retention and data backup before purging files ...

Страница 41: ...any phantom that might be present before continuing 2a Select the Daily Calibration option from the Tools menu 2b Alternatively you can push the F9 CAL key 3 A message will appear to confirm that all objects have been removed from the field of view Click OK to proceed 4 A message will appear to start the calibration process Click Calibrate to begin 5 A message will appear asking you if it is OK to...

Страница 42: ...protocol options are as follows Protocol Description Sinus 20s 600 20 second imaging protocol with 600 frames i e adult sinus scans Sinus 10s 300 10 second imaging protocol with 300 frames Scan is faster and lower dose but image quality will be somewhat reduced compared to Sinus 20s 600 i e adult follow up sinus scans and or pediatric scans Sinus 10s 150 10 second imaging protocol with 150 frames ...

Страница 43: ...ity 6 2 Prepare the Patient Note It is advisable to ask female patients of childbearing age if they are or may be pregnant Prior to the scan Instruct the patient to remove jewelry hair accessories and glasses Instruct the patient to sit upright relax and face straight ahead The patient can hold the Patient E Stop control in lap or hands Small lasers will be used for positioning Remind the patient ...

Страница 44: ...the Patient E Stop button on the Patient Control Box After the scan The overhead gantry will rewind when the scan is complete 6 3 Seat and Position Patient Caution Select protocol BEFORE positioning the patient in the scanner 1 After selecting the protocol and educating the patient seat the patient in the scanner Adjust the chair so that the patient s head is positioned in the scanner as shown bel...

Страница 45: ... 3 Use the Patient Align arrows on the controller to move the chair up and down 4 Seat the patient so the neck pad fits comfortably at the curve of their neck The patient s ears should be approximately 0 5 inches 1 cm below the sides of the head holder 5 Instruct the patient to close their eyes 6 Press the Alignment Light button on the controller to turn on the alignment lasers ...

Страница 46: ...n once to turn on the laser for a few seconds Press and hold for three seconds to turn on the laser for five minutes For a Sinus scan the laser should project the crosshairs on the patient s high cheekbone as shown below For a Temporal Bone scan the laser should project the crosshairs on the patient s tragus as shown below ...

Страница 47: ...urely on sides of head Included with each head holder are three pairs of different sized temple wedges to fit patients of varying head sizes 8 Secure forehead strap as shown below 9 Remind the patient to remain still and relax while positioned in the scanner 6 4 Dry Run and Scout Perform Dry Run ...

Страница 48: ...quisition button will change to Dummy Acquisition 2 A caution will appear Make sure that nothing is in the path of the rotating overhead gantry 3 Click OK and the gantry will rotate and rewind without firing the X ray source Acquire Scout A Scout is a single lateral X ray taken to verify that the patient is positioned properly Caution Distances in Scout image are not to scale Scout should not be u...

Страница 49: ...will be acquired 4 Check the Scout image to make sure that the following criteria are met If the Scout image does not meet these criteria the patient should be re positioned For sinus scans The sinuses are within the window Patient head appears facing sideways Head is upright not tilting forward or backward Space exists between the tip of nose and edge of the scout image The top part of the upper ...

Страница 50: ... Improper patient positioning is indicated by the visibility of the maxilla and upper teeth and no space in front of the nose For temporal bone scans The temporal bone area is centered in the Scout View image Note For temporal bone imaging a Scout may not be the best method to assess a patient s positioning Xoran recommends using only the laser alignment lights ...

Страница 51: ...ter confirming that your patient is properly positioned you are ready to acquire the CT scan 2 Stand behind the operator s barrier 3 Click Start Acquisition 4 Confirm that the scanner has been powered on for at least 60 minutes Click OK to continue if a confirmation dialogue appears ...

Страница 52: ...ll rotate around the patient and a series of X ray images will be acquired While the X ray source is turned on the system will make a chirping sound When the scan is complete the overhead gantry will rewind to its original position Warning To stop the scanner in case of an emergency press the Emergency Stop E Stop button 7 Reconstruction will begin automatically This takes approximately one minute...

Страница 53: ... view records listed under that patient 2 Double click on the Recon study you wish to view 3 The study will open in the Multi planar Reconstruction MPR window This is the default setting for viewing and manipulating reconstructed images Axial coronal sagittal and 3D views are all visible at once Note If the 3D window is not in view refer to Section 7 7 to enable the 3D view Tip An overlay containi...

Страница 54: ... several image viewing options They are described below Image Viewing Option Description MPR Four views are displayed at once This is a powerful way to navigate the 3D scan volume Axial A series of axial slices are displayed Coronal A series of coronal slices are displayed Sagittal A series of sagittal slices are displayed 3D A 3D viewer is displayed ...

Страница 55: ...on in the navigation menu For example clicking Coronal will present the coronal series of slices as shown below 7 3 Select Slices The Selected Slices view option allows you to view slices which have been selected by the user Slices can be selected in order to be printed or exported 1 Select a view option in the navigation menu Axial Coronal Sagittal or MPR 2 Click SELECT in the lower right corner ...

Страница 56: ...es LLC 3 When an image is selected the label will change to the word SELECTED 4 Thumbnail views of Selected Images will appear in the Selected Images window 5 Right clicking on the Selected Image thumbnail will provide a menu of the following options ...

Страница 57: ...ve All Removes all images in the Selected Images window Go To Displays the selected slice in MPR view Autosort Orders your selected slices from anterior to posterior Change Selection Allows the user to obtain pre selected sets of images which are customized by Xoran to fit your imaging needs Tip Hold down the SHIFT key to operate on multiple selected images at once Range Indicator ...

Страница 58: ...enting the locations of selected slices The spacing between tick marks represents the pitch Click on the Range Indicator and drag it side to side to move the entire selected series all at once 7 4 Viewing Tools Zoom 1 Select the Pan Zoom tool from the toolbar 2 Place the cursor anywhere in the image except over the colored lines Left click to zoom in Right click to zoom out ...

Страница 59: ...the toolbar 2 Place the cursor anywhere in the image except over the colored lines Click and hold down the left mouse button Move the mouse to pan the image until desired position is achieved Scroll There are three ways to scroll through the axial coronal and sagittal slices 1 The mouse wheel ...

Страница 60: ...on of the other two views shown in the MPR window For example in the Sagittal view shown below The green line represents the Axial slice plane The orange line represents the Coronal slice plane Cut plane lines can be moved by clicking and dragging This causes the images in the other view windows to change Two cut plane lines may be moved together simultaneously by grabbing the lines at their inter...

Страница 61: ...eled ST Slice thickness can be changed by clicking on the ST box and selecting from the list Minimum Slice Thickness ST for Sinus 0 4 mm Columns The number of slice images displayed on the screen in Axial Coronal or Sagittal views can be altered using the Columns pull down menu The following examples show 3 columns top versus 5 columns bottom in Coronal view 3 columns ...

Страница 62: ... User Manual v5 2 2014 Xoran Technologies LLC 5 columns Window Level The Window Level values determine the brightness and contrast of the displayed image To adjust 1 Click on the Window Level icon in the toolbar ...

Страница 63: ...the image and decreases towards the bottom 2b Alternatively you can manually input the desired window level values or adjust the sliders in the Window Level pane Note 2D and 3D window level values are independent of each other 3 The window level values appear in the patient information overlay labeled W L 4 Preset options for window level can be applied Click on the down arrow next to the brightne...

Страница 64: ...e rotated in MPR view Find the double ended arrow on the right side of the image Click and drag the arrow up and down to rotate the image Rotation angle adjustments are recorded in the patient information overlay listed as alpha beta and gamma angles values in degrees Images can be restored to their original non rotated orientations by selecting the Restore Original Tilt option from the Toolbox me...

Страница 65: ...indow where images are displayed To view annotations within a scan click the appropriate annotation within the Regions area Distance Tool In the MPR viewer the Distance Tool measures the distance between two points on an image in millimeters 1 Click on the Distance Tool icon in the toolbar to activate the tool Left click on the starting point of your desired measurement Click once on each endpoint...

Страница 66: ... objects can be moved by left clicking the line and dragging it to the desired location Line objects can be modified by right clicking the line A drop down menu will appear with the following options Line Options Description Change Name Changes the name of the line Change Color Changes the line color Set current color as default Sets the current color of the line as the default color for subsequen...

Страница 67: ... shape outline 1 Click on the Circle Tool icon or the Rectangle Tool icon in the toolbar to activate the tool 2 Left click on the center of the target region Click once Do not hold mouse button down 3 Left click again on the edge of the target region and a shape object will appear The mean standard deviation and surface area values will appear inside the ellipse Note The units of the mean and stan...

Страница 68: ...iew by right clicking the corresponding object from the Regions menu and selecting Visible Shape Changes the shape to a rectangle ellipse circle or square Delete Deletes the shape object Text Tool Text can be added to an image This simple but flexible tool can be useful for labeling anatomical features or making notes 1 Click on the Text Tool icon or the Label Tool icon from the toolbar 2 Left cli...

Страница 69: ...ill appear with the following options Text and Label Options Description Edit Edits the content of the text box Change Name Changes the name of the text box Change Color Changes the color of the font Set current color as default Set the current color of the font as the default font color for subsequent text boxes Visible De selecting this option makes the line disappear from view Bring the object ...

Страница 70: ...ox 7 6 Oblique and TMJ Tools The Oblique and Two Points Oblique tools can be used in any plane Oblique Tool 1 Click on the Oblique icon When this icon is active you have the ability to flatten oblique and curved objects into a two dimensional view 2 Left click to deposit points along the desired pathway and double click on the last point to end the line An example is shown below 3 The following sc...

Страница 71: ...top right shows the cut along the oblique pathway The slice thickness is 0 4 mm and can be changed by left clicking on the Slice Thickness ST value in the top right corner of the image and selecting a new value The thumbnail images in the bottom right frame are cuts that are perpendicular to the oblique pathway These are equally spaced along the length of the oblique pathway The highlighted thumbn...

Страница 72: ...dragging it to the desired location Make changes to the oblique line by moving the cursor over it until the oblique line changes color and then right clicking the mouse A drop down menu will appear with options Make similar changes by right clicking the corresponding oblique line in the Navigation menu and choosing from the menu options Oblique Options Description Change Name Changes the name of t...

Страница 73: ...g Visible Go To Opens the Oblique window the new screen that appears after you define an oblique line Delete Deletes the oblique line Insert Point Inserts an additional point to the oblique object Delete Point Deletes the selected point from the oblique object Two Points Oblique Tool 1 Click on the Two Points Oblique icon When this icon is active you have the ability to flatten oblique and curved ...

Страница 74: ...0 4 mm and can be changed by left clicking on the Slice Thickness ST value in the top right corner of the image and selecting a new value Move the oblique line by hovering over it with the cursor until it is active it will change color grabbing it by holding down the left mouse button and dragging it to the desired location Make changes to the oblique line by moving the cursor over it until the ob...

Страница 75: ... Regions menu and selecting Visible Go To Takes you to the Oblique window the screen that appears after you define an oblique line Delete Deletes the oblique line TMJ Tool The TMJ Temporomandibular Joint tool can be used in the Axial plane 1 Click on the TMJ icon When this icon is active you have the ability to look at the temporal mandibular joints in a two dimensional view 2 Left click below and...

Страница 76: ...over the center of the joint The second point chosen for this example is highlighted with the red arrow As soon as this point is selected the letter L appears over this line indicating the patient s left A second line appears on the patient s right side that may or may not be over the right condyle You can move this line so that it is positioned properly 4 The following screen will appear ...

Страница 77: ...ight corner of each image and selecting a new value The two panes of small images are cuts that are perpendicular to the TMJ lines These are equally spaced along the length of each TMJ line Move the TMJ lines by hovering over them with the cursor until they are active they will change color grabbing them by holding down the left mouse button and dragging them to the desired location Make changes t...

Страница 78: ...om view Bring the object back to view by right clicking the corresponding object from the Regions menu and selecting Visible Go To Takes you to the TMJ window the screen that appears after you define a pair of TMJ lines Delete Deletes the pair of TMJ lines 7 7 3D Viewing Window To enable the 3D viewing window click the Tools menu from the Patient Database and select Show 3D To reconstruct the 3D w...

Страница 79: ...Technologies LLC 2 Place the cursor anywhere in the image except over the colored lines Left click to zoom in Right click to zoom out Rotate 1 Click and hold anywhere on the screen Drag the cursor in the direction you want to rotate the view ...

Страница 80: ...rds the other parallel plane 7 8 Comparison Tool 1 To enable the comparison tool select any two reconstructed studies To select multiple studies click on two studies while holding Ctrl 2 Right click and select Compare When reconstructed studies from different patients are compared a confirmation window will appear asking to proceed ...

Страница 81: ...78 MiniCAT User Manual v5 2 2014 Xoran Technologies LLC 3 Side by side single planar views will appear You can switch between the coronal view shown below sagittal and axial ...

Страница 82: ...ted containing patient demographic information which is sent to the MiniCAT The scanner operator simply selects the patient name from a list of scans that have been ordered and performs the scan The scan image data is attached to the demographic data and sent out to the facility PACS system An active internet connection is required to use the Modality Worklist Client Query A Query searches the hos...

Страница 83: ...abase When a patient record in the server is similar i e two records have the same patient name and same birthdate to a patient record already in the Patient Database you can either merge the records by checking the box next to the patient name or create a new record if they are different patients If you choose to merge the records inconsistent data will be highlighted in red Click Yes to merge th...

Страница 84: ...ce Output Protocol Description Print Selected Images Automatically prints the images in the Selected Images window The default image layout is 3 rows by 2 columns Export Xoran Study Exports Xoran study data to either a CD or USB flash drive Burn DICOM CD Burns a Xoran image data onto a CD in DICOM format which is compatible with most IGS systems Export to HTML Exports a Xoran study in HTML format ...

Страница 85: ...ed tomography VCT imaging system designed for high resolution low radiation imaging of the sinuses skull base and temporal bones System Dimensions 40 L x 36 W x 67 H 102 cm x 91 cm x 170 cm Weight 450 lbs Patient Support Overall Dimensions 28 L x 18 W x 50 H 71 cm x 46 cm x 127 cm Weight 115 lbs 52 kg Seat Height Adjustment 15 5 to 42 39 cm to 107 cm Maximum Patient Weight 350 lbs 159 kg ...

Страница 86: ...83 MiniCAT User Manual v5 2 2014 Xoran Technologies LLC FRONT VIEW TOP VIEW ...

Страница 87: ...s scan approximately 270 Axial slices Number of Data Channels Used 744 Sinus scans 412 Temporal bone scan Views MPR Axial Coronal Sagittal Oblique 3D TMJ Side by Side Gray Scale Display 256 levels Display Window Adjustable level and width Compatibility DICOM 3 0 Acquisition Protocols SourceRay Source Tube Voltage Tube Current Pulse Length Number of Frames Exposure Scan Time Default Reconstruction ...

Страница 88: ...6 0 3 0 3 f0 Resolution Calibration 125 kVp 7 mA 18 ms 600 75 6 mAs 40 s SHARP 800x800 0 2 0 2 f0 Water Calibration 120 kVp 5 mA 16 ms 600 48 mAs 40 s SMOOTH 400x400 0 4 0 4 f1 Legacy Acquisition Protocols SourceRay Source Sinus 40s 600 120 kVp 7 mA 11 5 ms 600 48 30 mAs 40 s SMOOTH 400x400 0 4 0 4 f1 Sinus 20s 300 120 kVp 7 mA 11 5 ms 300 24 15 mAs 20 s SMOOTH 400x400 0 4 0 4 f1 Sinus 10s 150 120...

Страница 89: ...Provides smooth image detail with low noise MiniCAT Scan Parameters Maximum number of slices per acquisition Cone Beam CT Acquisition series Volume Reformat technique Multi planar reconstruction kVp mAs 600 Frame Sinus 120 kVp 48 mAs 300 Frame Sinus 120 kVp 24 mAs 150 Frame Sinus 120 kVp 12 mAs T Bone 20s 600 125 kVp 58 mAs T Bone 40s 600 ISI 125 kVp 76 mAs T Bone 40s 600 SourceRay 125 kVp 58 mAs ...

Страница 90: ...mSv Sinus 10s 150 0 04 mSv T Bone 20s 600 0 14 mSv Prescribed rotation time Sinus 20s 600 20 seconds Sinus 10s 300 10 seconds Sinus 10s 150 10 seconds T Bone 20s 600 20 seconds Sinus 40s 600 40 seconds Sinus 20s 300 20 seconds Sinus 10s 150 10 seconds T Bone 40s 600 40 seconds Increment N A Detector collimation mm Sinus 189 mm Temporal Bone 105 mm Slice thickness Sinus Selectable 0 4 mm minimum re...

Страница 91: ...m Superior of central slice 32 7 1 6 mm Inferior of central slice 96 8 4 8 mm Primary Beam Dimension at Isocenter for Temporal Bone scan 167 2 2 5 x 71 9 1 1 mm Superior of central slice 32 8 1 6 mm Inferior of central slice 39 1 1 9 mm Number of detector elements 1536 x 1920 Element Spacing dimensions 0 127 x 0 127 mm Image Noise The following table gives the noise for each imaging protocol with ...

Страница 92: ...048 Sinus 10s 300 Sinus 20s 300 0 547 0 071 Sinus 10s 150 0 536 0 130 T Bone 20s 600 T Bone 40s 600 0 532 0 043 Measuring Nominal Tomographic Section Thickness is obtained by finding the full width half maximum FWHM resolution of the Slice Sensitivity Profile SSP The SSP is obtained by scanning a small sub voxel bead in the QC module However the nominal tomographic section thickness is fixed for e...

Страница 93: ...90 MiniCAT User Manual v5 2 2014 Xoran Technologies LLC Sinus 20s 600 Sinus 40s 600 Sinus 10s 300 Sinus 20s 300 Sinus 10s 150 ...

Страница 94: ...chnologies LLC T Bone 20s 600 T Bone 40s 600 MTF Profiles The Modulation Transfer Function MTF is the amplitude frequency response of the imaging protocol and is a commonly used measure of system blur The MTF profiles are given in the figures ...

Страница 95: ...ng axially embedded with a tungsten wire filament The tungsten wire filament is 50 microns in diameter Data Acquisition Methodology An acquisition and reconstruction of the phantom is made in the desired imaging mode with the tungsten filament centered horizontally in the field of view and vertically about the equatorial plane of the scanner the plane of rotation of the focal spot The vertical axi...

Страница 96: ...93 MiniCAT User Manual v5 2 2014 Xoran Technologies LLC Sinus 20s 600 Sinus 40s 600 Sinus 10s 300 Sinus 20s 300 ...

Страница 97: ...94 MiniCAT User Manual v5 2 2014 Xoran Technologies LLC Sinus 10s 150 T Bone 20s 600 T Bone 40s 600 ...

Страница 98: ...wave rectified Max Tube Current r m s 8 mA Target Material Tungsten Target Angle 15 degrees Focal Spot Size 0 5 mm NEMA Minimum Inherent Filtration 2 0 mm Al 125 kVp Rated Line Voltage 120V AC 50 60 Hz 10A r m s max line current integrated into diagnostic system Range of Line Voltage Regulation 2 Maximum line current r m s 10A Technique Factors that Constitute the Maximum Line Current Condition 12...

Страница 99: ... duty cycle Beam Quality half value layer HVL SourceRay Source 9 4 mm equivalent Al 120 kVp 9 7 mm equivalent Al 125 kVp Beam Quality half value layer HVL ISI Source 10 6 mm equivalent Al 120 kVp 10 9 mm equivalent Al 125 kVp Minimum Permanent Filtration SourceRay Source 11 7 mm Al equivalent Minimum Permanent Filtration ISI Source 10 6 mm Al equivalent Measurement Criteria for Peak Voltage Curren...

Страница 100: ...T at 6 azimuthal locations A through F and at radii 1 0 1 5 and 2 0 meters from isocenter and in the same plane as the central slice i e level with the focal spot which was approximately 120 centimeters above the floor see diagram below The MiniCAT was operated at 120 kVp and 48 3 mAs per Sinus 20s 600 protocol for all secondary radiation measurements reported ...

Страница 101: ...98 MiniCAT User Manual v5 2 2014 Xoran Technologies LLC ...

Страница 102: ... 919 1 5 0 420 2 0 0 261 C 1 0 1 050 1 5 0 438 2 0 0 257 D 1 0 1 101 1 5 0 438 2 0 0 271 E 1 0 1 092 1 5 0 480 2 0 0 271 F 1 0 0 812 1 5 0 373 2 0 0 261 The secondary radiation doses were also recorded at 0 5 meters above and 0 5 meters below the horizontal plane intersection the central slice at azimuthal locations A through F and at a radius of 1 0 meter These measurements are reported in the fo...

Страница 103: ...l slice at radius of 1 meter Azimuthal Location Dose Per Scan millirad A 0 60 B 0 70 C 0 76 D 0 02 E 0 78 F 1 76 10 5 Dose Information SourceRay Source The CT conditions of operation used to provide dose and imaging performance information below are as follows Sinus 20s 600 120 kVp 7 mA 11 5 ms pulses 600 pulses 48 3 mAs 11 7 mm Al equivalent fixed filtration 0 542 0 048 mm tomographic section thi...

Страница 104: ...n 0 532 0 043 mm tomographic section thickness The nominal tomographic section thickness is fixed for each protocol and is not selectable prior to acquisition Dose Measurements SourceRay Source Protocol CTDIVOL mGy DLP mGy cm Sinus 20s 600 Sinus 40s 600 5 1 97 0 Sinus 10s 300 Sinus 20s 300 2 6 49 2 Sinus 10s 150 1 3 24 6 T Bone 20s 600 T Bone 40s 600 7 3 76 9 21CFR1020 33 Subsection Description Pr...

Страница 105: ...70 degrees from the position of maximum at periphery respectively Sinus 20s 600 Sinus 40s 600 5 0 4 8 and 4 7 mGy CTDI for locations at 90 180 and 270 degrees from the position of maximum at periphery respectively T Bone 20s 600 T Bone 40s 600 6 8 6 9 and 7 0 mGy c 2 i c ii For each selectable protocol that varies the duration of x ray exposure with all other factors are maintained the CTDI is nor...

Страница 106: ...l Effective Dose Estimate mSv Sinus 20s 600 0 17 Sinus 10s 300 0 09 Sinus 10s 150 0 04 T Bone 20s 600 0 13 Scout View 0 01 Legacy Protocols ISI Source The CT conditions of operation used to provide dose and imaging performance information below are as follows Sinus 40s 600 120 kVp 5 mA 16 ms pulses 600 pulses 48 mAs 10 6 mm Al equivalent fixed filtration 0 542 0 048 mm tomographic section thicknes...

Страница 107: ...iphery 90 from max Periphery 180 from max Periphery 270 from max Sinus 40s 600 4 8 4 3 4 2 3 8 3 5 Sinus 20s 300 2 6 2 1 1 9 1 9 1 9 Sinus 10s 150 1 3 1 0 1 0 1 0 1 0 Protocol ISI Source CTDI100 mGy Center Max periphery 2 o clock position Periphery 90 from max Periphery 180 from max Periphery 270 from max T Bone 40s 600 7 1 5 4 5 4 5 4 5 0 10 6 Installation Requirements Room Requirements Recommend...

Страница 108: ...ingle Single Single Main Circuit Breaker 5A 10A 5A 10A MiniCAT input voltage regulation range measured at UPS output 100 x VNO LOAD VLOADED VLOADED NB unit must be used with provided line conditioner UPS Do not initiate a scan without AC power to the UPS For immunity to electrical noise a dedicated AC power line with a separate circuit breaker dedicated neutral and ground is recommended to install...

Страница 109: ...of a flammable anaesthetic mixture with air oxygen or nitrous oxide Operating Requirements 60 to 80 degrees Fahrenheit 16 to 26 degrees Celsius 10 to 90 humidity Transportation and Storage Requirements 14 to 104 degrees Fahrenheit 10 to 40 degrees Celsius 10 to 90 humidity Heat Dissipation Approx 500W 1700 BTU hr Caution Allow system temperature to adapt to room temperature before powering up the ...

Страница 110: ...e and Patient Record Access ONLY with a workstation class desktop computer When a Viewing Station is used on a multi use computer platform environment such as an Administrative Station or a Physician s Office where a laptop computer may be used it is recommended that a minimum of additional 3rd Party Software be installed and that anti virus software be utilized Xoran cannot assure that the Minimu...

Страница 111: ... space may vary depending of the operating system installed e g 1GB for Windows 7 For example MiniCAT workstation that is running Windows 7 will require at least 200MB 500MB 1GB 1 7GB of free hard drive space Graphics card Xoran Verified Graphics Card and Drivers Nvidia GeForce GTS 250 GTS 450 GT 560 Nvidia Drivers 275 33 296 10 Note Above Graphics Cards designed for Desktop Computers NOT Laptops ...

Страница 112: ...computer should be able to reach Xoran dedicated router through local network USB port An available USB port is required for HASP key provided by Xoran Printer A local or network printer is required in order to print image reports 10 7 IGS Compatibility The following tables summarize the compatibility of MiniCAT with other image guided systems GE Platform Compatible with Xoran IT3500 ENTrak ConneC...

Страница 113: ...andmarX gen2 No Medtronic Stealth Treon Ion Tria No Medtronic Treon Plus w ENT software Tria Plus w ENT software Yes Medtronic Fusion Yes BrainLAB Requires Pac Xfer Version 5 2 or Higher Platform Compatible with Xoran VectorVision Yes VectorVision2 Yes VectorVision Compact for ENT Yes Kolibri Yes Stryker Platform Compatible with Xoran Stryker Navigation System original Yes NavII Yes mNAV Yes ...

Страница 114: ...ation Xoran provides a quality control phantom to use for these quality control tests Xoran has developed these procedures to scan only the sinuses and temporal bones which are high contrast or bone window imaging tasks that require isotropic high spatial resolution and do not require the level of contrast resolution needed for other imaging tasks such as brain or muscle tissue scanning etc Xoran ...

Страница 115: ... 3 Spatial Resolution Monthly 11 4 CT Number and Standard Deviation of Water Daily 11 5 Artifact Test Daily 11 6 Uniformity Test Monthly 11 7 Contrast Scale Annually 11 8 Image Noise Annually 11 9 Nominal Tomographic Section Thickness and Slice Sensitivity Profile Annually Note The required frequency of QC tests may vary according to state regulations accrediting organizations or your medical phys...

Страница 116: ... QC Phantom and the Custom QC and Uniformity Material modules in the MiniCAT Top Right Photo of the QC Module Bottom Left Simplified drawing of the QC Module Bottom Right Coronal and Axial images of an MiniCAT scan of the QC phantom Procedure Before QC is conducted a Daily Calibration should be performed ...

Страница 117: ...he phantom with the appropriate protocol s specified in the respective QC test 11 1 Laser Accuracy To confirm alignment light accuracy 1 Press and hold the Alignment Light button on the controller to turn on laser Press button once to turn on the laser for a few seconds Press and hold for three seconds to turn on the laser for five minutes Side lasers should align with the alignment stickers on pe...

Страница 118: ...ure 1 Using the Resolution QC scan scroll to the midpoint of the four reference material inserts Teflon LDPE Acrylic Air in the axial view of the reconstructed QC Phantom scan 2 Draw a circular region entirely within each of the reference material boundaries Each circular region should range in size from 65 80 square millimeters 3 Record the mean value for each material and compare with the accept...

Страница 119: ...000 to 650 HU Teflon 550 HU Acrylic 50 to 250 HU LDPE 200 to 0 HU 11 3 Spatial Resolution Equipment and Scan Quality Control Phantom Resolution QC scan High Contrast Procedure 1 Using the Resolution QC scan position the Quality Control phantom at the central slice ...

Страница 120: ... scroll to the graded line pair targets in the axial view of the reconstructed scan and adjust the window level and zoom level to achieve good viewing characteristics of the graded line pairs see picture below The picture below is an example of a typical window level for accurate lp cm viewing ...

Страница 121: ...cedure 1 Scroll to the six low contrast targets of the QC Module made of HDPE of sizes 10 8 6 4 3 and 2 mm diameter in the axial view of the reconstructed scan 2 Adjust the window level zoom level and slice thickness if necessary to achieve good viewing characteristics of all six targets Tolerance Greater or equal to 4 targets should be distinguishable 11 4 CT Number and Standard Deviation of Wate...

Страница 122: ...low Tolerance STD of water 30 Mean 100 HU 11 5 Artifact Test Equipment and Scan Quality Control Phantom Water Calibration protocol Procedure 1 To look for ring artifacts in the image start at one axial extreme of the reconstructed QC Phantom scan and scroll through all slices to the other extreme looking at each axial slice Ensure that no rotations of the data have been applied i e restore origina...

Страница 123: ...ologies LLC Tolerance The images should be free from artifacts 11 6 Uniformity Test Equipment and Scan Quality Control Phantom Water QC scan Procedure 1 Scroll axially approximately 2 cm above the QC Module to the large section of the Water Module ...

Страница 124: ...cale Equipment and Scan 2 30 mm Water Modules Sinus 20s 600 Sinus 10s 300 Sinus 10s 150 T Bone 20s 600 Procedure 1 Acquire a Scout for Sinus 20s 600 Sinus 10s 300 Sinus 10s 150 Label these scans Contrast Scan 1 2 Place a 30 mm Water Module over the source The 30 mm water module should be centered over the aperture of the source The 30 mm water module can be attached to the gantry with strong tape ...

Страница 125: ...Sinus 20s 600 Sinus 10s 300 Sinus 10s 150 Label these scans Contrast Scan 3 as well 11 Open a scout view of one of the sinus scans 12 Select Show Ruler from the Toolbox Zoom in to align the edges of the Scout with the ruler tick marks 13 Open the Study Details and note the Central slice pixel value 14 Using the Distance Tool draw a horizontal line across the scout Y value that matches the Central ...

Страница 126: ...e Scout 22 Go to tool box and click Save Planning File and save as T Bone Contrast 23 Open each temporal bone Scout load the planing file and record the mean value of the region in the appropriate section of the User QC Spreadsheet 24 Using the Attenuation Table below lookup the nearest attenuation value for water and trace the row right to find the Teflon Water Differential Record this number in ...

Страница 127: ...0 2 62 0 201 0 397 0 196 63 0 2 0 395 0 195 64 0 199 0 391 0 192 65 0 198 0 389 0 191 66 0 197 0 384 0 187 67 0 196 0 382 0 186 68 0 196 0 38 0 184 69 0 195 0 376 0 181 70 0 194 0 374 0 18 71 0 193 0 372 0 179 72 0 192 0 369 0 177 73 0 192 0 367 0 175 74 0 191 0 365 0 174 75 0 19 0 363 0 173 76 0 189 0 361 0 172 77 0 189 0 359 0 17 ...

Страница 128: ...8 89 0 181 0 339 0 158 90 0 18 0 337 0 157 25 Scan the QC Phantom with the QC module placed on the central slice the Front label facing forward and the entire module placed centrally in the field of view Scan the phantom with Sinus 20s 600 Sinus 10s 300 Sinus 10s 150 and T Bone 20s 600 26 Open the Sinus 20s 600 reconstruction and locate the central slice click Study Details The central slice is th...

Страница 129: ...nates are located in the upper right region of the MPR window 29 Scroll axially in the superior direction about 3 cm to the Water Module of the QC Phantom Draw a 65 80 mm2 circular region at approximately the same X Y location Record the mean value in this region in the CTw Section of the User QC Spreadsheet 30 Repeat Steps 26 29 for Sinus 10s 300 Sinus 10s 150 and T Bone 20s 600 Tolerance Sinus 2...

Страница 130: ... circular region of 550 mm2 20mm2 in the background reference area of the QC module centered left to right and below top to bottom the line pairs of the phantom in a uniform region 2 Record the standard deviation S measured in the appropriate cell of the User QC Spreadsheet Note that Contrast Scale must be performed before the Image Noise test 3 Repeat these steps for each of the clinical scans To...

Страница 131: ... Sinus 20s 600 Sinus 10s 300 Sinus 10s 150 T Bone 20s 600 Measuring Nominal Tomographic Section Thickness is obtained by finding the full width half maximum FWHM resolution of the Slice Sensitivity Profile SSP The SSP is obtained by scanning a small sub voxel bead in the QC module Specifically the custom QC module contains a 0 280 mm tungsten bead in the upper half of the phantom Note See below pi...

Страница 132: ...gnal not enough samples or poor centering center SSP selection tool on tungsten bead again 6 Record the Width value reported by the software in the SSP measured row of the User QC spreadsheet 7 Repeat these steps for the Sinus 10s 300 Sinus 10s 150 T Bone 20s 600 and compare with the tolerances below Tolerance Sinus 20s 600 0 494 to 0 589 Sinus 10s 300 0 476 to 0 618 Sinus 10s 150 0 406 to 0 665 T...

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