NewTom

Mod. QR-DVT 9000

Dental Volumetric Tomograph

USER MANUAL Software Version 3.4x

Rev. 15
(02/01/2006)

CONTENTS 1. About this manual ___________________________________________________________ 1

1.1 WARNING ____________________________________________________________________2
X-Ray Warning _____________________________________________________________________ 2 LASER WARNING _________________________________________________________________ 3 1.1.1 1.1.2

2. Device introduction __________________________________________________________ 4

2.1 2.2 2.3 2.4 3.1 3.2 3.3 4.1 4.2 4.3 4.4 4.5 Introduction ___________________________________________________________________4 Working principles _____________________________________________________________5 Composition ___________________________________________________________________5 Software configuration __________________________________________________________6 Device start-up _________________________________________________________________8 General description of commands _________________________________________________8 Device shutdown ______________________________________________________________11 Introduction __________________________________________________________________12 Daily Check___________________________________________________________________12 Procedure for exam execution ___________________________________________________12 Exam procedure summary scheme _______________________________________________16 Menu ________________________________________________________________________16
File Menu ________________________________________________________________________ 16 Scan Menu _______________________________________________________________________ 17 Primary Reconstruction Menu ________________________________________________________ 17 View Menu _______________________________________________________________________ 18 Tool Menu _______________________________________________________________________ 18 About Menu ______________________________________________________________________ 18

3. Getting started... _____________________________________________________________ 8

4. Exam Execution ____________________________________________________________ 12

4.5.1 4.5.2 4.5.3 4.5.4 4.5.5 4.5.6

5. Raw Data and primary reconstruction __________________________________________ 19

5.1 5.2 5.3 5.4 Introduction __________________________________________________________________19 Primary reconstruction _________________________________________________________19 Deferred primary reconstructions ________________________________________________20 Menu ________________________________________________________________________21
File Menu ________________________________________________________________________ 21 Edit Menu ________________________________________________________________________ 21 Primary Reconstruction Menu ________________________________________________________ 21 Scan Movie Menu __________________________________________________________________ 21 Toolbar Menu _____________________________________________________________________ 22 Window Menu ____________________________________________________________________ 22 About Menu ______________________________________________________________________ 22

5.4.1 5.4.2 5.4.3 5.4.4 5.4.5 5.4.6 5.4.7

6. Studies and secondary reconstructions __________________________________________ 23

6.1 Secondary reconstruction _______________________________________________________23
Setup of the visualization window _____________________________________________________ 23 Transaxial views ___________________________________________________________________ 24 Panoramic views ___________________________________________________________________ 26 6.1.1 6.1.2 6.1.3

6.1.4

3D Views ________________________________________________________________________ 28 Brightness and Contrast _____________________________________________________________ 30 Marker___________________________________________________________________________ 31

6.2

Utility________________________________________________________________________30

6.2.1 6.2.2

6.3 6.4

Graphic settings setup __________________________________________________________31 Menu ________________________________________________________________________33

File Menu ________________________________________________________________________ 33 Edit Menu _______________________________________________________________________ 34 Secondary Reconstruction Menu ______________________________________________________ 34 Report Menu _____________________________________________________________________ 35 Utility Menu______________________________________________________________________ 35 Images Menu______________________________________________________________________ 37 Toolbar Menu _____________________________________________________________________ 37 Window Menu ____________________________________________________________________ 38 About Menu ______________________________________________________________________ 38

6.4.1 6.4.2 6.4.3 6.4.4 6.4.5 6.4.6 6.4.7 6.4.8 6.4.9

7. Report page layout __________________________________________________________ 39

7.1 7.2 7.3 8.1 8.2 8.3 8.4 8.5 8.6 8.7 8.8 Creating a report page layout____________________________________________________39 Opening a report layout ________________________________________________________40 Deleting a report layout_________________________________________________________41 Report Header Setup ___________________________________________________________42 Creating a new report __________________________________________________________43 Changing an existing report _____________________________________________________45 Showing an existing report ______________________________________________________45 Report Page Notes _____________________________________________________________45 Report Attached Letter _________________________________________________________45 Print Enhancement ____________________________________________________________45 Report Menu__________________________________________________________________47
File Menu ________________________________________________________________________ 47 Edit Menu ________________________________________________________________________ 47 Toolbar Menu _____________________________________________________________________ 48 Window Menu ____________________________________________________________________ 48 About Menu ______________________________________________________________________ 48 Pop-Up Menu_____________________________________________________________________ 48

8. Creating and modifying a report _______________________________________________ 42

8.8.1 8.8.2 8.8.3 8.8.4 8.8.5 8.8.6

9. Documents managment ______________________________________________________ 49

9.1 Import/Export ________________________________________________________________49
Import/Export drive setup (Export Drive)________________________________________________ 49 Export ___________________________________________________________________________ 50 Import ___________________________________________________________________________ 50 Deleting documents from work drive ___________________________________________________ 50 Deleting documents from Export Drive _________________________________________________ 50 Exporting axial images as Bitmap______________________________________________________ 51 Exporting axial images as DICOM _____________________________________________________ 51 9.1.1 9.1.2 9.1.3

9.2

Deleting documents ____________________________________________________________50

9.2.1 9.2.2

9.3

Exporting axial images (OPTIONAL) _____________________________________________51

9.3.1 9.3.2

10.

Glossary _________________________________________________________________ 52

11.

Service __________________________________________________________________ 53

11.1 Introduction __________________________________________________________________53 11.2 Compliance ___________________________________________________________________53 11.3 Device modifications ___________________________________________________________54 11.4 Warnings_____________________________________________________________________54 11.5 Maintenance and cleaning_______________________________________________________55
11.5.1 11.5.2 11.5.3 11.5.4 General requirements _______________________________________________________________ 55 Preventive maintenance _____________________________________________________________ 55 Cleaning _________________________________________________________________________ 55 Disposal _________________________________________________________________________ 56

11.6 Quality Assurance (QA) ________________________________________________________56 11.7 Check List maintenance intervals ________________________________________________58 11.8 Error messages________________________________________________________________59 11.9 Log Files visualization __________________________________________________________73
11.9.1 11.9.2 Error Log File visualization __________________________________________________________ 73 Daily Check Log File visualization_____________________________________________________ 73

11.10

Suggestions for shipment, storage, preservation and installation _____________________73

12. 13.

Identification and marking__________________________________________________ 75 Safety ______________________________________________________________ 81

13.1 General warnings______________________________________________________________81 13.2 Device shutdown ______________________________________________________________81 13.3 Emergency shutdown __________________________________________________________82 13.4 Guide lines for patients and operators safety _______________________________________82 13.5 Safety devices _________________________________________________________________84 13.6 Important Warning _____________________________________________________________85

1. About this manual

This manual contains information about the QR-DVT 9000 tomograph features and its over all instructions. Particularly: chapter 2 (Device introduction) contains a general presentation of the device, operating principles and software configuration information; chapter 3 (Getting started...) contains preliminary information about device use, with particular reference to the user-interface description, that is to say software control mode by user; chapter 4 (Scan execution) contains the description of an exam execution procedure; chapter 5 (Raw data and primary reconstruction) contains exam data processing and patient study generation description; chapter 6 (Studies and secondary reconstructions) contains the description of study processing after primary reconstruction; chapter 7 (Report page layout) contains the report pages layout creation description; chapter 8 (Creating and modifying a report) contains the report generation and modify description; chapter 9 (Documents management) contains the description of the management of the documents created from the software; chapter10 (Glossary) contains a glossary with the description of some words of particular meaning in the manual and, in general, for a complete comprehension of the device operating mode; chapter 11 (service) contains information concerning the maintenance, cleaning, user and environment safety; chapter 12 (Identification and marking) contains information about device labels; chapter 13 (Safety) describes the safety procedures to follow;

The following agreements are used in the manual to represent words of particular meaning about software or about the same manual: text format bold italic <text> underlined italic CAPITAL LETTER Example Primary Reconstruction <Would you like start the scan?> Cancel primary reconstruction ENTER meaning Menu command software messages push-button commands glossary word keyboard command

THIS MANUAL WAS ORIGINALLY WRITTEN IN THE ITALIAN LANGUAGE

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1.1 WARNING
1.1.1 X-Ray Warning WARNING: The Tomograph mod. QR-DVT 9000 is a radiological device and, for this reason, the patient and the operators are exposed to risk resulting from ionizing radiations. It must be used in compliance with safety regulations, required by current radioprotection normative, in accordance with local laws. The operator, however, must not remain near QR-DVT 9000, when the device is in emission state.

WARNING: This x-ray unit may be dangerous to patient and operator unless safe exposure factors and operating instructions are observed.

or

Warning Label on the control panel containing the main power switch

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1.1.2 LASER WARNING

The following Warning label for Laser are placed near the Main switch control panel (as shown in figure):

AP Laser Line Label

LL Laser Point Label

Laser Device Warning Label

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2. Device introduction

2.1 Introduction
QR-DVT 9000 is a Computerized Tomograph dedicated to imaging of dental arcades (Dental Scan), working with "cone-beam" technics (CBCT = Cone Beam Computed Tomography). In approximately one minute (variable according to device model), the scan system, consisting mainly of the radiogen tube and the bidimensional detector, executes a complete rotation around the patients head, acquiring all necessary data for a complete volumetric reconstruction of the region of interest. The raw data primary reconstruction allows the operator to obtain all the axial sections (thickness slices of 0.3, 1 o 2 mm; as selected by operator) of the rebuilt volume, inclined according to an angle chosen by the operator. Secondary reconstructions allow the operator to obtain all other interest "views" for study of the examined region. In particular the images we can obtain are: bidimensional reconstructions on perpendicular planes with reference to the ones of the axial views. Single images could be obtained or sequences of following views orthogonal to a line drawn by the operator; panoramic views: these are bidimensional reconstructions always on perpendicular planes with reference to the axial views rebuilt along a line drawn by the operator; tridimensional views: these are 3D views of the rebuilt volume, made with reference to a point of view that can be moved around the region of interest. On all the rebuilt views (except 3D ones), it is possible to perform distances, angles and profile measurements (graphics of the grey levels along the lines drawn on the images). The whole of these images constitute a study performed on the raw data of the exam. From the same set of raw data more studies can be obtained, getting, e.g., started from primary reconstructions with different inclinations of the axial sections. All the rebuilt images, with the possible measurements on them reported, can be printed on transparency or paper support, or can be exported, cancelled and successfully relocated to any memory support. transaxial views:

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2.2 Working principles

The "cone-beam" technics introduces an innovation in modes of scan and volumetric reconstruction of Computerized Tomographs. In traditional Computerized Tomographs, the volume is rebuilt through the scan and following reconstruction of a series of following axial "slices", obtained by shifting the patient table between two following acquirements. In Volumetric Computerized Tomographs type "Spiral" (Spiral-CT) the examination table is shifted with continuity simultaneously at continue rotation of sorce-detectors system, increasing the speed of the acquirement process. In the "cone-beam" technics, the sorce-detector system (cone-shaped X-beam and bidimensional detector) performs a single rotation around the patient, acquiring simultaneously all necessary data for the volumetric reconstruction. The technics is then named CBCT = Cone Beam Computed Tomography or also TVCT = True Volumetric Computed Tomography. In practice, acquired data in every scan step are digital images, correspondent at the radiographic relative projection and these data (named also raw data) are then used in the algorithm of volumetric tomographic reconstruction. The advantages which are obtained with "cone-beam" technique in comparison with traditional systems are: direct reconstruction of whatever points ensemble of scanned object without passage through axial reconstructions and data reformat; through the use of sophisticated technology the total scan speed is controlled through the electronic program rather than the radiogen tube power; under same conditions of total scan time: less requirements in regards to the source/tube assembly power and scan mechanics, with constructive and maintenance advantages.

2.3 Composition
Scanner Motor-driven patient table Workstation Software composed by: a) hardware management program b) program for primary volumetric reconstruction c) program for secondary multiplane reconstructions d) program for 3D reconstructions e) integrate archive patients-exams-images Standard accessories a) calibration check phantom b) head-holder c) User Manual d) Line conditioner (mains stabilizer) The "scanner" is completely controlled by the "workstation" computer. The only manual commands on the scanner are two push button controls that are for the patient examination table vertical movement, two push button controls for the motor-driven system of the X-beam diaphragm opening, and the push button for startup of the laying optical system (at automatic shutdown). Also, the emergency switch is present on the top/front of the scanner.

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2.4 Software configuration

The QR-DVT 9000 software is available with more configurations to allow different use based on the user requirements. The configurations are listed below: Expert Scan TM Professional Standard Basic

EXPERT: This configuration allows the full potential use of the QR-DVT 9000 software. Particularly it is possible to execute a scan, if the scanner is directly connected with the station, and perform primary and secondary reconstruction, generate 3D images, create and print reports. SCAN TM: This configuration allows only to scan, verify the scan and store the raw data.

PROFESSIONAL: allows to create and visualize, by secondary reconstructions, single and multiple transaxials sections, panoramics, 3D images and for all of these images allows the use of the studys utility . Allows to create and print reports. With this configuration it is not possible to generate new studies from a raw data set of a scan. STANDARD: it includes all the properties of the professional configuration with the only exception that the 3D images can be visualized but cannot be created. BASIC: allows to visualize, print and save (in a personal archive), reports previously created with the other software configuration. It also allows the user to trace on these reports distances and angles and to modify the brightness and contrast of each image. Each configuration can be of two types (software architecture): Open Dedicated Open: the software can open, visualize and modify the documents (raw data, studies and report) created from any QR-DVT 9000 device. Dedicated: the software can open, visualize and modify the documents (raw data, studies and report) created from a unique QR-DVT 9000 device identified by a personal serial number (the serial number is reported inside the About box reported below). The software configuration and architecture can be showed by selecting About window will appear: About. The following

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Software Version

Software Configuration Software Architecture Workstation ID System RAM memory RawData Work Drive

Study Work Drive

Report Work Drive

With each a scanner it is possible to compose a working group with a maximun of 16 computers. The documents can be exchanged through procedures of Import/ Export on magnetic support or through a local network.

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3. Getting started...
3.1 Device start-up
To switch on the device, it is necessary to follow the sequential execution of the following operations: if you are working with the main workstation, switch on the line conditioner and the scanner; switch on computer switch; wait as the computer charges the operating system; when required by operating system, perform the login procedure as described on the operative system documentation; QR-DVT 9000 application base-window appears.

3.2 General description of commands

The software window have the utilities shown in the following figure. The software user-interface (ensemble of modes of information insert and display, and of commands selection) has the standard features of Windows 95 and Windows NT applications (see 4.0 and higher).
caption bar menu bar tool bar

work area

status bar

Windows bar

For your convenience, some of these features are reported here: 1. The base-window is divided into (6) zone, so organized (from top to bottom): the caption bar with name of application and 3 window's push button controls (see point 2) the menu bar (with menu commands) Page 8

 the tool bar (with push button commands) the work area the status bar to display: commands description, date and hour the Windows bar to select starting and the eventual selection commands of other active applications 2. All software windows (including the base one) have at the top/ right three push button commands (enabled or disabled according to the context), for checking the same window and having the following meaning: minimize the window size bringing it to the bottom of the window reduce the window size expand the window at the greatest possible size close the window and the eventual application associated at it 3. When the window has a dimension smaller than the object, showed in it (text, image, etc.), the scroll bars appear on its right and lower edge, allowing "to scroll" the window through the object. The scrolling can be obtained in three ways:

scrolling arrow

scrolling cursor

scroll bar bring the mouse pointer on the scroll cursor, move the pointer up and down holding down mouse left push button (cursor carrying away) bring the mouse pointer on one of the scroll arrows (placed at the scroll bar edges) and press (in sequence or in continue mode) the mouse left push button click with the mouse pointer on one of areas of the scroll bar included between the scroll cursor and the arrow 4. Any software window can be shifted and enlarged in the following way: if the mouse pointer is brought on the window header bar, the mouse left push button is held down and the mouse is shifted, as result the window is "scrolled" on the monitor if the mouse pointer is brought on the upper or lower window edge until the pointer changes from a normal pointer to a window stretching pointer and the mouse left push button is held down, shifting the same mouse up or down, the windows vertical dimension is modified if the mouse pointer is brought on right or left window edge until to see the pointer changing from normal pointer to window enlarging pointer and mouse left push button is held down, shifting the mouse right or left, the window horizontal dimension is modified if the mouse pointer is brought on the right lower window edge until the pointer changes from a normal pointer to a window diagonal rescaling pointer and the mouse left push button is held down, shifting the mouse, the windows horizontal and vertical dimension are modified simultaneously

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 if the window contains an image and has a dimension smaller than that same image, by means of the scroll cursors, the different image parts can be displayed; if the window is enlarged beyond the image dimensions, the image keeps its dimensions (will not be enlarged) while the empty space between the image and the windows edge will be black. 5. if many windows are present on the monitor, an "active" window is defined, on which the eventual commands work. The "active" window is characterized by a color on the header bar different than the other windows and can be modified through the Windows Control Panel starting definitions. A window is set "active" by simply placing the mouse pointer on it and clicking the mouse left push button. 6. the commands are of two types: push button or menu commands. The push button commands are all set by placing the mouse pointer on the push button and "clicking" with the mouse left push button. In regards to the push button commands displayed on the second line of application base-window, by placing the mouse pointer, without "clicking", it is possible to display a short description of the command. The Menu commands are organized in a vertical scroll Menu and are selectable either by keyboard or by mouse. By keyboard the commands are selected by: the push button ALT is pressed (the first Menu is displayed) using left and right arrows, to select the command of interest press ENTER (or whatever vertical arrow) to activate the chosen command by means of vertical arrows, select the command of interest press ENTER, to activate the chosen command By mouse, on the contrary, it is worked in this way: place the mouse pointer on Menu of interest click with left mouse push button drag the mouse pointer down to show the command of interest (eventually, going back by pointer to the Menu it is possible to drag the selection right or left on another Menu) click with left mouse push button to activate the chosen command IMPORTANT: before selecting a command (even if it is a button or a menu) is necessary to set active the window on which you desire to do the operation. This because, after giving the command, the mouse pointer will be limited in the active window up to the procedure, that is executing, wont be finished or cancelled. Some commands are active on some kind of images instead of some others. This prevent to operate with not executable functions in that contest but it need, as said, the preventive image selection. 7. windows displaying information (messages, results) usually have push: windows displaying information (messages, results) usually have push button commands that are activated in two ways: by mouse; by placing the pointer on the push button and "clicking" with the mouse left push button by keyboard; by pressing TAB to move from a one push button to another (the active push button is showed with a sectioned line) and then pushing ENTER to select the command Sometimes the window displays a series of options marked with a little circular indicator and selectable by mouse (point and click) or by keyboard (arrows). The chosen option can be activated by a confirmation push button with a double click, or with the push button ENTER. 8. windows for "data-entry" have a series of fields, which can be accessed directly with the mouse and pointer or by the push button TAB. The window edit box is usually activated by a push button command. 9. "list" windows show "objects" lists (patients, exams, reports) among which a choice is necessary. The choice can be performed by mouse or scrolling the list with keyboard vertical arrows and pressing ENTER or the confirmation push button.

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3.3 Device shutdown

To switch off the device, it is necessary to sequentially perform the following operations: 1. Close the application QR-DVT 9000 by selecting from the main window of the program the Exit command from the File menu; 2. Click, on the Windows bar Start button (usually at lower left); 3. Select "Shutdown" 4. The Shut Down Windows will appear: select Shut down the computer and push Yes, 5. Wait till the computer stops the system, confirming when finished; 6. When the message "stopped system" appears, the computer can be switched off 7. If you are working with the main workstation, switch off the scanner and the line conditioner;

WARNING: Shutdown the device after use, at the end of each working day!

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4. Exam Execution
4.1 Introduction
WARNING !!! The scan execution is only possible from a station directly connected with the scanner and with the EXPERT software configuration installed The exam (scan) is the acquirement procedure of the radiological projections obtained during the x-ray source-detector system rotation around the patient head. The ensemble of these projections, acquired in digital form by detector interfaced with the electronic processor, forms the exam raw data set. The exam raw data set are stored on the computer work drive.

4.2 Daily Check

This a calibration which must be performed at least once a day. The relative command is: Daily Check of Scan Menu; the software will show a window with the list of the tests. By clicking on the Start button the software will order the positioning of the QA phantom on the gantry. Use the pointing laser lights to position the phantom in the correct way. By Clicking the OK button the device will perform the procedure automatically in a few seconds time. The only conditions, which must be observed, is that the machine must be powered and the beam limiter completely opened. The software will show the results of the tests in real time; at the end of the procedure click on the Close button. The result of the daily check, with data and time of execution, will be store in a log file which can be viewed by selecting Tools Log File... and choosing DailyCheck (see Chap. 11.9.2 daily check log file).

4.3 Procedure for exam execution

Before starting an exam verify if the Daily Check has been executed: if not, it is advised that the user nperform the procedure (see Chap. 4.2 daily check).

WARNING NewTom may only perform 6 scans per hour. In case you overcome this value, an error message, indicating how many minutes you have to wait, will appear.

Select Scan from Menu New Scan; at this time enter the patient data, which will be attached to the exam raw data set and subsequently in the studies and reports created from these raw data. PatID and Accession Number fields are for Dicom WORKLIST or STORAGE module. In other cases will be unconsidered.

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Place the patient on the patient table. The patient head must be placed horizontally within the "gantry" and centered with reference to the laser indicators. To obtain the correct positioning, the patient is laid on the examination table in the supine position, with head supported by the special headrest. The patient table can be moved in two directions: horizontally, through manual labor and vertically by motor-driven command with the control keyboard. It is located on the front of the device and contains the following commands: 2 push buttons for vertical movement of the examination table (up and down) 2 push buttons for the scrolling of beam collimating diaphragm (forward and back) 1 push button to switch on the pointing laser lights (automatic shutdown after 40 seconds) The laser indicators are two: a vertical line on patient face to center him symmetrically respect the rotation axis; a lateral point to optimize the center of the reconstruction area; The shift of the beam limiter modifies the length of the vertical line such as it can be used also to optimize the size of the X beam of the patient face.
Vertical line Laser aperture Left Lateral point Laser aperture Left Control Keyboard Right Lateral point Laser aperture Right Control Keyboard

Gantry

CAUTION
Use of controls or adjustments or performance of procedures other than those specified herein may result in hazardous radiation exposure When the patient is placed on the patient table, the procedure is the following:

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1. the examination table is pushed towards the gantry, so that the patients head is brought about in the exam position; 2. pointing laser lights are switched on by the command on the control keyboard; 3. the patient is adjusted laterally so that the vertical line drawn on his face is in the symmetrically central position; 4. the patient table is adjusted vertically (with the motor driven command on the control keyboard) and horizontally (manually) so that the second pointing light (marking the side of the patient's face) resides in the center of the region of interest.

WARNING:
Warn the patient to close their eyes, during the positioning, to avoid looking directly at the laser beam!!! Control the patient movements during the positioning and warn him of table movement, to avoid potential injuried caused by collisions and/or crushing against mechanical parts of the device (scanner and/or patient table). Make sure there are no objects that would prohibit table movement. Before beginning the exam, be sure that the patient is positioned in the correct way, to avoid unnecessary exposures. If the exam is for only the lower area of the patient head, to avoid any useless exposure of delicate organs (for example, eyes), use the command Beam Limiter on the control keyboard on the gantry side: the beam will be limited to cover the anatomic area seen by the laser luminous indicators. Instruct the patient to remain motionless during the scan! Note: Any swallowing during the scan could create fluctuations caused by movement in any part of the images. Please instruct the patient not to swallow while scan is in progress. The real scan is preceded by two views (Scout-View) (Front-Back and Lateral), which the machine automatically performs at 0 and 90 to allow the verification and the eventual adjustment of the patient head position. These two views also allows the device to evaluate head dimensions and, in consequently, to automatically adjust the intensity profile of the radiological beam, which will be used during the scan. The first operation of the scan procedure is, therefore, the AP view presentation with the question: <Is the position of the patient correct?> If the positioning isn't correct, correctly adjust the head position and enter NO: repeat the AP view. On the contrary, if the positioning is correct, enter YES and the device proceeds automatically at LL view execution with a confirmation request like the previous view. By selecting the Stop Scan button the scan will be stopped.

ATTENTION ! The correct positioning of the patient is important to obtain a quality reconstructed images.

These are the guide lines to follow: in the AP view, the horizontal central line of the region of interest (for example, the line of the occlusal plane for exams on dental arcades) must center in the rectangle that is formed from the black frame; in the LL view, the horizontal central line of the region of interest must center in the rectangle that is formed from the black frame and the facial bone profile must be aligned on the left boundary of the same frame. The following two figures are an example of correct centering for an exam on dental arcades:

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The following two figures show an example of correct centering for an exam on bosoms-orbits area:

WARNING ! If the images, in correspondence with AP and LL views, are completely or partially darkened, probably the beam limiter isnt positioned correctly. Be careful during positioning of the initial centering of the patient using the top laser indicator (vertical line). Answering YES at the LL view confirmation request will begin the real scan. First, the chosen radiological parameters are showed: kV and average mAs. Then the message: <The scan is starting.> appears and confirmation is required by entering YES. It is necessary, at this point, to advise the patient to remain motionless for about 70 seconds, before giving the O.K. At the beginning of the scan, an acoustic signal will be heard (for at least 5 seconds). It indicates the start of X-Ray emission. During the whole scanning, the X-Ray emission will be signalled by the lamp placed up the gantry and from the X-Ray symbol in the bottom-right side of the monitor. During the scan, the monitor will show the radiological projections at regular angle intervals. These views are recorded in progress and their combining forms the so called exam raw data. The radiological projection display in real time enables the operator to observe each view, for example showing eventual patient movements. Page 15

The exam can be stopped at any moment, with a "click" on the Cancel push button on the display window of the process state. The end of the scan will be signalled by a brief acoustic signal. ATTENTION! During the scan execution it is SEVERELY FORBIDDEN: 1) moving the mouse; 2) pressing the mouse keys or keyboard buttons; 3) any other applications;

ATTENTION ! If during the acquisition process, the images are too dark or the Check Scan control, furnishes a very noisy image, perform a Daily Check to verify the correct operation of the system. At the end of the scan the software automatically stores the raw data on the work drive, open the new document and asks the user if he wants to perform a check scan (generating a temporary axial view) to locate eventual problems (patient movements, not satisfactory images, etc.) and to repeat, if necessary, the exam. This operation coincides with the command Check Scan from the Primary Reconstruction menu. It is possible, at this point to perform the primary reconstruction on the just acquired raw data (see Chap. 5 raw data and primary reconstruction).

4.4 Exam procedure summary scheme

1 2 3 4 5 6 Once a day the daily calibration must be performed Start the exam procedure; Insert the patient data; Place the patient on the patient table; Check the patient positioning; Exam execution; Scan command Daily Check New Scan ---------

Scan

4.5 Menu
The following tables show the commands description of the softwares main menu.

4.5.1 File Menu

Open Import Open a document (raw data , study or report) from the work drive Import a document. (see chapter 9.1 import/export)

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Export Delete from Work Drive Delete from Export Drive Graphic settings setup Report Pages Layout Setup New Report Pages Layout Setup Open Report Pages Layout Setup Delete Report Attached Letter Setup... Report Header Setup... Print Setup... Print Enhancement Setup... Export Drive Setup Recent file Exit

Export a document. (see chapter 9.1 import/export) Remove a document from the work drive. (see chapter 9.2 deleting document) Remove a document from Import/Export drive. (see chapter 9.2 deleting document) Change the graphic settings of the image overlays. (see chapter 6.3 graphic settings setup) Create a new report page layout. (see chapter 7 report page layout) Change an existing report page layout. (see chapter 7 report page layout) Remove a report page layout. (see chapter 7 report page layout) Change the report attached letter Change the report header (see chapter 8.1report header setup) Change the printer and printing options Change the printing filters (see chapter 8.7 print

enhancement)
Set the Import/Export drive. (see chapter 9.1

import/export)
Keep track of the four most recently used files Exit from the application

4.5.2 Scan Menu

Daily Check New Scan Phantom Scan Perform the Daily Check test (see chapter 4.2 daily check) Perform a new scan. (see chapter 4.3 procedure for exam execution) Start the procedure for phantom QA acquisition (see chapter 11.6 quality assurance (qa))

4.5.3 Primary Reconstruction Menu

Start Night Reconstruction Phantom Analysis Phantom Results Show the list of the planned night reconstructions. (see chapter 5.3 deferred primary reconstructions) Perform the analysis of the last phantoms scan. (see chapter 11.6 quality assurance (qa)) Show the results of the phantom analysis. (see chapter Page 17

11.6 quality assurance (qa))

4.5.4 View Menu

Toolbar Status Bar Show/Hide the Tool Bar Show/Hide the Status Bar

4.5.5 Tool Menu

Fault Restore Log File Enable the acquisition menu after a hardware error Show the dialog-box to choose the Log File to visualize (see chapter 11.9.1 error log file)

4.5.6 About Menu

About Show information about software version, system configuration, disk space and available memory

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5. Raw Data and primary reconstruction

5.1 Introduction
Raw data of an exam, needs a processing to be able giving images proper to display the studied anatomic zone. This process is named primary reconstruction, and allows to rebuild all axial sections of scan zone. They are the base for all following reconstructions Sequences of primary reconstructions can be programmed to be automatically performed later (for example, during the night). The ensemble of obtained images, after the raw data processing (through the primary reconstruction and the eventual secondary reconstructions) is a study. On a same scan (raw data set) many primary reconstructions can be performed, obtaining, therefore, many studies.

5.2 Primary reconstruction

ATTENTION !!! The primary reconstruction of a raw data is available only with the EXPERT software configuration Primary reconstruction is the operation which allows obtaining a set of axial sections from the raw data of the studied anatomic district. These axials images and the others produced from them (Cross section, panoramics, 3D), will be called Study. The study is automatically stored at the end of the Primary Reconstruction process. The procedure to perform a primary reconstruction is the following: 1. Load an exam raw data set: a) menu File Open Raw Data; b) select a patient from the raw data list; c) confirm by either pressing Ok or double clicking with the left button of the mouse. 2. A window with the 90 view is displayed. The "Scout-View" is necessary to locate axial reference planes. 3. Select Primary Reconstruction Primary Reconstruction.

4. A dialog box which allows the selection of the axial reconstructions thickness is displayed. The choice is between three possibilities: 0.3, 1, and 2 mm. Also, the Small Field option may be selected. This option allows axial images which are 10% larger than standard images to be displayed on monitor. On the other hand, with this option the maximum useful diameter drops down from 150 to 130 mm. Once the wanted options have been selected, push " O.K. to continue. 5. Selection of reconstruction volume: two axial planes, which limit the volume to be rebuilt must be chosen; this is performed by drawing two parallel lines on the Scout-View, which represent the intersection of the Scout-View plane with the two reference axial planes. The procedure is as follows: the first segment is drawn by left clicking the mouse a first time when the video cursor is in position of the starting point and a second time when it is in position of the end point. It is important to emphasize that the segment does not necessarily have to be horizontal, but can be inclined (for example, along the mandibular edge); at this point the software draws a second line parallel to the first, which can be moved in the vertical direction through the mouse by, positioning the mouse pointer on the square (target) placed in the Page 19

middle of the line, left clicking on this target while keeping the mouse button pressed. In the Scout-View top-left corner the total number of axials sections are reported. the targets are also drawn on the sides of the first segment traced: this allows the adjustment of the inclination of the two segments and therefore of the reconstruction; once the selection of reconstruction volume is completed press the right mouse to fix the settings;

number of axials

second segment

targets

first segment

6. At this point a window will appear where you can choose between three options: a) Start: start the primary reconstruction; b) Store: store the primary reconstruction settings in the postponed reconstruction list (see chapter 5.3 deferred primary reconstructions); c) Cancel: undo the operation; Choosing Start, starts primary reconstruction. The operation needs typically 20 seconds each axial plane. A window "Status process" shows the operation progress state; pushing the Cancel button on this window stops the reconstruction process. 7. Comment insertion: the software will show a window that will allow the user to insert a comment (optional) that will be attached to the study generated from the primary reconstruction: This comment will appear on the list of study. 8. end of primary reconstruction: the primary reconstruction creates the study. The study remains active and will show the Scout-View. It is now possible to see the axial images, perform secondary reconstruction and trace distance, angles etc.

5.3 Deferred primary reconstructions

The primary reconstructions could be performed at the end of an exam, or they can be performed later, provided that the raw data are kept in the folder. Also, it is possible to program a series of primary reconstructions from sets of raw data and store the "studies" obtained in the relative archive at a later time. This option can be , for example, used to perform the primary reconstructions of exams later at night rather than during business hours when the scanner may be in constant use. To execute a deferred primary reconstruction follow the procedure reported below:

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1. Perform the procedure described in chapter 5.2 primary reconstruction, with the only exception that, at point 6, choose the Store option; 2. A window will appear with the list of the stored raw data set, which will allow the loading of another exam. Repeat this procedure for all the deferred primary reconstructions you want to program; to stop the procedure select the Cancel button instead of the Ok button in the raw data list window. 3. To start the deferred primary reconstruction select from the main menu Primary Reconstruction Start Night Reconstruction. The list of the programmed reconstructions will appear: choosing the Start button will start the reconstruction, while selecting an item and clicking on the Remove button will allow the removal of one or more reconstruction from the list. Press the Cancel button to abort the procedure. While the process is running, pushing the Cancel button on the progress window causes the reconstruction process to stop. However the software keeps the reconstruction program that it have not performed.

5.4 Menu
In the following tables are reported the commands description of the raw datas menu.

5.4.1 File Menu

Close Save Close the active raw data Save the active raw data

5.4.2 Edit Menu

Patient Data Show the patient data

5.4.3 Primary Reconstruction Menu

Check Scan Primary Reconstruction Start the Check Scan procedure Start the primary reconstruction procedure (see chapter 5.2 primary reconstruction)

5.4.4 Scan Movie Menu

First Image Last Image Previous Image Show the first acquired image Show the last acquired image Show the previous image

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Next Image -90 +90 Movie Movie Movie Forward Stop Backward

Show the next image Show the image to -90 from the current position Show the image to +90 from the current position Start the scan movie forward Stop the scan movie Start the scan movie backward

5.4.5 Toolbar Menu

Main Toolbar Status Bar Movie Toolbar Show/Hide the Tool Bar Show/Hide the Status Bar Show/Hide the Movie toolbar

5.4.6 Window Menu

Resize Window Reset the position and size of the window with the original settings

5.4.7 About Menu

About Show information about software version, system configuration, disk space and available memory

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6. Studies and secondary reconstructions

6.1 Secondary reconstruction
Every time a study is active, it is possible to execute reconstructions of new images called secondary reconstructions. The study can be a newer one (see chapter 5 raw data and primary reconstruction) or it can be opened from the studies archive. The secondary reconstructions allow, from a "set" of axial images, new images which present either bidimensional sections of the examined volume (transaxial and panoramic views) or tridimensional representations of the same volume (3D views). At the end of a primary reconstruction, the software will automatically show the study that has been created. If you need to open a study from the archive, follow the instructions reported below: a) select the menu File Open Study; b) from the list of the studies select a study; c) choose Ok, or double-click on the selected study, to confirm.

6.1.1 Setup of the visualization window

The first time a study is shown ( and until the study has not been saved), the Visualization Window dialogbox appears.

This dialog-box defines the visualization window of the secondary images, specifically, the 256 visible levels of gray and how they relate to the values of the single pixels of the images. This window can be modified by selecting menu Utility Visualization Setup Windows and will show varying tissue density according to the analysis that the user chooses at that time. The image at the right side of the dialog display changes in real time. The first time this dialog appears it shows the central axial of the study otherwise it shows the selected image. At the first visualization, the gray scale is distributed on the whole range of the values of the images therefore the axial will have a lower contrast; to modify the scale move the cursors placed near the gray scale.

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It is possible to customize three windows that can be used subsequently. To do this follow the procedure reported below: select a button between Wnd1, Wnd2, Wnd3; modify the window settings by moving the cursors; select the Save button. Subsequently, selecting the button attached with the window that has been modified the software will show the new settings.

ATTENTION! The window visualization settings work simultaneously on all the images of the study (with the only exception of the Scout-View and 3D images). To modify a single image of the study use the command Utility Visualization Setup Brightness & Contrast (see chapter 6.2.1 brightness and contrast)

6.1.2 Transaxial views

The transaxial views are images of sections perpendicular to the plane of the axial views. They can be obtained in two ways: single images or sequences. In both cases, to locate the section (or sections), it is necessary to refer to an axial image called reference axial view. To do this, simply activate (by clicking the mouse) a window containing an axial image. To generate a single transaxial view, it is necessary to use the command Single Transaxial Section from the Secondary Reconstruction menu and to place a segment on the chosen axial image to locate the section of interest (the line represents the intersection between the two planes: axial and paraxial). The line is set in place by "clicking" the mouse two times on two ends of the line, first with the left mouse button (where the line is intended to begin) and then with the right mouse button (where the line is intended to end) . After the reconstruction a frame appears as illustrated in the right plane of the window as shown in the figure:

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In the left frame the reference axial view is displayed, with indication of the chosen segment for transaxial reconstruction, and in the other frame, the rebuilt transaxial view is displayed. The limits in vertical direction of the transaxial section are set by the chosen assembly of available axial views. To create a sequence of transaxial views (command Sequence of Transaxials Sections of Secondary Reconstruction Menu), it is necessary to trace on the reference axial view a broken line (that is to say a series of connected line segments) to accomplish this "click" the left mouse button in the corresponding positions that will form the line segments; to remove one or more points from the broken line push BACKSPACE (<-) on the keyboard. Clicking on the right mouse button ends the broken line. The software builds a sequence of transaxial images orthogonal at the broken line segments. At the end of the operation, the frames appear as in the figure:

Also in this case, in the left side of the window the reference axial frame is displayed, with the sequence of segments orthogonal at the broken line traced by user while the right side of the window shows the sequence of correspondent transaxial frames, each numbered with reference to the reference axial view. The Transaxials Setup command (Secondary Reconstruction Menu) displays a window (Analysis Setup), in which the sections features (which can be modified) are reported: pushing Save allows saving the modifications, pushing Exit closes the window, discarding the changes.

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 Width: Width of the single rebuilt section. Step: Reconstruction step. Distance between single sections. Broken Line: Reconstruction following a broken line defined by user by means of segments (min. 2 points). Parabolic Line: Reconstruction following a parabolic line defined by user by means of points (min. 5 points). With both a single transaxial section and a sequence of transaxials sections it is possible to drag the points of the segment or of the broken line that have been drawn in order to reposition them correctly. The procedure is as follows: 1. Click on the window containing the reference axial view of the single transaxial section or of the sequence of transaxials sections. 2. From the menu Secondary Reconstruction select the Drag command (the software will show a yellow target in correspondence to each point previously placed); 3. Move the mouse pointer on the yellow targets; 4. Push and keep pressed the left button of the mouse; 5. Position the point moving the mouse; 6. Release the left button of the mouse; 7. Repeat points 3, 4, 5 and 6 until the segment is positioned correctly; 8. Press the right button of the mouse to end the procedure; If the image is a single transaxial section the software will automatically replace the old image with the new image created from the dragged segment, otherwise if the image is a sequence of transaxials sections the following window appears:

Choosing Modify Current Image the new image created from the dragged broken line will replace the old image, otherwise selecting Create New Image the software will generate a new image, keeping the old image. Modify Current Image uses the setup values (Width e Step) of the image that is being modified while Create New Image uses the values contained in the Analysis Setup window. The Drag command is not enabled if the broken line of the sequence of transaxials has been traced using parabolic line. It is possible to have a full screen visualization of the transaxial image by the command Coronal View of the Window menu.

6.1.3 Panoramic views

The panoramic views are images of sections perpendicular to the axial planes, calculated along parabolic arches located by the user in correspondence with dental regions. After choosing a reference axial view, it is necessary to activate the command Panoramics (Secondary Reconstruction Menu). As in the case of transaxial images sequence, the broken line which represents the intersection of the axial view with the panoramic view to rebuild, is traced using the mouse. The result of the reconstruction is displayed on the monitor in the following way: Page 26

The command Panoramics Setup (Secondary Reconstruction Menu) displays a window (Analysis Setup), in which the sections features (which can be modified) are reported: pressing Save allows the saving of eventual modifications, pressing Exit closes the window, discarding changes.

Thickness: Thickness of the rebuilt slice (range 1 - 50 mm) Distance: Distance between the rebuilt slices Broken Line: Reconstruction following a broken line defined by user by means of segments (min. 2 points). Parabolic Line: Reconstruction following a parabolic line defined by user by means of points (min. 5 points). Like with the sequence of transaxials sections it is possible to move the points of the broken line that have been drawn in order to reposition them correctly. The procedure is as follows: 1. Click on the window containing the reference axial view of the panoramic image.

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2. From the menu Secondary Reconstruction select the Drag command (the software will show a yellow target in correspondence to each point previously placed); 3. Move the mouse pointer on the yellow targets; 4. Push and keep pressed the left button of the mouse; 5. Position the point by moving the mouse; 6. Release the left button of the mouse; 7. Repeat points 3, 4, 5 and 6 until the segment is positioned correctly; 8. Press the right button of the mouse to end the procedure; The following window will appear:

Choosing Modify Current Image the new image created from the dragged broken line will replace the old image, otherwise selecting Create New Image the software will generate a new image, keeping the old image. Modify Current Image uses the setup values (Width e Step) of the image that is being modified while Create New Image uses the values contained in the Analysis Setup window. The Drag command is not enabled if the broken line of the panoramic image has been traced using a parabolic line.

6.1.4 3D Views
ATTENTION!! The generation utility of 3D images is available only with the EXPERT and PROFESSIONAL software configuration The tridimensional views (3D) are representations of the object on a plane surface, equivalent to pictures of the object token from an observer placed at a specific distance. After a reference axial view has been activated select 3D command from the Secondary Reconstruction menu; at this point a rectangular ROI, in correspondence with the zone of interest for the reconstruction, must be placed. The ROI is placed by right clicking the mouse at the beginning point of a rectangle corner (e.g. top-left), dragging (without lifting the mouse button) to the opposite corner (bottom-right) and releasing the push button at desired position. The following window will appear :

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The window shows a preview with low resolution of the 3D image. That preview image is updated every time you modify the parameters. By selecting the option "More Resolution" the quality of the preview increases, but the update time increases too. The point of view of the image can be modified in three ways: using the scroll bar in the right and in the bottom of the preview image; editing the values in the MANUAL SETTINGS field and confirming with the Update button; using the predefined button in the ViewPoint Preset field; In the window: Phi (horizontal scroll bar) represents the observer angle "around" the object, with the following references: 90: front view 270: back view 0 and 180: lateral views Theta (vertical scroll bar) represents the observer azimuthal angle with the following references: 0: from top view 90: front view 180: from bottom view "Thresholds" Min and Max (gray scale level) values represent the gray values, which are recognized as bone tissue from the 3D reconstruction algorithm. These parameters can be varied to optimize the 3D representation; The button inside the ViewPoint Preset field allows changing the user viewpoint. The Preview Zoom field is used to zoom the preview image. The Drag Roi button allows changing the position and size of the ROI previously traced. The New Image button starts the process that creates a new 3D image. This image will be viewed when the window will be closed (clicking the Exit button), this allows creating many 3D images with the same ROI. Choosing the Modify Image button the user can replace the current image (only if he has selected Secondary Reconstruction Drag instead of Secondary Reconstruction 3D). Exit will close the window without discarding the changes.

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6.2 Utility
6.2.1 Brightness and Contrast
If you would like to modify the contrast or the brightness of the images, it is necessary to select the command Visualization Setup Brightness & Contrast. The following window will appear: Utility

The first set of arrows, on the upper left, adjusts the brightness; the second set of arrows adjusts the contrast. The push button restores both the contrast and the brightness at their default values. The right line in the plot gives a qualitative representation of parameters of interest, being the representation of correspondence between gray levels and image numerical values. Contrast variations will be represented by variations of slope, while brightness variations will be represented by vertical displacement. Pressing Cancel allows to abort the procedure.

It is necessary to remember that contrast and brightness variations are temporary, related to the image displaying. The numerical values contents remain unchanged. Choosing OK the following window will appear:

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This panel allows the user to choose where to apply the changes of brightness and contrast. If you want to apply them only to the current image select Current Image'', or else you can choose one or more kind of images to which the changes will apply.

6.2.2 Marker
The Marker is a color graphic overlay that you can trace on axials, cross sections and panoramics (with thickness less than 1 mm). The software will place it on every images that cross the traced line (except 3D Views). The typical usage is a highlight, in the panoramic view, along the mandibular channel to help its identification on cross sections. For more information, see the chapter 6.4.5 utility menu.

6.3 Graphic settings setup

The overlays added to the images of a study or report (angles, distances, lines, strings and markers) have some graphic attributes like color, font type, background type etc. These attributes can be modified by the user to create a custom graphic configuration. To do this select File Graphics Settings Setup. The following window will appear:

In the left side of the window is a list of items that the user can work with. In the right side are visualized the single attributes of each item ( with the addition of the transparency flag applicable to the background of the font). Each attribute button is enabled or disabled in reference to the item selected. The list of attributes contains: Font Type Font Color Font Bk Color Overlay Color Overlay Color Conversion (B/W Printer Only)

To change an attribute follow the procedure reported below: Page 31

a) select the item to modify b) push the Change button of the attribute to modify c) in the window that will appear do the changes d) Confirm will close the window e) select the OK button

The changes made during the setup of the graphic attributes only have an affect on the new traced elements, while those existing maintain the original attributes.

With the Overlay Color Conversion (B/W Printer Only) option, its possible to set the kind of color conversion that will apply to the marker when the printer is black/white. This command will show the next dialog box:

As shown in the bottom of the window, it' possible to select options for printing image overlays: Force colors print objects and references always using colors (or variations of gray), for any printer; Force monochrome print objects and references always using black/white (reversing overlay background system) , for any printer; The Automatically selected' option will automatically select (on the basis of the installed printer) how to print objects and references; The Report Overlay Width option will change the width of the overlay lines on the report.

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6.4 Menu
In the following tables are reported the command descriptions of the studys menu. All the commands to trace a segment, a broken line, a ROI etc. start by pressing the left mouse button and finishes by pressing the right mouse button. Pushing the right mouse button before starting, aborts the procedure. While the user is tracing a broken line it is possible to remove the last point with the BackSpace (<-) button on the keyboard.

6.4.1 File Menu

Save Save Image Close Graphic settings setup Report Pages Layout Setup New Report Pages Layout Setup Open Report Pages Layout Setup Delete Report Attached Letter Setup... Report Header Setup... Print Setup... Print Enhancement Setup... Print Preview Print Save the active study (if a report is opened it saves the report) Save the active image of the study as a bitmap file Close the active study (if a report is opened it closes the report) Change the graphics properties of overlays (see chapter 6.3 graphic settings setup) Create a new report page layout. (see chapter 7 report page layout) Open an existing report page layout. (see chapter 7 report page layout) Delete a report page layout. (see chapter 7 report page layout) Modify the default report attached letter Change the report header (see chapter 8.1 report header setup) Change the printer and printing options Set the printing filters (see chapter 8.7

print

enhancement)
Preview the current report Print the current report

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6.4.2 Edit Menu

Study Patient File Report Patient File Add Report Page Report Page Layout Show the patient data attached to the study Show the patient data attached to the report (only if a report is opened) Add a page to the report (only if a report is opened) (see chapter 8 creating and modifying a report) Show the report page layout of the active page (only if a report is opened)(see chapter 8 creating and modifying a report) Insert notes in the active report page (only if a report is opened) (see chapter 8 creating and modifying a report) Remove a report page (only if a report is opened) (see chapter 8 creating and modifying a report) Create a new report attached letter (only if a report is opened)

Report Page Notes

Remove Report Page Report Attached Letter

6.4.3 Secondary Reconstruction Menu

Single Transaxial Section Sequence of Transaxials Section Panoranics Sections 3D Transaxial Setup Panoramics Setup Drag... Sequence of Transaxials Panoramics Panoramics Transaxials Sequence of Create a new single Transaxial section (see chapter 6.1.2 transaxial views) Create a new sequence of Transaxials sections (see chapter 6.1.2 transaxial views) Create a Panoramic section (see chapter 6.1.3 panoramic views) Create a 3D image (see chapter 6.1.4 3d views) Change the parameters to generate Transaxials sections (see chapter 6.1.2 transaxial views) Change the parameters to generate Panoramics sections (see chapter 6.1.3 panoramic views) Modify a transaxial or panoramic section. Create a Panoramic section from the active sequence of Transaxials sections Create a sequence of Transaxials sections from the active Panoramic section Extract a single Transaxial section from the active sequence of Transaxials sections Toggle the label of the Transaxials sections between lingual/bucal and left/right Remove the current secondary image from the study

Extract Transaxial Image Label l/b <-> L/R Delete Current Image

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6.4.4 Report Menu

New Open Save Close Create a new report (see chapter 8 creating and modifying a report) Open an existing report (see chapter 8 creating and

modifying a report)
Save the current report (only if a report is opened) Close the current report (only if a report is opened)

6.4.5 Utility Menu

Angles Angles Angles Angles Distances Distances Distances Distances Distances 3D Distances Distance 3D Distances Distances 3D Distances Distance 3D Distances 3D Distances Lines Lines Lines Lines New Angle Drag Angles Delete Angle Delete All Angles New Distance Trace a new angle on the current image Drag the position of angle and of attached label Remove an angle from the current image Remove all the angles from the current image Trace a new distance on the current image

Drag Distances Drag the position of distance and of attached label Delete Distance Remove a distance from the current image Delete All New 3D Drag 3D Delete 3D Delete All Remove all the distances from the current image Trace a new 3D distance on the current image Drag the position of 3D distance and of attached label Remove a 3D distance from the current image Remove all the 3D distances from the current image Trace a new line on the current image Trace a new arrow on the current image Drag the position of the line Remove a line from the current image

New Line New Arrow Drag Lines Delete Line

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Lines Marker (0.5 mm)

Delete All Lines

Remove all the lines from the current image

New Small Marker Trace a marker 0.5mm thick Medium Trace a marker 1.5mm thick

Marker New Marker (1.5 mm) Marker (3 mm) Marker Marker Marker Strings String Strings String Strings Strings Strings Strings Profile Profile Profile Profile

New Large Marker Trace a marker 3mm thick Hide Markers Hide all the traced markers from the study

Delete Last Marker Delete the last traced marker from the current image Delete All Markers Delete all the traced markers from the study

Add Single Line Add a single line of comment on the current image Add Multiline Add a multi line comment on the current image Show the dialog with the list of the string contained in the database of comments

String Editor

Drag Strings Area Modify the comment area Delete One String Delete a comment from the current image Delete All Strings Trace Profile Increase Zoom Decrease Zoom Remove Profile Delete all the comments from the current image Show the gray levels of a segment traced on the image Increase the profile zoom on the current image Decrement the profile zoom on the current image Remove the profile from the current image Show a single image or multiple images Change the zoom of the current image Change brightness and contrast of the current image (see chapter 6.2.1 brightness and contrast) Change the visualization window of the all study images (with the only exception of the Scout-View and 3D images) (see chapter 6.1.1 setup of the visualization window) Show additionals informations about the exam from which the study has been created

Single/Multiple Images Zoom Image Visualization Setup Brightness & Contrast... Visualization Windows... Setup

Exam Info

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6.4.6 Images Menu

Axial Images Single Transaxial Images Sequence of Section Images Show the Axial images of the current study Section Show the images of the single Transaxials sections of the current study

Transaxial Show the images of the sequences of Transaxials sections of the current study Show the images of the Panoramics of the current study Show the 3D images of the current study Show the first image of the selected group of images Show the previous image to that visualized Show the next image to that visualized Show the last image of the selected group of images

Panoramics Section Images 3D Images First Image Previous Image Next Image Last Image

6.4.7 Toolbar Menu

Main Toolbar Status Bar 2nd Reconstruction Toolbar Angles Toolbar Distances Toolbar 3D Distances Toolbar Markers Toolbar Profile Toolbar Strings Toolbar Show/Hide the Tool Bar Show/Hide the Status Bar Show/Hide the Secondary Reconstruction toolbar Show/Hide the Angles toolbar Show/Hide the Distances toolbar Show/Hide the 3D Distances toolbar Show/Hide the Markers toolbar Show/Hide the Profile toolbar Show/Hide the Strings toolbar

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6.4.8 Window Menu

Resize Window Coronal View Tile Vertical Tile Horizontal Cascade Window list Reset the position and size of the window with the original settings Full screen visualisation of the transaxial image Tile the windows in a vertical fashion Tile the windows in a horizontal fashion Arrange the windows in a cascading fashion Show the window list and bring to foreground the selected one

6.4.9 About Menu

About Show information about software version, system configuration, disk space and available memory

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7. Report page layout

You must create a report page layout before you can create a report. A report page layout represents the combination of report header, patient data, notes and images of a patient report. It is possible to create different report page layout combinations. During the creation of the report, its possible to choose a different layout for each page of the report.

7.1 Creating a report page layout

With File Report Page Layout Setup box will appear: New its possible to create a new layout. The following dialog

Select the kind of printer used for print reports and confirm with OK; the following dialog box will appear:

Its possible to modify the printer page parameter. When finished confirm with the OK key. The next window will appear:

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On the window caption bar appears the layout identification code (for example #2), the kind of selected printer (for example KODAK XLS 8600 PS) and page sizes (for example 203 x 244 mm). This window contains more sheets, one for each layout field. The default layout contains the following 6 fields: Layout comment Report header Patient data Report note Device logo Image n1 (Comments) (Header) (Patient) (Notes) (Logo - reserved, read-only) (Img 1)

It is possible to move between the different sheets with the mouse pointer or by pressing the CTRL key and then pressing the TAB key as many times as is applicable. Each sheet (excluding the comment sheet) contains size and position control (arrow buttons) for the field. Modifications are in percent values, but also shown are the millimiters values to the right of each. Preview images on the right of the window show in real time the user changes. Comment sheets contain a string comment that the user can edit and that will appear in report page layout list. Image sheets contain also an image zoom control for increasing or decreasing the image scale. Every report page layout may contain up to 64 images (add an image with the Add button; the Del button will remove a selected image). At the end of a report page layout creation confirm with the OK button.

7.2 Opening a report layout

From the main window of the application and when a study or a report document is open, its possible to Report Page Layout Setup Open. A report page layout modify a report page layout by selecting File list will appear:

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The list shows all the created report page layouts, each with its identification number (ID#), its related comment, its kind of printer and its number of use (Rank). Select a layout from list and confirm with the Ok button.

7.3 Deleting a report layout

From the main window of the application and when a study or a report document is open, its possible to Report Page Layout Setup Delete. remove a report page layout from the work drive by selecting File From a report page layout list select the item to remove and confirm with the Ok button.

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8. Creating and modifying a report

In this chapter it will be explained how to create a report from the patience study images. First of all, its explained how to create a personal header of the report that will be included inside of the newly created report.

8.1 Report Header Setup

Every page of a report holds inside a field reserved to an optional header of the report itself. This field is copied in the first page of a new report and, then, on the any possible added pages. Once that the report has been created it is not possible to modify the header. But, the content of the header Report Header Setup. can be changed before creating a new report, selecting the command File A window will appear with the present state of the header as shown:

By clicking the right mouse button on a line of the header, the following menu will appear:

In it 6 (six) items are listed, they allow to change the different elements in the report, in particular: 1. 2. 3. 4. 5. 6. Font Text Style Add line Insert Line Delete Line (Font) : (Text) : (Style) : (Add Line) : (Insert Line) : (Delete Line) : allows to change type, color and height of the selected line font changes the text reported in the selected line changes the alignment (to the right, to the left or centered) of the text adds a new line at the end of the header inserts a new line just before of the selected one deletes the selected line

The change of the height of the text and the insertion of new lines are only possible if there is enough space inside the header. Otherwise, the software warns the user. Once the header has been changed, remember to save it, selecting File Save, before closing it.

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8.2 Creating a new report

A report can be made of 99 pages maximum (a maximum 64 images each report) and it can contain images taken from different studies. To create a new report, first of all, a study must be opened, then follow this procedure: 1. change if necessary, the header of the report as specified in chapter 8.1 report header setup. 2. Select the command Report New.

3. The list of the page layout is showed (see chapter 7 report page layout), from which you choose the layout with reference to what youd like to represent. 4. A window appears for editing the page layout (see chapter 7.2 opening a report layout): It is also possible to change the layout before starting the composition of the report or selecting it with the OK button. 5. At this point the report document appears on the right of the screen and together with the study document:

6. select, with the left mouse button, the rectangle of the report document where you want to insert the image: this rectangle will change from green (free) to yellow (waiting for an image of the study); 7. click the left mouse button on study image to be inserted in the report; there are two possibilities: a) the selected image is completely included in the rectangle of the report: its automatically inserted and than its possible to continue with another image; b) the selected image is larger than the rectangle of the report: a ROI of the same size appears and allows the choice of a portion of the image. The operation ends with the right button of the mouse. 8. repeat points 5 and 6 to insert other images in the page; Page 43

by clicking the right mouse button on an image of the reports page, the following pop-up menu appears:

the commands of this menu are explained in the chapter 8.8.6 pop-up menu. 9. to add one or more pages use the command Edit Add Report Page; the report page layout list is showed again (it is possible to choose a model different from the one previously used). The new page will be positioned under the previous one as in the figure below:

10. to delete one of the pages of the report, select its window and use the command Edit Report Page. If the report is made of just one page, it is not possible to delete it;

Remove

Report Page 11. to change the rectangles of a page, select its window and use the command Edit Layout. The rectangles that include images can only be moved (you cant change neither the size nor the scale);

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12. to enter text note in the reports page select the equivalent window and use the command Edit Report Page Notes; 13. it is possible, at this point, to see the report preview with the command File Print; directly with the command File Print Preview or print it

8.3 Changing an existing report

After having loaded a study document, with the command Report Open, choose from the list the report document that you want to change; this is loaded and showed together with the study document. At this point it is possible to edit the report as explained in the chapter 8.2creating a new report. In the case where the patient related to the report is not the same as the patient of the current study, the user is warned and asked for confirmation to use it.

8.4 Showing an existing report

With the command File Open Report of the main window of the application it is possible to show a report document alone (without an opened study). Its possible to change it as explained in chapter 8.2 creating a new report (without, of course, to insert images). In this case, measurements of distances and angles can be performed.

8.5 Report Page Notes

To change the text of the notes in the page of the report use the command Edit Report Page Notes: a window will appear that makes it possible to add text, line it, change text type and color etc...

8.6 Report Attached Letter

With the command Edit Report Attached Letter it is possible to create a letter document attached to the report document; it will be attached to the report during the import/export operations and it could be subsequently viewed by all who will receive the report.

8.7 Print Enhancement

Its possible to apply graphic filters to the reports images when they are printed: in this way the loss of quality of some printers can be compensated. These filters are in affect only while printing the report, without modify the content of the report images. With the command File Print Enhancement Setup the following window appears:

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With it, it is possible to choose a preferred filter for every type of image. Below is the available filters list: none Soften Sharpen Enhance Edge Adaptive (no filter applied) (low-pass filter. Smooths the edges of the image and reduces the noise) (high-pass filter. Sharpens the edges of the image, but doesnt reduce the noise) (sets evidence of the edges of the image, but doesnt reduce the noise) (analyzes the image, and for each pixel chooses a filter depending on the pixel information. It will consider both the noise (reducing it) and the real information (emphasizing it) )

The reference view image and the 3D image usually dont need any filter. However, it is recommended to print more reports changing the filters, because the final result depends on the printer and the judgment of the adjustments is purely subjective. Once the set-up has been set, confirm it by pressing OK. The settings will be used for all the next prints.

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8.8 Report Menu

In the following tables are reported the command descriptions of the reports menu.

8.8.1 File Menu

Save Close Graphic settings setup Report Pages Layout Setup New Report Pages Layout Setup Open Report Pages Layout Setup Delete Attached Letter Setup... Print Setup... Print Enhancement Setup... Print Preview Print Save the active report Close the active report Change the graphic properties of overlays (see chapter 6.3 graphic settings setup) Create a new report page layout. (see chapter 7 report page layout) Open an existing report page layout. (see chapter 7 report page layout) Delete a report page layout. (see chapter 7 report page layout) Modify the default report attached letter Change the printer and printing options Set the printer filters (see chapter 8.7

print

enhancement)
Preview the current report Print the current report

8.8.2 Edit Menu

(Enable when a report document is enabled) Report Patient File Add Report Page Report Page Layout Report Page Notes Remove Report Page Report Attached Letter Show the patient data attached to the report Add a page to the report (see chapter 8 creating and modifying a report) Show the report page layout of the active page (see chapter 8 creating and modifying a report) Insert notes in the active report page (see chapter 8 creating and modifying a report) Remove a report page (see chapter 8 creating and

modifying a report)
Create a new report attached letter

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8.8.3 Toolbar Menu

Main Toolbar Status Bar Report Toolbar Show/Hide the Tool Bar Show/Hide the Status Bar Show/Hide the Report toolbar

8.8.4 Window Menu

Resize Window Cascade Tile Vertical Tile Horizontal Window list Reset the position and size of the window with the original settings Arrange the windows in a cascading fashion Tile the windows in a horizontal fashion Tile the windows in a horizontal fashion Show the window list and bring to foreground the selected one

8.8.5 About Menu

About Show information about software version, system configuration, disk space and available memory

8.8.6 Pop-Up Menu

This menu appears clicking with the right button of the mouse on an image of a report.

Brightness & Contrast... Draw only image on

Change brightness and contrast of the current image (see chapter 6.2.1 brightness and contrast)

reference Draw the references of the current imege only on the reference view (if checked) on Draw the intersection between the Transaxials sections and the Panoramics sections for all the height of the Panoramics sections (if checked) Remove the current inage from the report

Hilight transaxial panoramics Remove Distances Distances Distances Distances Distances Angles Angles Angles Angles

New Distance

Trace a new distance on the current image

Drag Distances Drag the position of distance and of attached label Delete Distance Remove a distance from the current image Delete All New Angle Drag Angles Delete Angle Delete All Angles Remove all the distances from the current image Trace a new angle on the current image Drag the position of angle and of attached label Remove an angle from the current image Remove all the angles from the current image

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9. Documents managment
The software creates and manages three kind of documents: 1. raw data; 2. studies; 3. reports;

9.1 Import/Export
Because of the size of the three documents managed from the application, it is necessary to store (export) such documents to another memory supports, other than the work stations drive. Information about available space (megabytes free) of the work drive are shown in every documents list:

Free space on Work Drive

It is possible to make a copy of these documents on CD-R or CD-RW (using the CD-WRITER present on the device PC) or on every other memory support (optional) supported by the operating system.

9.1.1 Import/Export drive setup (Export Drive)

From the main menu of the application, by selecting File Export Drive Setup it is possible to set (or change) the drive used for import/export operations: if you are using CD-R or CD-RW, select the CDWRITER (normally E: drive).

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9.1.2 Export
With File Export command it is possible to select the kind of document (raw data, study or report) to copy on preset memory support (export drive). From the documents list of the work drive that appears it is possible to choose one or more items (in this case by holding pressed the keyboard Shift key to select a series of adjacent list nominatives or the Control key to select nominatives in random order) and then confirming by selecting the Ok button. The selected documents are copied from the work drive to the export drive.

9.1.3 Import
With File Import command it is possible to select the kind of document (raw data, study or report) to copy on work drive. From the documents list of the memory support (export drive) that appears its possible to choose one or more items (in this case by holding pressed the keyboard Shift key to select a series of adjacent list nominatives or the Control key to select nominatives in random order) and then confirming by selecting the Ok button. The selected documents are copied from the export drive to the work drive.

9.2 Deleting documents

It is possible to remove raw data , studies and report both from the Work drive and the Export drive.

9.2.1 Deleting documents from work drive

With File Delete from Work Drive command it is possible to select the kind of document (raw data, study or report) to delete from the work drive. From the documents list that appears its possible to choose one or more items; confirm with the Ok key.

9.2.2 Deleting documents from Export Drive

With File Delete from Export Drive command its possible to select the kind of document (raw data, study or report) to delete from the export drive. From the documents list that appears its possible to choose one or more items; confirm with the Ok key.

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9.3 Exporting axial images (OPTIONAL)

9.3.1 Exporting axial images as Bitmap
The menu item File Save in BMP format Sequence of axial Images, permits to export all axial images of the current study as Bitmap. The [Browse for folder] window appears, it permits to select the path in which the images will be stored. All images are placed in a subfolder named as [PatientSurname + PatientName]. In this subfolder there is also a text file (Attributes.txt), that contains all geometric informations about the current study.

9.3.2 Exporting axial images as DICOM

The menu item File Save in Dicom format Sequence of axial Images, permits to export all axial images (without any overlay) of the current study as Dicom file-set. The [Browse for folder] window appears, it permits to select the path in which the images will be stored. All images are placed in a subfolder named with a univocal code created from the Newtom study code.

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10. Glossary
Cone-Beam: x-ray beam of conic form used in the computerized tomographs of type CBCT = Cone Beam Computed Tomography CBCT = Cone Beam Computed Tomography: tomographic technics of volumetric type (see Volumetric Computerized Tomography) Raw Data: in a Computerized Tomography it is the ensemble of data acquired during the scan which when processed the tomographic images are obtained. In regards to the CBCT = Cone Beam Computed Tomography devices, such as QR-DVT 9000, the raw data is a series of digital images referenced from at the radiological projections performed during the scan. With the QR-DVT 9000 , from the raw data, through the primary reconstruction and the eventual secondary reconstructions, a "study" of comprehensive images (or views) of the examined volume is obtained DentalScan: conventional name assigned to software which in CT machines allows the multiplane reconstruction of the images necessary for a correct display of dental arcades Exam (scan): procedure of patient scan with storage of relative raw data. fan-beam: : x-ray beam of "fan" shape used in traditional computerized tomographs (axial) : such as volumetrics of the Spiral type (Spiral-CT) Intensity profile of the radiological beam: function which defines the X-Ray beam intensity value according to the scan angle. With the QR-DVT 9000 the X-beam intensity varies during the by considering the different dimension of the thickness of crossed tissue (SmartBeam) SmartBeam: QR-DVT 9000 characteristic so that the X-beam intensity is varied during the scan according to the different thickness of tissue crossed by the same beam. This option allows the patient to be spared unnecessary doses of radiation Spiral-CT: tomographic technics of the volumetric type (see Volumetric Computerized Tomography) Study: the ensemble of images (or views) of the examined zone comprehending axial, paraxial, panoramic, 3D views, resulting from the processing of raw data to primary and secondary reconstructions. From an exam more "studies" can be obtained, through different or following primary reconstructions Computerized Tomograph (CT=Computed Tomography): radiological device which, by means of electronic processing of radiological acquired projections on digital detectors, rebuilds the densitometric value of inner points of an object. If not otherwise specified, the term computerized tomograph traditionally indicates the computerized axial tomograph, that is to say a tomograph which rebuilds axial sections of the object using the "fan-beam" technics (X-Ray beam "fan" shape with detectors placed in line of an arch) Axial Tomograph: see computerized tomograph Volumetric Computerized Tomograph: computerized tomograph which can rebuild the densitometric value of all volume points of the examined object. Also the traditional tomograph (axial), performing a series of axial scans, can, by means of so called data reformat, produce an object volumetric reconstruction; the term volumetric tomograph is reserved to spiral tomographs (Spiral-CT), which use a "fan-beam" with continuos advancement of the patient holder examination table, synchronized at the rotation movement of tube-detectors system, and, particularly, the tomographs which use the "cone-beam" technics (CBCT = Cone Beam Computed Tomography). This last technique, by means of a unique rotation around the object, allows to acquire all necessary data for the volumetric reconstruction, also defined TVCT = True Volumetric Computed Tomography TVCT = True Volumetric Computed Tomography: see volumetric computerized tomograph Report: ensemble of study images of a patient.

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11. Service
This chapter is about general conditions of environmental safety, required for the system, and general procedures about maintenance.. For good operation, regular maintenance is required for patient and operator safety. The device and its parts must be maintained properly, and the components, if necessary, must be replaced by specialized and authorized personnel. See chapter 11.7 check list maintenance intervals.

11.1 Introduction
Scanning area: the system must be placed only in rooms for medical radiological use, according to dispositions of a Qualified Consultant. Follow carefully the safety requirements and signals, according to national and local regulation. The device isnt protected against dripping and spray: dont allow the insertion of any fluid into the scanner, which can cause breakdowns in electrical and electronical components and be dangerous for patients, operators and the environment. The system installation doesnt reduce the efficiency of the safety measures against fire, in the working environment. Electromagnetic Compatibility (EMC): the device is in conformity of the EMC regulation (EN 60601-1-2), for radiofrequency emission and immunity. Noise: the maximum measured level (phonometric analysis) is less than 70 dB.

11.2 Compliance
QR-DVT 9000 is a device of new typology for which specific safety regulations doesn't exist. As closely as possible, the device was built in conformity with IEC normatives regarding safety of electricmedical devices of similar typology and, particularly, with the normatives: IEC 601-1 (EN 60601-1): 1988 Medical electrical equipment - Part 1: General requirements for safety. IEC 601-1-1 (EN 60601-1-1): 1992 Medical Electrical Equipment - Part 1: General Requirements for Safety - 1. Collateral Standard: Safety Requirements for Medical Electrical Systems IEC 601-1-2 (EN 60601-1-2): 1993 Medical Electrical Equipment - Part 1: General Requirements for Safety - 2. Collateral Standard: Electromagnetic compatibility - Requirements and tests IEC 601-1-3 (EN 60601-1-3): 1994 Medical electrical equipment - Part 1: General requirements for safety. 3. Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment IEC 601-1-4: 1996 Medical electrical equipment - Part 1: General requirements for safety. 4. Collateral standard: Programmable electrical medical systems IEC 601-2-44: 1999 Particular requirements for the safety of X-ray equipment for computed tomography IEC 601-2-7: 1987 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of High Voltage Generators of Diagnostic X-Ray Generators IEC 601-2-28 (EN 60601-2-28): 1993 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of X-Ray Source Assemblies and X-Ray Tube Assemblies for Medical Diagnostic IEC 336 : 1982 Characteristics of focal spots in diagnostic X-ray tube assemblies for medical use IEC 522 : 1976 Inherent filtration of an X-ray tube assembly IEC 825-1 (EN 60825-1): 1993 Safety of Laser Devices. Part 1: Classification of Devices, Requirements and User Guide IEC 601-2-32 (EN 60601-2-32): 1994 Medical electrical equipment - Part 2: Particular Requirement for the safety of associated equipment of X-ray equipment Page 53

 IEC 1262-1 (EN 61262-1):1994 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 1. Determination of the entrance field size IEC 1262-2 (EN 61262-2):1994 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 2: determination of the conversion factor IEC 1262-3 (EN 61262-3):1994 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 3: Determination of luminance distribution and luminance non-uniformity IEC 1262-4 (EN 61262-4):1994 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 4: Determination of the image distortion IEC 1262-5 (EN 61262-5):1994 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 5. Determination of the detective quantum efficiency IEC 1262-6 (EN 61262-6):1994 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers - Part 6: Determination of the contrast ratio and veiling glare index EN 61262-7:1997 Medical electrical equipment - Characteristics of electro-optical X-ray image intensifiers Part 7: Determination of the modulation transfer function According to 93/42/CEE Directive (1993, 14 June) in regards to the medical devices, QR-DVT 9000 is in Class II b (X-ray emitting medical device).

CLASSIFICATION IEC 601-1

Protection against electrical shock Protection level against electrical shock CLASS I TYPE B

11.3 Device modifications

Device modifications or updating must be in conformity of all required regulation. WARNING Improper or not authorized handling or modifications of hardware and software components are forbidden as they can cause incorrect functioning of the system. They can also cause breakdowns and/or accidents and/or danger for patient, operator and system. The manufacturer isnt responsible for safety characteristics, reliability and performance of the system, if: installation, maintenance, modifications, repairs, updating are performed by personnel not directly authorized by producer or distributor; components arent replaced with spares approved by producer or distributor; the environmental safety conditions arent respected, according to the regulation requirements and the advice of a the Qualified Consultant; the system is used in a manner that is different than the requirements of this manual.

11.4 Warnings
The user is responsible for the correct use of the device, in conformity with instructions contained in the present manual and with the regulation requirements. Particularly, the following features must be emphasized: the device can be used only by authorized personnel with adequate knowledge of the device, X-ray emissions and local regulations that govern those emissions; the device must never be used, if it exhibits any electrical, mechanical or radiological problem. Particularly, it must never be used if it shows malfunctioning of signal and emergency devices.

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11.5 Maintenance and cleaning

WARNING: Always shut down the main power switch for any maintenance and cleaning of the device!

11.5.1 General requirements

Regular maintenance is required for proper system operation and patient, operator and environment safety. All system components must be checked and, if necessary, replaced by qualified technicians, authorized by producer or distributor. QR s.r.l. is responsible for device safety only if maintenance and repairs are performed by producer or distributor or by personnel authorized by them. The device must be periodically checked: refer to technical service to define a maintenance detailed program for the system. For cleaning and care of the system, see chapter 11.5.3 cleaning. If the system doesnt work according to the requirements or the working procedures show defects, refer immediately to technical service.

11.5.2 Preventive maintenance

Periodically check the computer-device interface cable and the power supply cables. Perform cable checks to computer, monitor, keyboard, mouse and printer according to the manufacturers instructions.

Supplied components and accessories must be conserved and used according to proper technical specifications.

11.5.3 Cleaning 11.5.3.1 Scanner

The device can be cleaned with a moist cloth, using a mild cleaning solution. Moisten the cloth before applying on the device surface. Never apply cleaning solution directly to the device!

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11.5.3.2 Computer and peripherals

In regards to the computer and connected peripherals, follow the manufacturers instructions. In absence of them, apply the same cautions described for device cleaning. To avoid Dont use spray or solvents, which can go into the device, damaging electrical and electronical parts, or creating possible flammables, creating danger for patient, operators and environment. Dont use abrasive fluids such as acetone, gas oil, alcohol (except: alcohol can be used only to clean monitor screen). These substances can degrade the components surface and cause damages to components intrical to the proper function of the device. Dont use agents releasing ammonia by dissipation or decomposition. Ammonia causes corrosive effects. Dont use agents containing silicone: this substance can accumulate, causing possible problems of electrical contacts. Note: For further details, about safety and maintenance, refer to the local distributor.

11.5.4 Disposal
Separate X-ray source power components, plastic shell parts, computer and peripherals, metallic components. The X-ray source contains oil, which must be extracted and delivered to a specialized center for fluids elimination and/or regeneration. In regards to the computer monitor, an improper disposal can cause the implosion of the cathode ray tube: refer to specialized technicians and to regulations for this type of component. In regards to plastic shells, the reject materials must be eliminated in authorized centers or, better, by means of incineration in approved conditions; in case of reusing, refer to recycling centers. In regards to the other parts, of which the manufacturer doesnt supply specific indications, refer to national and local regulations, as well as regulations about hygiene, job safety and environment protection.

11.6 Quality Assurance (QA)

It intrical to QA is the performance of a standard exam using an apposite phantom, by means of an automatic procedure. First, it is necessary to perform the acquisition of raw data (Scan Menu Phantom Scan). The procedure is the same as the patient scan the difference being that the patient file is pre-compiled by software. When the phantom positioning is being checked, be careful that it is centered with the rectangle, which appears on video. For a correct positioning see the following figure,

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After raw data has been acquired, the reconstruction procedure will start automatically. If not, select the command Phantom Analysis in the Primary Reconstruction Menu. The analysis is completely automatic and takes maximum 30-35 minutes (10 min. typical). At the end, a window, with results and validation ranges, is displayed. If one of the parameters is out of relative range, refer to technical service. Its possible to print the analysis results by selecting the command File Print paying attention to have the results window active. To visualize the analysis results, once the document has been closed from the main menu select Primary Reconstruction Phantom Results. To assure the proper operation of the device it is recommended to perform the QA Phantom check once a week. There are 3 kinds of quality checks: 1. Check the system parameters 2. Check Image quality / Radiation dose ratio 3. Check on the accuracy of the geometric measurements In the table below the parameters measured by the procedure are shown. Sigla AAP AAL Name
Phantoms angle on the Front-Back View Phantoms angle on the Lateral-Lateral View

Description Inclination angle of the phantoms axis of symmetry in the Front-Back View (0) Inclination angle of the phantoms axis of symmetry in the Lateral-Lateral View (90) Scan time in seconds Noise per cent on the phantoms central axial image expressed as standard deviation of the density values as to their average value in an area in the middle of the image (in correspondence of the water). External diameter of the aluminium cylinder on the x-axis in the central axial image Internal diameter of the aluminium cylinder on the x-axis in the central Page 57

ScanTime Scan Time RNS%

Noise per cent

HDE HDI

External Horizontal Diameter Internal Horizontal

Diameter

axial image External diameter of the aluminium cylinder on the y-axis in the central axial image Internal diameter of the aluminium cylinder on the y-axis in the central axial image Spatial resolution (millimeters) on the horizontal diameter of the central axial image Spatial resolution (millimeters) on the vertical diameter of the central axial image Average horizontal distance among the holes of the cylinder on the panoramic image

VDE VDI

External Vertical Diameter Internal Vertical Diameter

H FWHM Full Width Half Maximum horizontal V FWHM Full Width Half Maximum vertical HFD VFD
Horizontal Distance among holes

Vertical Distance among Average vertical distance among the holes of the cylinder on the holes panoramic image

The spatial resolution can be showed as MTF50 (lp/mm). Select the command Show MTF50 in the QA Report menu. Concerning verifying the dose, see the International Standard IEC 601-2-44 paragraph 29.102 In the figure below, there is a graphic presentation of the dose profile (see IEC 601-2-44 par. 29.103.1) 10 9 8 7 mSv 6 5 4 3 2 1 0 -5 -4 -3 -2 -1 0 cm 1 2 3 4 5 center 0 90 180 270

11.7 Check List maintenance intervals

The following check list specifies the time intervals for maintenance checking. For further information, refer to local distributor.

Person in charge
User Expert for the radiologic

Component
Whole system Whole system

Activity
Check by QA Phantom Radiological routine

Periodicity
Weekly Chosen by EPR Page 58

protection (EPR) Guasti.txt All external components Technical Assistance Service Emergency Stop Check Check of any possible damage Stop system check 12 months 12 months 12 months

Electrical parameters Mechanical parameters Patient table

Check Check Movement test, visual check structure and wood axis

12 months 12 months 12 months

11.8 Error messages

The software has a code for each error message it generates. The warning messages or the questions dont have any code. The missing Error code (Errcode) values (E.g. 200, 201) are reserved for future use. Below are listed the possible resolution to the errors listed (Errcode). Memory Error: Shutdown the application, switch off and restart the computer. If the problem persists, contact the technical assistance service.
ErrCode 301 302 303 304 305 306 307 401 402 403 404 405 501 502 503 504 505 601 602 603 604 Meaning The software cannot open the error message file Memory allocation error writing Access error writing Serialization error writing Access error reading Serialization error reading Memory allocation error reading Bitmap memory allocation error Bitmaps header memory allocation error Error reading the bitmaps header Error reading the bitmaps header The bitmap has more than 8 bit for pixel Error during the acquisition board initialization from the Service window The software cannot perform a continuos acquisition The software cannot perform an acquisition without RX The software cannot perform a single acquisition The software cannot perform a multiimpulse acquisition Error opening the deviation file Error reading the deviation file Error opening the theoretical centers file Error reading the theoretical centers file Counter Measures Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance

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605 606 607 608 609 610 611 612 613 614 615 901 902 903 904 905 906 907 908 909 910 911 912 913 914 915 916 917 918 919 920 1101 1102 1103 1104 1105 1106 1107 1108 1109 1301 1302 1303

Allocation memory error of the deviation buffer Deallocation memory error of the deviation buffer Deallocation memory error of the deviation buffer Allocation memory error of the theoretical centers buffer Deallocation memory error of the theoretical centers buffer Deallocation memory error of the theoretical centers buffer Allocation memory error of the destination image buffer Deallocation memory error of the destination image buffer Deallocation memory error of the destination image buffer Error opening the edges file Error writing the edges file Error opening the holes file Error writing the holes file Error opening the deviation file Error writing the deviation file Error opening the theoretical centers file Error writing the theoretical centers file Allocation memory error of the holes buffer Deallocation memory error of the holes buffer Deallocation memory error of the holes buffer Allocation memory error of the theoretical centers buffer Deallocation memory error of the theoretical centers buffer Deallocation memory error of the theoretical centers buffer Allocation memory error of the counters buffer Deallocation memory error of the counters buffer Deallocation memory error of the counters buffer Allocation memory error of the deviation buffer Deallocation memory error of the deviation buffer Deallocation memory error of the deviation buffer Error opening the edges file Error writing the edges file The physical data file does not exist Error opening to read the physical data file Memory allocation error reading Access error reading Serialization error reading Error opening to write the physical data file Memory allocation error reading Access error writing Serialization error writing Allocation memory error of the image buffer Allocation memory error of the sum image buffer Deallocation memory error of the image buffer

See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error See Memory Error See Memory Error

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1304 1305 1306 1307 1308 1401 1402 1403 1404 1405 1406 1407 1408 1409 1501 1502 1503 1504 1505 1506 1507 1508 1509 1601 1602 1603 1604 1605 1701 1702 1703 1704 1705 1706 1707 1708 1709 1710 1711 1712 1801 1802 1803

Deallocation memory error of the image buffer Deallocation memory error of the sum image buffer Deallocation memory error of the sum image buffer Error opening for read the image file Error reading the image file The mask file does not exists Error opening for read the mask file Memory allocation error reading Access error reading Serialization error reading Error opening for write the mask file Memory allocation error reading Access error writing Serialization error writing The counter file does not exist Error opening for read the counter file Memory allocation error reading Access error reading Serialization error reading Error opening for write the counter file Memory allocation error reading Access error writing Serialization error writing The image area to filter is too small The image area to filter is too small Allocation memory error of the filters buffer Deallocation memory error of the filters buffer Deallocation memory error of the filters buffer Error creating the strings database file Memory allocation error reading Access error writing Serialization error writing Memory allocation error reading Access error reading Serialization error reading Error opening for write the Error opening for write the strings database file (after the init) Memory error allocation writing during the init of the file Access error writing during the init of the file Serialization error writing during the init of the file Error during the acquisition board initialization before an exam The software cannot move the variac before a calibration scan

See Memory Error See Memory Error See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance

The software cannot shut down the X-Ray source at the end of a calibration Contact the Technical Service Assistance scan

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1804 1805 1806 1807 1808 1809 1901 1902 1903 1904 1905 1906 1907 1908 1909 1910 2001 2002 2003 2004 2005 2006 2007 2008 2201 2202 2203 2204 2205 2206 2207 2208 2501 2502 2503 2504 2505 2506 2507

Error performing the Zero-Crossing test at the start of the calibration scan The software cannot reset the variac at the start of a calibration scan The inductive switch is active before the end of a calibration scan The arm position is not correct The inductive switch is not active at the end of a scan calibration An image completely black was acquired The motor data file does not exist Error opening for read the motor data file Memory allocation error reading Access error reading Serialization error reading Error opening for write the motor data file Memory allocation error reading Access error writing Serialization error writing The software cannot move the arm Error opening for read the phantom data file Memory allocation error reading Access error reading Serialization error reading Error opening for write the phantom data file Memory allocation error reading Access error writing Serialization error writing Error opening for read the radiological parameters file Memory allocation error reading Access error reading Serialization error reading Error opening for write the radiological parameters file i Memory allocation error reading Access error writing Serialization error writing

Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance

Error printing because the print protocol for Special Radiological Printer is not Set as default printer a Windows printer enabled. (Menu File Print Setup) The software cannot create the bitmap resource to draw the report for the See Memory Error Special Radiological Printer The software cannot create the device context resource to print with Special See Memory Error Radiological Printer There is not enough space on work drive to store the print queues of the Special Free space on disk. If persists contact the Radiological Printer Technical Service Assistance The software cannot obtain a valid file name to use as temporary file during the Contact the Technical Service Assistance print process of a new report with a Special Radiological Printer. The temporary file used for the print queue of a Special Radiological Printer just Wait the end of the process. If persists exist. contact the Technical Service Assistance Error opening for write the temporary file used for the print queue of a Special Contact the Technical Service Assistance Radiological Printer

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2508 2509 2510 2511 2512 2513 2514 2515 2516 2601 2602 2603 2604 2605 2606 2607 2608 2701 2702 2703 2704 2705 2801 2802 2803 2804 3101 3201 3202 3203 3204 3205 3206 3207 3208 4201 4202 4203

Error writing the temporary file used for the print queue of a Special Radiological Contact the Technical Service Assistance Printer Error during the creation of the event of stop for the synchronization of the 3M Contact the Technical Service Assistance server Error during the creation of the event of reply of the stop for the synchronization Contact the Technical Service Assistance of the 3M server Error creating the 3M server The 3M server is just activated on another station and cannot be created. Contact the Technical Service Assistance Contact the Technical Service Assistance

Error opening for read the temporary file used for the print queue of a Special Contact the Technical Service Assistance Radiological Printer Error during the creation of the event of pause for the synchronization of the 3M Contact the Technical Service Assistance server Error during the creation of the event of reply of the stop for the synchronization Contact the Technical Service Assistance of the 3M server Error during the creation of the event of pause for the synchronization of the 3M Contact the Technical Service Assistance server Allocation memory error of the Gain and Offset values buffer Allocation memory error of the compensation X-Ray values buffer See Memory Error See Memory Error

The header file with the old raw format data that the user is opening does not Contact the Technical Service Assistance exist. Error opening for read a header file with the old raw format Memory allocation error reading Access error reading Serialization error reading Error of the control flag reading the raw data file passed Error closing/deleting 'n.xxx.yyy.zzzz.Lock' file Error writing on 'n.xxx.yyy.zzzz.Lock' file the lock information Error reading from n.xxx.yyy.zzzz.Lock' file the user data Error opening 'n.xxx.yyy.zzzz.Lock' file Error writing on 'n.xxx.yyy.zzzz.Lock' file the user data Error opening for read the grid results file Error reading the grid results file Error opening for write the grid results file Error writing the grid results file Error initializing hardware Error opening for read the laser printer data Memory allocation error reading Access error reading Serialization error reading Error opening for write the laser printer data Memory allocation error reading Access error writing Serialization error writing The selected header line is full The selected font size gives a text extent wider than the header line size Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Remove come characters or reduce the font size See 4201

The new header/footer line cannot be added because the total high is greater Remove some lines or reduce the font size

Page 63

than the available space 4204 4301 4302 4303 4304 4305 4306 4307 4401 4402 4403 4404 4405 4406 4407 4408 4501 4601 4602 4603 4604 4605 4606 4607 4608 4609 4610 4611 4612 4613 4614 4615 4616 4617 4618 4619 4620 4621 4622 4801 4802 See 4203 Memory deallocation error of the palette Memory deallocation error of the palette Memory allocation error of the palette Error initializing the palette Error coping the palette Error updating the palette Error updating the palette Error opening for read the results QA phantom file Memory allocation error reading Access error reading Serialization error reading Error opening for write the results QA phantom file Memory allocation error reading Access error writing Serialization error writing The max hourly tube was reached. Allocation memory error of the Gain and Offset buffer for a new scan Allocation memory error of the V buffer for a new scan Allocation memory error of the Gain and Offset buffer for an existing scan Allocation memory error of the V buffer for an existing scan Allocation memory error of the space reserved for the images Deallocation memory error of the space reserved for the images Deallocation memory error of the space reserved for the images Deallocation memory error of the space reserved for an image Deallocation memory error of the space reserved for an image Error locking 100 MByte Error locking the space reserved for the images Error opening for read an old raw data image file Error reading an old raw data image file Error opening for write an old raw data image file Error writing the an old raw data image file Error opening for write the file header an of old raw data image file Memory allocation error reading Access error writing Serialization error writing Allocation memory error of the RX values buffer Allocation memory error of the Gain values buffer Not enough space on the work drive to perform a new scan Error opening for write the scan duration file Error writing the scan duration file See 4203 See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Wait for the time showed in the message before to retry See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error See Memory Error Free space on disk. If persists contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance

Page 64

5307 5308 5309 5310 5311 5312 5313 5314 5315 5316 5401 5402 5403 5404 5405 5406 5601 5602 5603 5604 5605 5606 5607 5608 5609 5610 5611 5701 5702 5703 5704 5705 5706 5707 5708 5709 5801 5802 5901 5902 5903 5904 5905

Error opening for read a mattarellum image file Error reading the a mattarellum image file Error opening for write the file Stecca.txt Error writing the file Stecca.txt Error opening for write the mattarellum data file Error writing the mattarellum data file Error opening for write the mattarellum results file Error writing the mattarellum results file Error opening for read the mattarellum results file Error reading the mattarellum results file Error opening for write the Grid results file Error writing the Grid results file Error opening for write an info RD file Error writing an info RD file Error opening for write an info RD file Error writing an info RD file Allocation memory error of the space reserved for the image Allocation memory error of the data buffer Allocation memory error of the space reserved for the image Allocation memory error of the space reserved for the image Deallocation memory error of the data buffer Deallocation memory error of the data buffer Allocation memory error of the temporary buffer Deallocation memory error of the temporary buffer Deallocation memory error of the temporary buffer Error opening for read from service an image file (*.img, *.bmp) Error reading from service an image file (*.img, *.bmp) The Grid data file does not exist Error opening for read the Grid data file Memory allocation error reading Access error reading Serialization error reading Error opening for write the Grid data file Memory allocation error reading Access error writing Serialization error writing Error moving a file from the Root to the directory Exam Error creating the subdirectory to export axials in bitmap format The X-Ray tube file does not exist Error opening for read the X-Ray tube file Memory allocation error reading Access error reading Serialization error reading

Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Check that Patient Surname and Name dont have any non-alphanumeric characters. Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance

Page 65

5906 5907 5908 5909 5910 5911 5912 5913 5914 6001 6002 6003 6004 6005 6006 6007 6008 6009

Error opening for write the X-Ray tube file Memory allocation error reading Access error writing Serialization error writing Error opening for write the X-Ray tube report file Error writing the X-Ray tube report file Error opening for read the X-Ray tube report file Error reading the X-Ray tube report file Error performing the linear regression Error opening for write a generic image file saved as*.img o *.bmp Error writing the generic image saved as *.img or *.bmp file The device serial number is not valid. The software cannot find the default printer data because no printer are installed Error initializing the procedure to read the printer data Error reading the printer data No Export drive is installed

Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Start the application and insert a valid value Check if a Windows printer is installed and there is not anyone install ones. Contact the Technical Service Assistance See 6004. Select an Import/Export drive and retry

The software cannot recognize the type of Import/Export drive or the drive is not Reselect the Import/Export drive present The software cannot read from the Import/Export drive Verify the magnetic support and if it is not good change it. Moreover if is an Export procedure check if the magnetic support is read only. Insert a valid value Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error See Memory Error See Memory Error Contact the Technical Service Assistance

6010 6101 6102 6103 6104 6105 6106 6107 6108 6109 6201 6202 6203 6204 6205 6206 6207 6208 6209 6301 6302 6303 6304

The device serial number is not valid. The 3D configuration file does not exist Error opening for read the 3D configuration file Memory allocation error reading Access error reading Serialization error reading Error opening for write the 3D configuration file Memory allocation error reading Access error writing Serialization error writing The acquisition file does not exist Error opening for read the acquisition file Memory allocation error reading Access error reading Serialization error reading Error opening for write the acquisition file Memory allocation error reading Access error writing Serialization error writing Memory allocation error of the space reserved for the raw blank image Memory deallocation error of the space reserved for the raw blank image Memory deallocation error of the space reserved for the raw blank image Error opening for read the raw blank file

Page 66

6305 6401 6402 6403 6404 6405 6406 6407 6408 6409 6410 6411 6412 6413 6501 6502 6503 6504 6505 6506 6507 6508 6701 6702 7001 7002 7003 7004 7005 7501 7502

Error reading the raw blank file Error opening for write (during the init), the calibration parameters file Memory allocation error reading during the init Access error writing during the init Serialization error writing during the init Error opening for read the calibration parameters file after the init Error opening for read the calibration parameters file Memory allocation error reading Access error reading Serialization error reading Error opening for write the calibration parameters file Memory allocation error reading Access error writing Serialization error writing

Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance

Memory allocation error of the space reserved for the header of the image with See Memory Error the old format Memory allocation error of the space to initialize the header of the image with See Memory Error the old format Memory deallocation error of the space reserved for the header of the image See Memory Error with the old format Memory deallocation error of the space reserved for the header of the image See Memory Error with the old format Memory deallocation error of the space reserved for the header of the image See Memory Error with the old format Memory deallocation error of the space reserved for the header of the image See Memory Error with the old format Error reading the header of the image with the old format Error verifing the header of the image with the old format Error opening for read the edges file Error reading the edges file Memory allocation error of the space reserved for the blank image Memory deallocation error of the space reserved for the blank image Memory deallocation error of the space reserved for the blank image Error opening for write the blank file Error writing the blank file Error reading the driver Error performing the zero-crossing test: line frequency = 0 Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error See Memory Error See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Check if the machine is switched on. If the problem persist, contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance

7503 7504 7505 7506 7507 7508 7509 7510

Error reading the driver in read/write mode Line frequency out ranges 47-51 Hz, 56-61 Hz Error reading the driver in writing Error closing the driver Error writing the driver Error reading the driver Line frequency = 50Hz, frame grabber setup = 60Hz Line frequency = 60Hz, frame grabber setup = 50Hz

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7601 7602 7603 7604 7701 7702 7703 7704 7705 7706 7801 7901 7902 7903 7904 7905 7906 7907 7908 7909 8001 8002 8101 8102 8103 8104

The reconstruction plain is too much near Memory allocation error of the space reserved for the 3D image Memory deallocation error of the space reserved for the 3D image Memory deallocation error of the space reserved for the 3D image The row file does not exist Error opening for read the row data file Error closing the row data file Error performing the multiple regression Error performing the multiple regression Error performing the multiple regression Error initializing the acquisition board The primary reconstruction parameters file does not exist Error opening for read the primary reconstruction parameters file Memory allocation error reading Access error reading Serialization error reading Error opening for write the primary reconstruction parameters file Memory allocation error reading Access error writing Serialization error writing Error removing a file No file to delete Error performing the DailyCheck zero-crossing test Error resetting the variac during the DailyCheck Error setting the motor during the DailyCheck Error initializing the grabber during the DailyCheck

Contact the Technical Service Assistance See Memory Error See Memory Error See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Repeat the procedure Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance In case the device has been switched on more than 10 hours, try to switch it off for 2 hours and than restart to work. If the problem persist, contact the Technical Assistance Service. Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance, taking note of the values reported on the message. Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance

8105 8106 8107

Error setting the variac during the DailyCheck Error checking if the X-Ray source is shut down during the DailyCheck Error starting up the X-Ray source during the DailyCheck

8108 8109 8110 8111 8401

Error checking if the X-Ray source is shut down during the DailyCheck Error performing the DailyCheck watch-dog test Error resetting the arm during the DailyCheck Error resetting the variac during the DailyCheck

The file with the parameters to generate transaxials and panoramics sections Open a study, select Secondary does not exist Reconstruction Transaxials Setup, change the transaxials settings and save. Then select Secondary Reconstruction Panoramics Setup, change the panoramics settings and save.

8402 8403

Error opening for read the file with the parameters to generate transaxials and Contact the Technical Service Assistance panoramics sections Memory allocation error reading See Memory Error

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8404 8405 8406 8407 8408 8409 9201 9202 9203 9204 10801 10802 10803 10804 10805 10806 10807 10808

Access error reading Serialization error reading

Contact the Technical Service Assistance Contact the Technical Service Assistance

Error opening for write the file with the parameters to generate transaxials and Contact the Technical Service Assistance panoramics sections Memory allocation error reading Access error writing Serialization error writing Error performing the CPU registry test Error performing the CPU integer test Error performing the CPU float test Error performing the CPU memory test Not enough space on the work drive to perform a scan Error locking 100 MByte for the scan The Daily Check test has not been performed The blank image file does not exist Error opening for read the blank image file The computer memory RAM is lower than 130 MB Error initializing the acquisition board The software cannot calculate the dose to use See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error. If persists contact the Technical Service Assistance See 9201 See 9201 See 9201 Free space on disk. If persists contact the Technical Service Assistance See Memory Error Perform the Daily Check (see chapter 4.2 daily check ) Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance 1. If the image is very bright contact the Technical Service Assistance 2. If the image is very dark verify the beam limiter position and if persists contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance

10809 10810 10811 10812 10813 10814 10815 11001 11701

Error performing the Zero-Crossing test at the start of the scan The software cannot reset the variac at the start of a scan The inductive switch is active before the end of a scan The arm position is not correct The inductive switch is not active at the end of a scan The software cannot move the variac at the start of a scan The software cannot shut down the X-Ray source at the end of a scan

The software is unable to calculate the free space on the Studies drive while is Contact the Technical Service Assistance creating the primary deferred reconstruction list The primary deferred reconstructions file does not exist Create a new primary deferred reconstructions list (see chapter 5.3 deferred primary reconstructions) Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Change the selected report area size to include at least an image

11702 11703 11704 11705 11706 11707 11708 11709 14201

Error opening for read the primary deferred reconstructions file Memory allocation error reading Access error reading Serialization error reading Error opening for write the primary deferred reconstructions file Memory allocation error reading Access error writing Serialization error writing The report area selected is too small to contains a transaxial image

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14401 14402 14501 14601 14602 14701 14702

Error creating the default report attached letter Error opening the application to edit the letter There are less than 100 Mbytes free on work drive Advise that raw data with the old format cannot be exported The QA phantom is bad positionated The application cannot create a new frame Error creating a directory on the Export drive

Contact the Technical Service Assistance Check if WordPad accessory is present and if not install it. Free some space on work drive Export only raw data with the new format Check the phantom position See Memory Error Check if the Export drive is read only. If persists contact the Technical Service Assistance Check the Import drive. If persists contact the Technical Service Assistance Check the Export drive. If persists contact the Technical Service Assistance Contact the Technical Service Assistance Check the Export drive. If persists contact the Technical Service Assistance See Memory Error See Memory Error Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error Insert a valid patient birthdate Insert the patient surname See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error

14703 14704 14705 14706 16901 16902 16903 16904 16905 16906 16907 16908 16909 16910 16911 16912 16913 16914 16915 16916 16917 17401 17402 18101 18102 18103 18201 18202 18203 18204 18205 18206 18207

Error importing a document Error exporting a document Error removing files from the work drive Error removing files from the Import/Export drive Deallocation memory error of the space reserved for the image Deallocation memory error of the space reserved for the image Error opening for read the image file Memory allocation error reading Access error reading Serialization error reading Allocation memory error of the space reserved for the image Error opening for write the image file Memory allocation error reading Access error writing Serialization error writing Error reading the allocated image matrix Allocation memory error of the bitmap Deallocation memory error of the bitmap Deallocation memory error of the bitmap Error locking the memory reserved for the image Allocation memory error of the space reserved for the report image The patient birthdate is not valid The patient surname is missed Allocation memory error of the space reserved for a transaxial image Deallocation memory error of the space reserved for a transaxial image Deallocation memory error of the space reserved for a transaxial image Allocation memory error of the buffer Deallocation memory error of the buffer Deallocation memory error of the buffer Allocation memory error of the buffer Deallocation memory error of the buffer Deallocation memory error of the buffer Allocation memory error of the buffer

Page 70

18208 18209 18210 18211 18212 18213 18214 18215 18216 18217 18218 18219 18220 18221 18222 18223 18224 18301 18302 18303 18304 18305 18306 18307 18308 18309 18601 18602 18603 18901 19601 19602 19603 19604 19605 19606 19607 19608 20101

Deallocation memory error of the buffer Deallocation memory error of the buffer Allocation memory error of the buffer Deallocation memory error of the buffer Deallocation memory error of the buffer Allocation memory error of the buffer Deallocation memory error of the buffer Deallocation memory error of the buffer Allocation memory error of the buffer Deallocation memory error of the buffer Deallocation memory error of the buffer Allocation memory error of the buffer Deallocation memory error of the buffer Deallocation memory error of the buffer Allocation memory error of the buffer Deallocation memory error of the buffer Deallocation memory error of the buffer Allocation memory error of the buffer Deallocation memory error of the buffer Deallocation memory error of the buffer Allocation memory error of the buffer Deallocation memory error of the buffer Deallocation memory error of the buffer Allocation memory error of the buffer Deallocation memory error of the buffer Deallocation memory error of the buffer Allocation memory error of the buffer Deallocation memory error of the buffer Deallocation memory error of the buffer One of the extreme of the Primary Reconstruction doesn't intersect the edges Error opening for write a report layout file Memory allocation error reading Access error writing Serialization error writing Error opening for read a report layout file Memory allocation error reading Access error reading Serialization error reading Hardware key access error Verify the code : 7 - No key is present or the printer is shut-down

See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error See Memory Error Move the segment and retry Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance

Insert the hardware key or start-up the printer Contact the Technical Service Assistance Start-up the printer

14 - The hardware key driver has not been installed 257 - The printer is shut-down

Page 71

20102 20103 20104 20105 20106 20107 20108 20109 20110 20111 20112 20113 20114 20115 20116 20117 20118 20601 20602 20603 20604 20605 20606 20607 20608 20609 20610 20611 20612 21001 21201 21601 21603 21604 21605 23201 23202 23203

The current hardware key is not the same used to the start the application The software cannot read the hardware key configuration The hardware key configuration data are not valid The software cannot read the architecture from the hardware key The hardware key architecture data are not valid The software cannot read the expiration date from the hardware key The hardware key expiration date is not valid The software cannot read the last access date from the hardware key The last access date is not valid The software cannot write the last access date to the hardware key There is n. days to the software license expiration The software license is expired The software cant read the documents counter. The software cant write on documents counter. The documents counter is at the maximun possible. The software cant create the crypted code The software cant create the crypted code Error creating the report notes database file Memory allocation error reading Access error writing Serialization error writing Memory allocation error reading Access error reading Serialization error reading Error opening for write the report notes file Error opening for write the report notes database file (after the init) Memory error allocation writing during the init of the file Access error writing during the init of the file Serialization error writing during the init of the file Todays Phantom Scan is not present Division by zero Access error writing during the init of the file Errore creating the subdirectory to export axials in Dicom format The Subdirectory to export axials in Dicom format, already exist The drive selected to export axials in Dicom format is full. Unable to load the '%s' language resource.\nFile: %s\nOS Error: %d Unable to get the '%s' resource version.\nFile: %s\nOS Error: %d Version mismatch on the '%s' resource.\nFile: %s\nResource version: %s\nApplication version:%s

Insert the hardware key used to the start the application Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the manufacturer for the license renewal Contact the manufacturer for the license renewal Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the manufacturer for the license renewal Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance See Memory Error Contact the Technical Service Assistance Contact the Technical Service Assistance Perform a new Phantom Scan Contact the Technical Service Assistance Contact the Technical Service Assistance Contact the Technical Service Assistance The current study was already exported in Dicom format in the selected path Free space on the selected drive DLL file of the selected language not found. Contact the Technical Service Assistance DLL file of the selected language is corrupt Contact the Technical Service Assistance Wrong version of the DLL language file. Contact the Technical Service Assistance

Page 72

11.9 Log Files visualization

11.9.1 Error Log File visualization
The software stores on file all the error messages occurring on the scanner or computer. To screen the files Log File... and after choosing Error give confirmation with the content select from the main menu Tools OK button.

11.9.2 Daily Check Log File visualization

Moreover, the software also stores all the results of the daily check of the Check Scan. To screen the list, Log File... and after choosing Daily Check give confirmation with the select from the main menu Tools OK button.

11.10 Suggestions for shipment, storage, preservation and installation

Carriage and storage temperature : 0 50 Humidity for carriage and storage : 20 80 % (not condensing) No exposure to acid, saltiness, rain. Working temperature : 15 35 Working humidity : 20 80 % (not condensing) In normal conditions, the device can be installed in a room, according to the following conditions: Simulation of installation in room 3X3,5m
192 cm

71 cm

DVT

45 cm

120 cm

Patient bed Protection Pb

100 cm

Work station

Display Operator

Page 73

The electrical installation will have to foresee: a dedicated power outlet for the GANTRY, with the capacity to disburse 220-240V / 16A a dedicated power outlet for the computer, with the capacity to disburse 110V / 15A The power supplied must conform to local regulation requirements. The installation room must be designed by an expert in X-ray radiation risk protection, in conformity with applicable local and national regulations (in Italy DLS 230/95). The national and local regulation will regulate the signalling project in the installation. NOTE: The computer must be installed out of the patient area. The connectors for the computer and patient bed cables must be used only for their respective functions and for no other use what so ever. These connectors must be handled only by authorized and qualified personnel.

WARNING! Dont ever shift the device, after the installation: the shift can cause damages to patients and compromise the validity of the report The wheels are used only for small shifts, performed only by qualified personnel, authorized by QR S.r.l.

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12. Identification and marking

I- Label on DVT (one of the following): 50 Hz
QR srl Verona Italy 045-583500 Model no: QR-DVT 9000 Serial Number: Power: 230V / 10 A / 50Hz

60 Hz
QR srl - Verona Italy 045-583500 Model no: QR-DVT 9000 Serial Number: Power: 230V / 10 A / 60Hz

Manufactured: WARNING: This product includes X ray Source

Manufactured: WARNING: This product includes X ray Source

WARNING: This product includes two lasers.

WARNING: This product includes two lasers.

0051

0051

QR Srl Verona Italy +39 045 583500 QR Srl Verona Italy +39 045 583500 Model no: QR-DVT 9000 Serial Number : Power : 230V~ / 8A / 50Hz Manufactured : Manufactured : CCIB CCIB Model no: QR-DVT 9000 Serial Number : Power : 230V~ / 8A / 60Hz

0051 0051

Page 75

QR Srl Via Silvestrini, 20 37135 Verona Italy +39 045 583500 Model no: QR-DVT 9000 Serial Number : Power : 230V~ / 8A / 50Hz

QR Srl Via Silvestrini, 20 37135 Verona Italy +39 045 583500 Model no: QR-DVT 9000 Serial Number : Power : 230V~ / 8A / 60Hz

Manufactured : Manufactured : CCIB CCIB

0051 0051

Page 76

II- Label on X-ray source WARNING! The serial number on the X-ray source label is identical to the radiogen tube and tube assembly, because the two components are not separable.
QR srl - Verona Italy Model: Ardet-110-1 OX 1,5 Serial Number: X Tube: CEI-OX-110-1 HV: 110 kVp Focal spot: 1.5 mm IEC Inherent Filtration: 1.8 mm Al Total Filtration: 5.0 mm Al QR srl - Verona Italy Model: IMD MA5-50/60Hz OX 1,5 Serial Number: X Tube: CEI-OX/110-5 HV: 110 kVp Focal spot: 1.5 mm IEC Inherent Filtration: 1.8 mm Al Total Filtration: 8.0 mm Al

IMD S.p.A. Via Aldo Moro, 5/7 24020 Scanzorosciate (BG) Italy Model: MA5-50/60 Hz OX 1,5 Serial Number: Manufactured: Inherent filtration: 1.8 mm Al @ 110 kVp Total filtration: 8.0 mm Al @ 110 kVp X-ray tube: CEI - Bologna - Italy Model OX/110-5 HV: 110 kVp Focal spot: 1.5 IEC

QR s.r.l. Via Silvestrini, 20 37135 Verona, Italy Model: LFX1 Serial Number: Manufactured: Inherent filtration: 1.0 mm Al @ 110 kVp Total filtration: 7.2 mm Al @ 110 kVp X-ray tube: CEI - Bologna - Italy Model OX/110-5 Tube serial number

QR s.r.l. Via Silvestrini, 20 37135 Verona, Italy Model: LFX1 Serial Number: Manufactured: Inherent filtration: 1.3 mm Al @ 50 kVp Total filtration: 7.5 mm Al @ 110 kVp X-ray tube: Toshiba - Japan Model DF-151SB-T Tube serial number

HV: 110 kVp Focal spot: 1.5 IEC

HV: 110 kVp Focal spot: 1.5 IEC

Page 77

III- Label on X-ray beam limiter

QR srl - Verona Italy X-Ray Beam Limiter

IV- Label on additional mirror/filter

QR srl - Verona Italy X Ray Filter

QR Srl Verona Italy X Ray Filter

Filtration 3.2 mm Al @ 110 kVp

V- Label on patient table

QR srl - Verona Italy Patient Table Model: ______________

Page 78

VI- Label with indication of switching on and of input fuses

ON-OFF
0

POWER

FUSES: F1=F2=F10A 250V

VII- Label with indication of connectors

Page 79

VIII Warning Label about the main fuses

CAUTION: For continued protection against risk of fire, replace only with same type and rating of fuse

IX Warning Label placed near the laser output aperture

LASER

Page 80

13. Safety
The table below shows the description of the symbols you can find on the label of the device:
Symbol IEC Description

417-5032 348 417- 878-02-02

Alternate current Warning, consult the attached documentation Type B (Applied part)

13.1 General warnings

To guarantee continuous safety of people and the device, observe always the guide lines on safety of this manual, particularly about functionality tests, mechanical and electrical safety and radiation protection. Respect carefully all requirements in regards to the installation, the maintenance and the working of the device. Always follow local regulations if they are more stringent than those contained in this manual. Turn the device on and off, according to the manual requirements (see chapter 3.1 device start-up and chapter 3.3 device shutdown). In case of necessary, follow carefully the instructions for emergency stop (see chapter 13.3 emergency shutdown). Perform functional tests according the written specifications. Before the pointing laser beam is activated, always warn the patient inviting him to close their eyes. The operator should predict the use of an eye protection. Dont ever leave the system unattended during the scan execution. Always keep the patient under observation. Predict the repetition of the scan only if significative artifacts or suspects are evident in a patient image, or if the patient position has clearly changed. WARNING: All operators must have a sufficient knowledge of the systems working and environmental features and know the procedures to follow in case of danger or emergency stop. WARNING: Predict the implementation of an audio/video communication between operator and patient.

13.2 Device shutdown

For the device shutdown, follow carefully the instructions contained in chapter 3.3 device shutdown. To stop the scan, follow carefully the instructions contained in 4.3 procedure for exam execution. The interruption stops automatically the X-ray emission and the movement of the scan system. The system must be resetted and brought to normal operative conditions, after the risk situation was identified and solved. If the system doesnt work correctly, refer immediately to technical service.

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WARNING: Immediately shut down the system if the patient is in a danger condition, or if the system doesnt work correctly or if it shows an emergency situation. The system components can be switched on and off separately, without any danger for the patients or operators.

13.3 Emergency shutdown

The emergency stop is a large red push-button (red mushroom), placed above the space, in which the patient head is placed (see figure below). Its pressure, if necessary, causes the complete inhibition of all device functions and the complete shutdown of the system. To inhibit completely the connection between computer and scanner (which causes the complete shutdown of the X-ray source), it is always possible to switch off the computer. WARNING: The command of emergency stop must be used only in case of situations of harsh danger, for example: a) the procedure of STOP X-ray emission doesnt work b) danger conditions, which can cause damage to persons, environment and system, are shown

13.4 Guide lines for patients and operators safety

By correctly operating and positioning of the patient, risks are avoided for patients and operators. Patient positioning

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Follow carefully the instruction contained in 4.5 Patient positioning. Cautions in patient bed movement Dont move the patient bed until the patients safety is certain and there are no obstacles for the bed movement. Follow carefully the instruction for the correct bed positioning contained in chapter 4.3 procedure for exam execution. X-ray protection The operator must follow the exam from the control workstation according to applicable dispositions; nobody must be present near the patient during the exam execution. In case of a panic reaction by the patient and where the operator is required near the patient during the exam, he must wear appropriate protection devices, according to national and local regulations. If the exam is for only the lower area of the patient head, to avoid any needless exposure of delicate organs (for example eyes), use the command Beam Limiter on the control keyboard on the gantry side: the beam will be limited to cover the anatomic area seen by the laser luminous indicators. Follow carefully the applicable regulations pertaining to X-Ray safety and the requirements of a Qualified Consultant. The emission status is clearly identified by a visual signal and on the scanner: a) on computer screen

The signal EMISSION ON on video appears only after giving the START command at X-ray emission, by means keyboard or mouse (see chapter 4.3 procedure for exam execution) and remains visible for the entire scan time; b) on the scanner a lamp is present, signaled by the emission status of the X-ray source (each flash is correspondent to a tube flash). It begins to flash only after giving the START command at X-ray emission, by means of the keyboard or mouse (see chapter 4.3 procedure for exam execution) and remains visible for the entire effective emission time. WARNING: Dont ever approach the patient when the emission signals are active. WARNING: If the emission signals are active, when the command of X-ray emission was not given, or they dont became active when the command is started, or the emission hasnt stopped at the end of the scheduled time, shut the system down immediately and refer to technical service. Dose distribution The drawing below shows the isodose curves around the device. The measure was performed according to the requirements of IEC 601-1-3, in regards to the stray radiation test. It can be noted that stray radiation diminishs with distance from the gantry aperture; also, the radiation exposure levels are clearly lower behind the side of the gantry. The stray radiation test was performed measuring the radiation in a horizontal plane at a height of the rotation center of the device, and using as a diffuser the phantom (to simulate the patient head). The measures were performed with a ionization chamber CAPINTEC (electrometer mod.192, chamber PM-500 vol. 500cc). Distances (in meters) are in reference to the device center and positive distances in vertical direction indicate the device frontal side. The values are noted in kerma in Gy/exam, normalized to the dose value in input of 60 mR. Also, a measure of stray radiation, was performed beneath device with respect to the reconstruction volume center: Measured value (Gy/exam) = 0.70 Gy (Reference dose = 60 mR) Page 83

This last data can be used for the study of for the installation project, according to art. Dlgs 230/95, in which it establishs the outlines for operator protection from X-rays through structural protection, safe distances from working devices and the emissions of those devices. In regards to this point, the workstation of the system can be placed at a distance of up to 10m from the scanner, making it easier to design a layout that accomodates operator safety.

Stray radiation (Gy/exam) 1 - Distances in meters

13.5 Safety devices

The model QR-DVT 9000 is designed and manufactured according to EEC regulation. These standards foresee that the user and the patient are protected from electrical damages using, in the execution phase, techniques of protection against macro and micro shocks, in case of defects of principal insulation. The first type of protection was done by the introduction of an insulation transformer inside the machine. This one to enhance the electrical safety of peripherals connected (video, printer, computer, nuclear electronics), which are continuously in contact with operator and patient. This transformer is also protected, by means of fuses, against overheating and overloading. The X-ray source is made with an X-ray tube, powered by a high voltage generator, which can operate correctly with the pulsed method. In diagnostics, the applied potential difference must be 110 kVp-max, the anodic current 15 mA-max. The pulses are synchronized with the detector system and their frequency is determined by data acquisition and recording time. The X-ray beam intensity varies during the scan. Through the use of a technique called SmartBeam, a system AEC 1.1
1

1 Gy = 100 Rad Page 84

(Automatic Exposure Control), during the scan, the device chooses automatically the X-ray beam intensity, according to the dimensions and density of tissues being scanned. This option allows the elimination of unnecessarily high doses of X-rays to the patient. Also, a device, which interrupts automatically the X-ray emission in case of malfunctioning of the acquisition system or of the process control system, is employed: the computer-X-ray source system is protected against any computer stop or unintentional use, the tube emits only if it receives pulses by the computer, otherwise it shuts down automatically. WARNING: The X-ray source MUST be used ONLY with DVT and according the functions required by DVT software. Every use, different respect the required one, can cause damage to operators, patients and system DVT. Each maintenance operation must be performed by personnel authorized by QR S.r.l. The X-ray Beam limiter device is made by a filter composed by Fe 1.5 mm e Pb 2 mm, moved by a motor 6V CC - 100 mA. The mirror-filter, placed along the X-ray beam path, has purpose of X-ray beam filter and is a fundamental element for patient safety. It is made with a Si thickness 2.85 mm, with a double Cr layer, for total reflection of light on the first useful surface. WARNING: The X-ray source MUST be used ONLY with the DVT and according to the functions required by DVT . Every use, different in respect to the required one, can cause injury to patients. Each maintenance operation must be performed by personnel authorized by QR S.r.l.

13.6 Important Warning

All the following devices: computer, monitor, printer, mouse, keyboard and every other device connected to the computer of QR-DVT 9000 MUST be according to ISO and/or IEC and/or EN and/or other local regulations. QR Srl is available to give every further explanation. The producer is not responsible for faults and/or malfunctioning of parts and/or components not directly authorized by producer and installed by qualified technical personnel.

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QR-DVT 9000 Technical Specifications

QR-DVT 9000
Dental Volumetric Tomograph

Technical Features (Addendum to User Manual) ---------------------------------------------------------------

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QR-DVT 9000 Technical Specifications

Technical features Scan system 1. 2. 3. Exam area: dento-maxillo-facial district Scan system: single rotation with volumetric acquisition (cone-beam technique) Scan parameters : a) time: 75 77 sec b) X-ray emission time: 36s (50Hz) o 30s (60Hz) c) views number: 360 d) sampling angle: 360 Real view field: a) axial direction: (typ. 130 mm - max. 150 mm) 1 b) crossed direction: (max. 110 mm)2 Gantry aperture (on central axial plane): 510 mm Dimensions: a) width: 1890 mm b) depth: 710 mm c) height: 2000 mm Weight: 360 kg Patient centering: 1 linear vertical laser, 1 point lateral laser

4. 5. 6.

7. 8.

Radiological parameters X-RAY SOURCE

X-ray source Type Manufacturer Model Anode Focal spot Nominal high voltage Thermal accumulation capacitance Anode thermal dissipation capacitance

ARDET CEI OX-110-1 Tungsten (W) 19 1.5 mm IEC 110 kV 30 kJ (40 kHU) 250W (340 HU/sec)

IMD CEI OX-110-5 Tungsten (W) 12 1.5 mm IEC 110 kV 30 kJ (40 kHU) 230W (310 HU/sec)

X-ray source Type Manufacturer Model Anode Focal spot Nominal high voltage Thermal accumulation capacitance Anode thermal dissipation capacitance

LFX1 CEI OX-110-5 Static in Tungsten (W) 12 1.5 mm IEC 110 kV 30 kJ (40 kHU) 230W (310 HU/sec)

LFX1 Toshiba DT-151SB-T Static in Tungsten (W) 16 1.5 mm IEC 110 kV 28 kJ (40 kHU) 256W (379 HU/sec)

X-RAY SOURCE ASSEMBLY 1.1

1 2

Max value corresponding to central axial plane Depending on Z resolution

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QR-DVT 9000 Technical Specifications

X-ray source Type Manufacturer Model Nominal high voltage Max anodic current Nominal electric power3 Loading factors for max energy input4 Wave form Power High voltage Power Filament Inherent filtration

ARDET QR ARDET-110-1 110 kVp 15mA 940 W (110 kVp - 12 mA) Not applicable

IMD QR IMD MA5 110 kVp 15mA 940 W (110 kVp - 12 mA) Not applicable

LFX1 QR LFX1 110 kVp 15mA 940 W (110 kVp - 12 mA) Not applicable

Pulsed beam (10 ms pulses @ Pulsed beam (10 ms pulses @ Pulsed beam (10 ms pulses @ 50 Hz, 8,3 ms @ 60 Hz) 50 Hz, 8,3 ms @ 60 Hz) 50 Hz, 8,3 ms @ 60 Hz) 230 V ~ (10%), 50 Hz o 60Hz 230 V ~ (10%), 50 Hz o 60Hz 230 V ~ (10%), 50 Hz o 60Hz (1%), 8 A (1%), 6 A (1%), 10 A 45-65 V~, 50 Hz o 60Hz (1%), 45-65 V~, 50 Hz o 60Hz (1%), 45-65 V~, 50 Hz o 60Hz (1%), 60 VA 60 VA 60 VA 1.8 mm Al 1.8 mm Al 1,0 mm (con CEI OX-110-5), 1.3 mm (con TOSHIBA DF151SB-T) Al equivalent 23 kg 320x250x140 mm Class I Type B

Weight Dimensions Classification

27.5 kg 335 x 252 x 135 mm Class I Type B

24 kg 335 x 252 x 135 mm Class I Type B

X-RAY SYSTEM 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. 11. Additional filtration: mirror/filter NIM S-1-7 (3.2 mm Al) Total filtration: 5.0 mm Al (ARDET TUBE), 8.0 mm Al (IMD TUBE), 7.2 mm Al (LFX1 with CEI tube) or 7.5 mm (LFX1 with TOSHIBA tube) X-ray beam limiter: NIM L-1-7 (1.5 mm Fe + 2 mm Pb), 6 VDC - 100 mA, with laser luminous indicator Reference axis: connection line between focus and detector center (orthogonal at the last one) Focal spot to image detector distance : 950 mm (ARDET TUBE) or 935 mm (IMD LFX1) Focal spot to rotation center distance: 677 mm (ARDET TUBE) or 662 mm (IMD LFX1) Focal spot to skin distance (minimum): 430 mm Beam dimensions: cone aperture 14 Typical emission: 100 mAs/exam5 Patient dose: 6 mSv/exam6 Stray radiation: 1 Gy/exam7

Detector and connected systems 1. 2. 3. System: IB 9 with solid state sensor (CCD) 2/3 Quantum efficiency: 60 % Acquisition matrix: 512 x 512 o 640 x 480

1.1 According to IEC 60601-2-7, 6.8.2 According to IEC 60601-1-3, 29.204.2 - the x-ray source has loading factors, predefined and monitored by computer, then the measure of stray radiation will be performed conditions of normal use 5 Exam on head FDA phantom 6 Max value on central profile of head FDA phantom 7 Indicative value at 2 meters from device center on anterior side
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QR-DVT 9000 Technical Specifications

14. Laser
AP Laser Line Laser diode output power Wavelength Beam divergence Optical power on working plane LL Laser Point Laser diode output power Wavelength Beam divergence Optical power on working plane Workstation 1. 2. 3. 4. 5. 6. 7. 8. 9. 10. Processing system: CPU Intel Pentium II - 233 MHz or higher RAM : EXPERT or SCAN TM = 256 MB, PROFESSIONAL or STANDARD = 128 MB, BASIC = 32MB Hard disk: 4 GB or higher Image reconstruction matrix : 512 x 512 Scout-view matrix: 512 x 512 o 640 x 480 Voxel dimensions in reconstructed image: 0.25 x 0.25 x 0.3 (x 1, x 2)8 mm Primary reconstruction time (typical): 600 sec per 30 slices Possible deferred primary reconstructions Secondary reconstructions time : real time Operating system: Windows NT 4.0 / Windows 9x (optional for secondary workstations) 2.5 mW 630-680 nm 1.6 mrad < 1 mW 2.5 mW 630-680 nm 1.6 mrad < 1 mW

Images display 1. Image display matrix: 512 x 512 2. Gray scale display : 256 levels 3. Display window : regulation level and width 4. Display monitor: 17 colors, 1280 x 1024 pixel, 16 Millions colors 5. Display modes: a) cine o step display of raw data b) axial images: 3 per time with correspondent scout-view c) paraxial images: single or sequential with correspondent reference axial image d) panoramic images: 3 per time with correspondent reference axial image e) 3D display: possible modification of point of view f) setup parameters paraxial, panoramic and 3D reconstructions g) for all images: possible display with variable enhancing h) possible extraction of images by a sequence of paraxials in zoomx2 mode i) comments display j) insertion of manual markers with automatic display on all sections 6. Procedures of image analysis: a) distances measure: direct or on densitometric profile b) densitometric profile 7. Images print: standard parallel interface for printer or digital interface for radiological laser printer (digital protocol 3M-P831) (option) Performance 1. 1.1
8 9

Spatial resolution: 1 mm (FWHM-LSF)9

According to the resolution chosen in crossed direction Width at middle height of Line Spread Function
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QR-DVT 9000 Technical Specifications

2.

Geometrical accuracy: 0.8 - 1 % for measures on axial or paraxial planes, 2.2 % for measures on transaxial planes, evaluated with reference to different reconstruction modes and different spatial orientations of examined object

Patient bed 1. 2. 3. 4. 5. 6. Safety 1. 2. According to CE regulation Special devices: a) smart-beam10 b) safe-scan11 Type: longitudinal and vertical movement Command: 2 little keyboards on sides of the gantry for vertical motorized check Table height: from 770 to 970 mm Table width: 600 mm Table length: 1715 + 450 mm Weight: 90 kg

Other information 230 V ( 10%) 60 Hz ( 1%) 5 A (normal conditions) / 10 A (peak of 0.1 second) Electrical output: Patient Table power (60 V - 5 A) Line conditioner (stabilizer) Electro-dynamic variable transformer (variac) mains stabilizing unit Input 230 20% 50/60 Hz Output 230 2% 50/60 Hz Power a 2500VA Operating temperature: 15 35 Operating humidity: 20 80 % (not condensing) Transport and storing temp.: 0 50 Transport and storing humidity: 20 80 % (not condensing) Absorbed power:

As regard the type of protection against electrical dangers, the device belongs at Class I. As regard the type of protection against direct and indirect contacts, the device belongs at Type B. As regard the type of protection against la water insertion, the device is a common machine, with enclosure not protected against the water entry, not protected against the dripping and against spray, not protected against immersion. The device is supplied not sterile and it must not be subjected to sterilization and disinfecting processes. As regard the employing safety degree with an anesthetic mix, inflammable with air, oxygen, or Na protoxide, the device isnt adapt to be used with these substances; the device doesnt belong to category AP (that is, it isnt protected against mixing of inflammable anesthetic and air) and it doesnt belong to category APG (that is, it isnt protected against fire sources in a mixing of inflammable anesthetic and oxygen or Na protoxide).

1.1
10

AEC system (Automatic Exposure Control), which modulates the X-ray beam intensity according to the dimensions of crossed tissues 11 Device which stops automatically the X-ray emission in case of stop of the processing system
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QR-DVT 9000 Technical Specifications

Electromagnetic Compatibility
All components, accessories, spare parts must be approved and supplied by QR S.r.l. Particularly, the connection cables must be ONLY the following:
Interface cable 37P cod. NT32a RG58 Cable cod. NT33a WARNING! Use of accessories, transducers, and cables other than those specified may result in degraded electromagnetic compatibility performance of this device!

Electromagnetic Emissions IEC 601-1-2 QR-DVT 9000 is suitable for use in specified electromagnetic environment. The purchaser or user of QR-DVT 9000 should assure that it is used in an electromagnetic environment as described below: Emissions Test Compliance Electromagnetic Environment QR-DVT 9000 is suitable for use in domestic Radiated and conducted Class B establishments and in establishments directly RF emissions QR-DVT 9000 connected to the low voltage power supply network which supplies buildings used for domestic CISPR11 purposes. QR-DVT 9000 uses RF energy only for its internal QR-DVT 9000 Group 1 function. Therefore, the RF emission is very low and QR-DVT 9000 not likely to cause any interference in nearby electronic equipment.

CAUTION! QR-DVT 9000 should not be stacked directly on top of other equipment, and other equipment should not be stacked on top of QR-DVT 9000. If stacking is necessary, observe QR-DVT 9000 to verify normal operation in the stacked configuration in which it will be used!

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QR-DVT 9000 Technical Specifications

Electromagnetic Immunity IEC 601-1-2 QR-DVT 9000 is suitable for use in specified electromagnetic environment. The purchaser or user of QR-DVT 9000 should assure that it is used in an electromagnetic environment as described below: Immunity Test IEC 601-1-2 Compliance Electromagnetic Environment Test Level Level Floors are wood, concrete , or ceramic Electrostatic tile, or floors are covered with synthetic discharge (ESD) 6 kV contact 6 kV contact material and the relative humidity is at IEC 1000-4-2 8 kV air 8 kV air least 50 percent. Non-life-supporting Field strengths from fixed RF transmitters Radiated RF are less then 3 V/m, as determined by an IEC 1000-4-3 equipment electromagnetic site survey*. Portable and mobile RF communications equipment are 3 V/m 3 V/m 80 MHz to 1 GHz used no closer to any part of QR-DVT 9000, including cables, than the distance Life-supporting listed in the Recommended Separation equipment Distances Table. For portable RF sources, the distance can be estimated using 3 V/m Equation A or B, according to the 80 MHz to 800 MHz frequency of the transmitter. Interference and 10 V/m may occur in the vicinity of equipment 800 MHz to 2 GHz marked with the following symbol: Conducted RF IEC 1000-4-6 Electrical transient/burst IEC 1000-4-4 Surge IEC 1000-4-5 Voltage dips, short interruptions and voltage variations on power supply input lines IEC 1000-4-11 All equipment 3V 150 kHz to 80 MHz fast 2 kV for power supply lines 1 kV for input/output lines > 3 m 1 kV differential mode 2 kV common mode 0 % Un for 0.5 cycle 40 % Un for 5 cycles 70 % Un for 25 cycles 0 % Un for 5 sec 3V 2 kV Mains power quality is that of a typical commercial and/or hospital environment. 1 kV 1 kV Mains power quality is that of a typical commercial and/or hospital environment. 2 kV 0 % Un for 0.5 cycle 40 % Un for 5 cycles 70 % Un for 25 cycles 0 % Un for 5 sec

Mains power quality is that of a typical commercial and/or hospital environment. If the user of QR-DVT 9000 requires clinical utility during power mains interruptions, it is recommended that QRDVT 9000 be powered from an uninterruptible power supply. Power frequency magnetic fields are at Power frequency levels characteristic of a typical location in (50/60 Hz) magnetic 10 A/m N.A. a typical commercial and/or hospital field environment. IEC 1000-4-8 * Field strengths from fixed transmitters, such as cellular phone and land mobile base stations, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be estimated accurately. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be performed. If the measured field strength exceeds the RF compliance level above, observe QR-DVT 9000 to verify normal operation in each use location. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating QR-DVT 9000, shielding the room in which QR-DVT 9000 is used, and/or adding filters to signal and/or power lines. Note: These are guidelines. Actual conditions may vary.

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QR-DVT 9000 Technical Specifications

Recommended Separation Distances IEC 601-1-2

RF Source

Typical Rated Power (watts)

DISTANCE (meters)

microcellular phone, CT1, CT2, CT3 10 mW 0.3 m DECT cellular phone, wireless information technology 250 mW 2m equipment (modems, LANs) cellular phone, hand-held (USA) 600 mW 2m cellular phone, hand-held (e.g. GSM and NMT, Europe; 2W 4m DECS 1800) 8W 7m walkie-talkie (rescue, police, fire, maintenance) 5W 3m cellular phone, bag 16 W 10 m mobile radio (rescue, police, fire) 100 W 30 m For transmitters using frequencies below 800 MHz, the distance can be estimated using Equation A: d = 0.17 P (Equation A)

For transmitters using frequencies between 800 MHz and 2 GHz, the distance can be estimated using Equation B: d = 2.33 P (Equation B)

where P is the power rating of the transmitter in watts (W) according to the transmitter manufacturer.

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QR-DVT 9000 Technical Specifications

14.1 QR-DVT 9000 14.2 Technical Service

The model QR-DVT 9000 is manufactured and distributed by:

QR s.r.l. Via Silvestrini, 20 37135 Verona ITALIA Phone: ++39 045 8202727 Fax: ++39 045 8203040 e-mail: info@qrverona.it

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