new tom 9000 user manual

NewTomMod. QR-DVT 9000

Dental Volumetric Tomograph

USER MANUALSoftware Version 3.4x

Rev. 15(02/01/2006)

CONTENTS1. About this manual ___________________________________________________________ 1

1.1 WARNING ____________________________________________________________________21.1.1 X-Ray Warning_____________________________________________________________________ 21.1.2 LASER WARNING _________________________________________________________________ 3

2. Device introduction __________________________________________________________ 42.1 Introduction ___________________________________________________________________42.2 Working principles _____________________________________________________________52.3 Composition ___________________________________________________________________52.4 Software configuration __________________________________________________________6

3. Getting started... _____________________________________________________________ 83.1 Device start-up _________________________________________________________________83.2 General description of commands _________________________________________________83.3 Device shutdown ______________________________________________________________11

4. Exam Execution ____________________________________________________________ 124.1 Introduction __________________________________________________________________124.2 Daily Check___________________________________________________________________124.3 Procedure for exam execution ___________________________________________________124.4 Exam procedure summary scheme _______________________________________________164.5 Menu ________________________________________________________________________16

4.5.1 File Menu ________________________________________________________________________ 164.5.2 Scan Menu _______________________________________________________________________ 174.5.3 Primary Reconstruction Menu ________________________________________________________ 174.5.4 View Menu _______________________________________________________________________ 184.5.5 Tool Menu _______________________________________________________________________ 184.5.6 About Menu ______________________________________________________________________ 18

5. Raw Data and primary reconstruction __________________________________________ 195.1 Introduction __________________________________________________________________195.2 Primary reconstruction _________________________________________________________195.3 Deferred primary reconstructions ________________________________________________205.4 Menu ________________________________________________________________________21

5.4.1 File Menu ________________________________________________________________________ 215.4.2 Edit Menu ________________________________________________________________________ 215.4.3 Primary Reconstruction Menu ________________________________________________________ 215.4.4 Scan Movie Menu __________________________________________________________________ 215.4.5 Toolbar Menu _____________________________________________________________________ 225.4.6 Window Menu ____________________________________________________________________ 225.4.7 About Menu ______________________________________________________________________ 22

6. Studies and secondary reconstructions __________________________________________ 236.1 Secondary reconstruction _______________________________________________________23

6.1.1 Setup of the visualization window _____________________________________________________ 236.1.2 Transaxial views ___________________________________________________________________ 246.1.3 Panoramic views ___________________________________________________________________ 26

6.1.4 3D Views ________________________________________________________________________ 286.2 Utility________________________________________________________________________30

6.2.1 Brightness and Contrast _____________________________________________________________ 306.2.2 Marker___________________________________________________________________________ 31

6.3 Graphic settings setup __________________________________________________________316.4 Menu ________________________________________________________________________33

6.4.1 File Menu ________________________________________________________________________ 336.4.2 Edit Menu _______________________________________________________________________ 346.4.3 Secondary Reconstruction Menu ______________________________________________________ 346.4.4 Report Menu _____________________________________________________________________ 356.4.5 Utility Menu______________________________________________________________________ 356.4.6 Images Menu______________________________________________________________________ 376.4.7 Toolbar Menu _____________________________________________________________________ 376.4.8 Window Menu ____________________________________________________________________ 386.4.9 About Menu ______________________________________________________________________ 38

7. Report page layout __________________________________________________________ 397.1 Creating a report page layout____________________________________________________397.2 Opening a report layout ________________________________________________________407.3 Deleting a report layout_________________________________________________________41

8. Creating and modifying a report _______________________________________________ 428.1 Report Header Setup ___________________________________________________________428.2 Creating a new report __________________________________________________________438.3 Changing an existing report _____________________________________________________458.4 Showing an existing report ______________________________________________________458.5 Report Page Notes _____________________________________________________________458.6 Report Attached Letter _________________________________________________________458.7 Print Enhancement ____________________________________________________________458.8 Report Menu__________________________________________________________________47

8.8.1 File Menu ________________________________________________________________________ 478.8.2 Edit Menu ________________________________________________________________________ 478.8.3 Toolbar Menu _____________________________________________________________________ 488.8.4 Window Menu ____________________________________________________________________ 488.8.5 About Menu ______________________________________________________________________ 488.8.6 Pop-Up Menu_____________________________________________________________________ 48

9. Documents managment ______________________________________________________ 499.1 Import/Export ________________________________________________________________49

9.1.1 Import/Export drive setup (Export Drive)________________________________________________ 499.1.2 Export ___________________________________________________________________________ 509.1.3 Import ___________________________________________________________________________ 50

9.2 Deleting documents ____________________________________________________________509.2.1 Deleting documents from work drive ___________________________________________________ 509.2.2 Deleting documents from Export Drive _________________________________________________ 50

9.3 Exporting axial images (OPTIONAL) _____________________________________________519.3.1 Exporting axial images as Bitmap______________________________________________________ 519.3.2 Exporting axial images as DICOM _____________________________________________________ 51

10. Glossary _________________________________________________________________ 52

11. Service __________________________________________________________________ 5311.1 Introduction __________________________________________________________________5311.2 Compliance ___________________________________________________________________5311.3 Device modifications ___________________________________________________________5411.4 Warnings_____________________________________________________________________5411.5 Maintenance and cleaning_______________________________________________________55

11.5.1 General requirements _______________________________________________________________ 5511.5.2 Preventive maintenance _____________________________________________________________ 5511.5.3 Cleaning _________________________________________________________________________ 5511.5.4 Disposal _________________________________________________________________________ 56

11.6 Quality Assurance (QA) ________________________________________________________5611.7 Check List maintenance intervals ________________________________________________5811.8 Error messages________________________________________________________________5911.9 Log Files visualization __________________________________________________________73

11.9.1 Error Log File visualization __________________________________________________________ 7311.9.2 Daily Check Log File visualization_____________________________________________________ 73

11.10 Suggestions for shipment, storage, preservation and installation _____________________7312. Identification and marking__________________________________________________ 75

13. Safety ______________________________________________________________ 8113.1 General warnings______________________________________________________________8113.2 Device shutdown ______________________________________________________________8113.3 Emergency shutdown __________________________________________________________8213.4 Guide lines for patients and operators safety _______________________________________8213.5 Safety devices _________________________________________________________________8413.6 Important Warning _____________________________________________________________85

1. About this manualThis 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 orabout the same manual:

text format Example meaningbold italic Primary Reconstruction Menu command<text> <Would you like start the scan?> software messagesunderlined Cancel push-button commandsitalic primary reconstruction glossary wordCAPITAL LETTER ENTER keyboard command

THIS MANUAL WAS ORIGINALLY WRITTEN IN THE ITALIAN LANGUAGE

1.1 WARNING1.1.1 X-Ray Warning

WARNING:

The Tomograph mod. QR-DVT 9000 is a radiological device and, for this reason, thepatient and the operators are exposed to risk resulting from ionizing radiations. It

must be used in compliance with safety regulations, required by currentradioprotection normative, in accordance with local laws.

The operator, however, must not remain near QR-DVT 9000, when the device is inemission state.

or

Warning Label on the control panel containing the main power

WARNING: This x-ray unit may be dangerous topatient and operator unless safe exposurefactors and operating instructions are observed.

Page 2

switch

1.1.2 LASER WARNINGThe 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

2. Device introduction

2.1 IntroductionQR-DVT 9000 is a Computerized Tomograph dedicated to imaging of dental arcades (Dental Scan), workingwith "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 thebidimensional detector, executes a complete rotation around the patient’s head, acquiring all necessary datafor 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 of0.3, 1 o 2 mm; as selected by operator) of the rebuilt volume, inclined according to an angle chosen by theoperator. Secondary reconstructions allow the operator to obtain all other interest "views" for study of theexamined region. In particular the images we can obtain are:

• transaxial views: bidimensional reconstructions on perpendicular planes with reference to the ones ofthe axial views. Single images could be obtained or sequences of following viewsorthogonal to a line drawn by the operator;

• panoramic views: these are bidimensional reconstructions always on perpendicular planes withreference 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 profilemeasurements (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 ofraw data more studies can be obtained, getting, e.g., started from primary reconstructions with differentinclinations of the axial sections.

All the rebuilt images, with the possible measurements on them reported, can be printed on transparency orpaper support, or can be exported, cancelled and successfully relocated to any memory support.

2.2 Working principlesThe "cone-beam" technics introduces an innovation in modes of scan and volumetric reconstruction ofComputerized Tomographs.In traditional Computerized Tomographs, the volume is rebuilt through the scan and following reconstructionof a series of following axial "slices", obtained by shifting the patient table between two followingacquirements. In Volumetric Computerized Tomographs type "Spiral" (Spiral-CT) the examination table isshifted with continuity simultaneously at continue rotation of sorce-detectors system, increasing the speed ofthe 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 volumetricreconstruction. 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 inthe 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 axialreconstructions and data reformat;

• through the use of sophisticated technology the total scan speed is controlled through the electronicprogram rather than the radiogen tube power;

• under same conditions of total scan time: less requirements in regards to the source/tube assemblypower and scan mechanics, with constructive and maintenance advantages.

2.3 Composition• Scanner• Motor-driven patient table• Workstation• Software composed by:

a) hardware management programb) program for primary volumetric reconstructionc) program for secondary multiplane reconstructionsd) program for 3D reconstructionse) integrate archive patients-exams-images

• Standard accessoriesa) calibration check phantomb) head-holderc) User Manuald) Line conditioner (mains stabilizer)

The "scanner" is completely controlled by the "workstation" computer. The only manual commands on thescanner are two push button controls that are for the patient examination table vertical movement, two pushbutton controls for the motor-driven system of the X-beam diaphragm opening, and the push button for start-up of the laying optical system (at automatic shutdown). Also, the emergency switch is present on thetop/front of the scanner.

2.4 Software configurationThe QR-DVT 9000 software is available with more configurations to allow different use based on the userrequirements.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 andsecondary 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 study’sutility . Allows to create and print reports. With this configuration it is not possible to generate new studiesfrom 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 othersoftware configuration. It also allows the user to trace on these reports distances and angles and tomodify 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 numberis reported inside the About box reported below).

The software configuration and architecture can be showed by selecting About ⇒⇒⇒⇒ About. The followingwindow will appear:

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 alocal network.

SoftwareConfiguration

SoftwareArchitecture

Workstation ID

System RAMmemory

RawData Work Drive

Study Work Drive

Report Work Drive

Software Version

3. Getting started...

3.1 Device start-upTo 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 commandsThe software window have the utilities shown in the following figure.The software user-interface (ensemble of modes of information insert and display, and of commandsselection) has the standard features of Windows 95 and Windows NT applications (see 4.0 and higher).

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)

caption bar

menu bartool bar

work area

status bar

Windows bar

• 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 (enabledor 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 sizeclose 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 barsappear on its right and lower edge, allowing "to scroll" the window through the object. The scrolling can beobtained in three ways:

scroll bar

• bring the mouse pointer on the scroll cursor, move the pointer up and down holding down mouse left pushbutton (cursor carrying away)

• bring the mouse pointer on one of the scroll arrows (placed at the scroll bar edges) and press (insequence 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 thearrow

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 themouse 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 normalpointer to a window stretching pointer and the mouse left push button is held down, shifting the same mouseup 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 normalpointer 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 normalpointer to a window diagonal rescaling pointer and the mouse left push button is held down, shifting themouse, the windows’ horizontal and vertical dimension are modified simultaneously

scrolling arrow

scrolling cursor

• if the window contains an image and has a dimension smaller than that same image, by means of the scrollcursors, 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 thewindow’s edge will be black.

5. if many windows are present on the monitor, an "active" window is defined, on which the eventualcommands work. The "active" window is characterized by a color on the header bar different thanthe other windows and can be modified through the Windows Control Panel starting definitions. Awindow is set "active" by simply placing the mouse pointer on it and clicking the mouse left pushbutton.

6. the commands are of two types: push button or menu commands. The push button commands are all setby placing the mouse pointer on the push button and "clicking" with the mouse left push button. In regards tothe push button commands displayed on the second line of application base-window, by placing the mousepointer, 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 bymouse.

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 theMenu 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 thecommand, the mouse pointer will be limited in the active window up to the procedure, that isexecuting, won’t be finished or cancelled.Some commands are active on some kind of images instead of some others. This prevent to operatewith 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 activatedin 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 isshowed 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 bymouse (point and click) or by keyboard (arrows). The chosen option can be activated by a confirmation pushbutton 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 andpointer 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. Thechoice can be performed by mouse or scrolling the list with keyboard vertical arrows and pressing ENTER orthe confirmation push button.

3.3 Device shutdownTo 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 commandfrom 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 off7. 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!

4. Exam Execution

4.1 IntroductionWARNING !!!

The scan execution is only possible from a station directly connected with the scanner and with theEXPERT software configuration installed

The exam (scan) is the acquirement procedure of the radiological projections obtained during the x-raysource-detector system rotation around the patient head. The ensemble of these projections, acquired indigital 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 CheckThis a calibration which must be performed at least once a day. The relative command is: Daily Check ofScan Menu; the software will show a window with the list of the tests. By clicking on the Start button thesoftware will order the positioning of the QA phantom on the gantry. Use the pointing laser lights to positionthe phantom in the correct way. By Clicking the OK button the device will perform the procedureautomatically in a few seconds time. The only conditions, which must be observed, is that the machine mustbe 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 Closebutton. The result of the daily check, with data and time of execution, will be store in a log file which can beviewed by selecting Tools ⇒ Log File... and choosing “DailyCheck” (see Chap. “11.9.2 daily check log file”).

4.3 Procedure for exam executionBefore starting an exam verify if the Daily Check has been executed: if not, it is advised that the usernperform the procedure (see Chap. “4.2 daily check”).

WARNINGNewTom 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 examraw 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 beunconsidered.

Place the patient on the patient table. The patient head must be placed horizontally within the "gantry" andcentered with reference to the laser indicators.

To obtain the correct positioning, the patient is laid on the examination table in the supine position, with headsupported by the special headrest. The patient table can be moved in two directions: horizontally, throughmanual 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 thesize of the X beam of the patient face.

CAUTIONUse 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:

Left Control Keyboard Right Control Keyboard

Gantry

Vertical line Laser aperture

Right Lateral point Laser apertureLeft Lateral point Laser aperture

1. the examination table is pushed towards the gantry, so that the patient’s head is brought about in the examposition;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 centralposition;4. the patient table is adjusted vertically (with the motor driven command on the control keyboard) andhorizontally (manually) so that the second pointing light (marking the side of the patient's face) resides in thecenter of the region of interest.

WARNING:Warn the patient to close their eyes, during the positioning, to avoid looking directly at the laserbeam!!!Control the patient movements during the positioning and warn him of table movement, to avoidpotential 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 avoidunnecessary exposures.If the exam is for only the lower area of the patient head, to avoid any useless exposure of delicateorgans (for example, eyes), use the command “Beam Limiter” on the control keyboard on the gantryside: 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 ofthe 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 machineautomatically performs at 0º and 90º to allow the verification and the eventual adjustment of the patient headposition. These two views also allows the device to evaluate head dimensions and, in consequently, toautomatically 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 viewexecution 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 planefor 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 formedfrom 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:

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 isn’t positioned correctly. Be careful during positioning of the initialcentering 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 radiologicalparameters are showed: kV and average mAs. Then the message: <The scan is starting.> appears andconfirmation is required by entering YES.

It is necessary, at this point, to advise the patient to remain motionless for about 70 seconds, beforegiving the O.K.

At the beginning of the scan, an acoustic signal will be heard (for at least 5 seconds). It indicates thestart of X-Ray emission. During the whole scanning, the X-Ray emission will be signalled by the lampplaced 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 arerecorded in progress and their combining forms the so called exam raw data. The radiological projectiondisplay in real time enables the operator to observe each view, for example showing eventual patientmovements.

The exam can be stopped at any moment, with a "click" on the Cancel push button on the display window ofthe 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 newdocument and asks the user if he wants to perform a check scan (generating a temporary axial view) tolocate eventual problems (patient movements, not satisfactory images, etc.) and to repeat, if necessary, theexam.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. “5raw data and primary reconstruction”).

4.4 Exam procedure summary schemecommand

1 Once a day the daily calibration must beperformed

Scan ⇒⇒⇒⇒ Daily Check

2 Start the exam procedure; Scan ⇒⇒⇒⇒ New Scan

3 Insert the patient data; ---

4 Place the patient on the patient table; ---

5 Check the patient positioning; ---

6 Exam execution; ---

4.5 MenuThe following tables show the commands description of the software’s main menu.

4.5.1 File Menu

Open Open a document (raw data , study or report) from thework drive

Import Import a document. (see chapter “9.1 import/export”)

Export Export a document. (see chapter “9.1 import/export”)Delete from Work Drive Remove a document from the work drive. (see chapter

“9.2 deleting document”)Delete from Export Drive Remove a document from Import/Export drive. (see

chapter “9.2 deleting document”)Graphic settings setup Change the graphic settings of the image overlays. (see

chapter “6.3 graphic settings setup”)Report Pages Layout Setup⇒⇒⇒⇒ New

Create a new report page layout. (see chapter “7 reportpage layout”)

Report Pages Layout Setup⇒⇒⇒⇒ Open

Change an existing report page layout. (see chapter “7report page layout”)

Report Pages Layout Setup⇒⇒⇒⇒ Delete

Remove a report page layout. (see chapter “7 reportpage layout”)

Report Attached LetterSetup...

Change the report attached letter

Report Header Setup... Change the report header (see chapter “8.1reportheader setup”)

Print Setup... Change the printer and printing optionsPrint Enhancement Setup... Change the printing filters (see chapter “8.7 print

enhancement”)Export Drive Setup Set the Import/Export drive. (see chapter “9.1

import/export”)Recent file Keep track of the four most recently used filesExit Exit from the application

4.5.2 Scan Menu

Daily Check Perform the Daily Check test (see chapter “4.2 dailycheck”)

New Scan Perform a new scan. (see chapter “4.3 procedure forexam execution”)

Phantom Scan Start the procedure for phantom QA acquisition (seechapter “11.6 quality assurance (qa)”)

4.5.3 Primary Reconstruction Menu

Start Night Reconstruction Show the list of the planned night reconstructions. (seechapter “5.3 deferred primary reconstructions”)

Phantom Analysis Perform the analysis of the last phantom’s scan. (seechapter “11.6 quality assurance (qa)”)

Phantom Results Show the results of the phantom analysis. (see chapter

“11.6 quality assurance (qa)”)

4.5.4 View Menu

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

4.5.5 Tool Menu

Fault Restore Enable the acquisition menu after a hardware errorLog File 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, systemconfiguration, disk space and available memory

5. Raw Data and primary reconstruction

5.1 IntroductionRaw data of an exam, needs a processing to be able giving images proper to display the studied anatomiczone.This process is named primary reconstruction, and allows to rebuild all axial sections of scan zone. They arethe 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 theeventual secondary reconstructions) is a study.On a same scan (raw data set) many primary reconstructions can be performed, obtaining, therefore, manystudies.

5.2 Primary reconstructionATTENTION !!!

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 ofthe 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 PrimaryReconstruction 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 90º 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 isbetween three possibilities: 0.3, 1, and 2 mm. Also, the “Small Field” option may be selected. This optionallows axial images which are 10% larger than standard images to be displayed on monitor. On the otherhand, with this option the maximum useful diameter drops down from 150 to 130 mm. Once the wantedoptions 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 theScout-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 positionof the starting point and a second time when it is in position of the end point. It is important toemphasize that the segment does not necessarily have to be horizontal, but can be inclined (forexample, along the mandibular edge);• at this point the software draws a second line parallel to the first, which can be moved in the verticaldirection through the mouse by, positioning the mouse pointer on the square (target) placed in the

middle of the line, left clicking on this target while keeping the mouse button pressed. In the Scout-Viewtop-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 theinclination 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;

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 windowstops 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 onthe 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 reconstructionsThe 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 theprimary reconstructions of exams later at night rather than during business hours when the scanner may bein constant use.

To execute a deferred primary reconstruction follow the procedure reported below:

first segment

secondsegment

targets

numberof axials

1. Perform the procedure described in chapter 5.2 primary reconstruction, with the only exception that, atpoint 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 theprocedure 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 ⇒⇒⇒⇒ StartNight Reconstruction. The list of the programmed reconstructions will appear: choosing the Start buttonwill start the reconstruction, while selecting an item and clicking on the Remove button will allow theremoval 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 reconstructionprocess to stop. However the software keeps the reconstruction program that it have not performed.

5.4 MenuIn the following tables are reported the commands description of the raw data’s menu.

5.4.1 File Menu

Close Close the active raw data

Save Save the active raw data

5.4.2 Edit Menu

Patient Data Show the patient data

5.4.3 Primary Reconstruction Menu

Check Scan Start the Check Scan procedurePrimary Reconstruction Start the primary reconstruction procedure (see chapter

“5.2 primary reconstruction”)

5.4.4 Scan Movie Menu

First Image Show the first acquired image

Last Image Show the last acquired image

Previous Image Show the previous image

Next Image Show the next image

-90 Show the image to -90 from the current position

+90 Show the image to +90 from the current position

Movie ⇒⇒⇒⇒ Forward Start the scan “movie” forward

Movie ⇒⇒⇒⇒ Stop Stop the scan “movie”

Movie ⇒⇒⇒⇒ Backward Start the scan “movie” backward

5.4.5 Toolbar Menu

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

5.4.6 Window Menu

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

5.4.7 About Menu


6. Studies and secondary reconstructions

6.1 Secondary reconstructionEvery time a study is active, it is possible to execute reconstructions of new images called secondaryreconstructions. The study can be a newer one (see chapter “5 raw data and primary reconstruction”) or itcan be opened from the studies archive.The secondary reconstructions allow, from a "set" of axial images, new images which present eitherbidimensional sections of the examined volume (transaxial and panoramic views) or tridimensionalrepresentations 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 windowThe first time a study is shown ( and until the study has not been saved), the “Visualization Window” dialog-box appears.

This dialog-box defines the visualization window of the secondary images, specifically, the 256 visible levelsof 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 showvarying 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 itshows 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 thereforethe axial will have a lower contrast; to modify the scale move the cursors placed near the gray scale.

It is possible to customize three windows that can be used subsequently. To do this follow the procedurereported 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 showthe 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 viewsThe transaxial views are images of sections perpendicular to the plane of the axial views. They can beobtained in two ways: single images or sequences. In both cases, to locate the section (or sections), it isnecessary to refer to an axial image called reference axial view. To do this, simply activate (by clicking themouse) a window containing an axial image.To generate a single transaxial view, it is necessary to use the command Single Transaxial Section fromthe Secondary Reconstruction menu and to place a segment on the chosen axial image to locate thesection of interest (the line represents the intersection between the two planes: axial and paraxial). The lineis 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:

In the left frame the reference axial view is displayed, with indication of the chosen segment for transaxialreconstruction, and in the other frame, the rebuilt transaxial view is displayed. The limits in vertical directionof 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 SecondaryReconstruction Menu), it is necessary to trace on the reference axial view a broken line (that is to say aseries of connected line segments) to accomplish this "click" the left mouse button in the correspondingpositions that will form the line segments; to remove one or more points from the broken line pushBACKSPACE (<-) on the keyboard. Clicking on the right mouse button ends the broken line. The softwarebuilds 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 ofsegments orthogonal at the broken line traced by user while the right side of the window shows the sequenceof correspondent transaxial frames, each numbered with reference to the reference axial view.

The Transaxials Setup command (Secondary Reconstruction Menu) displays a window (AnalysisSetup), in which the sections features (which can be modified) are reported: pushing Save allows saving themodifications, pushing Exit closes the window, discarding the changes.

• 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 pointsof 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 newimage created from the dragged segment, otherwise if the image is a sequence of transaxials sections thefollowing window appears:

Choosing Modify Current Image the new image created from the dragged broken line will replace the oldimage, otherwise selecting Create New Image the software will generate a new image, keeping the oldimage.

Modify Current Image uses the setup values (Width e Step) of the image that is being modified while CreateNew 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 usingparabolic line.

It is possible to have a full screen visualization of the transaxial image by the command Coronal View of theWindow menu.

6.1.3 Panoramic viewsThe panoramic views are images of sections perpendicular to the axial planes, calculated along parabolicarches located by the user in correspondence with dental regions.After choosing a reference axial view, it is necessary to activate the command Panoramics (SecondaryReconstruction Menu). As in the case of transaxial images sequence, the broken line which represents theintersection of the axial view with the panoramic view to rebuild, is traced using the mouse. The result of thereconstruction is displayed on the monitor in the following way:

The command Panoramics Setup (Secondary Reconstruction Menu) displays a window (AnalysisSetup), in which the sections features (which can be modified) are reported: pressing Save allows the savingof 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 havebeen 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.

2. From the menu Secondary Reconstruction select the Drag command (the software will show a yellowtarget 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 oldimage, otherwise selecting Create New Image the software will generate a new image, keeping the oldimage.

Modify Current Image uses the setup values (Width e Step) of the image that is being modified while CreateNew 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 aparabolic 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 ofthe object token from an observer placed at a specific distance.

After a reference axial view has been activated select 3D command from the Secondary Reconstructionmenu; 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 releasingthe push button at desired position. The following window will appear :

The window shows a preview with low resolution of the 3D image. That preview image is updated every timeyou 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 asbone tissue from the 3D reconstruction algorithm. These parameters can be varied to optimize the 3Drepresentation;

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 thewindow 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 selectedSecondary Reconstruction ⇒⇒⇒⇒ Drag instead of Secondary Reconstruction ⇒⇒⇒⇒ 3D).

Exit will close the window without discarding the changes.

6.2 Utility

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

The first set of arrows, on the upper left, adjusts the brightness; the second set of arrows adjusts thecontrast.

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 representationof correspondence between gray levels and image numerical values. Contrast variations will be representedby 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 theimage displaying. The numerical values contents remain unchanged.

Choosing OK the following window will appear:

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

6.2.2 MarkerThe Marker is a color graphic overlay that you can trace on axials, cross sections and panoramics (withthickness less than 1 mm). The software will place it on every images that cross the traced line (except 3DViews).

The typical usage is a highlight, in the panoramic view, along the mandibular channel to help its identificationon cross sections.

For more information, see the chapter 6.4.5 utility menu.

6.3 Graphic settings setupThe overlays added to the images of a study or report (angles, distances, lines, strings and markers) havesome graphic attributes like color, font type, background type etc. These attributes can be modified by theuser 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 thesingle attributes of each item ( with the addition of the transparency flag applicable to the background of thefont). Each attribute button is enabled or disabled in reference to the item selected. The list of attributescontains:

• 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:

a) select the item to modifyb) push the Change button of the attribute to modifyc) in the window that will appear do the changesd) Confirm will close the windowe) select the OK button

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

With the Overlay Color Conversion (B/W Printer Only) option, it’s possible to set the kind of color conversionthat 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 printobjects and references;

The ‘Report Overlay Width‘ option will change the width of the overlay lines on the report.

6.4 MenuIn the following tables are reported the command descriptions of the study’s menu.All the commands to trace a segment, a broken line, a ROI etc. start by pressing the left mouse button andfinishes 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 (<-) buttonon the keyboard.

6.4.1 File Menu

Save Save the active study (if a report is opened it saves thereport)

Save Image Save the active image of the study as a bitmap fileClose Close the active study (if a report is opened it closes the

report)Graphic settings setup Change the graphics properties of overlays (see chapter

“6.3 graphic settings setup”)Report Pages Layout Setup⇒⇒⇒⇒ New



Open an existing report page layout. (see chapter “7report page layout”)


Delete a report page layout. (see chapter “7 reportpage layout”)

Report Attached LetterSetup...

Modify the default report attached letter

Report Header Setup... Change the report header (see chapter “8.1 reportheader setup”)

Print Setup... Change the printer and printing optionsPrint Enhancement Setup... Set the printing filters (see chapter “8.7 print

enhancement”)Print Preview Preview the current report

Print Print the current report

6.4.2 Edit Menu

Study Patient File Show the patient data attached to the studyReport Patient File Show the patient data attached to the report (only if a

report is opened)Add Report Page Add a page to the report (only if a report is opened) (see

chapter “8 creating and modifying a report”)Report Page Layout Show the report page layout of the active page (only if a

report is opened)(see chapter “8 creating andmodifying a report”)

Report Page Notes Insert notes in the active report page (only if a report isopened) (see chapter “8 creating and modifying areport”)

Remove Report Page Remove a report page (only if a report is opened) (seechapter “8 creating and modifying a report”)

Report Attached Letter Create a new report attached letter (only if a report isopened)

6.4.3 Secondary Reconstruction Menu

Single Transaxial Section Create a new single Transaxial section (see chapter“6.1.2 transaxial views”)

Sequence of TransaxialsSection

Create a new sequence of Transaxials sections (seechapter “6.1.2 transaxial views”)

Panoranics Sections Create a Panoramic section (see chapter “6.1.3panoramic views”)

3D Create a 3D image (see chapter “6.1.4 3d views”)

Transaxial Setup Change the parameters to generate Transaxialssections (see chapter “6.1.2 transaxial views”)

Panoramics Setup Change the parameters to generate Panoramicssections (see chapter “6.1.3 panoramic views”)

Drag... Modify a transaxial or panoramic section.

Sequence of Transaxials ⇒⇒⇒⇒Panoramics

Create a Panoramic section from the active sequenceof Transaxials sections

Panoramics ⇒⇒⇒⇒ Sequence ofTransaxials

Create a sequence of Transaxials sections from theactive Panoramic section

Extract Transaxial Image Extract a single Transaxial section from the activesequence of Transaxials sections

Label l/b <-> L/R Toggle the label of the Transaxials sections betweenlingual/bucal and left/right

Delete Current Image Remove the current secondary image from the study

6.4.4 Report Menu

New Create a new report (see chapter “8 creating andmodifying a report”)

Open Open an existing report (see chapter “8 creating andmodifying a report”)

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

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

6.4.5 Utility Menu

Angles ⇒⇒⇒⇒ New Angle Trace a new angle on the current image

Angles ⇒⇒⇒⇒ Drag Angles Drag the position of angle and of attached label

Angles ⇒⇒⇒⇒ Delete Angle Remove an angle from the current image

Angles ⇒⇒⇒⇒ Delete All Angles Remove all the angles from the current image

Distances ⇒⇒⇒⇒ New Distance Trace a new distance on the current image

Distances ⇒⇒⇒⇒ Drag Distances Drag the position of distance and of attached label

Distances ⇒⇒⇒⇒ Delete Distance Remove a distance from the current image

Distances ⇒⇒⇒⇒ Delete AllDistances

Remove all the distances from the current image

3D Distances ⇒⇒⇒⇒ New 3DDistance

Trace a new 3D distance on the current image

3D Distances ⇒⇒⇒⇒ Drag 3DDistances

Drag the position of 3D distance and of attached label

3D Distances ⇒⇒⇒⇒ Delete 3DDistance

Remove a 3D distance from the current image

3D Distances ⇒⇒⇒⇒ Delete All3D Distances

Remove all the 3D distances from the current image

Lines ⇒⇒⇒⇒ New Line Trace a new line on the current image

Lines ⇒⇒⇒⇒ New Arrow Trace a new arrow on the current image

Lines ⇒⇒⇒⇒ Drag Lines Drag the position of the line

Lines ⇒⇒⇒⇒ Delete Line Remove a line from the current image

Lines ⇒⇒⇒⇒ Delete All Lines Remove all the lines from the current image

Marker ⇒⇒⇒⇒ New Small Marker(0.5 mm)

Trace a marker 0.5mm thick

Marker ⇒⇒⇒⇒ New MediumMarker (1.5 mm)

Trace a marker 1.5mm thick

Marker ⇒⇒⇒⇒ New Large Marker(3 mm)

Trace a marker 3mm thick

Marker ⇒⇒⇒⇒ Hide Markers Hide all the traced markers from the study

Marker ⇒⇒⇒⇒ Delete Last Marker Delete the last traced marker from the current image

Marker ⇒⇒⇒⇒ Delete All Markers Delete all the traced markers from the study

Strings ⇒⇒⇒⇒ Add Single LineString

Add a single line of comment on the current image

Strings ⇒⇒⇒⇒ Add MultilineString

Add a multi line comment on the current image

Strings ⇒⇒⇒⇒ String Editor Show the dialog with the list of the string contained inthe database of comments

Strings ⇒⇒⇒⇒ Drag Strings Area Modify the comment area

Strings ⇒⇒⇒⇒ Delete One String Delete a comment from the current image

Strings ⇒⇒⇒⇒ Delete All Strings Delete all the comments from the current image

Profile ⇒⇒⇒⇒ Trace Profile Show the gray levels of a segment traced on the image

Profile ⇒⇒⇒⇒ Increase Zoom Increase the profile zoom on the current image

Profile ⇒⇒⇒⇒ Decrease Zoom Decrement the profile zoom on the current image

Profile ⇒⇒⇒⇒ Remove Profile Remove the profile from the current image

Single/Multiple Images Show a single image or multiple images

Zoom Image Change the zoom of the current image

Visualization Setup ⇒⇒⇒⇒Brightness & Contrast...

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

Visualization Setup ⇒⇒⇒⇒Windows...

Change the visualization window of the all study images(with the only exception of the Scout-View and 3Dimages) (see chapter “6.1.1 setup of the visualizationwindow”)

Exam Info Show additionals informations about the exam fromwhich the study has been created

6.4.6 Images Menu

Axial Images Show the Axial images of the current study

Single Transaxial SectionImages

Show the images of the single Transaxials sections ofthe current study

Sequence of TransaxialSection Images

Show the images of the sequences of Transaxialssections of the current study

Panoramics Section Images Show the images of the Panoramics of the current study

3D Images Show the 3D images of the current study

First Image Show the first image of the selected group of images

Previous Image Show the previous image to that visualized

Next Image Show the next image to that visualized

Last Image Show the last image of the selected group of images

6.4.7 Toolbar Menu

Main Toolbar Show/Hide the Tool BarStatus Bar Show/Hide the Status Bar2nd Reconstruction Toolbar Show/Hide the Secondary Reconstruction toolbar

Angles Toolbar Show/Hide the Angles toolbar

Distances Toolbar Show/Hide the Distances toolbar

3D Distances Toolbar Show/Hide the 3D Distances toolbar

Markers Toolbar Show/Hide the Markers toolbar

Profile Toolbar Show/Hide the Profile toolbar

Strings Toolbar Show/Hide the Strings toolbar

6.4.8 Window Menu

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

Coronal View Full screen visualisation of the transaxial imageTile Vertical Tile the windows in a vertical fashionTile Horizontal Tile the windows in a horizontal fashionCascade Arrange the windows in a cascading fashionWindow list Show the window list and bring to foreground the

selected one

6.4.9 About Menu


7. Report page layoutYou 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 patientreport. It is possible to create different report page layout combinations.During the creation of the report, it’s possible to choose a different layout for each page of the report.

7.1 Creating a report page layoutWith File ⇒⇒⇒⇒ Report Page Layout Setup ⇒⇒⇒⇒ New it’s possible to create a new layout. The following dialogbox will appear:

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

It’s possible to modify the printer page parameter. When finished confirm with the OK key. The next windowwill appear:

On the window caption bar appears the layout identification code (for example #2), the kind of selectedprinter (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 6fields:

• Layout comment (Comments)• Report header (Header)• Patient data (Patient)• Report note (Notes)• Device logo (Logo - reserved, read-only)• Image n°1 (Img 1)

It is possible to move between the different sheets with the mouse pointer or by pressing the CTRL key andthen 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. Previewimages 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 layoutlist.

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 willremove a selected image).

At the end of a report page layout creation confirm with the OK button.

7.2 Opening a report layoutFrom the main window of the application and when a study or a report document is open, it’s possible tomodify a report page layout by selecting File ⇒⇒⇒⇒ Report Page Layout Setup ⇒⇒⇒⇒ Open. A report page layoutlist will appear:

The list shows all the created report page layouts, each with its identification number (ID#), its relatedcomment, 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 layoutFrom the main window of the application and when a study or a report document is open, it’s possible toremove a report page layout from the work drive by selecting File ⇒⇒⇒⇒ Report Page Layout Setup ⇒⇒⇒⇒ Delete.From a report page layout list select the item to remove and confirm with the Ok button.

8. Creating and modifying a reportIn this chapter it will be explained how to create a report from the patience study images. First of all, it’sexplained how to create a personal header of the report that will be included inside of the newly createdreport.

8.1 Report Header SetupEvery page of a report holds inside a field reserved to an optional header of the report itself. This field iscopied 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 headercan be changed before creating a new report, selecting the command File ⇒⇒⇒⇒ Report Header Setup.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. Font (Font) : allows to change type, color and height of the selected line font2. Text (Text) : changes the text reported in the selected line3. Style (Style) : changes the alignment (to the right, to the left or centered) of the text4. Add line (Add Line) : adds a new line at the end of the header5. Insert Line (Insert Line) : inserts a new line just before of the selected one6. Delete Line (Delete Line) : 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 spaceinside the header. Otherwise, the software warns the user. Once the header has been changed, rememberto save it, selecting File ⇒⇒⇒⇒ Save, before closing it.

8.2 Creating a new reportA report can be made of 99 pages maximum (a maximum 64 images each report) and it can contain imagestaken 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 thelayout with reference to what you’d 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 OKbutton.

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 theimage: 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: it’s automatically inserted andthan it’s 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 andallows 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;

by clicking the right mouse button on an image of the report’s 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 pagewill 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 ⇒⇒⇒⇒ RemoveReport Page. If the report is made of just one page, it is not possible to delete it;

11. to change the rectangles of a page, select its window and use the command Edit ⇒⇒⇒⇒ Report Page

Layout. The rectangles that include images can only be moved (you can’t change neither the size northe scale);

12. to enter text note in the report’s 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 Preview or print itdirectly with the command File ⇒⇒⇒⇒ Print;

8.3 Changing an existing reportAfter having loaded a study document, with the command Report ⇒⇒⇒⇒ Open, choose from the list the reportdocument 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, theuser is warned and asked for confirmation to use it.

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

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

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

8.7 Print EnhancementIt’s possible to apply graphic filters to the report’s images when they are printed: in this way the loss of qualityof some printers can be compensated. These filters are in affect only while printing the report, without modifythe content of the report images.

With the command File ⇒⇒⇒⇒ Print Enhancement Setup the following window appears:

With it, it is possible to choose a preferred filter for every type of image. Below is the available filters list:

• none (no filter applied)• Soften (low-pass filter. Smooths the edges of the image and reduces the noise)• Sharpen (high-pass filter. Sharpens the edges of the image, but doesn’t reduce the noise)• Enhance Edge (sets evidence of the edges of the image, but doesn’t reduce the noise)• Adaptive (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 don’t need any filter.However, it is recommended to print more reports changing the filters, because the final result depends onthe printer and the judgment of the adjustments is purely subjective. Once the set-up has been set, confirm itby pressing OK. The settings will be used for all the next prints.

8.8 Report MenuIn the following tables are reported the command descriptions of the report’s menu.

8.8.1 File Menu

Save Save the active report

Close Close the active report

Graphic settings setup Change the graphic properties of overlays (see chapter“6.3 graphic settings setup”)

Report Pages Layout Setup⇒⇒⇒⇒ New



Open an existing report page layout. (see chapter “7report page layout”)


Delete a report page layout. (see chapter “7 reportpage layout”)

Attached Letter Setup... Modify the default report attached letterPrint Setup... Change the printer and printing optionsPrint Enhancement Setup... Set the printer filters (see chapter “8.7 print

enhancement”)Print Preview Preview the current report

Print Print the current report

8.8.2 Edit Menu(Enable when a report document is enabled)

Report Patient File Show the patient data attached to the report

Add Report Page Add a page to the report (see chapter “8 creating andmodifying a report”)

Report Page Layout Show the report page layout of the active page (seechapter “8 creating and modifying a report”)

Report Page Notes Insert notes in the active report page (see chapter “8creating and modifying a report”)

Remove Report Page Remove a report page (see chapter “8 creating andmodifying a report”)

Report Attached Letter Create a new report attached letter

8.8.3 Toolbar Menu

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

8.8.4 Window MenuResize Window Reset the position and size of the window with the

original settingsCascade Arrange the windows in a cascading fashionTile Vertical Tile the windows in a horizontal fashionTile Horizontal Tile the windows in a horizontal fashionWindow list Show the window list and bring to foreground the

selected one

8.8.5 About MenuAbout Show information about software version, system

configuration, disk space and available memory

8.8.6 Pop-Up MenuThis menu appears clicking with the right button of the mouse on an image of a report.

Brightness & Contrast... Change brightness and contrast of the current image(see chapter “6.2.1 brightness and contrast”)

Draw only on referenceimage

Draw the references of the current imege only on thereference view (if checked)

Hilight transaxial onpanoramics

Draw the intersection between the Transaxials sectionsand the Panoramics sections for all the height of thePanoramics sections (if checked)

Remove Remove the current inage from the reportDistances ⇒⇒⇒⇒ New Distance Trace a new distance on the current imageDistances ⇒⇒⇒⇒ Drag Distances Drag the position of distance and of attached labelDistances ⇒⇒⇒⇒ Delete Distance Remove a distance from the current imageDistances ⇒⇒⇒⇒ Delete AllDistances

Remove all the distances from the current image

Angles ⇒⇒⇒⇒ New Angle Trace a new angle on the current imageAngles ⇒⇒⇒⇒ Drag Angles Drag the position of angle and of attached labelAngles ⇒⇒⇒⇒ Delete Angle Remove an angle from the current imageAngles ⇒⇒⇒⇒ Delete All Angles Remove all the angles from the current image

9. Documents managmentThe software creates and manages three kind of documents:

1. raw data;2. studies;3. reports;

9.1 Import/ExportBecause 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 availablespace (megabytes free) of the work drive are shown in every documents list:

It is possible to make a copy of these documents on CD-R or CD-RW (using the CD-WRITER present on thedevice 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 (orchange) the drive used for import/export operations: if you are using CD-R or CD-RW, select the CD-WRITER (normally E: drive).

Free space on Work Drive

9.1.2 ExportWith File ⇒⇒⇒⇒ Export command it is possible to select the kind of document (raw data, study or report) to copyon 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 thiscase by holding pressed the keyboard Shift key to select a series of adjacent list nominatives or the Controlkey 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 ImportWith File ⇒⇒⇒⇒ Import command it is possible to select the kind of document (raw data, study or report) to copyon work drive.From the documents list of the memory support (export drive) that appears it’s possible to choose one ormore items (in this case by holding pressed the keyboard Shift key to select a series of adjacent listnominatives or the Control key to select nominatives in random order) and then confirming by selecting theOk button.

The selected documents are copied from the export drive to the work drive.

9.2 Deleting documentsIt 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 driveWith File ⇒⇒⇒⇒ Delete from Work Drive command it is possible to select the kind of document (raw data, studyor report) to delete from the work drive.From the documents list that appears it’s possible to choose one or more items; confirm with the Ok key.

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

9.3 Exporting axial images (OPTIONAL)

9.3.1 Exporting axial images as BitmapThe menu item File ⇒⇒⇒⇒ Save in BMP format ⇒⇒⇒⇒ Sequence of axial Images…, permits to export all axialimages of the current study as Bitmap. The [Browse for folder] window appears, it permits to select the pathin 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 informationsabout the current study.

9.3.2 Exporting axial images as DICOMThe menu item File ⇒⇒⇒⇒ Save in Dicom format ⇒⇒⇒⇒ Sequence of axial Images…, permits to export all axialimages (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 namedwith a univocal code created from the Newtom study code.

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 ComputedTomography devices, such as QR-DVT 9000, the raw data is a series of digital images referenced from atthe 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" ofcomprehensive images (or views) of the examined volume is obtained

• DentalScan: conventional name assigned to software which in CT machines allows the multiplanereconstruction 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 thedifferent dimension of the thickness of crossed tissue (SmartBeam)

• SmartBeam: QR-DVT 9000 characteristic so that the X-beam intensity is varied during the scan accordingto the different thickness of tissue crossed by the same beam. This option allows the patient to be sparedunnecessary 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 secondaryreconstructions. From an exam more "studies" can be obtained, through different or following primaryreconstructions

• Computerized Tomograph (CT=Computed Tomography): radiological device which, by means ofelectronic processing of radiological acquired projections on digital detectors, rebuilds the densitometricvalue of inner points of an object. If not otherwise specified, the term computerized tomograph traditionallyindicates the computerized axial tomograph, that is to say a tomograph which rebuilds axial sections ofthe object using the "fan-beam" technics (X-Ray beam "fan" shape with detectors placed in line of anarch)

• 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 ofaxial scans, can, by means of so called data reformat, produce an object volumetric reconstruction; theterm volumetric tomograph is reserved to spiral tomographs (Spiral-CT), which use a "fan-beam" withcontinuos advancement of the patient holder examination table, synchronized at the rotation movement oftube-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 theobject, allows to acquire all necessary data for the volumetric reconstruction, also defined TVCT = TrueVolumetric Computed Tomography

• TVCT = True Volumetric Computed Tomography: see volumetric computerized tomograph• Report: ensemble of study images of a patient.

11. Service

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

11.1 IntroductionScanning area: the system must be placed only in rooms for medical radiological use, according todispositions of a Qualified Consultant.Follow carefully the safety requirements and signals, according to national and local regulation.The device isn’t protected against dripping and spray: don’t 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 doesn’t reduce the efficiency of the safety measures against fire, in the workingenvironment.Electromagnetic Compatibility (EMC): the device is in conformity of the EMC regulation (EN 60601-1-2), forradiofrequency emission and immunity.Noise: the maximum measured level (phonometric analysis) is less than 70 dB.

11.2 ComplianceQR-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 electric-medical 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. Collateralstandard: 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 HighVoltage Generators of Diagnostic X-Ray Generators• IEC 601-2-28 (EN 60601-2-28): 1993 Medical Electrical Equipment - Part 2: Particular Requirements forthe 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, Requirementsand User Guide• IEC 601-2-32 (EN 60601-2-32): 1994 Medical electrical equipment - Part 2: Particular Requirement for thesafety of associated equipment of X-ray equipment

• IEC 1262-1 (EN 61262-1):1994 Medical electrical equipment - Characteristics of electro-optical X-rayimage intensifiers - Part 1. Determination of the entrance field size• IEC 1262-2 (EN 61262-2):1994 Medical electrical equipment - Characteristics of electro-optical X-rayimage intensifiers - Part 2: determination of the conversion factor• IEC 1262-3 (EN 61262-3):1994 Medical electrical equipment - Characteristics of electro-optical X-rayimage 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-rayimage intensifiers - Part 4: Determination of the image distortion• IEC 1262-5 (EN 61262-5):1994 Medical electrical equipment - Characteristics of electro-optical X-rayimage intensifiers - Part 5. Determination of the detective quantum efficiency• IEC 1262-6 (EN 61262-6):1994 Medical electrical equipment - Characteristics of electro-optical X-rayimage 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 inClass II b (X-ray emitting medical device).

CLASSIFICATION IEC 601-1Protection against electrical shock CLASS IProtection level against electrical shock TYPE B

11.3 Device modificationsDevice modifications or updating must be in conformity of all required regulation.WARNING Improper or not authorized handling or modifications of hardware and softwarecomponents are forbidden as they can cause incorrect functioning of the system. They can alsocause breakdowns and/or accidents and/or danger for patient, operator and system.The manufacturer isn’t 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 aren’t replaced with spares approved by producer or distributor;• the environmental safety conditions aren’t 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 WarningsThe user is responsible for the correct use of the device, in conformity with instructions contained in thepresent manual and with the regulation requirements. Particularly, the following features must beemphasized:• 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.

11.5 Maintenance and cleaningWARNING: Always shut down the main power switch for any maintenance and cleaning of thedevice!

11.5.1 General requirementsRegular 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 byproducer or distributor.QR s.r.l. is responsible for device safety only if maintenance and repairs are performed by producer ordistributor or by personnel authorized by them.The device must be periodically checked: refer to technical service to define a maintenance detailed programfor the system. For cleaning and care of the system, see chapter “11.5.3 cleaning”.If the system doesn’t work according to the requirements or the working procedures show defects, referimmediately to technical service.

11.5.2 Preventive maintenancePeriodically check the computer-device interface cable and the power supply cables. Perform cable checksto computer, monitor, keyboard, mouse and printer according to the manufacturers instructions.Supplied components and accessories must be conserved and used according to proper technicalspecifications.

11.5.3 Cleaning

11.5.3.1 ScannerThe device can be cleaned with a moist cloth, using a mild cleaning solution. Moisten the cloth beforeapplying on the device surface. Never apply cleaning solution directly to the device!

11.5.3.2 Computer and peripheralsIn regards to the computer and connected peripherals, follow the manufacturers instructions. In absence ofthem, apply the same cautions described for device cleaning.To avoid

Don’t use spray or solvents, which can go into the device, damaging electrical and electronical parts, orcreating possible flammables, creating danger for patient, operators and environment.Don’t use abrasive fluids such as acetone, gas oil, alcohol (except: alcohol can be used only to clean monitorscreen). These substances can degrade the components surface and cause damages to components intricalto the proper function of the device.Don’t use agents releasing ammonia by dissipation or decomposition. Ammonia causes corrosive effects.Don’t use agents containing silicone: this substance can accumulate, causing possible problems of electricalcontacts.Note: For further details, about safety and maintenance, refer to the local distributor.

11.5.4 DisposalSeparate X-ray source power components, plastic shell parts, computer and peripherals, metalliccomponents.The X-ray source contains oil, which must be extracted and delivered to a specialized center for fluidselimination 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 meansof incineration in approved conditions; in case of reusing, refer to recycling centers.In regards to the other parts, of which the manufacturer doesn’t supply specific indications, refer to nationaland 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 anautomatic procedure.First, it is necessary to perform the acquisition of raw data (Scan Menu ⇒⇒⇒⇒ Phantom Scan). The procedureis the same as the patient scan the difference being that the patient file is pre-compiled by software. Whenthe phantom positioning is being checked, be careful that it is centered with the rectangle, which appears onvideo. For a correct positioning see the following figure,

After raw data has been acquired, the reconstruction procedure will start automatically. If not, select thecommand Phantom Analysis in the Primary Reconstruction Menu. The analysis is completely automaticand takes maximum 30-35 minutes (10 min. typical). At the end, a window, with results and validationranges, is displayed. If one of the parameters is out of relative range, refer to technical service. It’s possibleto print the analysis results by selecting the command File ⇒⇒⇒⇒ Print paying attention to have the resultswindow “active”.To visualize the analysis results, once the document has been closed from the main menu select PrimaryReconstruction ⇒⇒⇒⇒ Phantom Results.

To assure the proper operation of the device it is recommended to perform the QA Phantom check once aweek.

There are 3 kinds of quality checks:1. Check the system parameters2. Check “Image quality / Radiation dose” ratio3. Check on the accuracy of the geometric measurements

In the table below the parameters measured by the procedure are shown.

Sigla Name Description

AAP Phantom’s angle on theFront-Back View

Inclination angle of the phantom’s axis of symmetry in the Front-BackView (0°)

AAL Phantom’s angle on theLateral-Lateral View

Inclination angle of the phantom’s axis of symmetry in the Lateral-LateralView (90°)

ScanTime Scan Time Scan time in seconds

RNS% Noise per cent Noise per cent on the phantom’s central axial image expressed asstandard deviation of the density values as to their average value in anarea in the middle of the image (in correspondence of the water).

HDE External HorizontalDiameter

External diameter of the aluminium cylinder on the x-axis in the centralaxial image

HDI Internal Horizontal Internal diameter of the aluminium cylinder on the x-axis in the central

Diameter axial image

VDE External VerticalDiameter

External diameter of the aluminium cylinder on the y-axis in the centralaxial image

VDI Internal VerticalDiameter

Internal diameter of the aluminium cylinder on the y-axis in the centralaxial image

H FWHM Full Width HalfMaximum horizontal

Spatial resolution (millimeters) on the horizontal diameter of the centralaxial image

V FWHM Full Width HalfMaximum vertical

Spatial resolution (millimeters) on the vertical diameter of the centralaxial image

HFD Horizontal Distanceamong holes

Average horizontal distance among the holes of the cylinder on thepanoramic image

VFD Vertical Distance amongholes

Average vertical distance among the holes of the cylinder on thepanoramic image

The spatial resolution can be showed as MTF50 (lp/mm). Select the command Show MTF50 in the QAReport menu.

Concerning verifying the dose, see the International Standard IEC 601-2-44 paragraph 29.102In the figure below, there is a graphic presentation of the dose profile (see IEC 601-2-44 par. 29.103.1)

0123456789

10

-5 -4 -3 -2 -1 0 1 2 3 4 5cm

mSv center0°90°180°270°

11.7 Check List maintenance intervalsThe following check list specifies the time intervals for maintenance checking. For further information, referto local distributor.

Person in charge Component Activity PeriodicityUser Whole system Check by QA Phantom WeeklyExpert for theradiologic Whole system Radiological routine Chosen by EPR

protection (EPR)Guasti.txt Check 12 monthsAll external components Check of any possible damage 12 months

TechnicalAssistanceService

Emergency Stop Stop system check 12 months

Electrical parameters Check 12 monthsMechanical parameters Check 12 monthsPatient table Movement test, visual check structure

and wood axis12 months

11.8 Error messagesThe software has a code for each error message it generates. The warning messages or the questions don’thave 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 Meaning Counter Measures301 The software cannot open the error message file Contact the Technical Service Assistance302 Memory allocation error writing See Memory Error303 Access error writing Contact the Technical Service Assistance304 Serialization error writing Contact the Technical Service Assistance305 Access error reading Contact the Technical Service Assistance306 Serialization error reading Contact the Technical Service Assistance307 Memory allocation error reading See Memory Error401 Bitmap memory allocation error See Memory Error402 Bitmap’s header memory allocation error See Memory Error403 Error reading the bitmap’s header See Memory Error404 Error reading the bitmap’s header See Memory Error405 The bitmap has more than 8 bit for pixel Contact the Technical Service Assistance501 Error during the acquisition board initialization from the Service window Contact the Technical Service Assistance502 The software cannot perform a continuos acquisition Contact the Technical Service Assistance503 The software cannot perform an acquisition without RX Contact the Technical Service Assistance504 The software cannot perform a single acquisition Contact the Technical Service Assistance505 The software cannot perform a multiimpulse acquisition Contact the Technical Service Assistance601 Error opening the deviation file Contact the Technical Service Assistance602 Error reading the deviation file Contact the Technical Service Assistance603 Error opening the theoretical centers file Contact the Technical Service Assistance604 Error reading the theoretical centers file Contact the Technical Service Assistance

605 Allocation memory error of the deviation buffer See Memory Error606 Deallocation memory error of the deviation buffer See Memory Error607 Deallocation memory error of the deviation buffer See Memory Error608 Allocation memory error of the theoretical centers buffer See Memory Error609 Deallocation memory error of the theoretical centers buffer See Memory Error610 Deallocation memory error of the theoretical centers buffer See Memory Error611 Allocation memory error of the destination image buffer See Memory Error612 Deallocation memory error of the destination image buffer See Memory Error613 Deallocation memory error of the destination image buffer See Memory Error614 Error opening the edges file Contact the Technical Service Assistance615 Error writing the edges file Contact the Technical Service Assistance901 Error opening the holes file Contact the Technical Service Assistance902 Error writing the holes file Contact the Technical Service Assistance903 Error opening the deviation file Contact the Technical Service Assistance904 Error writing the deviation file Contact the Technical Service Assistance905 Error opening the theoretical centers file Contact the Technical Service Assistance906 Error writing the theoretical centers file Contact the Technical Service Assistance907 Allocation memory error of the holes buffer See Memory Error908 Deallocation memory error of the holes buffer See Memory Error909 Deallocation memory error of the holes buffer See Memory Error910 Allocation memory error of the theoretical centers buffer See Memory Error911 Deallocation memory error of the theoretical centers buffer See Memory Error912 Deallocation memory error of the theoretical centers buffer See Memory Error913 Allocation memory error of the counters buffer See Memory Error914 Deallocation memory error of the counters buffer See Memory Error915 Deallocation memory error of the counters buffer See Memory Error916 Allocation memory error of the deviation buffer See Memory Error917 Deallocation memory error of the deviation buffer See Memory Error918 Deallocation memory error of the deviation buffer See Memory Error919 Error opening the edges file Contact the Technical Service Assistance920 Error writing the edges file Contact the Technical Service Assistance1101 The physical data file does not exist Contact the Technical Service Assistance1102 Error opening to read the physical data file Contact the Technical Service Assistance1103 Memory allocation error reading See Memory Error1104 Access error reading Contact the Technical Service Assistance1105 Serialization error reading Contact the Technical Service Assistance1106 Error opening to write the physical data file Contact the Technical Service Assistance1107 Memory allocation error reading See Memory Error1108 Access error writing Contact the Technical Service Assistance1109 Serialization error writing Contact the Technical Service Assistance1301 Allocation memory error of the image buffer See Memory Error1302 Allocation memory error of the sum image buffer See Memory Error1303 Deallocation memory error of the image buffer See Memory Error

1304 Deallocation memory error of the image buffer See Memory Error1305 Deallocation memory error of the sum image buffer See Memory Error1306 Deallocation memory error of the sum image buffer See Memory Error1307 Error opening for read the image file Contact the Technical Service Assistance1308 Error reading the image file Contact the Technical Service Assistance1401 The mask file does not exists Contact the Technical Service Assistance1402 Error opening for read the mask file Contact the Technical Service Assistance1403 Memory allocation error reading See Memory Error1404 Access error reading Contact the Technical Service Assistance1405 Serialization error reading Contact the Technical Service Assistance1406 Error opening for write the mask file Contact the Technical Service Assistance1407 Memory allocation error reading See Memory Error1408 Access error writing Contact the Technical Service Assistance1409 Serialization error writing Contact the Technical Service Assistance1501 The counter file does not exist Contact the Technical Service Assistance1502 Error opening for read the counter file Contact the Technical Service Assistance1503 Memory allocation error reading See Memory Error1504 Access error reading Contact the Technical Service Assistance1505 Serialization error reading Contact the Technical Service Assistance1506 Error opening for write the counter file Contact the Technical Service Assistance1507 Memory allocation error reading See Memory Error1508 Access error writing Contact the Technical Service Assistance1509 Serialization error writing Contact the Technical Service Assistance1601 The image area to filter is too small See Memory Error1602 The image area to filter is too small See Memory Error1603 Allocation memory error of the filters buffer See Memory Error1604 Deallocation memory error of the filters buffer See Memory Error1605 Deallocation memory error of the filters buffer See Memory Error1701 Error creating the strings database file Contact the Technical Service Assistance1702 Memory allocation error reading See Memory Error1703 Access error writing Contact the Technical Service Assistance1704 Serialization error writing Contact the Technical Service Assistance1705 Memory allocation error reading See Memory Error1706 Access error reading Contact the Technical Service Assistance1707 Serialization error reading Contact the Technical Service Assistance1708 Error opening for write the Contact the Technical Service Assistance1709 Error opening for write the strings database file (after the init) Contact the Technical Service Assistance1710 Memory error allocation writing during the init of the file See Memory Error1711 Access error writing during the init of the file Contact the Technical Service Assistance1712 Serialization error writing during the init of the file Contact the Technical Service Assistance1801 Error during the acquisition board initialization before an exam Contact the Technical Service Assistance1802 The software cannot move the variac before a calibration scan Contact the Technical Service Assistance1803 The software cannot shut down the X-Ray source at the end of a calibration

scanContact the Technical Service Assistance

1804 Error performing the Zero-Crossing test at the start of the calibration scan Contact the Technical Service Assistance1805 The software cannot reset the variac at the start of a calibration scan Contact the Technical Service Assistance1806 The inductive switch is active before the end of a calibration scan Contact the Technical Service Assistance1807 The arm position is not correct Contact the Technical Service Assistance1808 The inductive switch is not active at the end of a scan calibration Contact the Technical Service Assistance1809 An image completely black was acquired Contact the Technical Service Assistance1901 The motor data file does not exist Contact the Technical Service Assistance1902 Error opening for read the motor data file Contact the Technical Service Assistance1903 Memory allocation error reading See Memory Error1904 Access error reading Contact the Technical Service Assistance1905 Serialization error reading Contact the Technical Service Assistance1906 Error opening for write the motor data file Contact the Technical Service Assistance1907 Memory allocation error reading See Memory Error1908 Access error writing Contact the Technical Service Assistance1909 Serialization error writing Contact the Technical Service Assistance1910 The software cannot move the arm Contact the Technical Service Assistance2001 Error opening for read the phantom data file Contact the Technical Service Assistance2002 Memory allocation error reading See Memory Error2003 Access error reading Contact the Technical Service Assistance2004 Serialization error reading Contact the Technical Service Assistance2005 Error opening for write the phantom data file Contact the Technical Service Assistance2006 Memory allocation error reading See Memory Error2007 Access error writing Contact the Technical Service Assistance2008 Serialization error writing Contact the Technical Service Assistance2201 Error opening for read the radiological parameters file Contact the Technical Service Assistance2202 Memory allocation error reading See Memory Error2203 Access error reading Contact the Technical Service Assistance2204 Serialization error reading Contact the Technical Service Assistance2205 Error opening for write the radiological parameters file i Contact the Technical Service Assistance2206 Memory allocation error reading See Memory Error2207 Access error writing Contact the Technical Service Assistance2208 Serialization error writing Contact the Technical Service Assistance2501 Error printing because the print protocol for Special Radiological Printer is not

enabled.Set as default printer a Windows printer(Menu File ⇒⇒⇒⇒ Print Setup)

2502 The software cannot create the bitmap resource to draw the report for theSpecial Radiological Printer

See Memory Error

2503 The software cannot create the device context resource to print with SpecialRadiological Printer

See Memory Error

2504 There is not enough space on work drive to store the print queues of the SpecialRadiological Printer

Free space on disk. If persists contact theTechnical Service Assistance

2505 The software cannot obtain a valid file name to use as temporary file during theprint process of a new report with a Special Radiological Printer.

Contact the Technical Service Assistance

2506 The temporary file used for the print queue of a Special Radiological Printer justexist.

Wait the end of the process. If persistscontact the Technical Service Assistance

2507 Error opening for write the temporary file used for the print queue of a SpecialRadiological Printer


2508 Error writing the temporary file used for the print queue of a Special RadiologicalPrinter


2509 Error during the creation of the event of stop for the synchronization of the 3Mserver


2510 Error during the creation of the event of reply of the stop for the synchronizationof the 3M server


2511 Error creating the 3M server Contact the Technical Service Assistance2512 The 3M server is just activated on another station and cannot be created. Contact the Technical Service Assistance2513 Error opening for read the temporary file used for the print queue of a Special

Radiological PrinterContact the Technical Service Assistance

2514 Error during the creation of the event of pause for the synchronization of the 3Mserver


2515 Error during the creation of the event of reply of the stop for the synchronizationof the 3M server


2516 Error during the creation of the event of pause for the synchronization of the 3Mserver


2601 Allocation memory error of the Gain and Offset values buffer See Memory Error2602 Allocation memory error of the compensation X-Ray values buffer See Memory Error2603 The header file with the old raw format data that the user is opening does not

exist.Contact the Technical Service Assistance

2604 Error opening for read a header file with the old raw format Contact the Technical Service Assistance2605 Memory allocation error reading See Memory Error2606 Access error reading Contact the Technical Service Assistance2607 Serialization error reading Contact the Technical Service Assistance2608 Error of the control flag reading the raw data file passed Contact the Technical Service Assistance2701 Error closing/deleting 'n.xxx.yyy.zzzz.Lock' file Contact the Technical Service Assistance2702 Error writing on 'n.xxx.yyy.zzzz.Lock' file the lock information Contact the Technical Service Assistance2703 Error reading from ‘n.xxx.yyy.zzzz.Lock' file the user data Contact the Technical Service Assistance2704 Error opening 'n.xxx.yyy.zzzz.Lock' file Contact the Technical Service Assistance2705 Error writing on 'n.xxx.yyy.zzzz.Lock' file the user data Contact the Technical Service Assistance2801 Error opening for read the grid results file Contact the Technical Service Assistance2802 Error reading the grid results file Contact the Technical Service Assistance2803 Error opening for write the grid results file Contact the Technical Service Assistance2804 Error writing the grid results file Contact the Technical Service Assistance3101 Error initializing hardware Contact the Technical Service Assistance3201 Error opening for read the laser printer data Contact the Technical Service Assistance3202 Memory allocation error reading See Memory Error3203 Access error reading Contact the Technical Service Assistance3204 Serialization error reading Contact the Technical Service Assistance3205 Error opening for write the laser printer data Contact the Technical Service Assistance3206 Memory allocation error reading See Memory Error3207 Access error writing Contact the Technical Service Assistance3208 Serialization error writing Contact the Technical Service Assistance4201 The selected header line is full Remove come characters or reduce the font

size4202 The selected font size gives a text extent wider than the header line size See 42014203 The new header/footer line cannot be added because the total high is greater Remove some lines or reduce the font size

than the available space4204 See 4203 See 42034301 Memory deallocation error of the palette See Memory Error4302 Memory deallocation error of the palette See Memory Error4303 Memory allocation error of the palette See Memory Error4304 Error initializing the palette See Memory Error4305 Error coping the palette See Memory Error4306 Error updating the palette See Memory Error4307 Error updating the palette See Memory Error4401 Error opening for read the results QA phantom file Contact the Technical Service Assistance4402 Memory allocation error reading See Memory Error4403 Access error reading Contact the Technical Service Assistance4404 Serialization error reading Contact the Technical Service Assistance4405 Error opening for write the results QA phantom file Contact the Technical Service Assistance4406 Memory allocation error reading See Memory Error4407 Access error writing Contact the Technical Service Assistance4408 Serialization error writing Contact the Technical Service Assistance4501 The max hourly tube was reached. Wait for the time showed in the message

before to retry4601 Allocation memory error of the Gain and Offset buffer for a new scan See Memory Error4602 Allocation memory error of the V buffer for a new scan See Memory Error4603 Allocation memory error of the Gain and Offset buffer for an existing scan See Memory Error4604 Allocation memory error of the V buffer for an existing scan See Memory Error4605 Allocation memory error of the space reserved for the images See Memory Error4606 Deallocation memory error of the space reserved for the images See Memory Error4607 Deallocation memory error of the space reserved for the images See Memory Error4608 Deallocation memory error of the space reserved for an image See Memory Error4609 Deallocation memory error of the space reserved for an image See Memory Error4610 Error locking 100 MByte See Memory Error4611 Error locking the space reserved for the images See Memory Error4612 Error opening for read an old raw data image file Contact the Technical Service Assistance4613 Error reading an old raw data image file Contact the Technical Service Assistance4614 Error opening for write an old raw data image file Contact the Technical Service Assistance4615 Error writing the an old raw data image file Contact the Technical Service Assistance4616 Error opening for write the file header an of old raw data image file Contact the Technical Service Assistance4617 Memory allocation error reading See Memory Error4618 Access error writing Contact the Technical Service Assistance4619 Serialization error writing Contact the Technical Service Assistance4620 Allocation memory error of the RX values buffer See Memory Error4621 Allocation memory error of the Gain values buffer See Memory Error4622 Not enough space on the work drive to perform a new scan Free space on disk. If persists contact the

Technical Service Assistance4801 Error opening for write the scan duration file Contact the Technical Service Assistance4802 Error writing the scan duration file Contact the Technical Service Assistance

5307 Error opening for read a mattarellum image file Contact the Technical Service Assistance5308 Error reading the a mattarellum image file Contact the Technical Service Assistance5309 Error opening for write the file Stecca.txt Contact the Technical Service Assistance5310 Error writing the file Stecca.txt Contact the Technical Service Assistance5311 Error opening for write the mattarellum data file Contact the Technical Service Assistance5312 Error writing the mattarellum data file Contact the Technical Service Assistance5313 Error opening for write the mattarellum results file Contact the Technical Service Assistance5314 Error writing the mattarellum results file Contact the Technical Service Assistance5315 Error opening for read the mattarellum results file Contact the Technical Service Assistance5316 Error reading the mattarellum results file Contact the Technical Service Assistance5401 Error opening for write the Grid results file Contact the Technical Service Assistance5402 Error writing the Grid results file Contact the Technical Service Assistance5403 Error opening for write an info RD file Contact the Technical Service Assistance5404 Error writing an info RD file Contact the Technical Service Assistance5405 Error opening for write an info RD file Contact the Technical Service Assistance5406 Error writing an info RD file Contact the Technical Service Assistance5601 Allocation memory error of the space reserved for the image See Memory Error5602 Allocation memory error of the data buffer See Memory Error5603 Allocation memory error of the space reserved for the image See Memory Error5604 Allocation memory error of the space reserved for the image See Memory Error5605 Deallocation memory error of the data buffer See Memory Error5606 Deallocation memory error of the data buffer See Memory Error5607 Allocation memory error of the temporary buffer See Memory Error5608 Deallocation memory error of the temporary buffer See Memory Error5609 Deallocation memory error of the temporary buffer See Memory Error5610 Error opening for read from service an image file (*.img, *.bmp) Contact the Technical Service Assistance5611 Error reading from service an image file (*.img, *.bmp) Contact the Technical Service Assistance5701 The Grid data file does not exist Contact the Technical Service Assistance5702 Error opening for read the Grid data file Contact the Technical Service Assistance5703 Memory allocation error reading See Memory Error5704 Access error reading Contact the Technical Service Assistance5705 Serialization error reading Contact the Technical Service Assistance5706 Error opening for write the Grid data file Contact the Technical Service Assistance5707 Memory allocation error reading See Memory Error5708 Access error writing Contact the Technical Service Assistance5709 Serialization error writing Contact the Technical Service Assistance5801 Error moving a file from the Root to the directory Exam Contact the Technical Service Assistance5802 Error creating the subdirectory to export axials in bitmap format Check that Patient Surname and Name don’t

have any non-alphanumeric characters.5901 The X-Ray tube file does not exist Contact the Technical Service Assistance5902 Error opening for read the X-Ray tube file Contact the Technical Service Assistance5903 Memory allocation error reading See Memory Error5904 Access error reading Contact the Technical Service Assistance5905 Serialization error reading Contact the Technical Service Assistance

5906 Error opening for write the X-Ray tube file Contact the Technical Service Assistance5907 Memory allocation error reading See Memory Error5908 Access error writing Contact the Technical Service Assistance5909 Serialization error writing Contact the Technical Service Assistance5910 Error opening for write the X-Ray tube report file Contact the Technical Service Assistance5911 Error writing the X-Ray tube report file Contact the Technical Service Assistance5912 Error opening for read the X-Ray tube report file Contact the Technical Service Assistance5913 Error reading the X-Ray tube report file Contact the Technical Service Assistance5914 Error performing the linear regression Contact the Technical Service Assistance6001 Error opening for write a generic image file saved as*.img o *.bmp Contact the Technical Service Assistance6002 Error writing the generic image saved as *.img or *.bmp file Contact the Technical Service Assistance6003 The device serial number is not valid. Start the application and insert a valid value6004 The software cannot find the default printer data because no printer are installed Check if a Windows printer is installed and

there is not anyone install ones.6005 Error initializing the procedure to read the printer data Contact the Technical Service Assistance6006 Error reading the printer data See 6004.6007 No Export drive is installed Select an Import/Export drive and retry6008 The software cannot recognize the type of Import/Export drive or the drive is not

presentReselect the Import/Export drive

6009 The software cannot read from the Import/Export drive Verify the magnetic support and if it is notgood change it.Moreover if is an Export procedure check ifthe magnetic support is read only.

6010 The device serial number is not valid. Insert a valid value6101 The 3D configuration file does not exist Contact the Technical Service Assistance6102 Error opening for read the 3D configuration file Contact the Technical Service Assistance6103 Memory allocation error reading See Memory Error6104 Access error reading Contact the Technical Service Assistance6105 Serialization error reading Contact the Technical Service Assistance6106 Error opening for write the 3D configuration file Contact the Technical Service Assistance6107 Memory allocation error reading See Memory Error6108 Access error writing Contact the Technical Service Assistance6109 Serialization error writing Contact the Technical Service Assistance6201 The acquisition file does not exist Contact the Technical Service Assistance6202 Error opening for read the acquisition file Contact the Technical Service Assistance6203 Memory allocation error reading See Memory Error6204 Access error reading Contact the Technical Service Assistance6205 Serialization error reading Contact the Technical Service Assistance6206 Error opening for write the acquisition file Contact the Technical Service Assistance6207 Memory allocation error reading See Memory Error6208 Access error writing Contact the Technical Service Assistance6209 Serialization error writing Contact the Technical Service Assistance6301 Memory allocation error of the space reserved for the raw blank image See Memory Error6302 Memory deallocation error of the space reserved for the raw blank image See Memory Error6303 Memory deallocation error of the space reserved for the raw blank image See Memory Error6304 Error opening for read the raw blank file Contact the Technical Service Assistance

6305 Error reading the raw blank file Contact the Technical Service Assistance6401 Error opening for write (during the init), the calibration parameters file Contact the Technical Service Assistance6402 Memory allocation error reading during the init See Memory Error6403 Access error writing during the init Contact the Technical Service Assistance6404 Serialization error writing during the init Contact the Technical Service Assistance6405 Error opening for read the calibration parameters file after the init Contact the Technical Service Assistance6406 Error opening for read the calibration parameters file Contact the Technical Service Assistance6407 Memory allocation error reading See Memory Error6408 Access error reading Contact the Technical Service Assistance6409 Serialization error reading Contact the Technical Service Assistance6410 Error opening for write the calibration parameters file Contact the Technical Service Assistance6411 Memory allocation error reading See Memory Error6412 Access error writing Contact the Technical Service Assistance6413 Serialization error writing Contact the Technical Service Assistance6501 Memory allocation error of the space reserved for the header of the image with

the old formatSee Memory Error

6502 Memory allocation error of the space to initialize the header of the image withthe old format

See Memory Error

6503 Memory deallocation error of the space reserved for the header of the imagewith the old format

See Memory Error


See Memory Error


See Memory Error


See Memory Error

6507 Error reading the header of the image with the old format Contact the Technical Service Assistance6508 Error verifing the header of the image with the old format Contact the Technical Service Assistance6701 Error opening for read the edges file Contact the Technical Service Assistance6702 Error reading the edges file Contact the Technical Service Assistance7001 Memory allocation error of the space reserved for the blank image See Memory Error7002 Memory deallocation error of the space reserved for the blank image See Memory Error7003 Memory deallocation error of the space reserved for the blank image See Memory Error7004 Error opening for write the blank file Contact the Technical Service Assistance7005 Error writing the blank file Contact the Technical Service Assistance7501 Error reading the driver Contact the Technical Service Assistance7502 Error performing the zero-crossing test: line frequency = 0 Check if the machine is switched on. If the

problem persist, contact the TechnicalService Assistance

7503 Error reading the driver in read/write mode Contact the Technical Service Assistance7504 Line frequency out ranges 47-51 Hz, 56-61 Hz Contact the Technical Service Assistance7505 Error reading the driver in writing Contact the Technical Service Assistance7506 Error closing the driver Contact the Technical Service Assistance7507 Error writing the driver Contact the Technical Service Assistance7508 Error reading the driver Contact the Technical Service Assistance7509 Line frequency = 50Hz, frame grabber setup = 60Hz Contact the Technical Service Assistance7510 Line frequency = 60Hz, frame grabber setup = 50Hz Contact the Technical Service Assistance

7601 The reconstruction plain is too much near Contact the Technical Service Assistance7602 Memory allocation error of the space reserved for the 3D image See Memory Error7603 Memory deallocation error of the space reserved for the 3D image See Memory Error7604 Memory deallocation error of the space reserved for the 3D image See Memory Error7701 The row file does not exist Contact the Technical Service Assistance7702 Error opening for read the row data file Contact the Technical Service Assistance7703 Error closing the row data file Contact the Technical Service Assistance7704 Error performing the multiple regression Contact the Technical Service Assistance7705 Error performing the multiple regression Contact the Technical Service Assistance7706 Error performing the multiple regression Contact the Technical Service Assistance7801 Error initializing the acquisition board Contact the Technical Service Assistance7901 The primary reconstruction parameters file does not exist Contact the Technical Service Assistance7902 Error opening for read the primary reconstruction parameters file Contact the Technical Service Assistance7903 Memory allocation error reading See Memory Error7904 Access error reading Contact the Technical Service Assistance7905 Serialization error reading Contact the Technical Service Assistance7906 Error opening for write the primary reconstruction parameters file Contact the Technical Service Assistance7907 Memory allocation error reading See Memory Error7908 Access error writing Contact the Technical Service Assistance7909 Serialization error writing Contact the Technical Service Assistance8001 Error removing a file Contact the Technical Service Assistance8002 No file to delete Repeat the procedure8101 Error performing the DailyCheck zero-crossing test Contact the Technical Service Assistance8102 Error resetting the variac during the DailyCheck Contact the Technical Service Assistance8103 Error setting the motor during the DailyCheck Contact the Technical Service Assistance8104 Error initializing the grabber during the DailyCheck In case the device has been switched on

more than 10 hours, try to switch it off for 2hours and than restart to work. If the problempersist, contact the Technical AssistanceService.

8105 Error setting the variac during the DailyCheck Contact the Technical Service Assistance8106 Error checking if the X-Ray source is shut down during the DailyCheck Contact the Technical Service Assistance8107 Error starting up the X-Ray source during the DailyCheck Contact the Technical Service Assistance,

taking note of the values reported on themessage.

8108 Error checking if the X-Ray source is shut down during the DailyCheck Contact the Technical Service Assistance8109 Error performing the DailyCheck watch-dog test Contact the Technical Service Assistance8110 Error resetting the arm during the DailyCheck Contact the Technical Service Assistance8111 Error resetting the variac during the DailyCheck Contact the Technical Service Assistance8401 The file with the parameters to generate transaxials and panoramics sections

does not existOpen a study, select SecondaryReconstruction ⇒ Transaxials Setup,change the transaxials settings and save.Then select Secondary Reconstruction ⇒Panoramics Setup, change the panoramicssettings and save.

8402 Error opening for read the file with the parameters to generate transaxials andpanoramics sections


8403 Memory allocation error reading See Memory Error

8404 Access error reading Contact the Technical Service Assistance8405 Serialization error reading Contact the Technical Service Assistance8406 Error opening for write the file with the parameters to generate transaxials and

panoramics sectionsContact the Technical Service Assistance

8407 Memory allocation error reading See Memory Error8408 Access error writing Contact the Technical Service Assistance8409 Serialization error writing Contact the Technical Service Assistance9201 Error performing the CPU registry test See Memory Error. If persists contact the

Technical Service Assistance9202 Error performing the CPU integer test See 92019203 Error performing the CPU float test See 92019204 Error performing the CPU memory test See 920110801 Not enough space on the work drive to perform a scan Free space on disk. If persists contact the

Technical Service Assistance10802 Error locking 100 MByte for the scan See Memory Error10803 The Daily Check test has not been performed Perform the Daily Check (see chapter “4.2

daily check” )10804 The blank image file does not exist Contact the Technical Service Assistance10805 Error opening for read the blank image file Contact the Technical Service Assistance10806 The computer memory RAM is lower than 130 MB See Memory Error10807 Error initializing the acquisition board Contact the Technical Service Assistance10808 The software cannot calculate the dose to use 1. If the image is very bright contact the

Technical Service Assistance2. If the image is very dark verify the beam

limiter position and if persists contact theTechnical Service Assistance

10809 Error performing the Zero-Crossing test at the start of the scan Contact the Technical Service Assistance10810 The software cannot reset the variac at the start of a scan Contact the Technical Service Assistance10811 The inductive switch is active before the end of a scan Contact the Technical Service Assistance10812 The arm position is not correct Contact the Technical Service Assistance10813 The inductive switch is not active at the end of a scan Contact the Technical Service Assistance10814 The software cannot move the variac at the start of a scan Contact the Technical Service Assistance10815 The software cannot shut down the X-Ray source at the end of a scan Contact the Technical Service Assistance11001 The software is unable to calculate the free space on the Studies drive while is

creating the primary deferred reconstruction listContact the Technical Service Assistance

11701 The primary deferred reconstructions file does not exist Create a new primary deferredreconstructions list (see chapter “5.3deferred primary reconstructions”)

11702 Error opening for read the primary deferred reconstructions file Contact the Technical Service Assistance11703 Memory allocation error reading See Memory Error11704 Access error reading Contact the Technical Service Assistance11705 Serialization error reading Contact the Technical Service Assistance11706 Error opening for write the primary deferred reconstructions file Contact the Technical Service Assistance11707 Memory allocation error reading See Memory Error11708 Access error writing Contact the Technical Service Assistance11709 Serialization error writing Contact the Technical Service Assistance14201 The report area selected is too small to contains a transaxial image Change the selected report area size to

include at least an image

14401 Error creating the default report attached letter Contact the Technical Service Assistance14402 Error opening the application to edit the letter Check if WordPad accessory is present and

if not install it.14501 There are less than 100 Mbytes free on work drive Free some space on work drive14601 Advise that raw data with the old format cannot be exported Export only raw data with the new format14602 The QA phantom is bad positionated Check the phantom position14701 The application cannot create a new frame See Memory Error14702 Error creating a directory on the Export drive Check if the Export drive is read only. If

persists contact the Technical ServiceAssistance

14703 Error importing a document Check the Import drive. If persists contactthe Technical Service Assistance

14704 Error exporting a document Check the Export drive. If persists contactthe Technical Service Assistance

14705 Error removing files from the work drive Contact the Technical Service Assistance14706 Error removing files from the Import/Export drive Check the Export drive. If persists contact

the Technical Service Assistance16901 Deallocation memory error of the space reserved for the image See Memory Error16902 Deallocation memory error of the space reserved for the image See Memory Error16903 Error opening for read the image file Contact the Technical Service Assistance16904 Memory allocation error reading See Memory Error16905 Access error reading Contact the Technical Service Assistance16906 Serialization error reading Contact the Technical Service Assistance16907 Allocation memory error of the space reserved for the image See Memory Error16908 Error opening for write the image file Contact the Technical Service Assistance16909 Memory allocation error reading See Memory Error16910 Access error writing Contact the Technical Service Assistance16911 Serialization error writing Contact the Technical Service Assistance16912 Error reading the allocated image matrix See Memory Error16913 Allocation memory error of the bitmap See Memory Error16914 Deallocation memory error of the bitmap See Memory Error16915 Deallocation memory error of the bitmap See Memory Error16916 Error locking the memory reserved for the image See Memory Error16917 Allocation memory error of the space reserved for the report image See Memory Error17401 The patient birthdate is not valid Insert a valid patient birthdate17402 The patient surname is missed Insert the patient surname18101 Allocation memory error of the space reserved for a transaxial image See Memory Error18102 Deallocation memory error of the space reserved for a transaxial image See Memory Error18103 Deallocation memory error of the space reserved for a transaxial image See Memory Error18201 Allocation memory error of the buffer See Memory Error18202 Deallocation memory error of the buffer See Memory Error18203 Deallocation memory error of the buffer See Memory Error18204 Allocation memory error of the buffer See Memory Error18205 Deallocation memory error of the buffer See Memory Error18206 Deallocation memory error of the buffer See Memory Error18207 Allocation memory error of the buffer See Memory Error

18208 Deallocation memory error of the buffer See Memory Error18209 Deallocation memory error of the buffer See Memory Error18210 Allocation memory error of the buffer See Memory Error18211 Deallocation memory error of the buffer See Memory Error18212 Deallocation memory error of the buffer See Memory Error18213 Allocation memory error of the buffer See Memory Error18214 Deallocation memory error of the buffer See Memory Error18215 Deallocation memory error of the buffer See Memory Error18216 Allocation memory error of the buffer See Memory Error18217 Deallocation memory error of the buffer See Memory Error18218 Deallocation memory error of the buffer See Memory Error18219 Allocation memory error of the buffer See Memory Error18220 Deallocation memory error of the buffer See Memory Error18221 Deallocation memory error of the buffer See Memory Error18222 Allocation memory error of the buffer See Memory Error18223 Deallocation memory error of the buffer See Memory Error18224 Deallocation memory error of the buffer See Memory Error18301 Allocation memory error of the buffer See Memory Error18302 Deallocation memory error of the buffer See Memory Error18303 Deallocation memory error of the buffer See Memory Error18304 Allocation memory error of the buffer See Memory Error18305 Deallocation memory error of the buffer See Memory Error18306 Deallocation memory error of the buffer See Memory Error18307 Allocation memory error of the buffer See Memory Error18308 Deallocation memory error of the buffer See Memory Error18309 Deallocation memory error of the buffer See Memory Error18601 Allocation memory error of the buffer See Memory Error18602 Deallocation memory error of the buffer See Memory Error18603 Deallocation memory error of the buffer See Memory Error18901 One of the extreme of the Primary Reconstruction doesn't intersect the edges Move the segment and retry19601 Error opening for write a report layout file Contact the Technical Service Assistance19602 Memory allocation error reading See Memory Error19603 Access error writing Contact the Technical Service Assistance19604 Serialization error writing Contact the Technical Service Assistance19605 Error opening for read a report layout file Contact the Technical Service Assistance19606 Memory allocation error reading See Memory Error19607 Access error reading Contact the Technical Service Assistance19608 Serialization error reading Contact the Technical Service Assistance20101 Hardware key access error

Verify the code :7 - No key is present or the printer is shut-down Insert the hardware key or start-up the

printer14 - The hardware key driver has not been installed Contact the Technical Service Assistance257 - The printer is shut-down Start-up the printer

20102 The current hardware key is not the same used to the start the application Insert the hardware key used to the start theapplication

20103 The software cannot read the hardware key configuration Contact the Technical Service Assistance20104 The hardware key configuration data are not valid Contact the Technical Service Assistance20105 The software cannot read the architecture from the hardware key Contact the Technical Service Assistance20106 The hardware key architecture data are not valid Contact the Technical Service Assistance20107 The software cannot read the expiration date from the hardware key Contact the Technical Service Assistance20108 The hardware key expiration date is not valid Contact the Technical Service Assistance20109 The software cannot read the last access date from the hardware key Contact the Technical Service Assistance20110 The last access date is not valid Contact the Technical Service Assistance20111 The software cannot write the last access date to the hardware key Contact the Technical Service Assistance20112 There is n. days to the software license expiration Contact the manufacturer for the license

renewal20113 The software license is expired Contact the manufacturer for the license

renewal20114 The software can’t read the documents counter. Contact the Technical Service Assistance20115 The software can’t write on documents counter. Contact the Technical Service Assistance20116 The documents counter is at the maximun possible. Contact the manufacturer for the license

renewal20117 The software can’t create the crypted code Contact the Technical Service Assistance20118 The software can’t create the crypted code Contact the Technical Service Assistance20601 Error creating the report notes database file Contact the Technical Service Assistance20602 Memory allocation error reading See Memory Error20603 Access error writing Contact the Technical Service Assistance20604 Serialization error writing Contact the Technical Service Assistance20605 Memory allocation error reading See Memory Error20606 Access error reading Contact the Technical Service Assistance20607 Serialization error reading Contact the Technical Service Assistance20608 Error opening for write the report notes file Contact the Technical Service Assistance20609 Error opening for write the report notes database file (after the init) Contact the Technical Service Assistance20610 Memory error allocation writing during the init of the file See Memory Error20611 Access error writing during the init of the file Contact the Technical Service Assistance20612 Serialization error writing during the init of the file Contact the Technical Service Assistance21001 Today’s Phantom Scan is not present Perform a new Phantom Scan21201 Division by zero Contact the Technical Service Assistance21601 Access error writing during the init of the file Contact the Technical Service Assistance21603 Errore creating the subdirectory to export axials in Dicom format Contact the Technical Service Assistance21604 The Subdirectory to export axials in Dicom format, already exist The current study was already exported in

Dicom format in the selected path21605 The drive selected to export axials in Dicom format is full. Free space on the selected drive23201 Unable to load the '%s' language resource.\nFile: %s\nOS Error: %d DLL file of the selected language not found.

Contact the Technical Service Assistance23202 Unable to get the '%s' resource version.\nFile: %s\nOS Error: %d DLL file of the selected language is corrupt

Contact the Technical Service Assistance23203 Version mismatch on the '%s' resource.\nFile: %s\nResource version:

%s\nApplication version:%sWrong version of the DLL language file.Contact the Technical Service Assistance

11.9 Log Files visualization11.9.1 Error Log File visualizationThe software stores on file all the error messages occurring on the scanner or computer. To screen the file’scontent select from the main menu Tools ⇒⇒⇒⇒ Log File... and after choosing “Error” give confirmation with theOK button.

11.9.2 Daily Check Log File visualizationMoreover, the software also stores all the results of the daily check of the Check Scan. To screen the list,select from the main menu Tools ⇒⇒⇒⇒ Log File... and after choosing “Daily Check” give confirmation with theOK button.

11.10 Suggestions for shipment, storage, preservation and installationCarriage 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, thedevice can be installed in aroom, according to thefollowing conditions:Simulation of installation inroom 3X3,5m

120 cm

DVT

Patientbed

Protection Pb

Workstation

Display

Operator

100 cm

71 cm

192 cm

45 cm

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 / 15AThe 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 withapplicable local and national regulations (in Italy DLS 230/95). The national and local regulation will regulatethe signalling project in the installation.

NOTE: The computer must be installed out of the patient area. The connectors for the computer andpatient bed cables must be used only for their respective functions and for no other use what soever. These connectors must be handled only by authorized and qualified personnel.

WARNING!Don’t ever shift the device, after the installation: the shift can cause damages to patients and

compromise the validity of the reportThe wheels are used only for small shifts, performed only by qualified personnel, authorized by QR

S.r.l.

12. Identification and markingI- Label on DVT (one of the following):

50 Hz 60 HzQR srl – Verona Italy

045-583500

Model no: QR-DVT 9000

Serial Number:

Power: 230V∼∼∼∼ / 10 A / 50Hz

Manufactured:

WARNING: This product includes X raySource

WARNING: This product includes twolasers.

0051

QR srl - Verona Italy045-583500


Serial Number:

Power: 230V∼∼∼∼ / 10 A / 60Hz

Manufactured:

WARNING: This product includes X raySource

WARNING: This product includes twolasers.

0051

QR Srl – Verona Italy+39 045 583500


Serial Number :Power : 230V~ / 8A / 60Hz

Manufactured :

0051

CCIB

QR Srl – Verona Italy+39 045 583500



Manufactured :

0051

CCIB

QR Srl – Via Silvestrini, 2037135 Verona Italy

+39 045 583500Model no: QR-DVT 9000


Manufactured :

0051

CCIB

QR Srl – Via Silvestrini, 2037135 Verona Italy

+39 045 583500Model no: QR-DVT 9000

Serial Number :

Power : 230V~ / 8A / 60Hz

Manufactured :

0051

CCIB

II- Label on X-ray sourceWARNING!

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-110-1OX 1,5

Serial Number:

X Tube: CEI-OX-110-1HV: 110 kVp

Focal spot: 1.5 mm IECInherent Filtration: 1.8 mm Al

Total Filtration: 5.0 mm Al

QR srl - Verona Italy

Model: IMD MA5-50/60HzOX 1,5

Serial Number:

X Tube: CEI-OX/110-5ºHV: 110 kVp

Focal spot: 1.5 mm IECInherent Filtration: 1.8 mm Al

Total Filtration: 8.0 mm Al

IMD S.p.A.Via Aldo Moro, 5/7

24020 Scanzorosciate (BG) ItalyModel: MA5-50/60 Hz OX 1,5

Serial Number:

Manufactured:

Inherent filtration: 1.8 mm Al @ 110 kVpTotal filtration: 8.0 mm Al @ 110 kVp

X-ray tube: CEI - Bologna - ItalyModel OX/110-5°

HV: 110 kVpFocal spot: 1.5 IEC

QR s.r.l.Via Silvestrini, 20

37135 Verona, ItalyModel: LFX1

Serial Number:

Manufactured:


X-ray tube: CEI - Bologna - ItalyModel OX/110-5

Tube serial number


QR s.r.l.Via Silvestrini, 20

37135 Verona, ItalyModel: LFX1

Serial Number:

Manufactured:


X-ray tube: Toshiba - JapanModel DF-151SB-TTube serial number


III- Label on X-ray beam limiter

QR srl - Verona ItalyX-Ray Beam Limiter

IV- Label on additional mirror/filter

QR srl - Verona ItalyX Ray Filter

V- Label on patient table

QR srl - Verona ItalyPatient Table

Model: ______________

QR Srl – Verona ItalyX Ray Filter

Filtration 3.2 mm Al @ 110 kVp

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

ON-OFF

1

0

POWER

FUSES:F1=F2=F10A 250V

VII- Label with indication of connectors

VIII – Warning Label about the main fuses

IX – Warning Label placed near the laser output aperture

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

LASER

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 Alternate current

348 Warning, consult the attached documentation

417-…878-02-02

Type B (Applied part)

13.1 General warningsTo guarantee continuous safety of people and the device, observe always the guide lines on safety of thismanual, 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 thedevice. 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” andchapter “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. Theoperator should predict the use of an eye protection.Don’t ever leave the system unattended during the scan execution. Always keep the patient underobservation.Predict the repetition of the scan only if significative artifacts or suspects are evident in a patient image, or ifthe patient position has clearly changed.WARNING: All operators must have a sufficient knowledge of the system’s working andenvironmental 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 andpatient.

13.2 Device shutdownFor 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. Theinterruption stops automatically the X-ray emission and the movement of the scan system. The system mustbe resetted and brought to normal operative conditions, after the risk situation was identified and solved. Ifthe system doesn’t work correctly, refer immediately to technical service.

WARNING: Immediately shut down the system if the patient is in a danger condition, or if the systemdoesn’t 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 oroperators.

13.3 Emergency shutdownThe emergency stop is a large red push-button (“red mushroom”), placed above the space, in which thepatient head is placed (see figure below). Its pressure, if necessary, causes the complete inhibition of alldevice functions and the complete shutdown of the system.To inhibit completely the connection between computer and scanner (which causes the complete shutdownof 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 harshdanger, for example:a) the procedure of STOP X-ray emission doesn’t workb) danger conditions, which can cause damage to persons, environment and system, are shown

13.4 Guide lines for patients and operators safetyBy correctly operating and positioning of the patient, risks are avoided for patients and operators.Patient positioning

Follow carefully the instruction contained in 4.5 Patient positioning.Cautions in patient bed movementDon’t move the patient bed until the patient’s safety is certain and there are no obstacles for the bedmovement. Follow carefully the instruction for the correct bed positioning contained in chapter 4.3 procedurefor exam execution.X-ray protectionThe operator must follow the exam from the control workstation according to applicable dispositions; nobodymust 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 theexam, 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 beamwill 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 QualifiedConsultant.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, bymeans keyboard or mouse (see chapter “4.3 procedure for exam execution”) and remains visible for theentire scan time;b) on the scanner a lamp is present, signaled by the emission status of the X-ray source (each flash iscorrespondent to a tube flash). It begins to flash only after giving the START command at X-ray emission, bymeans of the keyboard or mouse (see chapter “4.3 procedure for exam execution”) and remains visible forthe entire effective emission time.WARNING: Don’t 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, orthey don’t became active when the command is started, or the emission hasn’t stopped at the end ofthe scheduled time, shut the system down immediately and refer to technical service.

Dose distributionThe drawing below shows the isodose curves around the device. The measure was performed according tothe 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 radiationexposure 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 therotation center of the device, and using as a diffuser the phantom (to simulate the patient head). Themeasures were performed with a ionization chamber CAPINTEC (electrometer mod.192, chamber PM-500vol. 500cc).Distances (in meters) are in reference to the device center and positive distances in vertical direction indicatethe device frontal side. The values are noted in kerma in µGy/exam, normalized to the dose value in input of60 mR.Also, a measure of stray radiation, was performed beneath device with respect to the reconstruction volumecenter:

Measured value (µGy/exam) = 0.70 µGy (Reference dose = 60 mR)

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

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

13.5 Safety devicesThe model QR-DVT 9000 is designed and manufactured according to EEC regulation. These standardsforesee 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 firsttype of protection was done by the introduction of an insulation transformer inside the machine. This one toenhance the electrical safety of peripherals connected (video, printer, computer, nuclear electronics), whichare 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 highvoltage generator, which can operate correctly with the pulsed method. In diagnostics, the applied potentialdifference must be 110 kVp-max, the anodic current 15 mA-max. The pulses are synchronized with thedetector system and their frequency is determined by data acquisition and recording time. The X-ray beamintensity varies during the scan. Through the use of a technique called SmartBeam, a system AEC

1.1 1 1 µGy = 100 µRad

(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 ofunnecessarily high doses of X-rays to the patient.Also, a device, which interrupts automatically the X-ray emission in case of malfunctioning of the acquisitionsystem or of the process control system, is employed: the computer-X-ray source system is protectedagainst 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 byDVT software. Every use, different respect the required one, can cause damage to operators, patientsand system DVT. Each maintenance operation must be performed by personnel authorized by QRS.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 6VCC - 100 mA.The mirror-filter, placed along the X-ray beam path, has purpose of X-ray beam filter and is a fundamentalelement for patient safety. It is made with a Si thickness 2.85 mm, with a double Cr layer, for total reflectionof light on the first useful surface.WARNING: The X-ray source MUST be used ONLY with the DVT and according to the functionsrequired 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 WarningAll the following devices: computer, monitor, printer, mouse, keyboard and every other device connected tothe computer of QR-DVT 9000 MUST be according to ISO and/or IEC and/or EN and/or other localregulations. 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 directlyauthorized by producer and installed by qualified technical personnel.

QR-DVT 9000 Technical Specifications

Page 1 of 9

QR-DVT 9000Dental Volumetric Tomograph

Technical Features

(Addendum to User Manual)

---------------------------------------------------------------


Page 2 of 9

Technical features

Scan system

1. Exam area: dento-maxillo-facial district2. Scan system: single rotation with volumetric acquisition (‘cone-beam’ technique)3. Scan parameters :

a) time: 75 ÷ 77 secb) X-ray emission time: 36s (50Hz) o 30s (60Hz)c) views number: 360d) sampling angle: 360°

4. Real view field:a) axial direction: (typ. 130 mm - max. 150 mm) 1b) crossed direction: (max. 110 mm)2

5. Gantry aperture (on central axial plane): 510 mm6. Dimensions:

a) width: 1890 mmb) depth: 710 mmc) height: 2000 mm

7. Weight: 360 kg8. Patient centering: 1 linear vertical laser, 1 point lateral laser

Radiological parameters

X-RAY SOURCEX-ray source Type ARDET IMDManufacturer CEI CEIModel OX-110-1 OX-110-5°Anode Tungsten (W) 19° Tungsten (W) 12°Focal spot 1.5 mm IEC 1.5 mm IECNominal high voltage 110 kV 110 kVThermal accumulation capacitance 30 kJ (40 kHU) 30 kJ (40 kHU)Anode thermal dissipation capacitance 250W (340 HU/sec) 230W (310 HU/sec)

X-ray source Type LFX1 LFX1Manufacturer CEI ToshibaModel OX-110-5 DT-151SB-TAnode Static in Tungsten (W) 12° Static in Tungsten (W) 16°Focal spot 1.5 mm IEC 1.5 mm IECNominal high voltage 110 kV 110 kVThermal accumulation capacitance 30 kJ (40 kHU) 28 kJ (40 kHU)Anode thermal dissipation capacitance 230W (310 HU/sec) 256W (379 HU/sec)

X-RAY SOURCE ASSEMBLY

1.1 1 Max value corresponding to central axial plane2 Depending on Z resolution


Page 3 of 9

X-ray source Type ARDET IMD LFX1Manufacturer QR QR QRModel ARDET-110-1 IMD MA5 LFX1Nominal high voltage 110 kVp 110 kVp 110 kVpMax anodic current 15mA 15mA 15mANominal electric power3 940 W (110 kVp - 12 mA) 940 W (110 kVp - 12 mA) 940 W (110 kVp - 12 mA)Loading factors for maxenergy input4

Not applicable Not applicable Not applicable

Wave form Pulsed beam (10 ms pulses @50 Hz, 8,3 ms @ 60 Hz)

Pulsed beam (10 ms pulses @50 Hz, 8,3 ms @ 60 Hz)

Pulsed beam (10 ms pulses @50 Hz, 8,3 ms @ 60 Hz)

Power – High voltage 230 V ~ (±10%), 50 Hz o 60Hz(±1%), 10 A

230 V ~ (±10%), 50 Hz o 60Hz(±1%), 8 A

230 V ~ (±10%), 50 Hz o 60Hz(±1%), 6 A

Power – Filament 45-65 V~, 50 Hz o 60Hz (±1%),60 VA

45-65 V~, 50 Hz o 60Hz (±1%),60 VA

45-65 V~, 50 Hz o 60Hz (±1%),60 VA

Inherent filtration 1.8 mm Al 1.8 mm Al 1,0 mm (con CEI OX-110-5),1.3 mm (con TOSHIBA DF-151SB-T) Al equivalent

Weight 27.5 kg 24 kg 23 kgDimensions 335 x 252 x 135 mm 335 x 252 x 135 mm 320x250x140 mmClassification Class I Type B Class I Type B Class I Type B

X-RAY SYSTEM

1. Additional filtration: mirror/filter NIM S-1-7 (3.2 mm Al)2. 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)3. X-ray beam limiter: NIM L-1-7 (1.5 mm Fe + 2 mm Pb), 6 VDC - 100 mA, with laser luminous

indicator4. Reference axis: connection line between focus and detector center (orthogonal at the last one)5. Focal spot to image detector distance : 950 mm (ARDET TUBE) or 935 mm (IMD – LFX1)6. Focal spot to rotation center distance: 677 mm (ARDET TUBE) or 662 mm (IMD – LFX1)7. Focal spot to skin distance (minimum): 430 mm8. Beam dimensions: cone aperture 14°9. Typical emission: 100 mAs/exam510. Patient dose: 6 mSv/exam611. Stray radiation: 1 µGy/exam7

Detector and connected systems

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

1.1 3 According to IEC 60601-2-7, 6.8.24 According to IEC 60601-1-3, 29.204.2 - the x-ray source has loading factors, predefined and monitored bycomputer, then the measure of stray radiation will be performed conditions of normal use5 Exam on head FDA phantom6 Max value on central profile of head FDA phantom7 Indicative value at 2 meters from device center on anterior side


Page 4 of 9

14. LaserAP Laser Line

Laser diode output power 2.5 mWWavelength 630-680 nmBeam divergence 1.6 mradOptical power on working plane < 1 mW

LL Laser PointLaser diode output power 2.5 mWWavelength 630-680 nmBeam divergence 1.6 mradOptical power on working plane < 1 mW

Workstation

1. Processing system: CPU Intel Pentium II - 233 MHz or higher2. RAM : EXPERT or SCAN TM = 256 MB, PROFESSIONAL or STANDARD = 128 MB, BASIC = 32MB3. Hard disk: 4 GB or higher4. Image reconstruction matrix : 512 x 5125. ‘Scout-view’ matrix: 512 x 512 o 640 x 4806. Voxel dimensions in reconstructed image: 0.25 x 0.25 x 0.3 (x 1, x 2)8 mm7. Primary reconstruction time (typical): 600 sec per 30 slices8. Possible deferred primary reconstructions9. Secondary reconstructions time : real time10. Operating system: Windows NT 4.0 / Windows 9x (optional for secondary workstations)

Images display

1. Image display matrix: 512 x 5122. Gray scale display : 256 levels3. Display window : regulation level and width4. Display monitor: 17” colors, 1280 x 1024 pixel, 16 Millions colors5. 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 sections6. Procedures of image analysis: a) distances measure: direct or on densitometric profile b) densitometric profile7. Images print: standard parallel interface for printer or digital interface for radiological laser printer

(digital protocol 3M-P831) (option)

Performance

1. Spatial resolution: 1 mm (FWHM-LSF)9

1.1 8 According to the resolution chosen in crossed direction9 Width at middle height of Line Spread Function


Page 5 of 9

2. Geometrical accuracy: 0.8 - 1 % for measures on axial or paraxial planes, 2.2 % for measures ontransaxial planes, evaluated with reference to different reconstruction modes and different spatialorientations of examined object

Patient bed

1. Type: longitudinal and vertical movement2. Command: 2 little keyboards on sides of the gantry for vertical motorized check3. Table height: from 770 to 970 mm4. Table width: 600 mm5. Table length: 1715 + 450 mm6. Weight: 90 kg

Safety

1. According to CE regulation2. Special devices:

a) ‘smart-beam’10b) ‘safe-scan’11

Other information

Absorbed power: 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 HzOutput 230 ± 2% 50/60 HzPower ≥ 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)

As regard the type of protection against electrical dangers, the device belongs at Class I. As regard the typeof protection against direct and indirect contacts, the device belongs at Type B. As regard the type ofprotection against la water insertion, the device is a common machine, with enclosure not protected againstthe water entry, not protected against the dripping and against spray, not protected against immersion. Thedevice is supplied not sterile and it must not be subjected to sterilization and disinfecting processes. Asregard the employing safety degree with an anesthetic mix, inflammable with air, oxygen, or Na protoxide, thedevice isn’t adapt to be used with these substances; the device doesn’t belong to category AP (that is, it isn’tprotected against mixing of inflammable anesthetic and air) and it doesn’t belong to category APG (that is, itisn’t 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 thedimensions of crossed tissues11 Device which stops automatically the X-ray emission in case of stop of the processing system


Page 6 of 9

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 degradedelectromagnetic compatibility performance of this device!

Electromagnetic EmissionsIEC 601-1-2

QR-DVT 9000 is suitable for use in specified electromagnetic environment. The purchaser or user of QR-DVT9000 should assure that it is used in an electromagnetic environment as described below:

Emissions Test Compliance Electromagnetic Environment

Radiated and conductedRF emissions

CISPR11

Class BQR-DVT 9000

QR-DVT 9000 is suitable for use in domesticestablishments and in establishments directlyconnected to the low voltage power supply networkwhich supplies buildings used for domesticpurposes.

QR-DVT 9000 Group 1QR-DVT 9000

QR-DVT 9000 uses RF energy only for its internalfunction. Therefore, the RF emission is very low andnot likely to cause any interference in nearbyelectronic equipment.

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


Page 7 of 9

Electromagnetic ImmunityIEC 601-1-2

QR-DVT 9000 is suitable for use in specified electromagnetic environment. The purchaser or user of QR-DVT9000 should assure that it is used in an electromagnetic environment as described below:

Immunity Test IEC 601-1-2Test Level

ComplianceLevel

Electromagnetic Environment

Electrostaticdischarge (ESD)IEC 1000-4-2

6 kV contact8 kV air

6 kV contact8 kV air

Floors are wood, concrete , or ceramictile, or floors are covered with syntheticmaterial and the relative humidity is atleast 50 percent.

Radiated RFIEC 1000-4-3

Conducted RFIEC 1000-4-6

Non-life-supportingequipment

3 V/m80 MHz to 1 GHz

Life-supportingequipment

3 V/m80 MHz to 800 MHzand 10 V/m800 MHz to 2 GHz

All equipment

3 V150 kHz to 80 MHz

3 V/m

3 V

Field strengths from fixed RF transmittersare less then 3 V/m, as determined by anelectromagnetic site survey*. Portable andmobile RF communications equipment areused no closer to any part of QR-DVT9000, including cables, than the distancelisted in the Recommended SeparationDistances Table. For portable RF sources,the distance can be estimated usingEquation A or B, according to thefrequency of the transmitter. Interferencemay occur in the vicinity of equipmentmarked with the following symbol:

Electrical fasttransient/burstIEC 1000-4-4

2 kV for powersupply lines

1 kV for input/outputlines > 3 m

2 kV

1 kV

Mains power quality is that of a typicalcommercial and/or hospital environment.

SurgeIEC 1000-4-5

1 kV differentialmode

2 kV common mode

1 kV

2 kV

Mains power quality is that of a typicalcommercial and/or hospital environment.

Voltage dips, shortinterruptions andvoltage variations onpower supply inputlinesIEC 1000-4-11

0 % Un for 0.5 cycle40 % Un for 5 cycles70 % Un for 25cycles0 % Un for 5 sec

0 % Un for 0.5 cycle40 % Un for 5 cycles70 % Un for 25cycles0 % Un for 5 sec

Mains power quality is that of a typicalcommercial and/or hospital environment.If the user of QR-DVT 9000 requiresclinical utility during power mainsinterruptions, it is recommended that QR-DVT 9000 be powered from anuninterruptible power supply.

Power frequency(50/60 Hz) magneticfieldIEC 1000-4-8

10 A/m N.A.Power frequency magnetic fields are atlevels characteristic of a typical location ina typical commercial and/or hospitalenvironment.

* 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 theelectromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should beperformed. If the measured field strength exceeds the RF compliance level above, observe QR-DVT 9000 toverify normal operation in each use location. If abnormal performance is observed, additional measures maybe necessary, such as re-orienting or relocating QR-DVT 9000, shielding the room in which QR-DVT 9000 isused, and/or adding filters to signal and/or power lines.Note: These are guidelines. Actual conditions may vary.


Page 8 of 9

Recommended Separation DistancesIEC 601-1-2

RF Source Typical Rated Power(watts)

DISTANCE(meters)

microcellular phone, CT1, CT2, CT3 10 mW 0.3 mDECT cellular phone, wireless information technologyequipment (modems, LANs)

250 mW 2 m

cellular phone, hand-held (USA) 600 mW 2 mcellular phone, hand-held (e.g. GSM and NMT, Europe;DECS 1800)

2 W8 W

4 m7 m

walkie-talkie (rescue, police, fire, maintenance) 5 W 3 mcellular phone, bag 16 W 10 mmobile radio (rescue, police, fire) 100 W 30 mFor 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 usingEquation 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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14.1 QR-DVT 900014.2 Technical Service

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

QR s.r.l.Via Silvestrini, 2037135 VeronaITALIAPhone: ++39 045 8202727Fax: ++39 045 8203040e-mail: [email protected]

new tom 9000 user manual

Documents

pointing laser

tool bar showhide

push button

confirmation

windows displaying

menuabout

horizontal

push button