First Chapter NewTom Safety Information:

This chapter includes all the operational safety information that the operator needs to be familiar with before

using the device.

Correct use of the Newtom 3G system requires that you as the operator have the appropriate specialist

knowledge and are familiar with the operating instructions.

The table below shows the description of the symbols you can find on the labels of the device:

Symbol IEC Description

~ 417-5032 Alternate current

417-5019 Protective earth

348 Warning, consult the attached documentation

417-…

878-02-02

Type B (Applied part)

2.1 Primary safety rules

To guarantee the safety of the patient and operator, always follow the guidelines reported in this manual,

particularly regarding functional tests, mechanical and electrical safety and radiation protection. Refer also

to:

Chapter 2 “Safety Information”.

Chapter 3 “Equipment safety and maintenance”.

Chapter 7 “Scanning a patient”.

Legal regulations

Carefully follow all the requirements regarding the installation, the maintenance and the usage of the device.

Always follow local regulations and standards if they are more stringent than the ones contained in this

manual.

Switching the system ON or OFF

Turn the device ON and OFF according to the procedures provided in this manual (see chapter 2.2

“Switching the system OFF” and chapter 4.8 “Switching the system ON”.

Stopping the system

In case of emergency carefully follow the instructions for an emergency shutdown of the device (see chapter

2.3 “Emergency shutdown”).

Maintenance intervals

Ensure maintenance checks are performed as prescribed in chapter 3.4 “Maintenance and service”.

During patient positioning

Before activating the centering system (comprised of two lasers) always warn the patient to close his/her

eyes. The operator should consider the use of an eyes protection.

During scanning

Never leave the system unattended during the execution of a scan. Always keep the patient under

observation.

2.2 Switching the system OFF

The following steps are used to switch the system OFF:

1. Close the Newtom 3G application by selecting File-> Exit from the main window.

2. On the bottom left corner of the window select Start -> Shut Down.

3. The “Shut Down” window will appear. From the drop list select “Shut Down” and click on the “OK”

button.

4. Wait until the computer has shut down.

5. Switch the scanner OFF by placing the main switch, located on the right side of the machine, in the

“OFF” position.

CAUTION:

Shutdown the device if not used for more than 3 hours.

2.3 Emergency shutdown

Two Emergency Stop buttons are provided in order to immediately stop the machine in case of emergency.

One button is located on the front panel of the machine above the gantry. A remote button is located next to

the operator console.

Stopping the system automatically switches off the radiation and blocks all gantry and table movements. The

patient tabletop can be pulled manually out of the gantry.

WARNING:

The emergency shutdown must be used only in case of hazardous situations like:

• The x-ray source doesn’t stop emitting.

• Dangerous conditions that can cause injury to person or damage to

the environment or to the system.

• The system indicates an emergency situation.

Remote emergency

2.4.3 Radiation protection WARNING: Since the Newtom 3G Tomograph is a radiological device, patients and operators are exposed to the risk resulting from ionizing radiations. The device must be used in compliance with safety regulations, required by current radioprotection normative and in accordance with local laws. Carefully follow the applicable regulations pertaining to X-ray safety and the requirements of a Qualified Consultant. Attendant persons The operator must monitor the scan from the operating console according to applicable procedures; nobody must be present near the patient during the exam execution. Persons required to be in vicinity of the patient during scanning must: • Put a protective clothing (lead apron etc). • Wear an appropriate dosimeter and/or a film badge. WARNING: Never approach the patient when the x-ray source is emitting. Patients If possible, reduce the exposed area of the patient by using the beam limiter system in combination with the centering system. This will allow selecting the specific area to be scanned and will protect other organs to be scanned. It is responsibility of the physician to protect patients from unnecessary exposure to radiation. WARNING: Always keep the focus-skin distance (FSD) as high as possible, according to the requested type of scan. NOTE: Consider the use of a lead apron in order to protect anatomical areas of the patient from scattered radiation. Software Configuration:  The NewTom 3G is shipped with a CD that contains the software capable of performing all NewTom 3G scanning, processing and reporting functions. However, the ability to perform these functions is controlled by several “Hardware security keys” each enabling different capabilities or “software levels”. These hardware keys are connected to the parallel or USB port of the computer workstation. The following is a list and description of each software level. SCAN: The Scan-only software allows for the operation of the NewTom 3G. The end user can only enter patient data, scan patients and perform primary reconstruction. The data may be saved on the scan computer or transferred over a LAN (local area network) or peer-to-peer network for volumetric and secondary reconstruction on another workstation. EXPERT: The Expert software provides full functionality: scanning the patient, compiling the acquired data into a volume or “primary reconstruction”, selected a “region of interest” (ROI) and create a study or “volumetric reconstruction”, performing studies (secondary reconstruction), making measurements, creating, viewing and printing reports. PROFESSIONAL: The Professional software allows reading the volumetric data produced by a primary reconstruction, creating new studies, performing secondary reconstruction, create, view and print reports. STANDARD: The Standard software allows performing secondary reconstruction on a study previously created. Besides it is possible to create, view and print reports. BASIC: The Basic software allows the end user to view reports, make accurate measurements on reports and print reports previously created with the Expert, Professional or Standard software. The software version can be showed by selecting Help _ About NNT The following window will appear: Preliminary Operation: This will help in get ready for a scan.  In this section, there is the description of all required operations that must be performed at the beginning of the day. It’s not possible to perform a patient scan, before these operations are successfully completed. 5.1 Performing the WarmUp The warm up, prepares the Xray source to perform standard operations. It’s also suggested to perform it, when the machine is off or in stand-by since a few hours (the software will advise you). Click on Scan -> X-Ray Source warm up The procedure will start automatically (it takes about 5 minutes). Warning: this procedure requires X-Ray emission. At the end, the software will return to the main window. To STOP the process, click on the Red Button placed on the bottom-left of the screen. 5.2 Running a daily check. The daily check verifies that all the system’s components are operating properly. To start a Daily Check click on Scan -> Daily Check. Note: at the beginnign of the day, the Daily Check procedure will start automatically at the end of the WarmUp procedure. Be sure the tabletop is out of the gantry. 1.8 - November 07, 2006 Page 36 of 245 The “Daily check” window will appear. This window shows the list of the tests that the system is ready to run. Click on the “Start” button. The system will perform each test and display the resulting status in real time. When the last test is completed click on Close. Now you are ready to scan a patient. During the daily check two types of error can occur. The critical error will be shown in red, the procedure will be terminated and it will not be possible to perform any patient scan. The not critical error will be shown in orange, the procedure will continue e it will be possible to perform patient scan. In any case contact the technical support. 5.3 Collimator check 1. Select Tools -> Scanner Test. 2. The scanner test window will open. Select Tools -> Collimator Check. 3. Using the three buttons located on the bottom right corner of the window select one of the three FOV, and then click on the “Acquisition” button. 4. Verify that the circle corresponding to the selected field is completely white. LARGE MEDIUM SMALL (only with 12” detector) 5. It is possible to verify each Field Of View by repeating steps 3 and 4. 6. Select File -> Close to return to the main window. 6 Blank Acquisition The Blank Acquisition process is required at the beginning of each day before scanning a patient, after a Daily Check, after the gantry has switched on and every time the operator switches between different FOV (Fields Of View). This procedure optimizes the performance of each FOV by acquiring a background image. The following steps are used to perform the Blank Acquisition. Using the IB fields dialog box, select the FOV you wish to use for the scan. In case of devices with the multiple FOV, three different options are available: • Large: corresponding to a 12” field (with 12” detector) or 9” field (with 9” detector). • Medium: corresponding to a 9” field (with 12” detector) or 6” field (with 9” detector). • Small: corresponding to a 6” field (only with 12” detector). A message indicating the arm is resetting will appear for a few seconds. Be sure the tabletop is out of the gantry. A new window will automatically be opened by the software. Click the “Rx shot” button to start the blank acquisition process. This Box will Help in how to scan a Patient, if you need a refresh course.  7 Scanning a patient: This chapter describes the procedures used for optimally preparing, positioning and scanning the patient. You should also refer to the following chapters: Chapter 2 “Safety Information”. Chapter 3 “Equipment safety and maintenance” 7.1 Preparing the patient Preparing a patient for a scan is a very important process in order to obtain a good scan. The goal is to assure that the patient feels comfortable and relaxed before and during the scan. Following are suggestions for effectively preparing a patient for a scan. Prepare the room Ensure that the patient table and the gantry are clean and the machine is ready to scan a patient (Daily Check and blank acquisition completed). Covering the patient table pad with sheet paper will suggest a clean and sterile environment. Accommodate the patient Lock the tabletop using the table brake and help the patient to sit down on the table. If necessary lower the table. If possible use a step stool. Wait before asking the patient to lie down. Arranging the patient Ask the patient to remove any earrings, necklaces, eyeglasses, or any other metal near the neck area (dentures stay in, partials are removed). Problematic patient Particular care should be taken if the patient is a child, an older person, or is obese or claustrophobic. Exam Explanation Briefly review the scan procedure with the patient, including entering patient data, patient positioning and scanning. Proper breathing  Breathing slowly avoids swallowing. Ask the patient to continue breathing slowly during the exam execution. (It is actually impossible to swallow while you are breathing.) Relax Ask the patient to keep the teeth together during the scan without clenching. Avoiding delays Complete all preliminary steps prior to examination. Keep examination times short and avoid any delays. Vocal instructions Instruct the patient about the vocal instruction and information that the operator may offer during the scan. 7.3 Entering patient data To start a scan click on Scan -> New scan. The “Patient List” window will appear. Two options are available: 1. New patient: the patient has never been scanned (he/she doesn’t have any record in the application database) 2. Existing patient: the patient has already been scanned (his/her data are stored in the application database). Depending on the status of the patient, insert the patient data as explained in the next sections. 7.3.1 Adding a new patient To add a new patient, select the “New” button. The “Patient File” window will appear. Insert the patient data (surname and birth date are required by the software, the other fields are optional). When you have finished, click on the “OK” button. 7.3.2 Opening an existing patient To select an existing patient type the initial, part or the entire surname inside the “Search” field, then click on the “Update list” button. The “Patient list” window will be updated, displaying all the patients that match the criteria used for the search. Highlight the patient to be scanned and select the “OK” button. The “Insert label” dialog will appear. Type a distinguishing comment related to this scan. This will help identify different scans conducted on the same patient. Type your comment and click on OK. 8.3 RawData window The RawData can be viewed in a window like the following one. This window includes patient data, exam data, an area to view the movie of the scan and different commands Following are brief descriptions of each field: 1. Patient Data: shows patient name and date of birth. 2. Image area: shows the images acquired during the scan. 3. Exam parameters: display information about the scan: KV: KiloVolt used by the x-ray source for the scan. mA: milliAmpere used by the x-ray source for the scan. mAs: product of the tube current and x-ray exposure time measured in seconds. S: time corresponding to the x-ray emission during the exam. Dose (mGy): dose (in milliGray) corresponding to the AIR RATE in the center of the acquired area, using the visualized radiological parameters (kV, mA, mAs). Detector field: size of the detector field used for the scan. 4. “Check Scan” button: allows creating a temporary axial slice. 5. “Primary Reconstruction” button: starts a Primary Reconstruction. 6. “Primary & Study Reconstructions” button: starts a Primary Reconstruction automatically followed by a study reconstruction. 7. Movie toolbar: includes all the commands to show the images of the scan. Shows the first image. Perform a 90 degrees step backward. Move to the previous image. Play the movie of the scan backward. Stop the movie of the scan. Play the movie of the scan forward. Move to the next image. Perform a 90 degrees step forward. Shows the last image. 8. Arm Position diagram: display the position of the x-ray source and the detector corresponding to the displayed image. 8.4 Starting a Primary Reconstruction The Primary Reconstruction is the process that compiles the RawData into a volume. This volume consists of a stack of axial slices. The following explains how to run a Primary Reconstruction. Select File->Open… The “Choose NNT Document” window will appear. Click on the “RawData” button. The “Raw Data List” window will appear. Highlight the desired patient by clicking on the name and then select the “OK” button. The software will show the first image of the scan. Select the “Primary Reconstruction” button  The “Reconstruction Parameters” dialog box will appear. Different settings can be selected for the Primary Reconstruction: Reconstruction Step: Define the thickness of the axial slices. H-High Resolution: Provide the best resolution with less noise reduction. Requires the longest processing time as well as the most storage space. High Resolution: Provide the best mix between image resolution and noise. This is the default option, suggested by the software. Standard: Provide images with lower resolution but apply the maximum noise reduction. Field Size: Define the size of the axial images. Small Field: The axial images will have a smaller size with a higher resolution. Large Field: The axial images will have the maximum size. Once you have selected your settings click on the “OK” button. NOTE: It is suggested to perform the primary reconstruction using one of the two high resolution options. Infact acting in this way give the opportunity to still choose between high and standard resolution subsequently during the study creation. Two green lines will appear on the lateral image. Using the mouse move the two lines in order to define the area that will be reconstructed. The lines can be moved just up or down, without changing the inclination Once the size of the area has been defined right click. The “Reconstruction Options” box will appear. You can insert a comment that will be associated with this Primary Reconstruction, by typing on the upper box. After typing a comment three different options can be selected: 1. Start: starts the Primary Reconstruction process. 2. Store: store the settings in order to run the Primary Reconstruction later. 3. Cancel: abort the process Select “Start”. The reconstruction process will start immediately and a progress bar will appear. At the end of the process the “Visualization window” will appear, showing the central axial of the reconstructed area. For a detailed explanation of this dialog refer to 10.10.1 “Visualization window After changing your settings click on the “Apply” After changing your settings click on the “Apply” button. NOTE: The adjustments made with the Visualization Window will be applied to all the axial images, before creating the volumetric data. The volumetric data window will appear.