NewTom VG User Manual rev 4.0 - Image Works

VGi User Manual 

Rev. 1.0 - February, 15 2009

NOTES: 

This document is provided for the own use of the operator of the equipment. 

QR s.r.l. reserves the right to change the contents of this manual without notice. 

This document may not, in whole or in part, be modified, copied, reproduced, distributed, translated, stored 

on magnetic or optical media and published, over networks, electronic bulletin boards, web sites or other online 

services, without the express written permission of QR s.r.l. 

The original version of this manual has been written in English language. 

NEWTOM VGi is a commercial trademark of QR s.r.l. 

All other products and brand names are registered trademarks or trademarks of their respective companies. 

NEWTOM VGi is manufactured and distributed by: 

QR srl 

Via Silvestrini, 20 

37135 Verona 

Italy 

Phone: +39 045 8202727 

Fax +39 045 8203040 

e-mail: info@qrverona.it 

www.qrverona.it 

All rights reserved. 

Rev. 1.0 - 02/15/2009 Page 1 of 72

MANUFACTURER’S NOTICE ABOUT MEDICAL DEVICES: 

The medical device described in this manual, composed by Scan Unit (gantry), patient support (patient table) 

and Control, display and computation unit (Main Workstation) as delivered and configured by the 

manufacturing and servicing personnel, is a medical radiological device subject to the safety requirement 

stated by both international standards and local regulation. 

Any change, modification, update on either hardware 1 or software 2 , on the device and operating settings as 

released form factory and as installed (and in any case different from what has been specified on the 

device's attached documentation), can cause the partial or total device impossibility to operate as expected. 

Moreover its safety features can be changed with increased hazard for the patient, operator and surrounding 

environment. 

So, in case that the final user need to modify or change any of the above specified items, he/she has to be 

allowed in written by QR s.r.l. 

Any act outside of what has been stipulated on this notice will cancel the warranty. Moreover the person 

and/or organization will be liable for any damage and/or incident and/or deterioration in the state of health of 

a patient, user or other person and/or the surrounding environment. 

1 Adding a memory expansion, a new board on the connection bus, a new printer, the replacement of the graphic adapter is a 

significant change. 

2 Including the Operating System an applications already installed when the device has been delivered and/or installed. Operating 

system automatic updates, changes on the network connection parameters, modification and/or addition and/or removal of hardware 

interface software (device driver) and/or system services (example: file sharing) and/or applications, constitute a significant change. 

Rev. 1.0 - 02/15/2009 Page 2 of 72

Index 

INDEX 

1 INTRODUCTION TO THIS MANUAL........................................................................................................ 5 

1.1 CONTENTS................................................................................................................................................. 5 

1.2 STRUCTURE............................................................................................................................................... 5 

1.3 STYLE CONVENTIONS ................................................................................................................................. 6 

1.4 ABOUT USING THIS MANUAL ........................................................................................................................ 6 

2 ABOUT SAFETY ....................................................................................................................................... 7 

2.1 GENERAL SAFETY RULES ............................................................................................................................ 7 

2.2 TURNING THE DEVICE OFF........................................................................................................................... 8 

2.3 EMERGENCY SHUTDOWN ............................................................................................................................ 9 

2.4 PATIENT'S AND USER'S SAFETY GUIDELINES ............................................................................................... 10 

2.4.1 Patient positioning ........................................................................................................................... 10 

2.4.2 Patient's exit .................................................................................................................................... 11 

2.4.3 Protection from ionizing radiation.................................................................................................... 11 

2.5 LASER EXPOSURE .................................................................................................................................... 12 

2.6 SAFETY NOTES......................................................................................................................................... 12 

3 SAFETY AND MAINTENANCE OF THE DEVICE.................................................................................. 14 

3.1 INSTALLATION REQUIREMENTS .................................................................................................................. 14 

3.2 GUIDELINES FOR SAFETY .......................................................................................................................... 15 

3.3 CHANGES IN THE DEVICE .......................................................................................................................... 15 

3.4 DEVICE MAINTENANCE .............................................................................................................................. 16 

3.5 CLEANING AND DISINFECTION.................................................................................................................... 17 

3.5.1 Chemical agents to avoid................................................................................................................ 17 

3.5.2 Cleaning .......................................................................................................................................... 18 

3.5.3 Disinfection...................................................................................................................................... 18 

3.5.4 Sterilization...................................................................................................................................... 18 

3.6 TRANSPORT AND STORAGE....................................................................................................................... 18 

3.7 DEVICE DISPOSAL..................................................................................................................................... 19 

3.7.1 Information for the device owner..................................................................................................... 19 

3.7.2 Information for the Disposing/Recycle centers ............................................................................... 19 

4 GETTING STARTED…............................................................................................................................ 20 

4.1 AN INTRODUCTION TO THE SYSTEM............................................................................................................ 20 

4.2 WORKING PRINCIPLE ................................................................................................................................ 20 

4.3 OVERALL VIEW ......................................................................................................................................... 21 

4.4 SCANNER UNIT ......................................................................................................................................... 22 

4.4.1 Controls placed on the scanner unit................................................................................................ 22 

4.4.2 Controls on the head support keyboard .......................................................................................... 23 

4.5 CONTROL BOX.......................................................................................................................................... 24 

4.5.1 Main switch...................................................................................................................................... 24 

4.5.2 Input panel....................................................................................................................................... 24 

4.6 STANDARD ACCESSORIES ......................................................................................................................... 25 

4.6.1 Cables ............................................................................................................................................. 26 

4.7 OPTIONAL ACCESSORIES .......................................................................................................................... 26 

4.8 SYSTEM STARTUP .................................................................................................................................... 27 

4.9 SYSTEM SHUTDOWN................................................................................................................................. 27 

5 PRELIMINARY PROCEDURES .............................................................................................................. 28 

5.1 X-RAY SOURCE CONDITIONING.................................................................................................................. 28 

5.2 DAILY CHECK........................................................................................................................................... 28 

5.3 BLANK ACQUISITION.................................................................................................................................. 29 

5.3.1 Invalidate blank acquisition ............................................................................................................. 29 

5.4 BEAM LIMITER TEST .................................................................................................................................. 30 

5.5 COMPLETELY LIFT DOWN THE ROTATING ARM............................................................................................. 30 

6 SCANNING .............................................................................................................................................. 31 

6.1 SCANNING A PATIENT................................................................................................................................ 31 

Rev. 1.0 - 02/15/2009 Page 3 of 72

Index 

6.1.1 Preparing the patient ....................................................................................................................... 31 

6.1.2 Positioning the patient and starting a new scan.............................................................................. 33 

6.2 SCANNING A DENTURE.............................................................................................................................. 35 

6.2.1 Preliminary operations..................................................................................................................... 35 

6.2.2 Denture positioning ......................................................................................................................... 35 

7 QUALITY ASSURANCE.......................................................................................................................... 36 

7.1 PHANTOM POSITIONING ............................................................................................................................ 36 

7.2 SAMPLE IMAGES....................................................................................................................................... 38 

7.3 STORAGE OF QA DATA............................................................................................................................. 38 

8 TROUBLESHOOTING............................................................................................................................. 39 

8.1 COMMUNICATIONS PROBLEM..................................................................................................................... 39 

8.2 ROTATING ARM......................................................................................................................................... 39 

8.3 IMAGE ACQUISITION .................................................................................................................................. 39 

9 IEC61223: ACCEPTANCE TEST............................................................................................................ 40 

9.1 POSITIONING OF THE PATIENT SUPPORT [PARAGRAPH 5.1].......................................................................... 40 

9.2 PATIENT POSITIONING ACCURACY [PARAGRAPH 5.2]................................................................................... 40 

9.2.1 Axial patient positioning accuracy [paragraph 5.2.1] ...................................................................... 40 

9.2.2 Sagittal and coronal patient positioning light [paragraph 5.2.2] ...................................................... 40 

9.3 TOMOGRAPHIC SECTION THICKNESS [PARAGRAPH 5.3]............................................................................... 40 

9.3.1 Tomographic section thickness for axial scanning [paragraph 5.3.1] ............................................. 40 

9.3.2 Tomographic section thickness for helical scanning [paragraph 5.3.2] .......................................... 40 

9.4 DOSE [PARAGRAPH 5.4]............................................................................................................................ 40 

9.5 NOISE, MEAN CT NUMBER AND UNIFORMITY [PARAGRAPH 5.5] ................................................................... 40 

9.6 SPATIAL RESOLUTION [PARAGRAPH 5.6] .................................................................................................... 40 

9.7 IEC 61223-3-5 REFERENCE TABLE........................................................................................................... 41 

APPENDIX A: TECHNICAL REFERENCE .................................................................................................. 43 

APPENDIX B: STANDARDS CONFORMITY .............................................................................................. 63 

APPENDIX C: LABELS ................................................................................................................................ 65 

Rev. 1.0 - 02/15/2009 Page 4 of 72

Introduction to this manual 

1 Introduction to this manual 

1.1 Contents 

This manual was created as a mean to provide information and instructions about using a NewTom VGi 

device. 

Dedicated software routines (scan, data processing, reporting, document management) and their user 

instructions are described in the attached Software Manual. 

"User Manual" and "Software Manual" should be read and clearly understood in every part before starting 

using the device. 

It is suggested to store this manual along with any other documentation and to use it whenever a new staff 

member has to be trained for using the device. 

1.2 Structure 

This manual is divided in the following chapters: 

• Chapter 1 (Introduction to this manual): 

it provides information about contents, structure and conventions inside the document. 

• Chapter 2 (About safety): 

information about user's and patients' safety and primary procedures regarding the use of the 

device. 

• Chapter 3 (Safety and maintenance of the device): 

information about safety requirements and the device maintenance. 

• Chapter 4 (Getting started…): 

gives an overall description of the system and of its main parts. 

• Chapter 5 (Preliminary procedures): 

illustrates the procedure for a proper initialization of the device. 

• Chapter 6 (Scanning): 

describes the process for patient's positioning and scanning. 

• Chapter 7 (Quality assurance): 

gives instructions about executing the Quality Assurance process. 

• Chapter 8 (Troubleshooting): 

a list of faults and suggestions about their resolution. 

• Chapter 9 (IEC61223: Acceptance Test): 

procedures for testing as required by IEC61223 standard. 

Besides these chapters, you can find the appendices: 

• APPENDIX A: Technical Reference 

• APPENDIX B: Standards conformity 

• APPENDIX C: Labels 

Rev. 1.0 - 02/15/2009 Page 5 of 72

Introduction to this manual 

1.3 Style conventions 

Primary information about safety and possible notes are included in this manual in the following form: 

DANGER: 

It alerts for a potential danger which may cause injury or death of a person. 

WARNING: 

It signals the presence of a potential danger which may damage the device. 

NOTE: 

It gives information not regarding the device and/or the user's and/or a 

patient's safety. 

1.4 About using this manual 

This manual is written in such a way to provide the user all the know-how that is necessary for the device, 

the user's and a patient's safety. To this purpose, chapters regarding people and device safety must be read 

carefully, getting confident with the procedures described there. 

Rev. 1.0 - 02/15/2009 Page 6 of 72

About safety 

2 About safety 

This chapter includes information about safety that must be learnt by the user before using the device. 

For a proper use of a NewTom VGi device, the operator needs to have in-depth knowledge of the mode of 

operation and of the related controls. 

The table below describes the symbols found on the device labels. 

Symbol IEC Description 

~ 417-5032 Alternate current 

348 Caution, consult the attached documentation 

417-5019 Protection ground 

417-5017 Functional ground 

N 445 Connection point of the neutral wire 

L 

Connection point of the Line 

417-… 

878-02-02 

Type B (Applied part) 

ISO 361 

Ionizing Radiation 

Directive 

2002/96/CE 

WEEE - Waste from Electrical and Electronic 

Equipment Symbol 

2.1 General safety rules 

In order to guarantee people's safety, please always follow the instructions inside this manual, especially the 

ones about functional tests, mechanical and electrical safety and protection against ionizing radiation 

exposure. Please refer to: 

Chapter 2 "About safety" 

Chapter 3 "Safety and maintenance of the device" 

Chapter 6 "Scanning" 

Rev. 1.0 - 02/15/2009 Page 7 of 72

About safety 

Local laws 

Carefully follow every requirements about installation and maintenance of the device. Please refer to the 

local laws whenever these may be more strict than the instructions inside this manual. 

Switching on and off of the device 

Turning the device on and off must be performed according to the procedures described inside this manual 

(see 2.2 "Turning the device off" and 4.8 "System startup"). 

Emergency stop 

In case of an emergency, follow the instructions referring to the device emergency stop, see 2.3 "Emergency 

shutdown". 

Maintenance time lag 

Please be sure that the maintenance controls that are described in 3.4 "Device maintenance" are performed. 

During patient positioning 

Before activating the positioning laser always warn the patient to close his/her eyes. 

While scanning a patient 

NEVER leave the system without a supervisor during the execution of an exam. Always watch the patient all 

along the scan process. 

Artifacts 

Please contemplate the repeating of a scan ONLY if suspect or significant artifact are evident in a patient's 

images, or if a patient's position appreciably changed during the exam. 

WARNING: 

Every operator must have a deep knowledge of the system operative and 

environmental features, he/she also must know the procedures to follow in 

case of emergency. 

WARNING: 

Never use the device without the supervision of an operator. 

NOTE: 

Please consider the realization of an audio/video communication system between the 

operator and the patient, especially when the operator controls the device from a 

protected and remote location. 

2.2 Turning the device off 

Hereafter the procedure for a proper turning off of the device is described: 

1. Close the software. 

2. Shutdown the operating system. 

3. Wait for the workstation power off. 

4. Turn the unit off by mean of the main switch, which is situated on the Control Box. 

Rev. 1.0 - 02/15/2009 Page 8 of 72

About safety 

WARNING: 

Turn off the device when it has not been used for longer than 3 hours. 

WARNING: 

Always turn the device off at the end of the working time. 

2.3 Emergency shutdown 

The device is supplied with two emergency buttons. A first button is placed on the user's table (see figure), 

whereas the second one is by the main switch, on the control box. The switching off of the device through an 

emergency button causes a prompt break in the x-ray emission and the interdiction of every motor 

movement function. 

WARNING: 

The emergency button must be used only in a danger situation, such as: 

• The X-Ray source does not stop emitting; 

• Dangerous conditions may damage people, the environment or the device; 

• Whenever the system signals an emergency state. 

Remote emergency button 

Rev. 1.0 - 02/15/2009 Page 9 of 72

About safety 

2.4 Patient's and user's safety guidelines 

Risks for a patient and for involved people are avoided working in a proper way and correctly positioning the 

patient. Special care should be taken in case of disabled or injured people. 

2.4.1 Patient positioning 

Be sure that a patient is properly placed inside the scan area, with his/her head on the head support, and 

that no part of his/her body may impact the device or be pressed during the positioning and the examination. 

Be sure that a patient's garments and hair may not get caught. Similarly regarding catheters and ECG 

cables. 

Do not perform any movement until the patient's safety is assured and there are no obstacles to the device 

movement. 

Refer to Par. 6.1.2 - "Positioning the patient and starting a new scan" for a proper positioning for a patient. 

Rev. 1.0 - 02/15/2009 Page 10 of 72

About safety 

2.4.2 Patient's exit 

After the end of an exam or after an emergency shutdown, you can let the patient go without waiting for the 

rotating arm to return to the start position. 

2.4.3 Protection from ionizing radiation 

WARNING: 

NewTom VGi is a radiological device and therefore it exposes operators and 

patients to the risks consequent to the exposure to ionizing radiation. It must 

be used according to safety rules that are contemplated by the local laws 

regarding this matter. 

Always carefully follow the applicable regulations about radio-protection and the directions from a Certified 

Radiation Protection Expert. 

Operator 

An operator must oversee the examination process from his/her control position according to the laws in 

force; NO ONE SHOULD BE BY THE PATIENT DURING THE EXAMINATION PROCESS. 

If a patient panics and an operator's intervention is needed during the examination process, the operator 

must be equipped with proper protection clothing and devices, according to the laws. 

WARNING: 

Never stand close to the device during x-ray emission. 

Patient 

It is the user's responsibility to protect the patients from needless exposures to x-ray. 

NOTE: 

Consider the possibility to use a leaded cloth to protect the patient from the 

scattered radiation. 

Devices displaying the emission 

The x-ray emission is signalled by: 

1. A signal on the workstation screen such as the one reported below. It appears on video just after the 

START command has been sent via keyboard or mouse (see Chapter 6 "Scanning"). It is displayed all 

along the scan process. 

2. Light indicators (LEDs) inside the control panels. They can be found on the sides of the Scanner Unit. 

They light on just after the START command has been sent via keyboard or mouse (see Chapter 6 

"Scanning"). They stay on all along the scan process. 

Rev. 1.0 - 02/15/2009 Page 11 of 72

About safety 

WARNING: 

If the x-ray emission signals are on when the specific command has not been 

sent or if they are off after a START emission command or if the x-ray emission 

does not stop after the supposed time, IMMEDIATELY TURN THE DEVICE OFF 

and contact technical assistance. 

2.5 Laser exposure 

WARNING: 

Do not stare into the laser beams, do not view directly with optical instruments, 

and avoid direct exposure to the beam. The beams can cause permanent eye 

damage. 

WARNING: 

Keep your eyes at least 50 cm from the laser when the beam is on. 

If necessary, use appropriate protective glasses. 

WARNING: 

The use of controls, adjustments, or the performance of procedures other than 

those specified herein may result in hazardous radiation exposure. 

The device is equipped with a cross shaped positioning laser. The beam is emitted from an aperture in the 

front cover. 

The vertical line shows the reconstructed volume sagittal central plane. The horizontal line shows the 

reconstructed volume axial central plane. 

Fori apertura laser 

2.6 Safety notes 

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About safety 

Workstations, displays, printers, keyboards and other devices which may be connected to the main NewTom 

VGi workstation MUST comply with ISO and/or IEC and/or EN standards and/or local laws in force. QR srl is 

available for further information. 

The manufacturer is not accountable for faults and/or malfunctioning of parts that were not supplied or 

approved by QR srl, or not installed by technical staff qualified and certified by QR srl. 

Food and beverage may not be placed or eaten/drunk close to the device and the workstation. 

Rev. 1.0 - 02/15/2009 Page 13 of 72

Safety and maintenance of the device 

3 Safety and maintenance of the device 

This chapter includes information about environmental safety and care for the device. General information 

and procedures regarding the device maintenance are also provided. 

The user is responsible for a proper use of the system, according to the instructions and procedures which 

are described inside this manual. Particularly an user must comply with the following points: 

• The device may be used only by authorized and properly trained (about the system and the 

protection from radiation exposure) personnel. He/she may also know the regulations regarding the 

use of radiological devices. 

• The device may never be used in case of any evident electrical mechanical or radiological 

malfunctioning. Especially a device can not be used whenever the x-ray emission displays and/or 

the emergency button are not working properly. 

3.1 Installation requirements 

The system must be installed in a medical environment, according to a Qualified Expert recommendations. 

A device may not be exposed to acids, corrosive substances, saltiness and wet. 

Operating temperature: +10° ÷ +35° Celsius. 

Operating humidity condition: min 10%, max 85% not condensing. 

Installation site minimum dimensions: 80” x 80”. 

The device must be installed on a flat horizontal floor. 

When using a chair make sure it is a safe supportive chair with a backrest lower than 30”. 

The power supply connection must be implemented according to the laws in force and to the instructions 

from the Service Manual. 

Don’t use temporary connections such as adapter and extension cords to connect the computer and 

peripherals to the mains. 

The equipment should be permanently connected to the mains according to the instructions stated in the 

Service Manual. 

The medical environment for the installation has to be designed by an expert in protection from ionizing 

radiation exposure according to the laws in force. Local laws shall also rule the design of the signposting. 

WARNING: 

Never move a device after it has been installed. Moving a device may damage 

people, the device itself or the environment. 

Connect only approved peripherals, computer and cables to the equipment as 

specified by the manufacturer. 

NOTE: 

The workstation must be located outside the patient's area (keeping a distance of at 

least 1,5m away from the patient) . Cables connected to the workstation can ONLY 

be used to connect the workstation itself. Such cable and their connections can 

ONLY be handled by authorized and qualified personnel. 

Rev. 1.0 - 02/15/2009 Page 14 of 72


3.2 Guidelines for safety 

The device is not protected against liquid or gas infiltration. Liquid intrusion may damage the electrical parts 

and put the patient, the user and the environment in danger. 

Safety systems of the device do not decrease safety measures against the risk of fire in the place in which 

the device has been installed. 

Electrostatic discharge 

Electrostatic discharge may damage electrical parts in the device. Consequently the floor in the installation 

room should be made of antistatic materials. 

Extinguishers 

CO 2 extinguishers should be installed in an easily accessible area. 

X-Ray lamp 

It is possible for the user to install a x-ray lamp in order to signal the ready and emission states of the x-ray 

source. 

Door switches 

The system contemplates the possibility for the installation of an external switch that can stop the emission 

(typically installed on the entrance of the device room). 

Electromagnetic compatibility 

For information regarding the electromagnetic compatibility please refer to APPENDIX A: 

Reference. 

Technical 

3.3 Changes in the device 

Possible changes or updates for the system must comply with the laws in force. 

WARNING: 

It is forbidden to open or manumit the device with any tool. 

Whatever change (hardware or software) that was not previously authorized is 

forbidden and can inhibit a proper working in the device. It may also damage the 

patient, the user, the device and the environment. 

Responsibility limits 

The manufacturer is not in charge for safety, reliability and performance features in the following 

cases: 

• Installation, maintenance, changes, repairs and/or updates were not performed by personnel 

that was not directly authorized by the manufacturer or distributor. 

• Replace parts were not approved by the manufacturer or distributor. 

• Environmental conditions were not conform according to the requirements of the laws in force 

and to the suggestions of a qualified expert. 

• The device is used in a way that is not corresponding to what is described inside this manual. 

Rev. 1.0 - 02/15/2009 Page 15 of 72


3.4 Device maintenance 

WARNING: 

Always turn the power off the device before any maintenance act. 

WARNING: 

The device has no repairable part inside. Never remove the device covers. 

WARNING: 

The only part that can be repaired by the user is the input fuse. It is placed in 

the input panel, on the control box side. New fuses must comply with the 

manufacturer specification. 

WARNING: 

In order to guarantee protection against the risk of fire, replace only with fuses 

of the same type and range. 

Regular maintenance 

Regular maintenance is required to guarantee a proper working of the device and safety for the patient, the 

user and other people. 

The device maintenance and repair must be performed only by personnel that was directly authorized by the 

manufacturer or the distributor. Every part of the system can only be tested and if needed substituted by 

qualified personnel. 

WARNING: 

If the x-ray source has not been working for longer than three months, please 

perform a beam forming procedure (see "Software Manual" - Appendix A). 

Dangerous cleaning substances 

Some cleaning substances should be avoided to prevent damage to people and to the device (see 3.5.1 

"Chemical agents to avoid"). 

Preventive maintenance 

Please periodically check the workstation-scanner, workstation-control box and control box power supply 

cables. Also verify the connections between the workstation parts (display, keyboard, mouse, printer) 

according to the manufacturer instructions. 

Parts and accessories storage 

Other parts or accessories must be stored according to their technical specifications. 

Malfunctioning 

If the system is not working as described inside this manual, please immediately contact the technical 

service. 

Rev. 1.0 - 02/15/2009 Page 16 of 72


Maintenance agreement 

The device should be periodically checked: please contact the manufacturer or distributor to discuss for a 

maintenance contract. 

System testing check list 

The following check list specifies the suggested time spaces for the system controls. For further information 

please contact Your local distributor. 

Responsible Part Activity Frequency 

User Global system QA phantom check Weekly 

Radioprotection 

expert (RPE) Global system Radiological routine In charge of the 

RPE 

Error Log Check 12 months 

Every external part Damage check 12 months 

Technical staff Emergency button Emergency test 12 months 

Electrical functioning Check 12 months 

Mechanical functioning Check 12 months 

3.5 Cleaning and disinfection 

This chapter gives general information about cleaning and disinfection of the device. 

WARNING: 

Power the device off before any cleaning. 

Some cleaning or disinfecting products may damage Your health. Such products concentration in the air 

should never exceed the local laws' limits. In this aim always follow the manufacturer instructions and be 

sure that the room is well airy. 

3.5.1 Chemical agents to avoid 

• Do not use spray or solvent which may enter the device, causing damage electrical parts or forming 

inflammable mixtures. This could put in danger the patient, the user and the environment. 

• Do not use abrasive liquids such as acetone, gas oil or alcohol (exception: alcohol can be used for the 

cleaning of the workstation display). These substances can deteriorate surfaces and materials that are 

responsible for the device proper working. 

• Do not use substances that may release ammonia due to dissociation or decomposition. Ammonia can 

corrode. 

• Do not use cleaning products containing silicone: it tends to accumulate and possibly damage electrical 

contacts. 

Rev. 1.0 - 02/15/2009 Page 17 of 72


3.5.2 Cleaning 

3.5.2.1 Scanner and control box 

The device must be cleaned with a wet cloth and a soft solution. The cloth should be wet before applying it 

on the scanner surface. 

WARNING: 

Do not apply cleaning solutions directly on the device surface. 

3.5.2.2 Workstation and periphera ls 

Follow the manufacturer's instructions for cleaning the workstation and its peripheral units. If these are 

missing, please refer to the previous paragraph. 

To clean the display use a wet cloth with alcohol or a solution made up of 1/3 to 2/3 distilled water and 

alcohol. 

NOTE: 

For further information about safety and maintenance of the device please contact 

your local distributor. 

3.5.3 Disinfection 

Despite the device do not require any disinfection, it is suggested to use standard disinfection product for the 

cleansing of the head support. 

3.5.4 Sterilization 

No sterilization is required for the normal use of the device. 

3.6 Transport and storage 

During transport and storage the following conditions must be observed: 

Transport and storage temperature: 

Transport and storage humidity: 

-20° to +70° (Ce lsius) 

min 10%, max 85% not condensing. 

Do not expose to acids, saltiness, rain. 

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3.7 Device disposal 

3.7.1 Information for the device owner 

This symbol, on a device label, shows that the product can not be disposed along with other urban 

garbage. 

The separate collection of this equipment at the time of disposal is managed by the dealer. When 

disposing the equipment the user should contact the dealer and follow the suggested procedure to 

allow the separate collection and recycling of this equipment at the time of disposal. 

The separate collection and recycling of your waste equipment at the time of disposal will help to 

conserve natural resources and ensure that it is recycled in a manner that protects human health 

and the environment. 

In case of unauthorized disposal of the device there are sanctions that vary according to the local 

and/or regional regulations. 

For workstations and every other peripheral disposal it is necessary to refer to the attached instructions 

provided by their manufacturers. 

3.7.2 Information for the Disposing/Recycle centers 

Divide the x-ray source, the mechanical and electrical parts, plastic covers and workstation with its 

peripherals. 

X-ray sources contain oil that must be extracted for its proper disposal. 

Plastic parts must be disposed through approved procedures. 

For other parts that have no specific instructions by its manufacturer, please refer to the local laws and 

guidelines about health, safety and environment protection. 

Rev. 1.0 - 02/15/2009 Page 19 of 72

Getting started… 

4 Getting started… 

This chapter provides a brief introduction for the NewTom VGi system, its power on and off routines and 

control devices. 

4.1 An introduction to the system 

The device NewTom VGi is a panoramic 3D system, dedicated to dento-maxillo-facial area imaging. It 

performs the so called "cone-beam" technology. 

NewTom VGi is intended for diagnosis of the dento-maxillo-facial complex. 

It’s designed for: 

 

 

 

imaging of temporo mandibular joints; 

imaging of mandibula/jaw for surgical planing; 

imaging of nasal/sinus and maxillofacial complex; 

A patient is made to lean on the head support and centered by means of 2 laser modules and "scout view" 

images. 

The scanning system performs a completely rotation around the patient's head. Radiological images are 

acquired, that are then automatically processed by the system. The result is the slices set that forms the 

reconstructed volume. At the end of this process the axial slices set composes the Volumetric Data. Through 

these data it is possible to display coronal and sagittal views of the reconstructed volume in real time. 

After defining a Region Of Interest (ROI), from the volumetric data the user can start the creation of a study. 

The ROI can be inclined from the volumetric data both to obtain perpendicular images and to correct 

positioning errors. 

Working on the study data it is possible to create panoramic, transaxial and 3D images. You can also work 

on these kinds of images measuring distances, angles, putting comment etc. 

Finally new images can be saved inside the study. 

The study images can be used to compile a report, that can be then printed and/or saved on a physical 

support. 

To study in deep these themes please refer to the Software Manual. 

4.2 Working principle 

According to the cone-beam technology, the source detector system performs a single rotation around the 

patient's head, simultaneously acquiring every necessary data for the volumetric reconstruction. Data 

acquired each scan step are the digital images corresponding to the radiographic projection. The raw data 

set so collected is used in the volumetric tomographic reconstruction process. 

This technology brings some advantages: 

• direct reconstruction of any set of the scanned object points without passing through axial reconstruction 

and data re-formatting; 

• total scan time related to the acquisition electronics, rather than to the x-ray tube power and the 

mechanics, usually shorter; 

• under same conditions of total scan time, less requirements in regards to the source/tube assembly 

power and scan mechanics, with constructive and maintenance advantages. 

Rev. 1.0 - 02/15/2009 Page 20 of 72


4.3 Overall view 

The system is made up of three main parts: scanner unit, control box and main workstation. It is also 

possible to add more workstations for data processing and storage. This subject is discussed in the 

"Software Manual". 

NOTE: 

The system may not be expanded with parts or accessories other than the ones 

described inside this manual. 

Rev. 1.0 - 02/15/2009 Page 21 of 72


4.4 Scanner unit 

4.4.1 Controls placed on the scanner unit 

The scanner unit is the main part of the system, it performs the scan. Two control panels are placed on the 

columns side. They have the same appearance and function: the control of the positioning movements, the 

light display of the x-ray source emitting state and the control of the positioning laser beam. 

Hereafter a short description of each button and sign. 

X-ray light display: 

the LEDs turn on during the x-ray. 

Vertical movement enable button: 

it enables the functioning of the buttons for vertical movements. 

Vertical movement buttons (up/down): 

to move up or down the structure supporting the rotating arm, press 

one of them simultaneously with the corresponding enabling button. 

Rotation movement enable button: 

it enables the functioning of the buttons for rotating arm movements. 

Rotating arm movement buttons: 

to rotate the arm clockwise or anti-clockwise, press one of them 

simultaneously with the corresponding enabling button. 

Laser button (only for devices with positioning laser beam): 

press to turn the positioning laser beam on/off. The laser will stay light 

up for about 60 seconds 

Rev. 1.0 - 02/15/2009 Page 22 of 72


4.4.2 Controls on the head support keyboard 

Now it comes described the function of every button: 

Horizontal movement buttons (DX/SX): 

allows the movement of the head support system in the horizontal 

direction (right / left) 

Vertical movement buttons (UP/DOWN): 

allows the movement of the head support system in the vertical 

direction (up / down) 

Transversal movement buttons (FR/RR): 

allows the movement of the head support system in the transversal 

direction (front / rear) 

Rev. 1.0 - 02/15/2009 Page 23 of 72


4.5 Control box 

The control box contains the electronics devices that manage the functioning of the system. 

4.5.1 Main switch 

On the external surface of the control box You can find the main switch to turn the system on/off and the fuse 

support. 

Main Switch 

Emergency Button 

Input Fuse Holder 

4.5.2 Input panel 

On the same side of the main switch You can find the panel from which cables depart to the power supply, to 

the scanner and to the CAN bus interface on the workstation. 

CAN bus connection to 

workstation 

Optional output for door switch 

Optional output 

for external lamp 

Power supply input 

Output for table 

emergency button 

Rev. 1.0 - 02/15/2009 Page 24 of 72


4.6 Standard accessories 

Along with the device some standard accessories are supplied. They are: 

Head support: 

it is fixed to the scanner unit. It makes possible for correct 

patient's positioning and prevents excessive movement of 

the patient during the scan. 

QA phantom: 

used for the execution of the quality assurance procedure. 

Calibration base: 

it allows for placing the QA phantom on the scanner unit. 

Rev. 1.0 - 02/15/2009 Page 25 of 72


4.6.1 Cables 

The device also includes linking cables between workstation-scanner unit and workstation-control box. They 

are: 

Ethernet cable (4 pairs/26 AWG-FTP-5E) (workstation scanner unit) 

CAN bus cable (2 pairs/24 AWG-shielded) (workstation control box). 

Furthermore, a bundle of cables exits the control box and connects to the scanner unit. 

The manufacturer also provides the power supply cable with an end connected to the control box, it is in 

charge of the user to connect it to the mains during installation. 

WARNING: 

Accessories, transducer and cables different from the ones here specified may 

change the electromagnetic compatibility characteristics of the device. 

4.7 Optional accessories 

At the present time there are no optional accessories for a NewTom VGi system. 

Rev. 1.0 - 02/15/2009 Page 26 of 72


4.8 System startup 

To properly turn the device on: 

1. Power the scanner unit on with the main switch (on the control box). 

2. Turn on the workstation. (Please refer to its manual). 

3. Wait for the workstation operating system to startup. 

4. Log in the operating system with user name and password as described in the Software Manual. 

5. NNT application will automatically open. 

NOTE: 

Always turn the scanner unit on first. If You try to use the NNT software before the 

appliance has done its initialization successfully, an error will occur (see 8.1 - 

Communications problem). 

4.9 System shutdown 

Please refer to the Par. "2.2 - Turning the device off". 

Rev. 1.0 - 02/15/2009 Page 27 of 72

Preliminary procedures 

5 Preliminary procedures 

This chapter describes the procedures to perform compulsorily before starting scanning patients. 

These procedures are three: 

• X-Ray source conditioning; 

• Daily check; 

• Blank acquisition; 

This chapter describes also some required and/or useful functions: 

• Beam limiter test 

• Completely lift down the rotating arm 

X-Ray source conditioning and Blank acquisition must be performed every two weeks (14 days), while Daily 

check is mandatory every day, before patients acquisitions. 

If these procedures are not performed the software will disable the scan functions. 

Operating modes are described in detail in the same named chapter from the "Software Manual". 

5.1 X-Ray source conditioning 

The conditioning procedure is needed to prepare the x-ray source for its routine working. 

The software asks to perform it every two weeks. It is suggested to perform the conditioning also if the 

device does not operate for days. 

REMOVE 

Before starting the procedure, please verify that the 

scan area is completely free from objects. 

Remove the head support. 

At the end of conditioning process, the software will automatically starts Daily check and Blank acquisition 

procedures. 

5.2 Daily Check 

By mean of the Daily Check procedure the system verifies that each every part of itself properly works. 

Rev. 1.0 - 02/15/2009 Page 28 of 72


5.3 Blank acquisition 

Blank acquisition allows to optimize the scan performance acquiring a background image. 

This procedure is request by the software every two weeks. 

REMOVE 

Before starting the procedure, please verify that the 

scan area is completely free from objects. 


The resulting blank acquisition image will look like 

shown in the figure. Please verify that no artifacts or 

objects appear. 

5.3.1 Invalidate blank acquisition 

To invalidate blank acquisition follow the steps below: 

Select the wished detector field 

Rev. 1.0 - 02/15/2009 Page 29 of 72


From the NNT software main toolbar select Scan 

Invalidate Blank. 

At the next detector field selection the NNT software 

will ask a new blank acquisition 

5.4 Beam limiter test 

NOTE: 

This procedure applies only to devices with multiple FOV. 

From the NNT software main toolbar select Tools Scanner Test. The service window will appear.From 

the service window toolbar select the Tools Beam Limiter Test. To verify hires field lead collimator 

position: 

Press “Beam limiter test Acquisition” button. 

Verify the acquired image: the light gray rectangle must be vertically center between the two red lines. 

5.5 Completely lift down the rotating arm 

This function is useful to completely move down the rotating arm. For example during transport , in case of 

mobile application , is suggested to position the arm completely down. 

WARNING: 

Please, verify there are no objects that can obstruct the downward movement of 

the arm before using this function! 

To completely lift down the rotating arm follow the steps below: 

1. From the NNT software main toolbar select Tools Scanner Test. The service window will appear. 

2. From the service window toolbar select the Tools Lift down the rotating arm. 

Rev. 1.0 - 02/15/2009 Page 30 of 72

Scanning 

6 Scanning 

This chapter describes the procedures to follow for a proper patient's or denture positioning and examination. 

The exact procedure to perform a scan on a patient or on a denture can be found in the corresponding 

chapter inside the Software Manual. 

Please also refer to: 

Chapter 2 "About safety"; 

Chapter 3 "Safety and maintenance of the device". 

It is possible to perform the scanning in 3 modalities: 

Full field ("Full"), High Resolution Zoom ("HiRes Zoom") 

and "Zoom". 

Select the modality in the "Scan Manager" panel. 

6.1 Scanning a patient 

6.1.1 Preparing the patient 

An important step in a scan routine is well preparing the patient. This can contribute to a proper scanning 

and to high quality images. The aim of such preparing is making the patient relaxed and in a good position 

before and during the scan. Here are some suggestions that can help in this concern. 

Room setting 

Be sure that the scanner unit is clean and ready to scan ("Daily Check" and "Blank Acquisition" already 

performed). 

Preparing the patient 

Ask the patient to remove if present any jewelry (earrings, necklaces), glasses and removable metallic 

prothesis. 

Accommodate the patient 

After to have made accommodate the patient in the scanning area, set the scanner and the head support 

system so as to frame the interested area and the neck/bust of the patient assumes an erected position. 

Particular patients 

A special care has to be taken in case of children, elderly people, claustrophobic people, physically or 

mentally disabled. 

Explanation of the examination 

Please explain in short the scan routine to the patient, including the data collection process, the positioning 

and scanning. 

Proper breathing 

Ask the patient to breathe slowly during the scanning (a slow and continuous breath helps from swallowing). 

Rev. 1.0 - 02/15/2009 Page 31 of 72

Scanning 

Relaxation 

Ask the patient to keep the mouth closed without grinding the teeth together. 

Avoiding delays 

Good examination times can be obtained also by carrying out all the preliminary procedures before starting 

the scan itself. 

Voice instructions 

Introduce the patient possible voice instructions that the operator may give during the scan. 

Rev. 1.0 - 02/15/2009 Page 32 of 72

Scanning 

6.1.2 Positioning the patient and starting a new scan 

Hereafter is a description of how to position and center a patient inside the scan area. Perform these action 

just when the software signals them. 

WARNING: 

The scan area (the place in which a patient is positioned during the scan) must 

be free from any objects, except from the head support. They may damage the 

patient or invalidate the scan results. 

C 

B 

A 

Set the head support to the default condition (the 

positioning of the three rulers (A, B, C) must be set 

on the "D" position) by means of the head support 

keyboard (make reference to the Par. “4.4.2 - 

Controls on the head support keyboard”) 

Using the positioning keyboard located on the side of 

the scanner (make reference the Par. “4.4.1 - 

Controls placed on the scanner unit”), move the 

rotating arm structure vertically so that the patient 

can easily enter the gantry (the head support should 

be approximately at the patient's head height). 

Move the patient to the head support without leaning 

on the structure. 

Turn on the positioning lasers through the positioning 

keyboard. 

NOTE: 

Ask the patient to close the eyes before turn on the 

positioning lasers. 

The vertical line crosses through the vertical axis of 

the scanned volume, and should correspond to the 

patient's sagittal plane. 

Scanned 

Height when in 

zoom mode 

Upper horizontal 

line 

Lower horizontal 

line 

The upper horizontal line is: 

- The center of the scanned volume when in "Full" 

Volume mode 

- The upper limit of the scanned volume when in 

one of the "Zoom" mode 

The lower horizontal line is the lower limit of the 

scanned volume in both "Full" Volume mode and 

"Zoom" modes. 

Rev. 1.0 - 02/15/2009 Page 33 of 72

Scanning 

Set the height of scanner with the positioning 

keyboard so to frame the area of interest with the 

laser lines (the lower line being the lower limit of the 

scanned volume). 

When in "Zoom" mode, adjust the height of the chin 

support with the head support keyboard, so to level 

with the patient's chin. 

Make the patient lean the head onto the chin and the 

head support, and ask him/her to grab the handle at 

the sides. 

You may now want to finely further adjust the location 

of the scanned volume with the head support 

keyboard. 

NOTES: 

Head support at the highest position is for 

mandibulary "Zoom" mode, at the lowest position is 

for maxillary "Zoom" mode. 

If the patient ends up in a forced position, you may 

need to re-adjust the height of the gantry via the 

positioning keyboard. 

Stabilize the patient’s head with the provided strap. 

After to make sure that the rotating arm does not hit 

the patient's shoulders (rotate shortly the arm through 

the movements keyboards), proceed with the 

verification of the corrected positioning of the patient 

by means of the AP (anterior - posterior) and the LL. 

Rev. 1.0 - 02/15/2009 Page 34 of 72

Scanning 

6.2 Scanning a denture 

6.2.1 Preliminary operations 

Data about the denture are to be inserted, if they are not already in the software database. For details refer 

to the Software Manual. 

6.2.2 Denture positioning 

Hereafter are the operations to perform to properly position and center the denture inside the scanning area. 

Perform such steps according to the software instructions. 

Remove from the head support the movable lower 

part for the patient's chin. 

Fix the denture to a proper support in such a way 

that it assumes the same position as in the patient's 

mouth. 

A better centering of a patient's head is achievable 

through the use of the AP (anterior - posterior) and 

the LL (lateral - lateral) scout views. 

Then it is possible to perform the scanning, as 

described in the "Software Manual". 

Rev. 1.0 - 02/15/2009 Page 35 of 72

Quality assurance 

7 Quality assurance 

The quality assurance process consists in performing a routine scan on the specific phantom, through an 

automated procedure. It is recommended to perform such a test at least once a week, in order to assure the 

proper functioning of the device and the validity of a scan results. 

Before starting the Quality Assurance (QA) procedure the FOV must be selected. 

The test procedure is described inside the Software Manual. 

7.1 Phantom positioning 

Hereafter the procedure to properly place and center the QA phantom inside the scan area is described. 

Please perform these actions exactly when the software signal them. 

REMOVE 


Fix the calibration base. 

Rev. 1.0 - 02/15/2009 Page 36 of 72


B 

A 

C 

Place the QA phantom on its base in a central 

position. 

In order to facilitate the correct positioning of the 

phantom, set up the head support being used the 

keys of the head support keyboard (make reference 

to the Par. “4.4.2 - Controls on the head support 

keyboard”). 

Ruler A (Height) position “QA” 

Rulers B and C (width, depth) default position (“D”) 

1a scout view 

The first displayed scout view represents the 

phantom as seen by the scanner in the start position. 

Using this reference one can center the phantom in 

the direction perpendicular to the rotating arm. 

Repeat this step as many times as necessary (the 

aluminium cylinder should appear between the 

vertical sketched red lines and the inner small 

spheres to the QA should be crossed from the 

horizontal sketched red lines). 

Frontally center the QA phantom using the 

information from the second scout view, which is 

acquired as the rotating arm is in a 90 degrees 

position. 

It is now possible to perform the scan of the 

phantom. 

For more details about the QA scan please refer to 

the "Software Manual". 

2a scout view 

Rev. 1.0 - 02/15/2009 Page 37 of 72


7.2 Sample Images 

Hereafter some sample images from a QA phantom analysis. 

Side view. 

Axial view. 

Panoramic view. 

7.3 Storage of QA data 

The software automatically stores each phantom analysis report. The reports can be opened by selecting 

from the main menu View QA Report. 

To move among the reports list use the PAGE DOWN, PAGE UP keyboard button. 

It is possible to save a copy of the QA report analysis in PDF format: select menu File Save as PDF. 

It is recommended to save a printed copy of each report. 

Rev. 1.0 - 02/15/2009 Page 38 of 72

Troubleshooting 

8 Troubleshooting 

The following tables list problems that may occur and quick instructions to follow to solve them. If the "What 

to do…" column lists more than a solution, please try with the first one and so on till the problem full 

resolution. 

8.1 Communications problem 

The workstation cannot connect to the scanner unit or to the control box 

ErrCode Hal Error Cause What to do… 

2103 n.a. Emergency button is pressed. Unlock the emergency button. 

17601 16-001 

The device is not powered. 

The CANbus cable might be 

disconnected. 

See 4.8 System startup 

Connect and/or verify the cable. 

17601 20-001 

The Ethernet cable might be 

disconnected. 

Connect and/or verify the cable. 

8.2 Rotating arm 

The rotating arm does not move 

Cause 

What to do… 

The internal part controlling the rotating arm Close the software, turn the device off, wait for about ten seconds, 

motor encountered a problem. 

then retry. See 4.8 System startup. 

8.3 Image acquisition 

Image quality 

Description Probable cause What to do… 

Reconstructed axial 

images are completely 

dark. 

Blank acquisition may have been 

performed with some object or even 

someone inside the scan area. 

Perform a new Blank Acquisition. The scans that 

resulted in dark images must be repeated. 

Every reconstructed axial 

images contain white 

circular artifacts. 

The head support structure was 

mounted during the Blank Acquisition 

routine. 

Perform a new Blank Acquisition. The scans that 

resulted in dark images must be repeated. 

Rev. 1.0 - 02/15/2009 Page 39 of 72

IEC61223: Acceptance Test 

9 IEC61223: Acceptance Test 

A description of the software utilities for the execution of acceptance test can be found in the Software 

Manual. Here are reported specific instructions to perform such tests (please refer to norm IEC61223-3-5) 

along with the corresponding paragraph from the norm. 

9.1 Positioning of the patient support [paragraph 5.1] 

Not applicable. 

9.2 Patient positioning accuracy [paragraph 5.2] 

The NewTom VGi (version Zoom/HiRes) is equipped with cross-shaped laser pointer aimed to help the 

patient positioning. The horizontal line locates the scanned volume central axial plane, the vertical line 

locates the scanned volume central sagittal plane. No location pointer has been provided for coronal plane 

location. 

9.2.1 Axial patient positioning accuracy [paragraph 5.2.1] 

Position an object along the axial plane located by the horizontal line and scan it. 

See Software manual for data analysis. 

9.2.2 Sagittal and coronal patient positioning light [paragraph 5.2.2] 

Position an object along the sagittal plane located by the horizontal line and scan it. 

See Software manual for data analysis. 

9.3 Tomographic section thickness [paragraph 5.3] 

9.3.1 Tomographic section thickness for axial scanning [paragraph 5.3.1] 

See "Software Manual". 

9.3.2 Tomographic section thickness for helical scanning [paragraph 5.3.2] 

Not applicable. 

9.4 Dose [paragraph 5.4] 

Take required scans for each modality according to IEC 60601-2-44. The machine calculates automatically 

the loading factors, according to the scanned object. There is no way to select manually loading factors for a 

scan. 

9.5 Noise, mean CT number and uniformity [paragraph 5.5] 


9.6 Spatial resolution [paragraph 5.6] 


Rev. 1.0 - 02/15/2009 Page 40 of 72


9.7 IEC 61223-3-5 reference table 

This table supplies reference values and reference conditions to be used when applying the IEC 61223-3-5 

as acceptance test, when specified by contractual agreements. 

5.1 Positioning of the 

patient support 

N.A. 

5.2 Patient positioning 

accuracy 

5.2.1 Axial patient positioning 

accuracy 

±10mm from isocenter 

5.3 Tomographic section 

thickness 

5.2.2 Sagittal and coronal patient 

positioning light accuracy 

5.3.1 Tomographic section 

thickness for axial scanning 

5.3.2 Tomographic section 

thickness for helical scanning 

±10mm from isocenter 

Loading factors: automatically selected by the 

software. 

Thickness 

Raccomanded criteria 

5.0 mm ±1.0 mm 

1.0 mm ±0.5 mm 

0.5 mm -0 +0.5 mm 

N.A. 

5.4 Dose 

Loading factors: automatically selected by the software. 

Dose Mode: Standart Dose 

CTDI FREE AIR 

CTDIvol 

Full Mode CTDI 100w 

Zoom Mode CTDI 100w 

HiRes Zoom Mode CTDI 100w 

N.A. 

Equal to CTDI 100w 

2.4 mGy ±30% 

2.0 mGy ±30% 

7.3 mGy ±30% 


Dose Mode: Boosted Dose 

CTDI FREE AIR 

CTDIvol 

Full Mode CTDI 100w 

Zoom Mode CTDI 100w 

N.A. 

Equal to CTDI 100w 

4.5 mGy ±30% 

3.3 mGy ±30% 

5.5 Noise, mean CT 

number and uniformity 


Values are calculated as Arbitrary Unit (a.u.) because of the machine is not designed to 

give HU. 

Measured with Catphan 500. 

Dose Mode: Standart Dose 

Standard deviation (water) 

Full Mode 340 a.u. ± 80 

Zoom Mode 340 a.u. ± 80 

HiRes Zoom Mode 400 a.u. ± 80 

Rev. 1.0 - 02/15/2009 Page 41 of 72


Dose Mode: Boosted Dose 

Full Mode 250 a.u. ± 80 

Zoom Mode 240 a.u. ± 80 

Mean CT number (water) 

Full Mode 8000 a.u. ± 1000 

Zoom Mode 8000 a.u. ± 1000 

HiRes Zoom Mode 8000 a.u. ± 1000 

Uniformity (water) 

Full Mode less than a 1600 a.u. 

Zoom Mode less than a 1100 a.u. 

HiRes Zoom Mode less than a 1100 a.u. 

5.6 Spatial resolution 


FP MTF 50 (lp/cm) MTF 10 (lp/cm) 

(Full Mode) >7 >12 

(Zoom Mode) >7 >13 

(HiRes Zoom Mode) >9 >17 

Rev. 1.0 - 02/15/2009 Page 42 of 72

APPENDIX A: Technical Reference 


Rev. 1.0 - 02/15/2009 Page 43 of 72


Scanner unit 

Scanning system 

(cone beam technology) 

Single rotation and volumetric acquisition. 

Scan parameters 

Full mode: 

Time / X-Ray emission time 

18 s / 3.6 s 

HiRes Zoom Mode: 


27 s / 3.6 – 5.4 s 

Zoom Mode: 


18 s / 3.6 s 

Sampling angle 360° 

Patient's centring Fixed position Motorized Head support and 

positioning lasers 

Anatomical analyzed volume Cylinder Full mode: 

Ø max 15 cm 

h max 15 cm 

HiRes Zoom e Zoom: 

Ø max 12 cm 

h max 7.5 cm 

Weight and dimensions 

Scanner Unit 

Width (diameter occupied 

during a scan) 

1130 mm 

Depth (max) 

1500 mm 

Height 

2300 mm 

1970 mm (VG Short version) 

Max Weight 

272 Kg 

Control Box 

Width 

605 mm 

Depth 

310 mm 

Height 

925 mm 

Weight 

100 Kg 

Rev. 1.0 - 02/15/2009 Page 44 of 72


Detector 

Pixels 1920 x 1536 

Pixel size 127 x 127 µm 

Pixel depth 14 bit 

S/N 90 dB 

Frame rate Max 30 F/s 

Scout view radiological images 

Full mode: 

Image pixels 960 x 768 Pixels 

Pixel depth 14 n. 

Pixel Size 0.254 x 0.254 mm 

HiRes Zoom mode: 




Zoom mode: 




Reconstructed volume 

Full mode: 

Shape 

Cylinder 

Diameter 150 mm 

Voxel Size 0.3 mm 3 



HiRes zoom mode: 

Shape 

Cylinder 





Rev. 1.0 - 02/15/2009 Page 45 of 72


Zoom mode: 

Shape 

Cylinder 





Rev. 1.0 - 02/15/2009 Page 46 of 72


Radiological parameters 

TUBE IAE mod. x22 0.3/0.6 

Rev. 1.0 - 02/15/2009 Page 47 of 72


Rev. 1.0 - 02/15/2009 Page 48 of 72


Rev. 1.0 - 02/15/2009 Page 49 of 72


Rev. 1.0 - 02/15/2009 Page 50 of 72


Rev. 1.0 - 02/15/2009 Page 51 of 72


X-ray tube head 

Brand 

Modello 

P.S.M. s.r.l. 

HF1R 

X-ray tube IAE X22 0.3/0.6 

Classification (IEC 601-1) 

Class I Type B 

Mechanical data 

Head material 

Heat storage capacity 

Maximum continuos heat dissipation 

Aluminum 

550 kJ 

60 W @ 110kV, 3.6 mA, 10 ms, 15 FPS 

Maximum temperature 3 60° 

Minimum inherent filtration @ 70 kV 

Oil volume compensation 

1.4 mm Al 

Rubber tank 410 cm³ 

Dimensions 325 x 145 x 215 

Weight 

15 kg 

Electrical Data 

Maximum output voltage 

Cathode to Ground 

Anode to Ground 

Maximum anodic current @ 110 kV 

Maximum tube voltage @ 20 mA 

Maximum electrical output power 4 

Nominal electrical power, 4s emission 5 

120 kV 

60 kV 

60 kV 

20 mA 

110 kV 

2.2 kW 

2.2 kW 

Maximum power ripple


Cooling Curve 

Rotor 

HF1R 

Startup 230Vac / 0.8s / 10A 

Running 60Vac / 2A 

X-ray source assembly 

X-ray tube head 

HF1R 

X-ray tube IAE X22 0.3/0.6 

Focal spot to image detector distance 

630 mm 

Focal spot to skin distance (minimum) 

150 mm 

Total filtration 

1.4 mm Al (inherent filtration) + 13 mm Al (Additional filtration) 

Beam size (cone aperture) 

238 mm x 179 mm (detector area) 

X-ray voltage accuracy 6 < 10% 

X-ray current accuracy 7 < 20% 

Radiation Linearity 8 < 20% 

X-Ray emission time accuracy 9 

< 10% + 1 ms 

INVERTER 

Manufacturer 

P.S.M. s.r.l. 

Model 

HF1 3.5kW 

6 According to IEC 60601-2-7, par. 50.104.1 




Rev. 1.0 - 02/15/2009 Page 53 of 72


INPUT 

Maximum power 

3.5 kW 

Power supply 230 V∼ (± 10%) 

Wave form 

Sinusoidal 50/60 Hz 

Maximum current 

16 A 

Apparent resistance of supply mains 

0.14 ohm 

OUTPUT 

Peak voltage 

350 Vpk 

Maximum peak current 

120 Apk Max. 

Wave form 

Sinusoidal 20 kHz 

MECHANICAL DATA 

Dimensions 

160 x 280 x 235 mm 

Weight 

7 kg 

Rev. 1.0 - 02/15/2009 Page 54 of 72


Dose declaration 10 

Dose declaration for Standard Dose Mode 

Values are expressed in mGy/scan. Their tolerance is ± 30% 

FOV Full Mode 11 Zoom Mode 12 HiRes Zoom Mode 13 

CTDI 100 Center 2.34 2.10 7.54 

CDTI 100 0 2.24 1.80 7.35 

CDTI 100 90 2.26 2.00 7.25 

CDTI 100 180 2.24 1.80 7.35 

CDTI 100 270 2.26 2.00 7.25 

CTDI 100 (periferico) 2.25 1.90 7.30 

CTDI w 2.34 1.96 7.23 

Dose declaration for Boosted Dose Mode 

Values are expressed in mGy/scan. Their tolerance is ± 30% 

Date: 2009-02-04 

FOV Full Mode 14 Zoom Mode 15 

CTDI 100 Center 4.48 3.36 

CDTI 100 0 4.51 3.21 

CDTI 100 90 4.53 3.23 

CDTI 100 180 4.51 3.21 

CDTI 100 270 4.53 3.23 

CTDI 100 (periferic) 4.52 3.22 

CTDI w 4.48 3.25 

Date: 2009-02-04 

10 Measured using “head phantom” according to IEC 60.601-2-44 Sec. 29.1.102.2 

11 Loading factors: automaticamente impostati dal software, normalizzati a 110kV, 2.4mA, 3.6s, 8.45mAs 



14 Loading factors: automaticamente impostati dal software, normalizzati a 110kV, 6.5mA, 3,6s, 23.58mAs 


Rev. 1.0 - 02/15/2009 Page 55 of 72


16 

16 Measured using head phantom according to IEC 60601-2-44 par.29.1.102.2 

Rev. 1.0 - 02/15/2009 Page 56 of 72


Laser 

Laser diode output power 

0.9 mW 

Wavelength 

635 nm 

Beam divergence 70º 

Pulse length 

Continuous wave 

Classification Class 1 

Other data 

Absorbed power 

200 V ∼ (± 10%) / 215 V ∼ (± 10%) / 230 V ∼ (± 10%) / 240 V ∼ (± 10%) 

50/60 Hz (± 1%) 

5 A (during x-ray emission) 

0.66 A (stand by) 

100 V ∼ (± 10%) / 115 V ∼ (± 10%) 

50/60 Hz (± 1%) 

10 A (during x-ray emission) 

1.16 A (stand by) 

Operating temperature: +10 ÷ +35 °C 

Operating humidity: 

10% ÷ 85 % (not condensing) 

Transport and storage temperature: -20 ÷ +70 °C 

Transport and storage humidity: 

10% ÷ 85 % (not condensing) 

Rev. 1.0 - 02/15/2009 Page 57 of 72


Electromagnetic Compatibility 

Clause 6.8.3.201 Technical Description - Tab 201 Guidance and manufacturer's declaration - 

electromagnetic emissions - for all equipment and systems 

TABLE: Guidance and manufacturer's declaration - electromagnetic emissions 

The device NewTom VGi is intended for use in the electromagnetic environment specified below. The customer 

or the user of the device NewTom VGi should assure that is used in such an environment. 

Emission Test Compliance Electromagnetic environment – guidance 

RF emissions 

CISPR11 Group 1 The equipment NewTom VGi uses RF energy only for its internal function. 

Therefore its RF emissions are very low and are not likely to cause any interference 

in nearby electronic equipment. 

RF emissions 

CISPR11 

Class A 

The equipment NewTom VGi is suitable for use in all establishments other than 

domestic and those directly connected to the public low-voltage power-supply 

network that supplies buildings used for domestic purposes. 

Harmonic emissions 

IEC 61000-3-2 

Class A 

Voltage fluctuation/flicker 

emissions 

IEC 61000-3-3 

Complies 

Rev. 1.0 - 02/15/2009 Page 58 of 72



electromagnetic immunity - for all equipment and systems 

TABLE: Guidance and manufacturer’s declaration – electromagnetic immunity 

The equipment NewTom VGi is intended for use in the electromagnetic environment specified below. The 

customer or the user of the device NewTom VGi should assure that is used in such an environment. 

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – 

guidance 

Electrostatic 

discharge 

(ESD) 

IEC 61000-4-2 

± 6 kV contact 

±8 kV air 

6 kV contact 

8 kV air 

Floors should be wood, concrete, or ceramic 

tile. 

If floors are covered with synthetic material the 

relative humidity should be at least 50 percent. 

Electrical fast 

transient / burst 

IEC 61000-4-4 

±2 kV for power supply lines 

±1 kV for input/output lines 

2 kV 

1 kV 

Mains power quality should be that of a typical 

commercial and/or hospital environment. 

Surge 

IEC 61000-4-5 

±1 kV differential mode 

±2 kV common mode 

1kV 

2kV 


commercial and/or hospital environment. 

Voltage dips, short 

interruptions and 

voltage variations on 

power supply input 

lines 

IEC 61000-4-11 

95% dip in U t) for 0,5 cycles 

40% U t 

(60% dip in U t) for 5 cycles 

70% U t 

(30% dip in U t) for 25 cycles 

Complies 

Complies 

Complies 


commercial and/or hospital environment. If the 

user of NewTom VGi requires continued 

operation during power main interruptions, it is 

recommended that NewTom VGi be powered 

from an uninterruptible power supply or a 

battery. 

95% dip in U t) for 5 sec 

Functions Interruption 

Power frequency 

50/60Hz magnetic field 

IEC 61000-4-8 

3 A/m Complies 

Power frequency magnetic fields should be at 

least characteristic of a typical location in a 

typical commercial or hospital environment. 

Rev. 1.0 - 02/15/2009 Page 59 of 72



electromagnetic immunity - for equipment and systems that are not life-supporting 

TABLE: Guidance and manufacturer’s declaration – electromagnetic immunity 

The equipment NewTom VGi is intended for use in the electromagnetic environment specified below. The 

customer or the user of the device NewTom VGi should assure that is used in such an environment. 

Immunity Test IEC 60601 Test Level Compliance Level Electromagnetic Environment – guidance 

Portable and mobile RF communications equipment 

should be used no closer to any part of the NewTom 

VGi, including cables, than the recommended 

separation distance calculated from the equation 

applicable to the frequency of the transmitter. 

Conducted RF 

IEC 61000-4-6 

3 Vrms 

150 kHz to 80 MHz 

3 Vrms 

Recommended separation distance: 

d = 1.2 √P 

Radiated RF 

IEC 61000-4-3 

3 V/m 

80 MHz to 2,5 GHz 

3 V/m 

d = 1.2 √P 80 MHz to 800 MHz 

d = 2.3 √P 800 MHz to 2.5 GHz 

where P is the maximum output power rating of the 

transmitter in watts (W) according to the transmitter 

manufacturer and d is the recommended separation 

distance in meters(m). 

Fields strengths from fixed RF transmitters, as 

determined by an electromagnetic site survey*, should 

be less than the compliance level in each frequency 

range**. 

Interference may occur in the vicinity of equipment 

marked with the following symbol: 

Notes: 

(1) At 80 MHz and 800MHz, the separation distance for the higher frequency range applies 

(2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, 

objects and people 

*Field strengths from fixed transmitters, such as base stations for radio (celular/cordless), telephones and land mobile radios, amateur radio, 

AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment 

due to fixed RF transmitters, an electromagnetic site survey should be performed. If the measured field strength in the location in which the 

NewTom VGi is used exceeds the RF compliance level above, the NewTom VGi should be observed to verify normal operation. If abnormal 

performance is observed, additional measures may be necessary, such as re-orienting or relocating NewTom VGi 

**Over the frequency range 150 kHz to 80 MHz, field strhgths should be less than 3 V/m 

Rev. 1.0 - 02/15/2009 Page 60 of 72


Clause 

6.8.3.201 Technical Description - Tab 206 Recommended separation distances between 

portable and mobile RF communications equipment and the equipment or system - for 

equipment and systems that are not life-supporting 

TABLE: Recommended separation distances between portable and mobile RF 

communications equipment and the equipment 

The device NewTom VGi is intended for use in the electromagnetic environment in which radiated RF 

disturbances are controlled. The customer or the user of the device NewTom VGi can help prevent 

electromagnetic interference by maintaining a minimum distance between portable and mobile RF 

communications equipment and the device NewTom VGi as recommended below, according to the maximum 

output power of the communication equipment. 

Rated maximum output power of 

transmitter 

W 

Separation distance according to frequency of transmitter 

150 kHz to 80 MHz 

d= 

m 

80 MHz to 800 MHz 

0,001 0.037 0.037 0.072 

d= 

800 MHz to 2,5 GHz 

d= 

0,1 0.37 0.37 0.72 

1 1.2 1.2 2.3 

10 37.9 37.9 7.27 

100 120 120 23 

For transmitter rated at a maximum output power not listed above, the recommended separation distance in meters (m) can be estimated 

using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts 

(w) according to the transmitter manufacturer. 

Notes: 

(1) At 80 MHz and 800MHz, the separation distance for the higher frequency range applies 

(2) These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from structures, 

objects and people. 

Rev. 1.0 - 02/15/2009 Page 61 of 72

APPENDIX B: Standards conformity 

All components, accessories, spare parts must be approved and supplied by QR S.r.l. 

Particularly, the connection cables must be ONLY the ones described under 4.6.1 “Cables”. 

WARNING: 

Use of accessories, transducers, and cables other than those specified may 

result in degraded electromagnetic compatibility performance of this device! 

CAUTION! 

NewTom VGi should not be stacked directly on top of other equipment, and 

other equipment should not be stacked on top of NewTom VGi. If stacking is 

necessary, observe NewTom VGi to verify normal operation in the stacked 

configuration in which it will be used! 

Essential performance 

In case of a scan stopped by a temporary or permanent malfunctioning, the operator will have the 

opportunity to store the data acquired until the failure appeared. 

The quality of the reconstructed images will vary depending on the size of acquired data but it will be 

probably lower compared to the standard performance of the equipment. 

Rev. 1.0 - 02/15/2009 Page 62 of 72



Rev. 1.0 - 02/15/2009 Page 63 of 72


The NewTom VGi equipment has been built in conformity with IEC normative regarding safety of electricmedical 

devices of similar typology and, particularly, with the normative: 

• IEC 60601-1: 1988-12 Medical electrical equipment - Part 1: General requirements for safety 

• IEC 60601-1-1: Edition 2.0 2000-12 Medical electrical equipment - Part 1-1: General requirements for 

safety - Collateral standard: Safety requirements for medical electrical systems 

• IEC 60601-1-2: 2001-09 Medical electrical equipment - Part 1-2: General requirements for safety - 

Collateral standard: Electromagnetic compatibility - Requirements and tests 

• IEC 60601-1-3:1994-07 Part 1: General requirements for safety - 3. Collateral standard: General 

requirements for radiation protection in diagnostic X-ray equipment 

• IEC 601-1-4: Edition 1.1 2000-04 Medical electrical equipment - Part 1-4: General requirements for safety - 

Collateral Standard: Programmable electrical medical systems 

• IEC 601-2-7: Edition 2 1998-02 Medical electrical equipment - Part 2-7: Particular requirements for the 

safety of high-voltage generators of diagnostic X-ray generators 

• IEC 601-2-28: Edition 1.0 1993-03 Medical electrical equipment - Part 2: Particular requirements for the 

safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis 

• IEC 601-2-32: Edition 1.0 1994-03 Medical electrical equipment - Part 2: Particular requirements for the 

safety of associated equipment of X-ray equipment 

• IEC 601-2-44: Edition 2.1, 2002-11 Medical Electrical Equipment - Part 2.44:Particular requirements for the 

safety of X-ray equipment for computed tomography 

• IEC 60825-1: 2003-02 Edition 4, Safety of laser products - Part 1: Equipment classification, requirements 

and user's guide 

• 21 CFR 1020.33 Computed tomography (CT) equipment April 1, 2006] 

CLASSIFICATION IEC 601-1 

Protection against electrical shock 

Degree of protection against electric shock 

Use with flammable anesthetics 

CLASS I 

TYPE B 

Have not been evaluated for use in the 

presence of a flammable anaesthetic mixture 

with air, oxygen, or nitrous oxide. 

Sterilization and disinfection methods 

The device is supplied not sterile and it must 

not be subjected to sterilization. 

See chapter 3.5 “Cleaning and disinfection” 

Mode of operation 

Continuous with intermittent loading. 

Duty cycle 

18sec ON / 15 min. OFF 

modalities 

Full and Zoom 

27sec ON / 15 min. OFF HiRes Zoom modality 

Rev. 1.0 - 02/15/2009 Page 64 of 72

APPENDIX C: Labels 


Rev. 1.0 - 02/15/2009 Page 65 of 72


PLATE ON THE NEWTOM VGi 

Position: dx upright of the scanning unit, lower side 

Rev. 1.0 - 02/15/2009 Page 66 of 72


PLATE ON THE CONTROL BOX 

Serial Number : 

QR s.r.l. – Via Silvestrini, 20 

37135 Verona Italy 

+39 045 8202727 

Model no: NewTom VG 

CONTROL BOX 

Manufactured : 

Power : 100 / 115 V ~ 10A 

200 / 215 / 230 / 240 V ~ 5A 

50/60Hz 

WARNING: This x-ray unit may be dangerous 

to patient and operator unless safe exposure 

factors and operating instructions are observed. 

WARNING: X-RAYS – ATTENTION: XRAY 

ON WHEN EQUIPMENT IN OPERATION 

UNAUTHORIZED USE IS STRICTLY 

PROHIBITED 

Posizione: left side of the control box 

CONTROL BOX LABEL 

(devices destined at the Chinese market only) 

产品名称口腔 X 射线计算机体层摄影设备 

产品型号 NewTom VG 

系统编号 VGXXXXXX 

运行方式 

间歇加载连续运行 

输入电压 

输入功率 

220AC+/-10% 

50/60Hz 

瞬时 :5A 稳态 : 0.75A 

制造商 QR s.r.l. 意大利 

生产地址 Via Silvestrini,20 - 37135 维罗纳意大利 

生产日期 YYYY-MM 

安全标志 

Position: left side of the control box, on the right of the control box plate 

Rev. 1.0 - 02/15/2009 Page 67 of 72


LABELS ON THE X-RAY SOURCE 

X-Ray source with rotating anode 

Inverter 

Position: on the structure of the X-Ray source and on the Inverter structure. 

Rev. 1.0 - 02/15/2009 Page 68 of 72


DEVICE TRADE NAME LABEL 

Position: on the cover of the scanning unit in frontal and centered position 

Rev. 1.0 - 02/15/2009 Page 69 of 72


LABEL ON THE BRASS PLATE OF BEAM LIMITER (Full Field) 

QR s.r.l. – Italy 

P.N. 001092 

S.N. ______________ 

6.73 mm Al @ 

70 

kV 

Position: in the center of the brass plate 

LABEL ON SMALL FIELD BEAM LIMITER (Zoom) 


P.N. 001067 

S.N. ______________ 

Position: on the lead plate 

EQUIVALENT RADIATION LABEL 


P.N. 001065 

S.N. ______________ 

2.34mm @ 70kV 

Position: inside the plastic cover of the rotating arm, opposite the x-ray output 

LABEL INDICATING THE MAIN SWITCH AND INPUT FUSE 

ON-OFF 

I 

0 

FUSE: 

Condition Ratings 

100 - 115 V~ F1=T10A 250V 

200 - 240 V~ F1=T5A 250V 

CAUTION: For continued 

protection against risk of fire, 

replace only with same type 

and rating of fuse. 

Position: left side of the control box 

Rev. 1.0 - 02/15/2009 Page 70 of 72


LABEL WITH CONNECTOR INDICATION 

AUX 

CAN-BUS 

Position: left side of the control box, below 

WARNING LABELS FOR DEVICES WITH LASER 

CLASS 1 LASER PRODUCT 

Wavelenght:630-680 nm Max.Output


HEAD SUPPORT LABELS 

Posizion: on the covers of the head support 

Rev. 1.0 - 02/15/2009 Page 72 of 72

NewTom VG User Manual rev 4.0 - Image Works

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