EN VGi User Manual

Rev 2.1 - November, 23th 2011

www.qrverona.it

COD. 97050272
NOTE
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 on-line
services, without the express written permission of QR s.r.l.

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

NEWTOM™ VG is a commercial trademark of QR s.r.l.

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

MANUFACTURER’S NOTICE ABOUT MEDICAL DEVICES

The medical device described in this manual, composed by Scan Unit (gantry), patient support (patient table) and
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 hardware1, or software2, 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.
 SOMMARIO
1 INTRODUCTION TO THIS MANUAL ......................................................................................................... 1-1
1.1 CONTENTS ................................................................................................................................................ 1-1
1.2 STRUCTURE ............................................................................................................................................... 1-1
1.3 STYLE CONVENTIONS ................................................................................................................................... 1-2
1.4 ABOUT USING THIS MANUAL .......................................................................................................................... 1-2
2 ABOUT SAFETY ....................................................................................................................................... 2-1
2.1 GENERAL SAFETY RULES ............................................................................................................................... 2-1
2.2 DEVICE SWITCHING ON AND TURNING OFF ........................................................................................................ 2-3
2.3 EMERGENCY STOP ....................................................................................................................................... 2-3
2.4 PATIENT'S AND USER'S SAFETY GUIDELINES ....................................................................................................... 2-4
2.4.1 Patient positioning ........................................................................................................................ 2-4
2.4.2 Patient's exit ................................................................................................................................... 2-5
2.4.3 Protection from ionizing radiation ............................................................................................... 2-5
2.5 LASER EXPOSURE ........................................................................................................................................ 2-6
2.6 SAFETY NOTES ........................................................................................................................................... 2-7
3 SAFETY AND MAINTENANCE OF THE DEVICE ........................................................................................ 3-1
3.1 INSTALLATION REQUIREMENTS ....................................................................................................................... 3-1
3.2 GUIDELINES FOR SAFETY .............................................................................................................................. 3-2
3.3 CHANGES IN THE DEVICE .............................................................................................................................. 3-2
3.4 DEVICE MAINTENANCE.................................................................................................................................. 3-4
3.5 CLEANING AND DISINFECTION ........................................................................................................................ 3-5
3.5.1 Chemical agents to avoid .............................................................................................................. 3-5
3.5.2 Cleaning ......................................................................................................................................... 3-6
3.5.3 Disinfection .................................................................................................................................... 3-6
3.5.4 Sterilization ................................................................................................................................... 3-6
3.6 TRANSPORT AND STORAGE............................................................................................................................ 3-6
3.7 DEVICE DISPOSAL ........................................................................................................................................ 3-7
3.7.1 Information for the device owner................................................................................................. 3-7
3.7.2 Information for the Disposing/Recycle centers ............................................................................ 3-7
4 GETTING STARTED… ............................................................................................................................... 4-1
4.1 INTRODUCTION TO THE SYSTEM ..................................................................................................................... 4-1
4.2 WORKING PRINCIPLE ................................................................................................................................... 4-1
4.3 OVERALL VIEW ........................................................................................................................................... 4-2
4.4 SCANNER UNIT (SCANNER) ........................................................................................................................... 4-3
4.4.1 Indicators panels on the scanner unit ........................................................................................... 4-3
4.4.2 Remote control command ............................................................................................................. 4-4
4.5 CONTROL BOX ........................................................................................................................................... 4-5
4.5.1 Main switch .................................................................................................................................... 4-5
4.5.2 Input panel..................................................................................................................................... 4-5
4.6 STANDARD ACCESSORIES............................................................................................................................... 4-6
4.6.1 Cables............................................................................................................................................. 4-7
4.7 OPTIONAL ACCESSORIES ............................................................................................................................... 4-7
4.8 SYSTEM STARTUP ........................................................................................................................................ 4-8
4.9 SYSTEM SHUTDOWN .................................................................................................................................... 4-8
5 PRELIMINARY PROCEDURES ................................................................................................................... 5-1
5.1 X-RAY SOURCE CONDITIONING....................................................................................................................... 5-1
5.2 DAILY CHECK............................................................................................................................................. 5-3
5.3 BLANK ACQUISITION.................................................................................................................................... 5-4
5.3.1 Invalidate Blank Acquisition .......................................................................................................... 5-5
5.4 BEAM LIMITER TEST .................................................................................................................................... 5-6
5.4.1 Beam Limiter Test (VGi 7 FOV option) ......................................................................................... 5-6
5.4.2 Beam Limiter Test (VGi 3 FOV option) ......................................................................................... 5-7
5.5 COMPLETELY LIFT DOWN THE ROTATING ARM ................................................................................................... 5-7
6 SCANNING ................................................................................................................................................ 6-1
 6.1 SCANNING A PATIENT .................................................................................................................................. 6-2
6.1.1 Preparing the patient .................................................................................................................... 6-2
6.1.2 Positioning the patient and starting a new scan .......................................................................... 6-3
6.2 SCANNING A DENTURE ................................................................................................................................. 6-5
6.2.1 Preliminary operations .................................................................................................................. 6-5
6.2.2 Denture positioning ....................................................................................................................... 6-5
7 QUALITY ASSURANCE ............................................................................................................................. 7-1
7.1 PHANTOM POSITIONING................................................................................................................................ 7-1
7.2 SAMPLE IMAGES .......................................................................................................................................... 7-3
7.3 STORAGE OF QA DATA ................................................................................................................................ 7-3
8 TROUBLESHOOTING ............................................................................................................................... 8-1

9 IEC61223: ACCEPTANCE TEST ............................................................................................................... 9-1

9.1 POSITIONING OF THE PATIENT SUPPORT [PARAGRAPH 5.1] ................................................................................. 9-1
9.2 PATIENT POSITIONING ACCURACY [PARAGRAPH 5.2].......................................................................................... 9-1
9.2.1 Axial patient positioning accuracy [paragraph 5.2.1] .................................................................. 9-1
9.2.2 Sagittal and coronal patient positioning light [paragraph 5.2.2] ................................................ 9-1
9.3 TOMOGRAPHIC SECTION THICKNESS [PARAGRAPH 5.3] ....................................................................................... 9-1
9.3.1 Tomographic section thickness for axial scanning [paragraph 5.3.1] .......................................... 9-1
9.3.2 Tomographic section thickness for helical scanning [paragraph 5.3.2] ...................................... 9-1
9.4 DOSE [PARAGRAPH 5.4] .............................................................................................................................. 9-1
9.5 NOISE, MEAN CT NUMBER AND UNIFORMITY [PARAGRAPH 5.5] ............................................................................ 9-2
9.6 SPATIAL RESOLUTION [PARAGRAPH 5.6] ......................................................................................................... 9-2
9.7 IEC 61223-3-5 REFERENCE TABLE ................................................................................................................ 9-3
10 APPENDIX A - TECHNICAL REFERENCE ............................................................................................ 10-1

11 APPENDIX B – STANDARDS CONFORMITY ......................................................................................... 11-1

12 APPENDIX C - LABELS ....................................................................................................................... 12-1

1 Introduction to this manual
1.1 Contents
This manual was created as a mean to provide information and instructions about using a NewTom™ VG
series device, version “NewTom VGi”.

Dedicated software routines (scan, data processing, reporting, document management) and their user
instructions are described in the “Software Manual” document.
"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

NewTom VGi – User Manual 1-1

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.

CAUTION:
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.

NewTom VGi – User Manual 1-2

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-… Type B (Applied part)

878-02-02

ISO 361 Ionizing Radiation

Directive WEEE - Waste from Electrical and Electronic

2002/96/CE 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”.

NewTom VGi – User Manual 2-1

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 in the Par. 2.2 -
"Device switching on and turning off"

Emergency stop
In case of an emergency, follow the instructions referring to the device emergency stop, refer to Par. 2.3
- Emergency stop".

Maintenance time lag

Please be sure that the maintenance controls that are described in the Par. 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.

CAUTION:
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.

CAUTION:
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.

NewTom VGi – User Manual 2-2

2.2 Device switching on and turning off
Switching on and the turning off of the device must be effect according to the procedures reported in the
Par. 4.8 and 4.9 .

2.3 Emergency stop

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 turning 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.

CAUTION:
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.

Emergency
Button

Figure 1: Emergency buttons on the device

NewTom VGi – User Manual 2-3

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.

NewTom VGi – User Manual 2-4

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

CAUTION:
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.

CAUTION:
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.

CAUTION:
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 Chap. 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 Chap. 6 -
“Scanning”). They stay on all along the scan process.

NewTom VGi – User Manual 2-5

 CAUTION:
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 OFF THE
DEVICE and contact technical assistance.

2.5 Laser exposure

CAUTION:
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.

CAUTION:
Keep your eyes at least 50 cm from the laser when the
beam is on.
If necessary, use appropriate protective glasses.

CAUTION:
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.

NewTom VGi – User Manual 2-6

2.6 Safety notes
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.

NOTE:
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.

NewTom VGi – User Manual 2-7

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’t 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.

CAUTION:
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.

NewTom VGi – User Manual 3-1

 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.

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
CO2 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 - Technical
Reference.

3.3 Changes in the device

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

CAUTION:
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.

NewTom VGi – User Manual 3-2

 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.

NewTom VGi – User Manual 3-3

3.4 Device maintenance

CAUTION:
Always turn the power off the device before any
maintenance act !

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

CAUTION:
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.

CAUTION:
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.

CAUTION:
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.

NewTom VGi – User Manual 3-4

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.

CAUTION:
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.

NewTom VGi – User Manual 3-5

3.5.2 Cleaning

3.5.2.1 Scanner Unit 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.

CAUTION:
Do not apply cleaning solutions directly on the device
surface.

3.5.2.2 Workstation and peripherals

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: -20° to +70° (Celsius)

Transport and storage humidity: min 10%, max 85% not condensing.

Do not expose to acids, saltiness, rain.

NewTom VGi – User Manual 3-6

3.7 Device disposal

3.7.1 Information for the device owner

This symbol, on a device label, shows that the product can’t 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.

NewTom VGi – User Manual 3-7

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 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.

NewTom VGi – User Manual 4-1

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".

SCANNER

CONTROL
WORKSTATION BOX

NOTE:
The system may not be expanded with parts or accessories
other than the ones described inside this manual.

NewTom VGi – User Manual 4-2

4.4 Scanner Unit (Scanner)

4.4.1 Indicators panels on the scanner unit

The scanner unit is the main part of the system, it performs the scan. Two indicators panels are placed on
the columns side. They have the same appearance and function: the indication of the state of the "Power
ON" and the state of x-ray emission.

The light display the "Power On" device state and 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:

Power ON indicator:
A green LED turn on after the push of the main switch located on
the control box.

X-ray emission indicator

3 LEDs turn on simultaneously during the x-ray emission.

NewTom VGi – User Manual 4-3

4.4.2 Remote control command

R1 R2

V1 V2

EB L

H1 H4

H3 H2

H5 H6

Now it comes described the function of every button placed on the remote control:

EB Enable button:
it enables the functioning of the buttons for rotating arm / vertical
movements.

R1 / R2 Rotating arm movement buttons:

to rotate the arm clockwise or anti-clockwise, press one of them
simultaneously with the corresponding enabling button (EB).

V1 / V2 Vertical movement buttons:

to move up or down the structure supporting the rotating arm, press
one of them simultaneously with the corresponding enabling button
(EB).

L Laser button:
press to turn the positioning laser beam on/off. The laser will stay
light up for about 60 seconds

H1 / H2 Head support - Vertical movement buttons:

allows the movement of the head support system in the vertical
direction (up / down)

H3 / H4 Head support - Horizontal movement buttons:

allows the movement of the head support system in the horizontal
direction (right / left)

H5 / H6 Head support - Transversal movement buttons:

allows the movement of the head support system in the transversal
direction (front / rear)

NewTom VGi – User Manual 4-4

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

NewTom VGi – User Manual 4-5

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.

Version A - FrontRest set to internal holes, short ChinRest

Default ChinRest, for most of the acquisitions.

Version B - FrontRest set to external holes, long ChinRest

To be used for small FOV acquisitions ([6x6], [8x8]) and

large FOV acquisitions [15x15] when the nose must be
included.

QA phantom:
used for the execution of the quality assurance procedure.

Calibration support:
it allows for placing the QA phantom on the scanner unit.

Denture support:
it allows for placing the denture on the scanner unit.

NewTom VGi – User Manual 4-6

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)

 CAN bus cable (2 pairs/24 AWG-shielded) (workstation  box di controllo)

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.

CAUTION:
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.

NewTom VGi – User Manual 4-7

4.8 System startup
To properly switching 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.

4.9 System shutdown

The following procedure describe the correct steps to turn off the device:

1. Close the NNT software .

2. Shutdown the Operating System and attend the turning off of the workstation.

3. Turn off the device by using the main switch placed on the input panel of the Control Box.

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

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

NewTom VGi – User Manual 4-8

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".

NOTE:
In case of mobile device (NewTom™ VGi Flex), if the
ambient temperature is too high or low, it is recommended
to restore it into the device operating range (+10 ÷ +35 °C).
After that, attend at least 2 hours in order that the thermal
equilibrium is restored.

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.

Figure 2: Screenshot of NNT with Source Conditioning request

NewTom VGi – User Manual 5-1

 REMOVE

Before starting the procedure, please verify that the

scan area is completely free from objects.

Remove the head support.

Figure 3: Source Conditioning in progress

At the end of conditioning process, the software will automatically starts Daily check and Blank
Acquisition procedures.

NewTom VGi – User Manual 5-2

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

Figure 4: Screenshot of NNT with Daily check request

CAUTION:
Before starting the procedure, please verify that the scan
area is completely free from objects.

Remove the head support.

Figure 5: Daily check in progress

NewTom VGi – User Manual 5-3

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.

Remove the head support.

The resulting blank acquisition image will look

like shown in the figure.

Please verify that no artifacts or objects appear.

NewTom VGi – User Manual 5-4

5.3.1 Invalidate Blank Acquisition

This functionality is valid only for the main workstation. To invalidate the Blank Acquisition please follow
the steps below:

To invalidate blank acquisition From the NNT

software main toolbar select Scan  Invalidate
Blank.

At the next detector field selection (FOV) the

NNT software will ask a new blank acquisition

NewTom VGi – User Manual 5-5

5.4 Beam Limiter Test

5.4.1 Beam Limiter Test (VGi 7 FOV option)

From the main toolbar select Tools  Scanner Test.

From the window bar select Tools  Beam Limiter Test. Select the desired FOV.

Set the radiological parameters depending on the selected FOV (Standard: SFS, 1 mA, 10 msec, KV = 110;
HiRes standard: SFS, 6 mA, 10 msec, KV = 110)

Perform an acquisition.

Verify the acquired image following these rules:

- The green rectangle must be completely included

inside of the light gray one.

- The light gray rectangle limits have to pass between

the couple of red lines where they are drawn.

NewTom VGi – User Manual 5-6

5.4.2 Beam Limiter Test (VGi 3 FOV option)

From the main toolbar select Tools  Scanner Test.

From the window bar select Tools  Beam Limiter Test. Select the desired FOV.

In order to verify the position of specific beam limiter for HiRes Zoom and Zoom fields:

Select Beam limiter test Acquisition button.

Verify the acquired image following these rules:

- The green rectangle must be completely included

inside of the light gray one.

- The light gray rectangle limits have to pass between

the couple of red lines where they are drawn.

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.

CAUTION:
Prima di usare questa funzione accertarsi che non vi siano
oggetti che ostacolino il movimento verso il basso del
braccio!

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.

NewTom VGi – User Manual 5-7

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”.

Si raccomanda inoltre di fare riferimento ai Chap. 2 – “About safety” and Chap. 3 – “Safety and
maintenance of the device”.

It is possible to perform the scans in the following modalities:

VGi 7 FOV option

 [15x15] (volume diameter 15cm, height 15cm);
 [15x12] (volume diameter 15cm, height 12cm);
 [12x8] (volume diameter 12cm, height 8cm);
 [8x8] (volume diameter 8cm, height 8cm);
 [12x8] HiRes (High Resolution, volume diameter 12cm, height 8cm);
 [8x8] HiRes (High Resolution, volume diameter 8cm, height 8cm);
 [6x6] HiRes (High Resolution, volume diameter 6cm, height 6cm).

VGi 3 FOV option

 Full (volume diameter 15cm, height 15cm);
 HiRes Zoom (High Resolution, volume diameter 12cm, height 7.5cm);
 Zoom (volume diameter 12cm, height 7.5cm).

The choice of the modality can be performed selecting the corresponding FOV button from the "Scan
Manager" panel located on the bottom right corner of the NNT main window.

Figura 6: "Scan Manager" panel of the NNT software (VGi 7 FOV option)

NewTom VGi – User Manual 6-1

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).

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.

NewTom VGi – User Manual 6-2

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.

CAUTION:
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.

B 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
buttons on the remote control (make reference to
the Par. 4.4.2 – “Remote control command”)
A
C

Using the remote control device (make reference

the Par. 4.4.2 – “Remote control command”), 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 remote
control.

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.

The upper horizontal line is the center of the

scanned volume when in "Full" or [15x15] volume
mode.
The lower horizontal line is the lower limit of the
scanned volume.

NewTom VGi – User Manual 6-3

 Set the height of scanner with the remote control so
to frame the area of interest with the laser lines.

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 remote
control.

NOTE:
If the patient ends up in a forced position, you may
need to re-adjust the height of the gantry via the
remote control.

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.

NewTom VGi – User Manual 6-4

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".

NewTom VGi – User Manual 6-5

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

Remove the head support.

Fix the calibration base.

NewTom VGi – User Manual 7-1

 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
B head support buttons on the remote control device
C (make reference to the Par. 4.4.2 – “Remote control
command”).
A
Ruler A (Height)  position “QA”

Rulers B and C (width, depth)  default position

(“D”)

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).

1a scout view

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

NewTom VGi – User Manual 7-2

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.

NewTom VGi – User Manual 7-3

8 Troubleshooting
For the problem resolution about the device, please refer to the document “NNT – Error Guide”

NewTom VGi – User Manual 8-1

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]

V
The NewTom VGi is equipped with cross-shaped laser pointer aimed to help the patient positioning. The
a
horizontal line locates the scanned volume central axial plane, the vertical line locates the scanned
l
volume central sagittal plane. No location pointer has been provided for coronal plane location.
u
e
9.2.1 Axial patient positioning accuracy [paragraph 5.2.1]
o
Position an object along the axial plane located by the horizontal line and scan it. f
See “Software Manual” for data analysis.
F
9.2.2 Sagittal and coronal patient positioning light [paragraph 5.2.2] W
H
M
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.

NewTom VGi – User Manual 9-1

9.5 Noise, mean CT number and uniformity [paragraph 5.5]
See "Software Manual".

9.6 Spatial resolution [paragraph 5.6]

See "Software Manual".

NewTom VGi – User Manual 9-2

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 N.A.

patient support

5.2 Patient positioning 5.2.1 Axial patient positioning 10mm from isocenter
accuracy accuracy

5.2.2 Sagittal and coronal patient 10mm from isocenter

positioning light accuracy

Loading factors: automatically selected by the

5.3 Tomographic section 5.3.1 Tomographic section software.
thickness thickness for axial scanning
Thickness Recommended criteria
5.0 mm 1.0 mm
1.0 mm 0.5 mm
0.5 mm -0 +0.5 mm

5.3.2 Tomographic section N.A.

thickness for helical scanning

Loading factors: automatically selected by the software.

5.4 Dose
Dose Mode: Standard Dose

CTDIFREE AIR N.A.

CTDIvol Equal to CTDI100w

CTDI100w (VGi 3 FOV option):

Full 2.4 mGy 30%
Zoom 2.0 mGy 30%
HiRes Zoom 7.3 mGy 30%

CTDI100w (VGi 7 FOV option):

[15x15] 2.4 mGy 30%
[15x12] 2.2 mGy 30%
[12x8] 2.0 mGy 30%
[8x8] 1.7 mGy 30%
[12x8] HiRes 7.3 mGy 30%
[8x8] HiRes 6.2 mGy 30%
[6x6] HiRes 4.6 mGy 30%

NewTom VGi – User Manual 9-3

 Loading factors: automatically selected by the software.

Dose Mode: Boosted Dose

CTDIFREE AIR N.A.

CTDIvol Equal to CTDI100w

CTDI100w (VGi 3 FOV option):

Full 4.5 mGy 30%
Zoom 3.3 mGy 30%

CTDI100w (VGi 7 FOV option):

[15x15] 4.5 mGy 30%
[15x12] 4.5 mGy 30%
[12x8] 3.3 mGy 30%
[8x8] 2.7 mGy 30%

Loading factors: automatically selected by the software.

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: Standard Dose, Standard Voxel

Full < 80 a.u.

Zoom < 70 a.u.
HiRes Zoom < 80 a.u.

[15x15] < 80 a.u.

[8x8] < 60 a.u.
[12x8] HiRes < 80 a.u.
[6x6] HiRes < 80 a.u.

Dose Mode: Standard Dose, Ultra Small Voxel

Full < 125 a.u.

Zoom < 100 a.u.
HiRes Zoom < 200 a.u.

[15x15] < 125 a.u.

Standard deviation [8x8] < 90 a.u.
[12x8] HiRes < 200 a.u.
[6x6] HiRes < 200 a.u.

Dose Mode: Boosted Dose, Standard Voxel

Full < 60 a.u.

Zoom < 50 a.u.

[15x15] < 60 a.u.

[8x8] < 45 a.u.

Dose Mode: Boosted Dose, Ultra Small Voxel

Full < 90 a.u.

Zoom < 80 a.u.

[15x15] < 90 a.u.

[8x8] < 80 a.u.

NewTom VGi – User Manual 9-4

 Full 980 a.u. 10%
Zoom 1000 a.u. 10%
HiRes Zoom 1050 a.u. 10%
Mean CT number
[15x15] 980 a.u. 10%
[8x8] 1020 a.u. 10%
[12x8] HiRes 1050 a.u. 10%
[6x6] HiRes 1200 a.u. 10%

Standard Voxel

Full < 200 a.u.

Zoom < 125 a.u.
HiRes Zoom < 150 a.u.

[15x15] < 200 a.u.

[8x8] < 100 a.u.
[12x8] HiRes < 150 a.u.
[6x6] HiRes < 70 a.u.
Uniformity
Ultra Small Voxel

Full < 125 a.u.

Zoom < 125 a.u.
HiRes Zoom < 120 a.u.

[15x15] < 125 a.u.

[8x8] < 100 a.u.
[12x8] HiRes < 100 a.u.
[6x6] HiRes < 50 a.u.

Loading factors: automatically selected by the software.

5.6 Spatial resolution
Mode MTF50 (lp/cm) MTF10 (lp/cm)
Full >7 >13
Zoom >7 >13
HiRes Zoom >9 >17

[15x15] >7 >13

[8x8] >7 >13
[12x8] HiRes >9 >17
[6x6] HiRes >9 >17

NewTom VGi – User Manual 9-5

10 APPENDIX A - Technical Reference
Scanner Unit

Scanning system Single rotation and volumetric acquisition.

(cone beam technology)

Mode: Time / X-Ray emission time

Scan parameters
Full: 18 s / 3.6 s
HiRes Zoom: 26.7 s / 5.4 s
Zoom: 18 s / 3.6 s

[15x15] 18 s / 3.6 s
[15x12] 18 s / 3.6 s
[12x8] 18 s / 3.6 s
[8x8] 18 s / 3.6 s
[12x8] HiRes 26.7 s / 5.4 s
[8x8] HiRes 26.7 s / 5.4 s
[6x6] HiRes 26.7 s / 5.4 s

Sampling angle 360°

Patient's centring Fixed position Motorized Head support and

positioning lasers

Anatomical analyzed volume Cylinder Full:

Ø max 15 cm, h max 15 cm

HiRes Zoom and Zoom:

Ø max 12 cm, h max 7.5 cm

[15x15]:
Ø max 15 cm, h max 15 cm

[15x12]:
Ø max 15 cm, h max 12 cm

[12x8] and [12x8] HiRes:

Ø max 12 cm, h max 8 cm

[8x8] and [8x8] HiRes:

Ø max 8 cm, h max 8 cm

[6x6] HiRes:
Ø max 6 cm, h max 6 cm

Weight and dimensions Scanner Unit Width Weight and dimensions

(diameter occupied during a
scan)

Depth (max) 1130 mm

Height 1500 mm

Max Weight 2300 mm

1970 mm (VG Short version)

Width 272 Kg

NewTom VGi – User Manual 10-1

 Depth 605 mm

Control Box Height 310 mm

Weight 925 mm

NewTom VGi – User Manual 10-2

Detector
Pixels 1920 x 1536

Pixel size 127 x 127 m

Pixel depth 14 bit

S/N 90 dB

Frame rate Max 30 F/s

Scout view radiological images

Full:
Image pixels 768 x 960 Pixels

Pixel depth 14 n.

Pixel Size 0.254 x 0.254 mm

HiRes Zoom:
Image pixels 1344 x 1088 Pixels

Pixel depth 14 n.

Pixel Size 0.127 x 0.127 mm

Zoom:
Image pixels 672 x 544 Pixels

Pixel depth 14 n.

Pixel Size 0.254 x 0.254 mm

[15x15]:
Image pixels 768 x 960 Pixels

Pixel depth 14 n.

Pixel Size 0.254 x 0.254 mm

[15x12]:
Image pixels 768 x 848 Pixels

Pixel depth 14 n.

Pixel Size 0.254 x 0.254 mm

[12x8]:
Image pixels 672 x 544 Pixels

Pixel depth 14 n.

Pixel Size 0.254 x 0.254 mm

NewTom VGi – User Manual 10-3

[8x8]:
Image pixels 544 x 544 Pixels

Pixel depth 14 n.

Pixel Size 0.254 x 0.254 mm

[12x8] HiRes:
Image pixels 1344 x 1088 Pixels

Pixel depth 14 n.

Pixel Size 0.127 x 0.127 mm

[8x8] HiRes:
Image pixels 1088 x 1088 Pixels

Pixel depth 14 n.

Pixel Size 0.127 x 0.127 mm

[6x6] HiRes:
Image pixels 800 x 864 Pixels

Pixel depth 14 n.

Pixel Size 0.127 x 0.127 mm

Reconstructed volume

Full:
Shape Cylinder

Reconstructed Volume Size (max) Ø15 x H15 cm

Voxel Size 0.300 0.250 0.200 0.150 mm

Image pixels 512 x 512 614 x 614 680 x 680 672 x 672 Pixels

Pixel depth 16 bit

HiRes Zoom:
Shape Cylinder

Reconstructed Volume Size (max) Ø12 x H7.5 cm

Voxel Size 0.150 0.125 0.100 0.075 mm

Image pixels 820 x 820 884 x 884 672 x 672 672 x 672 Pixels

Pixel depth 16 bit

Zoom:
Shape Cylinder

Reconstructed Volume Size (max) Ø12 x H7.5 cm

Voxel Size 0.300 0.250 0.200 0.150 mm

Image pixels 410 x 410 492 x 492 614 x 614 820 x 820 Pixels

Pixel depth 16 bit

NewTom VGi – User Manual 10-4

[15x15]:
Shape Cylinder

Reconstructed Volume Size (max) Ø15 x H15 cm

Voxel Size 0.300 0.250 0.200 0.150 mm

Image pixels 512 x 512 614 x 614 680 x 680 672 x 672 Pixels

Pixel depth 16 bit

[15x12]:
Shape Cylinder

Reconstructed Volume Size (max) Ø15 x H12 cm

Voxel Size 0.300 0.250 0.200 0.150 mm

Image pixels 512 x 512 614 x 614 764 x 764 672 x 672 Pixels

Pixel depth 16 bit

[12x8]:
Shape Cylinder

Reconstructed Volume Size (max) Ø12 x H8 cm

Voxel Size 0.300 0.250 0.200 0.150 mm

Image pixels 410 x 410 492 x 492 614 x 614 820 x 820 Pixels

Pixel depth 16 bit

[8x8]:
Shape Cylinder

Reconstructed Volume Size (max) Ø8 x H8 cm

Voxel Size 0.300 0.250 0.200 0.150 mm

Image pixels 272 x 272 326 x 326 408 x 408 544 x 544 Pixels

Pixel depth 16 bit

[12x8] HiRes:
Shape Cylinder

Reconstructed Volume Size (max) Ø12 x H8 cm

Voxel Size 0.150 0.125 0.100 0.075 mm

Image pixels 820 x 820 884 x 884 672 x 672 672 x 672 Pixels

Pixel depth 16 bit

NewTom VGi – User Manual 10-5

[8x8] HiRes:
Shape Cylinder

Reconstructed Volume Size (max) Ø8 x H8 cm

Voxel Size 0.150 0.125 0.100 0.075 mm

Image pixels 544 x 544 652 x 652 672 x 672 672 x 672 Pixels

Pixel depth 16 bit

[6x6] HiRes:
Shape Cylinder

Reconstructed Volume Size (max) Ø6 x H6 cm

Voxel Size 0.150 0.125 0.100 0.075 mm

Image pixels 410 x 410 492 x 492 614 x 614 672 x 672 Pixels

Pixel depth 16 bit

NewTom VGi – User Manual 10-6

Radiological parameters

TUBE IAE mod. x22 0.3/0.6

NewTom VGi – User Manual 10-7

NewTom VGi – User Manual 10-8
NewTom VGi – User Manual 10-9
NewTom VGi – User Manual 10-10
NewTom VGi – User Manual 10-11
X-Ray tube head

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

Model HF1R

X-ray tube IAE X22 0.3/0.6

Classification (IEC 601-1) Class I Type B

Mechanical data

Head material Aluminum

Heat storage capacity 550 kJ

Maximum continuos heat dissipation 60 W @ 110kV, 3.6 mA, 10 ms, 15 FPS

Maximum temperature3 60

Minimum inherent filtration @ 70 kV 1.4 mm Al

Oil volume compensation Rubber tank 410 cm³

Dimensions 325 x 145 x 215

Weight 15 kg

Electrical Data

Maximum output voltage 120 kV

Cathode to Ground 60 kV

Anode to Ground 60 kV

Maximum anodic current @ 110 kV 20 mA

Maximum tube voltage @ 20 mA 110 kV

Maximum electrical output power4 2.2 kW

Nominal electrical power, 4s emission5 2.2 kW

Maximum power ripple <1%

High voltage rise time at maximum power <0.5 ms

3 According to IEC60601-2-28, par. 6.8.2.bb) 4

4 According to IEC60601-2-7, par. 6.8.2 a) 4
5 According to IEC60601-2-44, par. 6.8.2 a)

NewTom VGi – User Manual 10-12

 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 accuracy6 < 10%

X-ray current accuracy7 < 20%

Radiation Linearity8 < 20%

X-Ray emission time accuracy9 < 10% + 1 ms

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

7 According to IEC 60601-2-7, par. 50.104.2
8 According to IEC 60601-2-7, par. 50.105.4
9 According to IEC 60601-2-7, par. 50.104.3

NewTom VGi – User Manual 10-13

INVERTER

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

Model HF1 3.5kW

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

NewTom VGi – User Manual 10-14

Dose declaration10

CTDIw values declared for operative modalities of the device

Values are expressed in mGy/scan. Their tolerance is  30%. CTDIvol values for this application correspond to CTDIw.

FOV Standard Dose Boosted Dose

2.411 4.512
Full

2.013
HiRes Zoom -

7.314 3.315
Zoom

Date: 2011-01-12

FOV Standard Dose Boosted Dose

[15x15] 2.416 4.517

[15x12] 2.218 4.519

[12x8] 2.020 3.321

[8x8] 1.722 2.723

[12x8] HiRes 7.324 -

[8x8] HiRes 6.225 -

[6x6] HiRes 4.626 -

Date: 2011-01-12

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

11 Loading factors: automatically set by software: 110kV, 6.9mAs
12 Loading factors: automatically set by software, 110kV, 20.9mAs
13 Loading factors: automatically set by software, 110kV, 55.6mAs
14 Loading factors: automatically set by software, 110kV, 10.1mAs
15 Loading factors: automatically set by software, 110kV, 20.3 mAs
16 Loading factors: automatically set by software, 110kV, 6.6mAs
17 Loading factors: automatically set by software, 110kV, 20.5mAs
18 Loading factors: automatically set by software, 110kV, 7.0mAs
19 Loading factors: automatically set by software, 110kV, 21.4mAs
20 Loading factors: automatically set by software, 110kV, 9.1mAs
21 Loading factors: automatically set by software, 110kV, 19.2mAs
22 Loading factors: automatically set by software, 110kV, 10.6mAs
23 Loading factors: automatically set by software, 110kV, 21.6mAs
24 Loading factors: automatically set by software, 110kV, 52.4mAs
25 Loading factors: automatically set by software, 110kV, 58.0mAs
26 Loading factors: automatically set by software, 110kV, 69.6mAs

NewTom VGi – User Manual 10-15

 27

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

NewTom VGi – User Manual 10-16

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)

NewTom VGi – User Manual 10-17

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 Group 1 The equipment NewTom VGi uses RF energy only for its internal function.
CISPR11 Therefore its RF emissions are very low and are not likely to cause any
interference in nearby electronic equipment.

RF emissions Class A The equipment NewTom VGi is suitable for use in all establishments other
CISPR11 than domestic and those directly connected to the public low-voltage power-
supply network that supplies buildings used for domestic purposes.

Harmonic emissions Class A

IEC 61000-3-2

Voltage Complies
fluctuation/flicker
emissions
IEC 61000-3-3

NewTom VGi – User Manual 10-18

Clause 6.8.3.201 Technical Description - Tab 202 Guidance and manufacturer's declaration
- 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

Floors should be wood, concrete, or

Electrostatic discharge
ceramic tile.
(ESD) ± 6 kV contact 6 kV contact If floors are covered with synthetic
IEC 61000-4-2 8 kV air material the relative humidity should be at
±8 kV air least 50 percent.

Electrical fast transient ±2 kV for power supply lines 2 kV Mains power quality should be that of a
/ burst typical commercial and/or hospital
IEC 61000-4-4 ±1 kV for input/output lines 1 kV environment.

Surge ±1 kV differential mode 1kV Mains power quality should be that of a

IEC 61000-4-5 typical commercial and/or hospital
±2 kV common mode 2kV environment.

Voltage dips, short <5% Ut Complies

(>95% dip in Ut) for 0,5 cycles Mains power quality should be that of a
interruptions and typical commercial and/or hospital
voltage variations on 40% Ut Complies environment. If the user of NewTom VGi
power supply input (60% dip in Ut) for 5 cycles requires continued operation during power
main interruptions, it is recommended
lines that NewTom VGi be powered from an
70% Ut Complies
IEC 61000-4-11 (30% dip in Ut) for 25 cycles uninterruptible power supply or a battery.

<5% Ut
Functions Interruption
(>95% dip in Ut) for 5 sec

Power frequency magnetic fields should be

Power frequency 3 A/m Complies at least characteristic of a typical location
in a typical commercial or hospital
50/60Hz magnetic field environment.
IEC 61000-4-8

NewTom VGi – User Manual 10-19

Clause 6.8.3.201 Technical Description - Tab 204 Guidance and manufacturer's declaration
- 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 3 Vrms 3 Vrms Recommended separation distance:
IEC 61000-4-6 150 kHz to 80 MHz d = 1.2 P

Radiated RF 3 V/m 3 V/m d = 1.2 P 80 MHz to 800 MHz

IEC 61000-4-3 80 MHz to 2,5 GHz 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

NewTom VGi – User Manual 10-20

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 Separation distance according to frequency of transmitter

transmitter
m
W
150 kHz to 80 MHz 80 MHz to 800 MHz 800 MHz to 2,5 GHz
d= d= d=
0,001 0.037 0.037 0.072

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.

NewTom VGi – User Manual 10-21

All components, accessories, spare parts must be approved and supplied by QR S.r.l. Particularly, the
cables connection must be ONLY the ones described under Par. 4.6.1 - “Cables”.

DANGER:
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.

NewTom VGi – User Manual 10-22

11 APPENDIX B – Standards conformity
The NewTom VG device, version NewTom VGi has been built in conformity with IEC normative regarding
safety of electric-medical 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 60601-1-4: Edition 1.1 2000-04 Medical electrical equipment - Part 1-4: General requirements for
safety - Collateral Standard: Programmable electrical medical systems
- IEC 60601-1-6: Edition 2.0 2006-06: Medical electrical equipment - Part 1-6: General requirements for
basic safety and essential performance - Collateral Standard: Usability
- IEC 60601-2-7: 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 60601-2-28: 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 60601-2-32: 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
- IEC 62304 Edition 1.0b: 2006 Medical device software - Software life cycle processes 21 CFR 1020.33
Computed tomography (CT) equipment April 1, 2006]

IEC 601-1 Classification

Protection against electrical shock CLASS I

Degree of protection against electric shock TYPE B

Use with flammable anesthetics 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 Chap. 3.5 - “Cleaning and disinfection”)

Mode of operation Continuous with intermittent loading.

Duty cycle 18sec – 36sec ON / 15 min. OFF

NewTom VGi – User Manual 11-1

12 APPENDIX C - Labels

SCANNER UNIT PLATE

A B C

Position: dx upright of the scanning unit, lower side

A: NewTom VGi device plate

B: NewTom VGi Flex device plate
C: NewTom VGi plate for chinese market

NewTom VGi – User Manual 12-1

 CONTROL BOX PLATE

A B C

Posizione: left side of the control box

A: NewTom VGi device plate

B: NewTom VGi Flex device plate
C: NewTom VGi plate for chinese market

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 220AC+/-10% 50/60Hz
输入功率 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

NewTom VGi – User Manual 12-2

 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.

NewTom VGi – User Manual 12-3

 DEVICE TRADE NAME LABEL

Position: on the cover of the scanning unit in frontal and centered position
(NewTom VGi Flex label: device NewTom VGi Flex only)

NewTom VGi – User Manual 12-4

 BEAM LIMITER LABES - VGi 7 FOV OPTION

GLOBAL BEAM LIMITER LABEL

QR s.r.l. – Italy
P/N 96600741
P/N 99934493
S/N _____________

Posizione: in the proximity of beam limiter assembly code 96600741

BRASS FILTER 1 LABEL – 7FOV

QR s.r.l. – Italy
CuZn - P/N 99934502
3.90 mm Al @ 70 kV

Posizione: in the proximity of the brass filter code 99934502,

external of beam radiation

BRASS FILTER 2 LABEL – 7FOV

QR s.r.l. – Italy
CuZn - P/N 99934491
6.70 mm Al @ 70 kV

Posizione: in the proximity of the brass filter code 99934491

NewTom VGi – User Manual 12-5

 BEAM LIMITER LABES - VGi 3 FOV OPTION

BRASS FILTER 1 LABEL – 3FOV

QR s.r.l. – Italy
CuZn - P/N 99934334
6.70 mm Al @ 70 kV

Posizione: in the proximity of the brass filter code 99934334

BRASS FILTER 2 LABEL – 3FOV

QR s.r.l. – Italy
CuZn - P/N 99934547
3.90 mm Al @ 70 kV

Posizione: in the proximity of the brass filter code 99934547

LEAD PLATE LABEL – 3FOV

QR s.r.l. – Italy
P/N 99934325
S/N _____________

Posizione: in the proximity of the lead plate code 99934325

NewTom VGi – User Manual 12-6

 MAIN SWITCH AND INPUT FUSE LABEL

ON-OFF
I

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.
ATTENTION: Pour une
protection continue contre les
risques d'incendie, remplacez
seulement avec an fusible de
le même type et
caractéristiques

Position: left side of the control box

FRENCH X-RAY WARNING LABEL

AVVERTISSEMENT: Cette dispositif à rayons

X mai être dangereux pour le patient et l'opérateur
si les facteurs d'exposition et le instructions de
fonctionnement ne sont pas respectées.

ATTENTION:
RAYONS X ÉMISSION DE RAYONS X QUAND
LE DISPOSITIF EST EN MARCHE

L’UTILISATION NON AUTORISÉE DE

L’APPAREIL EST INTERDITE

Position: left side of the control box, near/under the control box plate

NewTom VGi – User Manual 12-7

 CAN CONNECTOR INDICATION LABEL

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<1mW CW
IEC 60825-1:1993 + A1:1997 + A2:2001

APPARECCHIO LASER DI CLASSE 1

Lunghezza d’onda:630-680 nm Pot. Max.<1mW CW

IEC 60825-1:1993 + A1:1997 + A2:2001

Position: left side of the control box under the emergency push-button

NewTom VGi – User Manual 12-8

 HEAD SUPPORT LABELS

Position: on the covers of the head support

NewTom VGi – User Manual 12-9

 www.qrverona.it

NEWTOM™ VG 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™ VG is manufactured and distributed by:

QR srl
Via Silvestrini, 20
37135 Verona, Italy
Phone: +39 045 8202727
Fax +39 045 8203040
e-mail: [email protected]

All rights reserved.