Tomografo Gemed 5G - User Manual

0051
97050196
Rev. 5
28.04.2017
NewTom 5G – User Manual
EN
NOTES
This document is provided as a consultation manual intended for the device users.
CEFLA s.c. follows a policy based on the constant development and update of the product. For this reason, it
reserves the right to change the content of this manual without prior notice.
This document can not be modified, copied, reproduced, distributed, saved on magnetic or optical supports,
or published on websites and other on-line services, in full or in part, without the prior written authorisation of
CEFLA s.c.
The original version of this manual is in Italian.
NEWTOM™ 5G is a trademark of CEFLA s.c.

All other products and trade names mentioned in this document are registered marks of the relevant
manufacturers.
INFORMATIVE NOTE OF THE MANUFACTURER ON THE MEDICAL DEVICES

The medical device referred to in this manual consists of a scanner and a control, display and calculation unit
(Main Workstation). Such device, as delivered and configured by the production and assistance technical
personnel, is an X-ray device compliant with the safety requirements set forth by the Italian Legislative
Decree of 19 September 1994, no. 626 implementing Directives 89/391/EEC, 89/654/EEC, 89/655/EEC,
89/656/EEC, 90/269/EEC, 90/270/EEC, 90/394/EEC and 90/679/EEC concerning the improvement of the
health and safety of workers in the workplace, and with the essential requirements set forth by the Italian
Legislative Decree 24 February 1997, no. 46 implementing Directive 93/42/EEC as amended, on the medical
devices.
The medical device referred to in this manual is an X-ray device compliant with Directive 2011/65/EU on the
restriction of the use of certain hazardous substances in electrical and electronic equipment.
Any tampering with, modification, updating or other change both of hardware 1 and software2 of the device as
supplied and installed by the company (and in the conditions specified in the attached documentation) may
partially or totally compromise the device expected operation. This may also alter the safety features with
consequent hazard increase for patients, operators and surrounding environment.
For this reason, should the user need to modify the device, he/she must request a written authorisation by
CEFLA s.c.
Failure to comply with what is specified in this informative note will null and void the device warranty and the
civil and/or penal responsibility for any consequent damage and/or accident and/or worsening of the patient,
operator or other people health (including the surrounding environment) will be borne by the person who
tampered with the device or his/her legal representative.
1 Adding of a new memory expansion, a new hardware on the connection bus, a printer, the replacement
of the graphic display interface represents an important modification.
2 Including the operative system and the applications already installed upon medical device delivery.
Automatic updates of the operative system, changes to network connection parameters, modification
and/or addition and/or removal of interface software with hardware (device driver) and/or services (e.g.
file and printer sharing service) and/or applications represent an important modification.
Summary
1 INTRODUCTION TO THIS MANUAL......................................................................1-1
1.1 Contents.......................................................................................................... 1-1
1.2 Structure......................................................................................................... 1-1
1.3 Graphic conventions............................................................................................1-3
1.3.1 Text conventions......................................................................................... 1-3
2 ABOUT SAFETY............................................................................................2-1
2.1 Local law......................................................................................................... 2-1
2.2 Symbols overview............................................................................................... 2-2
2.3 Switching ON and OFF the device.............................................................................2-3
2.4 Emergency stop.................................................................................................. 2-3
2.5 Patient's and user's safety guidelines.........................................................................2-4
2.5.1 Patient's positioning.....................................................................................2-4
2.5.2 During the scan........................................................................................... 2-4
2.5.3 Patient's exit from the scanning area................................................................2-5
2.5.4 Patient's exit during fault / malfunctioning of the patient's table..............................2-5
2.6 Artifacts and repetition of a scan.............................................................................2-6
2.7 Protection from ionizing radiation............................................................................2-7
2.8 Protection from laser exposure...............................................................................2-9
2.9 Devices connected to the NewTom 5G console ...........................................................2-10
2.10 Maintenance time lag........................................................................................2-11
3 SAFETY AND MAINTENANCE OF THE DEVICE.........................................................3-1
3.1 Installation requirements......................................................................................3-1
3.2 Guidelines for safety........................................................................................... 3-2
3.3 Device modifications...........................................................................................3-3
3.3.1 Responsibility limits.....................................................................................3-3
3.4 Device maintenance............................................................................................ 3-3
3.5 Cleaning and disinfection......................................................................................3-6
3.5.1 Hygiene procedures for patient protection..........................................................3-7
3.5.2 Sterilization.............................................................................................. 3-8
3.6 Transport and storage..........................................................................................3-8
3.7 Device disposal.................................................................................................. 3-9
3.7.1 Information for the device owner.....................................................................3-9
3.7.2 Information for the Disposing/Recycle centers.....................................................3-9
4 GETTING STARTED........................................................................................4-1
4.1 Introduction to the system....................................................................................4-1
4.1.1 Intended use.............................................................................................. 4-1
4.1.2 Indications for use.......................................................................................4-1
4.1.3 Improper Use............................................................................................. 4-2
4.1.4 Device Operation........................................................................................4-3
4.2 Working principle................................................................................................4-3
4.3 Overall view...................................................................................................... 4-4
4.3.1 Control panels............................................................................................ 4-5
4.3.2 Patient table console...................................................................................4-6
4.3.3 Patient table with stretcher console.................................................................4-8
4.3.4 Input panel and main switch.........................................................................4-10
4.4 Standard accessories.......................................................................................... 4-10
4.4.1 Cables.................................................................................................... 4-11
4.4.2 Optional accessories...................................................................................4-11
4.5 System start-up................................................................................................ 4-12
4.6 System shut down.............................................................................................. 4-12
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 Invalidating the Blank acquisition.....................................................................5-5
5.4 Beam limiter test...............................................................................................5-6
6 SCANNING...................................................................................................6-1
6.1 Patient scan...................................................................................................... 6-2
6.1.1 Patient preparation.....................................................................................6-2
6.1.2 Positioning the patient and starting a new scan....................................................6-4
6.1.2.1 Patient positioning with patient table.....................................................6-6
6.1.2.2 Patient positioning with patient table with stretcher...................................6-9
6.2 Scanning a denture............................................................................................ 6-13
6.2.1 Preliminary operations and denture positioning..................................................6-13
6.2.1.1 Denture positioning with patient table...................................................6-13
6.2.1.2 Denture positioning with patient table with stretcher.................................6-14
7 QUALITY ASSURANCE.....................................................................................7-1
7.1 Phantom positioning............................................................................................7-1
7.2 Images samples.................................................................................................. 7-4
7.3 Storage of QA data.............................................................................................. 7-5
8 TROUBLESHOOTING.......................................................................................8-1
9 IEC61223: ACCEPTANCE TEST..........................................................................9-1
10 APPENDIX A- TECHNICAL REFERENCES.............................................................10-1
10.1 Scanner........................................................................................................ 10-1
10.2 Detector....................................................................................................... 10-2
10.3 Scout view radiological images.............................................................................10-3
10.4 Reconstructed volume ......................................................................................10-4
10.5 Radiological parameters.....................................................................................10-6
10.5.1 X-Ray Tube IAE model X22 0.3/0.6 ................................................................10-6
10.5.2 X-Ray tube head.....................................................................................10-11
10.5.3 X-Ray source assembly..............................................................................10-12
10.6 Inverter....................................................................................................... 10-13
10.7 Dose declaration............................................................................................ 10-14
10.8 Stray radiation diagram....................................................................................10-22
10.9 Laser.......................................................................................................... 10-23
10.10 Other data..................................................................................................10-23
10.11 Electromagnetic compatibility..........................................................................10-24
10.11.1 Essential performance.............................................................................10-28
11 APPENDIX B – SECURITY STANDARDS...............................................................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 ™ 5G
device.
This manual comprises all versions of the series (NewTom 5G, NewTom 5G version FP), in the following
generically called “NewTom 5G”.
NewTom 5G series devices are distributed under CEFLA s.c. or NewTom brand.
Dedicated software routines (scan, data processing, reporting, document management) and their user
instructions are described in the “Acquisition Operations with NewTom VGi-5G” annex to the “NNT User
Manual” document.
"User Manual", "NNT User Manual" and “Acquisition Operations with NewTom VGi-5G” 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

Provides information about contents, structure and conventions inside the document.
✔ Chapter 2: About safety

Provides information about user's and patients' safety and primary procedures regarding the use of
the device.
✔ Chapter 3: Safety and maintenance of the device

Provides 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 procedures for a proper initialization of the device.
✔ Chapter 6: Scanning
Describes the process for patient and prosthesis's positioning and scanning.
✔ Chapter 7: Quality assurance

Gives instructions about the execution of the Quality Assurance process in order to verify the image
NewTom 5G – User Manual 1-1

quality.
✔ Chapter 8: Troubleshooting
Provides information about possible faults of the device and their solution.
✔ Chapter 9: IEC61223: Acceptance Test

Provides procedures for testing as required by IEC61223 standard.
✔ APPENDIX A- Technical references

Provides the technical reference of the device.
✔ APPENDIX B – Security standards

Lists the standards conformity of the device.
✔ APPENDIX C - Labels
Lists the labels of the device.
1-2 NewTom 5G – User Manual

1.3 Graphic conventions
Primary information about safety and possible notes are highlighted by the following symbols:
DANGER:
Alerts for a potential danger which may cause injury or
death of a person.
WARNING:
Signals the presence of a potential danger which may
damage the device.
NOTE:
Provides information not related to the device and/or the
user's and/or the patient's safety.
IMPORTANT:
Instructions that you MUST follow to complete a task.
1.3.1 Text conventions
Bold text Indicates a menu or an item to select
Italics Used to emphasize a word or a phrase
<Key> Key enclosed in the less-than and greater-than sign means

that you must press the enclosed key.
<Key1+Key2> If you must press two or more keys simultaneously, the key
names are linked with a plus sign (+)
Example: <Ctrl+Alt+D>
Command Means that you must type the command exactly as shown.

2 About safety
2 About safety
This chapter includes information about safety to which the user should be familiar before using the
NewTom 5G device.
In order to ensure the patient and user's safety, the operator must follow the instructions included in this
manual, particularly for the functional tests, the electrical and mechanical safety and for the protection
against ionizing radiations exposure.
For these guidelines, please refer to the current chapter, to Chapter 3 - “Safety and maintenance of the
device“ and to Chapter 6 - “Scanning“.
WARNING:
All the operators must be familiar with the operating and
environment features of the equipment and have in-
depth knowledge of the procedures to follow in case of
danger or in case an emergency shut down of the device
is required.
2.1 Local law
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.

2 About safety
2.2 Symbols overview
The table below describes the symbols found on the device labels:
Symbol Standard Description

IEC 60417-5010 ON / OFF (push-push)
~ IEC 60417-5032 Alternating current
ISO 7000-0434A Caution
ISO 7010-W001 General warning sign
IEC 60878 Warning: dangerous voltage

ISO 3864-B.3.6
IEC 60417-5019 Protective earth (ground)
IEC 60417-5017 Earth (ground)
N IEC 60445 Connection point for the neutral conductor on

permanently installed equipment
L IEC 60445 Connection point for the line conductor on
permanently installed equipment
IEC 60417-5841 Defibrillation-proof type B applied part
ISO 361 Ionizing radiations
Directive Disposal of WEEE (Waste from Electrical and

2012/19/EU Electronic Equipment)
Directive CE Mark
93/42/CEE

2 About safety
EN 980:2008 Serial Number
EN 980:2008 Date of manufacture
EN 980:2008 Manufacturer
ISO 7000-1641 Operating instructions
ISO 7010-M002 Refer to instruction manual/booklet
IEC 60417-5638 Emergency stop
2.3 Switching ON and OFF the device
Turning the device ON and OFF must be performed according to the procedures described in Chap. 4.5 -
“System start-up” and 4.6 - “System shut down”.
2.4 Emergency stop
The device is supplied with 4 emergency buttons. The first button is installed close to the operator table. The
second button is located on the patient's table below the table control panel. Two additional buttons are
placed on the side of the scanner gantry next to the control panels.
Figure 1: From left : Emergency button on the operator's table, on the patient's table, on the scanner

2 About safety
Switching off the device through an emergency button will result in a prompt break of the x-ray emission and
in an interdiction of all the motor movements.
WARNING:
The emergency buttons must be used only in a danger
situation, such as:
• The X-Ray source does not stop emitting;
• Dangerous conditions that may damage people, the

environment or the device;
• Whenever the system signals an emergency state.
2.5 Patient's and user's safety guidelines
Risks for patients 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.
2.5.1 Patient's 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.
For additional information about positioning the patient, refer to Par. 6.1.2 - “Positioning the patient and
starting a new scan“.
2.5.2 During the scan
NEVER leave the system without a supervisor during the positioning of the patient and the execution of an
exam.
Always watch the patient all along the scan process.
WARNING:
Never use the device without the supervision of an operator.

2 About safety
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.
2.5.3 Patient's exit from the scanning area
At the end of an exam or after an emergency shutdown, the patient can be extracted from the scan area and
can walk away from the scanner.
2.5.4 Patient's exit during fault / malfunctioning of the patient's table
In case of patient table malfunctioning, act on the manual release to take out the patient from the gantry, and
operate as follows:
In case of patient table with stretcher malfunctioning, manually remove the patient from the gantry by sliding
the stretcher completely out (for more details about this procedure please refer to Par. 6.1.2.2)

2 About safety
Here are some general guidelines for the extraction in case of disabled patient or unconscious:
1. Get help from other people. Three person are required. Two people on each side of the patient and a
third person to check and help the movements of the patient head.
2. On each side of the patient, place one hand under the patient's shoulder and the other under the
patient's pelvis.
3. Remove the head support from the gantry and hold up the patient's head.
4. Gently, slide the patient out of the gantry verifying the patient's head is safely supported.
5. If possible, ask the patient to collaborate during the procedure in order to facilitate the entire process.
Operator's guidelines during the aforementioned process:
✔ Avoid to flex the back, by bending the knees;

✔ Increase the support area by enlarging and bending the legs transversely or longitudinally
depending on the direction of the movement.
✔ Get close to patient as much as possible;
✔ Ensure a good hand grid on the patient before starting any movement;
✔ During the process impart the necessary indications through words, single phrases and gesture.
✔ Do not lift the patient.
NOTE:
For additional movement of the patient toward a stretcher, a
wheelchair or a different device, in case of unconscious or
ambulant patient, please refer to the standard procedures.
NOTE:
In case of involuntary power supply interruption, the
maximum vales of the distance of motorized patient table
movements (with a maximum rated load applied) are the
following:
Longitudinal Movement: <5mm

Transversal Movement: <10mm
Vertical movement: <5mm
2.6 Artifacts and repetition of a scan
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.

2 About safety
2.7 Protection from ionizing radiation
WARNING:
NewTom 5G 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.
WARNING:
NewTom 5G mustn't be used for routine examinations or
screening.
For this purpose consider other diagnostic tools.
Imaging examinations performed on each patient must be
justified, so that it can be shown that the benefits outweigh
the risks of use.
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 operator's responsibility to protect the patients from needless exposures to x-ray.
WARNING:
Consider the possibility to use a leaded cloth to protect the
patient from the scattered radiation.
WARNING:
In the prescription of radiographs for pregnant women,
consider carefully the possible consequences of the fetus
irradiation.
When possible the irradiation of a fetus should be avoided.

2 About safety
WARNING:
Consider the possibility to use a leaded apron with thyroid
collar to protect the patient from the scattered radiation.
WARNING:
Potential detrimental interaction off the CT X radiation with
active implantable medical devices and body worn active
medical devices.
Contact the manufacturer of such devices for more
infomations.
✔ Devices displaying the emission
The x-ray emission status is identified 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 selected 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
gantry. 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 or emission.

2 About safety
WARNING:
If the x-ray emission signals are on when the specific command
has not been selected or if they are off after a START emission
command or if the x-ray emission does not stop after the
expected time, IMMEDIATELY TURN THE DEVICE OFF and
contact technical assistance.
2.8 Protection from laser exposure
The device is equipped with a double laser in order to aid the operator during the patient positioning.
The vertical line identifies the central sagittal plane of the reconstructed volume. The horizontal line identifies:
– in case of Large field scan, the occlusal plane.

– In case of other scan modalities, the central axial plane of the reconstructed volume.

2 About safety
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 40 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.
2.9 Devices connected to the NewTom 5G console
Workstations, displays, printers, keyboards and other devices which may be connected to the NewTom 5G
console MUST comply with ISO and/or IEC and/or EN standards and/or local laws in force. CEFLA s.c. is
available for further information.
CEFLA s.c. is available for additional details about this matter.
NOTE:
The manufacturer is not accountable for faults and/or
malfunctioning of parts that were not supplied or
approved by the manufacturer, or not installed by
technical staff qualified and certified by the manufacturer
itself.
Food and beverage may not be placed or eaten/drunk close to the device and the workstation.

2 About safety
2.10 Maintenance time lag
Please be sure that the maintenance controls that are described in Par. 3.4 “Device maintenance“ are
performed.

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: from +10° to +35° (Celsius)

Operating humidity condition: min 10%, max 85% (not condensing)
Installation site minimum dimensions: 3.30m x 2.50 x 2 m (130'' x 98.5'' x 80'')
The device must be installed on a flat horizontal floor.
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.

WARNING:
Be sure that the device is connected to a power supply with
protective earth (ground)
NOTE:
The workstation must be located outside the patient's area.
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 discharges
Electrostatic discharge may damage electrical parts in the device. Consequently the floor in the
installation room should be made of antistatic materials.
✔ Extinguisher
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
references“.

3.3 Device modifications
Possible modifications 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.
3.3.1 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.
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 NewTom 5G unit has not been used to scan patients for
longer than three months, it will be necessary to perform a
beam forming procedure (for more details please contact the
Technical Support)
✔ Dangerous cleaning substances

Some cleaning substances should be avoided to prevent damage to people and to the device
(See Par. 3.5 - “Cleaning and disinfection”).
✔ 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 carefully stored according to their technical specifications.
✔ Malfunctioning
If the system is not working as described inside this manual, please immediately contact the
Technical Support.
✔ 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.

Responsable Part Activity Frequency

Routine testing
User Global system QA Phantom check Weekly
Error log Check 12 months
Every external part Damage check 12 months
Local Support
Service
Emergency buttons Emergency test 12 months
Electrical functioning Check 12 months
Mechanical functioning Check 12 months
Other test depending of local regulations
Radioprotection Global system Radiological test Radiological test
expert or other conforming to the local conforming to the
qualified person regulation concerning X-ray local standard
depending on medical electrical
local regulations equipment.
This tests in not in charge
by user or local support
service but may be
established by local
regulations.

3.5 Cleaning and disinfection
WARNING:
Power OFF the device before any cleaning.
WARNING:
Cleaning is the first step necessary in any disinfection process.
The physical action of rubbing a surface with detergents and
surface-active agents and rinsing with water removes a large
number of microorganisms. If a surface is not cleaned first, the
disinfection process cannot be successful.
When a surface cannot be adequately cleaned, it should be protected with barriers.
The external parts of the device must be cleaned and disinfected using a product for hospital use with
indications for HIV, HBV and tuberculosis (medium-level disinfectant) specifically for small surfaces.
The various drugs and chemical products used in dentist’s surgeries may damage the painted surfaces and
the plastic parts. The tests and research conducted have demonstrated that the surfaces cannot be fully
protected against attack of all the products found on the market. It is therefore recommended to use barrier
protections whenever possible.
The aggressive effects of chemical products also depend on the time they stay in contact with the surfaces. It
is therefore important not to leave the product on the surfaces of the device for longer than the time indicated
by the manufacturer.
It is recommended to use the specific medium-level disinfectant, STER 1 PLUS (CEFLA S.C.), which is
compatible with the painted surfaces, plastic parts and unpainted metal surfaces. Alternatively, it is
recommended to use products that contain:
- 96% ethanol Concentration: maximum 30 g for every 100 g of disinfectant.

- 1-propanol (N-propanol, propyl alcohol, N-propyl alcohol). Concentration: maximum 20g for every 100g of
disinfectant.
- Combination of ethanol and propanol. Concentration: the combination of the two must be at maximum
40g for every 100g of disinfectant.
WARNING:
- Do not use products containing isopropyl alcohol (2-propanol,
isopropanol).
- Do not use products containing sodium hypochlorite (bleach).
- Do not use products containing phenols.
- Whatever product you use, follow the instructions given by
the manufacturer.
- Do not mix the STER 1 PLUS disinfectant with other products.
- Do not spray the product directly on the device surfaces.

For cleaning and disinfection use disposable,

soft, non-abrasive paper (do not use recycled paper)
or sterile gauze.
✔ It is recommended to turn off the device
before cleaning and disinfecting the external
parts.
✔ Everything used for cleaning and disinfection
must be thrown away after use.
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.
NOTE:
For further information about safety and maintenance of the
device please contact your local distributor.
3.5.1 Hygiene procedures for patient protection
Single-use hygienic protections are the main means of protection against transmission of cross-infections
between patients. In order to prevent transmission of infectious diseases from patient to patient, it is
essential to always use the single-use protections. The single-use protections are classified as Class
I medical device and may not be replaced with others in a lower class.
The single-use protections must be in compliance with the ISO 10993-1 standards on biocompatibility and
approved by the control bodies where required (e.g. FDA, CE).
The disposable protective covers must be stored in a clean dry place away from direct sunlight and UV rays.
Cover all the components that will come into contact with the hands of the dental staff with disposable single-
use protections, as they might be contaminated by indirect contact with the patient’s mouth. In particular, be
careful how you handle the control console of the device, the mouse and keyboard of the PC.
Note for users in Canada:

ask your trusted dental material distributor for any plastic barrier that is suitable in size and is marketed in
Canada according to the local regulations in force.
According to Health Canada, bite block covers are Class I devices and are distributed by
authorised establishments only, as listed in the MDEL database.
NOTE:
For further information about safety and maintenance of the
device please contact your local distributor.

3.5.2 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: from -20° to +70° (Celsius)

Transport and storage humidity: min 10%, max 85% (non condensing)
Do not expose to acids, saltiness, rain.

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.

4 Getting started
4 Getting started
This chapter provides a brief introduction for the NewTom 5G system, its power on and off routines and
control devices.
4.1 Introduction to the system
4.1.1 Intended use

The device NewTom 5G is a cone beam computed tomography x-ray system. It is intended for diagnostic
use obtaining geometric information and radiologic density from two-dimensional and three-dimensional
images of anatomic particulars and objects in the examined area.
4.1.2 Indications for use

The NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires sequences of
the head including the ear, nose and throat (ENT), dento-maxillofacial complex, teeth, mandible and jaw,
temporo-mandibular-joint (TMJ), other areas of human skull and neck with sections of upper cervical spine,
and upper and lower extremities for use in diagnostic support. The device accomplishes this task by
reconstructing a three dimensional matrix of the examined volume and producing two dimensional views of
this volume, displaying both two and three dimensional images.
The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified
professionals.
WARNING:
NewTom 5G is able to produce panoramic reconstructions from
CBCT acquisitions. This may reduce dose in the case where both
CBCT and panoramic images are needed. However, if the
system is used to simulate a panoramic image when a CBCT is
not necessary, this can lead to excess radiation dose to the
patient.
WARNING:
Federal law restricts this device to sale by or on the order of a
practitioner licensed by the law of the State in which he practices
to user or order the use of x-ray imaging systems
21CFR801.109(b)
WARNING:
Cone beam imaging should not be used for 'routine' (or
'screening') examinations. Other diagnostic tools must be
considered. The imaging examinations must be justified for
each patient to demonstrate that the benefits outweigh the
risks.
WARNING:
Where it is likely that evaluation of soft tissues will be required
as part of patient's radiological assessment, the appropriate
imaging should follow the Diagnostic Imaging Referral
Guidelines of the Canadian Association of Radiologists, rather
than using cone beam technology

4 Getting started
WARNING:
In prescribing radiographic examinations of pregnant or
possibly pregnant women, full consideration should be taken of
the consequences of fetal irradiation. Irradiation of a fetus
should be avoided whenever possible.
WARNING:
This device is particularly designed for use on patients more
than approximately 11 kg (24 lb) in weight and 87 cm (34.25 in)
in height; these height and weight measurements
approximately correspond to that of an average 3 year old.
Studies have shown that pediatric patients may be more
radiosensitive than adults (i.e., the cancer risk per unit dose of
ionizing radiation is higher), and so unnecessary radiation
exposure is of particular concern for pediatric patients.
4.1.3 Improper Use

The NewTom 5G device has not been designed for the following uses and/or applications (reasonably
foreseeable improper use):
– use with patients that cannot stand still during the entire scanning cycle (30 seconds max.);
– use in anatomic regions that are not within the scope of the device intended use (e.g., chest and
abdomen);
– use for studying cerebral soft tissues;
– use by staff that have not received training on the device;
– use by staff that do not meet the requirements specified in the user profile;
– use in the operating theatre;
– use with removable metal objects (eye glasses, jewels, rings, necklaces) in the scanning field;
– use in environmental conditions other than the indicated ones.

4 Getting started
4.1.4 Device Operation

A patient is made to lay down on the patient table and centered by means of 2 laser modules and "scout
view" images.
The scanning system performs a completely rotation around the patient. 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 ”NNT User Manual” document
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.
The advantages compared to a traditional technique are:
✔ 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.

4 Getting started
4.3 Overall view
The system is composed by three main parts: scanner unit, patient table accessory (patient table version,
cod. 96600722 or patient table with stretcher version, cod. 96600822) and main workstation installed out of
the patient area.
It is also possible to add more workstations for data processing and storage.
For additional informational about this matter, please refer to the "NNT User Manual" document
Figure 2: NewTom 5G complete system
NOTE:
The system may not be expanded with parts or
accessories other than the ones described inside this
manual

4 Getting started
4.3.1 Control panels
The scanner unit is the main part of the system. Two control panels are placed on each side of the scanner
gantry. These two panel includes the indicators for the device “power ON” status and for the emission status.
The control panels also include the laser button that turn ON the laser used during the patient's positioning
Figure 3: Control panels
Next is a brief description of each button and sign:
Emergency button:
to be used only during danger situations.
To restore the default condition after pressing the button,
rotate it in the direction indicated by the arrows.
Power ON indicator:
A green LED turns on after the device has been switched
ON by pushing the main switch located on the input panel.
X-Ray emission indicator:

3 LEDs turn on simultaneously during the x-ray emission.
Laser Button(L):
Turns the positioning laser beam on/off. The laser will
light up for about 60 seconds.

4 Getting started
4.3.2 Patient table console
Figure 4: Patient table console
UP/DOWN buttons
to be used after the patient is positioned inside the gantry,
to adjust the vertical position of the table (z axis).
LEFT/RIGHT-FORWARD/BACK buttons
to be used after the patient is positioned inside the gantry,
to adjust the position along the x and y axis of the table.
P1 button
to be used after the patient is sitting in the table to move
him/her inside the gantry.
P2 button
to be used after the device has been turned ON to move
the table to the default position.
Use the P2 button also at the end of the scan to move the
patient out of the gantry.

4 Getting started
LASER button
Turns the positioning laser beam on/off. The laser will
light up for about 60 seconds (only available if the
connection between patient table and NNT software is
active).
READY – XRAY EMISSION – FAULT indicators

A green LED turns on once the connection between
patient table and NNT software is active.
A yellow LED turns on during x-ray emission.
A red LED turns on in case of patient table fault condition.
For more details about the use of patient table and complete available buttons and functions, please refer to
the “Patient Table User Procedures” document.

4 Getting started
4.3.3 Patient table with stretcher console
Figura 5: Patient table with stretcher console
Button Function Warnings

UP/DOWN Raise and lower the table These movements are not allowed in
case of "facilitated uphill position".
The minimum / maximum excursions
of the movements are limited to
defaults values by active collision
controls.
FORWARD/BACK Not available Not available. Physically, the stretcher

can be moved only in manual mode
LEFT/RIGHT Transversal movement Transversal table movement is not

allowed in case of "facilitated uphill
position". The minimum / maximum
excursions of the movements are
limited to defaults values by active
collision controls.
P1 Start sequence Operation allowed when the display
"Exam Preparation Position" show a window with P1 symbol (ie if
the stretcher is completely out of the
gantry with active limit switch).
P2 Start sequence Operation allowed when the display
“Facilitated Uphill Position” show a window with P2 symbol (ie if
the stretcher is completely out of the
gantry with active limit switch).
+/- + / - buttons The function depends on the current

page displayed on the screen

4 Getting started
LASER Laser ON / OFF buttons The button is active only if the

communication 5G / PC is active
F1 / MODE / F2 Navigation menu buttons The function depends by the icon

F1 / MODE / F2 displayed on the screen in
correspondence of the relevant key
READY 5G/PC connection Led A green LED is on when the
connection between 5G and PC is
active
X-RAY EMITTION X-ray emission Led A yellow LED is on when an x-ray
emission is active
FAULT Fault Led A red LED is on when when an
anomaly occurs. The operator
attention is required
For more details about the use of patient table and complete available buttons and functions, please refer to
the “Patient Table User Procedures” document.

4 Getting started
4.3.4 Input panel and main switch
On the left side of the device is located the input panel, which includes the main switch to turn the system
ON/OFF and the fuse holder.
The input panel also includes the connectors for the CAN Bus and the Ethernet cables (to be connected to
the workstation console) and the cable glands for the power supply cable and for the cable of the remote
emergency button.
MAIN SWITCH
CANBUS CONNECTOR
CONNECTOR
FUSE HOLDER
ETHERNET
CONNECTOR
Figure 6: Input Panel and connectors
4.4 Standard accessories
The device is supplied with a few standard accessories:
QA phantom:
used for the execution of the Quality Assurance procedure.
Calibration support:
Plate to be used for the positioning of the QA phantom on the
patient table.

4 Getting started
Calibration support:
Plate to be used for the positioning of the denture on the patient
table.
4.4.1 Cables
The device also includes linking cables between workstation console and scanner unit. They are:
✔ Ethernet cable (4 pairs/26 AWG-FTP-5E)
✔ CAN bus cable (2 pairs/24 AWG shielded)
The manufacturer also provides the power supply cable with an end connected to the scanner unit, it is in
charge of the user to connect it to the mains during installation.
ETHERNET CABLE
CANBUS CABLE
WARNING:
Accessories, transducer and cables different from the
ones here specified may change the electromagnetic
compatibility characteristics of the device.
4.4.2 Optional accessories
At the present time no optional accessories are available for a NewTom 5G system.

4 Getting started
4.5 System start-up
To properly switching the device on:
1. Turn on the scanner unit by pushing the main switch located on the input panel (left side of the
device).
2. Turn on the workstation. Wait for the Operating System to be load.
3. Log in the Operating System with assigned User name and Password .
4. Start NNT software.
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 Chap. 8 -
“Troubleshooting“)
4.6 System shut down
Next is the procedure for a proper turning off of the device:
1. Close the NNT software.
2. Shutdown the workstation console.
3. Turn off the scanner unit by pushing the main switch located on the input panel(left side of the
device).
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.

5 Preliminary procedures
This chapter describes the procedures to perform compulsorily before starting scanning patients.
There are three of these procedures:
✔ X-Ray source conditioning;
✔ Daily check;
✔ Blank acquisition;
This chapter also describes the following functionality:
✔ Beam limiter test
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 "NNT User Manual" document.
5.1 X-Ray Source Conditioning
The conditioning procedure is necessary in order to prepare the x-ray source for its routine working.
It is compulsorily and automatically required by the NNT software every two weeks.
Figure 7: Initial NNT screenshot with request of X-Ray Source Conditioning

WARNING
Before launching the procedure, please verify that the
scan area is completely free from objects.
Figure 8: X-Ray Source conditioning process running
At the end of conditioning process, the software will automatically run the Daily Check and Blank acquisition
procedures.

5.2 Daily Check
By running the Daily Check procedure the system verifies that each part of itself properly works.
Figure 9: Initial NNT screenshot with request of Daily check
WARNING:
scan area is completely free from objects. To that end,
take out the patient table

Figure 10: Daily check running
5.3 Blank acquisition
During Blank acquisition a background image is acquired in order to verify and calibrate the detector
performances.
This procedure is automatically performed by the software every two weeks.
The resulting blank acquisition image should look like shown in the figure.
Please carefully verify that no artifacts or objects appear.
WARNING:
scan area is completely free from objects. To that end, if
not done previously, take out the patient table

5.3.1 Invalidating the Blank acquisition

In the event that Blank acquisition has been performed with an object inside the scanning area, you will have
to invalidate the blank acquisition and repeat the operation.
To invalidate the blank acquisition select Scan  Invalidate Blank from the main toolbar.
At the next detector field selection the NNT software will ask a new blank acquisition.
WARNING:
If the test has been performed correctly but has not been
completed successfully, please contact our Technical Support.

5.4 Beam limiter test
This functionality has the purpose of allowing the user to check proper collimation.
The collimator's positions are pre-set by the manufacturer and may not be changed by the user.
1. From the main toolbar select Tools  Scanner Test.
2. From the window bar select Tools  Beam Limiter Test. Select the desired FOV.
3. 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)
4. Perform an acquisition.
5. Verify the acquired image is correctly collimated (the green rectangle should be entirely included in
the gray acquired area. The edges of the rectangle must be included between the two couples of red
lines).
Figure 11: Beam limiter test
WARNING:
If the grey image acquired is not correctly collimated
within the red lines, please contact our Technical
Support.

6 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 “Acquisition Operations with NewTom VGi-5G” document, annex to the “NNT User
Manual” document.
It is also suggested to refer to Chapter 2 - “About safety“ and Chapter 3 - “Safety and maintenance of the
device“
It is possible to perform the scans in the following modalities:
– [18x16] (volume diameter 18cm, height 16cm);

– [15x22e] (eFOV scan)3
– [15x12];
– [12x8];
– [8x8];
– [15x5] HiRes (High Resolution);
– [12x8] HiRes;
– [8x8] HiRes;
– [6x6] HiRes.
WARNING:
Use the smallest field of view required, based on the clinical
requirements. In general, for small size and pediatric patients
it is recommended to use the smallest FOVs available (i.e.,
6x6, 8x8, 12x8, 15x5).
It is possible to perform the scans with 3 different options for each reported modalities 4:
– Eco Scan: < image quality, < exposure time for all modalities
< scan time only for HiRes modalities
– Regular Scan: default option for image quality, scan time and exposure time
– Enhanced Scan: > image quality, > scan time and exposure time
WARNING:
For children, we recommend using the lowest dose and
fastest scanning mode available: ECO SCAN.
3 FOV available only with the patient table with stretcher and software option enabled.
4 “Enhanced Scan” option not available in case of eFOV scan

6 Scanning
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.
6.1 Patient scan
6.1.1 Patient preparation
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.
✔ Accommodating the patient

After accommodating the patient in the patient table, move it in the scan area and adjust the table so
as to frame the interested area and the neck/bust of the patient assumes a correct position.
✔ Explanation of the examination

Please explain in short the scan routine to the patient, including the data collection process, the
positioning and scanning.
✔ Particular patients
A special care has to be taken in case of children, elderly people, claustrophobic people, physically
or mentally disabled.
✔ Proper breathing
Ask the patient to breathe slowly during the scanning (a slow and continuous breath helps from
swallowing).

6 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 to possible voice instructions that the operator may give during the scan.

6 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.
For more details about use of the patient table, please refer to the “Patient Table User Procedures”
document.
The guidelines for patient positioning during examination of the different anatomic regions are outlined in the
attached document “General guidelines for the use of the NewTom 5G device in the dental and medical
field”.
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.
WARNING:
Pay attention while moving the patient's table in order to
avoid possible collision with object and/or person.
NOTE:
Pay attention to don't load excessively the parts of the patient
table. The allowed maximum loads are:
Patient Table:
Head-Rest: 15 Kg / 33 lbs
Back-Rest: 52.5 Kg / 115 lbs
Seat: 62.5 Kg / 138 lbs
Feet-Rest: 30 Kg / 66 lbs
Patient Table with stretcher:
1) Maximum load (for zone)
Stretcher out of the gantry

Zone A: 35 Kg / 77 lbs
Zone B: 175 Kg / 385 lbs
Zone C: 175 Kg / 385 lbs

6 Scanning
Stretcher into the gantry

Zone A: 35 Kg / 77 lbs
Zone B: 90 Kg / 198 lbs
Zone C: 175 Kg / 385 lbs
2) Sitting areas for adult patient (maximum weight 160Kg)
3) Distribution of maximum rated load 175kg (160kg + 15Kg

accessories)

6 Scanning
6.1.2.1 Patient positioning with patient table
1) After the device has been turned ON, the patient's table position should be reset (default position
for patient accommodation). This task can be accomplished by pressing the P2 button on the
table console.
PATIENT TABLE
DEFAULT POSITION
2) Help the patient to sit down on the table with the head resting on the head support.

6 Scanning
3) Move the table inside the scan area by pressing the P1 button.
Assure the patient will keep a correct posture and remember him/her to do not swallow, gnash the
teeth and move during the positioning process.
PATIENT TABLE
SCAN POSITION
4) Finely adjust the patient position by using the table console buttons.(UP/DOWN – LEFT/RIGHT -
FORWARD/BACK).
In order to help the operator during the positioning of the patient, the laser can be turned on by
pressing the LASER button on the scanner control panels or on the table console (required the
NNT software to be open).

6 Scanning
5) For the patient scan please refer to Par. “Patient scan” and “Remote patient position adjustment”
included in the “Acquisition Operations with NewTom VGi-5G” document annex to the “NNT User
Manual” document.
6) Once the scan process is finished, press the P2 button in order to slide out the table from the
gantry, restore the default position and allow the patient to leave the room.

6 Scanning
6.1.2.2 Patient positioning with patient table with stretcher
NOTE:
eFOV (extra Field of View) scan mode, an acquisition mode
that uses 2 contiguous exposures, is available if the software
option is enabled.
eFOV scan is recognizable by the presence of the "e" letter
next to the selected FOV (eg [15x22e]).
For more details about this acquisition mode, please refer to
the “Acquisition Operations with NewTom VGi-5G” document
annex to the “NNT User Manual” document.
1) After the device has been turned ON, the patient's table position should be reset (facilitated uphill
position).
Make sure that the stretcher is completely out of the gantry and locked by the handle positioned
at the side of the table console.
Then, press P2 button on the table console.
Figure 12: Patient table in facilitated uphill position

6 Scanning
2) Help the patient to sit down on the table with the head resting on the head support.
3) Press P1 button on the console by moving the patient table to “exam preparation” position.
Figure 13: Patient table in exam preparation position
4) Unlock the stretcher and slide it into the gantry. Then relock the stretcher.
Figure 14: Patient table with stretcher into the gantry

6 Scanning
5) Assure the patient will keep a correct posture and remember him/her to do not swallow, gnash the
teeth and move during the positioning process.
6) Finely adjust the patient position by using the table console buttons.(UP/DOWN – LEFT/RIGHT).
In order to help the operator during the positioning of the patient, the laser can be turned on by
pressing the LASER button on the scanner control panels or on the table console (required the
NNT software to be open).
7) For the patient scan please refer to Par. “Patient scan” and “Remote patient position adjustment”
Manual” document.
8) Once the scan process is finished, remove the patient from the gantry by sliding the stretcher
completely out, then relock the stretcher.

6 Scanning
Figure 15: Patient table with stretcher out of the gantry
Press P2 button in order to reset the patient table to the default position (facilitated uphill position)
and allow the patient to leave the room.

6 Scanning
6.2 Scanning a denture
6.2.1 Preliminary operations and denture positioning
Hereafter are the operations to perform to proper positioning and centering of the denture inside the
scanning area. Perform such steps according to the software instructions.
document.
6.2.1.1 Denture positioning with patient table
1) Press the P2 button on the table console in order to reset the table to the default position.
2) Remove the head support and slide the table inside the gantry by pressing the P1 button on the
table console.
3) Insert the denture in the provided slit of the denture support, and position the support on the table
carbon fiber board as shown in the following picture. Pay attention to do not reverse the denture
(must be in the same position as in the patient mouth).
4) Finely adjust the denture position by using the table console buttons. (UP/DOWN – LEFT/RIGHT -
FORWARD/BACK).
In order to help the operator during the positioning of the patient the laser can be turned on by
pressing the LASER button on the scanner control panels or on the table console (required the NNT
software to be open).
5) For the denture scan please refer to Par. “Denture scan” and “Remote patient position adjustment”
Manual” document.
6) Once the scan process is finished, remove the denture support from the table and press the P2
button in order to slide out the table from the gantry.
7) Place the patient head support on the on the table carbon fiber board.

6 Scanning
6.2.1.2 Denture positioning with patient table with stretcher
1) Make sure that the stretcher is completely out of the gantry and locked by the handle positioned
at the side of the table console.
2) Press the P2 button on the console in order to reset the patient table to the default position
(facilitated uphill position)
3) Remove the head support and press P1 button on the console by moving the patient table to “exam
preparation” position.
4) Unlock the stretcher and slide it into the gantry. Then relock the stretcher.
5) Insert the denture in the provided slit of the denture support, and position the support on the table
carbon fiber board as shown in the following picture. Pay attention to do not reverse the denture
(must be in the same position as in the patient mouth).

6 Scanning
6) Finely adjust the denture position by using the table console buttons. (UP/DOWN – LEFT/RIGHT).
7) For the denture scan please refer to Par. “Denture scan” and “Remote patient position adjustment”
Manual” document.
8) Once the scan process is finished, remove the denture support from the table, unlock the stretcher
and slide completely out of the gantry, relock the stretcher then press P2 button in order to reset the
patient table to the default position (facilitated uphill position)
9) Place the patient head support on the on the patient table carbon fiber board.

7 Quality assurance
7 Quality assurance
The quality assurance process consists in performing a routine scan on the specific phantom ( QA phantom)
supplied with the device, 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 complete test procedure is described inside the “Acquisition Operations with NewTom VGi-5G”
document annex to the “NNT User Manual” document.
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.
document.
1) Press the P2 button on the table console in order to reset the table to the default position.
PATIENT TABLE WITH STRETCHER ONLY

Before pressing P2 button, make sure that the stretcher is completely out of the gantry and locked
by the handle positioned at the side of the table console.
2) PATIENT TABLE ONLY

Remove the head support and slide the table inside the gantry by pressing the P1 button on the
table console.

Remove the head support and move the table to the “exam preparation position” by pressing P1
button.
Unlock the stretcher and slide it into the gantry. Then relock the stretcher.
3) Position the phantom support on the table carbon fiber board, then place the phantom on the support

7 Quality assurance
as shown in the following picture.
4) Finely adjust the phantom position by using the table console buttons. (UP/DOWN – LEFT/RIGHT –
[FORWARD/BACK – patient table only] ).
Position the phantom in such a way the laser will match with the reference line located on the
phantom (see next picture=.
5) For the phantom scan please refer to Par. “QA Phantom scan” and “Remote patient position
adjustment” included in the “Acquisition Operations with NewTom VGi-5G” document annex to the
“NNT User Manual” document.

7 Quality assurance
6) PATIENT TABLE ONLY

Once the scan process is finished, remove the phantom and the support from the table and press
the P2 button in order to slide out the table from the gantry (default position).

Once the scan process is finished, remove the phantom and the support from the table, unlock the
stretcher and slide completely out of the gantry, relock the stretcher then press P2 button in order to
reset the patient table to the default position (facilitated uphill position)
7) Place the patient head support on the table carbon fiber board.

7 Quality assurance
7.2 Images samples
Hereafter some sample images from a QA phantom analysis.
Lateral view
Axial view
Panoramic view

7 Quality assurance
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.

8 Troubleshooting
8 Troubleshooting
For the troubleshooting of the device please refer to the “NNT – Error Guide” document.

9 IEC61223: Acceptance Test
A description of the software utilities for the execution of acceptance test can be found in the “ NNT User
Manual” document.
Here are reported specific instructions to perform such tests (please refer to norm IEC61223-3-5) along with
the corresponding paragraph from the norm.
At the end of this chapter a table containing the reference value can be found.
✔ Positioning of the patient support [paragraph 5.1]

Not applicable.
✔ Patient positioning accuracy [paragraph 5.2]

The NewTom 5G is equipped with two cross shaped laser pointer aimed to help the patient
positioning. The horizontal line identify the axial plane of the acquired volume, the vertical line
identify the sagittal plane of the acquired volume.
✗ Axial patient positioning accuracy [paragraph 5.2.1]

Position an object along the axial plane identified by the horizontal line and scan it by using
the [6x6] HiRes FOV (refer to the "NNT User Manual" for data analysis).
✗ Sagittal and coronal patient positioning light [paragraph 5.2.2]

Position an object along the sagittal plane identified by the vertical line and scan it by using
the [6x6] HiRes FOV (refer to the "NNT User Manual" for data analysis).
✔ Tomographic section thickness [paragraph 5.3]
✗ Tomographic section thickness for axial scanning [paragraph 5.3.1]

Refer to "NNT User Manual".
✗ Tomographic section thickness for helical scanning [paragraph 5.3.2]

Not applicable.
✔ Dose [paragraph 5.4]

Take required scans for each modality according to IEC 60601-2-44: 2009.
The machine calculates automatically the loading factors, according to the scanned object. There is
no way to select manually loading factors for a scan.
✔ Noise, mean CT number and uniformity [paragraph 5.5]

✔ Spatial resolution [paragraph 5.6]


✔ IEC 61223-3-5: reference values

The following table contains the reference values and the reference conditions to be applied for the
execution of the tests.
5.1 Positioning of the patient N.A.

support
5.2 Patient positioning 5.2.1 Axial patient positioning  2mm from isocenter
accuracy accuracy
5.2.2 Sagittal and coronal patient  2mm 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
Standard Dose, Eco Scan
CTDIFREE AIR N.A.
CTDIvol
[15x22e] 4.6 mGy 30%

other FOVs Equal to CTDI100w
CTDI100w:
[18x16] 2.9 mGy 30%

[15x22e] 4.2 mGy 30%
[15x12] 2.9 mGy 30%
[12x8] 2.9 mGy 30%
[8x8] 2.2 mGy 30%
[15x5] HiRes 6.7 mGy 30%
[12x8] HiRes 7.6 mGy 30%
[8x8] HiRes 6.4 mGy 30%
[6x6] HiRes 4.6 mGy 30%
Standard Dose, Regular Scan

CTDIFREE AIR N.A.
CTDIvol
[15x22e] 7.0 mGy 30%

CTDI100w:
[18x16] 4.4 mGy 30%

[15x22e] 6.4 mGy 30%
[15x12] 4.4 mGy 30%
[12x8] 3.8 mGy 30%
[8x8] 3.3 mGy 30%
[15x5] HiRes 10.2 mGy 30%
[12x8] HiRes 11.5 mGy 30%
[8x8] HiRes 9.6 mGy 30%
[6x6] HiRes 5.6 mGy 30%
Boosted Dose, Regular Scan

CTDIFREE AIR N.A.
CTDIvol
[15x22e] 10.9 mGy 30%

CTDI100w:
[18x16] 8.8 mGy 30%

[15x22e] 10.0 mGy 30%
[15x12] 9.2 mGy 30%
[12x8] 6.2 mGy 30%
[8x8] 5.3 mGy 30%
Standard Dose, Enhanced Scan
CTDIFREE AIR N.A.
CTDIvol Equal to CTDI100w
CTDI100w:
[18x16] 5.8 mGy 30%

[15x12] 5.8 mGy 30%
[12x8] 5.0 mGy 30%
[8x8] 4.4 mGy 30%
[15x5] HiRes 13.5 mGy 30%
[12x8] HiRes 15.3 mGy 30%
[8x8] HiRes 12.8 mGy 30%
[6x6] HiRes 9.4 mGy 30%
Boosted Dose, Enhanced Scan

CTDIFREE AIR N.A.
CTDIvol Equal to CTDI100w
CTDI100w:
[18x16] 11.7 mGy 30%

[15x12] 12.2 mGy 30%
[12x8] 8.2 mGy 30%
[8x8] 7.0 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.
Standard Dose, Eco Scan
[18x16] (standard voxel) < 65

[18x16] (ultra small voxel) < 110
[15x5] HiRes (standard voxel) < 80

[15x5] HiRes (ultra small voxel) < 190
Standard Dose, Regular Scan

Standard deviation [18x16] (ultra small voxel) < 75

Boosted Dose, Regular Scan


Standard Dose, Enhanced Scan


Boosted Dose, Enhanced Scan

Standard Dose
[18x16] (standard voxel) 1000 10%

[18x16] (ultra small voxel) 1000 10%
[15x5] HiRes (standard voxel) 1120 10%

[15x5] HiRes (ultra small voxel) 1120 10%
Mean CT number [12x8] HiRes (ultra small voxel) 1050 10%
[6x6] HiRes (ultra small voxel) 1300 10%
Boosted Dose

Standard Dose


Uniformity [12x8] HiRes (ultra small voxel) < 40
Boosted Dose


5.6 Spatial resolution [18x16] (standard voxel) >8

[15x22e] (standard voxel) >7
[8x8] (standard voxel) >8
MTF50 (lp/cm)
[15x5] HiRes (standard voxel) > 10
[18x16] (standard voxel) > 14

[15x22e] (standard voxel) > 13
[8x8] (standard voxel) > 14
MTF10 (lp/cm)

10 APPENDIX A- Technical references
10.1 Scanner
Scanning system Single rotation and volumetric acquisition.

(cone beam technology)
Scan parameters Scan time / X-ray emission time 18-36 s / 2.4-7.3 s
Sampling angle 360°
Patient's centering Fixed position Positioning lasers
Anatomical analyzed volume Cylinder Standard Resolution:

(Ø-max x H-max)
18x16 cm
15x22cm
15x12cm
12x8cm
8x8cm
High Resolution:
(Ø-max x H-max)
15x5cm
12x8cm
8x8cm
6x6cm
Weight and dimensions Scanner unit Width 1750 mm / 68.8”
Depth 850 mm / 33.4”
Height 1780 mm / 70.0”
Weight (max) 350 Kg / 771.6 lbs
Gantry diameter 580 mm / 22.8”
Patient table Width (max) 1500 mm / 59”
Depth (max) 700 mm / 27.5”
Height (max) 1400 mm / 55.1”

(back rest in vertical position)
Height (max seat) 770 mm / 30.3”
Height (min seat) 560 mm / 22.0”

Weight (max) 180 Kg / 396.8 lbs
Maximum load 160 Kg / 352.7 lbs
Head-Rest: 15 Kg / 33 lbs
Back-Rest: 52.5 Kg / 115 lbs
Seat: 62.5 Kg / 138 lbs
Feet-Rest: 30 Kg / 66 lbs
Patient table with Width (max) 3600 mm / 141.7”

stretcher
Depth (max) 840 mm / 33”
Height (max) 900 mm / 35.4“
Weight (without package) 300 Kg / 661.3 lbs
Maximum load 175Kg / 385.8 lbs

(160Kg patient + 15Kg accessories)
10.2 Detector
Pixels 1920 x 1536 Pixels
Pixel size 127 x 127 m

Pixel depth 14 bit
Frame rate Max 30 F/s

10.3 Scout view radiological images

[18x16]
Image pixels 768 x 960 Pixels
Pixel depth 14 n.
Pixel Size 0.254 x 0.254 mm
[15x22e]
Image pixels 2 x (672 x 768) Pixels
Pixel depth 14 n.
[15x12]
Pixel depth 14 n.
[12x8]
Pixel depth 14 n.
[8x8]
Pixel depth 14 n.
[15x5] HiRes
Pixel depth 14 n.
[12x8] HiRes
Pixel depth 14 n.
[8x8] HiRes
Pixel depth 14 n.

[6x6] HiRes
Pixel depth 14 n.
10.4 Reconstructed volume
[18x16]
Shape Cylinder
Reconstructed Volume Size Ø18 x H16 cm
Voxel Size 0.300 0.250 0.200 0.150 mm
Image pixels 610 x 610 732 x 732 680 x 680 672 x 672 Pixels
Pixel depth 16 bit
[15x22e]
Shape Cylinder
Voxel Size 0.300 0.250 0.200 0.150 mm
Image pixels 610 x 610 - - - Pixels
Pixel depth 16 bit
[15x12]
Shape Cylinder
Voxel Size 0.300 0.250 0.200 0.150 mm
Pixel depth 16 bit
[12x8]
Shape Cylinder
Voxel Size 0.300 0.250 0.200 0.150 mm
Pixel depth 16 bit

[8x8]
Shape Cylinder
Voxel Size 0.300 0.250 0.200 0.150 mm
Pixel depth 16 bit
[15x5] HiRes
Shape Cylinder
Voxel Size 0.150 0.125 0.100 0.075 mm
Pixel depth 16 bit
[12x8] HiRes
Shape Cylinder
Voxel Size 0.150 0.125 0.100 0.075 mm
Pixel depth 16 bit
[8x8] HiRes
Shape Cylinder
Voxel Size 0.150 0.125 0.100 0.075 mm
Pixel depth 16 bit
[6x6] HiRes
Shape Cylinder
Voxel Size 0.150 0.125 0.100 0.075 mm
Pixel depth 16 bit

10.5 Radiological parameters
10.5.1 X-Ray Tube IAE model X22 0.3/0.6





10.5.2 X-Ray tube head
Manufacturer IMD s.r.l.
Model HF1R
X-ray tube IAE X22 0.3/0.6
Classification (IEC 601-1) Class I Type B
PHYSICAL DATA
Material X-ray tube housing Aluminum
Thermal capacity 550 kJ
Maximum continuous thermal dissipation 60 W @ 110kV, 3.6 mA, 10 ms, 15 FPS
Temperature maximum5 60
Incident filtering minimum @ 70 kV 1.4 mm Al
Oil volume compensation Rubber sack 410 cm³
Size 325 x 145 x 215
Weight 15 kg
ELECTRICAL DATA
Output voltage maximum 120 kV
Cathode-Earth 60 kV
Anode-Earth 60 kV
Anode current maximum @ 120 kV 18.3 mA
Tube voltage maximum @ 18.3 mA 120 kV
Electrical power maximum6 2.2 kW
Nominal electrical power, 4s emission7 2.2 kW
Maximum power ripple < 1%
Maximum power voltage rise time < 0.5 ms
5 According to IEC60601-2-28, par. 6.8.2.b)

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

Cooling curve
Rotor HF1R
Startup 230Vac / 0.8s / 10A Running 60Vac / 2A
10.5.3 X-Ray source assembly
Model HF1R
X-ray tube IAE X22 0.3/0.6
Focus - detector distance 970 mm
Focus - skin distance minimum 150 mm
Total filtration 4.4 mm Al @ 70 kV
Cone beam maximum size 238 mm x 179 mm (detector area)
Reproducibility of the radiation output8 Δ < 10%

9
Tube voltage accuracy < 10%
Tube current accuracy10 < 20%
Radiation linearity11 < 20%
Emission time accuracy12 < 10% + 1 ms
mAs accuracy13 < 30%
8 According to IEC 60601-2-44:2009 par. 203.6.3.2

9 According to IEC 60601-2-7:1998 par. 50.104.1

10.6 Inverter
Manufacturer IMD S.r.l.
Model HF1 3.5kW / HF1 3.5kW PLUS
INPUTS
Maximum power 3.5 kW
Supply voltage 230 V ( 10%)
Waveform Sinusoidal 50/60 Hz
Maximum current 16 A
Apparent supply resistance 0.14 ohm
OUTPUTS
Peak voltage 350 Vpk
Peak current maximum 120 Apk Max.
Waveform Sinusoidal 20 kHz
PHYSICAL DATA
Size 160 x 280 x 235 mm
Weight 7 kg

10.7 Dose declaration
CTDI100 table declared for operative modalities of the device 14

Values are expressed in mGy. Tolerance is  30%. Values measured according to IEC 60601-2-44: 2009 Par 203.109.1
Eco Scan Regular Scan Regular Scan Enhanced Scan Enhanced Scan
FOV Standard Dose Standard Dose Boosted Dose Standard Dose Boosted Dose
CTDI100 (centre) 2,9 4,2 8,6 5,8 11,5

CTDI100 (0°) 3,4 5,1 10,1 6,7 13,1
CTDI100 (90°) 3,2 4,8 9,6 6,4 12,8
[18x16]15
CTDI100 (180°) 2,8 4,1 8,5 5,6 11,2
CTDI100 (270°) 3,0 4,7 9,2 6,1 12,1
CTDI100 (periph.) 3,1 4,7 9,4 6,2 12,3
CTDI100 (centre) 3,9 5,7 9,5 - -
CTDI100 (0°) 4,9 7,2 11,6 - -
CTDI100 (90°) 5,0 7,4 10,9 - -
[15x22e]16
CTDI100 (180°) 3,5 5,1 8,7 - -
CTDI100 (270°) 3,9 6,0 10,0 - -
CTDI100 (periph.) 4,3 6,3 10,3 - -
CTDI100 (centre) 2,9 4,2 8,7 5,8 10,7
CTDI100 (0°) 3,6 5,1 10,1 7,1 13,7
CTDI100 (90°) 3,4 5,0 10,2 6,8 14,0
[15x12]17
CTDI100 (180°) 2,8 4,1 8,4 5,6 11,4
CTDI100 (270°) 3,0 4,5 9,0 6,0 12,6
CTDI100 (periph.) 3,2 4,7 9,5 6,4 12,9
CTDI100 (centre) 3,5 5,2 8,3 6,9 11,2
CTDI100 (0°) 3,9 5,1 9,9 7,8 12,6
CTDI100 (90°) 3,6 4,8 8,9 7,3 11,9
[12x8]18
CTDI100 (180°) 2,7 4,3 6,5 5,4 8,8
CTDI100 (270°) 3,2 4,6 7,8 6,5 10,3
CTDI100 (periph.) 3,4 4,7 8,3 6,7 10,9
CTDI100 (centre) 3,3 5,2 8,2 6,9 11,0
CTDI100 (0°) 3,1 4,7 7,7 6,4 9,6
CTDI100 (90°) 2,8 4,2 6,8 5,7 9,0
[8x8]19
CTDI100 (180°) 2,2 3,3 5,4 4,5 7,6
CTDI100 (270°) 2,5 4,0 6,3 5,2 8,7
CTDI100 (periph.) 2,6 4,1 6,6 5,4 8,7
14 Measured by using “head phantom” according to IEC 60601-2-44: 2009 Par. 203.108
15 Loading factors: automatically set by software
Eco Scan Std Dose: 110kV 17.76mAs - Reg. Scan Std Dose: 110kV 26.35mAs - Reg. Scan Boosted Dose: 110kV 67.20mAs
- Enh. Scan Std Dose: 110kV 35.52mAs - Enh. Scan Boosted Dose: 110kV 87.64mAs
Eco Scan Std Dose: 110kV 32,85mAs - Reg. Scan Std Dose: 110kV 48,84mAs - Reg. Scan Boosted Dose: 110kV 97,63mAs

CTDI100 (centre) 12,1 18,1 - 24,8 -

CTDI100 (0°) 14,4 23,2 - 29,4 -
[15x5] CTDI100 (90°) 14,0 20,9 - 28,6 -
HiRes20 CTDI100 (180°) 12,0 18,0 - 24,5 -
CTDI100 (270°) 13,2 19,5 - 26,9 -
CTDI100 (periph.) 13,4 20,4 - 27,4 -
CTDI100 (centre) 10,1 15,1 - 20,5 -
CTDI100 (0°) 11,6 17,4 - 23,5 -
[12x8] CTDI100 (90°) 10,3 15,7 - 21,0 -
HiRes21 CTDI100 (180°) 8,4 12,8 - 17,1 -
CTDI100 (270°) 9,7 14,7 - 19,8 -
CTDI100 (periph.) 10,0 15,1 - 20,4 -
CTDI100 (centre) 9,5 14,2 - 19,2 -
CTDI100 (0°) 8,9 13,6 - 18,1 -
[8x8] CTDI100 (90°) 7,9 11,8 - 16,1 -
HiRes22 CTDI100 (180°) 6,6 9,8 - 13,3 -
CTDI100 (270°) 7,6 11,5 - 15,5 -
CTDI100 (periph.) 7,7 11,7 - 15,8 -
CTDI100 (centre) 10,5 12,8 - 21,3 -
CTDI100 (0°) 8,7 10,7 - 17,6 -
[6x6]
HiRes23 CTDI100 (90°) 7,5 9,1 - 15,1 -
CTDI100 (180°) 6,3 7,7 - 12,8 -
CTDI100 (270°) 7,4 9,1 - 15,1 -
CTDI100 (periph.) 7,5 9,2 - 15,2 -
Date: 2013-07-11

Eco Scan Std Dose: 110kV 72.60mAs - Reg. Scan Std Dose: 110kV 108.90mAs - Enh. Scan Std Dose: 110kV 147.01mAs
23 Loading factors: automaticamente impostati dal software

CTDIW table declared for operative modalities of the device 24
Values expressed in mGy. Tolerance is  30%. The values correspond to CTDIw CTDIvol for this application25.
Values calculated according to IEC 60601-2-44: 2009 Par 201.3.211 and 201.3.212 c)
FOV
Standard Dose Standard Dose Boosted Dose Standard Dose Boosted Dose
[18x16]26 3,0 4,5 9,1 6,1 12,0
[15x22e]27 4,2 6,4 10,0 - -
[15x12]28 3,1 4,5 9,2 6,2 12,2
[12x8]29 3,4 4,9 8,3 6,8 11,0
[8x8]30 2,9 4,4 7,1 5,9 9,5
[15x5] HiRes31 13,4 19,6 - 26,5 -
[12x8] HiRes32 10,0 15,1 - 20,4 -
[8x8] HiRes33 8,3 12,5 - 16,9 -
[6x6] HiRes34 8,5 10,4 - 17,2 -
Date: 2013-07-11
24 Measured by using “head phantom” according to IEC 60601-2-44: 2009 Par. 203.108
25 For [15x22e] FOV please refer to the following table

CTDIvol table
Values expressed in mGy. Tolerance is  30%.

Values calculated according to IEC 60601-2-44: 2009 Par 201.3.211 and 201.3.212 c)
FOV
[15x22e]35 4,6 7,0 10,9 - -


DLP table declared for operative modalities of the device 36

Values expressed in mGy x cm. Tolerance is  30%. Values calculated according to IEC 60601-2-44: 2009 Par 201.3.214 c)
FOV
[18x16]37 48,5 72,2 145,8 96,9 192,2
[15x22e]38 101,2 154,0 239,8 - -
[15x12]39 37,0 54,0 110,5 74,0 146,3
[12x8]40 27,1 38,9 66,1 54,2 87,9
[8x8]41 23,0 35,5 56,9 47,4 75,7
[15x5] HiRes42 64,8 98,2 - 132,5 -
[12x8] HiRes43 80,2 120,9 - 163,3 -
[8x8] HiRes44 66,5 100,2 - 135,2 -
[6x6] HiRes45 51,0 62,3 - 103,3 -
Date: 2013-07-11
36 Measured using “head phantom” according to IEC 60601-2-44: 2009 Par. 203.108

CTDIfree air table declared for operative modalities of the device

Values expressed in mGy. Tolerance is  30%. Values calculated according to IEC 60601-2-44: 2009 Par 203.109.2
FOV
[18x16]46 4,9 6,7 13,7 11,2 18,1
[15x22e]47 7,0 10,4 17,3 - -
[15x12]48 5,2 7,0 14,6 11,9 19,6
[12x8]49 7,3 9,6 15,5 16,3 20,7
[8x8]50 7,7 10,6 16,6 17,3 22,2
[15x5] HiRes51 18,9 28,2 - 38,3 -
[12x8] HiRes52 16,6 25,0 - 33,5 -
[8x8] HiRes53 16,8 25,1 - 34,0 -
[6x6] HiRes54 19,7 24,4 - 39,9 -
Date: 2013-07-12


Indication of the dose profiles
Graphs calculated according to IEC 60601-2-44: 2009 Par. 203.110
Regular scan, Standard dose, 1.96mAs 3.6s

Date: 2012-06-20

10.8 Stray radiation diagram
55
Figure I – Stray radiation (uGy/mAs) according to IEC 60601-2-44: 2009 Par. 203.13
(stray radiation on the vertical axis corresponds to the horizontal plane)
55 Measured by using “head phantom" according to IEC 60601-2-44: 2009 Par 203.108

10.9 Laser
Output power 0.9 mW
Wavelenght 635 nm
Beam divergence 70º
Pulse lenght Continuous Wave
Classification Class 1
10.10 Other data
Absorbed power: 220 V ~ (± 10%) / 230 V ~ (± 10%) / 240 V ~ (± 10%)

50/60 Hz (± 1%)
5 A (during x-ray emission)
0.66 A (stand by)
200 V ~ (± 10%)
50/60 Hz (± 1%)
6.3 A (during x-ray emission)
0.72 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)
Operating altitude: ≤ 3000m
Over voltage category: II
Pollution degree: 2
Transport and storage -20 ¸ +70 °C

temperature:
Transport and storage humidity: 10% ¸ 85 % (not condensing)

10.11 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 5G is intended for use in the electromagnetic environment specified below. The
customer or the user of the device NewTom 5G should assure that is used in such an environment.
Emission test Compliance Electromagnetic environment - guidance
RF emissions Group 1 The equipment NewTom 5G uses RF energy only for its internal function.
Therefore its RF emissions are very low and are not likely to cause any
CISPR11 interference in nearby electronic equipment.
RF emissions Class A The equipment NewTom 5G is suitable for use in all establishments other
than domestic and those directly connected to the public low-voltage power-
CISPR11 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

- electromagnetic immunity - for all equipment and systems
TABLE: Guidance and manufacturer's declaration - electromagnetic immunity
Immunity test IEC 60601 Test level Compliance level Electromagnetic environment -
guidance
Floors should be wood, concrete, or

Electtrostatic discharge ± 6 kV contact 6 kV contact ceramic tile.
(ESD) 8 kV air If floors are covered with synthetic
±8 kV air material the relative humidity should be
IEC 61000-4-2 at least 30 percent.
±2 kV for power supply lines 2 kV Mains power quality should be that of a

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

Voltage dips, short <5% Ut Complies typical commercial and/or hospital
interruptions and voltage (>95% dip in Ut) for 0,5 cycles environment. If the user of NewTom 5G
variations on power supply requires continued operation during
input lines power main interruptions, it is
40% Ut
Complies recommended that NewTom 5G be
IEC 61000-4-11 (60% dip in Ut) for 5 cycles
powered from an uninterruptible power
supply or a battery.
70% Ut
Complies
(30% dip in Ut) for 25 cycles
<5% Ut
Functions Interruption
(>95% dip in Ut) for 5 sec
Power frequency (50/60 Hz) 3 A/m Complies Power frequency magnetic fields should
magnetic field be at least characteristic of a typical
location in a typical commercial or
IEC 61000-4-8 hospital environment.

- electromagnetic immunity - for equipment and systems that are not life-supporting
TABLE: Guidance and manufacturer's declaration - electromagnetic immunity
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 5G, including cables, than the
recommended separation distance calculated
from the equation applicable to the frequency of
the transmitter.
Recommended separation distance:
Conducted RF 3 Vrms 3 Vrms d = 1.2 ÖP
IEC 61000-4-6 150 kHz to 80 MHz
Radiated RF 3 V/m 3 V/m d = 1.2 ÖP da 80 MHz a 800 MHz

IEC 61000-4-3 80 MHz to 2,5 GHz d = 2.3 ÖP da 800 MHz a 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:
NOTE:
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 5G is used exceeds the RF compliance level above, the NewTom 5G should be observed to verify
normal operation. If abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating
NewTom 5G.
**Over the frequency range 150 kHz to 80 MHz, field strhgths should be less than 3 V/m.

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 5G is intended for use in the electromagnetic environment in which radiated RF
disturbances are controlled. The customer or the user of the device NewTom 5G can help prevent
electromagnetic interference by maintaining a minimum distance between portable and mobile RF
communications equipment and the device NewTom 5G as recommended below, according to the
maximum output power of the communication equipment.
Rated maximum output power of transmitter Separation distance according to frequency of transmitter
(W) (m)
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.
NOTE:
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.

All components, accessories, spare parts must be approved and supplied by CEFLA s.c.
Particularly, the connection cables must be ONLY the ones described under Par. 4.4.1 - “Cables“.
WARNING:
Use of accessories, transducers, and cables other than those
specified may result in degraded electromagnetic
compatibility performance of this device!
WARNING:
NewTom 5G should not be stacked directly on top of other
equipment, and other equipment should not be stacked on
top of NewTom 5G. If stacking is necessary, observe
NewTom 5G to verify normal operation in the stacked
configuration in which it will be used!
10.11.1 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.

11 APPENDIX B – Security standards
11 APPENDIX B – Security standards
The NewTom 5G equipment 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: 2005 + CORR. 1 (2006) + CORR. 2 (2007) - General requirements for basic safety
and essential performance.
• IEC 60601-1-2: 2007 (3rd Ed.) - Electromagnetic compatibility - Requirements and tests – See
clause 17;
• IEC 60601-1-3:2008 (2nd Ed.) - Radiation protection in diagnostic X-ray equipment
• IEC 60601-1-6:2010 (3rd Ed.) - General requirements for safety - Collateral Standard: Usability
including
• IEC 60601-2-28: 2010 (2nd Ed.) - Particular requirements for the basic safety and essential
performance of X-ray tube assemblies for medical diagnosis
• IEC 60601-2-44: 2009 (3rd Ed.) - Particular requirements for the basic safety and essential
performance of X-ray equipment for computed tomography
• IEC 60825-1: 1993 + A1:1997 + A2:2001 - 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
• IEC 62366: 2007 (1st Edition) Medical devices - Application of usability engineering to medical
devices
• ANSI/AAMI ES60601-1: 2005 / A2:2010 -Medical electrical equipment, Part 1: General
Requirements
• CAN/CSA-C22.2 No. 60601-1:08 Medical Electrical Equipment - Part 1: General Requirements
for Safety
IEC 601-1 CLASSIFICATION

Protection against electrical shock CLASS I
Degree of protection against electric shock TIPE 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 Par. 3.5- “Cleaning and disinfection“)
Mode of operation Continuous with intermittent loading.
Duty cycle atient support – movements:

16% (2.20 min / 15 min)
Gantry – movements:
14% (2 min / 15 min)
X-ray operating:
2.7% max. 24 sec. / 15 min for standard resolutions
4% max. 36 sec. / 15 min for HiRes resolutions
Planned time of use 10 years, by following the instructions for use

12 APPENDIX C - Labels
✔ PLATE ON SCANNER
5G Plate and 5G FP Plate (only for chinese market)
Position: Rear plastic cover on the bottom left side
✔ IDENTIFICATION LABEL FOR CHINESE MARKET

(only for devices intended for chinese market)
Position: Rear plastic cover on the bottom left side, near the plate on scanner

✔ X-RAY WARNING LABEL
WARNING
This x-ray unit may be dangerous to patient and
operator unless safe exposure factors and
operating instructions are observed.
AVVERTISSEMENT
Cet appareil à rayons X peut être dangereux pour
le patient et l'opérateur si les paramètres
d'exposition et instructions d'utilisation ne sont pas
respectées.
WARNING
X-RAYS ATTENTION: X-RAY ON WHEN
EQUIPMENT IN OPERATION
UNAUTHORIZED USE
IS STRICLY PROHIBITED
AVERTISSEMENT
RAYONS X - ATTENTION: PRESENCE RAYONS
X QUAND L'EQUIPEMENT EST EN
FONCTIONNEMENT
UTILISATION NON AUTORISÉE
STRICTEMENT INTERDITE
Position: Front plastic cover on the bottom left side.

✔ MAIN SWITCH AND INPUT FUSE LABEL
Position: Rear plastic cover on the bottom left side, next to the main switch.
✔ WARNING LABEL FOR DEVICES WITH LASER (NORMAL USE)
Position: Rear plastic cover on the bottom left side on top of the scanner label.

✔ INFORMATIVE LABEL FOR LASER DEVICES (DISTANCE <40MM)
Position: Inside the “Ralla 5G”, next to the laser modules (1 couple for each side).
✔ WARNING LABEL FOR LASER DEVICES (DISTANCE <40MM)
Position: On the laser brackets next to the laser modules (1 for each laser).
✔ BEAM LIMITER GLOBAL LABEL
CEFLA s.c. – Italy

P/N 96600716
P/N 99934389
S/N ___________
Position: On the beam limiter lead collimator plate.

✔ BEAM LIMITER EQUIVALENT FILTER LABEL

Al - P/N 99934483
2 mm Al @ 75 kV
Position: On the 2mm aluminum filter of the beam limiter.
✔ BEAM LIMITER EQUIVALENT MIRROR PLATE LABEL

Al - P/N 99934388
0.7 mm Al @ 75 kV
Ubicazione: On the beam limiter mirror collimator plate.
✔ PLASTIC COVER EQUIVALENT FILTRATION LABEL

P/N 97465007
0.3 mm Al @ 75 kV
Position: On the internal plastic cover of the gantry.
✔ CAN BUS CONNECTOR LABEL
AUX
CAN-BUS
Position: Rear plastic cover on the bottom left side, next to the CAN BUS connector.

✔ RJ45 ETHERNET CONNECTOR LABEL
AUX
ETHERNET
Position: Rear plastic cover on the bottom left side, next to the Ethernet connector.
✔ HAND CRUSHING WARNING LABEL
Position: On the main structure, next to the points with risk of hand crushing.
✔ FOLLOW INSTRUCTIONS FOR USE LABEL
Position: Rear plastic cover on the bottom left side on top of the main switch and input fuse label
✔ STOP LABEL
Position: Emergency buttons

✔ X-RAY SOURCE LABEL
Position: On the X-ray source tube head.
✔ INVERTER LABEL
Position: On the inverter chassis.
✔ USA FEDERAL LAW LABEL
CAUTION:
Federal law restricts this device to sale by
or on the order of a practitioner licensed by
the law of the State in which he practices to
use or order the use of x-ray imaging
systems.
21CFR801.109(b)
Position: Rear plastic cover on the bottom left side on top of the main switch and input fuse label

www.newtom.it
NEWTOM™ 5G is a commercial trademark of CEFLA s.c.
All other products and brand names are registered trademarks

or trademarks of their respective companies.
NEWTOM™ 5G is manufactured by:
CEFLA s.c.
Phone: +39 045 8202727
Fax +39 045 8203040
e-mail: info@newtom.it
All rights reserved.

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0051

NewTom 5G – User Manual

The original version of this manual is in Italian.

NEWTOM™ 5G is a trademark of CEFLA s.c.

INFORMATIVE NOTE OF THE MANUFACTURER ON THE MEDICAL DEVICES

1 Introduction to this manual

This manual is divided in the following chapters:

✔ Chapter 1: Introduction to this manual

✔ Chapter 2: About safety

✔ Chapter 3: Safety and maintenance of the device

✔ Chapter 4: Getting started

✔ Chapter 5: Preliminary procedures

✔ Chapter 7: Quality assurance

NewTom 5G – User Manual 1-1

✔ Chapter 9: IEC61223: Acceptance Test

✔ APPENDIX A- Technical references

✔ APPENDIX B – Security standards

1-2 NewTom 5G – User Manual

1.3 Graphic conventions

1.3.1 Text conventions

Bold text Indicates a menu or an item to select

Italics Used to emphasize a word or a phrase

<Key> Key enclosed in the less-than and greater-than sign means

NewTom 5G – User Manual 1-3

2.1 Local law

NewTom 5G – User Manual 2-1

2.2 Symbols overview

Symbol Standard Description

~ IEC 60417-5032 Alternating current

ISO 7000-0434A Caution

ISO 7010-W001 General warning sign

IEC 60878 Warning: dangerous voltage

IEC 60417-5019 Protective earth (ground)

IEC 60417-5017 Earth (ground)

N IEC 60445 Connection point for the neutral conductor on

ISO 361 Ionizing radiations

Directive Disposal of WEEE (Waste from Electrical and

2-2 NewTom 5G – User Manual

EN 980:2008 Serial Number

EN 980:2008 Date of manufacture

ISO 7000-1641 Operating instructions

ISO 7010-M002 Refer to instruction manual/booklet

IEC 60417-5638 Emergency stop

2.3 Switching ON and OFF the device

2.4 Emergency stop

NewTom 5G – User Manual 2-3

• The X-Ray source does not stop emitting;

• Dangerous conditions that may damage people, the

• Whenever the system signals an emergency state.

2.5 Patient's and user's safety guidelines

2.5.1 Patient's positioning

2.5.2 During the scan

2-4 NewTom 5G – User Manual

2.5.3 Patient's exit from the scanning area

2.5.4 Patient's exit during fault / malfunctioning of the patient's table

NewTom 5G – User Manual 2-5

Operator's guidelines during the aforementioned process:

✔ Avoid to flex the back, by bending the knees;

Longitudinal Movement: <5mm

2.6 Artifacts and repetition of a scan

2-6 NewTom 5G – User Manual

2.7 Protection from ionizing radiation

NewTom 5G – User Manual 2-7