CEFLA NewTom 5G User manual

NewTom 5G – User Manual
0051
97050196
Rev. 5
28.04.2017
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 talian.
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 MEDICA 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 talian 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 talian
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 hardware1 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 he connec ion bus, a prin er, he replacemen
of he graphic display in erface represen s an impor an modifica ion.
2 Including he opera ive sys em and he applica ions already ins alled upon medical device delivery.
Au oma ic upda es of he opera ive sys em, changes o ne work connec ion parame ers, modifica ion
and/or addi ion and/or removal of in erface sof ware wi h hardware (device driver) and/or services (e.g.
file and prin er sharing service) and/or applica ions represen an impor an modifica ion.

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 an OFF the evice.............................................................................2-3
2.4 Emergency stop..................................................................................................2-3
2.5 Patient's an user's safety gui elines.........................................................................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 uring fault / malfunctioning of the patient's table..............................2-5
2.6 Artifacts an repetition of a scan.............................................................................2-6
2.7 Protection from ionizing ra iation............................................................................2-7
2.8 Protection from laser exposure...............................................................................2-9
2.9 Devices connecte 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 Gui elines for safety........................................................................................... 3-2
3.3 Device mo ifications...........................................................................................3-3
3.3.1 Responsibility limits.....................................................................................3-3
3.4 Device maintenance............................................................................................3-3
3.5 Cleaning an isinfection......................................................................................3-6
3.5.1 Hygiene proce ures for patient protection..........................................................3-7
3.5.2 Sterilization..............................................................................................3-8
3.6 Transport an storage..........................................................................................3-8
3.7 Device isposal.................................................................................................. 3-9
3.7.1 Information for the evice owner.....................................................................3-9
3.7.2 Information for the Disposing/Recycle centers.....................................................3-9
4 GETTING STARTED........................................................................................4-1
4.1 Intro uction to the system....................................................................................4-1
4.1.1 Inten e use.............................................................................................. 4-1
4.1.2 In ications 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 an main switch.........................................................................4-10
4.4 Stan ar 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 own.............................................................................................. 4-12
5 PRELIMINARY PROCEDURES.............................................................................5-1
5.1 X-Ray Source Con itioning.....................................................................................5-1
5.2 Daily Check....................................................................................................... 5-3
5.3 Blank acquisition................................................................................................5-4
5.3.1 Invali ating 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 an 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 enture............................................................................................ 6-13
6.2.1 Preliminary operations an enture 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 ata..............................................................................................7-5
TROUBLESHOOTING....................................................................................... -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 ra iological images.............................................................................10-3
10.4 Reconstructe volume ......................................................................................10-4
10.5 Ra iological parameters.....................................................................................10-6
10.5.1 X-Ray Tube IAE mo el X22 0.3/0.6 ................................................................10-6
10.5.2 X-Ray tube hea ..................................................................................... 10-11
10.5.3 X-Ray source assembly..............................................................................10-12

10.6 Inverter....................................................................................................... 10-13
10.7 Dose eclaration............................................................................................ 10-14
10.8 Stray ra iation iagram....................................................................................10-22
10.9 Laser..........................................................................................................10-23
10.10 Other ata..................................................................................................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 Intro uction to this manual
1 Introduction to this manual
1.1 Contents
This manual was created as a mean to provide information and instructions about using a NewTom™ 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.
t 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
llustrates 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
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1 Intro uction to this manual
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 EC61223 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 - abels
Lists the labels of the device.
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1 Intro uction to this 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:
nstructions that you MUST follow to complete a task.
1.3.1 Text conventions
Bold text ndicates a menu or an item to select
talics Used to emphasize a word or a phrase
<Key>
<Key1+Key2>
Key enclosed in the less-than and greater-than sign means
that you must press the enclosed key.
f 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.
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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.
n 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.
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2 About safety
2.2 Symbols overview
The table below describes the symbols found on the device labels:
Symbol Standard Description
EC 60417-5010 ON / OFF (push-push)
~EC 60417-5032 Alternating current
SO 7000-0434A Caution
SO 7010-W001 General warning sign
EC 60878
SO 3864-B.3.6
Warning: dangerous voltage
EC 60417-5019 Protective earth (ground)
EC 60417-5017 Earth (ground)
NEC 60445 Connection point for the neutral conductor on
permanently installed equipment
EC 60445 Connection point for the line conductor on
permanently installed equipment
EC 60417-5841 Defibrillation-proof type B applied part
SO 361 onizing radiations
Directive
2012/19/EU
Disposal of WEEE (Waste from Electrical and
Electronic Equipment)
Directive
93/42/CEE
CE Mark
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2 About safety
EN 980:2008 Serial Number
EN 980:2008 Date of manufacture
EN 980:2008 Manufacturer
SO 7000-1641 Operating instructions
SO 7010-M002 Refer to instruction manual/booklet
EC 60417-5638 Emergency stop
2.3 Switching ON an OFF the evice
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
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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 an user's safety gui elines
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.
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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 uring fault / malfunctioning of the patient's table
n case of patient table malfunctioning, act on the manual release to take out the patient from the gantry, and
operate as follows:
n 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)
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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. f 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;
✔ncrease 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:
n 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 an 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.
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2 About safety
2.7 Protection from ionizing ra iation
WARNING:
NewTom 5G is a radiological device and therefore it
exposes operators and patients to the risks consequent to
the exposure to ionizing radiation.
t 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.
maging 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 PAT ENT DUR NG THE EXAM NAT ON PROCESS.
f 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
t 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:
n 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.
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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. t appears on video just after
the START command has been selected via keyboard or mouse (see Chapter 6 “Scanning“). t 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.
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2 About safety
WARNING:
f 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, MMED ATELY TURN THE DEV CE 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.
–n case of other scan modalities, the central axial plane of the reconstructed volume.
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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.
f 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 connecte to the NewTom 5G console
Workstations, displays, printers, keyboards and other devices which may be connected to the NewTom 5G
console MUST comply with SO and/or EC 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.
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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.
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3 Safety an maintenance of the evice
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)
nstallation 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.
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