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
NewTom 5G – User Manual 1-1

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.
NewTom 5G – User Manual 1-3

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.
NewTom 5G – User Manual 2-1

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
2-2 NewTom 5G – User Manual