CEFLA NewTom GO User manual

97050801
Rev. 09
2018-07
NewTom GO
EN

2
OPERATOR'S MANUAL
EN
ITALIANO
Contents
0. DEVICE IDENTIFICATION........................................................................................................................................4
1. INTRODUCTION AND INDICATIONS FOR USE .....................................................................................................5
1.1. DESCRIPTION OF THE MANUAL .......................................................................................................................6
1.2. GENERAL WARNINGS........................................................................................................................................7
1.3. REQUIREMENTS (NOT PROVIDED WITH THE PRODUCT) ............................................................................8
1.4. STANDARDS AND REGULATIONS ....................................................................................................................8
1.5. CLASSIFICATIONS..............................................................................................................................................8
1.6. STYLISTIC CONVENTIONS ................................................................................................................................9
1.7. GENERAL SAFETY WARNINGS.......................................................................................................................10
1.7.1. INSTALLATION CONDITIONS ...................................................................................................................10
1.7.2. CONDITIONS OF USE ...............................................................................................................................11
1.7.3. WARRANTY ................................................................................................................................................11
1.7.4. MAINTENANCE AND DISPOSAL...............................................................................................................12
1.7.5. CLEANING AND DISINFECTION ...............................................................................................................13
1.7.6. HYGIENE PROCEDURES FOR PATIENT PROTECTION ........................................................................14
1.8. SAFETY WARNINGS .........................................................................................................................................15
1.8.1. CONDITIONS OF USE ...............................................................................................................................15
1.8.2. GENERAL SAFETY ....................................................................................................................................15
1.8.3. SAFETY DURING X-RAY DEVICE MOVEMENTS ....................................................................................15
1.8.4. EMERGENCY BUTTON .............................................................................................................................16
1.8.5. EXPOSURE TO LASER RADIATION .........................................................................................................16
1.8.6. ELECTROMAGNETIC SAFETY .................................................................................................................17
1.8.7. PROTECTION AGAINST RADIATION .......................................................................................................19
1.8.8. APPLIED PARTS ........................................................................................................................................19
1.8.9. STRAY RADIATIONS..................................................................................................................................20
2. DESCRIPTION OF OPERATION ............................................................................................................................21
3. COMPONENTS .......................................................................................................................................................22
4. CONTROL PANEL ..................................................................................................................................................23
4.1. CONSOLE ONBOARD THE MACHINE .............................................................................................................23
4.2. X-RAY EMISSION REMOTE CONTROL ...........................................................................................................23
4.3. PERFORM A SIMULATION (DUMMY RUN) .....................................................................................................24
5. PERFORMING A 2D X-RAY EXAMINATION .........................................................................................................25
5.1. STARTING THE SYSTEM..................................................................................................................................25
5.2. SELECTING THE EXAMINATION FROM THE CONTROL CONSOLE ............................................................26
5.2.1. 2D EXAMINATIONS AVAILABLE ...............................................................................................................26
5.2.2. SELECTING AN EXAMINATION ................................................................................................................29
5.2.2. SELECTING AN EXAMINATION.....................................................................................................................29
5.2.3. SETTING THE PROJECTION TYPE ..........................................................................................................33
5.3. PREPARATION OF THE X-RAY EXAMINATION..............................................................................................34
5.3.1. EDENTOLOUS PATIENTS DEVICES (OPTIONAL) ..................................................................................34
5.4. PATIENT POSITIONING ....................................................................................................................................34
5.4.1. LASER TRACES .........................................................................................................................................35
5.4.2. PATIENT POSITIONING DESCRIPTION (CRANIOSTAT) ........................................................................36
5.4.3. PAN, DENT EXAMINATIONS .....................................................................................................................37
5.4.4. TMJ EXAMINATION....................................................................................................................................38
5.4.4.1. LATERAL TMJ ...................................................................................................................................38
5.4.4.2. FRONTAL TMJ ..................................................................................................................................39
5.4.5. SIN EXAMINATION.....................................................................................................................................39
5.5. ACQUISITION OF THE EXAM ...........................................................................................................................40
5.6. TYPICAL IMAGES OF THE EXAMS..................................................................................................................41
5.6.1. ADULT PANORAMIC IMAGING .................................................................................................................41
5.6.2. CHILD PANORAMIC IMAGING ..................................................................................................................41
5.6.3. TMJ EXAMINATIONS (TEMPOROMANDIBULAR JOINT) ........................................................................41
5.6.4. SIN EXAMINATIONS ..................................................................................................................................42
5.6.5. DENTITION/BITEWING EXAMINATIONS..................................................................................................42
6. 3D TOMOGRAPHIC EXAMINATION (CB3D) .........................................................................................................43
6.1. SELECTING THE EXAMINATION FROM THE CONTROL CONSOLE ............................................................43
6.2. POSITIONING THE PATIENT FOR 3D EXAMINATIONS .................................................................................49

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6.3. PERFORMING THE EXAMINATION .................................................................................................................49
6.4. SPECIAL CONSIDERATIONS FOR CBCT EXAMINATIONS WITH CHILDREN OR SMALL PATIENTS .......50
7. VIEWING AND SAVING..........................................................................................................................................51
8. PERIODIC CHECKS AND MAINTENANCE ...........................................................................................................52
8.1. PERIODIC INSPECTIONS TO CHECK THE IMAGE ........................................................................................52
8.1.1. X-RAY EMISSION QUALITY CONTROL....................................................................................................52
8.1.2. COLLIMATOR TEST...................................................................................................................................53
8.1.3. 2D IMAGE QUALITY CONTROLS BY MEANS OF PHANTOM.................................................................53
8.1.4. 3D IMAGE QUALITY CONTROLS..............................................................................................................54
8.2. QA PHANTOM ACQUISITION ...........................................................................................................................55
8.2.1. QA PHANTOM TROUBLESHOOTING.......................................................................................................57
9. TECHNICAL DATA..................................................................................................................................................58
9.1. ELECTRICAL CHARACTERISTICS ..................................................................................................................58
9.2. RADIOLOGICAL CHARACTERISTICS..............................................................................................................58
9.3. ISODOSE CURVES FOR 2D EXAMINATIONS.................................................................................................60
9.4. ISODOSE CURVES FOR CBCT EXAMINATIONS ...........................................................................................60
9.5. PANORAMIC SENSOR CHARACTERISTICS(PAN).........................................................................................61
9.6. 3D PANEL FEATURES ......................................................................................................................................61
9.7. LASER CHARACTERISTICS.............................................................................................................................61
9.8. DIMENSIONAL CHARACTERISTICS................................................................................................................62
9.9. ENVIRONMENT CHARACTERISTICS ..............................................................................................................65
9.10. PC REQUIREMENTS ....................................................................................................................................66
9.11. MOBILE DEVICE REQUIREMENTS .............................................................................................................67
9.12. IDENTIFICATION LABEL POSITION ............................................................................................................68
10. ERROR MESSAGES ..............................................................................................................................................69
11. USER’S LICENCE CONTRACT..............................................................................................................................70
11.1. GENERAL CONDITIONS OF THE IMAGE SOFTWARE LICENCE .............................................................70
11.1.1. USER’S LICENCE .................................................................................................................................70
11.1.2. COPYRIGHT..........................................................................................................................................70
11.1.3. USE OF THE SOFTWARE PRODUCT AND EXPRESS TERMINATION CLAUSE.............................71
11.1.4. GUARANTEE AND EXCLUSIONS FROM THE GUARANTEE ............................................................71
11.1.5. LIMITS OF RESPONSIBILITY...............................................................................................................71
11.1.6. APPLICABLE LAWS, JURISDICTION AND COURT OF JURISDICTION ...........................................71
11.1.7. WRITTEN FORM ...................................................................................................................................72
11.1.8. TRANSLATION......................................................................................................................................72
11.1.9. SOFTWARE COMPLIANCE WITH THE REGULATIONS IN FORCE..................................................72
12. INSPECTION AND MAINTENANCE.......................................................................................................................73
12.1. USER INSPECTION ......................................................................................................................................73
12.2. TECHNICAL MAINTENANCE........................................................................................................................74

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0. DEVICE IDENTIFICATION
This manual applies to the following models of the NewTom GO family:
-NewTom GO REF. 708J (NewTom GO 2D version);
-NewTom GO REF. 708K (NewTom GO 3D version).
Unless otherwise indicated, the instructions included in this manual apply to all models of the NewTom GO family
(hereinafter referred to as "NewTom GO").
In the following part of this manual, instructions that only apply to the device model NewTom GO REF. 708J are
identified by the description “ Only for 2D machines ”.
Instructions that only apply to the device model NewTom GO REF. 708K are identified by the icon, by the
description “ Only for 3D machines ” or by both.

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1. INTRODUCTION AND INDICATIONS FOR USE
For 2D machine only :
NewTom GO is an extraoral X-ray system for digital panoramic exams. It is intended to produce orthopanoramic
images of the maxillofacial region and to carry out diagnostic examination on teeth, dental arches and other
structures in the oral cavity.
For 3D machine only :
NewTom GO is an extraoral X-ray system for digital panoramic exams and tomographies, intended to:
(i) produce orthopanoramic images of the maxillofacial region and carry out diagnostic examination on teeth, dental
arches and other structures in the oral cavity;
(ii) produce tomographic images of the oral cavity and maxillofacial structures and carry out diagnostic examination
on teeth, dental arches, structures of the oral cavity and some cranial bones.
The system performs tomographic exams with the acquisition of X-ray images through a rotating sequence and the
reconstruction of a three-dimensional matrix of the examined volume, thus producing two- and three-dimensional
views of the volume itself. This technique is known as CBCT.
NewTom GO is a digital X-ray device, suitable for expert professionals, which allows to obtain dental images in a
simple and automatic way. The image is acquired by means of an X-ray detector and a constant potential X-ray
source, powered by a high-voltage and high-frequency generator. The image is then transmitted to a computer in real
time.
USA federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.
NewTom GO allows the following 2D projections:
- standard or panoramic views for paediatric patients (PAN);
- complete or partial views of the teeth, selected by the user (DENT);
- front and side views of maxillary sinuses (SIN);
- side and posteroanterior views of the temporomandibular joints (TMJ), from different angles.
Furthermore, the 3D version machine also allows to acquire tomographic images.
NewTom GO is intended for use in dentistry, in the following fields:
- endodontics;
- periodontology;
- dental prosthesis;
- functional diagnosis and therapy of craniomandibular dysfunctions;
- dental surgery;
- dental implants;
- maxillofacial surgery;
- orthodontics.
Do not use on patients (children) less than approximately 104 cm in height and less than 19 kg in weight.
These height and weight measurements approximately correspond to that of an average 4 year old.
Use of equipment and exposure settings designed for adults of average size can result in excessive
radiation exposure for a smaller patient. 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.
Not for use with patients not vigilant and cooperative, since the patient must be able to understand and
follow the operator's instructions for a correct positioning.

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Contraindications:
- visualisation of cartilaginous structures;
- the CBCT technique ( for 3D machines only ) has a limited ability to detect soft tissues.
In order to ensure a safe use of the device, specifically in the radiography of children it is suggested to
consult the general indications described in the guidelines for dental radiographs as i.e. the ones referred on
the website Image Gently (www.imagegently.org), for dental Rx, or even in the FDA website for “Pediatric X-
Ray imaging”.
The manufacturer’s website contains a list of authorised agents.
Address for circulation of consumers within the Russian Federation:
Zenith R.S. LLC
Bldg 3, Property 15, Gorodok-17 Str., Bolshie Vyazemy Settlement, Odintsovo District
143051 Moscow Region, Russia
phone: [phone]
[phone]
e-mail: [e-mail]
Website: www.zenith-rs.ru
For technical service, it is possible to contact the local distributor.
1.1. DESCRIPTION OF THE MANUAL
This manual is an essential consultation tool and contains important information and instructions for the use
of the X-ray system and the relevant controls.
These instructions describe how to properly and safely use the digital X-ray system.
Carefully read and familiarise yourself with the entire contents of the manual before attempting to use the
system.
To use the software, refer to the specific manual.
The manual is only provided in electronic format and can be consulted directly on the PC screen during use.
It is advisable to keep a copy of this manual within reach with the aim of training the operators and as guide
for consultation during the use of the device. This manual also contains all the essential information for the
safety of patient, operator and device.
It is therefore advisable to read carefully the paragraphs on the safety rules.
The original text is in Italian.

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1.2. GENERAL WARNINGS
The digital X-ray system with its drivers and software have been developed and manufactured by CEFLA s.c. - Via
Selice Prov.le 23/A 40026 Imola (Italia), hereinafter referred to as the Manufacturer, which is the manufacturer and
distributor in compliance with the EC Medical Device Directive.
In order to use the system, the user must have a Personal Computer with a suitable software for capturing and
saving images; further information about its installation and use is included in the Software user manual. Carefully
read this Manual and the Computer and Software manuals before using the equipment.
- The contents of this publication are valuable trade secrets and must not be given to third parties, stored, copied,
reproduced, disclosed or transferred in any manner (via computer, photocopies, translations or other means)
without the prior written consent of the Manufacturer.
- The Manufacturer pursues a policy of continual improvement of its products; therefore, some specific instructions
and images contained in this manual may differ from the product purchased.
- The Manufacturer reserves the right to make changes without prior notice.
- The information, technical specifications and illustrations contained in this publication are not binding. The
Manufacturer reserves the right to make technical modifications and improvements without modifying these
instructions.
- All the registered trademarks and the product names mentioned are the property of the respective owners.
- Carefully read the USER LICENSE AGREEMENT before using the product. When installing the program, you will
explicitly be asked to accept the agreement; if you do not accept, the program cannot be installed.
Please pay particular attention to the sections in the manual where the following symbols appear:
Patient or operator safety-related warnings.
Important information on product use.
For 3D machine only.
In accordance with the privacy laws in force in several countries, all sensitive personal information must be
adequately protected. In addition, patients must sign a consent form before any personal information or
images are transmitted across networks. If required by the laws in force, dentists are obliged to protect data
using a protection password. Refer to the Microsoft® Windows operating system manual for data access
protection methods by means of password.
It is recommended to regularly (at least once a week) make a backup copy of the databases. This will allow
restoring the data in the event of damage to the hard disc of the PC or the databases themselves.

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1.3. REQUIREMENTS (NOT PROVIDED WITH THE PRODUCT)
For proper functioning, the device requires connection to a personal computer (PC) and the relative software. For the
minimum requirements of the PC, refer to the paragraph TECHNICAL DATA.
The PC is not included with the device. It is recommended to only use a PC compliant to the IEC 60950-
1:2007 standards for information technology devices.
1.4. STANDARDS AND REGULATIONS
This system has been designed in accordance with the following standards:
- Directive 93/42/EEC and subsequent amendments and integrations
(Dir. 2007/47/EC) - Medical Device Directive;
- Directive 2006/42/EC - Machinery Directive.
Technical standards:
IEC 60601-1:2005
IEC 60601-1-2:2007
IEC 60601-1-3:2008
IEC 60601-2-63:2012
IEC 60601-1-6:2010
IEC 62366:2007
IEC 62304:2006
IEC 60825-1:1993
The CE mark certifies the compliance of the product described below with the European Community
Medical Device Directive 93/42/EEC and subsequent amendments.
1.5. CLASSIFICATIONS
The system is classified as Class I and Type B as regards safety according to IEC 60601-1.
The system is classified as a Class IIB medical electrical X-ray device in accordance with Medical Device Directive
93/42/EEC and subsequent amendments.

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1.6. STYLISTIC CONVENTIONS
The following symbols may be found on the X-ray device:
Equipment compliant with directive 93/42/EEC as amended.
Notified body: IMQ spa.
Applied part of type B, according to IEC 60601-1.
Product/equipment identification code.
Product serial number.
Manufacturer.
Date of manufacture (month / year).
Consult the enclosed documentation before using the relevant part of the equipment.
It is necessary to read the user's manual before using the device.
POWER
Power switch.
I
Unit ON.
O
Unit OFF.
Ionizing radiation warning symbol.
Class 1 LASER radiation warning symbol.
Crushing hazard.
Disposal symbol in accordance with Directive 2012/19/EU.
Ukraine compliance mark.

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1.7. GENERAL SAFETY WARNINGS
These instructions describe how to use the system correctly. Please carefully read this manual before using
the device.
The owner or the installation site manager is obliged to verify compliance with the local regulations in force and/or
ask a Qualified Expert for advice. Pay particular attention to fulfilling the obligations of the law regarding the
protection of workers, the population and patients against radiation.
The main REFERENCE STANDARDS are listed in this manual (1.4 - Standards and Regulations).
Do not use the system for uses different from those described in the indications for use (Introduction) and do not use
it if you do not have the necessary knowledge in the dentistry and radiological field.
The law restricts and reserves the sale and use of this device exclusively to physicians, dentists or radiology
specialists.
1.7.1. INSTALLATION CONDITIONS
- The system must not be used if it shows any electrical, mechanical or radiation defect. Like for all medical
electrical systems, this device requires proper installation, use, maintenance and service with the aim of assuring
safe and efficient operation.
- The entire system must be installed by a technician authorised by the Manufacturer under supervision of a
Qualified Expert.
- The room where the system is installed must exclusively be for medical use and designed by an expert in
protection against the risks associated with exposure to radiation in accordance with the regulations in force in
the country of use.
- For Europe, the electric system in the room where the device is installed must comply with the IEC 60364-7-710
standards (requirements for electric systems in rooms used for medical purposes).
- The X-ray system requires special precautions with respect to electromagnetic compliance and must be installed
in accordance with the recommendations given in the paragraph “Electromagnetic safety” in this manual.
- The maximum dimensions reached while the unit is being installed must be taken into consideration to avoid
banging into any objects present in the room. Refer to the dimensional diagram in the service manual.
- Make sure that the operator can communicate verbally and visually with the patient during the examination.
- The system can be installed in the following configurations:
1. wall mounting;
2. on the floor surface with a static baseplate (optional).
- Installation not in compliance with the instructions provided by the Manufacturer might cause increased
electromagnetic emission of the X-ray system and reduce its immunity to disturbances.
- In particular, use a screened cable for connection of the X-ray remote control and make the connection as
specified in the technical manual.
For further details, refer to the installation template and the detailed instructions given in the service manual.