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

EN
OPERATOR'S MANUAL
3
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

4
OPERATOR'S MANUAL
EN
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.

EN
OPERATOR'S MANUAL
5
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.