ENG - 6907913003 - Rev4 (User's Manual)

Rotograph EVO D 0051
User's Manual
Version 2 January 2019 (Rev. 4)
USER'S MANUAL
Revision history
Revision history Manual code 6907913003
Rev. Date Page/s Modification description
0 21.03.14 - Document approval.

1 09.07.14 35, 43 Added paragraph "Open Source Software".
Added note about the use of the image displayed
on the touch screen.
(Ref. RDM 7929)
2 31.08.16 7, 8, 9, 14, 35, Improvement of Implant exam.

38, 39, 40, 99, Added Password 172: Panoramic X-ray beam
from 103 to 105 centering and dimension verification.
Added distribution of stray radiation
informations.
(Ref. RDM 8294, Complaint D1618)
3 27.06.17 55, 70, 86, 96, New SINUS chin support.

111, 124, 132 Added NOTE for image recovery.
(Ref. RDM 8296, Complaint D16105)
4 02.01.19 1, from 3 to 13, Adapted to the third edition of IEC 60601-1 and
from 17 to 29, 33, its collateral applicable rules.
34, from 36 to 39, Added 110-120V version information.
45, 46, 48, 51, Release QuickVision 5.04.
from 55 to 60, (Ref. RDM 8835, RDM 8883)
from 72 to 75, 83,
85, 89, 90, 92,
98, 100, 103, 104,
108, 113, 115,
118, 119, 132, 135,
144, 146, 155,
183, 184, 185
(Rev. 4) Rotograph EVO D

USER'S MANUAL
Revision history
THIS PAGE IS INTENTIONALLY LEFT BLANK
Rotograph EVO D (Rev. 4)

USER'S MANUAL
Contents
Contents
1. INTRODUCTION 1
1.1 Icons appearing in the manual ............................................................... 2
2. SPECIFICATION OF THE INTENDED USE 3

2.1 Application and medical purpose ............................................................ 3
2.1.1 Intended patient population ....................................................... 3
2.1.2 Operator profile (intended user) .................................................. 4
2.1.3 Application environments ........................................................... 4
2.2 Applied parts .......................................................................................... 4
2.3 Typical doses delivered to the patient during extra-oral exams ............... 5
2.3.1 Panoramic mode ......................................................................... 6
2.3.2 Cephalometric mode ................................................................... 7
3. SAFETY INFORMATION 8
3.1 Warnings ................................................................................................ 9
3.1.1 Precautions while using laser centring devices ......................... 11
3.2 Protection against radiation .................................................................. 12
3.2.1 Distribution of stray radiation in Panoramic examination......... 14
3.2.2 Distribution of stray radiation in Ceph examination ................. 15
3.2.3 Electromagnetic information..................................................... 17
3.2.4 Electromagnetic emissions ....................................................... 18
3.2.5 Electromagnetic immunity ........................................................ 19
3.2.6 Recommended separation distances for non-life supporting
equipment ................................................................................ 21
3.3 Cybersecurity measures........................................................................ 22
3.4 Environmental risks and displacement ................................................. 23
3.5 Symbols used ....................................................................................... 24
4. CLEANING AND DISINFECTION 26

5. DESCRIPTION 27
5.1 Identification labels and laser labels ..................................................... 27
5.1.1 Identification labels and laser labels "220-240V" version .......... 28
5.1.2 Identification labels and laser labels "110-120V" version .......... 29
5.2 Functions, models and versions............................................................ 30
5.2.1 Basic version ............................................................................ 30
5.2.2 Version with cephalometric device ............................................ 31
5.2.3 EVO XP (Extended Projection Package) - Optional .................... 32
6. TECHNICAL CHARACTERISTICS 33
6.1 PC requirements ................................................................................... 39
6.2 Open Source Software .......................................................................... 40
6.3 Dimensions........................................................................................... 41
(Rev. 4) i Rotograph EVO D

USER'S MANUAL
Contents
6.4 Loading curve of the tube and cooling curve of the anode ..................... 43
6.5 Applied safety regulations ..................................................................... 45
6.6 Note on constant magnification for Panoramic and TMJ (mouth
open/closed) examinations ................................................................... 47
6.7 Measurement method of technical factors (paragraph for authorised
personnel) ............................................................................................. 48
6.8 Verification method of technical factors (paragraph for authorised
personnel) ............................................................................................. 49
6.8.1 Verification method of Panoramic X-ray beam centering and
dimension ................................................................................. 52
7. QUALITY ASSURANCE PROGRAM 55

7.1 Quality check tools ............................................................................... 56
7.2 External inspection ............................................................................... 57
7.3 Laser alignement check ........................................................................ 57
7.4 Image quality check .............................................................................. 58
8. GENERAL INSTRUCTIONS FOR USE 61

8.1 Control panel – description and functions ............................................. 61
8.1.1 Key function description ........................................................... 66
8.1.2 Pen Drive function description .................................................. 67
8.1.2.1 Acquired image display description....................................... 68
8.2 Digital Sensor ....................................................................................... 69
8.2.1 Inserting the sensor in the sensor holder .................................. 70
8.2.2 Release of the sensor from the sensor holder ............................ 71
8.3 Switching ON and OFF the device ......................................................... 72
8.4 Positioning of chin support ................................................................... 75
8.5 Panoramic examination ........................................................................ 77
8.5.1 Device preparation .................................................................... 78
8.5.2 Anatomic / manual exposure ................................................... 82
8.5.2.1 Anatomic exposure .............................................................. 83
8.5.2.2 Manual exposure ................................................................. 84
8.5.3 Patient preparation ................................................................... 85
8.5.4 Making an exposure ................................................................. 88
8.6 TMJ examination .................................................................................. 93
8.6.1 Device preparation .................................................................... 95
8.6.2 Anatomic / Manual Exposure ................................................... 97
8.6.2.1 Anatomic exposure .............................................................. 98
8.6.2.2 Manual exposure ................................................................. 99
8.6.3 TMJ closed mouth .................................................................. 100
8.6.3.1 Patient preparation ............................................................ 100
8.6.3.2 Carrying out the first exposure (mouth closed) .................... 102
8.6.4 TMJ open mouth .................................................................... 105
8.6.4.1 Patient preparation ............................................................ 105
8.6.4.2 Carrying out the second exposure (mouth open) ................. 107
Rotograph EVO D ii (Rev. 4)

USER'S MANUAL
Contents
8.7 SINUS examination............................................................................. 110

8.7.1 Anatomic / Manual Exposure ................................................. 112
8.7.1.1 Anatomic exposure ............................................................. 113
8.7.1.2 Manual exposure ............................................................... 114
8.7.2 Patient preparation ................................................................. 115
8.7.3 Making an exposure ............................................................... 117
8.8 IMPLANT examination ........................................................................ 121
8.8.1 Anatomical parameters ........................................................... 123
8.8.2 Implant Bite Block set-up ....................................................... 124
8.8.2.1 Bite block preparing: Maxilla Implant ................................. 125
8.8.2.2 Bite block preparing: Mandible Implant .............................. 126
8.8.3 Equipment preparation .......................................................... 127
8.8.4 Manual / Anatomic exposure ................................................. 130
8.8.4.2 Manual exposure ............................................................... 131
8.8.5 How to prepare the patient ..................................................... 132
8.8.7 Radiographic results............................................................... 137
8.8.7.1 Right side tomography (quadrants 1 and 4) ......................... 138
8.8.7.2 Left side tomography (quadrants 2 and 3) ........................... 138
8.9 Cephalometric examination ................................................................ 139
8.9.1 Device preparation ................................................................. 140
8.9.2 Anatomic / Manual Exposure ................................................. 143
8.9.2.2 Manual exposure ............................................................... 145
8.10 Examination to assess bone growth (Carpus) ...................................... 151
8.10.1 Device preparation ................................................................. 152
8.11 Messages on display ........................................................................... 159
8.11.1 Error message with error code E000 ÷ E199 ........................... 160
8.11.1.1 E110 – Battery fault ........................................................... 160
8.11.3.1 Error message with code error E300 ÷ E303 ....................... 161
8.11.3.2 Error message with code error E320 ÷ E323 ....................... 161
8.11.3.3 E340 - Sensor holder not in PAN position ........................... 161
8.11.3.4 E360 / E361 - X-ray button pressed during start up or
axis movement ................................................................... 161
8.11.3.5 E362 - X-ray button released during examination ............... 162
8.11.3.6 E364 / E365 - Sensor connection lost ................................ 162
(Rev. 4) iii Rotograph EVO D

USER'S MANUAL
Contents
8.11.5.1 E755 – Safety Buckup Timer intervention ........................... 163
8.11.5.2 E774 - X-rays button not pressed ....................................... 163
8.11.5.3 E775 - X-rays button released prematurely ........................ 163
8.11.6.1 E850 - One or more keys appear to be pressed on
start-up ............................................................................. 164
8.11.6.2 E851 - Column key pressed ............................................... 164
8.11.6.3 E852 - Key "Patient Entrance" pressed during the
movement .......................................................................... 164
8.12 Research and correction of possible defects in dental X-rays .............. 165
8.12.1 Faults due to the wrong positioning of the patient .................. 165
8.12.2 Defects due to wrong data setting ........................................... 166
8.12.3 Defects due to the device ........................................................ 167
8.13 Analysis of the problems on the panoramic examinations ................... 168
8.13.1 Proper positioning of the patient ............................................. 169
8.13.1.1 Errors due to poor positioning of patient ............................ 171
8.13.1.2 Images with artefacts ......................................................... 178
8.14 Storing of automatic exposure parameters .......................................... 181
8.14.1 Table of pre-set anatomic parameters ..................................... 182
9. MAINTENANCE 184
No part of this publication can be reproduced, transmitted, transcribed or

translated without the approval of VILLA SISTEMI MEDICALI S.p.A.
This manual in English is the original version.
Rotograph EVO D iv (Rev. 4)

USER'S MANUAL
Introduction
1. INTRODUCTION
NOTE:
The present manual is updated for the product it is sold with, in order to
guarantee an adequate reference to use the product properly and safely.
The manual may not reflect changes to the product that do not affect
operating modes or safety.
The aim of this publication is to instruct the user on the safe and
effective use of the device.
This Manual is limited to the description of the X-ray device; instructions
on the Digital Acquisition System are given in the relevant Manuals,
supplied with the Direct Digital Sensor.
Rotograph EVO D, produced by VILLA SISTEMI MEDICALI S.p.A., is an

X-ray device for the radiographic analysis of the maxillo-facial complex.
The basic version of the Rotograph EVO D performs Panoramic, Sinus
and TMJ examinations of the maxillo-facial complex.
The following options are available, and must be ordered separately:
• EVO XP (Extended Projection Package); it allows the execution of the
following examinations: Emi-panoramic, Reduced dose Panoramic,
Frontal dentition, Improved orthogonality Panoramic and Bitewing.
• IMPLANT; it allows to perform images of cross-sections of the dental
arch, for Implant medical treatment.
• DIGITAL CEPH; it allows the execution of the following examinations:
- CEPH exam in different formats, all available in high resolution
and normal resolution (high speed) modality
- CARPUS exam, available in high resolution modality.
WARNING:
1. Rotograph EVO 3D is an electro-medical device and it can be used
only under the supervision of a physician or of highly qualified
personnel, with the necessary knowledge on X-ray protection.
2. The device must be used in compliance with the procedures
described, and never be used for purposes different from those
herewith indicated.
3. Please read this manual thoroughly before starting to use the unit; it
is advisable to keep the manual near the device, for reference while
operating.
4. The user is liable as concerns the legal fulfilment related to the
installation and the operation of the device.
(Rev. 4) 1 Rotograph EVO D

USER'S MANUAL
Introduction
1.1 Icons appearing in the manual

This icon indicates a “NOTE”: please read the items marked by this
icon thoroughly.
This icon indicates a “WARNING”: the items marked by this icon refer
to the safety aspects of the patient and/or the operator.
Rotograph EVO D 2 (Rev. 4)

USER'S MANUAL
Specification of the intended use
2. SPECIFICATION OF THE INTENDED USE
2.1 Application and medical purpose

Rotograph EVO D is dedicated to perform radiographies –using the
standard narrow beam technique- of the maxillofacial anatomic district,
including exams of the dental arc, of tempomandibular joint and
paranasal sinuses. It can be equipped with cephalometric arm to take
cranial cephalometric exams in different projections and the wrist
(carpus) exam dedicated to the evaluation of bone growth.
The system can be used on all the patient type; from the Graphical User
Interface the selection of specific programs dedicated to adult or child
patients, patient size and type of dentition for panoramic exams.
Caution
Federal law restricts this device to sale by or on the order of a dentist, a
radiologist or another legally qualified health care professional.
2.1.1 Intended patient population
Rotograph EVO D system can be used with the following type of patient:
• Age: paediatric to geriatric
• Patient status/health: patient with intact skin, conscious, not
anaesthetized and not incapacitated
• Nationality: multiple.
NOTE:
PATIENT is not the OPERATOR.

USER'S MANUAL
2.1.2 Operator profile (intended user)
This system may only be operated by a physician, dentist or skilled

technician who have the necessary expertise in radiation protection or
knowledge of radiation protection and who have been instructed in the
operation of the X-ray equipment.
Service engineers who install and maintain the device are also operator.
They need knowledge of radiation protection and must read the Service
Manual prior to use the X-ray equipment. They must be qualified and
authorized by Villa Sistemi Medicali.
2.1.3 Application environments
Rotograph EVO D is dedicated both to the dental practitioner market and

to radiologist's, for this reason the equipment can be installed both in
residential buildings and in professional buildings (e.g. hospitals or
clinics). Anyway, the room where the equipment is installed in must have
comply with local regulations concerning radiation protection.
NOTE:
In the radiographic room, direct audio and visual communication
between operator and patient shall be always possible. Otherwise,
provide proper support (i.e. lead glass or similar, interphone, etc.).
2.2 Applied parts

During normal use, Rotograph EVO D is in contact with the patient via
the handle, the chin rest and bite and mono-use sleeves, the temple
clamps; Ceph nasion, ear centering pins and Carpus plate if Ceph arm is
present.
All the listed parts are classified as Type B applied parts.

USER'S MANUAL
2.3 Typical doses delivered to the patient during extra-

oral exams
The Dose per Area Product delivered by Rotograph Evo D to the patient
during extra-oral exams is indicated in the graphical user interface.
NOTE:
The dosimetric indications result from the average of dose measures on a
lot of X-rays source assemblies.
The dose is measured at a certain distance from the focal spot of the
X-ray source and then reported to the imaging plane. To get the DAP
value, the dose on the imaging plane is multiplied by the X-ray field area
measured on the imaging sensor that is 50 cm far away from focal spot in
panoramic exams and 165 cm in cephalometric exams.
The typical size of the X-ray beam on the imaging sensor depends on the
selected exam:
• for Panoramic, Sinus and TMJ exams: 139x4.5 mm
• for Cephalometric exams: 220x9 mm
The distance between the focal spot and the patient skin is variable
during the X-ray and on average we can assume the mean distance
between the focal spot and the patient skin as 264 mm for panoramic
and 1395 mm for cephalometric exams.
The overall uncertainty of the indicated value of the airKerma and dose
per area product is 50%.
NOTE:
As stated in IEC 60601-2-63, no deterministic effects are known with
extra-oral dental X-ray equipment.

USER'S MANUAL
2.3.1 Panoramic mode
The air Kerma value at the entrance of the X-ray image receptor for the
Panoramic STD exam is reported in the table below as functions of kV
and mA.
mA
6 7 8 9 10
60 7.94 9.28 10.63 11.84 13.18
62 8.34 9.82 11.16 12.64 13.99
64 9.01 10.49 11.97 13.45 15.07
66 9.68 11.30 12.78 14.39 16.01
68 10.22 11.97 13.72 15.33 17.08
70 11.03 12.91 14.66 16.54 18.43
72 11.43 13.45 15.33 17.22 19.10
kV
74 12.11 14.12 16.14 18.16 20.18

76 12.78 14.80 16.95 19.10 21.25
78 13.32 15.60 17.76 20.04 22.33
80 14.12 16.54 18.83 21.25 23.54
82 14.53 16.95 19.37 21.79 24.21
84 15.33 17.89 20.45 23.00 25.56
86 16.14 18.83 21.52 24.21 26.90
Table 1: Air Kerma values in mGy for Panoramic STD exams
The air Kerma for the other Panoramic STD exams available on the
equipment can be calculated using the ratios vs Panoramic exam in the
table below:
Exam Ratio
EVO Panoramic 1.07
Half panoramic 0.60
Low Dose 0.92
Ortho Rad panoramic 0.90
Frontal dentition 0.33
Bitewing L or R 0.25
Bitewing L and R 0.48
TMJ 0.72
Sinus 0.69

USER'S MANUAL
2.3.2 Cephalometric mode
The air Kerma value at the entrance of the X-ray image receptor for the
Cephalometric exams 30x22 cm in High Definition mode is reported in
the table below as functions of kV and mA.
mA
6 7 8 9 10 12
60 0.50 0.58 0.66 0.75 0.83 0.91
62 0.54 0.64 0.72 0.82 0.89 1.00
64 0.57 0.66 0.76 0.87 0.96 1.06
66 0.61 0.72 0.82 0.92 1.01 1.12
68 0.66 0.77 0.88 1.00 1.10 1.21
70 0.70 0.82 0.93 1.05 1.16 1.28
72 0.74 0.86 0.98 1.10 1.23 1.35
kV
74 0.78 0.91 1.03 1.17 1.30 1.43

76 0.82 0.96 1.10 1.24 1.37 1.51
78 0.87 1.00 1.15 1.29 1.43 1.58
80 0.94 1.06 1.20 1.35 1.51 1.66
82 0.98 1.14 1.31 1.48 1.64 1.80
84 1.03 1.20 1.37 1.55 1.73 1.90
86 1.08 1.27 1.45 1.63 1.81 1.99
Table 2: Air Kerma values in mGy for Cephalometric exams 30x22 cm in

High Definition mode
The air Kerma for the other cephalometric formats can be calculated
using the ratio in the table below vs the values from Table 2:
Exam Ratio
18x22 HS 0.28
18x22 HD 0.56
24x22 HS 0.41
24x22 HD 0.81
30x22 HS 0.50
18x22 Carpus 0.65

USER'S MANUAL
Safety information
3. SAFETY INFORMATION
WARNING:
Please read this chapter thoroughly.
VILLA SISTEMI MEDICALI designs and builds its devices in compliance

with the safety requirements; furthermore it supplies all information
necessary for correct use, and the warnings related to danger associated
with X-ray generating units.
Villa Sistemi Medicali cannot be held responsible for:
• the use of Rotograph EVO D different from the intended use

• damage to the unit, the operator or the patient, caused both by
installation and maintenance procedures different from those
described in this Manual and in the Service Manual supplied with
the unit, and by wrong operations
• mechanical and/or electrical modifications performed during and
after the installation, different from those described in the service
manual.
Installation and any technical intervention must only be performed

by qualified technicians authorised by Villa Sistemi Medicali.
Only authorised personnel can remove the covers and/or have

access to the components under tension.
WARNING:
In compliance with the IEC 60601-1 standard, the modification of
the equipment or its parts is strictly prohibited.

USER'S MANUAL
Safety information
3.1 Warnings
The device must be used in compliance with the procedures described
and never be used for purposes other than those indicated herein.
Before performing any maintenance operation, disconnect the unit from
the power supply.
Rotograph EVO D is an electric medical device and so can only be used
under the supervision of suitably qualified medical personnel, with
necessary knowledge of X-ray protection.
The user is responsible for compliance with legal requirements as regards
ownership, installation and use of the equipment.
This device has not been designed to be used in environments where
vapours, anaesthetic mixtures flammable with air, or oxygen and nitrous
oxide, can be detected.
Do not let water, or other liquids, into the device, as this could cause
short-circuits and corrosion.
Before cleaning the device, please disconnect it from the line voltage.
Wherever necessary, use the appropriate accessories, such as the leaded
aprons, to protect the patient from radiation.
While performing the radiography, no-one, apart from the patient, must
remain in the room.
Rotograph EVO D has been built to support a continuous operation at
intermittent load; therefore please follow the described use cycles to
enable the device to cool down.
Rotograph EVO D must be switched off while using devices such as
electrosurgical devices or similar apparatus.
WARNING:
To avoid the risk of electric shock, the equipment must only be connected
to a mains supply with earthing.
Please clean and disinfect, when necessary, all parts that can be in
contact with the patient.
The centring bite or the bite protective sleeve and the ear centring
devices of the Cephalostat must be replaced after each examination
in which they were used.
Never try to rotate the moving arm manually when the unit is
switched on, to avoid permanent damage to the unit.
Movement is only possible in case of Error 206 because motors are
disabled to permit the patient exit.

USER'S MANUAL
Safety information
WARNING:
The USB port on the keyboard MUST NOT be used with an external Hard
Disk with own mains connection. It has to be used only with USB Pen
Drives.
NOTE:
The dimension of the "patient's environment" is defined as a distance of
at least 1.5 m from the actual patient.
If the PC is positioned inside the patient's environment, it must conform
to the requirements specified by the IEC 60601-1 standard for medical
devices; if located outside of the patient's environment, it must be
compliant with the IEC 60950 standard.

USER'S MANUAL
Safety information
3.1.1 Precautions while using laser centring devices
WARNING: PRECAUTIONS WHILE USING LASER CENTRING

DEVICES:
Although the laser centring devices used on the Rotograph EVO D system
are classified in Class 1 in compliance with the IEC 60825-1:2007
standard and attachments, the following precautions are recommended:
• Always keep the room well lit.
• Do not look into the output windows of laser centring units.
• Do not stare at the reflections of laser pointers.
• Instruct the patient to keep his/her eyes closed as long as the laser
pointers are active.
• Before starting an examination, the patient must remove earrings,
glasses, necklaces and whatever else could reflect the laser beam or
be impressed on the radiographic image.
• Do not clean the openings of laser centring devices with tools that
could modify the optics. Any cleaning must be performed only by
authorised technicians.
Operations other than those indicated could cause the ejection of
dangerous non-ionising radiation.

USER'S MANUAL
Safety information
3.2 Protection against radiation

Although the dose supplied by dental X-ray units is quite low and
distributed on a fairly small surface, the operator must adopt
precautions and/or suitable protection for the patient and himself,
during radiography.
WARNING:
Protection against radiation is regulated according to law.
The equipment may only be used by specialised personnel.
It is advisable to control the X-ray emission from a protected area, by

remote control. If it is necessary to operate near the patient, stay as far
as the remote control cable allows, or at least 2 m both from the X-ray
source and from the patient, as shown in the following figure.

USER'S MANUAL
Safety information
Minimum distance from

X-ray source 2 m
Protected area
Figure 1 - Panoramic version
Minimum distance from

X-ray source 2 m
Protected area
Figure 2 - Cephalometric version

USER'S MANUAL
Safety information
3.2.1 Distribution of stray radiation in Panoramic examination
-1.5 -1 -0.5 0 0.5 1 1.5m

0,000233 0,000297 0,00053 0,000445 0,000423 0,000331 0,000201
0,000268 0,000197
1.5 1.5m
0,000546 0,000248
1 1
0,000666 0,000282
0.5 0.5
0,00049 0,000163
0 C 0
0,000474 0,000266
-0.5 -0.5
0,000376 0,000248
-1 -1
0,00025 0,000449 0,000655 0,000588 0,000447 0,000182 0,000434

-1.5 -1.5
0,000318 0,000228
-1.5 -1 -0.5 0 0.5 1 1.5m
Figure 3: Distribution of stray radiation in Panoramic examination
The Figure above illustrates the distribution of scatter radiation in the

horizontal plane at the centre of rotation of the scanning unit in the area
of a 3 x 3m rectangle.
The measurement was performed using as scattering element an
anthropomorphic phantom complete of soft tissues simulating the head
of the typical patient (in size, dimensions and tissues) of the intended use
of the machine.
This phantom was placed in the same position as a patient taking a
panoramic exam. C is the center of patient head.
The measures were taken during a panoramic exam setting the following
parameters: 86kV, 10mA, 14.4s.
NOTE:
They are the maximum kV and mA that can be set on the equipment.
The distribution values in the table are expressed as air Kerma for mAs
(µGy/mAs).

USER'S MANUAL
Safety information
3.2.2 Distribution of stray radiation in Ceph examination
-1.5 -1 -0.5 0 0.5 1 1.5m

0.00031 0.00034 0.00038 0.00036 0.00028 0.0006 0.00093
1.5 1.5m
0.00012 0.00155
1(1) 1
0.00023 0.0022
0.5(1) 0.5
0.0008
Primary x-ray C 0
S beam
0.00022 0.0003
- -0.5
0.5(1)
0.00012 0.00021
-1(1) -1
0.00029 0.00032 0.00034 0.00033 0.00019 0.00015 0.00012

-1.5 -1.5
-1.5 -1 -0.5 0 0.5 1 1.5m
Figure 4: Distribution of stray radiation in Ceph examination
NOTE (1):
The doses reported on the source side (S) are just the head scattering
term and these values doesn' take into account of tubehead leakage
radiation.
The Figure above illustrates the distribution of scatter radiation in the

horizontal plane at the centre of rotation of the scanning unit in the area
of a 3 x 3m rectangle.
The measurement was performed using as scattering element an
anthropomorphic phantom complete of soft tissues simulating the head
of the typical patient (in size, dimensions and tissues) of the intended use
of the machine.
This phantom was placed in the same position as a patient taking a
30x22 cephalometric exam; this exam is the maximum in size among
those the user can select.
C is the center of patient head; S is the X-ray source and the primary
X-ray beam is also represented in Figure above.

USER'S MANUAL
Safety information
The measures were taken during a cephalometric exam setting the

following parameters: 86kV, 12mA, 7.5s.
NOTE (1):
They are the maximum kV and mA that can be set on the equipment.
The distribution values in the table are expressed as air Kerma for mAs
(µGy/mAs).

USER'S MANUAL
Safety information
3.2.3 Electromagnetic information
Medical electrical equipment needs special precautions regarding EMC

and needs to be installed and put into service according to the EMC
information provided in the accompanying documents.
Portable and mobile RF communications equipment can affect medical
electrical equipment.
WARNING:
The use of cables other than:
- Ethernet cable CAT.5E L=5 m - code 5007090100
- Ethernet cable CAT.5E L=10 m - code 5007090300
with the exception those sold by the manufacturer of the equipment or
system as replacement parts for internal components, may result in
increased emission or decreased immunity of the equipment or system.

USER'S MANUAL
Safety information
3.2.4 Electromagnetic emissions
In accordance with the IEC 60601-1-2 standard, the Rotograph EVO D is

suitable for use in the specified electromagnetic environment.
The purchaser or user of the system should assure that it is used in an
electromagnetic environment as described below.
Emissions test Compliance Electromagnetic environment

Radiated and conducted Group I Rotograph EVO D uses RF energy only for its
RF emission internal function. Therefore, R.F. emissions is
very low and not likely to cause any interference
CISPR 11 in nearby electronic equipment.
Class B Rotograph EVO D is suitable for use in all
establishments other than domestic venues and
those directly connected to the low voltage power
supply network which supplies buildings used
for domestic purposes.
Harmonics emissions Complies Rotograph EVO D is suitable for use in
IEC 61000-3-2 establishments directly connected to a public
low voltage power supply network.
Voltage fluctuations/ Complies Rotograph EVO D is suitable for use in
flicker emissions establishments directly connected to a public
IEC 61000-3-3 low voltage power supply network.

USER'S MANUAL
Safety information
3.2.5 Electromagnetic immunity
In accordance with the IEC 60601-1-2 standard, the Rotograph EVO D is

suitable for use in the specified electromagnetic environment.
The purchaser or user of the system should assure that it is used in an
electromagnetic environment as described below.
IEC 60601-1-2 Compliance Electromagnetic

Immunity test
Test level level environment
Electrostatic ± 6 kV contact ± 6 kV contact Floor should be wood,
discharges (ESD) ± 8 kV air ± 8 kV air concrete or ceramic tile.
IEC 61000-4-2 If floors are covered with
synthetic material, the
relative humidity should
be at least 30%
Electrical fast ± 2 kV for power ± 2 kV for power Residential/Hospital
transient/burst supply lines supply lines
IEC 61000-4-4
± 1 kV for ± 1 kV for
input/output lines input/output lines
Surge ± 1 kV lines to lines ± 1 kV lines to lines Residential/Hospital
IEC 61000-4-5
± 2 kV lines to earth ± 2 kV lines to earth
Voltage dips, short 0 % Un for 0.5 cycles 0 % Un for 0.5 cycles Residential/Hospital
interruptions and 40 % Un for 5 cycles 40 % Un for 5 cycles
voltage variations on 70 % Un for 25 cycles 70 % Un for 25 cycles
power supply input 0 % Un for 5 s 0 % Un for 5 s
lines IEC 61000-4-11
Power frequency 3 A/m 3 A/m Residential/Hospital
(50/60 Hz) magnetic
field
IEC 61000-4-8
Note: Un is the AC mains voltage prior to application of the test level.

USER'S MANUAL
Safety information
IEC 60601-1-2 Compliance

Immunity test Electromagnetic environment
Test level level
Portable and mobile RF
communications equipment should be
used no closer to any part of the
Rotograph EVO D, including cables,
than the recommended separation
distance calculated from the equation
applicable to the frequency of the
transmitter.
Recommended separation distance:
Radiated RF 3 V/m 3 V/m d = 1.2 x √ P 80 MHz to 800 MHz
IEC 61000-4-3 80 MHz to 2.5 GHz
d = 2.3 x √ P 800 MHz to 2.5 GHz
Conducted RF 3V 3V d = 1.2 x √ P
IEC 61000-4-6 50 kHz to 80 MHz
Where "P" is the maximum output
rating of the transmitter in watts (W)
according to the transmitter
manufacturer and "d" is the
recommended separation distance in
meters (m).
Field strength for fixed RF
transmitters, as determined by an
electromagnetic site survey, should be
less than the compliance level in each
frequency range.
Interference may occur in the vicinity
of the equipment marked with the
following symbol:

USER'S MANUAL
Safety information
3.2.6 Recommended separation distances for non-life supporting

equipment
Rated maximum Separation distance according to

output power of frequency of transmitter (m)
the transmitter 150kHz to 80MHz 80MHz to 800MHz 800MHz to 2.5GHz
(W) d = 1.2 x √ P d = 1.2 x √ P d = 2.3 x √ P
0.01 0.12 0.12 0.23
0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23
For transmitters rated at the maximum output power not listed above, the recommended
separation distance "d" in meters (m), can be estimated using the equation applicable to the
frequency of the transmitter, where "P" is the maximum output power rating of the
transmitter in watts (W) according to the transmitter manufacturer.
Note: at 80 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
These guidelines may not apply to all situations. Electromagnetic propagation is affected by
absorption and reflection of structures, objects and people.

USER'S MANUAL
Safety information
3.3 Cybersecurity measures

The device can be supplied without the host PC. In order to protect the
computer, the equipment and data from unauthorized access or data
corruption caused by cyber-attacks, it is highly recommended to:
• Password-protect each user account on the Windows login.
Passwords shall be strong enough (at least made of 8 alphanumeric
characters), shall be safely managed by every user (for example they
have not been written down), and should be periodically changed
• Activate a screensaver that requires a password to be unblocked after
a timeout of 5-10 minute, giving this way an automatic timed method
to terminate sessions, preventing an unauthorized access to the
computer when it is not used
• Install an antivirus software
• Activate the windows firewall on the host PC
• If the Local Area Network has an internet connection, activate a
hardware firewall on the WAN router/modem used for internet
connection
• Make sure that all PC in the network are protected by an anti-virus
• Make a virus scan of USB sticks or CD/DVD media before using
them to check they are free from viruses, malware or any dangerous
software
• Avoid installation of an unknown or untrusted software since it may
undermine performance and safety of the computer and the
equipment
• Keep the Windows operating system up to date by installing all
security patches
• Make regular copies (backup) of all your valuable data and store
them in a safe place, separately from the host PC
• Have any software or firmware upgrade of the equipment done by
authorized and trained personnel only
• Make some test exams without patients after any software or
firmware upgrade to ensure the system is working as expected.

USER'S MANUAL
Safety information
3.4 Environmental risks and displacement

In some of its parts, the device contains materials and liquids that, at the
end of the lifespan of the unit, must be disposed of at the appropriate
disposal centres.
In particular, the device contains the following materials and/or

components:
• Tube-head: dielectric oil, lead, copper, iron, aluminium, glass,
tungsten.
• Control Panel: iron, copper, aluminium, glass-resin, non-
biodegradable plastic material packaging.
• Column, rotating arm and extensions: iron, lead, aluminium,
copper, glass-resin, and non-biodegradable plastic material.
• Applied parts: non-biodegradable plastics, iron, aluminium.
• Digital sensor: iron, lead, copper, integrated electronic components.
The centring bite or the bite protective sleeve and the ear centring devices
of the Cephalostat that must be replaced after each examination in which
they were used, must be disposed of at the appropriate disposal centres.
Information for users of the European Community according to

2011/65/EU Directive on the restriction of the use of certain
hazardous substances in electrical and electronic equipment.
The symbol of the crossed waste container on the equipment or on the

packaging, shows that the product, at the end of its lifecycle, must be
collected separately from other type of waste.
The separate collection of this equipment at the end of its lifecycle is
organised and managed by the manufacturer. Users who need to dispose
of this equipment, should therefore contact the manufacturer and follow
the procedure adopted by the manufacturer themselves for the separate
collection of the equipment at the end of its lifecycle.
The proper separate collection for the subsequent recycling, treatment
and compatible environmental disposal of the equipment, contributes to
avoid possible negative effects on the environment and on health and it
encourages the reuse or recycling of materials the equipment consists of.
Illegal disposal of the product by the possessor of the equipment, results
in the application of administrative sanctions provided by the regulations
in force

USER'S MANUAL
Safety information
3.5 Symbols used

In this manual and on the Rotograph EVO D itself, apart from the
symbols indicated on the control panel, the following icons are also used:
Symbol Description
Device with type B applied parts
In some of its parts, the device contains materials and liquids

that, at the end of the lifespan of the unit, must be disposed of
at the appropriate disposal centres
∼ Alternating current
N Connection point to the neutral conductor
L Connection point to the line conductor
Protection earthing
Operation earthing
OFF; device not connected to the mains
 ON; device connected to the mains
Laser
Dangerous voltage
Product identification code
Serial number
Date of manufacture (year and month)
Manufacturer's name and address
Total filtration
Tube-head
X-ray tube

USER'S MANUAL
Safety information
Symbol Description
Focal spot according to IEC 60336
Follow instructions for use
Conformity to the Directive 93/42/EEC and its revised version

0051 and all other applicable Directives
Exposure enabled status (the corresponding green LED is on)
X-Ray emission (the corresponding yellow LED is on)

USER'S MANUAL
Cleaning and disinfection
4. CLEANING AND DISINFECTION

In order to guarantee a good level of hygiene and cleaning, it is necessary
to respect the following procedures.
WARNING:
Disconnect the unit from the mains
before performing any cleaning.
Do not let water or other liquids enter the unit, as these could cause
corrosion or short-circuiting.
Use only a wet cloth and a mild

detergent to clean the painted
surfaces, the accessories and the
connection cables, and then wipe
with a dry cloth; do not use
corrosive, abrasive solvents
(alcohol, benzine, trichloro-
ethylene, products containing
quaternary ammonium).
The centring bite or the bite protective sleeve and the ear centring
devices of the cephalostatus must be replaced after each
examination in which they have been used.
Thoroughly clean the chin support, TMJ positioner, resting handles,
nose-rest and temple clasps group any time these are used.
The chin support, TMJ positioner, resting handles, nose-rest and temple
clasps group should be disinfected (when considered necessary) with a
solution of 2% glutaraldehyde.

USER'S MANUAL
Description
5. DESCRIPTION
5.1 Identification labels and laser labels
5 7
2 6
3, 4
1c, 9 (*)
1a, 1b (*)
(*) Labels 1b, 1c and 9 present only for 110-120V version

USER'S MANUAL
Description
5.1.1 Identification labels and laser labels "220-240V" version
1a 2
Rotograph EVO D Tube-head
identification label identification label
3 4
EVO XP – Extended Projection Package IMPLANT Package
5
CEPHALOMETRIC device
identification label
6 7
PANO PANCEPH.
Digital Sensor Digital Sensor
8
(N° 2) Laser
symbol label

USER'S MANUAL
Description
5.1.2 Identification labels and laser labels "110-120V" version
1a
Rotograph EVO D identification label
1b
Rotograph EVO 3D
UDI plate
1c
ETL certification
label
2 3 4
Tube-head identification label EVO XP – IMPLANT Package
Extended Projection identification label
Package
identification label
5 6 7
CEPHALOMETRIC device PANO PANCEPH.
identification label Digital Sensor Digital Sensor
9
WARNING label
8
(N° 2) Laser
symbol label

USER'S MANUAL
Description
5.2 Functions, models and versions

Rotograph EVO D, produced by VILLA SISTEMI MEDICALI S.p.A., is a
complete panoramic system, which enables to perform all X-rays
commonly necessary in dental field (except for endoral X-rays).
In some versions, certain examination modes are not available but the
device (thanks to its computerised control system) can be expanded and
updated with new releases, directly at the Dentist premises.
The basic version performs Panoramic, Sinus, and TMJ examinations.
Optional functions enable the system to perform the following additional
examinations:
• EVO XP (Extended Projection Package)
Allows you to carry out the following additional examinations:
Emi-panoramic, Reduced dose Panoramic, Frontal dentition,
Improved orthogonality Panoramic and Bitewing.
• IMPLANT
Allows you to perform images of cross-sections of the dental arch, for
Implant medical treatment.
• CEPH
Allows you to carry out the following examinations:
− CEPH exam in different formats
− CARPUS exam.
The values of the exposure factors shown in the tables of paragraph

8.14.1, set as default, are for guidance only.
The real adjustment of these values depends on users trade off between
expose dose and image contrast.
Image processing should help you getting the best contrast.
5.2.1 Basic version
The basic version enables to perform the following examinations:

• Panoramic Adult or Child, with 3 Sizes and 3 Types of Biting for a
total of 18 combinations in Automatic selection; in manual selection
it is possible to select high voltage between 60kV and 86kV, in 2kV
steps and anodic current from 6 mA to 10 mA in 1 mA steps.
• Sinus enables to perform images of the paranasal sinuses with front
projection (postero/anterior).
• TMJ mouth closed/open in lateral projection.

USER'S MANUAL
Description
5.2.2 Version with cephalometric device
The version with cephalometric device allows you to perform the following
examinations:
• Panoramic, Sinus, and TMJ, Adult and Child, with the same
characteristics described for the base version.
• Digital Cephalometry for Adult and Children with 3 Sizes each.
Within each combination, it is possible to select an examination in
Hight or Normal Resolution, for a total of 12 combinations in
Automatic selection. In Normal Resolution, the examination is carried
out with a lower scanning time, allowing a further reduction of the
dose. In Manual selection it is possible to vary the Hight Voltage from
60kV to 86kV, with 2kV steps, the anodic current from 6mA to 12mA
with 1mA steps. The positioning of the sliding primary collimator, the
secondary collimator and the Digital Sensor (inside the relative
sensor holder) is automatic according to the selected format
projection. The Soft Tissues Filter is motorized, to obtain the best
possible emphasis of the face profile.
• Examination to evaluate the bone growth (Carpus) only Child with 3
Sizes. It is possible to select an examination in High Resolution, for a
total of 3 combinations in Automatic selection. In Manual selection it
is possible to vary the tension from 60kV to 86kV, with 2kV steps,
the anodic current from 6mA to 12mA with 1mA steps. The
positioning of the sliding primary collimator, the secondary collimator
and the Digital Sensor (inside the relative sensor holder) is automatic

USER'S MANUAL
Description
5.2.3 EVO XP (Extended Projection Package) - Optional
The unit, both the base and the version with cephalometric device, is
prearranged to be fitted with the EVO XP (Extended Projection Package)
function, which enables to perform the following examinations:
• The right or left Emi-panoramic is used when the patient is known to
have a problem only on one side of the arch, in order to reduce the
radiation
• The reduced dose Panoramic reduces the dose radiated on the
dentition by excluding the TMJ's ascending rami from the exams
• The frontal dentition enables to perform examinations of the front
part (roughly from canine to canine)
• The Panoramic with improved orthogonality reduces the overlap of
the teeth, thereby improving the diagnosis of interproximal decay
• Bitewing left or right, allows the execution of examination of the
lateral dentition (generally from eighth to fourth) with a trajectory
that reduces the overlap of the teeth
• Bitewing (left and right) sequentially performs both bitewings,
showing them on the same image.
NOTE:
All these examinations can be added to Rotograph EVO D systems
already installed in the field.
NOTE:
The code inserted into Rotograph EVO D to enable the optional
examinations is protected by a Unique Identification Code (UIC); in the
event the UIC is not present or is faulty, an error E107 will be shown.
Pressing the "Patient Entrance" (6) push-button will reset such
condition, although at the end of the start-up position, only the

Panoramic, Sinus, and TMJ functions will remain active.
The UIC is simply an identifier of the single Rotograph EVO D unit; in

order to enable the optional functions it is necessary to request the
activations code from Villa Sistemi Medicali, which derives from the
Unique Identification Code or from the device serial number.

USER'S MANUAL
Quality assurance program
6. TECHNICAL CHARACTERISTICS
General features
Type Rotograph EVO D

Manufacturer VILLA SISTEMI MEDICALI
Buccinasco (MI) Italia
Class Class I with type B applied parts
according to IEC 60601-1
classification
Protection degree IPX0 standard device
Rated line voltage 220-240 V∼ 110-120 V∼
Line frequency 50/60 Hz
Maximum line current 7 A @ 230V∼ 15 A @ 115 V∼
50/60 Hz 50/60 Hz
Power consumption 1.6 kVA @ 230V∼ 1.7 kVA @ 115 V∼
50/60 Hz 50/60Hz
Protection fuse (F1) 7AT 15 A T
Protection fuse (F2) of switching 1.6 A T 3AT
power supply
Generator board protection fuses F1: 10 A F
F2: 5 A HF
F3: 2 A T
Line apparent resistance 0.5 Ω max 0.2 Ω max
Line voltage regulation -- < 3 % at 99 V∼
Rated output voltage (kVp) 60 ÷ 86 kVp, with 2 kVp steps
Anodic current 6 ÷ 10 mA, with 1 mA steps for PAN, TMJ,
and Sinus
6 ÷ 12 mA in 1 mA steps for Ceph (up to 76
kVp)
6 ÷ 10 mA in 1 mA steps for Ceph (from 78
kVp to 86 kVp)
Sensor cover additional filtration 0.1 mm Al eq @ 70 kVp

USER'S MANUAL
Exposure times
EVO Panoramic 14.4 s Adult / 13.3 s Child

Panoramic STD 13.8 s Adult / Child
EVO EmiPanoramic 7.8 s Adult / 7.3 s Child
STD EmiPanoramic 7.4 s Adult / 7.3 s Child
Improved orthogonality Panoramic 11.9 s Adult / Child
EVO Reduced dose Panoramic 11.9 s Adult / 10.8 s Child
STD Reduced dose Panoramic 11.4 s Adult / Child
Frontal Dentition 4.4 s Adult / Child
Bitewing 3.2 s right / left
6.3 s right and left
TMJ mouth closed/open 2.44 s per image for left and right joint in
open and closed condition, total of 9.7 s
Sinus P/A projection 9.4 s
Implant 9.2 s for incisive e canine
7.3 s for pre-molars and molars
Cephalometry (Ceph) Exposure time variable according to the
type of resolution and format selected.
Minimum 4.5 s (18x22 nR), maximum
15 s (30x22 hR)
Exposure time accuracy ± 5 % or ± 50ms whichever is greater
Examination modes
Examination selection • Automatic selection for Adult and

Child, 3 Sizes
• 3 biting modes (in Panoramic)
• Automatic selection for Adult, 3 Sizes
(in Implant)
• Manual selection
• Collimator with automatic positioning
Panoramic • EVO Panoramic
NOTE: • Standard Panoramic
Some of these exams are optional and • Half Panoramic L/R
depend on the system configuration. • Improved orthogonality Panoramic
• Reduced dose Panoramic
• Frontal dentition
• Bitewing L/R
• Bitewing L and R

USER'S MANUAL
Examination modes
TMJ (Temporal Mandibular Joint) TMJ open and closed mouth

Sinus Sinus P/A projection
Cephalometry and Carpus • Normal resolution cephalometry in
Latero-Lateral or Antero-Posterior
projection (different formats)
• High resolution cephalometry Latero-
Lateral or Antero-Posterior projection
(different formats)
• High Resolution Carpus exam
• Motorized Soft Tissue Filter.
Geometric Magnification after
Image magnification
magnification software correction
Adult / Child standard Panoramic 1 : 1.23 (constant 1 : 1 (*)
over dentition part)
TMJ open/closed mouth, 4 images 1 : 1.20 (nominal) 1 : 1 (*)
Sinus 1 : 1.22 (nominal) 1 : 1 (*)
Implant 1 : 1.32 (constant) 1 : 1 (*)
Ceph (on the sagittal medial plane in 1 : 1.10 1 : 1 (*)
LL projection)
(*) WARNING:
The declared image magnification value is valid after proper software
calibration.

USER'S MANUAL
Tube-head characteristics
Model MRE 05
Manufacturer Villa Sistemi Medicali S.p.A.
20090 Buccinasco (MI) Italia
Maximum tube voltage 86 kVp
kVp accuracy ±8%
Maximum anodic current 12 mA
Anodic current accuracy ± 10 %
Duty cycle Adaptive Duty Cycle according to
exposure factors: from 1 : 8 (at 60kV,
6mA) up to 1 : 20 (at 76kV, 12mA).
Further reduction for three consecutive
exposures: from 1 : 36 (at 60kV, 6mA) up
to 1 : 9 (at 76kV, 12mA)
Reference loading conditions related to 2700mAs/h @ 86 kVp
maximum energy input to the anode
Nominal power 1.032 kW (86 kVp - 12 mA)
Total filtration 2.5mm Al eq. @ 70 kVp
HVL (Half value layer) > 3.1mm Al eq. @ 80 kVp
Transformer insulation Oil bath
Cooling By convection
Leakage radiation at 1 m < 0.5 mGy/h @ 86 kVp - 12 mA - 3 s duty
cycle 1/16
Tube-head maximum thermic capacity 310 kJ
8°
Figure 5 - Tube-head target angle (view from the bottom)

USER'S MANUAL
X-ray tube characteristics

Manufacturer CEI Bologna (Italy)
Type OPX 105
Nominal focal spot 0.5 IEC 60336
Inherent filtration 0.5 mm Al eq.
Anode tilt 5°
Anode material Tungsten
Nominal maximum voltage 105 kVp
Filament max current 4A
Filament max voltage 8V
Anode thermal capacity 30 kJ
Digital Sensor
Sensible area (H x L) • PAN sensor: 151 x 7 mm

• PANCEPH sensor: 220 x 7 mm
Pixel dimensions 27 µm, 81 µm in binning 3x3 (PAN and
PANCEPH HD), 135 µm in binning 5x5
(CEPH HS)
Pixel (H) • PAN: 1860
NOTE: • CEPH: 1632 in HS, 2720 in HD
Number of horizontal pixels depends on
the exam and resolution on CEPH.
Laser centring devices
2 laser beams are used for the patient positioning; beams align mid Sagittal and
Frankfurt planes (please refer to relevant paragraphs for detailed explanation).
Wave length 650 nm ± 10 nm
Divergence < 2.0 mRad
Optical power < 1 mW
Classification Class 1 laser device according to
standard IEC 60825-1:2007

USER'S MANUAL
Mechanical characteristics
Focus-receptor distance (PAN, TMJ and 50 cm (20")

Sinus)
Focus-receptor distance (CEPH) 165 cm (65")
Telescopic motorised column run 85 cm (33.5")
Maximum total height 245 cm (96.5")
Weight • 161 kg base version
• 186 kg version with Ceph
Column weight 87 kg
Weight of arm support, rotating arm and 74 kg
tube head
CEPH arm 25 kg
Legs (optional) 30 kg
Sensor holder weight 2 kg
Working conditions
Minimum room size (please refer to the • 130x120 cm (51.2"x47.2") without

Service Manual) CEPH
• 145x202 cm (57"x78.7") with CEPH
Recommended room size (please refer to • 130x140 cm (51.2"x55.1") without
the Service Manual) CEPH
• 160x222 cm (63"x86.6") with CEPH
Maximum working temperature range + 10° ÷ + 40°
Relative working humidity (RH) range 30% ÷ 75%
Range of working atmospheric pressure 700 ÷ 1060 hPa
Temperature range for transport and - 20° ÷ + 70°
storing
Humidity range for transport and < 95% without condense
storing
Minimum atmospheric pressure for 630 hPa
transport and storing
NOTE:
In order to properly view images taken with Rotograph EVO D, the PC
monitor must have the following minimum characteristics:
• Resolution: 1366 x 768 pixels
• Colour depth: 16M of colour
• Contrast: 500:1
• Luminosity: 200cd/m^2.

USER'S MANUAL
6.1 PC requirements
WARNING:
PC to be used with the machine must comply with the standard IEC
60601-1 if it is positioned inside the patient's environment, or with the
standard IEC 60950-1:2005.
The dimension of the "patient's environment" is defined as a distance of
at least 1.5 m from the actual patient.
The minimum PC characteristics are the following:

• Processor Intel core I5 Quad core.
• 4Gb Ram.
• Hard drive 500 GB.
• Graphic card 1GB.
• Network card 10/100 Mb/sec.
• Operating System Windows 7, 8, 8.1, 10 / 32 or 64 bit.
• 3 USB port.
• DVD recorder.
NOTE:
In case of connection to DICOM network or LOCAL network are required
two network boards inside the PC.

USER'S MANUAL
6.2 Open Source Software

Parts of the software included in this product use the LINUX® operating
system and software packages that operate in that environment. Such
packages are used without alterations and are subject to various open
source licenses such as the General Public License (GPL or LGPL) and
others.
You may obtain the corresponding source code by writing to:

Villa Sistemi Medicali
Via delle Azalee, 3
20090 – Buccinasco – MI
Italy
Ph. +39-02-48 859 1
Fax. +39-02-48 859 303
e-mail: [email protected]
For proper processing of your request it is necessary to indicate "Open

Source Code" in the subject of your message. Distribution charges may
apply.
All Open Source Software will be provided "AS IS"; there are (i) no
representations or warranties and (ii) neither Villa Sistemi Medicali, nor
any of the developers or contributors to Open Source Software shall have
any liability or obligation to the customer with respect to Open Source
Software beyond what is granted in the particular Open Source Software
license. Any modification to software code residing in Villa Sistemi
Medicali product shall void all warranties, render product "Not for
Clinical Use" and not compliant to applicable standards. Villa Sistemi
Medicali shall have no liability or obligation for products containing
modified software.

USER'S MANUAL
6.3 Dimensions
1020 (40,16")
1600 (63,00") ÷ 2450 (96,46")

905 (35,63") ÷ 1755 (69,10")
1271 (50,04")
Ø 1040 (40,95")
Ø 1140 (44,88")
with free standing base
Figure 6 - Rotograph EVO D dimensions

Base version

USER'S MANUAL
1020 (40,16")
1600 (63,00") ÷ 2450 (96,46")

927 (36,50") ÷ 1777 (69,96")
905 (35,63") ÷ 1755 (69,10")
1271 (50,04")
Ø 1040 (40,95")
Ø 1140 (44,88")
with free standing base
1910 (75,20")
1970 (77,56") with free standing base
Figure 7 - Rotograph EVO D dimensions

Version equipped with cephalometric unit

USER'S MANUAL
6.4 Loading curve of the tube and cooling curve of the

anode
Tube "CEI - OPX/105" (0.5 IEC 336)
Load
Anode cooling curve

USER'S MANUAL
Tube-head heating and cooling curve
400
350
300
250
E[kJ]
200
150
100
50
0
0 100 200 300 400 500 600
min

USER'S MANUAL
6.5 Applied safety regulations

Medical electrical equipment for extra-oral dental radiography
Rotograph EVO D complies with:
IEC 60601 1: 2005 + Corr.1 (2006) + Corr.2 (2007)
IEC 60601 1: 2005 (3rd ed.) + Am1: 2012 (ed. 3.1) with North
American deviations (US+CA)
Medical electrical equipment - Part 1: General requirements for basic
safety and essential performance
IEC 60601-1-6:2010 (3rd ed.)
IEC 60601-1-6:2010 (3rd ed.) + Am1:2013
Medical electrical equipment - Part 1-6: General requirements for safety -
Collateral Standard: Usability including IEC 62366: Application of
usability engineering to medical devices.
IEC 60601-1-2:2007 (3rd ed.)
Medical electrical equipment - Part 1-2: General requirements for basic
safety and essential performance - Collateral standard: Electromagnetic
compatibility - Requirements and tests.
IEC 60601-1-3:2008 (2nd ed.)
IEC 60601-1-3:2008 (2nd ed.) + Am1:2013 (ed. 2.1)
Medical electrical equipment - Part 1-3: General Requirements for
Radiation Protection in Diagnostic X-Ray Equipment.
IEC 60601-2-63:2012
IEC 60601-2-63:2012 (1st ed.) + Am1:2017 (ed. 1.1)
Medical electrical equipment - Part 2-63: Particular requirements for the
basic safety and essential performance of extra-oral dental X-ray
equipment.
IEC 62304: 2006 (1st ed.)
IEC 62304: 2006 (1st ed.) + Am1:2015 (ed. 1.1)
Medical device software – Software life-cycle processes.
IEC60825-1:2007 (2nd ed.)
Safety of laser product - Part 1: equipment classification and
requirements.
EN-ISO 14971:2012
Medical Devices - Application of Risk Management to Medical Devices.
CAN/CSA-C22.2 No 60601-1:08
CAN/CSA-C22.2 No 60601-1:14
Medical electrical equipment - Part 1: General Requirements for Basic
Safety and Essential Performance.
ANSI/AAMI ES60601-1:2005/A2:2010
Medical electrical equipment, Part 1: General Requirements for Basic
Safety and Essential Performance.
CFR 21
Code Federal Regulation. Sub Chapter J.

USER'S MANUAL
0051 Guarantees the compliance of Rotograph EVO D with

Directives 93/42/EEC (as amended), 2011/65/EU,
2006/42/EC.
Classifications
Rotograph EVO 3D is an electrical medical X-ray device classified as
class I type B according to EN 60601-1, with continuous operation at an
intermittent load.
According to 93/42/EEC Medical Devices Directive, the equipment is
classified as class II B.
According to Canadian MDR, the equipment belongs to class II.
According to FDA 21 CFR, the equipment belongs to class II.

USER'S MANUAL
6.6 Note on constant magnification for Panoramic and

TMJ (mouth open/closed) examinations
NOTE:
Rotograph EVO D is based on a standard dentition and ascending rami
shape.
This shape, based on statistical studies, establishes a form for the
dentomaxillofacial complex, adopted as "standard".
Rotograph EVO D follows a rototranslation path which maintains
constant the magnification factor stated in the Technical Characteristics
of each type of exam along this "standard" shape only along the dentition
area. The patient’s anatomy can differ significantly from the statistical
model, so the magnification factor is not maintained and can be different
from the value stated. Based on his experience and competence, the user
has to judge this variation.
IN ANY CASE, THE RADIOGRAPHY IMAGES CANNOT BE USED TO

PERFORM CALCULATIONS OF DISTANCES, ANGLES ETC. ON THE
IMAGE.
WARNING:
The measurement of lengths on digital images depends on the specific
length calibration of the program used.
It is therefore very important to check the length calibration of the
program to obtain the measurement of the anatomical part.

USER'S MANUAL
6.7 Measurement method of technical factors

(paragraph for authorised personnel)
WARNING:
These measurements require the removal of the HF group covers; this
means to gain access to internal parts where high voltage are normally
present.
For the measurement of the exposure parameters with the invasive

method, please follow the procedure described in the Service manual.
WARNING:
During the panoramic examination, the set value of kV and tube current
varies according to a fixed curve, to compensate the variations in
absorption by the patient's tissues; in this way, it is possible to obtain a
good uniformity of the image contrast. In particular, the chosen value is
lowered during the initial phase, and increased on the canine/incisor
zone, in order to compensate the effect of greater attenuation owing to
the spine.
The value displayed during the panoramic examination corresponds to
the one chosen by the user, while the real value can be different; this fact
must be considered if the exposure parameters are checked using
standard diagnostic mode.
The accuracy of the exposure parameters kV and mA, stated in the
Technical Data section, refers to the accuracy compared with the
instantaneous value set by the system.
In any case, the manufacturer guarantees that the accuracy of the
exposure parameters is within the maximum limits required by
international regulations on the safety of medical devices IEC 60601-1
and attachments. In particular, in accordance with IEC 60601-2-63, the
maximum deviation (including correction and instrumental doubt) is less
than or equal to ±8% for kV, while for tube current it is less than or equal
to ±10%.

USER'S MANUAL
6.8 Verification method of technical factors

(paragraph for authorised personnel)
The exposure parameters (kV, time and dose) can be checked using the
so-called "non-invasive method".
WARNING:
The device collimator gives a narrow X-ray beam.
Measurements taken with a non-invasive instrument and a narrow beam
can be difficult and/or unreliable; it is therefore necessary to use a
special probe with a reduced sensitive area.
It may be helpful to use a fluorescent screen to locate the X-ray beam,
and consequently position the probe of the kV meter.
If the unit is ready to Ceph or is equipped with Ceph arm, place the kV
meter probe in the lower part of the sensor since the Ceph collimator
window is used in this function.
The procedure to measure the exposure parameters by a non-invasive kV

meter is the following:
1. With the unit switched ON, select the Panoramic Examination mode
by pressing the "Exam Mode Selection" area (11) .
2. Press the key "Service Menu" (18) ; the following image will
be displayed:
3. Select "Xray Menu".

USER'S MANUAL
4. Using the relevant increase/decrease arrows , select the
password equal to "72".
5. Confirm with key "Enter". The following image will be displayed:
WARNING:
The following operations involve the emission of X-rays, so the
Authorised Technician must pay the greatest attention and respect the
protection regulations in force in that country.
NOTE:
This program allows you to carry out the measuring of the exposure
parameters with the tube-head arm in a fixed position (not rotating)
without variation due to spine compensation.
6. Place the measuring instrument.

USER'S MANUAL
7. The kV, mA and s parameters can be modified by pressing the
increase key and the decrease key of the kV, mA and s on
the display.
8. Set the radiological parameters (kV, mA and s) as indicated in the

first three columns of the table below:
kV acceptance Time acceptance

kV mA s
range range
60 6 3 55.2 to 64.8 2.35 to 3.65
86 12 3 79.1 to 92.8 2.35 to 3.65
Table 1
9. Perform an exposure; technical factors can be read on the measuring

instrument.
NOTE:
The performance is guaranteed only if the measurement of kV and time is
done with the invasive method, due to the fact that non-invasive method
may introduce errors for instruments tolerance or wrong measurement
condition.
10. Press key "Home" to end the control program, the display will
visualize the "Service Menu". Pressing key (18) the unit will
return to standard mode.

USER'S MANUAL
6.8.1 Verification method of Panoramic X-ray beam centering and

dimension
1. On Dental Studio program, open a test patient used to make the test
images and select the "Panoramic" icon to open the virtual keyboard.
2. On the unit keyboard, press key "Service Menu" (18) ; the
following image will be displayed:
3. Select "Xray Menu".
4. Using the relevant increase/decrease arrows , select the
password equal to "172".

USER'S MANUAL
5. Confirm with key "Enter". The following image will be displayed:
6. Press the X-ray button and keep it depressed until the end of the
exposure.
7. On Dental Studio program, press "Accept Image", then "Yes".
8. On the "LUT" option, select button " " to improve the image
contrast and brightness.
Figure 8
9. Verify that the obtained narrow image of the X-ray beam is vertical
and centered in left/right direction and that there is a small
unexposed border in the bottom of the white sensor area.

USER'S MANUAL
At the end of the exposure the unit automatically exit the menu. To take
a new exposure, repeat steps from 1 to 8.
NOTE:
If the virtual keyboard display the message "SENSOR NOT READY", exit
from "Service Menu" and repeat steps from 1.

USER'S MANUAL
7. QUALITY ASSURANCE PROGRAM

Here following the list of the operation required to maintain the
continued proper functioning of the unit:
Frequency Type of check Done by Reference
Daily Laser alignment check User Paragraph 7.3
Monthly Image quality check User Paragraph 7.4
Yearly Dosimetry test Authorized Paragraphs

personnel 6.7 and 6.8

USER'S MANUAL
7.1 Quality check tools

The following tools are required to perform the quality check:
• Support plate (P/N 6195170100): used to check laser alignment and
to hold the centering tool (P/N 6195170200)
• Centering tool (P/N 6195170200): used to check image quality
• kV meter (NOT provided by Villa Sistemi Medicali S.p.A.): used to
measure exposure parameters.
Except kV meter, all these tools are provided with the unit.
Centering tool
(P/N 6195170200)
Support plate
(P\N 6195170100)
Figure 9: Support plate and centering tool positioning

USER'S MANUAL
7.2 External inspection

Check the following items:
• Check that the labels are complete and well fixed
• Check possible oil leaks from the tube-head
• Check that the X-ray button cable does not show breaking or wearing
signs
• Check that the unit is not damaged externally as to compromise the
safety of protection from radiation.
In case of fault or abnormalities, call technical assistance.
7.3 Laser alignement check

Power ON the unit and perform the axis reset by pressing the
key "Patient Entrance" (6) .
At the end of the axis positioning, place the support plate (P/N
6195170100 – Figure 9) on the chin rest support and power ON the laser.
Check that the mid-sagittal laser beam is aligned to the reference line of
the support plate (± 3mm).
Laser correctly aligned Laser misaligned

Figure 10
In case the test fails, repeat it checking that were is no mechanical

interference. If misalignment is still present, call technical assistance.

USER'S MANUAL
7.4 Image quality check
WARNING:
X-rays will be emitted during the performance of the following operations.
It is recommended to use the greatest caution and comply with local
safety regulation and laws.
1. Switch ON the unit and go to Exam Selection.

2. On Dental Studio program, open a test patient used to make the test
images and select the "Panoramic" icon to open the virtual keyboard.
Figure 11
3. Select a Panoramic STD exam.
Figure 12

USER'S MANUAL
4. Place the centering tool (P/N 6195170200) on the support plate (P/N
6195170100) and place it on the chin rest (Figure 9).
5. Make an exposure in Adult mode at 60kV - 6mA, acquired in the
DentalStudio program.
6. Set contrast and brightness level to have good visibility of all
centering balls. Select from the menu "Measure" (Figure 13) the icon
"Single" and measure the dimension of the image using as reference
the two external balls. The image has to be 191mm ± 2mm with
Panoramic STD trajectory selected.
Figure 13
7. Measure also the two half of the image in order to check symmetry.
The difference has to be max. 2mm.
Figure 14

USER'S MANUAL
WARNING:
The declared image magnification value is valid after proper software
calibration.
In case the measured values are out of tolerance, call technical assistance.

USER'S MANUAL
General instructions for use
8. GENERAL INSTRUCTIONS FOR USE
8.1 Control panel – description and functions

The Rotograph EVO D keyboard is divided into function areas.
The next figure shows a general view of the control interface, while details
on each functional area are provided in the following pages.
"Exam mode Messages display

selection" area
USB Pen Drive"
"Test" button button
"Service menu"
button "Acquisition
mode" button
Led signalling
type of device
connected "Exposure mA
variation" button
"Exposure kV
variation" button
"Type of biting
"Size Selection" selection" button
button
"Adult/Child
selection" button
"Centering device
ON" button
"Centring/ Patient "Column movement"

Entrance" button button
Light signalling Light signalling
"X-ray in progress" "Ready for X-rays"
Figure 15
WARNING:
The USB port on the keyboard MUST NOT be used with an external Hard
Disk with own mains connection. It has to be used only with USB Pen
Drives.

USER'S MANUAL
The next figure shows a general view of the display of the Service menu.
Figure 16
Here following a sample description of each key functionality:

• Image viewer: enabled only when the USB Pen Drive is present
in the relevant port
• Save parameter: allows to store the automatic exposure
parameters (see paragraph 8.14)
• Exam counter: allows to display the numbers of exam
performed in each exam mode
• Network info: allows to display the IP addresses and SubNet
mask of the devices connectet to the Network
• Software revision: allows to display the software revision of the
Rotograph EVO D system microcontroller
• Graphic Custom, XRay Menu and Save CPU date (not active):
these keys are reserved to authorised personnel.
Press key "Home" to go back to the "Service Menu".
Pressing key (18) the unit will return to standard mode.

USER'S MANUAL
The "Centring/Patient Entrance" key is

used to:
- start/stop the examination
procedures
- bring the rotation arm to the
patient entrance position at the end
of the exam.
The "Exam Selection Mode" area takes

place by means of three keys: the first
one, the main area, helps select the
exam mode between Panoramic, TMJ,
Sinus, Implant and Cephalometric.
The other two, identified by the arrows,
help navigate within the exams of each
mode.
Child
It is possible to select the anatomic

mode examinations (anatomic Adult
selection), using prefixed exposure
values.
This kind of selection enables to choose Large
between Adult/Child, each with three
different sizes (small, medium, large).
Medium
Small
The Panoramic mode enables to select

the patient's type of biting between: Protruded
protruded, standard or retracted, as
indicated within the button.
The arch selection does not influence Standard
the values of kV and mA but acts on
the position of the focus layer.
Retracted

USER'S MANUAL
Furthermore there is the possibility to

manually select the exposure
parameters; in this case, it is possible
to set the parameter with the desired
value.
The parameters available are: kV and
mA (Soft Tissue Filter position only in
cephalometry).
There are two light indicators; the first

one on the right indicates the condition
"Machine Ready", indicating the user
that by pressing the X-ray button key
once more, X-rays emission will start;
the second indicates the effective
emission of X-rays.
The movement of the column is

controlled by the appropriate keys.
The speed has two set values.
The movements are enabled during
equipment setting.
The key "Luminous centring device"

helps turn ON/OFF the laser centring
devices that allow the correct
positioning of the medial-sagittal and
Frankfurt planes, by adapting
Rotograph EVO D to the patient's
anatomy.
The key "Test" is used to avoid the

X-rays emission, in order to check the
absence of collisions with the patient.
When the LED is green, the test
function is enabled.

USER'S MANUAL
This key displays the "Service Menu":

the main menu area is replaced by the
service menu area.
Use this key also to return to the
control panel (main menu).
This key is used to un-mount the Pen

Drive inserted in the USB connector of
the control panel.
When the LED is green, the pen drive is
recognised.
In Cephalometric mode, this key allows

to perform the exam in High Definition High Definition
modality or in High Speed (normal
resolution) modality.
High Speed

USER'S MANUAL
8.1.1 Key function description
5 11
18 Display
19 17
20
21 7
12 13
3 3
4 10
9
15
8
14
6
16
2 1
Figure 17 - Control panel
LEGEND:
Messages Anatomic selection
Display: indicates operative messages and warnings 8 - Patient selection key: Adult or Child
9 - Size selection key: Small, Normal, or Large
Signal lights 10 - Arch selection key: Protruded, Standard or
1 - Light indicating the machine is ready for X-ray Retracted (for panoramic execution)
emission (green LED)
2 - Yellow LED indicating X-ray emission Examination mode
11 - Exam mode selection area
Manual setting of exposure parameters 12 +13 - Type of exam selection keys
3 - kV/mA increase key
4 - kV/mA decrease key Centring devices
14 - Sagittal and Frankfurt plane centring device
Preparation functions ON/OFF key
5 - Key to set Test function
(green LED) Column height adjustment
6 - Key for: 15 - Column up key
> Resetting and realigning the device's axes (in 16 - Column down key
case of collision with patient or in case of
release of rays button) Other
> Repositioning the rotation group (to bring the 17 - USB Pen Drive key
group to the initial position after the examination 18 - Service menu key
and to exit from the "making an exposure") 19 - Virtual keyboard active (green LED)
mode 20 - Presence of PAN only sensor (only for dual sensor
> Confirmation unit) (green LED)
7 - Key to select the modality in use (High 21 - Presence of sensor (green LED)
Definition or High Speed)

USER'S MANUAL
8.1.2 Pen Drive function description
NOTE:
If pen drive is inserted and virtual keyboard is open, the image will be
acquired and displayed only on the computer.
In case of use of the pen drive, it is necessary to close the virtual
keyboard on the computer.
A pen drive can be inserted in the USB port at the top of the control
panel. The pen drive has to be formatted in FAT32 (not in NTFS; please
refer to your Windows Manual and help for more information on
formatting).
As soon as the pen drive has been inserted, the unit will verify it.
• If the pen drive is formatted with the right file system and there is
enought free space available to save at least one image, the green
LED of the "USB Pen Drive" key (17) light ON.
• If the pen drive is not formatted with the right file system or if there
is not enought free space available to save at least one image, the
LED will not turn ON.
Please verify that there is enough free space on the pen drive, if not
please free up at least 25 MB of space. Plase verify that the pen drive
has been formatted with the FAT32 and not with the NTSF (or Linux
or Mac) file system, if not please use another pen drive or reformat
the pen drive with the correct file system.
WARNING:
Make sure, before reformatting a pen drive, to copy all the data it
contains onto your harddisk or CD/DVD; once the pen drive is
reformatted all data on it will be irreparably lost!
• Once an image has been completely acquired and displayed on the

touch screen, before to extract the pen drive from the control panel
press key "USB Pen Drive" (17) and wait until the green LED switch
OFF.

USER'S MANUAL
8.1.2.1 Acquired image display description
NOTE:
The image displayed on the touch screen can not be used for
diagnostic purposes.
Once an image has been acquired, it is written on the USB pen drive and
displayed on the touch screen.
During acquisition, the image is progressively displayed on the screen,
adjusted to have the whole image in the screen.
As soon as the image is acquired and fully processed, it is displayed on
the screen of the control panel.
The image can be zoomed in and out on, using keys and .
Key returns to the full view.
When the image is zoomed in on, it is possible to move around the image
to display parts of the image that are not visible on the screen; this can
be done using a stylus or using a finger.
Key returns to the control panel, allowing for the acquisition of a
new image.
Use keys and to scroll the image present in the pren drive.

USER'S MANUAL
8.2 Digital Sensor

Rotograph EVO D is equipped with two types of digital sensors,
depending on the version:
• Sensor PAN: it is a sensor suitable for Panoramic-type imaging, i.e.
all images with a 15cm-high field; all Panoramic, TMJ, Sinus and
Implant images belong to this type. Depending on the version, this
sensor can be either movable from the sensor holder, or fixed (not
removable) on the same holder. In case the sensor is fixed to the
sensor holder, the latter cannot be rotated to make free the part
where rays go through for the execution of the cephalometric
examination.
• PAN/CEPH sensor: it offers a wider use flexibility, as it can carry out
both Panoramic and Cephalometric-type images. This sensor can
always be removed from its sensor holder's.
Rotograph EVO D can also be configured in the "double sensor" version,

where both PAN and PAN/CEPH sensors are present.
Rotograph EVO D control system takes care of checking the consistency

of the safety measures that allow for the correct use of the digital sensor;
in particular:
• To prevent the acquisition in case the image management and
processing system is not ready to receive the image itself, by
displaying the message "Sensor not ready"
• To prevent the CEPH exposure in case the PAN sensor is in the CEPH
position, by displaying the message "Sensor not on Ceph"
• To prevent the exposure in case, when a double-sensor system is
present, the PAN sensor holder is not completely open, allowing the
clearing of the X-ray beam path. The message "Open cassette holder"
is displayed.
NOTE:
All sensor types are equipped with a shock detection sensor; this sensor
is also visible from the outside to enable to operator to perform checks.
Possible shocks are displayed by a change in colour (from
transparent/white to red) of this sensor. The digital sensor can still
function correctly also when the colour changes, displaying a fall that
might also not have damaged the sensor.
NOTE:
The fall sensor colour change interrupts the warranty on the sensor.

USER'S MANUAL
8.2.1 Inserting the sensor in the sensor holder
The digital sensor is equipped with a handgrip used to safely transport

the sensor from one holder to the other, in order to minimise the risk of
fall. The system used to hook the mobile sensor to the holder is also
engineered to reduce the sensor's risk of fall due to failure to hook the
sensor and/or due to early release.
Inside the transport handgrip there is a lever that controls the sensor's
hooking and release operations; at the same time, this lever works on the
electronic connector in order to guarantee the correctness of the
connection operations. On the fixed part of the sensor holder, there are
two hooks that need to be inserted into the corresponding gaps on the
mobile part of the sensor. On this latter, metallic plugs have been
mounted which, by joining in the corresponding fixed part, guide all
parts to a position suitable for the execution of a safe and stable contact.
In order to insert the sensor in the desired station, carry out the following
operations:
1. Grip the sensor by the appropriate handgrip; close your fingers to
form a fist, by engaging the control lever and bring it to the position
where the same disappears inside the handgrip, so that the whole
mobile system retracts.
2. Keep the sensor with the relative handgrips vertical, so that the
upper plane is parallel to the horizontal part of the sensor holder,
bring the sensor close to the fixed station, by engaging the protruding
part of the mobile sensor into the relative casing.
3. Push the sensor mobile part to the very end, in order to engage the
mobile part onto the fixed hooking system.
4. Carry out a movement towards the lower part, ensuring that the
movement is complete.
5. Only at this point, release the hooking lever, checking that the
sensor is correctly engaged before releasing the handgrip.
WARNING:
During the lever releasing operation, hold the sensor firmly, to prevent
the sensor from falling during the insertion phase due to possible errors.
NOTE:
In case of single sensor unit, moving the sensor from PAN to CEPH
position or viceversa, it is necessary to wait about 40 second (LED 20/21
light ON) before to start the device alignment phase pressing key "Patient
Entrance" (6) .
Faster pressure may provide "SENSOR NOT READY" error.

USER'S MANUAL
8.2.2 Release of the sensor from the sensor holder
The operations for releasing the sensor from the relative sensor holder
are specular to the ones described for the hooking of the same.
1. Grip the sensor by the appropriate handgrip; close the fingers to form
a fist, by engaging the control lever and bring it to the position where
the same disappears inside the handgrip, so that the whole mobile
system retracts and the electronic connectors and the reference plugs
are completely released.
2. Grip firmly the handgrip, and move towards the upper part of the
digital sensor, in order to free the mobile part from the hooking
system.
3. By keeping the sensor with the upper part parallel to the relative
horizontal part, carry out a horizontal movement in order to free the
protruding part of the sensor from the relative casing of the sensor
holder, disengaging thus the hooking system.
4. Always gripping firmly the sensor, in order to avoid accidental falls, it
is possible to freely move the sensor to the desired position.

USER'S MANUAL
8.3 Switching ON and OFF the device
WARNING:
The unit must be connected to a differential magneto-thermal switch to
divide the unit from the supply. This switch must comply the electrical
regulations in force in the country of installation.
Minimum requirements at 230V: working voltage 250V, current 10A and
differential current 30 mA.
Minimum requirements at 115V: working voltage 150V, current 25A and
differential current 30 mA.
Press the green button on the base of the column to switch the system
on; the display shows the starting image:
This image will be present for about 1 minute.

After this time the "Ready for X-ray" and the "X-ray emission" LEDs blink
two times and on the display will be present the Villa logo.

USER'S MANUAL
NOTE:
During this phase, Rotograph EVO D does not perform any movement, it
just performs a series of checks which, in the event of negative result,
could require the intervention of the technician.
The only problem that can be solved by the user is related to the position
of the PAN sensor holder; in this case, the following message will be
displayed:
" CLOSE PANO SENSOR HOLDER "
When the self-diagnosis is completed, the following appears on the

display:
" MACHINE SETTING – Press >0< "
Press key (6) to start the device alignment phase.
Once the key has been pressed, the message disappears and the display
shows the following message during the alignment of the axes:
" WAIT FOR MACHINE SETTING "
WARNING:
During equipment axis zero reset, check that the unit does not collide
with external objects.
After 3 seconds, the following configuration will be automatically set by

the system:
• ADULT with the display of the corresponding graphic in the button
• MEDIUM SIZE with the display of the corresponding graphic in the
button
• NORMAL DENTITION with the display of the corresponding graphic
in the button
and the display shows (for instance):

USER'S MANUAL
When the connection with the digital sensor is properly established, the
equipment is ready for exposure.
NOTE:
The above mentioned position is chosen also in the event that, for any
reason, the device repeats the initialisation phase.
To switch OFF the unit press the green button on the base of the column.
The display and the LEDs will go off.

USER'S MANUAL
8.4 Positioning of chin support

Rotograph EVO D is equipped with three types of supports: a standard
support fitted with a special removable appendix for edentulous patients,
one (lowered) for SINUS examinations and a third one, to be used for TMJ
examinations.
The standard chin support must be used, in Panoramic mode, with all
the people who can assure a tight grip on the centring bite. The appendix
for edentulous patients must be applied only for patients who cannot
assure a tight grip on the bite or are not co-operating and might move
during the examination.
For the SINUS examination, the chin support is made by lowered chin
rest and appendix for edentulous patients.
For TMJ examinations, a specific positioner is included, allowing the
patient to open and close the mouth without touching any positioner
with the chin.
NOTE:
A fourth chin support, at a low height for Panoramic, is provided to
ensure a better view of the lower section of the chin for patients with
particular anatomy.
This chin support is marked by a down arrow "▼" on the front of the chin
support itself.
Standard Panoramic chin support Appendix for edentulous patients

(code 6104011519+5407098200) (code 5407098119)
SINUS chin support

(code 6104011619+5407098200)
TMJ positioning support
(code 6104011800)

USER'S MANUAL
NOTE:
For the Implant examination, specific bite blocks are used to position the
patient.
Always remove the chin support when performing Ceph examinations.

USER'S MANUAL
8.5 Panoramic examination

When making a panoramic examination, the tube-head support arm
(X-rays generator) makes a continuously rotating movement.
During the examination, the patient's centring is assisted by two linear

luminous laser beams, which indicate the position of the sagittal medial
plane and the Frankfurt plane; the corresponding patient's planes need
to be aligned with these planes. The latter is held in place, during the
examination phase, by means of temple clasps rods and of a forehead
support. A fourth fixing point is determined by the chin support.
45
46
Legend of Reference Lines
45 Mid-Sagittal line
46 Frankfurt plane line: plane that identifies a line that ideally connects the hole in the auricular
canal - external auditory meatus - with the bottom edge of the orbital fossa
Figure 18

USER'S MANUAL
8.5.1 Device preparation
NOTE:
In case of single sensor unit, moving the sensor from CEPH to PAN
position, it is necessary to wait about 40 second (LED 20/21 light ON)
before to start the device alignment phase pressing key "Patient
Entrance" (6) .
When the unit is switched on, the Panoramic Examination is selected as

standard. If the operator has previously made another kind of
examination, to select Panoramic press "Exam Mode Selection" area
(11) until the following image is displayed:
The system positions itself with the following configuration:

• ADULT with the highlight of the corresponding graphic in the button
• MEDIUM SIZE with the highlight of the corresponding graphic in the
button
• NORMAL DENTITION with the highlight of the corresponding graphic
in the button
and the display shows the default exposure parameters (if this is the first
panoramic exposure), or the exposure parameters (kV and mA) of the last
exposure performed.

USER'S MANUAL
Pressing key (8) to change from Adult to Child, the
display will show:
Once the settings have been completed, the chin support must be placed
in position (see paragraph 8.4).
The "Exam Mode Selection" (11) area enables the selection of specific
submodes, selectable by means of the keys "Arrow right" (13) and "Arrow
left" (12), enabling the sliding in one direction or another.
Previous examination Next examination
For the Panoramic examination, the system is factory set with two
different trajectory: EVO Panoramic and Panoramic STD. The EVO
Panoramic is more tolerant towards typical errors of patient positioning,
thanks to an enlarged focal layer in the region of the frontal dentition.
During installation it is possible to select as first the most used trajectory
type or enable only one of them (refer to Service Manual - Password 92
menu – Pano order submenu).
Where the option EVO XP (Extended Projection Package) is enabled, the

following selections are possible:
EVO Panoramic -> STD Panoramic -> Right Emi-panoramic ->
Left Emi-panoramic -> Improved orthogonality dentition ->
Reduced dose Panoramic -> Frontal dentition -> Bitewing Right ->
Bitewing Left -> Bitewing RGT,LFT -> EVO Panoramic.
This selection is cyclic, so pressing the button repeatedly will change the
selected mode.

USER'S MANUAL
• Right / Left Emi-panoramic

The Emi-panoramic mode, right or left, means that only the
corresponding half arch is irradiated; the emission will start from the
beginning, to just after the mid sagittal plane for the right part. For
the left, it will start just before the mid sagittal plane and continue
until the end of the rotation.
These two kinds of examinations are usually used when it is already
known that the patient has a problem on only one half of the arch, so
it is possible to reduce the irradiation of the patient.
To position the patient, follow the instructions given for the

Panoramic examination.
• Reduced dose Panoramic

The reduced dose Panoramic examination makes an X-ray only of the
dental arch, excluding from the image the ascending rami of the
temporo-mandibular joint; the examination is performed with the
same trajectory of the standard Panoramic, by reducing the rays
emission time.
This examination is used, for instance, during the treatment
continuation phases or where the lack of pathologies of the same
joint is already known.

• Improved orthogonality dentition

The improved orthogonality Panoramic delivers the image of the pure
dental arch cutting out from the image the ascending rami branches
of the temporo mandibular joint; the trajectory of the rotating arms
is, however, optimised for a better orthogonality between the X-ray
beam and the incident sections of near teeth.
Thus the image has reduced overlapping of the teeth, improving the
diagnosis of interproximal decay.
As a consequence of the different trajectory, the focus layer, mainly

in the front teeth area, is smaller and the patient positioning for this
examination needs more care.


USER'S MANUAL
• Frontal dentition
The Frontal dentition examination performs an X-ray of the dentition
frontal area (roughly from canine to canine).

• Bitewing
The Bitewing examination, left or right, allows the execution of
examinations of the lateral dentition (generally from eighth to fourth).
The trajectory of the rotating arms is, however, optimised for a better
orthogonality between the X-ray beam and the incident sections of
near teeth.
Thus the image has reduced overlapping of the teeth, improving the
diagnosis of interproximal decay.
Bitewing right and left sequentially perform both Bitewing,
supporting them on the same image.

NOTE:
shape.
This shape, based on statistic study, establishes a form for the
dentomaxillofacial complex that it is assumed as "standard".
Rotograph EVO D follows a rototranslation path which maintains
constant the magnification factor stated in the technical characteristics
of each type of exam along this "standard" shape and in the dentition
area. The patient’s anatomy can differ significantly from the statistical
model, so the magnification factor is not maintained and can be different
from the value stated. Based on his experience and competence, the user
has to judge this variation.

PERFORM CALCULATIONS OF DISTANCES, ANGLES ETC. ON THE
IMAGE.
WARNING:
program.
In Panoramic examination, to obtain the measurement of the anatomical
part, taking into consideration the enlargement factor, the length
calibration factor is 100 pixels = 6.5 mm (in the centre of the focus layer).

USER'S MANUAL
8.5.2 Anatomic / manual exposure
NOTE:
If the previous exam was carried out manually, just press the "Exam
Mode Selection" area (11) to change to Anatomic exposure.
After setting the machine, it is possible to choose between the following

two operating modes:
• ANATOMIC: with the values of kV and mA programmed on the basis
of the type of patient and the size.
• MANUAL: with the possibility to vary the kV and mA values already
set.
NOTE:
In manual mode, the kV and mA parameters values are displayed in
green color.
It is possible to press key (8) to change from Adult to
Child and press key (10) to modify the type of biting
from Normal to Protruded to Retracted; the setted parameters values

remain the same.

USER'S MANUAL
8.5.2.1 Anatomic exposure
Select the type of patient with the Adult/Child key (8).
Select the type of build with the Size (9) key (small - medium - large).
On the basis of these selections, the display will visualise the kV and mA
settings as in the tables.
Exposure values in Panoramic mode
Adult Patient Child Patient

kV mA kV mA
Small 70 8 66 8
Medium 74 8 68 8
Large 76 8 70 8
Table 3
NOTE:
The exam parameters set as the default are values to be taken as the
starting point. Users can optimise the parameters according to their
needs.
Select the type of biting with the arrow key "Type of Biting Selection"
(10) .
NOTE:
The type of biting does not affect the kV and mA values, but it affects the
position of the focus layer, by adapting the rotation movement to the
patient's anatomy.

USER'S MANUAL
8.5.2.2 Manual exposure
If the kV and mA combinations of the Table 3 are not considered suitable

for a specific examination, it will be possible to set new parameters using
the manual mode.
To modify the kV or mA values, press any of the increase (3) or
decrease (4) arrows of the kV or mA parameters; the values
change their color from black to green.
A parameter can be modified by pressing the increase key (3) and the
decrease key (4) of that paramenter repeatedly.
The kV value can vary between 60 and 86 kV, with 2 kV steps.
The value of mA can vary between 6 and 10 mA, with 1 mA steps.
NOTE:
To change the values rapidly, keep the increase key (3) or decrease key
(4) pressed.

USER'S MANUAL
8.5.3 Patient preparation
1. Ask the patient to remove all metallic objects located in the area to be
X-rayed (necklaces, earrings, glasses, hairpins, removable dental
prosthesis, etc.). Ensure that there are no thick garments in the area
to be X-rayed (coats, jackets, ties, etc.).
2. Ask the patient to put on the protective apron, or something similar,
making sure that it does not interfere with the trajectory of the X-ray
beams.
3. Place the patient in a standing position at the chin support.
With the keys "Column movement" (15/16) lift/lower
the column until the chin support is aligned with the patient's chin.
WARNING:
During the patient positioning, make sure the equipment can not collide
with any objects in the room.
4. Position the patient with the temple clasps (Figure 19) ensuring that
the chin rests on the special support; the hands should rest on the
front handles. Ask the patient to bite the reference notch of the bite
with his incisors. In case of edentulous patients, he/she must rest
the chin against the reference shoulder of the edentulous chin
support.
5. Instruct the patient to close his eyes.
6. Press the key "Centring devices ON" (14) .
Two laser beams will light up the sagittal medial plane line and the
horizontal line for the Frankfurt plane reference (the plane that
identifies a line that ideally links the ear hole - the auditory meatus -
with the lower part of the orbital fossa in Figure 18). Position the
patient's head in such a way as to ensure that the luminous beams
fall in correspondence with the respective anatomical references.
The luminous beam of the Frankfurt plane can be adjusted according
to the patient's height; this can be adjusted by means of the laser
knob on the side of the mirror.

USER'S MANUAL
NOTE:
The laser centring devices remain on for approximately 1 minute;
shutdown can be anticipated by pressing the "Centring Device On" key
(14) or, with alignment complete, by pressing the "Patient entrance" key
(6) to begin preparation for exposure.
4
3
45
46
2

45 Sagittal medial line
46 Frankfurt plane line
Legend positioning devices and patient centring

1 Panoramic chin rest
2 Centring bite
3 Forehead support closing/release knob
4 Temple clasps closing/release knob
Figure 19: Panoramic positioning

USER'S MANUAL
7. At this point, the patient must move his feet towards the column,
making sure to keep his head within the pre-aligned anatomical
references. In this way, you will have a greater extension of the spine
in the cervical area, improving the darkening of the X-ray in the
apical area of the incisors, and avoiding the collision of the tube-head
with the patient's shoulders. Check that the Frankfurt plane is still
horizontal.
8. Close the temple clasps (Figure 19) to help the patient keep a correct
position; bring also the forehead support close to the patient's
forehead and ensure that, in this phase, the patient has not changed
position.
9. Press the key "Patient Entrance" (6) to confirm the
parameters. The luminous centring devices switch off and the

rotating arm goes to its examination start position.
Once alignment has been completed, the following message will be
displayed:
" EXAM INIT "
The green LED "Ready for X-ray" lights up to indicate that pressing
the X-ray button once more will start the radiation phase.
10. Ask the patient to: keep the lips closed, bring the tongue
towards the palate, keep perfectly still and do not look at the
rotating arm during the movements.

USER'S MANUAL
8.5.4 Making an exposure
NOTE:
When the key "Test" (5) is pressed the Test function is activated.
In this condition, it will be possible to make the unit perform all the
movements made during the examination without emitting X-rays.
Once the cycle is completed, deactivate the "Test" function by pressing
the key again.
WARNING:
During the emission of X-rays, the protection procedures for the operator
and personnel in the area must be in compliance with the local
regulations.
In all cases, it is recommended that during the emission of X-rays, only
the patient and operator be present in the room. If the operator is not
protected by suitable screens, he must stand at least 2 meters away from
the emission of the rays (see the Figure 1 and Figure 2).
1. Verify once again that the exposure data are correct. If not, correct
them as described in paragraph 8.5.2.2; ensure that the machine's
indicator light "Ready for X-rays" will come on, so press the X-ray
button for the entire duration of the exposure, checking the
simultaneous working of the X-ray indicator light "X-rays emission"
(if you are within sight of the machine) and the acoustic ray signal.
The following message will be displayed first:
" PRE-HEATING "
and then (after 2 seconds), the following message will be displayed:
" X-RAY "
NOTE:
If the machine is in the "Test" mode, the display will show:
" TEST X-RAY NOT ACTIVE "

USER'S MANUAL
NOTE:
If message:
" DIGITAL SENSOR IS NOT READY "
is present on the display, it means that the Digital Sensor is not properly
inserted or configured.
If message:
" ERROR NO MEDIA ACQ VERIFIED "
is present on the display, it means that none of the possible acquisition

media (virtual keyboard on the PC or USB Pen Drive) is enable.
LEDs 19 and 20 or 21 (Figure 17) indicate the status of connection.
To reset the message on the Rotograph EVO D, press key .
NOTE:
The rotation of the arm and the emission of the X-rays will start with a
delay of 2 seconds from when the X-ray button is pressed. Since the
X-ray button is a "dead man's switch", it must be kept pressed until
the end of the exposure.
2. Once the exposure is completed, the system will rotate back. When it
has completed this movement, the display shows the message:
" PATIENT EXIT – Press >0< "
and it will be necessary to free the patient from the positioning

device.
NOTE:
If the examination is made in "Test" mode with the patient already in
position, he must not be removed from the temple clamp, to avoid having
to reposition the patient.
Press the "Patient entrance" key (6) : the unit will move back to
the starting position.

USER'S MANUAL
NOTE:
The keyboard is disabled during the movement of the system, but by
pressing the "Patient entrance" key (6) , the movement is stopped.
This operation is useful in case a movement anomaly is noticed.
Press the "Patient Entrance" key (6) to reset the error condition.
3. Press the key "Patient Entrance" (6) , the unit will move back
to the starting position showing the message:
" AXIS POSITIONING PLEASE WAIT… "
The Digital Acquisition System will, in the meantime, process the

image and display it.
NOTE:
In case the acquisitions process can not be completed by the acquisition
software, it is possible to recover a copy of the image in the directory
C:/temp/.
To display the image, open the virtual keyboard and press the USB icon;
a file explorer window will open: select the folder C:/temp/ and select the
TIFF file named with the exam date (i.e. YYYY_MM_DD_HH_mm_ss.tiff).
NOTE:
If you try to perform a new exam before the cooling period has elapsed,
the following message will be displayed indicating the time to wait before
performing a new examination:
" TUBE COOLING… PLEASE WAIT: xxx s "
The waiting time allows the anode in the radiogenic tube to cool down.
WARNING:
After every examination, clean the chin support, the handles and
the temple clasps group thoroughly and change the centring bite or
the bite protective sleeve.

USER'S MANUAL
NOTE:
If, during the exposure, the patient moves, or the machine collides with
the patient himself (or with any object), or you realise that the
parameters set are not correct, you must release the X-ray button
immediately, interrupting the emission of X-rays and the movement of
the arm.
If this occurs, the following message will be displayed:
" ERROR: 206 PRESS >0< "
All the motors will switch off, and it will be possible, if necessary, to
manually rotate the arm, allowing the patient to come out; it is
recommended that this movement has to be made with great care in
order to prevent damage to the machine.
Then press the "Patient Entrance" (6) key and the display will
show:
and then:
The system now returns to its initial position and the patient must be
repositioned.

USER'S MANUAL
NOTE:
During the Panoramic, the value of the exposure parameters varies
according to a fixed curve, to compensate the variations in absorption by
the patient's tissues. In this way, it is possible to obtain a good
uniformity of the image contrast. In particular, the chosen value of the
kV is lowered in the initial and end sections of the panoramic and
increased on the incisors/canine zone.
The tube current varies according to the kV, also if the set value is
slightly increased on the initial/end sections. These variations have the
effect of compensating the higher absorption of X-ray in the zone of the
spinal column. As an example, the variation of the parameters follows the
curve below:
Set value Actual value kV
Actual value mA
The values displayed during the panoramic examination correspond to

the ones chosen by the user, while the real value in the various positions
of the examination cycle can be different; in any case, the system
guarantees that the accuracy of the exposure parameters is always
within the limits set by the international standards for the safety of
medical devices, IEC 60601-1. In particular, in accordance with IEC
60601-2-63, the maximum deviation (including correction and
instrumental doubt) is less than or equal to ±8% for kV, while for tube
current it is less than or equal to ±10%.

USER'S MANUAL
8.6 TMJ examination

The TMJ examination with open or closed mouth is similar to panoramic;
the only difference is that the exposure is performed only on the involved
area (the temporo mandibular joint), then it stops, and starts again on
the second joint. The operation sequence of the examination is therefore
identical to the one described for the panoramic.
The temporo-mandibular joint examination makes use of a projection

geometry giving an image of the X-rayed condyle along a direction almost
parallel with its major axis, in order to achieve a clear view of its
positioning inside the cavity.
This TMJ function enables to obtain 4 different acquisitions on the same
image, by performing two rotational movements. The 4 images represent
the right and left condyle of the temporo-mandibular arch (TMJ) with
closed mouth and open mouth.
Selecting close mouth exam only the external sectors of the image are
exposed, while selecting open mouth exam, the exposure occurs on the
inner sectors.
The position of the images couples the images corresponding to the same
condyle to help a diagnosis. Figure 20 shows the information related to
the single sectors.
RIGHT condyle with RIGHT condyle with LEFT condyle with LEFT condyle with
closed mouth open mouth open mouth closed mouth
1st exposure 3rd exposure 4th exposure 2nd exposure
R L
Figure 20

USER'S MANUAL
NOTE:
During the TMJ examination, the emission of X-rays is intermittent (it is
interrupted during the transition phases between the various exposures),
but it is necessary to keep the X-ray button pressed for the whole
rotation time.
Do not release the X-ray button during the emission interruption if not
necessary.
The cooling phase of the tube-head occurs at the end of all 4 exposures.
In the CHILD position, exposure start is delayed by a few degrees with
respect to the ADULT position.

USER'S MANUAL
NOTE:
Entrance" (6) .
To select the TMJ examination, press "Exam Mode Selection" area
The system is positioned in the following configuration:

button
and the display showing the default exposure parameters (if this is the
first TMJ exposure), or the exposure parameters (kV and mA) of the last
exposure performed.

USER'S MANUAL
display will show:
Once the settings have been completed, the chin support must be placed
in position if it has been removed (see paragraph 8.4).
NOTE:
shape.
This shape, based on statistical data, establishes a standard shape for
the dentomaxillofacial complex, defining also the position and the
direction of the condyles. The patient anatomy can differ significantly
from the statistical model; based on his experience and competence, the
user has to judge this variation.
PERFORM CALCULATIONS OF DISTANCES, ANGLES ETC.
WARNING:
program.
In TMJ examination, to obtain the measurement of the anatomical part,
taking into consideration the enlargement factor, the length calibration
factor is 100 pixels = 6.75 mm (in the centre of the focus layer).

USER'S MANUAL
8.6.2 Anatomic / Manual Exposure
NOTE:

set.
NOTE:
green color.
Child, the setted parameters values remain the same.

USER'S MANUAL
On the basis of the selections made, the display will visualise the kV and
mA settings as in the table.
Exposure values in TMJ examination (9.7 sec)
Examination Adult Child

TMJ mouth closed/open kV mA kV mA
Small 70 8 62 8
Medium 74 8 66 8
Large 78 8 70 8
Table 4
The time (9.7 sec.) refers to the sum of the four exposures (2 closed
mouth exposures and 2 open mouth exposures).
NOTE:
needs.

USER'S MANUAL

the manual mode.
decrease key (4) of that parameter repeatedly.
NOTE:
(4) pressed.

USER'S MANUAL
8.6.3 TMJ closed mouth
8.6.3.1 Patient preparation
beams.
3. Place the patient in a standing position at the TMJ positioner.
With the keys "Column movement" (15/16) lift/lower
the column until the TMJ positioner is aligned with the patient's
nose.
WARNING:
4. Position the patient with the temple clasps (Figure 21) asking him to
place his hands on the front support.
with the lower part of the orbital fossa in Figure 18).
Using as reference the sagittale medial plane laser, position the
patient's head in such a way that the sagittal medial plane is lit by
the corresponding laser beam as in Figure 21.
The reference of the Frankfurt plane can be used to make sure the
head of the patient is remaining in the same position when
examination is taken with eighter open or closed mouth.

USER'S MANUAL
NOTE:
45 Midsagittal line
4
3
Legend positioning devices

and patient centring
1 TMJ positioner
45 3 Forehead support
closing/release knob
4 Temple clasps
1
Figure 21 – TMJ closed mouth positioning
7. Close the temple clasps and bring the forehead support close; this
will help the patient to stay in a correct position. Check that, during
this phase, the patient has not changed position.
8. Press the key "Patient Entrance" (6) to confirm the
parameters. The luminous centring devices switch off and the

rotating arm goes to its examination start position. Once alignment
has been completed, the following message will be displayed:
" EXAM INIT "
The green LED "Ready for X-ray" lights up to indicate that pressing
the X-ray button once more will start the radiation phase.
9. Ask the patient to: keep the lips closed, keep perfectly still and
do not look at the rotating arm during the movements.
USER'S MANUAL
8.6.3.2 Carrying out the first exposure (mouth closed)
WARNING:
regulations.
NOTE:
If deemed necessary, it is possible to check the interference of the
rotation movement with the shoulder of the patient; it is possible,
by pressing the key "Test" (5) , to activate the Test function.
In this condition, it will be possible to make the machine perform all the
movements made during the examination, but without emitting rays.
The test function of the TMJ closed/open mouth is the same as for the
panoramic mode and so there will not be a second rotation corresponding
to the open mouth exam. Once the cycle is completed, deactivate the
"Test" function by pressing the key again.
1. Check once again that the exposure data are correct. If not, correct
them as described in paragraph 8.6.2.2. ensure that the machine's
indicator light "Ready for X-ray" will come on, so press the X-ray
simoltaneous working of the ray indicator light "X-ray emission" (if
you are within sight of the machine) and the acoustic ray signal. The
following message will be displayed first:
" PRE-HEATING "
" X-RAY "
NOTE:

USER'S MANUAL
NOTE:
If message:
If message:

NOTE:
delay of 2 seconds from pressing the X-ray button. As the X-ray button
is a "dead man's switch", it is necessary to keep it pressed until the
end of the exposure.
The X-ray emission to the central part of the dental arch is suspended
during the examination phase, so the relative signals (sound and visual)
are therefore also suspended.
2. Once the exposure is completed, the system will carry out a short
return rotation and the following message will be displayed:
It will then be possible to set up the system for the open mouth
examination, keeping the patient in position or releasing him from
the working area.
NOTE:

USER'S MANUAL
NOTE:
3. Press the key "Patient Entrance" (6) . The machine will
reposition itself back to the starting position displaying the message:
" PLEASE WAIT… "
The end of the movement, the display will show the message:
" INSTRUCT PATIENT TO OPEN MOUTH "

USER'S MANUAL
8.6.4 TMJ open mouth
8.6.4.1 Patient preparation

1. The patient must be prepared following the operations described in
paragraph 8.6.3.1.
The following message will be displayed:
" INSTRUCT PATIENT TO OPEN MOUTH "
2. Press the key "Patient Entrance" (6) to confirm.
" PATIENT ENTRY "
3. Position the patient again if he has been removed from the centring
device. Tell him to open his mouth (helping him to keep in position
using appropriate mechanical devices - not supplied - if necessary).
45 Midsagittal line
4
3

1 TMJ positioner
45 3 Forehead support
4 Temple clasps
closing/release knobs
1
Figure 22 – Open mouth examination positioning

USER'S MANUAL
horizontal line for the Frankfurt plane reference (Figure 18).
Using as reference the sagittal medial plane laser, position the
patient's head in such a way that the sagittal medial plane is lit by
the corresponding laser beam as in Figure 22.
The reference of the Frankfurt plane can be used to make sure the
head of the patient is remaining in the same position when
examination is taken with either open or closed mouth.
NOTE:
7. Advise the patient to remain perfectly still and not look at the
rotating arm during the movements.

USER'S MANUAL
8.6.4.2 Carrying out the second exposure (mouth open)
WARNING:
regulations.
WARNING:
Using the laser centring devices, check that the system is still aligned
with the patient's sagittal medial plane.
1. Press the key "Patient Entrance" (6) . The display will show:
" EXAM INIT "
Check again that the exposure data are correct (see paragraph 8.6.2).
NOTE:
The Adult/Child and Size small - medium - large selection keys are
deactivated. The exposure parameters can be changed as described in
paragraph 8.6.2.
Press the X-ray button for the entire duration of the exposure,
checking the concurrent working of the ray indicator light "X-ray
emission" (if you are within sight of the machine) and the acoustic
ray signal. The following message will be displayed first:
" PRE-HEATING "
and then (after 2 seconds), the following message will be

displayed:
" X-RAY "

USER'S MANUAL
NOTE:
delay of 2 seconds from when the X-ray button is pressed. As the X-ray
button is a "dead man's switche", it is necessary to keep it pressed
until the end of the exposure.
During the examination, the emission of rays in correspondence with the
central part of the dental arch is suspended; the relative signals (sonant
and visual) are also suspended.
has completed this manoeuvre, the display shows the message:

device.
NOTE:
3. Press the "Patient Entrance" (6) key ; the machine will return
to the patient entry position and the following message will be

displayed:
NOTE:
C:/temp/.

USER'S MANUAL
WARNING:
After every examination, clean the TMJ positioner, the handles and
the temple clasps group thoroughly and change the protective sleeve
if used.
NOTE:
the arm.
All the motors will switch off, and it will be possible, if necessary, to
recommended that this movement be made with great care in order
to prevent damage to the machine.
Then press the "Patient Entrance" (6) key and the display
will show:
and then:
repositioned.
NOTE:
If the open mouth exposure is not completed, the closed mouth exposure
must be repeated or the four complete pictures will not appear.

USER'S MANUAL
8.7 SINUS examination
NOTE:
Entrance" (6) .
To select the SINUS examination, press "Exam Mode Selection" area
During the examination, one single rotation of the rotating arm is to be

expected, with the X-rays emission limited to the interested area.
display will show:

USER'S MANUAL
NOTE:
shape.
This shape, based on statistical data, establishes a standard shape for
the dentomaxillofacial complex, defining also the position and the
direction of the condyles. The patient anatomy can differ significantly
from the statistical model; based on his experience and competence, the
user has to judge this variation.
PERFORM CALCULATIONS OF DISTANCES, ANGLES ETC.
WARNING:
program.
In SINUS examination, to obtain the measurement of the anatomical
calibration factor is 100 pixels = 6.6 mm (in the centre of the focus layer).

USER'S MANUAL
NOTE:

set.
NOTE:
green color.
Child; the setted parameters values remain the same.

USER'S MANUAL
mA settings as in the table.
Exposure values in SINUS examination (9.4 sec)

Adult Child
kV mA kV mA
Small 68 8 64 8
Medium 72 8 66 8
Large 74 8 68 8
Table 5
NOTE:
needs.

USER'S MANUAL

the manual mode.
NOTE:
(4) pressed.

USER'S MANUAL
beams.
3. Place the patient in a standing position at the SINUS chin support.
With the keys "Column movement" (15/16) raise/lower
the column until the chin support rest is aligned with the patient's
chin.
WARNING:
4. Position the patient with the temple clasps (Figure 23) ensuring that
the chin rests on the special support; ask the patient to place his
hands on the front supports. Ensure that the patient rests his chin
on the chin support for SINUS.
with the lower part of the orbital fossa in Figure 18). Position the
patient's head in such a way as to ensure that the first two luminous
beams fall in correspondence with the respective anatomical
references.
The luminous beam of the Frankfurt plane can be adjusted according
to the patient's height; this can be adjusted by means of the laser
knob on the side of the mirror.

USER'S MANUAL
NOTE:
45 Midsagittal line
46 Frankfurt plane line
4
3

1 SINUS support
3 Forehead support
45 closing/release knob
46 4 Temple clasps
Figure 23 – SINUS positioning
8. Press the key "Patient Entrance" (6) to confirm.
The luminous centring devices switch off and the rotating arm goes
to its examination start position. Once alignment has been
completed, the following message will be displayed:
" EXAM INIT "
9. Ask the patient to: close his mouth, remain perfectly still and
not look at the rotating arm during the movement.

USER'S MANUAL
WARNING:
regulations. In all cases, it is recommended that during the emission of
X-rays, only the patient and operator be present in the room. If the
operator is not protected by suitable screens, he must stand at least
2 meters away from the emission of the rays (see the Figure 1 and Figure
2).
NOTE:
Before performing a lateral Sinus examination, because of the specific
trajectory described by the rotating arm, it is recommended to check for
possible mechanical interferences with the patient's shoulder during the
rotation.
By pressing the key "Test" (5) , to activate the Test function.
In this condition, it will be possible to make the machine perform all the
movements made during the examination, but without emitting rays.
Once the cycle is completed, deactivate the "Test" function by pressing
the key again.
them as described in paragraph 8.5.2.2; ensure that the machine's
simultaneous working of the ray indicator light "X-ray emission" (if
" PRE-HEATING "
" X-RAY "
NOTE:

USER'S MANUAL
NOTE:
If message:
If message:

NOTE:
delay of 2 seconds from when the X-ray button is pressed. As the X-ray
button is a "dead man's switch", it is necessary to keep it pressed
until the end of the exposure.
During the examination, the emission of rays in correspondence with the
central part of the dental arch is suspended; the relative signals (sonant
and visual) are also suspended.
has completed this manoeuvre, the display shows the message:

device.
NOTE:

USER'S MANUAL
NOTE:
At the end, the following message is displayed:
" PATIENT ENTRY "
A new exposure can now be made.
NOTE:
C:/temp/.
NOTE:
WARNING:
After every examination, clean the chin support, the handles and
the temple clasps group thoroughly.

USER'S MANUAL
NOTE:
the arm.
all the motors will switch off, and it will be possible, if necessary, to
will show:
and then:
repositioned.

USER'S MANUAL
8.8 IMPLANT examination

The Implant package for Rotograph EVO D is a valuable tool for taking
transversals cross sections of the dental arch for preliminary Implant
evaluation and follow up.
Essential requirements for a tomographic examination in the surgical
planning phase are to correctly determine the available space for
Implant; these requirements comprise the lingual and vestibular contour,
bone thickness on the point of interest, position of the floor of the
maxillary sinus or the distance between the alveolar crest and the upper
board of the mandibular canal. All these structure are not adequately
visualised using a standard panoramic or periapicals radiographs.
An additional advantage of linear tomography is that the dose is reduced,
compared to the standard CT examination.
NOTE:
The presence of radio-opaque material close to the area under
examination may generate artifacts which make a good diagnosis
difficult.
The Implant examination is made by three transversal layers displayed

on the same image: one in the theoretical centre of the dental element
and two others at a distance of 4 mm from the center for incisors and
canine and 6 mm for premolars and molars. The first slice of the image is
taken on the back of tooth of interest, the second is centered on tooth of
interest the third on the front of the tooth of interest (Figure 24).
On these images, considering the constant magnification factor (+132%),

it is possible to obtain the real values of anatomical parts allowing you to
evaluate all the relevant dimensions of the jaw (height and bone
thickness).
The thickness of the focus layer is 4mm for incisors/canine and 5mm for
molars/premolars.
WARNING:
space calibration of the program used.
It is therefore very important to check the space calibration of the
program.
In IMPLANT examination, to obtain the measurement of the anatomical
calibration factor is 100 pixels = 6.14 mm (in the centre of the focus
layer).

USER'S MANUAL
3
2
1
Figure 24
Please refer to paragraph 8.8.7 to have suggestions on how to view

images and their correct interpretation (please refer to Figure 28 and
following).

USER'S MANUAL
8.8.1 Anatomical parameters
The point of interest is based on the statistical model of the dental arch.
By default the touch screen is set to the standard European mode
number teeth.
The first digit defines the quadrant (from 1 to 4) while the second digit
identifies the tooth itself, from 1 to 8.
The quadrant is selected pressing "Exam Mode Selection" area
(11) ; the tooth number is selected by means of the keys
"Arrow right" (13) and "Arrow left" (12) .
In the set up menu, the tooth number ID can be changed to American

standard, which is based on a different method. In Figure 25 both
European and American standard numberings are provided.
American
Standard 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
European 18 17 16 15 14 13 12 11 21 22 23 24 25 26 27 28
Standard
Patient Right side Patient Left side
European
Standard 48 47 46 45 44 43 42 41 31 32 33 34 35 36 37 38
American 32 31 30 29 28 27 26 25 24 23 22 21 20 19 18 17
Standard
Figure 25
The linear tomography implemented on Rotograph EVO D is based on a

statistical model of dental arch, as defined in international literature.
However, it must be considered that the natural deviation from the model
due to the individual variability can lead to the possibility that the point
of interest may be not perfectly centered on the middle of the images.
During the patient positioning, the use of the sagittal medial plane laser
lead the operator to the correct centering of the poit of interest.

USER'S MANUAL
8.8.2 Implant Bite Block set-up
To perform the implant mode, Rotograph EVO D is delivered with two

special "Implant bite blocks", used to hold the patient on the point of
interest: the first bite block is used for the maxilla while the second one
is used for mandible (for simplicity, they will be referred to as: maxilla
implant bite block and mandible implant bite block).
Three parts make up both devices: a metal plate (base), a support and a
bite. Particularly, the mandible implant bite block has been studied to
hold the mandibular border horizontal during the examination and for
this reason has an angle of 7.5°.
The metal plate has two faces: one for right emi-arch and one for the left
emi-arch.
In order to avoid assembling mistakes, the metal plates and the bite
supports are designed to allow a correct and univocal positioning.

USER'S MANUAL
8.8.2.1 Bite block preparing: Maxilla Implant
1. Insert the bite in the relevant Maxilla bite support; tighten the knob 1
to fix the bite at the maximum height.
2. Select the desired metal place face according to the Figures below.
3. Select the bite support position according to the tooth under
examination; insert it and tighten knob 2.
Bite
Knob 1
Knob 2
Right emi-arch face
Base
Maxilla bite support
Left emi-arch face
xx = Tooth number according to

reference standard FDI or US
Figure 26

USER'S MANUAL
8.8.2.2 Bite block preparing: Mandible Implant
This examination has to be performed with the patient’s head inclined in

order to keep the mandible border in the point of interest as horizontal as
possible; in this way, the radiographs will be of better quality and with all
the clinical points of interest.
1. Insert the bite in the relevant Maxilla bite support; tighten the knob 1
to fix the bite at the maximum height.
2. Select the desired metal place face according to the Figures below.
3. Select the bite support position according to the tooth under
examination; insert it and tighten knob 2.
Bite
Knob 1
Right emi-arch face Knob 2
Base Mandible support

Left emi-arch face
xx = Tooth number according to

reference standard FDI or US
Figure 27

USER'S MANUAL
8.8.3 Equipment preparation
NOTE:
position, it is required to wait about 40 second (LED 20/21 light ON)
before starting the device alignment phase pressing key "Patient
Entrance" (6) .
Faster pressure may came up to "SENSOR NOT READY" message.
To select the IMPLANT examination, press "Exam Mode Selection" area

button
• Mandibular IMPLANT, right arch and 44 as default tooth
and the display showing the default exposure parameters (if this is the
first exposure), or the exposure parameters (kV, mA and tooth) of the last
exposure performed.
NOTE:
CHILD selection cannot be performed.

USER'S MANUAL
By pressing key "Exam Mode Selection" area (11) you can
pass from mandibular Implant right arch to mandibular IMPLANT left

arch; the display will show:
to maxillary Implant right arch; the display will show:
to maxillary Implant left arch; the display will show:

USER'S MANUAL
By means of the keys "Arrow right" (13) and "Arrow left" (12)
select the tooth.

Please note that in anatomic mode kV and mA changes according to the
selected teeth.
After this selection, remove the skull clamp assy and the chin support;
position the implant bite block chosen according to the maxilla or
mandible examination.
NOTE:
In case that values of kV or mA are considered not adequate, it is
possible to select a new exposure parameter value, using the method of
manual exposure described in paragraph 8.8.4.
Press the "Patient Entrance" (6) key to confirm; the display will
show:
" EXAM INIT "
for left arch selection, or
" PATIENT ENTRY & EXAM INIT"
for right arch selection.
Position the patient as described in paragraph 8.8.5.
NOTE:
If message:
If message:
NOTE:
Before use, it is mandatory to perform a cold disinfecting of the plastic
bite using, for instance, a 2% water solution of Glutaraldehydes
according to the instruction for use specified by its manufacturer.

USER'S MANUAL
8.8.4 Manual / Anatomic exposure
NOTE:

of the patient’s size and the chosen tooth.
set.
NOTE:
green color.

USER'S MANUAL
mA settings.
If the kV and mA combinations are not considered suitable for a specific

examination, it will be possible to set new parameters using the manual
mode.
NOTE:
(4) pressed.

USER'S MANUAL
8.8.5 How to prepare the patient
The patient’s preparation is the key factor in order to have diagnostic

images, because of the geometrical relations between Rotograph EVO D
and the natural individual variability of patients.
The following suggestions must be adapted with the experience and the
user radiological skill.
X-rayed (necklaces, earrings, glasses, hairpins, movable dental
prosthesis, etc.). Ensure that there no thick garments in the area to
be X-rayed such as coats, jackets, ties, etc.
2. Provide the patient with a protective apron or similar protection.
Ensure that the protection device does not interfere with the path of
the X-ray beam.
3. Place the patient in a standing position at the Implant support.
With the keys "Column movement" (15/16) raise/lower
the column until the Implant bite is aligned with the patient's mouth.
WARNING:
4. Position the patient asking him to bite with his incisors against the
reference notch of the plastic Implant bite block, already prepared
following the instructions of paragraphs 8.8.2.1 and 8.8.2.2. The
hands should rest on the front supports.
with the lower part of the orbital fossa).
Using as reference the sagittal medial plane laser, position the

patient's head in such a way that the relevant tooth is lit by the
corresponding laser beam.

USER'S MANUAL
The laser beam of the Frankfurt plane must be adjusted using laser
knob on the side of the mirror according to maxilla or mandible
examinations as follows:
• Maxilla: position the patient's head in such a way as to ensure
that the Frankfurt laser beam fall in correspondence of the
respective anatomical references.
• Mandible: using the Frankfurt laser beam, position the head of
the patient in such a way as that mandibular border at the point
of interest is as horizontal as possible.
NOTE:
shutdown can be anticipated by pressing the "Centring Device On"
key (14)" .
7. Make the following recommendations to the patient: the mouth

must remain closed, he/she must remain perfectly still and do
not look at the rotating arm during movements.

USER'S MANUAL
WARNING:
regulations. In all cases, it is recommended that during the emission of
X-rays, only the patient and operator be present in the room. If the
operator is not protected by suitable screens, he must stand at least
2 meters away from the emission of the rays.
them as described in paragraph 8.8.4; ensure that the machine's
simultaneous working of the ray indicator light "X-ray emission" (if
" PRE-HEATING "
" X-RAY "
NOTE:
If message:
If message:


USER'S MANUAL
NOTE:
delay of 2 seconds from when the X-ray button is pressed.
In addition, during the examination the emission of the X-rays is
interrupted and started again more than once, to produce the 3
projections.
It is therefore necessary to keep the X-rays button pressed
continuously until the end of the examination because, being a
"dead man" type, it is necessary to keep it pressed until the end of
the exposure.
2. Once the exposure is completed, the system will carry out a short
return rotation and the following message will be displayed:
Release the patient from the working area.
NOTE:

" PATIENT ENTRY "
A new exposure can now be made.
NOTE:
C:/temp/.

USER'S MANUAL
NOTE:
WARNING:
After every examination, clean the Implant bite support, the bite
and the handles thoroughly and change the protective sleeve if used.
NOTE:
the arm.
all the motors will switch off, and it will be possible, if necessary, to
will show:
and then:
repositioned.

USER'S MANUAL
8.8.7 Radiographic results
The result obtained at the end of the examination is indicated in Figure

28.
Second
First transversal transversal Third transversal
image image image
(point of interest)
Figure 28: Implant complete exam
WARNING:
All images obtained with the Implant program have a magnification
factor of 1.32.

USER'S MANUAL
8.8.7.1 Right side tomography (quadrants 1 and 4)
The next three images show the transversal sections, with the vestibular
part on the left and the lingual or palatal part on the right (Figure 29).
Palatal / Lingual
Palatal / Lingual
Palatal / Lingual
Second
First Third
Vestibolar
Vestibolar
Vestibolar
transversal
transversal transversal
image
image image
POINT OF
DISTAL MESIAL
INTEREST
Figure 29
8.8.7.2 Left side tomography (quadrants 2 and 3)
The next three images show the transversal sections, with the lingual or
palatal part on the left and the vestibular part on the right (Figure 30).
Palatal / Lingual
Palatal / Lingual
Palatal / Lingual
Second
First Third
Vestibolar
Vestibolar
Vestibolar
transversal
transversal transversal
image
image image
POINT OF
DISTAL MESIAL
INTEREST
Figure 30

USER'S MANUAL
8.9 Cephalometric examination

There is no rotation of the tube-head (X-ray generator) support arm and
sensor holder for the cephalometric examination.
Various projections are possible for the cephalometric examination. On
the basis of the image format selected and the projection chosen, the
primary diaphragm will automatically place itself in the correct position,
at the same time as the secondary collimator and the digital sensor.
The Cephalometric examination is fitted with a Soft Tissues Filter (STF);
this filter reduces the dose in areas with low bone content and highlights
the patient's profile which, under normal conditions, would be
overexposed and so not visible.
Rotograph EVO D makes different kinds of exposures, according to the

type of selection made:
24x22
18x22 Symmetric 24x22 30x22 18x22
Asymmetric for Asymmetric Symmetric Symmetric
for Posterior- for for for assessment
Latero-Lateral Anterior (P.A.) Latero-Lateral Latero-Lateral of bone growth
(L.L.) and Antero- (L.L.) (L.L.) (A.P.)
Posterior (A.P.)
For all these Ceph formats, it is possible to carry out the examination in
High Definition (indicated by "HD") or High Speed (Normal Resolution -
indicated by "HS").
It also possible to carry out the examination to assess bone growth,
following the instructions in paragraph 8.10 below.
WARNING:
program.
In Cephalometric examination, to obtain the measurement of the
anatomical part, taking into consideration the enlargement factor, the
length calibration factor is:
− 100 pixels = 7.36 mm in High Resolution
− 100 pixels = 12.3 mm in Normal Resolution.

USER'S MANUAL
NOTE:
position or viceversa, it is necessary to wait about 40 second (LED 20/21
light ON) before to start the device alignment phase pressing key "Patient
Entrance" (6) .
To select the CEPH examination, press "Examination Mode Selection"
area (11) until the following image is displayed:
1. Press the "Patient Entrance" (6) key ; the display will show
alternatively the following messages:
" REMOVE CHIN REST "
and
" CLOSE TEMPLE SUPPORT "
The first message tells the operator to remove the chin support, while
the second message tells him to close the temple clasps. These
operations are necessary to prevent interference with the rays beam
and with the panoramic sensor holder when the arm is being
positioned.

USER'S MANUAL
WARNING:
Neither of the two messages are controlled by the system and they can
therefore appear even if the unit has been set correctly until the "Patient
Entrance" (6) key is pressed.
WARNING:
There is no need to position any type of chin support for the
cephalometric examination. The chin support used for panoramic
examinations must be removed as indicated on the display. If the chin
support is not removed, it will collide with the sensor holder during
alignment and can obscure some anatomical parts of the patient during
the examination.
At the same time, the temple clasps must be closed, in order to avoid
collision with the rotating arm.
2. Once what was required is performed, press the key "Patient
Entrance" (6) ; messages will disappear and the machine will
align automatically with respect to the digital sensor and the

following message will be displayed:

and then:
" PATIENT ENTRY "
NOTE:
In case of a single sensor unit, if the sensor holder is in PAN position,
once the alignment is completed, the following message will be displayed:
" INSERT CEPH SENSOR IN CEPH SENSOR HOLDER "
Move the sensor in CEPH position following instruction in paragraph 8.2

and wait some seconds before to press "Patient Entrance" (6) key.
NOTE:
In case of a double sensor unit, once the alignment is completed, the
" OPEN PANO SENSOR HOLDER "
requesting the operator to open the sensor holder for panoramic

examination.

USER'S MANUAL
NOTE:
The position of the sensor holder for panoramic examination is controlled
by two micro-switches, it must therefore be completely opened.
You can pass from High Speed (Normal resolution - indicated by

"HS") to High Definition (indicated by "HD"), by pressing key
(7) and viceversa.
Pressing "Exam Mode Selection" area (11) the unit will
return to EVO PANORAMIC position; the display shows:
" CONFIRM EXIT? Y=Press >0<; N=Press T "
Press the "Patient Entrance" (6) key to confirm or the
"Test" (5) key to cancel the setting.
NOTE:
With the same image format, the scanning time is lower in Normal
Resolution; this allows you to give the patient a smaller dose, yet still
obtaining an image of sufficient quality for the orthodontic diagnostics,
albeit with a spatial resolution lower compared with that obtained from
High Resolution images.
NOTE:
button.
3. By means of the keys "Arrow right" (13) and "Arrow left" (12)
select the dimensions of the image and the type of projection (see the
table at the beginning of the Chapter).

USER'S MANUAL
NOTE:
After setting the machine accordingly, the following two operating modes
may be selected:
• ANATOMIC: with the kV and mA values programmed according to
the type of patient and size; Soft Tissue Filter in default position
• MANUAL: with the possibility of changing the kV, mA and Soft Tissue
Filter values set.
NOTE:
green color; it is possible to press key (8) to change
from Adult to Child; the setted parameters values remain the same.

USER'S MANUAL
The kV and mA values will be displayed, according to the selections

made, as per the following tables:
Adult Child
kV mA kV mA
Small 74 8 72 8
Medium 76 8 74 8
Large 78 8 76 8
Table 6: Latero-Lateral projection
Adult Child
kV mA kV mA
Small 76 12 74 12
Medium 78 12 76 12
Large 82 12 78 12
Table 7: Antero-Posterior projection
NOTE:
needs.

USER'S MANUAL
If the kV and mA combinations in the table Table 6 are not considered

suitable for a specific examination, it will be possible to set new
parameters using the manual mode.
NOTE:
It will be possible to modify manually kV, mA and Soft Tissue Filter
position.
The position of the STF has to be adjusted according to the value read on
the graduate scale present on the nose rest (Figure 31).
To modify the Soft Tissue Filter value, press the left (decrease) or
right (increase) arrows of the STF parameter.
A parameter can be modified by pressing the increase arrow and the

decrease arrow of that parameter repeatedly.
The "kV" value can vary between 60 and 80 kV, with 2 kV steps.
The "mA" value can vary between 4 and 12 mA, with 1 mA steps.
The "Soft Tissue Filter" value can vary between 6 and 10.5 cm, with
0.1 cm steps.
NOTE:
To change the values rapidly, keep ony of the arrows pressed.

USER'S MANUAL
beams.
3. Open the ear centring device (Figure 31) to its maximum span by
using the upper part of the rods of the centring device itself. Move the
nose rest (Figure 31) away outwardly to its maximum extension.
Manually rotate the craniostat group according to the cephalometric
projection to be made, moving the upper part of the ear centring
device (Figure 31).
4. Position the patient upright near the auricular centring device.
With the keys "Column movement" (15/16) lift/lower,
the column till the centring pins (Figure 31) are close to the ear to
clasp the patient's head so that the pivots penetrate the ear (Figure
31) moving the upper part of the rods.
If a Latero-Lateral examination is performed, position the nose rest.
WARNING:

USER'S MANUAL
Legend
1 Nose rest
2 Ear centring device
3 Pins for ear centring
device
4 4 Graduated scale
2
1
Figure 31
5. By selecting an "asymmetric" projection, the Soft Tissues Filter (STF)

will be automatically inserted.

USER'S MANUAL
WARNING:
and personnel in the area must be in compliance with the regulations in
force in the country where the machine is used.
the emission of the rays (see Figure 1 and Figure 2).
1. Verify once again that the exposure data are correct (see paragraph
8.9.2). Advise the patient to remain still and to keep his mouth
closed, with the teeth touching, throughout the duration of the
exposure.
Press the "Patient Entrance" (6) key .
The unit will move into the selected examination start position.
The signalling LED "Ready for X-ray" will light up, indicating that the
machine is ready to produce X-rays.
NOTE:
If you want to cancel the operation, press key "Patient Entrance" (6)
2. Press the X-ray button for the entire duration of the exposure,
ray signal.
" PRE-HEATING "
" X-RAY "

USER'S MANUAL
NOTE:
If message:
If message:

NOTE:
X-rays are emitted with a delay of two seconds from pressing the X-ray
button to allow the heating of the filament and the control of all set
parameters. Since the X-ray button is a "dead man's switch", it must
be kept pressed until the end of the exposure.
3. Once the exposure is completed, the secondary collimator moves into

a back resting position, to allow the patient to come out.
The display will again show all the exposure values relating to the
exposure just completed.
NOTE:
C:/temp/.
NOTE:
This time enables the X-ray tube's anode to cool down.

USER'S MANUAL
NOTE:
If the patient moves during the exposure, or if you realise that incorrect
parameters have been set, it will be necessary to stop pressing the X-ray
button immediately, to interrupt the emission of rays.
Then press the "Patient Entrance" (6) key .
The system now returns to the position for Ceph exam and the unit
starts the procedure for the new examination.
NOTE:
After every examination, clean the ear centring device and temple
clasps group thoroughly.

USER'S MANUAL
8.10 Examination to assess bone growth (Carpus)

The cephalometric device can also be used to carry out X-rays to evaluate
the state of calcification and bone growth, X-raying the hand/wrist
complex to obtain an X-ray that contains the anatomic details necessary
to evaluate the patient's bone growth trend.
The image format set in order to carry out this examination is 18x22
Symmetric, not adjustable; it is therefore necessary to position the
auricular rods and the nose-rest as for the cephalometric Antero-
Posterior examination, so that these elements do not interfere with the
X-ray trajectory. Refer to Figure 32.
WARNING:
program.
In CARPUS examination, to obtain the measurement of the anatomical
calibration factor is 100 pixels = 7.36 mm.

USER'S MANUAL
NOTE:
Entrance" (6) .
1. Select the CEPH examination, pressing key "Exam Mode Selection"
area (11) until the following image is displayed:
2. By means of the keys "Arrow right" (13) and "Arrow left" (12)
select the CARPUS examination:

USER'S MANUAL
3. Press the "Patient Entrance" (6) key ; the display will show
alternatively the following messages:
" REMOVE CHIN REST "

and
" CLOSE TEMPLE SUPPORT "
The first message tells the operator to remove the chin support, while
the second message tells him to close the temple clasps.
These operations are necessary to prevent interference with the rays
beam and with the panoramic sensor holder when the arm is being
positioned.
WARNING:
Neither of the two messages are controlled by the system and they can
therefore appear even if the unit has been set correctly.
WARNING:
There is no need to position any type of chin support for the Carpus
examination. The chin support used for panoramic examinations must be
removed as indicated on the display. If the chin support is not removed,
it will collide with the sensor holder during alignment and can obscure
some anatomical parts of the patient during the examination.
At the same time, the temple clasps must be closed, in order to avoid
collision with the rotating arm.
4. Once what was required is performed, press the key "Patient
Entrance" (6) ; messages will disappear and the machine will
align automatically with respect to the digital sensor and the

and then:
" PATIENT ENTRY "

USER'S MANUAL
NOTE:
In case of a single sensor unit, if the sensor holder is in PAN position,
once the alignment is completed, the following message will be displayed:
" INSERT CEPH SENSOR IN CEPH SENSOR HOLDER "
Move the sensor in CEPH position following instruction in paragraph 8.2

and wait some seconds before to press "Patient Entrance" (6) key.
NOTE:
In case of a double sensor unit, once the alignment is completed, the
" OPEN PANO SENSOR HOLDER "
requesting the operator to open the sensor holder for panoramic

examination.
NOTE:
The position of the sensor holder for panoramic examination is controlled
by two micro-switches, it must therefore be completely opened.
Pressing "Exam Mode Selection" area (11) the unit will
return to EVO PANORAMIC position; the display shows:
"CONFIRM EXIT? Y=Press >0< ; N=Press T "

USER'S MANUAL
5. Regulate the exposure parameters as required, using the pre-set

values or manual selection; the display will show the kV and mA
settings as per the following table.
Child
kV mA
Small 62 8
Medium 62 8
Large 62 8
Table 8
NOTE:
needs.

USER'S MANUAL
1. Turn the ear centring device to the Antero-Posterior position; bring

the nose-rest to a parking position.
2. Hook up the positioning support for hand projection, by screwing it
on the related housings close to the ear centering device. The
reference line on the metal positioner must face the sensor.
3. Place the patient slightly to the side of the cephalometry device.
4. Position the patient's hand on the positioning support (Figure 32), so
that the hand results between the sensor and the plate itself.
The support leads the operator to place the body part in the centre of
the irradiated area. The horizontal reference line should help the
vertical adjustment of the hand.
The common radiological procedure to assess bone growth in
children's, suggests placing the end of the middle finger tangent to
the reference line.
The patient's hand must be fully in contact with the metal plate and
it must form a vertical line with the arm, in order to avoid any risk of
collision with the sensor during the scanning movement.
Figure 32

USER'S MANUAL
WARNING:
and personnel in the area must be in compliance with the regulations in
force in the country where the machine is used.
the emission of the rays (see Figure 1 and Figure 2).
1. Press the "Patient Entrance" (6) key .
The unit will move into the selected examination start position.
The signalling LED "Ready for X-ray" will light up, indicating that the
machine is ready to produce X-rays.
NOTE:
If you want to cancel the operation, press key "Patient Entrance" (6)
2. Press the X-ray button for the entire duration of the exposure,
ray signal.
" PRE-HEATING "
" X-RAY "
NOTE:
If message:
If message:

USER'S MANUAL
NOTE:
X-rays are emitted with a delay of two seconds from pressing the X-ray
button to allow the heating of the filament and the control of all set
parameters. Since the X-ray button is a "dead man's switch", it must
be kept pressed until the end of the exposure.
3. Once the exposure is completed, the secondary collimator moves into

a backward resting position, to allow the patient to come out.
The display will again show all the exposure values relating to the
exposure just completed.
NOTE:
C:/temp/.
NOTE:
This time enables the X-ray tube's anode to cool down.
NOTE:
If the patient moves during the exposure, or if you realise that incorrect
parameters have been set, it will be necessary to stop pressing the X-ray
button immediately, to interrupt the emission of rays.
Then press the "Patient Entrance" (6) key .
The system now returns to the position for the Ceph exam and the unit
starts the procedure for the new examination.

USER'S MANUAL
8.11 Messages on display

Rotograph EVO D is fully controlled by a microprocessor which controls
the programming of the emission parameters and signals the various
conditions of the machine, the possible abnormalities and errors via
displayed messages.
The messages can be divided into two groups:
• operation messages: these messages tell the operator how to set up
the unit for the examination
• error messages: these messages are displayed when an error occurs;
there are two kinds of error messages as follows:
1- Messages prompted when the X-ray emission button is released by
the operator or by pressing key "Patient Entrance" (6) .
The message displayed will be as follows
" ERROR: xxx PRESS >0< "
Operations are reset by pressing key (6) .
2- Messages generated by a system error. In this case, the Technical

Service must be called.
Messages that require the intervention of the Technical Service are
displayed as follows:
" ERROR: xxx CALL TECH SUPP "
3- Messages related to H.F. board problems. If this occurs, switch off

the unit. Wait a few minutes for the capacitors of the relative circuit
to discharge, and then switch the machine on again. If the problem
persists, call the Technical Service.
" ERROR: xxx POWER OFF "
Following are reported the different error messages and the relative
controls and operations to be performed.

USER'S MANUAL
8.11.1 Error message with error code E000 ÷ E199
NOT resettable errors.

These are internal errors of the control system; it is necessary to call the
Technical Assistance Service.
8.11.1.1 E110 – Battery fault
This message means that the clock battery is low or fault.

If after power ON, a 90 second cooling time starts, wait until the end of
the time; then display will show "E110 – Press >0<".
Follow the message shown on the display and perform an examination.
At the end of the examination, power OFF the machine and wait a couple
of minutes before powering ON again.
If the message is not yet present, it means that the battery is low. Leave
the machine powered ON to recharge it.
If the error does not disappear, call the Technical Assistance Service.
This category of errors apply to the rotation motor; of these only the error
"E206 - Collision with patient", caused by a possible collision between
the rotation arm and the patient, it is an actual reversible.
Press the key "Patient Entrance" (6) to reset the error and to
perform the axes centring operation.
For all other cases, call the Technical Assistance Service.

USER'S MANUAL
8.11.3.1 Error message with code error E300 ÷ E303

These errors are related to the secondary collimator of the Digital CEPH.
Switch off the system and on again, in case of further error message, call
the Technical Assistance Service.
8.11.3.2 Error message with code error E320 ÷ E323

These errors are related to the primary collimator.
8.11.3.3 E340 - Sensor holder not in PAN position
A Panoramic type examination was requested, but the sensor holder does
not appear to be closed; close it in the PAN position and press the
key "Patient Entrance" (6) to reset the error condition.
8.11.3.4 E360 / E361 - X-ray button pressed during start up or axis

movement
Release the X-ray button if pressed; press the key "Patient Entrance"
(6) to reset the error condition.

USER'S MANUAL
8.11.3.5 E362 - X-ray button released during examination
NOTE:
The X-ray button has the so-called "dead man's switch" function, i.e. it
must be kept pressed for the whole time of the examination, also during
the phases of the examination with emission interruption (for
instance, in open/close mouth TMJ).
This message signals that the button was released during the
examination phase; the motors are unlocked, therefore the patient can
get out of the system. Repeat the system centring phase and repeat the
examination.
8.11.3.6 E364 / E365 - Sensor connection lost
Release the X-ray button if pressed; press the key "Patient Entrance"
(6) to reset the error condition and repeat the exam procedure.
If the error is still present, switch OFF and ON the unit.


USER'S MANUAL

These errors are related to the Soft Tissue Filter of the Digital CEPH.
WARNING:
These error codes refer to the X-rays generation, therefore, they can also
indicate a safety problem.
With error code E759, turn off immediately the system as a not
requested X-ray emission was detected. In this case, call
immediately the Technical Assistance Service.
8.11.5.1 E755 – Safety Buckup Timer intervention
This message is signalling that the RX emission has not ended at the
correct time, but it has been terminated by the Safety Backup Timer.
This hardware device has interrupted the emission, but in any case
power off the system.
8.11.5.2 E774 - X-rays button not pressed
The lack of the button is signalled also if the emission software control is
present.
The error signals a possible failure on the connection of the X-rays
button with the generator card.
8.11.5.3 E775 - X-rays button released prematurely
The release of the X-rays button during the emission phase is signalled;
this signalling has a different meaning from that of the corresponding
E362 error, as this message is generated by the HF board, which signals
a possible failure on the connection of the X-rays button with the board
itself.

USER'S MANUAL
These errors signal abnormal situations due to the operator's interface.
8.11.6.1 E850 - One or more keys appear to be pressed on start-up
The system checks that all keys are not pressed at start-up; if one or
more appear to be pressed, this error is displayed.
Release the key and switch ON again the unit. If the problem is still
present, call Technical Service.
8.11.6.2 E851 - Column key pressed
This error is displayed in case, when releasing the up/down column key,
the movement itself is not completed; pressing any other key interrupts
the movement to avoid injuries to the patient.
Press the key "Patient Entrance" (6) to reset the error condition.
8.11.6.3 E852 - Key "Patient Entrance" pressed during the movement
During the system movement, the keyboard is disabled, but
if the key "Patient Entrance" (6) is pressed the movement is
interrupted. This operation is useful in case a movement anomaly is

noticed.
Press the key "Patient Entrance" (6) to reset the error condition.

USER'S MANUAL
8.12 Research and correction of possible defects in

dental X-rays
8.12.1 Faults due to the wrong positioning of the patient
Problem Description Solution

Overlarge and blurred The patient is not positioned Position the patient correctly, check
incisors. correctly. He is too far from that he holds the bite with the
the optimal focal plane. incisors on the appropriate notch
and that the bite holder rod is
vertical.
Over-small and The patient is not positioned Position the patient correctly, check
blurred incisors. correctly. He is too near the that he holds the bite with the
optimal focal plane. incisors on the appropriate notch
and that the bite holder rod is
vertical.
Radiography with The spine of the patient Check the alignment of the
blank central area. inhibits the passage of the Frankfurt plane, try to stretch the
X-ray as it is too cervical part of the spine by moving
compressed. the patient's feet forward (see
paragraph 8.5.3 points 3/4/6/7)
and, if necessary, correct the height
of the chin support.
Asymmetric dental The sagittal medial line does Realign the patient (see paragraph
arch. not correspond to the laser 8.5.3 point 6).
centring beam.
Upper apical area too The patient does not keep See paragraph 8.5.3 point 8.
dark. his lips shut and the tongue
is not against the palate.
Upper central apical The patient keeps his head Position the patient again and
area out of focus. rotated backwards realign the Frankfurt plane.
(Frankfurt plane not
aligned).
The image is slanted in The patient's head is slanted Position the patient again, correcting
comparison with the (not vertical). the position of the sagittal plane.
longitudinal axis of the
image and some
anatomical structures
are not symmetric.
The teeth on one side The patient's head is rotated Position the patient again, correcting
are bigger than those with respect to the axis of the position of the sagittal plane and
on the other side. the bite. controlling that his head does not
rotate.
Presence (in CEPH Panoramic chin-rest still Perform the exam again, removing
examination) of a mounted. the PAN chin-rest.
white area in the lower
part of the image.

USER'S MANUAL
8.12.2 Defects due to wrong data setting
Problem Description Solution

Light or poorly The set kV values are not Try to modify the contrast, using the
contrasted image. adequate for the size of the appropriate commands of the image
Over-dark image. patient. acquisition/management program; if
necessary, repeat the examination,
varying the kV and/or the mA.
Increase them if the image was too
clear, and reduce them if it was too
dark.
If the error is repeated, call the
Technical Service.
Image completely No X-ray emission. Verify the emission of the X-rays by
white. acoustical and luminous signal. If
no solution can be found, call the
Technical Service.
Soft Tissue not (or The STF value is not correct. Refer to paragraph 8.9.3 to adjust
poorly) visible in L-L the position of the "STF".
projection. A symmetric image format Select an asymmetrical image
was selected. format (which will enable the STF
filter).

USER'S MANUAL
8.12.3 Defects due to the device
1. Should the image show non irradiated areas or be completely white,

this can mean that there is a defect in the alignment between X-ray
beams and sensor (PAN or CEPH) or a partial or total missing of
irradiation; in any case, call the Technical Service.
2. In the event the soft tissue of the patient is not highlighted while
performing a cephalometry, in a latero-lateral, let the technician
verify the adjustment of the Soft Tissue Filter.

USER'S MANUAL
8.13 Analysis of the problems on the panoramic

examinations
The panoramic radiography is the examination of the maxillo-facial
region normally used to view the dental region inside the complete head
and sinuses-orbital complex.
In a good Panoramic, you can distinguish the main anatomic structures
that are simplified in the diagram below (which indicates only the main
ones, and is not complete).
Figure 33
Ref. Anatomic structure

1 Palatal plane
2 Maxillary sinus
3 Maxilla and maxillary tuberosity
4 Temporo mandibular condyle
5 Ascending ramus of the TMJ
6 Coronoid process (overlap with maxilla)
7 Mandibular canal
8 Chin foramen
9 Anterior nasal spine
10 Nasal cavities
11 Ioid bone (normally duplicated)

USER'S MANUAL
8.13.1 Proper positioning of the patient
The proper positioning of the patient during the panoramic examination

is very important in order to get good quality radiography. This is due to
the fact that the shape of the focussed area, e.g. of the layer clearly
shown on the image, tends to follow the dental arch and has a non-
constant deepness.
The objects outside this focused area will therefore appear blurred on the
radiography.
1. The patient should not wear clothes that may interfere with the X-ray
beams, also to leave more space between the patient’s shoulders and
the rotating arm of the machine. Care must be taken in order to
avoid interference between the X-ray beam and the protective
apron worn by the patient.
2. Metal objects (necklaces, earrings etc.) must be avoided; these objects
not only create radio-opaque images in their own position, but also
false images projected in other parts of the radiography, so
disturbing the correct view of the anatomy.
3. The patient’s head must be slightly tilted downward in order to make
the Frankfurt plane horizontal. In this way, the hard palatal ceiling
will be projected slightly over the superior apex of the anterior teeth.
If the patient has a low palatal ceiling, slightly increase the
downward tilting.
4. Align the sagittal medial plane with the centre of the chin support,
normally indicated by the relevant light beam.
Figure 34
5. The patient must extend his spine; this is normally obtained by

asking the patient to step forward, making sure that all other
conditions are unchanged. If not properly extended, the spine will
cause the appearing of a lower exposed area (clearer) in the front part
of the image.

USER'S MANUAL
6. The patient’s tongue must be positioned against his palate.

Otherwise, the air between the tongue and the palate forms an area
of lower absorption, which leads to a darker area that hides the apex
of the teeth of the maxilla.
The result of all the above listed actions will be a radiography where all
the parts are properly exposed and are well identifiable as in the diagram
of Figure 35.
Figure 35
It must be noted that the radiography is quite symmetrical, with the

ascending rami of the temporo mandibular joints almost parallel. The
occlusal plane is shown slightly tilted upward, the palatal plane does not
overlap the apex of the upper arch and therefore allows a good view of the
apex itself.

USER'S MANUAL
8.13.1.1 Errors due to poor positioning of patient
• The image shows the anterior teeth with reduced

magnification and not well defined. The cervical spine is
shown as evident white shadow.
In addition, on the molar zone there are too many shadows,
disturbing the reading.
The resulting image is similar to the schema shown on Figure 36.
Figure 36
Possible causes:
The patient it positioned too much forward.
Solution:
Check the patient's positioning by using luminous beams.
If, after the correct positioning of the patient, the problem still
remains, check the alignment of the centring laser lights, simply
switching on the centring lights and checking their position.
The sagittal medial luminous beam must hit the centre of the chin
support.

USER'S MANUAL
• Anterior teeth are enlarged and blurred

Figure 37 shows the result of this error.
Figure 37
Possible causes:
The patient it positioned too much backward.
Solution:
Check the patient's positioning by using luminous beams.

USER'S MANUAL
• Part of the image is enlarged while the other is reduced
The schema described on Figure 38 the image obtained; it is possible

to observe that one part of the radiography is blurred and enlarged,
while the other is reduced and seems to be in focus; the two condylar
rami are at the same height on the X-ray.
Figure 38
Possible cause:
This effect can be due to two different causes.
In the first one, the sagittal medial plane is not aligned
with the relevant centring light beam, which falls at
the centre of the chin support.
In the second case, the centre of the sagittal medial
plane corresponds with the centre of the chin support,
but the patient’s head is rotated.
In both cases, one side is closer to the sensor plane than the other,
thus resulting in a different magnification of the two sides; the part
more distant from the sensor will be more magnified while the part
closer to the sensor plane will result smaller. The result will be an
image as shown in Figure 38; the left-hand area of the image shows a
bigger magnification that can be noticed both on the teeth and on the
ascending rami of the TMJ.
Solution:
Check the positioning of the sagittal medial plane by using the
relevant centring light beam.
Check also the position of the sagittal medial beam; lighted, it must
fall both on the centre of the chin rest and also on the centre of the
bite.

USER'S MANUAL
• The image shows the upper vertex of the condylar rami of

different heights;
Figure 39 shows the result of this error.
Figure 39
Possible causes:
The sagittal medial plane is not vertical. This can be the patient’s
problem, but if the defect is always present, check the laser beam.
Solution:
Verify that the laser beam is vertical; this check can be performed
very quickly by using the laser beam and verifying that it falls on the
centre of the chin support; remove the chin support itself and check
that the beam falls in the centre of the two holes used to fix the
support itself.
If not, a possible cause can be the imperfect horizontality of the chin
support arm, that must be adjusted using the relevant screws.

USER'S MANUAL
• The image shows undulated teeth rows
As can be seen in Figure 40, the upper teeth are magnified and
unfocused, with the shadow of the hard palate positioned over the
superior apex. The temporo-mandibular joints are exposed outward,
with lines divergent upward. In some cases, the condylar vertices
might not appear on the image.
Figure 40
Possible causes:
A Frankfurt plane tilted too much upward produces different
anomalies that may also appear simultaneously. A chin support
plane too high during the patient positioning, or when extending the
spine, may generate this mistake. In this condition, the rear side of
the patient’s head may also interfere with the rotating arm of the
panoramic equipment.

USER'S MANUAL
• The radiographic image shows the teeth row too curved

upward with the lower incisor not focused
Figure 41 shows the result of this type of error. The temporo-

mandibular joints are shown very high up, with lines converging
towards the top. In some cases the upper condyle might not be
visible in the image.
Figure 41
Possible causes:
Patient’s head tilted downward, as on the diagram alongside.
Solution:
Check the positioning of the patient by aligning the Frankfurt plane
with the corresponding light beam.

USER'S MANUAL
NOTE:
In some cases, the positioning of the Frankfurt plane too tilted downward
produces a correct image of the lower incisors, but the projection of the
palate falls on the upper teeth apex, as shown in Figure 42.
Figure 42
In this case, a light tilting forward and downward of the Frankfurt plane
causes the palate to be projected over and far enough from the roots of
the teeth of the maxilla arch, without distortion of the incisor teeth, as in
Figure 43.
Figure 43

USER'S MANUAL
8.13.1.2 Images with artefacts
• Radiographs that show images with soft tissues or artefacts
The radiographs may show anatomical parts of the soft tissues or

show radiographic artefacts.
Normally the soft tissues might be more or less present, depending
on the patient positioning, while the presence of artefacts is strictly
dependent on the presence of foreign objects on the trajectory of the
X-ray beam.
The next figure shows these cases; please consider that all structures
have a bilateral duplicate.
Figure 44
Soft tissue Description Artefacts Description
2 Ear soft tissue 1 Space between tongue and

palate. All the structures of
the oropharynx cavity can be
shown
3 Nose soft tissue 4 Spinal column
7 Epiglottis 5 Image of the patient's leaded
protective apron (light area)
The part identified with "6" in Figure 44 represents the image of the
controlateral mandible (the other side of the mandible). That
therefore results as a clearer area overlapped with the real image.
Very often the resulting darker area in the bottom corner is noticed
and is considered as an artefact of the radiological image.

USER'S MANUAL
This is not true, because it is derived from the projection

geometry used to obtain the panoramic image. The effect can be
more evident if the image in underexposed due to wrong
radiological parameters.
With reference to Figure 44 above, let’s analyse some errors.
• Wrong positioning of the spine
In the event the image shows an over-bright and unfocused part in

the central area (see point "4" - Figure 44), this is probably caused by
the wrong position of the spine that has not been properly extended
by the patient. In this case, the spine absorbs an excessive quantity
of radiation that therefore causes the image to be over-bright. This
excessive brightness can be seen above all in the lower part, but is
less visible in the upper part of the X-ray.
Solution:
Ask the patient to step forward, thus extending his spine, in order to
reduce X-ray absorption.
• Shadows or bright artefacts
The most common cause for the presence of these artefacts is the
presence of metal objects worn by the patient (earrings, necklaces,
etc.).
The necklaces worn by the patient normally result in a radio-opaque
arch positioned in the chin area. This arch normally overlaps the
chin itself and the shadow of the spine, disturbing the diagnosis of
possible problems in the chin area and in the area of the apices of
the mandibular incisors.
The earrings, on the other hand, create real images in the proper
position and shadow images projected in the contro-lateral area, thus
hiding possible problems or generating bright areas within the
paranasal sinuses.
In some cases, that may depend either on the trajectory of the
panoramic machine or on the position of the metal objects, they can
generate up to three images (one real and two shadows), thus further
disturbing the correct diagnosis.
This situation may occur especially if the patient has large prothesis
or metal fillings, and is associated with a positioning error, that
projects the shadow of the metal part on wide areas of the image.

USER'S MANUAL
• Non-exposed area in the lower-central part of the image
If the problem appears as shown in point "5" of Figure 44 above, it

indicates that there has been interference between the leaded apron
worn by the patient and the X-ray beam.
Solution:
Properly position the leaded apron (tight around the patient's
shoulders and neck) then carry out a new examination.
• The teeth rows are overexposed
As already described, if the tongue is not positioned against the

palate during the exposure, it will create an air chamber between the
tongue and the palate; this air gap creates a less absorbing area that
overlaps the teeth, often in the apex area. This area is identified as
reference "1" in Figure 44.
Solution:
Ask the patient to position his tongue against the palate during the
exposure.

USER'S MANUAL
8.14 Storing of automatic exposure parameters

The pre-set technical exposure factors can be varied according to the
needs of the user, or the aim for somewhat contrasted images.
To modify the automatic exposure parameters, please follow the indicated

procedure:
1. Select the examination, the type of patient and the size to be

modified.
2. Press any of the increase (3) or decrease (4) arrows to
modify the kV and/or mA parameters to suit your needs; the values

3. Press the key "Service Menu" (18) ; the following image will
be displayed:
4. Press the "Save Parameter" key to store the modified parameters for
the examination and type and size of patient you have selected.
5. After pressing the key, the display will show the following message:
" SAVE THE NEW PARAMETERS?

Y=PRESS >0<; N=PRESS T "
Pressing key (18) the unit will return to standard mode.

USER'S MANUAL
8.14.1 Table of pre-set anatomic parameters
PANORAMIC TMJ open/close mouth

Adult Child Adult Child
70 kV 66 kV 70 kV 62 kV
Small Small
8 mA 8 mA 8 mA 8 mA
74 kV 68 kV 74 kV 66 kV
Medium Medium
8 mA 8 mA 8 mA 8 mA
76 kV 70 kV 78 kV 70 kV
Large Large
8 mA 8 mA 8 mA 8 mA
SINUS
Adult Child
68 kV 64 kV
Small
8 mA 8 mA
72 kV 66 kV
Medium
8 mA 8 mA
74 kV 68 kV
Large
8 mA 8 mA
CEPHALOMETRY (L.L.) CEPHALOMETRY (A/P - P/A)

Adult Child Adult Child
74 kV 72 kV 76 kV 74 kV
Small Small
8 mA 8 mA 12 mA 12 mA
76 kV 74 kV 78 kV 76 kV
Medium Medium
8 mA 8 mA 12 mA 12 mA
78 kV 76 kV 82 kV 78 kV
Large Large
8 mA 8 mA 12 mA 12 mA

USER'S MANUAL
Maxilla IMPLANT
Tooth Tooth Tooth Tooth Tooth Tooth Tooth Tooth
11/21 12/22 13/23 14/24 15/25 16/26 17/27 18/28
9.20 9.20 9.20 9.20 7.30 7.30 7.30 7.30 s

Small 62 62 68 68 64 64 64 64 kV
8 8 8 8 8 8 8 8 mA
9.20 9.20 9.20 9.20 7.30 7.30 7.30 7.30 s

Medium 62 62 72 72 66 66 66 66 kV
8 8 8 8 9 9 9 9 mA
9.20 9.20 9.20 9.20 7.30 7.30 7.30 7.30 s

Large 62 62 74 74 68 68 68 68 kV
8 8 9 9 10 10 10 10 mA
Mandible IMPLANT
Tooth Tooth Tooth Tooth Tooth Tooth Tooth Tooth
31/41 32/42 33/43 34/44 35/45 36/46 37/47 38/48
9.20 9.20 9.20 9.20 7.30 7.30 7.30 7.30 s

Small 62 62 62 62 68 62 62 62 kV
8 8 8 8 8 8 8 8 mA
9.20 9.20 9.20 9.20 7.30 7.30 7.30 7.30 s

Medium 62 62 62 64 70 64 64 64 kV
8 8 8 9 9 9 9 9 mA
9.20 9.20 9.20 9.20 7.30 7.30 7.30 7.30 s

Large 62 62 62 66 72 66 66 66 kV
8 9 9 10 10 10 10 10 mA
NOTE:
needs.

USER'S MANUAL
Maintenance
9. MAINTENANCE
NOTE:
Maintenance and inspection procedure must be performed without
patient positioned in the equipment.
This unit, like all other electrical appliances, must be used correctly and
also serviced and controlled at regular intervals. This precaution ensures
a safe and efficient performance.
The periodical maintenance consists in checks performed by the operator
himself and/or by a qualified technician.
The operator can control the following items:
Frequency Type of check Method
Daily Functioning of the indicator lights Visual inspection

Daily Check that the cables do not show signs of Visual inspection
breaking or wear
Daily Check that the unit is not damaged externally Visual inspection
in such a way that the safety of protection
from radiation is compromised
Daily Check that there are no traces of oil on the Visual inspection
tube-head
Daily Check that arm movement is smooth Practical inspection
Monthly Integrity of equipment and labels Visual inspection
WARNING:
If the operator detects irregularities or failures, he must immediately call
Technical Service.

USER'S MANUAL
Maintenance
Besides the above controls, the Service Engineer will also check the
following during preventive maintenance:
Frequency Type of check Method
Annually General visual inspection Visual inspection

Annually Grounding of all the accessible conductive parts Practical inspection
Annually Condition of the internal and external cables: Visual and practical
wear and tear and fastenings inspection
Annually Tightening of the primary bolts and screws such Practical inspection
as the wall fastening systems, the moving
mechanisms and the chin rest arm
Annually Correct functioning of the luminous indicators of Visual inspection
the console
Annually Correct equipment centring See Service Manual
paragraph 7.2
Annually Check technical factors See Service Manual
paragraph 4.4
Annually Detector calibration See Service Manual
paragraph 7.3

USER'S MANUAL
Maintenance
MAINTENANCE LOGBOOK
Installation: Date ........... Technician ....................
Maintenance: Date ............. Technician ....................
Cause .............................................
Cause .............................................
Cause .............................................
Cause .............................................
Cause .............................................
Cause .............................................
Cause .............................................

Cod. 6907913003_Rev.4 0051
VILLA SISTEMI MEDICALI S.p.A.

Via Delle Azalee, 3
20090 Buccinasco (Milan) - ITALY
Tel. (+39) 02 48859.1
Fax (+39) 02 4881844

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Rotograph EVO D 0051

Revision history Manual code 6907913003

Rev. Date Page/s Modification description

0 21.03.14 - Document approval.

2 31.08.16 7, 8, 9, 14, 35, Improvement of Implant exam.

3 27.06.17 55, 70, 86, 96, New SINUS chin support.

(Rev. 4) Rotograph EVO D

THIS PAGE IS INTENTIONALLY LEFT BLANK

Rotograph EVO D (Rev. 4)

2. SPECIFICATION OF THE INTENDED USE 3

4. CLEANING AND DISINFECTION 26

(Rev. 4) i Rotograph EVO D

7. QUALITY ASSURANCE PROGRAM 55

8. GENERAL INSTRUCTIONS FOR USE 61

Rotograph EVO D ii (Rev. 4)

8.7 SINUS examination............................................................................. 110

(Rev. 4) iii Rotograph EVO D

No part of this publication can be reproduced, transmitted, transcribed or

Rotograph EVO D iv (Rev. 4)

Rotograph EVO D, produced by VILLA SISTEMI MEDICALI S.p.A., is an

(Rev. 4) 1 Rotograph EVO D

1.1 Icons appearing in the manual

Rotograph EVO D 2 (Rev. 4)

2. SPECIFICATION OF THE INTENDED USE

2.1 Application and medical purpose

2.1.1 Intended patient population

(Rev. 4) 3 Rotograph EVO D

2.1.2 Operator profile (intended user)

This system may only be operated by a physician, dentist or skilled

2.1.3 Application environments

Rotograph EVO D is dedicated both to the dental practitioner market and

2.2 Applied parts

Rotograph EVO D 4 (Rev. 4)

2.3 Typical doses delivered to the patient during extra-

(Rev. 4) 5 Rotograph EVO D

2.3.1 Panoramic mode

74 12.11 14.12 16.14 18.16 20.18

Table 1: Air Kerma values in mGy for Panoramic STD exams

Rotograph EVO D 6 (Rev. 4)

2.3.2 Cephalometric mode

74 0.78 0.91 1.03 1.17 1.30 1.43

Table 2: Air Kerma values in mGy for Cephalometric exams 30x22 cm in

(Rev. 4) 7 Rotograph EVO D

VILLA SISTEMI MEDICALI designs and builds its devices in compliance

Villa Sistemi Medicali cannot be held responsible for:

• the use of Rotograph EVO D different from the intended use

Installation and any technical intervention must only be performed

Only authorised personnel can remove the covers and/or have

Rotograph EVO D 8 (Rev. 4)

(Rev. 4) 9 Rotograph EVO D

Rotograph EVO D 10 (Rev. 4)

3.1.1 Precautions while using laser centring devices

WARNING: PRECAUTIONS WHILE USING LASER CENTRING

(Rev. 4) 11 Rotograph EVO D

3.2 Protection against radiation

It is advisable to control the X-ray emission from a protected area, by

Rotograph EVO D 12 (Rev. 4)

Minimum distance from

Figure 1 - Panoramic version