Acteon X-MIND prime User manual

USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C
X-MIND prime
User Manual

User Manual –Contents
USER MANUAL • X-MIND prime • (19) • 01/2020 • NXMPEN010C
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Contents
1. INTRODUCTION 1
1.1 Icons appearing in the manual 1
2. SPECIFICATION OF THE INTENDED USE 2
2.1 Application and medical purpose 2
2.1.1 Intended patient population 2
2.1.2 Operator Profile 2
2.1.3 Application environments 2
2.2 Applied parts 3
2.3 Typical doses delivered to the patient during extra-oral exams 4
3. SAFETY INFORMATION 6
3.1 Warnings 7
3.1.1 Precautions while using laser centring devices 8
3.2 Protection against radiation 9
3.2.1 Pediatric Use: Summary 10
3.3 Information about Electromagnetic Compatibility 11
3.3.1 Electromagnetic emissions 12
3.3.2 Electromagnetic immunity 13
3.4 Cybersecurity measures 14
3.5 Environmental risks and disposal 15
3.6 Symbols used 16
4. CLEANING AND DISINFECTION 18
5. DESCRIPTION 19
5.1 Identification labels and laser labels 19
5.1.1 Identification labels and laser labels 20
5.2 Functions, models and versions 21
6. TECHNICAL CHARACTERISTICS 22
6.1 Dimensions 28
6.2 Tube loading curves, anode heating and cooling curves 31
6.3 PC requirements 34
6.3.1 PC minimum characteristics 34
6.4 Software 35
6.5 X-MIND prime –PC communication 35
6.6 Reference standard 36
7. QUALITY ASSURANCE PROGRAM 38

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7.1 Quality check tools 39
7.2 Functioning of the indicator lights 40
7.3 Laser alignment check 40
7.4 Image quality check 41
7.4.1 Geometry check 41
7.4.2 Signal to noise check 43
7.5 Dosimetry test (paragraph for authorised personnel) 45
7.6 LOG book 47
7.6.1 Image quality check 47
7.6.2 Verification of radiological parameters 48
8. GENERAL INSTRUCTIONS FOR USE 49
8.1 Switching the device ON and OFF 49
8.1.1 Emergency button 49
8.2 Positioning the chin support 50
8.3 Keyboard - Description and functions 51
8.4 Graphical User Interface - Description and functions 53
8.4.1 Main GUI area functions 55
8.5 Digital sensor 56
8.6 Making an exam 57
8.7 Anatomic / Manual exposure 58
8.7.1 Anatomic exposure 59
8.7.2 Manual exposure 59
8.8 Panoramic and Bitewing exams 60
8.8.1 Laser references 60
8.8.2 Preparation of the device 61
8.8.3 Preparation of the patient 68
8.8.4 Taking an exposure 71
8.8.5 Image processing windows 74
8.9 Sinus exam 77
8.9.1 Preparation of the patient 79
8.9.2 Taking an exposure 81
8.10 TMJ exam 83
8.10.1 Preparation of the device 85
8.10.2 TMJ closed mouth: preparation of the patient 88
8.10.3 Carrying out the first exposure 90
8.10.4 TMJ open mouth: preparation of the patient 92
8.10.5 Carrying out the second exposure 94
8.11 Table of pre-set anatomic parameters 95
9. ERROR MESSAGES 96

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10. MAINTENANCE 99
11. PANORAMIC IMAGE ASSESSMENT 101
11.1 Proper positioning of the patient 102
11.2 Patient positioning errors 104
11.2.1 Turned head 104
11.2.2 Tilted head 105
11.2.3 Downward angulation of the head 106
11.2.4 Backward angulation of the head 107
11.2.5 Tongue effect 108
11.2.6 Spine effect 109
Note
No part of this publication can be reproduced, transmitted, transcribed or
translated without the approval of ACTEON.
This manual in English is the original Manual version.

User Manual –Contents
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User Manual - Introduction
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1. INTRODUCTION
Note
This manual is updated for the product it is sold with, to guarantee an adequate
reference for using the product properly and safely.
The manual may not reflect changes made to the product that do not affect
operating procedures or safety.
X-MIND prime, manufactured by de Götzen, is an X-ray device for the radiographic
analysis of the maxillo-facial complex.
X-MIND prime performs Panoramic, Half-panoramic, Low dose Panoramic, Frontal
dentition, Ortho Rad Panoramic, Bitewing Bilateral, Bitewing Left and Bitewing Right,
Sinus and TMJ of the maxillo-facial complex.
The aim of this Manual is to instruct the user on the safe and effective use of the device.
The device must be used complying with the procedures described in this Manual and
never be used for purposes other than those indicated herein.
Please read this Manual thoroughly before starting to use the unit; it is advisable to keep
the manual close to the device, for reference while operating.
X-MIND prime is an electrical medical device and can only be used under the supervision
of a physician or of highly qualified personnel, with necessary knowledge of X-ray
protection. The user is liable for legal compliance in relation to the installation and
operation of the device.
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 safety
aspects of the patient and/or operator.

User Manual –Specification of the intended use
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2. SPECIFICATION OF THE INTENDED USE
2.1 Application and medical purpose
X-MIND prime is an extra-oral dental panoramic X-ray unit to radiograph teeth, jaw and
oral structures.
The device is operated and used by dentists, radiologists and other legally qualified
health care professionals. It can be used with both paediatric and adult patients.
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
X-MIND prime system can be used with the following type of patient:
• Age: paediatric (from about 7 years) to geriatric
• Patient status:
 self-sufficient patient (the patient can autonomously place himself as requested
by the physician)
 non self-sufficient patient (the patient is assisted by medical personnel).
 In any case the patient must be conscious, not anaesthetized and not
incapacitated
• Nationality: multiple.
2.1.2 Operator Profile
This system may only be operated by persons who have suitable experience in radiation
protection or knowledge of radiation protection and who have been instructed in the
operation of the X-ray equipment.
2.1.3 Application environments
X-MIND prime may be used in professional buildings (e.g. hospitals, private clinics) or in
residential buildings. For the purpose of EMC environment classification both
installations are classified as "Professional healthcare facility environment".
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.).

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2.2 Applied parts
During normal use, X-MIND prime is in contact with the patient via the handle, the chin
rest and bite and the temple clamp, classified as Type B applied parts.

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2.3 Typical doses delivered to the patient during extra-
oral exams
The air kerma at the entrance of the X-ray image receptor for the standard PANORAMIC
exam is:
mA
2
2.2
2.5
2.8
3.2
3.6
4
4.5
5
5.6
6.3
7.1
kV
Air Kerma [mGy]
60
2.54
2.79
3.17
3.55
4.06
4.56
5.07
5.70
6.34
7.10
7.99
9.00
62
2.65
2.91
3.31
3.71
4.24
4.77
5.30
5.96
6.62
7.41
8.34
9.40
64
2.87
3.16
3.59
4.02
4.60
5.17
5.75
6.46
7.18
8.05
9.05
10.20
66
3.10
3.41
3.87
4.34
4.96
5.58
6.20
6.97
7.75
8.68
9.76
11.00
68
3.24
3.56
4.05
4.54
5.18
5.83
6.48
7.29
8.10
9.07
10.20
11.50
70
3.52
3.89
4.40
4.93
5.63
6.34
7.04
7.92
8.80
9.86
11.10
12.50
The air kerma for the other exams available on the equipment can be calculated using
the ratios in the table below:
Exam
Ratio
Child panoramic
0.92
Child half-panoramic
0.52
Child low dose
0.77
Half-panoramic
0.55
Low Dose
0.85
Ortho Rad panoramic
0.90
Frontal dentition
0.33
Bitewing L or R
0.24
Bitewing L and R
0.47
TMJ
0.71
Sinus
0.65

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The dose per area of products delivered by X-MIND prime 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 taken 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 (the typical size
of the X-ray beam on the imaging sensor is 140 mm x 4.5 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.
The overall uncertainty of the indicated value of the air Kerma 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 Manual –Safety information
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3. SAFETY INFORMATION
Warning
Please read this chapter thoroughly.
Acteon designs and manufacture its devices in compliance with safety requirements;
furthermore it supplies all information necessary for correct use, and warnings related to
dangers associated with X-ray generating units.
Acteon cannot be held liable for:
•Use of X-MIND prime other than its intended use
•Damage to the unit, the operator or the patient, caused both by installation and
maintenance procedures other than those described in this Manual and in the
Service Manual supplied with the unit, and by erroneous operations
•Mechanical and/or electrical modifications performed during and after the
installation, other than those described in the Service Manual.
Installation and any technical operations must only be performed by qualified technicians
authorised by Acteon.
Only authorised personnel may remove the covers and/or have access to live
components.
The responsibility for the quality assurance program is defined in chapter 7.
Acteon provides specific training for service engineers.
Acteon technical support sends to all authorized dealer training course calendar.
One copy of User and Service Manual are always provided with the unit.
Warning
In compliance with the IEC 60601-1 standard, the modification of the equipment
or its parts is strictly prohibited.

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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.
X-MIND prime 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.
The user is responsible for a safe set-up and maintenance of the host PC; as a general
guidance cybersecurity suggestions are given in paragraph 3.4 of this Manual.
The user is responsible for the execution of the routine quality control procedure
described in chapter 7 of this Manual.
This device has not been designed for use in environments where vapours, anaesthetic
mixtures flammable with air, or oxygen and nitrous oxide, may be present.
Do not let water, or other liquids, penetrate the device, as this could cause short circuits
and corrosion.
Before cleaning the device, make sure the main power supply has been disconnected
from the equipment. When pushing the ON/OFF button of the equipment, it must not
come on.
Wherever necessary, use appropriate accessories, such as leaded aprons, to protect the
patient from radiation.
While performing the X-ray, no-one, apart from the operator and the patient, must remain
in the room.
X-MIND prime has been built for continuous operation with an intermittent load; so the
described use cycles must be observed, to enable the device to cool down.
X-MIND prime must be switched off while using electrosurgical devices or similar
apparatus.
Warning
For safety reasons, the patient support arm must not be abnormally overloaded,
for example by leaning on it. The traction on the handle must be less than 16
kg.
Warning
To avoid the risk of electric shock, the equipment must only be connected to a
mains supply with earthing.
Clean and disinfect, when necessary, all parts that may come into contact with the
patient.
The centring bite or the bite protective sleeve must be replaced after each exam.
To avoid permanent damage to the unit, never try to rotate the moving arm manually
when the unit is switched on.
In the case of Error 362 or Error 760, movement is possible to let the patient exit.
Note
When the unit is switched on, do not move the rotating arm.

User Manual –Safety information
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3.1.1 Precautions while using laser centring devices
For patient positioning, X-MIND prime uses two laser diodes with optical power on the
working surface < 1 mW.
The directive CEI-EN 60825-1 defines the laser as "any device that produces or amplifies
electromagnetic radiation in a coherent manner which includes a wave lengths from 180
nm to 1 mm by means of a stimulated emission". In reference to this directive, the lasers
present on the X-MIND prime are parts of class 2.
A laser in class 2 can be potentially dangerous if the ray is reflected into not protected
eyes by a mirror, watch, a ring etc.
The warning label below is affixed to X-MIND prime to indicate a laser in class 2 is
mounted internally and caution is advised:
Warning
• 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 exam, the patient must remove earrings, glasses,
necklaces and any other item that 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 only be performed by authorized
technicians.
• Operations other than those indicated could cause the emission of
dangerous non-ionizing radiation.

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

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3.2.1 Pediatric Use: Summary
3.2.1.1 Introduction
Special care should be exercised when imaging patients outside the typical adult size
range, especially smaller pediatric patients whose size does not overlap the adult size
range (e.g., patients less than 50kg (110lb) in weight and 150cm (59") in height,
measurements, which approximately correspond to that of an average 12 years old or a
5th percentile U.S. adult female).
3.2.1.2 References for pediatric dose optimization
The following resources provide information about pediatric imaging radiation safety
and/or radiation safety for extra-oral dental panoramic and CBCT (aka CBVT) X-ray
devices:
1. HTTPS://WWW.FDA.GOV/RADIATION-
EMITTINGPRODUCTS/RADIATIONEMITTINGPRODUCTSANDPROCEDURES/
MEDICALIMAGING/UCM298899.HTM
2. www.imagegently.org
3. HTTPS://WWW.FDA.GOV/RADIATION-
EMITTINGPRODUCTS/RADIATIONEMITTINGPRODUCTSANDPROCEDURES/
MEDICALIMAGING/MEDICALX-RAYS/UCM315011.HTM
4. https://www.iaea.org/resources/rpop/resources/training-material#11
5. HTTPS://WWW.IAEA.ORG/RESOURCES/RPOP/RESOURCES/TRAINING-
MATERIAL#3
3.2.1.3 Device specific features and instructions
X-MIND prime provides as standard with all units, the following specific design features
and instructions that enable safer use of our device with pediatric patients:
Design features important to paediatric imaging
Paragraph
Adult/Child exam modality: child selection adapts exposure
current (mA) and High voltage (kV) reducing the overall dose
supplied to the patient.
8.4 and 8.11
For the panoramic exams (panoramic, half-panoramic and low
dose panoramic programs) Child selection also corresponds to a
reduced trajectory exam time giving a further 10% of dose
reduction.
8.11
A function to run the exam in test mode without X-ray to check
the behaviour of the patient during the exam and reduce the
possibility of exam interruption and retake
8.6 and 8.8.3

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3.3 Information about Electromagnetic Compatibility
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.
The equipment can be installed both in professional buildings (e.g. hospitals or clinics)
and in residential buildings. Residential buildings, according to IEC 60601-1-2 4th
edition, are intended to be connected to dedicated power supply system (normally fed
by separation transformers).
For the purpose of EMC environment classification according to IEC 60601-1-2 4th
edition, both installations are classified as "Professional healthcare facility environment".
The EMISSIONS characteristics of this equipment make it suitable for use in industrial
areas and hospitals (CISPR 11 class A). If it is used in a residential environment (for
which CISPR 11 class B is normally required) this equipment, even if it is usually
permanently installed in X-Ray shield locations, might not offer adequate protection to
radio-frequency communication services. If abnormal performance is observed, such as
degradation of essential performance in the form of lack of accuracy of exposure
parameters and lack of reproducibility of exposure parameter, additional measures may
be necessary, such as re-orienting or relocating the device.
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.
Warning
X-MIND prime should not be used adjacent to or stacked with other equipment;
if adjacent use is necessary, X-MIND prime has to be observed to verify if it
operates in a normal way.
Interference may occur in the vicinity of equipment marked with the symbol
.
Warning
Portable and mobile RF communications equipment should be used no closer
to any part of X-MIND prime, including cables. Minimum distance 30 cm.

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3.3.1 Electromagnetic emissions
In accordance with the IEC 60601-1-2 Ed4 standard, X-MIND prime is suitable for use in
the electromagnetic environment specified below.
The customer or user of the system must ensure that it is used in the said environment.
Emissions test
Compliance
Electromagnetic environment
RF emissions
CISPR 11
Group I
X-MIND prime uses RF energy only for its
internal function. Therefore, its R.F.
emissions are very low and are not likely to
cause any interference in nearby electronic
equipment.
Class A
X-MIND prime is suitable for use in all
establishments other than domestic and
those directly connected to the public low
voltage power supply network that supplies
buildings used for domestic purposes.
Harmonics emissions
IEC 61000-3-2
Class A
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Complies

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3.3.2 Electromagnetic immunity
In accordance with the IEC 60601-1-2 Ed4 standard, X-MIND prime is suitable for use in
the electromagnetic environment specified below.
The customer or user of the system must ensure that it is used in the said environment.
Immunity
test
IEC 60601-1-2
test level
Compliance
level
Electromagnetic
environment
Electrostatic
discharge (ESD)
IEC 61000-4-2
8 kV contact
2/4/8/15 kV air
IEC 60601-1-
2
Test level
Floors should be wood,
concrete or ceramic tile. If
floors are covered with
synthetic material, the relative
humidity should be at least
30%
Radiated
electromagnetic
field
IEC 61000-4-3
3 V/m
80 MHz to 2.7 GHz
IEC 60601-1-
2
Test level
Portable and mobile RF
communications equipment
should be used no closer to
any part of X-MIND prime
including cables.
Minimum distance 30 cm
Electrical fast
transient/burst
IEC 61000-4-4
2 kV for power
supply lines
1 kV for
input/output lines >
3 m
IEC 60601-1-
2
Test level
Mains power quality should be
that of a typical commercial or
hospital environment
Surge
IEC 61000-4-5
0.5/1 kV differential
mode
0.5/1/2 kV common
mode
IEC 60601-1-
2
Test level
Mains power quality should be
that of a typical commercial or
hospital environment
Conducted
disturbances
induced by RF
fields
IEC 61000-4-6
3 V
150 kHz to 80 MHz
6 V
ISM frequencies
IEC 60601-1-
2
Test level
Portable and mobile RF
communications equipment
should be used no closer to
any part of X-MIND prime,
including cables.
Minimum distance 30 cm
Voltage dips,
short
interruptions and
voltage
variations on
power supply
input lines
IEC 61000-4-11
10 ms –0 % a 0°,
45°, 90°, 135°,
180°, 225°, 270°,
315°
20 ms –0% a 0°
500 ms –70% a 0°
5 s –0%
IEC 60601-1-
2
Test level
Mains power quality should be
that of a typical commercial or
hospital environment. If the
user of X-MIND prime
requires continued operation
during power mains
interruptions, it is
recommended that X-MIND
prime be powered from an
uninterruptible power supply
or a battery
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
30 A/m
IEC 60601-1-
2
Test level
Power frequency magnetic
fields should be at levels
characteristics of a typical
location in a typical
commercial or hospital
environment

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3.4 Cybersecurity measures
Like all computer-based systems, X-MIND prime might be exposed to Cybersecurity
threats.
X-MIND prime is equipped with hardware provisions that make sure that no unwanted
X-ray exposure, laser radiation or motorized movements can be activated even in case
of cyber-attack or software failure.
Nevertheless, in order to minimize the possibility of cyber-attacks, it is the user
responsibility to make sure that the following protection measures are followed.
• The initial software installation and system set-up shall be done by authorized and
trained personnel only and using the software provided with the machine
• Any software or firmware upgrade of the equipment shall be done by authorized and
trained personnel only
• After any software or firmware upgrade, or any other maintenance operation, image
quality checks shall be performed to ensure the system is working as expected.
Instructions are given in chapter 7
• 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 (if the system is supplied with a PC, the Windows user is
password-protected, but it is user responsibility to change the default password and
set new ones for all the different users that will have access to the system)
• 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 (if the system
is supplied with a PC, the screen saver is activated by default)
• Install an antivirus software and keep virus definitions up to date
• Activate the windows firewall on the host PC (if the system is supplied with a PC,
the Windows firewall is activated by default)
• It is recommended to activate a hardware firewall on the WAN router/modem used
for internet connection, if present
• Make sure that all other PCs 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 that
they are free of viruses, malware or any dangerous software
• Avoid installation of an unknown or untrusted software since it may undermine the
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