Acteon X-MIND prime 3D ceph User manual

SERVICE MANUAL • X-MIND prime 3D • (19) • 11/2019 • NXMPEN080A
X-MIND prime 3D
ceph version
Service Manual

Service Manual - Introduction
SERVICE MANUAL • X-MIND prime 3D • (19) • 11/2019 • NXMPEN080A
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Contents
1. INTRODUCTION 7
1.1. Icons appearing in the manual 8
1.2. How to contact Technical Service 9
2. SAFETY INFORMATION 10
2.1 Warnings 11
2.1.1 Precautions while using laser centring devices 13
2.2 Protection against radiation 14
2.3 Information about Electromagnetic Compatibility 15
2.3.1 Electromagnetic emissions 17
2.3.2 Electromagnetic immunity 18
2.4 Cybersecurity measures 19
2.5 Environmental risks and disposal 21
2.6 Symbols used 22
3. CLEANING AND DISINFECTION 24
4. DESCRIPTION 25
4.1 Functions, models and versions 25
4.2 Block diagram 27
4.2.1 Power supply circuit 29
4.2.2 MCU board (A1) 30
4.2.3 Generator board (A2) and Tubehead 33
4.2.4 3D Sensor Power board (A10) 33
4.2.5 CCU Ceph Control Board (A11) 33
4.2.6 Collimator Driver Board (A12) 34
4.2.7 Ceph Driver Board (A13) 34
4.2.8 Ceph sensor power supply board (A14) 34
4.3 Keyboard - Description and functions 36
5. TECHNICAL CHARACTERISTICS 39
5.1 Dimensions 46
5.2 Tube loading curves, anode heating and cooling curves 48
5.3 Characteristics of the supplied workstation 50
5.4 Software 51
5.5 X-MIND prime 3D –PC communication 51
5.6 Separate parts supplied with X-MIND prime 3D 52

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5.7 Reference standard 54
6. PRE-INSTALLATION 56
6.1 Electrical setting up 57
6.2 Packaging 59
6.3 Space requirements 61
6.4 Drilling templates 62
7. INSTALLATION 68
7.1 Mechanical installation 69
7.2 Fuses installation 91
7.3 Electrical connections 92
7.4 How to mount the covers 97
7.4.1 Wall plate cover 97
7.4.2 Upper cover 98
7.4.3 Ceph arm covers 99
7.4.4 Temple supports 100
7.5 Unit full installed 101
7.6 How to position the cables 101
7.7 PC configuration 102
7.7.1 Network Interface board configuration 102
7.7.2 3D sensor Network Interface board configuration 106
7.8 Software installation 110
7.9 Detector Calibration files installation 112
7.10 Verification of the PANORAMIC function 113
7.11 Verification of 3D function 116
7.12 Verification of CEPH function 119
7.13 Verification of exposure parameters 123
7.13.1 Verification of Exposure parameters with invasive method 124
7.13.2 Verification of Exposure parameters with NON invasive method 128
7.14 Storing of automatic exposure parameters 130
7.14.1 Table of pre-set anatomic parameters 132
7.15 Data backup 135
7.16 Exhibition mode setup 136
7.16.1 Graphical User Interface (G.U.I.) demo (without unit connected) 136
7.16.2 Unit movements demo (without PC connection) 137
8. SERVICE PROGRAMS DESCRIPTIONS 142
8.1 Network setting 144
8.2 Exposition 145

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8.3 Logs 146
8.4 Machine configuration and setup 147
9. TROUBLESHOOTING 153
9.1 LEDs 153
9.1.1 MCU board A1 LEDs 153
9.1.2 Generator board A2 LEDs 154
9.1.3 3D Power Sensor board A10 LEDs 155
9.1.4 CCU Ceph Control Board A11 LEDs 155
9.1.5 Collimator Driver Board A12 LED 156
9.1.6 Ceph Driver Board A13 LEDs 157
9.1.7 Ceph sensor power supply board A14 LED 157
9.2 Displayed messages 158
9.2.1 Errors with code from E001 to E003 162
9.2.2 Errors with code from E100 to E104 162
9.2.3 Errors with code from E200 to E299 164
9.2.4 Errors with code from E300 to E399 170
9.2.5 Error with code from E500 to E505 173
9.2.6 Error with code from E600 to E680 174
9.2.7 Error with code from 750 to 770 184
9.2.8 Errors with code E850 and E852 193
9.2.9 Error with code from E1201 to E1205 195
9.2.10 Error with code from 1401 to 1405 195
9.3 User Interface (G.U.I.) messages 204
9.3.1 “Unit and computer not synchronized” 204
9.3.2 “Sensor not ready” 204
9.3.3 “Software error” 204
9.4 System Anomalies 205
9.4.1 White panoramic image or/and empty volumes 205
9.4.2 3D Bad reconstruction 206
9.4.3 Panoramic acquisition with less frames 207
9.4.4 Asymmetries on the panoramic images 207
9.4.5 Unit/MCU connection problems 208
9.4.6 The column does not moves 209
10. PERIODIC MAINTENANCE 210
10.1 Service tools 212
10.2 Sensor Calibration 213
10.2.1 Password generation 223
11. CORRECTIVE MAINTENANCE 226
11.1 Firmware upgrade 226

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11.1.1 MCU Firmware upgrade 226
11.1.2 CCU Firmware upgrade 230
11.2 Checks, settings and adjustment 234
11.2.1 Logs files recover 234
11.2.2 RAW files recovery 240
11.2.3 24V Power supply check 241
11.2.4 Network interface board drivers upgrade 243
11.2.5 EEPROM Memory values verification and modification 247
11.2.6 3D Sensor static IP address setting 249
11.2.7 Ceph sensor IP address modification 251
11.2.8 MCU IP address modification and factory reset 253
11.2.9 Primary collimator alignment 255
11.2.10 3D Reconstruction adjustment 265
11.2.11 Ceph Axis alignment 269
11.2.12 How to remove slight vertical lines on HD and HS ceph images 294
11.3 Parts replacement 308
11.3.1 Fuses replacement 308
11.3.2 MCU board replacement 310
11.3.3 A11 CCU board replacement 312
11.3.4 A2 Generator board replacement 312
11.3.5 A12 Collimator driver board replacement 312
11.3.6 A13 CEPH driver board replacement 312
11.3.7 A14 Ceph sensor board replacement 312
11.3.8 Ceph sensor replacement 312
11.3.9 3D sensor replacement 312
11.3.10 Tube head replacement 315
11.3.11 Column replacement 320
11.3.12 Chin support replacement 326
12. SCHEMATICS AND DRAWINGS 331
13. SPARE PARTS 350
13.1 Top side of the unit 350
13.1.1 Electrical and mechanical part 350
13.1.2 Cable 352
13.2 Rotating arm 353
13.3 Collimator 355
13.4 Chin support 356
13.5 UP/DOWN Column 357
13.5.1 Electrical and mechanical part 357
13.5.2 Cable 359
13.6 TOP side / Rotation arm cables 359

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13.7 Covers 360
13.8 CEPH Arm and Mobile Sensor 362
13.8.1 Electrical - mechanical part & cables 362
13.8.2 Mobile Sensor 365
13.8.3 Covers 366
13.9 Accessories and Service tools 368
14. APPENDIX 370
14.1 Appendix A: Setup parameters table 370
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.

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1. INTRODUCTION
Note
The present manual is updated for the product it is sold with in order to
grant an adequate reference in performing diagnostics and repair
operations normally carried out by the service engineer.
The manual may not reflect changes to the product not impacting service
operations.
This manual provides the instructions for proper and safe installation and
maintenance of the appliance by technical personnel.
This manual is limited to the description of the radiographic equipment; the
instructions for the image acquisition, manipulation and processing are given in
the user manual supplied with the imaging software used with the X-MIND prime
3D unit.
Warning
• The X-MIND prime 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.
• The device must be used in compliance with the procedures described,
and never be used for purposes different from those herewith
indicated.
• The user is liable with regards to the legal fulfilment related to the
installation and the operation of the device.
• Service engineers who install and maintain the device 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 Acteon.
Note
For installation in USA, a report of assembly (Form FDA 2579) must be filled
out to certify that the medical equipment was assembled according to the
instructions provided by the manufacturer, and meets the requirements
of the applicable Federal standards contained in 21 CFR 1020.30 through
1020.33.
Reports must be filed with FDA's Center for Devices and Radiological
Health (CDRH) within 15 days of completion of the assembly. The report
must be filled in according to the methods provided in:
https://www.fda.gov/industry/fda-esubmitter/diagnostic-x-ray-reports-assembly
(remember to check the updated web address since this may change over
time)

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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.

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1.2. How to contact Technical Service
For any technical queries please contact the following:
• Telephone number [phone]
• E-mail: [e-mail]
If a technical service intervention is required it is mandatory to provide Technical
Service the following information:
• Unit Serial Number
• Unit firmware&driver version: MCU, CCU, HF(XCU), ASP (Acteon System
Package), AIS
• Other software version used with X-MIND prime 3D
• Problem description including: condition/unit-state, sequence in which the
anomaly occurs and how it can be reproduced.
• If one or more errors messages are displayed:
- Errors messages numbers.
- Results of all the errors troubleshooting tests.
- Part codes to be replaced (if required by the troubleshooting tests).
- Additional information or data required by the troubleshooting of the
displayed errors.

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2. SAFETY INFORMATION
Warning
Please read this chapter thoroughly.
Acteon designs and manufactures 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 3D 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.
Warning
In compliance with the IEC 60601-1 standard, the modification of the
equipment or its parts is strictly prohibited.

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2.1 Warnings
The device must be used in compliance with the procedures described and never
be used for purposes different from those herewith indicated.
Before performing any maintenance operation, disconnect the unit from the power
supply using the provided circuit breaker.
X-MIND prime 3D is an electro-medical device and therefore it can be used only
under the supervision of suitably qualified medical personnel, with the necessary
knowledge on X-ray protection.
The user is responsible for the fulfilment of the legal requirements regulating the
ownership, installation and use of the equipment itself.
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, be sure that the main power supply has been
disconnected from the equipment. Pushing the ON/OFF button of the equipment,
it mustn't switch on.
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 operator and the
patient, must remain in the room.
X-MIND prime 3D 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.
X-MIND prime 3D must be switched off while using electrosurgical devices or
similar apparatus.
Warning
For safety reasons, it is prohibited to abnormally overload the patient
support arm, for example by leaning on it. The traction force on the handle
shall be less than 16kg.
Warning
To avoid risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
Please clean and disinfect, when necessary, all parts that can be in contact with the
patient.
The centering bite or the bite protective sleeve and the ear pin covers 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 362 because motors are disabled to
permit the patient exit.

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Note
When the unit is switched on, do not move the rotating arm or the tube-
head or secondary collimator or the pan/ceph sensor).
Warning for free standing floor mounted unit
In case the unit shall be moved for service or other extraordinary
operation, maximum caution shall be taken to prevent the unit from tilting
and falling to the ground.

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2.1.1 Precautions while using laser centring devices
For patient positioning, X-MIND prime 3D 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 3D 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 3D 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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2.2 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

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2.3 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 6 L=5 m - code 5007090100
• Ethernet cable CAT 6 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 3D should not be used adjacent to or stacked with other
equipment; if adjacent use is necessary, X-MIND prime 3D 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 .

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Warning
Portable and mobile RF communications equipment should be used no
closer to any part of X-MIND prime 3D, including cables. Minimum distance
30 cm.

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2.3.1 Electromagnetic emissions
In accordance with the IEC 60601-1-2 Ed4 standard, X-MIND prime 3D 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 3D 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 3D 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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2.3.2 Electromagnetic immunity
In accordance with the IEC 60601-1-2 Ed4 standard, X-MIND prime 3D 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
3D 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
3D, including cables.
Minimum distance 30 cm