CEFLA NewTom VGi evo User manual

97050725
Rev. 6
05.02.2017
NewTom VGi evo - Service Manual
EN

NOTES
This document is provided as a consultation manual intended for the device technicians.
CEFLA s.c. follows a policy based on the constant development and update of the product. For this reason, it
reserves the right to change the content of this manual without prior notice.
This document can not be modified, copied, reproduced, distributed, saved on magnetic or optical supports,
or published on websites and other on-line services, in full or in part, without the prior written authorisation of
CEFLA s.c.
The original version of this manual is in English.
NEWTOM™ VG is a trade mark of CEFLA s.c.
All other products and trade names mentioned in this document are registered marks of the relevant
manufacturers.
INFORMATIVE NOTE OF THE MANUFACTURER ON THE MEDICAL DEVICES
The medical device referred to in this manual consists of a scanner and a control, display and calculation unit
(Main Workstation). Such device, as delivered and configured by the production and assistance technical
personnel, is an X-ray device compliant with the safety requirements set forth by the Italian Legislative Decree
of 19 September 1994, no. 626 implementing Directives 89/391/EEC, 89/654/EEC, 89/655/EEC, 89/656/EEC,
90/269/EEC, 90/270/EEC, 90/394/EEC and 90/679/EEC concerning the improvement of the health and safety
of workers in the workplace, and with the essential requirements set forth by the Italian Legislative Decree 24
February 1997, no. 46 implementing Directive 93/42/EEC as amended, on the medical devices.
The medical device referred to in this manual is an X-ray device compliant with Directive 2011/65/EU on the
restriction of the use of certain hazardous substances in electrical and electronic equipment.
Any tampering with, modification, updating or other change both of hardware1and software2of the device as
supplied and installed by the company (and in the conditions specified in the attached documentation) may
partially or totally compromise the device expected operation. This may also alter the safety features with
consequent hazard increase for patients, operators and surrounding environment.
For this reason, should the user need to modify the device, he/she must request a written authorisation by
CEFLA s.c.
Failure to comply with what is specified in this informative note will null and void the device warranty and the
civil and/or penal responsibility for any consequent damage and/or accident and/or worsening of the patient,
operator or other people health (including the surrounding environment) will be borne by the person who
tampered with the device or his/her legal representative.

1
Adding of a new memory expansion, a new hardware on the connection bus, a printer, the
replacement of the graphic display interface represents an important modification.
2
Including the operative system and the applications already installed upon medical device delivery.
Automatic updates of the operative system, changes to network connection parameters, modification
and/or addition and/or removal of interface software with hardware (device driver) and/or services (e.g.
file and printer sharing service) and/or applications represent an important modification.

SUMMARY
1ABOUT THIS MANUAL.......................................................................................................................... 1-1
CONTENTS.............................................................................................................................................. 1-1
STRUCTURE ............................................................................................................................................1-1
ATTACHED DOCUMENTS........................................................................................................................... 1-1
CONVENTIONS USED IN THIS MANUAL........................................................................................................1-2
TYPHOGRAPHY........................................................................................................................................ 1-2
2SAFETY INFORMATIONS............................................................................................................................... 2-1
GENERAL SAFETY....................................................................................................................................2-1
ELECTRICAL SAFETY................................................................................................................................2-2
2.2.1 Input power connection ......................................................................................................................2-4
SAFETY INSPECTION GUIDE ...................................................................................................................... 2-4
HANDLING ELECTROSTATIC DISCHARGE-SENSITIVE DEVICES ....................................................................2-5
GROUNDING REQUIREMENTS.................................................................................................................... 2-5
X-RAY WARNINGS.................................................................................................................................... 2-6
LASER WARNINGS....................................................................................................................................2-6
SPECIAL SAFETY NOTES...........................................................................................................................2-6
3GENERAL INFORMATION ............................................................................................................................. 3-1
SYMBOLS ON THE PACKAGE .....................................................................................................................3-1
SYMBOLS ON THE LABELS ........................................................................................................................3-2
ENABLING THE SERVICE LEVEL ................................................................................................................. 3-3
OPENING THE “GENERAL SETTINGS”WINDOW........................................................................................... 3-3
4SYSTEM OVERVIEW..................................................................................................................................... 4-1
CABLES ..................................................................................................................................................4-2
5INSTALLATING THE SYSTEM ......................................................................................................................... 5-1
6CONSOLE PREPARATION.............................................................................................................................. 6-1
7NETWORKING ............................................................................................................................................ 7-1
8CALIBRATING THE SYSTEM........................................................................................................................... 8-1
CHINREST CALIBRATION...........................................................................................................................8-1
TIN CALIBRATION....................................................................................................................................8-3
VERIFYING THE CALIBRATION.................................................................................................................... 8-5
HEAD REST CALIBRATION........................................................................................................................8-8
8.4.1 QA scan acquisition ............................................................................................................................8-8
8.3.3 Laser alignment ................................................................................................................................8-9
CALIBRATION BACKUP............................................................................................................................8-11
VIEW CALIBRATION ................................................................................................................................8-11
FACTORY BACKUP FOLDER.....................................................................................................................8-11
9MAINTENANCE OF THE SYSTEM ................................................................................................................... 9-1
REMOTE ASSISTANCE SUPPORT................................................................................................................9-1
REPLACING THE COMPUTER .....................................................................................................................9-2
ROTATING ARM........................................................................................................................................9-3
9.3.1 Running a motor test...................................................................................................................... 9-3
TESTING THE LIMIT SWITCHES...................................................................................................................9-4
TESTING THE MOTOR CONTROLLER POWER SUPPLY...................................................................................9-5
MODIFYING THE FLAT PANEL IP ADDRESS..................................................................................................9-5
REPLACING THE X-RAY SOURCE AND INVERTER.........................................................................................9-7
UNCORRECTED PIXEL MANAGEMENT.........................................................................................................9-8
REPLACING THE FLAT PANEL DETECTOR..................................................................................................9-12
REGULATING THE MOTOR CONTROLLER FOR VERTICAL SCANNER MOTION...............................................9-13
KVCURVE ...........................................................................................................................................9-17
MACURVES.........................................................................................................................................9-17
ADJUSTING THE COLLIMATOR ...............................................................................................................9-20
IMAGE BY IMAGE CHECK.......................................................................................................................9-24

LASER VOLTAGE..................................................................................................................................9-24
CONSOLLE ..........................................................................................................................................9-25
DAILY CHECK...................................................................................................................................... 9-26
10 BOARDS LAYOUT...................................................................................................................................10-1
CONTROL BOX ....................................................................................................................................10-1
INVERTER............................................................................................................................................ 10-3
11 TROUBLESHOOTING ..............................................................................................................................11-1
NNT LOG ERROR VIEWER (ONLY FROM NNT 8.0)..................................................................................11-2
PHANTOM ANALYSIS ............................................................................................................................11-3
12 EXTRANET SITE .....................................................................................................................................12-1

About this manual
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NewTom VGi evo – Service Manual rev 6 1-1
1 About this manual
Contents
This manual has been prepared to provide informations and instructions regarding the installation, use, maintenance,
and troubleshooting of the device “NewTom VGi evo”. This manual comprises all versions of the series.
This manual is intended only for trained personnel recognized by the manufacturer of the “NewTom VGi evo” device.
Before servicing the “Newtom VGi evo” device, be sure to read and understand all the information under Chapter 2
“Safety information” and Chapter 3 “General information”.
Keep this and other associated manuals for future reference and for new operators or qualified service personnel.
Structure
This manual contains the following chapters:
Chapter 1 - “About this manual”:
provides general information about the structure of the manual and the conventions used.
Chapter 2 –“Safety information”:
provides guidelines, and safety information required servicing the machine.
Chapter 3 –“General information”:
includes information about the labels used for the shipment and located on the equipment, and an overview of
the service window on the software.
Chapter 4 –“System overview”:
provides a general description of the equipment.
Chapter 5 –“Installating the system”:
describe the procedures to follow to unpack, disassemble, move the equipment and perform a correct
installation of a “NewTom VGi evo”. Some procedures make reference to the "Installation Manual".
Chapter 6 –“Console preparation”:
describes the procedure for a console preparation of the system.
Chapter 7 –“Networking”:
provides general information about the installation of the system inside a network
Chapter 8 –“Calibrating the system”:
describes the procedure for a complete calibration of the system.
Chapter 9 –“Maintenance of the system”:
provides procedures in order to test and perform the maintenance of the machine.
Chapter 10 –“Boards Layout”:
Shows the layout of the board installed in the control box.
Chapter 11 –“Troubleshooting”:
provides guidelines to solve problem or failure that could happen.
Chapter 12 –“Extranet site”
describes how to access to the documentation included in the extranet site http://extranetmedical.cefla.it.
Attached documents
The following documents are attachments of this manual:
- “VGi evo - Installation Manual”Cod. 97070043
- “Workstation Setup annex” Cod. 97050818

About this manual
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NewTom VGi evo – Service Manual rev 6 1-2
Conventions used in this manual
The general safety information in this part of the manual is for servicing personnel. Specific warning and cautions will be
found throughout the manual where they apply.
DANGER/WARNING:
Statements in manual identifying conditions or practices that could
result in personal injury.
CAUTION:
Statements in manual identifying conditions or practices that
could result in damage to the equipment or other property.
IMPORTANT:
Statements in manual providing instructions that MUST be followed
to complete a task.
NOTE:
Tips and additional information to help to perform a task.
Typhography
Bold text
Indicates a menu label or an item to select
Italics
Used to emphasize a word or a phrase
<Key>
<Key1+Key2>
Key enclosed in the less-than and greater-than sign means that you
must press the enclosed key.
If you must press two or more keys simultaneously, the key names are
linked with a plus sign (+)
Example: <Ctrl+Alt+D>
Command
Means that you must type the command exactly as shown, then supply
the required item or value enclosed in brackets.

Safety information
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NewTom VGi evo – Service Manual rev 6 2-1
2 Safety informations
The following section contains the safety information that you need to be familiar with before servicing a “NewTom VGi
evo”. Additional information are included inside the “User Manual”.
General safety
Follow these rules to ensure general safety:
Observe good housekeeping in the area of the machines during and after maintenance.
When lifting any heavy object:
1) Ensure you can stand safely without slipping.
2) Distribute the weight of the object equally between your feet.
3) Use a slow lifting force. Never move suddenly or twist when you attempt to lift.
4) Lift by standing or by pushing up with your leg muscles; this action removes the strain from
the muscles in your back. Do not attempt to lift any objects that you think are too heavy for you.
Do not perform any action that causes hazards to the customer, or that makes the equipment unsafe.
Perform an installation that achieve a optimal use. Care to
Obstacles do motorized motion,
Mechanical damage of connecting cable,
Patient-operator visibility,
Device accessibility for maintenance and cleaning, etc.
Before you start the machine, ensure that other service representatives and the customer's personnel are not
in a hazardous position.
Place removed covers and other parts in a safe place, away from all personnel, while you are servicing the
machine.
Keep your tool case away from walk areas so that other people will not trip over it.
Do not wear loose clothing that can be trapped in the moving parts of a machine. Ensure that your sleeves are
fastened or rolled up above your elbows. If your hair is long, fasten it.
Insert the ends of your necktie or scarf inside clothing or fasten it with a non-conductive clip.
Do not wear jewelry, chains, metal-frame eyeglasses, or metal fasteners for your clothing.
Wear safety glasses when you are: hammering, drilling soldering, cutting wire, using solvents, or working in any
other conditions that might be hazardous to your eyes.
Follow all cautions and instructions marked on the equipment.
Do not under any circumstances, remove any Caution, Warning or any other descriptive labels from the device
until the conditions warranting the label are eliminated.
To avoid fire or explosion, do not operate this device in an explosive environment or near flammable anesthetics.
After service, reinstall all safety shields, guards, labels, and ground wires. Replace any safety device that is worn
or defective.

Safety information
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NewTom VGi evo – Service Manual rev 6 2-2
Reinstall all covers correctly before returning the machine to the customer.
Do not under any circumstances make mechanical or electrical modifications to the equipment. Manufacturer
is not responsible for regulatory compliance of a modified product.
Connect to the device only computers, computer peripherals and cables in compliance to the manufacturer
specifications.
CAUTION:
There are no user serviceable parts inside the unit.
Broken and/or defective parts must be returned to manufacturer and
replaced with spare part approved by the manufacturer or distributor.
CAUTION:
For continued protection against risk of fire, replace only with same
type and rating of fuse.
Electrical safety
Observe the following rules when working on electrical equipment.
WARNING:
The “Newtom VGi evo” is an equipment, containing high voltage
devices and must be opened only by qualified personnel, authorized
by CEFLA s.c.
WARNING:
Use only approved tools and test equipment. Some hand tools have
handles covered with a soft material that does not insulate you when
working with live electrical currents.
WARNING:
Metal objects are good electrical conductors.
Find the room emergency power-off (EPO) switch, disconnecting switch, or electrical outlet.
If an electrical accident occurs, you can then operate the switch or unplug the power cord quickly (if applied).
Do not work alone under hazardous conditions or near equipment that has hazardous voltages.
Disconnect all power before:
1. Performing a mechanical inspection
2. Working near power supplies
3. Removing or installing main units
Before you start working on the machine, unplug the power cord. If you cannot unplug it, ask the customer to
power-off the wall box that supplies power to the machine and to lock the wall box in the off position.

Safety information
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NewTom VGi evo – Service Manual rev 6 2-3
If you need to work on an exposed electrical circuit, observe the following precautions:
Ensure that another person, familiar with the power-off controls, is near you.
WARNING:
Another person must be there to switch off the power, if necessary.
Use only one hand when working with powered-on electrical equipment; keep the other hand in your
pocket or behind your back.
NOTE:
There must be a complete circuit to cause electrical shock.
By observing the above rule, you may prevent a current from passing
through your body.
When using testers, set the controls correctly and use the approved probe leads and accessories for that
tester.
Stand on suitable rubber mats (obtained locally, if necessary) to insulate you from grounds such as metal
floor strips and machine frames.
Regularly inspect and maintain your electrical hand tools for safe operational condition.
Never push objects of any kind through openings in the equipment. Dangerous voltages may be present.
Conductive foreign objects could produce a short circuit that could cause fire, electric shock, or damage to
your equipment.
Do not use worn or broken tools and testers.
Never assume that power has been disconnected from a circuit. First, check that it has been powered-off.
Always look carefully for possible hazards in your work area. Examples of these hazards are moist floors, no-
grounded power extension cables, power surges, and missing safety grounds.
Do not use household extension cords to supply the console workstation or the equipment.
Do not touch live electrical circuits with the reflective surface of a plastic dental mirror. The surface is
conductive; such touching can cause personal injury and machine damage.
To avoid electrical shock hazard, do not remove covers or panels when power is supplied to the device.
Do not under any circumstances remove the ground wire from any power plug.
Do not service the following parts with the power on when they are removed from their normal operating
places in a machine:
- X-Ray source
- X-Ray Detector
- All the electronic boards

Safety information
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NewTom VGi evo – Service Manual rev 6 2-4
If an electrical accident occurs:
- Use Caution: do not become a victim yourself.
- Switch Off power.
- Send another person to get medical aid.
Never connect to the system any other parts or accessories not specified from the manufacturer.
Install the equipment in a way that an optimal usage can be made by the operator. (Easy cleaning, servicing
and patient positioning).
2.2.1 Input power connection
Consider the following precautions:
Follow rigorously the instructions included in the “VGi evo - Installation Manual” about the permanent power
cord connection. Do not connect the cable to any plug or follow any other type of connection not specified in
the aforementioned manual.
Not all power cords have the same current ratings. Household extension cords do not have overload protection
and are not meant for use with this device. Do not use household extension cords with this product.
In order to remove all power from this unit power-off the wall box that supplies power to the machine and lock
the wall box in the off position.
Safety inspection guide
The intent of this inspection guide is to assist you in identifying potentially unsafe conditions of the device.
When inspecting a machine good judgment should be used to identify potential safety hazards.
If any unsafe conditions are present, you must determine how serious the apparent hazard could be and whether you
can continue without first correcting the problem.
Consider these conditions and the safety hazards they present:
Electrical hazards, especially primary power (primary voltage on the frame can cause serious or fatal electrical
shock).
Explosive hazards, such as a damaged or bulging capacitor
Mechanical hazards, such as loose or missing hardware
Checklist:
1. Check exterior covers for damage (loose, broken, or sharp edges).
2. Power Off the machine. Disconnect the power cord in case of detachable cable or power-off the wall box
3. Check the power cord for:
a) A third-wire ground connector in good condition.
b) The power cord should be the appropriate type.
c) Insulation must not be frayed or worn.
4. Remove the cover.

Safety information
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NewTom VGi evo – Service Manual rev 6 2-5
5. Check for any obvious alterations. Use good judgment as to the safety of any alterations.
6. Check inside the unit for any obvious unsafe conditions, such as metal filings, contamination, water or other
liquids, or signs of fire or smoke damage.
7. Check for worn, frayed, or pinched cables.
8. Check for loosen or missing bolts.
Handling Electrostatic Discharge-Sensitive Devices
Any boards containing transistors or integrated circuits (ICs) should be considered sensitive to electrostatic discharge
(ESD). ESD damage can occur when there is a difference in charge between objects.
Protect against ESD damage by equalizing the charge so that the machine, the part, the work mat, and the person handling
the part are all at the same charge.
NOTES:
1) Use product-specific ESD procedures when they exceed the
requirements noted here.
2) Make sure that the ESD protective devices you use have been
certified (ISO 9000) as fully effective.
When handling ESD-sensitive parts:
Keep the parts in protective packages until they are inserted into the product.
Avoid contact with other people.
Wear a grounded wrist strap against your skin to eliminate static on your body.
Prevent the part from touching your clothing. Most clothing is insulate and retains a charge even when you are
wearing a wrist strap.
Use the black side of a grounded work mat to provide a static-free work surface. The mat is especially useful
when handling ESD-sensitive devices.
Select a grounding system to provide protection that meets the specific service requirement.
NOTE:
The use of a grounding system is desirable but not required to protect
against ESD damage.
Grounding requirements
Electrical grounding of the machine and computer is required for operator safety and correct system function. Proper
grounding of the electrical outlet can verified by a certified electrician.

Safety information
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NewTom VGi evo – Service Manual rev 6 2-6
X-Ray warnings
This equipment is a radiological device that can expose the personnel to the risk resulting from ionizing radiation. It must
be used in compliance with safety regulations, required by current radioprotection regulations in accordance with local
laws.
WARNING:
The use of controls, adjustments, or the performance of procedures
other than those specified herein may result in hazardous radiation
exposure.
WARNING:
In the “NewTom VGi evo” an X-Ray source is present. Each action,
which causes the switching on of the NewTom 5G, must be performed
by qualified personnel, trained on the dangers and risks connected
with X-Rays for people.
Before switching on the “NewTom VGi evo”, verify that the radiation
protection regulations for environment, people and operators safety
are respected.
Laser warnings
The device is equipped with cross shaped positioning laser. The beam is emitted from the front cover aperture.
WARNING:
Do not disassemble the optical instrument or attempt to perform any
internal servicing.
WARNING:
Do not stare into the laser beams, do not view directly with optical
instruments, and avoid direct exposure to the beam. The beams can
cause permanent eye damage.
WARNING:
Keep your eyes at least 40mm from the laser when the beam is on. If
necessary, use appropriate protective glasses.
WARNING:
The use of controls, adjustments, or the performance of procedures
other than those specified herein may result in hazardous radiation
exposure.
Special safety notes
For the Chinese market the computer, monitor and power cables MUST be CCC (China Compulsory Certification)
approved.
They must be consistent to the specifications included in the attached document “Console preparation“.

General information
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NewTom VGi evo – Service Manual rev 6 3-1
3 General information
Symbols on the package
The following table illustrates the symbols used for the shipment of the equipment:
Symbol
Meaning
FRAGILE
THIS WAY UP
KEEP AWAY FROM RAIN
DO NOT STACK
TEMPERATURE LIMITS

General information
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NewTom VGi evo – Service Manual rev 6 3-2
Symbols on the labels
Next table provides a description of the symbols included on the device’s labels.
Symbol
Standard
Description
IEC 60417-5010
ON / OFF (push-push)
~
IEC 60417-5032
Alternating current
ISO 7000-0434A
Caution
ISO 7010-W001
General warning sign
IEC 60878
ISO 3864-B.3.6
Warning: dangerous voltage
IEC 60417-5019
Protective earth (ground)
IEC 60417-5017
Earth (ground)
N
IEC 60445
Connection point for the neutral conductor on
permanently installed equipment
L
IEC 60445
Connection point for the line conductor on
permanently installed equipment
IEC 60417-5841
Defibrillation-proof type B applied part
ISO 361
Ionizing radiations
Directive
2002/96/CE
WEEE - Waste from Electrical and Electronic
Equipment Symbol
Directive 93/42/CEE
CE Mark
EN 980:2008
Serial Number

General information
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NewTom VGi evo – Service Manual rev 6 3-3
EN 980:2008
Date of manufacture
EN 980:2008
Manufacturer
ISO 7000-1641
Operating instructions
ISO 7010-M002
Refer to instruction manual/booklet
Enabling the service level
In order to enable the service level, first left click on the NNT main window and then press CTRL + ALT + SHIFT + END on
the keyboard:
The service level is automatically disabled, every time the software is closed.
Opening the “General Settings” window
Through the “General Setting” window is possible to access to different parameters related to the device. The appearance
of the window may differ depending on the current software level (user or service).
To open the “General Setting” window proceed as following:
1. Open the software and press <ALT + F10>.
2. In the “Insert Password” window that will appear type “336699” and select the “OK” button.
The “General Setting” window will appear.

System overview
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NewTom VGi evo – Service Manual rev 6 4-1
4 System overview
The “NewTom VGi evo” is a cone beam computed tomography x-ray system.
It is intended for diagnostic use obtaining geometric information and radiologic density from two-dimensional and three-
dimensional images of objects in the examined area.
Through a scan process the system acquires the data which, after have been stored inside a computer, are used by the
software to reconstruct the volume of the patient’s anatomical parts.
SCANNER
CONTROL
BOX
WORKSTATION
Fig. 1:“Newtom VGi evo” system
The system can be divided in 3 main components:
Console workstation
Scanner unit
Control Box
The console workstation is the computer that controls the scanner. In order to do that, the console runs a dedicated
software that provides the user interface to run and monitor the scanner unit.
Besides the software can be also used to perform the analysis of the acquired data.
The scanner is the main components of the system. It includes a radiological system, composed by the x-ray generator
and a flat panel. These components are mounted on a rotating arm driven by a motor. During the scan the arm performs
a rotation around the patient’s head taking maximum 360 images that are acquired by the console.
The control box hosts various circuits and electronic boards in order to control the functional components of the machine.
It is connected both to the workstation and to the scanner unit.

System overview
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NewTom VGi evo – Service Manual rev 6 4-2
Cables
The system includes the cables for the connection between main workstation and scanner and between the main
workstation and the control box. These two cables are:
Ethernet Cable(4 couples/26 AWG-FTP-Cat. 6) (workstation scanner)
CAN bus Cable (2 couples/24 AWG shilded) (workstation control box)
The power supply cable is already connected inside the control box, but needs to be connected to the main power of the
installation site by the installer.
ATTENTION:
The usage of accessories and cables different from the expected
ones can results in a decay of the electromagnetic compatibility
of the device!

Installating the system
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NewTom VGi evo – Service Manual rev 6 5-1
5 Installating the system
For a detailed description of the installation procedure, refer to the attached document “VGi evo -Installation Manual”
COD. 97070043.

Console preparation
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NewTom VGi evo – Service Manual rev 6 6-1
6 Console preparation
The console workstation (or main workstation) is the computer that controls the scan machine.
Specific requirements, procedures and settings must be followed in order to prepare the computer to run the machine
and to obtain extreme performance.
The computer must comply with the specifications described in the “Workstation Setup” annex document.
For instructions, about settings and installation on Main or Secondary Workstations (workstations that are not directly
connected with the machine) refer to document “97060818 - Workstation Setup Annex”.