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Service Manual

INTRODUCING THE MANUAL


GMDN: 61019 - Cone beam computed tomography system, head/neck
Trade Name: Dental CT Scanner AXR
Models: AXR90, AXR120
Brand: Eagle Edge / Dabi Atlante

Technical Manager: Daniel R. de Camargo


CREA-SP: 5062199650

ANVISA Registration No.: 10101130088

Alliage S/A Industrias Médico Odontológica


Rodovia Abrão Assed, Km 53 + 450m - CEP 14097-500
Ribeirão Preto - SP - Brazil
Phone: +55 (16) 3512-1212

CINTERQUAL – Soluções de Comércio


Internacional, Lda.
Avenida Defensores de Chaves, Nº 4
Escritório Idea Spaces
1000-117 Lisboa, Portugal

77000000866 - Rev.: 04 - August/22

Document originally written in the Portuguese language.

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TRADEMARKS
All terms mentioned in this manual that are known trademarks, registered trademarks or service
marks have been appropriately labeled as such. Other products, services or terms that are mentioned
in this manual may be trademarks, registered trademarks, or service marks of their respective owners.
Alliage S/A makes no claims regarding these trademarks. The use of a term in this manual should
not be considered to influence the validity of any trademark, registered trademark, or service mark.

Eagle is a registered trademark of Alliage S/A.


Dabi Atlante is a registered trademark of Alliage S/A.

Microsoft, Windows, .NET Framework, Microsoft Visual C++ 2010, Report Viewer 2012 RunTime,
System CLR Types for SQL Server 2012 are registered trademarks of Microsoft Corporation in the
US and other countries.

MacOS is a registered trademark of Apple Inc.

PostgreSQL is a registered trademark of Oracle.

Java is a programming language maintained by Oracle.

eBUS™ is a registered trademark of Pleora Technologies.

Copyright © 2019 Alliage S/A. All rights reserved.

The performance characteristics given in this manual are for reference only and are not to be
considered as warranted specifications.

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Service Manual

TABLE OF CONTENTS
1. GENERAL INFORMATION ................................................................................................................... 9
1.1. INDICATION FOR USE................................................................................................................................... 9
1.2. CONTRAINDICATION...................................................................................................................................... 9
1.3. SYMBOLOGY.................................................................................................................................................. 9

2. WARNINGS, CAUTIONS AND RECOMMENDATIONS ....................................................................... 14

3. INSTALLATION ................................................................................................................................ 21
3.1. RECEIVING THE PRODUCT......................................................................................................................... 21
3.2. OPENING THE PACKAGES.......................................................................................................................... 22
3.2.1. Main unit.................................................................................................................................................. 22
3.2.2. Optional Cephalostat............................................................................................................................. 26
3.2.3. Optional Base.......................................................................................................................................... 28
3.3. MOVING THE UNIT...................................................................................................................................... 30
3.3.1. Moving the unit in the horizontal plane........................................................................................... 30
3.3.2. Going up a step...................................................................................................................................... 31
3.3.3. Going down a step................................................................................................................................. 31
3.3.4. Going up ramps....................................................................................................................................... 31
3.3.5. Going down ramps................................................................................................................................. 31
3.4. MAIN UNIT INSTALLATION......................................................................................................................... 31
3.4.1. Attaching a main unit without base option...................................................................................... 31
3.4.1.1. Installing the wall mount.................................................................................................................. 31
3.4.1.2. Fixing the main unit to the floor...................................................................................................... 33
3.4.1.3. Leveling the main unit....................................................................................................................... 36
3.4.2. Attaching a main unit with base option........................................................................................... 37
3.4.2.1. Attaching the main unit to the base............................................................................................... 37
3.4.2.2. Leveling the base................................................................................................................................ 37
3.4.3. Removing the transport locks............................................................................................................ 38
3.4.4. Installing the sensors............................................................................................................................ 39
3.4.5. Electrical installations.......................................................................................................................... 41
3.4.5.1. Power cables........................................................................................................................................ 41
3.4.5.2. Port switch installation..................................................................................................................... 42
3.4.5.3. Installing the shooting lamp............................................................................................................. 43
3.4.5.4. Remote Shutter Connection and Computer Communication...................................................... 44
3.4.5.5. Finishing the installation................................................................................................................... 44
3.5. INSTALLING THE OPTIONAL CEPHALOSTAT............................................................................................. 48
3.5.1. Installing the optional cephalostat in the main unit..................................................................... 48
3.5.2. Electrical installations......................................................................................................................... 50

4. CALIBRATION ................................................................................................................................... 53
4.1. COMMON SOFTWARE STARTING INFORMATION..................................................................................... 53
4.2. HOME SCREEN............................................................................................................................................ 53
4.3. PANORAMIC CALIBRATION........................................................................................................................ 54
4.3.1. Information.............................................................................................................................................. 54
4.3.2. Communication....................................................................................................................................... 56
4.3.3. Potentiometer......................................................................................................................................... 57
4.3.4. Collimator................................................................................................................................................ 59
4.3.5. Sensor....................................................................................................................................................... 61
4.3.6. Chinrest position.................................................................................................................................... 62
4.3.6.1. Levelling................................................................................................................................................ 62
4.3.6.2. Three-point adjustment (X,Y and ROT)........................................................................................... 63

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TABLE OF CONTENTS
4.3.6.3. Calibration in the chinrest software...............................................................................................64
4.3.7. Laser.........................................................................................................................................................66
4.3.8. Temple support.......................................................................................................................................71
4.3.9. Start adjusting the temple support....................................................................................................71
4.3.10. Report.....................................................................................................................................................72
4.4. CEPHALOMETRY CALIBRATION.................................................................................................................72
4.4.1. Front level initial settings....................................................................................................................72
4.4.2. Side level initial settings......................................................................................................................73
4.4.3. Starting calibration................................................................................................................................75
4.4.4. Information..............................................................................................................................................76
4.4.5. Preparation..............................................................................................................................................77
4.4.6. Collimator I..............................................................................................................................................77
4.4.7. Rotation...................................................................................................................................................79
4.4.8. Sensor.......................................................................................................................................................80
4.4.9. Collimator II.............................................................................................................................................81
4.4.10. Ear plugs (olives).................................................................................................................................83
4.4.11. Laser.......................................................................................................................................................85
4.4.12. Report.....................................................................................................................................................86
4.5. CALIBRATING THE 3D CT SCANNER..........................................................................................................87
4.5.1. Levelling...................................................................................................................................................87
4.5.2. Initial sensor and machine configurantion settings........................................................................88
4.5.3. Communication.......................................................................................................................................92
4.5.4. Potentiometer.........................................................................................................................................92
4.5.5. Tomography collimator.........................................................................................................................93
4.5.6. 3D sensor.................................................................................................................................................95
4.5.7. Turning center........................................................................................................................................95
4.5.8. 2D Calibration.........................................................................................................................................97
4.5.9. Tomography collimator.........................................................................................................................98
4.5.10. 3D sensor...............................................................................................................................................98
4.5.11. Reconstruction license........................................................................................................................99
4.5.12. Density.................................................................................................................................................100
4.5.13. Metal.....................................................................................................................................................101
4.5.14. 2D laser................................................................................................................................................102
4.5.15. 3D laser................................................................................................................................................102
4.5.16. Temple support...................................................................................................................................104
4.5.17. Report...................................................................................................................................................105

5. MAINTENANCE................................................................................................................................... 106
5.1. GENERAL INFORMATION............................................................................................................................. 107
5.2. QUALITY DIAGNOSES .............................................................................................................................. 108
5.2.1. PANORAMIC QUALITY DIAGNOSIS ..................................................................................................... 109
5.2.1.1. Geometric calibration....................................................................................................................... 110
5.2.1.2. Spatial resolution.............................................................................................................................. 111
5.2.2. CEPHALOMETRIC QUALITY DIAGNOSIS ............................................................................................. 112
5.2.2.1. Calibration .............................................................................................................................................. 112
5.2.2.2. Spatial resolution.............................................................................................................................. 113
5.2.3. Tomographic Quality Diagnosis ........................................................................................................ 114
5.2.3.1. Contrast scale ................................................................................................................................... 115
5.2.3.2. Slice thickness................................................................................................................................... 115
5.2.3.3. Spatial resolution .............................................................................................................................. 115
5.2.3.4. Uniformity .......................................................................................................................................... 116

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TABLE OF CONTENTS
5.2.3.5. Noise ................................................................................................................................................... 117
5.2.3.6. Low contrast detectability ............................................................................................................ 117
5.2.4. DOSE MEASUREMENT............................................................................................................................... 117
5.2.5. QA REPORT............................................................................................................................................. 117
5.3. PROBLEM DIAGNOSTICS..........................................................................................................................118
5.3.1. Warning and Error Messages.............................................................................................................118
5.4. BELT REPLACEMENT................................................................................................................................123
5.4.1. Swivel belt.............................................................................................................................................123
5.4.2. Tele belt.................................................................................................................................................126
5.5. FUSE CHANGE...........................................................................................................................................127
5.5.1. Input fuses.............................................................................................................................................127
5.5.2. Generator fuses....................................................................................................................................128
5.5.3. Main board fuses..................................................................................................................................128
5.6. POWER CABLE CHANGE...........................................................................................................................129
5.7. ELECTRICAL CONNECTIONS.....................................................................................................................130
5.7.1. Main board.............................................................................................................................................130
5.7.2. C-ARM board.........................................................................................................................................131

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Service Manual

1
GENERAL INFORMATION

Alliage S/A Industrias Médico Odontológica


Telephone: +55 (16) 3512-1212
Rod. Abrão Assed, Km 53 – Postal Code 14097-500 –Ribeirão Preto – SP –Brazil

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1.GENERAL INFORMATION
1.1.INDICATION FOR USE
The Dental CT Scanner AXR is intended for the acquisition of radiological images of the oral anatomy,
including teeth, maxillofacial areas, oral structures, carpal images, and head-neck bone region, and
it is for exclusive dental use, and must be handled by professionals qualified and trained health
professionals.

1.2.CONTRAINDICATION
The equipment is contraindicated for:
- People being treated with radioiodine for thyroid cancer.
- People with allergies to polyvinyl chloride (PVC) or substances used in its manufacturing process, such
as bisphenol A, adipic polyester, composed of Propylene glycol and ethylhexyl maleate.

1.3.SYMBOLOGY
The following symbols are used both throughout this manual and on the product. Make sure you
fully understand each symbol and follow the instructions that come with it.

Fragile, handle with care Maximum stacking

Protect from rain Temperature limit

This side up Center of gravity

Keep away from sunlight Do not step

Recyclable Catalog number

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Service Manual

Model number Serial Number

Manufacturer Model

Sterilizable in a steam sterilizer


Manufacture Date (autoclave) at specified
temperature

Indicates that this product has Indicates that equipment complies


been evaluated for specific with directives 2011/65/EU and
properties, a limited range of 2015/863/EU on the Restriction
hazards, or suitability for use of the Use of Certain Hazardous
under limited or special conditions Substances in Electrical and
by UL. Electronic Equipment.

Indicates that equipment


Authorized representative in the complies with the regulation
European community (EU) 2017/745 of the European
Parliament and Council (MDR)

Indicates that the product must


be taken to a special waste
Type B applied parts collection site at the end of its
useful life. Applies to both device
and accessories.

Ionizing radiation
Indicates the presence or potential Electrostatic Sensitive Devices
presence of Ionizing Radiation/ (ESD)
Physiological Effect

Location of Focal Point Focal Point

Attention Emergency stop

10
Protective ground Hazardous voltage

Two-Phase Configuration:
Phase 2 Conductor
Condutor de fase 1
Single-Phase Configuration:
Neutral Phase

Alternating current Fuse

Ethernet connector Remote Shutter Connection

Turn off Power up


(Power disconnect from the main (Power supply: main switch
switch) connection)

Move up Move down

Chinrest Equipment

Positioning Laser (Appliance with Position the equipment to start


laser radiation) the exhibition

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Service Manual

Return Ready
Return the equipment to the initial Indicates that the equipment is
position ready to operate

Shutter Ionizing radiation emission

Mandatory action Follow the instructions for use

Warning;
General warning
High voltage

Warning; Warning;
Hand crush Ionizing radiation

Warning;
Do not reuse
Entanglement hazard

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Service Manual

2
WARNINGS, CAUTIONS AND RECOMMENDATIONS

Alliage S/A Industrias Médico Odontológica


Telephone: +55 (16) 3512-1212
Rod. Abrão Assed, Km 53 – Postal Code 14097-500 –Ribeirão Preto – SP –Brazil

13
2. WARNINGS, CAUTIONS AND RECOMMENDATIONS
General warnings

Read and understand all instructions contained in these Instructions for Use
before installing or operating this equipment.

Only use the equipment in perfect condition and protect yourself, patients
and third parties against possible dangers.

This equipment must be installed and operated by personnel familiar with


the necessary precautions to avoid excessive exposure to both primary and
secondary radiation.

The Dental CT Scanner AXR has eight different interactions with the user, they
are:
- Identification tag: Located on the back of the equipment;
- Safety symbologies: Located at risk sites and on their identification tag;
- Image acquisition software: Found installed along with a computer where
the equipment is connected;
- Main control panel: located on the chinrest support;
- Cephalostat Control Panel: located on the cephalostat;
- Local display button: located on the chinrest;
- emote exposure button: located outside the operating area;
- Emergency button: located at the bottom of the chinrest.

During transportation
The equipment must be transported and stored, observing the following:
• Handle with care to avoid falls, excessive vibrations and impacts;
• The arrows on the package must be pointing up;
• To handle the package as a single unit consider the center of gravity indicator;
• Do not stack above the quantity indicated on the package;
• Do not walk or stand above the pack.
• Protect from sunlight, moisture, water and dust;
• Observe temperature, pressure, and relative humidity limits.

During equipment installation

Installation instructions are found in the service manual, accessible only to


authorized technicians.

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Service Manual

The equipment is configured for mains voltage during installation of the


equipment only by the authorized technician. This is a technical procedure
that cannot be performed by the user.

The equipment must be correctly affixed according to the service manual and
must not be subjected to an inclination greater than 5°. Risk of tipping over.

To avoid the risk of electric shock, this equipment must only be connected to
a grounded mains supply for protection.

For single-phase installation, fuse F1 must be replaced by the metal pin


provided to eliminate the fuse from the neutral conductor.

Before turning on the equipment, make sure it is connected to the correct


voltage.

• The equipment must only be installed by authorized technical assistants.


• The recommendations of the service manual must be followed regarding the mandatory existence of
protective grounding.
• The recommendations of the service manual must be followed regarding the mandatory existence of
a protection circuit breaker.
• The equipment and the computer must not be connected to the same power source.
• Install the equipment in a place where it will not be in contact with moisture, water, plants, and animals.
• Install the equipment in a location where it will not be damaged by pressure, temperature, humidity,
direct sunlight, dust, salts, or corrosive products.
• The equipment must be correctly affixed according to the service manual and must not be subjected
to an inclination greater than 5°. Risk of tipping over.
• This equipment is not designed for use in the presence of flammable anesthetic mixture vapors or
nitrous oxide.
• Place the computer and any other external devices at least 1.5 meters away from the X-ray unit so
that the patient cannot touch the computer or any other external device while it is being x-rayed.
• The recommendations in this manual regarding EMC must be followed. Communications equipment
and RF generating sources can affect the equipment's operation.
• Equipment can cause radio interference or interrupt the operation of nearby equipment, requiring
mitigation measures such as reorientation, relocation of equipment or shielding the site.
• Depending on local regulations, remote exposure control must be installed in a radiation-protected
zone by means of a fixed barrier or screen with X-ray protection, so that the operator is protected
during the radiographic exposure process so that the operator must have visual contact with the patient.
• The radiological clinic in Brazilian territory must follow all sanitary requirements for the organization
and operation of diagnostic radiology services, including control of medical, occupational and public
exposures arising from the use of diagnostic radiological technologies according to Collegiate Board

15
Resolution RDC No. 330, of December 20, 2019 and Normative Instruction No. 94, of May 27, 2021 of
sanitary requirements for the guarantee of quality and safety in extraoral radiology systems or their
substitutes. See current legislation.

Before using the equipment


To help ensure proper hygiene and protect against infectious diseases, prior to first use, the equipment
must be cleaned and disinfected following the instructions contained in this manual.

While using the equipment


• Under no circumstances may the patient operate the unit.
• The patient should not touch any parts other than those specific to performing the exam.
• The equipment should only be operated by qualified healthcare professionals including knowledge of
precautions against excessive radiation exposure.
• To operate the unit, operating personnel must:
- Read and understand the user manual.
- Be familiar with the fundamental structure and functions of this unit.
- Be familiar with the emergency protocols for this equipment.
- Be able to recognize irregularities in the operation of the unit and implement appropriate measures
when necessary.
• The equipment has been designed in accordance with electromagnetic compatibility standards,
but under very extreme conditions, it may cause interference with other equipment. Do not use this
equipment in conjunction with other devices that are very sensitive to interference or with devices that
create high electromagnetic disturbances.
• The equipment is not recommended for displaying cartilage structures and displaying soft tissue.
• Do not place the patient in the unit while starting the unit, as the patient could be injured if the
equipment does not work properly. In case of an error that requires turning the equipment off and on,
remove the patient before turning it on again.
• During an exposure, the operator must position themselves at least 3 meters away from the X-ray
unit to reduce the amount of ionizing radiation absorbed by maintaining eye contact with the patient
and the unit throughout the exposure.
• In case of risk to the patient, cancel the exposure immediately by releasing the exposure button or
pressing the emergency stop button located on the lower part of the chinrest support.
• Operators should ask the patient to remain still while the equipment arm is in motion.
• If this product is exposed to water, moisture, or foreign substances, unplug it immediately and contact
an Alliage Authorized Service Center.
• In case of damage or defect, do not use the equipment and contact an Alliage Authorized Service Center.
• Do not use the drive if any of its compartments or parts are damaged, loose, or have been removed.
Contact an Alliage Authorized Service Center and request repair or replacement of any damaged, loose,
or removed enclosures or parts from the unit before using the unit again.
• Do not touch the drive or use it if it is being repaired or if the drive enclosures have been removed.
• Do not open or remove any of the drive enclosures. No internal parts are user serviceable.
• In case of falling or impact of moving parts causing their breakage, be careful when handling them,
there may be sharp parts.

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Service Manual

Radiation protection

Protection measures against ionizing radiation must be taken to avoid side


effects to users and operators.

The lead shot apron and collar are not included with the equipment.

• Exposure to X-rays can damage cells in the human body.


• Radiation protection equipment should be used to reduce radiation exposure to the patient,
specifically for pediatric and pregnant patients.
• The patient must wear a lead apron and thyroid collar during exposures.
• The use of X-ray equipment on pregnant women is not recommended without medical authorization.
• It is not recommended for use in people with involuntary muscle spasms in the neck and head
or Parkinson's disease.
• A patient with a cardiac pacemaker or an implantable cardioverter defibrillator (ICD) should
consult their manufacturer before performing an exposure to confirm that the X-ray unit will not
interfere with their operation.
• Exposure to X-rays can damage cells in the human body. Thus, radiation protection equipment
must be used to reduce the patient's radiation exposure, especially for pediatric patients. It is
recommended to wear an apron or a bismuth or lead vest during exhibitions.
• No person should remain in the room during an exhibition unless the patient needs to be restrained.
In this case, a third person must be properly protected against the emission of ionizing radiation.
• During an exposure, the operator should position himself/herself as far as possible from the focus
of the X-ray generator, maintaining a minimum distance of 3 m, or behind a physical barrier, to
minimize the amount of ionizing radiation absorbed.

Prevention against cross contamination

Appropriate cleaning and disinfection/sterilization measures should be taken


to avoid cross-contamination between patients, users and others.

• To help prevent cross-contamination between patients, the use of protective disposable plastic
covers is mandatory. The protective plastic cover must cover the teether, nose support and ear
plug (olive) support.
• For each new patient, the plastic covers must be properly discarded.
• Never use damaged protective plastic covers.
• For each new patient, carry out the cleaning, disinfection/sterilization procedures and according
to the instructions contained in this manual.
• Turn off the equipment if not in use for a long time.
• Plastic protective covers must be discarded and all parts that came into contact with the patient
must be cleaned and disinfected/sterilized for each new patient to avoid the transmission of
infectious agents that can cause serious illness.

17
• Perform cleaning and disinfection/sterilization as instructed in this manual.
• Do not unplug the cable or other connections unnecessarily.
• Do not modify any part of the equipment.

Precautions in case of equipment operation change


If the equipment presents any abnormality, check if the problem is related to any item listed in
the topic “Trouble diagnosis” of this user manual.
If the problem cannot be solved, turn off the equipment, disconnect the cables and contact an
Alliage Authorized Technical Service.

The manufacturer is NOT responsible for:


• The equipment is used for purposes other than those for which it was designed.
• Damage caused to the equipment, the operator and/or the patient, as a result
of incorrect installation and maintenance procedures not in accordance with
the operating instructions accompanying the equipment.

Precautions for reducing environmental impact


Alliage S/A aims to achieve an environmental policy to promote the supply of environmentally
conscious medical and dental products that continuously minimize the environmental impact and are
friendlier to the environment and human health. To maintain a minimal impact on the environment,
please observe the recommendations below:
• After installation, forward the recyclable materials to the recycling process.
• During the equipment's life cycle, turn it off when not in use.
• To prevent environmental contamination, the disposal of protective plastic covers and other
consumables should follow the normal procedure for biomedical waste.
Biomedical waste includes non-acute materials likely to cause disease or suspected of harboring
pathogenic organisms that must be stored in a yellow bag properly labeled with a biological risk
symbol, stored in a puncture-resistant, watertight container, until collection and incineration.

Dental CT Scanner AXR packaging is composed of wood, cardboard, plastic and


expanded polystyrene (EPS) which are 100% recyclable materials.

SIZE:
Main unit: 1711*586*1318 /MASS: Approximately: 49.3 Kg
Cephalostat: 1105*665*963mm /MASS: Approximately: 24 Kg
Base: 1215*770*300mm /MASS: Approximately: 50 Kg

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Service Manual

Precautions in case of equipment destruction


To avoid environmental contamination or misuse of the Dental CT Scanner AXR, when it is not used, it
must be discarded (according to current legislation) in an appropriate place, as the materials inside
it can contaminate the environment. For the European Economic Area (EEA), this product is subject
to Directive 2012/19/EU as well as corresponding national laws. This directive requires that the
product must be taken to a special waste collection site at the end of its useful life. This applies to
both device and accessories. Please contact your dealer if final disposal of the product is required.

This equipment must not be disposed of as household waste.

19
3
INSTALLATION

Alliage S/A Industrias Médico Odontológica


Telephone: +55 (16) 3512-1212
Rod. Abrão Assed, Km 53 – Postal Code 14097-500 –Ribeirão Preto – SP –Brazil

20
Service Manual

3.INSTALLATION
3.1.RECEIVING THE PRODUCT
Before opening the packages, inspect the equipment received and make sure that it has not been
damaged during transport.
On the outside of the boxes, there are two types of labels that provide proof of any handling errors.
The figure below shows the two labels.

Tilt Label Impact Label

Enabling impact-related monitoring indicates an impact greater than the predetermined level. Turning
on slope-related monitoring indicates an unacceptable tilt. Both are used to monitor cargo during
transport, ensuring that your product reaches its destination in its original condition.
If they have been activated, follow the procedure below to receive them.

• PLEASE DO NOT REFUSE THE EQUIPMENT DELIVERY.


• An activated indicator (RED) on the tag does not mean that any damage has occurred. It only
indicates that the box has been impacted or handled above a normally anticipated level. Only an
inspection can determine if any damage has occurred.
• If the indicator on the label is RED, please make a note on the bill of lading or on the receipt or
delivery document.
• Examine the content immediately for possible damage.

If the equipment was damaged during shipment, document all damage carefully
and contact the responsible shipping agent immediately and file a confidential
damage claim.

21
3.2. OPENING THE PACKAGES
3.2.1. Main unit
You will receive the package with the equipment horizontally, as shown in the figure below.

Remove the lid and the side of the package leaving only the base pallet. The equipment will
be wrapped in plastic. Remove the plastic.
The Styrofoam cradle accommodates some parts on its surface. Remove the QA kit and the
head cover from the top and the table cover from the side as shown in the figure below. Reserve
them for later installation.

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Service Manual

Remove the Styrofoam cradles in the direction shown in the figure below. Reserve the cradle
highlighted in the figure for later.

Detach the counterweight, wall mount and side covers of the pallet from the base, loosening the
fastening screws. Remove the parts from the pallet and set them aside for later.

23
Carefully lift the equipment to the vertical position, supporting it on the transport trolley, as shown
in the figure below.

Remove the pallet from the base, which is now on the side, loosening the fastening screws.

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Service Manual

Make use of the previously reserved wall mount, position it as shown in the figure below and secure it
to the equipment with the screws provided in the package. The main unit will be ready for installation.

25
3.2.2. Optional Cephalostat
You will receive the optional cephalostat package as shown in the figure below.

Remove the lid and the side of the package leaving only the base pallet. Reserve these parts
for later. The equipment will be wrapped in plastic. Remove the plastic and top cradle.

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Service Manual

Remove the parts accommodated in the cradle and set them aside for later installation.

Loosen the fixing screws to release the arm and rotate in the direction indicated on the package,
as shown in the figure.

27
Refit the packaging lid on its side, forming a support table. Position the cradle with the
cephalostat on top. The main unit will be ready for installation.

3.2.3. Optional Base


You will receive the base option packaging, as shown in the figure below.

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Service Manual

Remove the top cover from the packaging to gain access to the optional base and loosen the
fixing screws to remove the transport locks.

The base option will be ready for installation.

29
3.3. MOVING THE UNIT

THE UNIT IS DESIGNED TO BE EASILY HANDLED BY ONE PERSON AND TO BE


EASILY MOVED INSIDE THE FACILITIES, WHEREAS THERE ARE NO STAIRS AND
ROOMS AND ENTRANCES ARE OF STANDARD DIMENSIONS.

IF THERE IS A RISK OF TIPPING, HANDLE THE EQUIPMENT WITH THE HELP OF


ANOTHER PERSON.

MOVING THE EQUIPMENT PROPERLY IS THE ENTIRE RESPONSIBILITY OF THE


AUTHORIZED TECHNICIAN. THE MANUFACTURER SHALL NOT BE LIABLE IN THE
EVENT OF AN ACCIDENT DURING TRANSPORTATION.

THE INFORMATION HEREIN IS INTENDED FOR A GUIDANCE ONLY.

3.3.1. Moving the unit in the horizontal plane


The package already comes with a transport device to move the equipment to the installation
site.

To move the unit in the horizontal plane, tilt the unit until you feel its center of gravity is
above the casters of the transport device. Move the unit by pushing or pulling.

MAKE SURE THAT THERE IS ENOUGH SPACE TO MOVE THE EQUIPMENT, THAT THE
FLOOR IS A HORIZONTAL PLANE AND YOU'RE AWARE OF THE PHYSICAL EFFORT
NECESSARY TO MOVE IT.

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Service Manual

3.3.2. Going up a step


Move the unit forward until reaching the step. Tilt the unit towards you until it reaches the
height of the step. Push the unit in until the front caster is above the step. Tilt the unit up and
drive it until both casters are above the step.

3.3.3. Going down a step


Move the unit back until you reach the step. Tilt the unit away from you until it reaches the
height of the step. Pull the unit until the front caster is above the step. Tilt the unit up and drive
it until both casters are above the step.

3.3.4. Going up ramps


Push the unit to go up ramps. The maximum recommended tilt is 7 (seven) degrees.

3.3.5. Going down ramps


Carefully push the unit to climb ramps. The maximum recommended tilt is 7 (seven) degrees.

3.4. MAIN UNIT INSTALLATION

3.4.1. Attaching a main unit without base option

3.4.1.1. Installing the wall mount


For the installation of the wall mount, follow the measures provided in the gauges that come
with the equipment.

HOLE HOLE

WITHOUT BASE WITH BASE WALL DRILLING GUIDE

NEVER DRILL INTO A WALL WITHOUT FIRST VERIFYING THE EXISTENCE OF HIDDEN
TUBES AND CABLES.
RISK OF FLOOD AND ELECTROCUSSION.

31
Place the plugs provided on the wall, inserting them manually. Lightly tap the plug with a
hammer to level it with the wall, if necessary.

CONSULT A SPECIALIST TO IDENTIFY THE MOST INDICATED TYPE OF BUSHING


FOR THE INSTALLATION LOCATION.

Position the support, securing with 2 screws and two washers (included with the product).

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Service Manual

3.4.1.2. Fixing the main unit to the floor


With the wall mount fixed, position the plumb in the region indicated on the gauge and let it
hang down to the floor to determine the position of the floor gauge.

For fixing the main unit to the floor, follow the measures provided in the templates that
accompany the equipment.

33
PLUMB BOB

WALL WALL

HOLE HOLE

HOLE HOLE
FLOOR DRILLING GUIDE

Figure 1 - Base fastening distance in mm

Move the main unit to the marking on the floor and fix it to the wall mount as shown in the
figure below.

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Service Manual

Secure the unit to the floor by tightening the fixing screws as shown in the figure below.

Remove the screws securing the transport cart to the column of the main unit.

35
3.4.1.3. Leveling the main unit
After attaching the main unit to the wall bracket, place a spirit level horizontally on top of
the unit.

Move the equipment over the wall bracket, adjusting its placement until it is level.
Tighten the wall bracket screws to secure the equipment.

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Service Manual

3.4.2. Attaching a main unit with base option

FOR FIXING THE WALL MOUNT, CONSIDER THE RELATIVE ELEVATION TO THE BASE.

3.4.2.1. Attaching the main unit to the base


Locate the column mounting holes in the front center and position the unit by aligning it with
the holes. Tighten the fixing screws, firmly securing the unit to the base.

INSTALL THE EQUIPMENT ON THE BASE BEFORE ATTACHING IT TO THE WALL.


RISK OF TIPPING OVER.

3.4.2.2. Leveling the base


The base can be leveled by turning the leveling screws on the levelers as shown in the photo
below. Use an Allen wrench to tighten the leveling screws. Once leveled, adjust the remaining
levelers by squeezing toward the floor for maximum stability.

Levelers Adjustment of leveling screws

37
3.4.3. Removing the transport locks
After fixing the machine, remove all transport locks as shown in the figure below.

DO NOT TURN ON THE EQUIPMENT UNTIL ALL LOCKS HAVE BEEN REMOVED.
THIS CAN DAMAGE YOUR EQUIPMENT.

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Service Manual

3.4.4. Installing the sensors


Dispose of the cradle previously reserved and open its halves as shown in the figure below.
Remove the kit box contained inside.

Dispose of the counterweight previously reserved. Position it as shown and secure it to the
main unit using the screws provided.

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With the counterweight installed, dispose of the previously reserved sensor. Position it as
shown and secure it to the main unit using the screws provided.

DO NOT INSTALL THE SENSOR BEFORE YOU HAVE FIXED THE COUNTERWEIGHT
TO THE EQUIPMENT. RISK OF TIPPING OVER.

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Service Manual

3.4.5. Electrical installations


3.4.5.1. Power cables
To connect the equipment to the electrical network, arrange the cables in the order indicated
on the lower right side of the column. After connecting the cables, secure them with the bracket
as shown in the figure below.

IN CASE OF SINGLE-PHASE INSTALLATION, FUSE 1 MUST BE REPLACED WITH THE


METALLIC PIN SUPPLIED.

41
3.4.5.2. Port switch installation
For the correct connection of the switch from the port to the equipment, the switch must be
configured as normally closed.
Connect the switch cables to the two connector terminals, loosening the screw to open and
tightening to secure the cables.

Below is an electrical diagram of the connection.

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Service Manual

3.4.5.3. Installing the shooting lamp


Connect the lamp power face cable to the left terminal of the connector and the lamp return
cable to the right terminal of the connector. Loosening the screw to open and tightening the screw
to tighten the cable to the terminal.

Below is an electrical diagram of the connection.

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3.4.5.4. Remote Shutter Connection and Computer Communication
Connect the remote shutter and computer communication cables as shown below.

3.4.5.5. Finishing the installation


Have the sensor cover shown in Figure 35. Position it as shown in the figure below and fasten
the screws provided.

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Service Manual

Have the head cover, reserved in Figure 4. Position the halves as shown in the figure below
and secure the fixing screws.

Take the table cover, reserved in Figure 4. Position it as shown in the figure below and secure
the fixing screws.

45
Take the side covers, reserved in Figure 6. Position them as shown in the figure below and
secure the fixing screws.

Note that when installing the side covers, the electrical wiring must pass through the slot
located at the lower end of the equipment, near its base.

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Service Manual

Have the temple support provided in the kit. Fit it to the equipment shafts, and secure it using
the fixing screws, as shown in the figure below.

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3.5. INSTALLING THE OPTIONAL CEPHALOSTAT
3.5.1. Installing the optional cephalostat in the main unit
Remove the table cover from the main unit and remove the protective trim from the cephalostat
inlet, as shown in the figure below.

Turn on the equipment and set the height of the column until the table reaches the height of
the package + cephalostat set.
Move the assembly in the direction indicated in the figure below until reaching the locking
device. Secure the cephalostat to the main unit using the screws provided in the package.

Locking device

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Service Manual

After attaching the optional cephalostat to the main unit, remove the bottom of the cradle
and replace the table cover on the main unit.
Take the tube finishing, reserved in figure 12. Position it as shown in the figure below and
secure the fixing screw.

Take the cephalostat sensor, reserved in Figure 12. Connect to the equipment using the snap
on coupling system.

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3.5.2. Electrical installations
The optional cephalostat has 5 (five) electrical connections, as identified in the figure below:
1. Ceph power;
2. Ceph signals;
3. Ceph key;
4. Ethernet cable;
5. Ground wire.

Harnesses 1, 2 and 3 are connected to the main unit board as indicated in the figure below:

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Service Manual

The Ethernet cable (4) can be plugged into any of the input ports shown in the figure below.

Finally, the ground wire (5) must be connected to the pin indicated in the figure below.

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4
CALIBRATION

Alliage S/A Industrias Médico Odontológica


Telephone: +55 (16) 3512-1212
Rod. Abrão Assed, Km 53 – Postal Code 14097-500 –Ribeirão Preto – SP –Brazil

52
4. CALIBRATION
4.1. COMMON SOFTWARE STARTING INFORMATION
01) Connect a communication cable (ethernet) from the equipment to the network card of the
computer that will run the calibration software.

4.2. HOME SCREEN

a) Topics used to configure the machine.

b) Within the “Options” box the following topics (Machine Configuration - Beam Test). Topics used
for machine configuration.

c) Inside the “Calibration” box there are the following topics (Tomography – Panoramic –
Cephalometry). These are the types of calibration to be applied to the equipment.

d) The "Status" is indicative informed by colors by the software.

e) It is an information bar indicated by tabs; they are “General - Board - Sensors -SW Version”.
They contain step-by-step descriptions of the activities to be performed.

f) The “Progress Bar” is an indicator of the progress of an operation that is being executed.

02) After checking the connection, choose the equipment (Tomography – Panoramic – Cephalometry)
to be calibrated.

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Service Manual

4.3. PANORAMIC CALIBRATION

01) Fill out the information requested by the software tabs.

- Information;
- Preparation;
- screws
- screws
- Collimator;
- Sensor;
- Chinrest position;
- Laser;
- Temple support;
- Report.

4.3.1. INFORMATION
01) Fill out the information of the chosen product in the "Information - Equipment Information"
tab.

- Product Code;
- Serial Number;
- Main board serial number;
- Head plate serial number;
- Sensor serial number
- Production Order.

02) The fields indicated with * are mandatory.

54
IF YOU FAIL TO FILL OUT THE INFORMATION IN THE SOFTWARE FIELDS, YOU WILL
NOT MOVE ON TO THE NEXT STEP.

03) Fill in the information of the chosen product in the "Information -Materials" tab

- Computer;
- Calibration Device;
- Bubble level.

04) When you finish filling out the information, click on "Next".

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Service Manual

05) If any field is NOT filled out, the step will be BLOCKED and INFORMED in red, it will NOT be
possible to proceed to the next step.

06) Fill out all fields and click on "Next".

4.3.2. COMMUNICATION
01) Wait for the machine to communicate with the software.

Communicating

Approved

02) With the equipment positioned in the cabin click on “Next” in the software.

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4.3.3. POTENTIOMETER
01) Fully rotate the turning arm to the position shown in the image, close to the rotation stroke
end, place the head as close as possible to the column.

02) In the “Preparation” subtab, follow the software images that indicate the position of the
potentiometer to be calibrated, and how the screws that secure it must be loosened.

03) The “General” tab describes the procedure to be followed for this step.

Loosen the screw with the wrench; Until you get away from the gear;

Position the potentiometer; Release it.

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Service Manual

04) Click on the next button to enter the "Setting" tab, this tab shows the reading of the
potentiometer signal in real time. Rotate the potentiometer in the direction indicated by the software
until the target value is reached.

05) Adjust the potentiometer manually on the machine, according to the software orientation.

Save - Adjust

Mechanical adjustment

THE FOCUS IS TO ACHIEVE THE TARGET INDICATED BY THE SOFTWARE.

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06) When adjusting on the software screen the APPROVAL of the saved calibration will appear.

Calibration saved

07) When finished, click on the “Save” and “Next” button.

4.3.4. COLIMATOR
01) Motor support hex.

02) The software will position the turning arm and collimator in the proper positions for an X-ray shot.

03) During shooting, the collimator will be positioned by the software in the best lighting position.
Figure 14

04) Make the indicated adjustment and click on "Run" again until no mechanical adjustment is
necessary.

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Service Manual

05) At the end of the mechanical adjustment process, the software ends the analysis.

Analysis Completed

06) Once the collimator position is approved, the software enters the repeatability test mode. In
this part, observe the Status and when requested press the shutter.

07) Getting Approvals: 1/5 – 2/5 – 3/5 – 4/5, the message “Approved” will be displayed, click on
the save button.

08) The data obtained will be demonstrated in the tables (Pixels - Beam - Motor) next to the
image.

09) After saving, proceed to the next step “Next”.

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4.3.5. SENSOR
01) Click on the "Run" button to start the sensor image capture process.

02) In this step, the software positions the turning arm and captures the Dark image automatically.

03) Then, when requested by the software, press the shutter to capture images from the sensor
being - Dark / Light / Masked Pixels. screws

04) Figure 17

05) The software automatically generates the calibration files. When the status is “Analysis
completed” click on the “Next” button.

CORRECTION OF INCORRECT LINES. THE SOFTWARE ANALYZES AND CORRECTS


THEM.

Analysis Completed

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Service Manual

4.3.6. CHINREST POSITION


4.3.6.1. LEVELING
01) Chinrest movable support hex.

02) head M4 Allen screw din 7994 When leveled, fix the two central screws.

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4.3.6.2. THREE-POINT ADJUSTMENT (X,Y AND ROT)

01) Mount the phantom as shown below.

02) When level access the “Chinrest Position” tab in the calibration software.

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Service Manual

4.3.6.3. CALIBRATION IN THE CHINREST SOFTWARE


01) Add the parameter values according to the table below.

CALIBRATION BINARIZATION
X:0 L : 6000
Y : 28000
Z :0

02) Click on the "Run" button to capture. Wait for the positioning of the machine, press the
shutter when prompted.

03) The software will measure the dimensions and distances of the spheres and provide the value
to adjust X,Y and ROT automatically.

04) If the image obtained is not APPROVED/PASS, click on the "Run" button again, until the result
is as indicated in the following image.

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screws

Figure 19

05) When the image is approved, proceed “Next” to the next step.

THE ADJUSTMENTS ARE MADE ON THE CALIBRATION SOFTWARE.

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Service Manual

4.3.7. LASER
01) Figure 20

02) Perform the mechanical adjustment of the laser according to the sequence below.

Loosen the screws with a Philips wrench Using needle-nose pliers and a T Allen
and Allen T wrench to adjust the laser. key, position the laser light on the
phantom.

The light that radiates from the laser Position the cover on the chinrest and the
must not extend beyond the sides of precise red light is between the edges of
the end of the right and left side of the the cover.
phantom.

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Software - Maximum Position Position limit -
Panoramic

Software - Central Position Central position -


Panoramic

Software - Minimum Position Minimum Position -


Panoramic

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Service Manual

03) When the laser is in the correct position it will be indicated on the software screen in green
color. Click on the "Save" button.

04) If you cannot find the approval position for the canine laser, the software will guide you with
a red indication and showing the direction to adjust the laser.

05) For the alignment of the FRANKFURT laser, position the phantom and align the laser according
to the images in the software.

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Software - Maximum Position screws

Figure 22 Snap Mounting

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Service Manual

SNAP ASSEMBLY Nut

06) To align the SAGITTAL laser, position the phantom and align the laser according to the software
images.

Software - Vertical Position Vertical Position

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4.3.8. TEMPLE SUPPORT
4.3.9. START ADJUSTING THE TEMPLE SUPPORT
01) Adjust the rod as described in the software images below.

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Service Manual

4.3.10. REPORT
01) On the last tab, the calibration software generates a panoramic calibration completion report.

02) Click on the export button for the calibration record to be saved in PDF format, digitally signed
or physically printed and signed.

4.4. CEPHALOMETRY CALIBRATION


4.4.1. FRONT LEVEL INITIAL SETTINGS
01) Adjust the Cephalometry leveling.

02) Loosen the four screws indicated in the images below:

Right Side Left Side

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06) Turn the screw indicated below to level the front level.

Back

07) Retighten the screws of step 2 when it is leveled.

4.4.2. SIDE LEVEL INITIAL SETTINGS


01) Loosen the screws indicated below:

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Service Manual

02) Turn the screw indicated below to level the axis transverse to the displacement of the sensor.
Position the level on the sensor rail and on the secondary collimator rail to check the level.

03) When it is leveled, retighten the screws of step 5.

Right Side Left Side

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4.4.3. STARTING THE CALIBRATION

01) Fill out the information requested by the software tabs.

- Information;
- Preparation;
- Rotation;
- Collimator II;
- Sensor;
- Ear plugs (olives)
- Laser;
- Report.

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Service Manual

4.4.4. INFORMATION
01) Fill out the information of the chosen product in the "Information - Equipment Information"
tab.

02) The fields indicated with * are mandatory.

IF YOU FAIL TO FILL OUT THE INFORMATION IN THE SOFTWARE FIELDS, YOU WILL
NOT MOVE ON TO THE NEXT STEP.

- Product code.
- Equipment serial number.
- Sensor serial number.
- Production Order.

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03) Fill in the information of the chosen product in the "Information - Materials" tab.

- Calibration Computer.
- Tele calibration device.
- Brightness level.

4.4.5. PREPARATION
01) Remove the cover protections from the equipment as instructed in the “General” tab.

02) After removing the protections, click on “Next”.

4.4.6. COLLIMATOR I
01) Click on the “Run” button to start the collimator I calibration sequence.

02) The software will position the turning arm and collimator I in the proper positions for an x-ray shot.

03) While shooting, it will be positioned by the software in the best lighting position. The software
collimator will evaluate the image obtained and propose mechanical corrections regarding the
angle and height of the collimator.

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04) Make the indicated adjustment and click on "Run" again until no mechanical adjustment is
necessary.

05) At the end of the mechanical adjustment process, the software ends the analysis.

Analysis Completed

06) Once the collimator position is approved, the software enters the repeatability test mode. In
this part, observe the Status and when requested press the shutter.

Analysis Completed

07) Obtaining Approvals: 1/5 – 2/5 – 3/5 – 4/5 you will get the message “Approval”, click on the
save button.

08) The data obtained will be demonstrated in the tables (Pixels - Beam - Motor) next to the image.

09) After saving, proceed to the next step “Next”.

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Remove the Sensor from the Pan Put the Sensor on the Tele

4.4.7. ROTATION
01) Connect the sensor in tele mode, position the system of the ear plugs and nose rest and click
on the “Run” button to obtain the images and values obtained. Remove all objects from the image
acquisition areas.

Awaiting test Analysis completed

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Service Manual

4.4.8. SENSOR
01) Starting sensor calibration.

Awaiting Test

02) Wait for the sensor to calibrate.

Analysis Completed

03) The software automatically generates the calibration files. When the status is “Analysis
completed” click on the “Next” button.

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4.4.9. COLLIMATOR II
01) The software prompts you to place the phantom on the sensor.

Awaiting Test

02) Position the Collimator II calibration phantom.

03) Click on the "Run" button to start the Collimator II calibration.

04) If a mechanical adjustment of the phantom is necessary, follow the sequence guided by the
software.

05) After the result, click on the “Continue” button to continue the REPEATABILITY TEST.

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Service Manual

06) Wait for the REPEATABILITY TEST to run.

Cooling

07) When the status is “Analysis completed” click on the “Next” button.

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Analysis Completed

4.4.10. EAR PLUGS (OLIVES)


01) Place the Ear Plugs as instructed by the software.

Awaiting test

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Service Manual

02) Click on the "Run" button to start the calibration process for the ear plugs.

03) Observe the image obtained and adjust the screws for fixing the ear plugs indicated below.

Positioning the Ear Plugs Turning

Positioning the Ear Plugs Height

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04) Repeat the capture of the images by clicking on the “Run” button again until the result is as
indicated in the image below.

Ear Plugs Calibrated

05) Click on "Next".

4.4.11. LASER
01) The software indicates the Ear Plugs calibration.

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Service Manual

02) Stick a masking tape between the Ear Plugs as shown below.

03) After completing the laser setting with the Ear Plugs, click on the software click on "Next".

4.4.12. REPORT
Click the export button to have the calibration record saved in PDF format, digitally sign, or
physically print and sign.

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4.5. CALIBRATING THE 3D CT SCANNER
4.5.1. LEVELING
01) Initially, attach the machine to the wall, as shown in the image below.

02) Make the leveling measurements of the machine, so that the machine shows good leveling.

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Service Manual

4.5.2. INITIAL SENSOR AND MACHINE CONFIGURATION SETTINGS


01) Ensure the connection between the computer and the machine from the “ethernet network”
configuration, selecting the “ethernet 2” properties and configuring the “Teledyne”, “VIVIX” and
“IP v.4” connections. Make sure the “IP address” is 192.168.200.50, according to the figure below.

02) From the “VIVIX” software, import the 3D sensor drive. In the "Calibration" tab, click on "Import"
and select the drive mode of the 3D sensor. Click on "Open". In the "Device" tab, click on "Reboot".

88
03) Also in the “VIVIX” software, configure the 3D sensor.

04) Initially, on the “Device” tab, click on “Refresh” for the computer to reset the settings and find
the sensor.

05) In “device”, select the sensor in “Select device”. Open the item "Detail..." and change the sensor
IP in "Force IP", being: 192.168.200.110 (3D sensor IP) to "IP address", 255.255.255.0 to "Subnet mask"
and 192.168.200.XX (The last two numbers being the gateway of the computer being calibrated,
located as IPv4 Address). Set the changes in “Change IP”, check if the sensor IP has been changed
and close the “Device information detail” window.

06) From there, click on “Open” and check the sensor and sensor address information.

07) From now on, open the “Service SW” software and enter the initialization code: alt + (D, 4, B,
1).

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Service Manual

08) In the Main Menu, under "Options", click "Machine Configuration".

09) On the "Equipment" tab, select the 3D machine configuration, which can be "MFOV", "MFOV
+ TELE”, “SFOV” and “SFOV + TELE”.

10) Select the Horizontal/Vertical collimator option, exclusive to the CT scanner.

11)Check that the door key is installed and select the "Installed" option.

12) Select the 120 kV head option, exclusive to the CT scanner.

13) Click on "Save"

14) In the “Sensors” tab, check the sensor's IP configuration and click on “Save”.

15) Go back to the “Main menu”, check the communication situation of the sensors, and select the
machine configuration for “Pan/CT”.

16) Enter the equipment information, such as: serial number, main board, head number, etc., as
shown in the figure below.

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17) Test the communication between the electronic components, through the "Main menu".

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Service Manual

4.5.3. COMMUNICATION
01) For the first calibration step, perform the communication check between the machine's boards
and components.

02) Check that the result has been approved and proceed to the next step.

4.5.4. POTENTIOMETER
01) Then adjust the potentiometer.

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02) If necessary, adjust the potentiometer.

03) Check that the result is approved and proceed to the next step.

4.5.5. TOMOGRAPHY COLLIMATOR


01) Calibrate the CT collimator and ensure it matches the software parameters.

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Service Manual

02) Make the 5 shots, according to the Software. If necessary, adjust the collimator, following the
software instructions.

03) Check for approval and proceed to the next step.

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4.5.6. 3D SENSOR
01) Check the sensor calibration and the result of its dark and light images. Check if the parameters
of the images are correct.

4.5.7. TURNING CENTER


01) To calibrate the center of rotation, check the leveling of the chinrest.

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Service Manual

02) Fit the geometric calibration phantom into the upper hole of the bracket and position them on
the chinrest.

03) Calibrate the turning center.

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04) Check the results obtained and adjust, if necessary.

05) Proceed to the next step.

4.5.8. 2D CALIBRATION
01) To calibrate the center of rotation, check the leveling of the chinrest.

01) Calibrate the PAN collimator, according to item 3.6.4.

02) Calibrate the PAN sensor, according to item 3.6.5.

03) Calibrate the chinrest, according to item 3.6.6.

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Service Manual

4.5.9. TOMOGRAPHY COLLIMATOR


01) Calibrate the CT collimator once again to ensure that the previous steps have not affected it.

02) Check the results and proceed to the next step.

4.5.10. 3D SENSOR
01) Put on the sensor cover and remove any object from the acquisition area.

02) Calibrate the 3D sensor with the cover, verify the results and, if approved, proceed to the next
step.

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4.5.11. RECONSTRUCTION LICENSE

01) Update the Hardlock ID.

02) Click on "Download file from server" and select the file under "Browse file".

03) Restart the “Service SW” software, fill out the product information again and go back to the
“License” tab. Click on "Update" to recover the data entered and then "Test license".

04) If approved, proceed to the next step.

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4.5.12. DENSITY
01) Assemble the density phantom, according to the software mounting video.

02) Place the calibration phantom on the machine and the density phantom on it. Fill the space
indicated by the software completely with water.

03) Run density calibration and verify results. If approved, proceed to the next step.

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4.5.13. METAL
01) Still with the density phantom on the machine, perform the metal calibration.

02) Make sure the result is approved and proceed to the next step.

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4.5.14. 2D LASER
01) Calibrate the 2D laser, according to item 3.6.7.

4.5.15. 3D LASER
01) Adjust the laser leveling:

a. 5x5

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b. 6x9

c. 9x9 : 9x16

d. 15x16 : 21x16

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02) Calibrate with a scout and check the result. If necessary, adjust the lasers. If the result is
approved, proceed to the next step.

4.5.16. TEMPLE SUPPORT


01) Attach the temple support.

02) Check the function of the temple support mechanism and adjust.

03) Go to the next step.

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4.5.17. REPORT
To verify calibration, take one image of each type.

Click the export button to have the calibration record saved in PDF format, digitally sign, or
physically print and sign.

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5
MAINTENANCE

Alliage S/A Industrias Médico Odontológica


Telephone: +55 (16) 3512-1212
Rod. Abrão Assed, Km 53 – Postal Code 14097-500 –Ribeirão Preto – SP –Brazil

106
5. MAINTENANCE
5.1. GENERAL INFORMATION
Before starting maintenance work, always perform a functional test and inform the customer
or dental unit team of any defects found.
If it is necessary to replace defective components together with parts subject to wear, this
must be agreed in advance with the customer or the dental unit team.
Replacement parts are discontinued after a certain period for each system. The system owner
will be responsible for safety-relevant failures of systems that remain in operation after this period
and are no longer serviceable due to lack of spare parts.

Observe precautionary measures used for handling printed circuit boards (ESD).
Touch a ground point to discharge static electricity before handling any
component.

During the maintenance procedure, x-ray exposure may be necessary. Take


necessary measures to comply with local safety regulations.

The AXR CT scanner or any of its parts cannot be serviced or serviced during
use with a patient.

The equipment contains high voltage parts. Risk of electric shock. Turn off the
main switch before servicing.

Moving parts can cut or crush.

Keep hands away from the rotating belts, risk of entanglement.

This equipment cannot be tilted more than 5°. Risk of tipping over.

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Power cords can only be changed by an authorized technician. See service


manual for connection and docking information.

5.2. QUALITY DIAGNOSES


This section will occasionally use procedures described in previous sections. Please refer to those
sections when needed.

In order to assure image quality of the equipment, Quality Assurance (QA) Devices will be provided
(Reference 21CFR 1020.33 (d)(1)) to test of the system performance and quality. These Devices were
designed to provide maximum performance information with minimum effort.

During the installation or after a repair this QA procedure will create a baseline performance data.
Make a periodic evaluation and compare with the baseline data.
If degradation in image quality or a change in QA values is noticed, contact the Alliage Service
Department.

In order to perform the quality diagnoses, the user must log in into the control software and click
on the QA Diagnosis icon at the home screen.

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The following screen will be displayed:

D E

Description
A. QA Diagnosis: View the information and status of the QA tests.
B. Test information: Enter the test registration information.
C. QA Tests: View the date and status of the last test.
D. Back: Return to the previous screen.
E. Next: Perform the QA test.
Enter with the test registration information (B) and choose between the QA tests options (C)
(Panoramic, Cephalometric and 3D).
Click in Next (E). The software will display the capture screen with the acquisition parameters
configured to perform the test.

5.2.1. PANORAMIC QUALITY DIAGNOSIS


For 2D images it will be validating the beam position, geometric calibration and the maximum
contrast resolution. The QA Devices are show below.

QA Device for QA Device for


panoramic resolution test

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5.2.1.1. Geometric calibration


The software will indicate that the calibration will be checked.
Place the QA Device for Panoramic on chin rest support and level it.

QA Device for Panoramic

Make an exposure.

The software will measure in the image the geometric distance between all spheres, rotation and
geometric form. It will indicate if the calibration is correct.

Calibration Check for Panoramic

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5.2.1.2. Spatial resolution
The software will indicate that the spatial resolution will be checked.
Remove the QA Device for Panoramic from the support, and place QA device for resolution test as
shown below.

QA device for resolution test

Make an exposure.

The software will display the following image.

Check the image shown which lines of the image you can identify the separation.

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5.2.2. CEPHALOMETRIC QUALITY DIAGNOSIS


5.2.2.1. Calibration
The software will indicate that the calibration will be verified.
Rotate the cephalostat and lock in the lateral cephalometric position. Perform an exposure, the
software will present the radiographic image obtained.

Both ear rods have metal that appear in a clear way on the x-ray. The validation consists of verifying
if the sphere is inside the circle as shown in the following picture bellow:

Calibration Check for Cephalometric

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5.2.2.2. Spatial resolution
The software will indicate that the maximum contrast resolution will be checked.
Remove the chin rest support, open the head holder. Rotate the cephalostat to lock at PA/AP
position and open the ear rods.
Place the QA device for resolution test at carpal support and place it at the cephalostat as shown
below.

QA device for Carpal support


resolution test position

Make an exposure.

The software will display the following image.

Check the image shown which lines of the image you can identify the separation.

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5.2.3. Tomographic Quality Diagnosis


For 3D exams, the software checks the density scale, image uniformity, artifacts, spatial resolution,
and noise level. The quality device is shown below.
Position the CT QA device on top of the chin rest support. The cavity indicated in the image must
be filled with water.

Water

CT QA device

The CT QA device consists of three cylindrical sections designed to measure all imaging parameters
with as few exams as possible. Layers are described in the image below.

Section 1

Section 2

Section 3

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5.2.3.1. Contrast scale
CT numbers, also called Hounsfield Units (HU), represent the values of attenuation of the passage
of X-rays through a variety of material densities.
Section 1 of the calibration device has two cavities. One cavity is a hole with air, and the other
cavity must be filled with water.
The software measures these two cylindrical Regions of Interest (ROIs) and calculates the average
values for each of the two materials (Water and Air).

Hounsfield validation

The CT values of water and air referring to the image of the tomographic quality diagnostic device
will be used to assess the density scale over time.

5.2.3.2. Slice thickness


For this evaluation, the software will use Section 2 of the tomographic quality diagnostic device,
performing a scan on the axial slices of the volume to verify the actual size of the voxel. During the
sweep, the initial and final axial cut of the volume of the square object made of PVC, positioned in the
center of the cylinder, will be identified. Once you know the real height of this object in millimeters
and the height measurement in voxels, the real size of the image's slice thickness will be calculated.

5.2.3.3. Spatial resolution


The modulation transfer function (MTF) mathematically quantifies the contrast resolution. MTF
measures preserved contrast for a sine wave pattern as a function of spatial frequency. An MTF
curve starts at 1 for zero frequency and decreases as the spatial frequency increases. Threshold
resolution is equal to the frequency at which the MTF drops to 0. The measure of frequency is in
pairs of lines per millimeter.

For the calculation of the MTF, the software will use the Slanted-Edge technique, which is an edge
gradient MTF method specifically suited for calculations using spatially sampled capture devices.

For this evaluation, the software will use Section 2 of the tomographic quality diagnostic device.
The identification of the spatial resolution will be made from the transition of gray levels provided
by the PVC piece fitted in the center of the cylinder. Air and PVC will create a black-white contrast
of the slanted edge.

Using the generated image, the software will select a rectangular region of interest (ROI) around
the black-white transition of the slanted edge.

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Black-white PVC/air slanted edge transition.

From the image, the Spatial Frequency Response (SFR) is calculated. The line propagation function
(LSF) is generated by numerically calculating the first derivative of the SFR. Once the LSF is known,
the magnitude of the FFT of this LSF is calculated. A graph of the relationship between the magnitude
of the FFT versus the spatial frequency resulting in the MTF will be generated.

5.2.3.4. Uniformity
The aim of this analysis is to evaluate the uniformity of voxels within this region of homogeneous
material. Section 3 of the device is a uniform region of acrylic. The software selects 5 ROIs and
measures the pixel values within these ROIs, calculating the mean value and standard deviation
for each ROI.

Noise and Uniformity Section

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5.2.3.5. Noise
Using Section 3 of the tomographic quality diagnostic device, the software evaluates the noise
behavior in the middle of the image. For this, the standard deviation of the gray levels of the voxels
of a cylindrical ROI centered on a uniform region of acrylic is calculated, divided by the difference
between the mean values of the CT number of acrylic and air.

5.2.3.6. Low contrast detectability


Low contrast detectability (LCD) measures the ability of a CT scanner to differentiate a low contrast
object from its background. The visibility of objects depends on the size and contrast level of the
background. As the size of these objects decreases, it becomes more difficult to recognize them
for the same contrast level.
To determine the LCD, the software will use the uniform region of Section 3 of the tomographic
quality diagnostic device. The central region of this slice is divided into several circular ROIs of the
same diameter. The mean voxel value of each ROI is calculated and the standard deviation of the
means is obtained. The contrast of an object the same size as these ROIs is defined as 3.29 times
the standard deviation to be differentiated from the background. This analysis is repeated with
different ROI sizes and a contrast detail diagram is created in the report.

5.2.4. DOSE MEASUREMENT


For periodic dose measurement, a radiation detector should be used to measure Kerma in air.

Configure the exposure parameters (kV, mA and Time) in the software. Position the radiation detector
at the tube outlet and perform an exposure.

Access the dose measurement tool in the software and enter the exposure parameter values and
measured air kerma to generate a report that can be saved to compare the results with previous
or optimal values.

5.2.5. QA REPORT
After diagnosis, the software will create a quality control report that can be saved to compare
results with previous or reference values.

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5.3. PROBLEM DIAGNOSTICS


5.3.1. WARNING AND ERROR MESSAGES
Occasionally, malfunctions may occur during use. In case of an error, an audible signal will be
emitted by the equipment and an error message will be displayed on the software interface.
The table below lists the error indicated by the equipment.

BIP CODE ERROR DESCRIPTION


3 short beeps General error
5 short beeps Exposure error

The detailed description of the error can be found in the software manual.
It is possible to identify a head error directly using the 7-segment display of the head.
The following table lists generator errors.

CODE ERROR DESCRIPTION


0x0010 3.3V source error
0x0011 5V source error
0x0012 +15V source error
0x0013 -15V source error
0x0014 24V source error
0x0015 Oil temperature error
0x0016 Plate temperature error
0x0017 CPU temperature error
0x0018 Flip Flop Protection Error
0x0019 Kv error
0x001A mA error
0x001B Filament current error
0x001C Filament current error at preheat
0x001D Resonant current error
0x001E Error in the high voltage off value greater than the maximum off value
0x001F Error in the high voltage off value less than the minimum off value
0x0020 Error on cooler 1
0x0021 Error on cooler 2
0x0022 5V source current error
0x0023 +15V source current error
0x0024 -15V source current error

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0x0025 24V source current error
0x0026 5V source current error with seven-segment display on
0x0030 Error Generator not ready to expose
0x0031 Attempt to expose error during cooling
0x0032 Release button error
0x0033 Low kV error
0x0034 High kV error
0x0035 Low mA error
0x0036 High mA error
0x0037 Low filament current error
0x0038 High filament current error
0x0039 Hardware error
0x0040 Unexpected preheat time error
0x0041 Preheat timeout error
0x0042 DC 400V busbar error not available
0x0043 Control error during shooting
0x0050 Error reading or writing to FLASH memory
0x0051 Error loading settings from memory
0x0070 Uncalibrated filament current error
0x0071 Calibration error in filament current
0x0072 Uncalibrated anodic current error
0x0073 Calibration error in anode current
0x0090 Incorrect parameter error for kV less than minimum value
0x0091 Incorrect parameter error for kV greater than maximum value
0x0092 Incorrect non-zero kV parameter error
0x0093 Incorrect parameter error of mA less than minimum value
0x0094 Incorrect parameter error of mA greater than maximum value
0x0095 Incorrect mA non-zero parameter error
0x0096 Incorrect parameter error of time less than minimum value
0x0097 Incorrect parameter error of time greater than maximum value
0x0098 Incorrect parameter error of power greater than maximum value
0x0099 Incorrect energy parameter error greater than maximum value
Incorrect duty cycle parameter error in filament current less than
0x009A
minimum value

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Incorrect duty cycle parameter error in filament current greater than


0x009B
maximum value
0x009C Incorrect duty cycle parameter error at zero different filament current
0x009D Incorrect filament current parameter error less than minimum value
0x009E Incorrect filament current parameter error greater than maximum value
0x009F Incorrect parameter error of non-zero filament current value
0x00A0 Incorrect duty cycle parameter error at kV less than minimum value
0x00A1 Incorrect duty cycle parameter error at kV greater than maximum value
0x00A2 Incorrect duty cycle parameter error at non-zero kV
0x00A3 Invalid exposure type error
0x00A4 Error Exposure Parameters Not Configured
0x00B0 Instruction error must be unique
0x00B1 Invalid Sequence Error in Command to Head
0x00B2 Error command that does not depend on time must be provided first
0x00B3 Start exposure command error without stopping previous exposure
0x00B4 KV or mA ramp command error after end of exposure
0x00B5 Command error during exposure dead time
0x00B6 Command error at start of exposure dead time
0x00B7 Command error during kV or mA ramp execution
0x00B8 KV ramp tilt error
0x00B9 mA ramp tilt error
0X00BA Invalid command size error
0X00BB Invalid kV, mA, or power value error after ramping
0x00BC Non-zero parameter error
0x00BD Invalid pulse timing error
0x00BE Error stop exposure command before starting exposure
0x00BF Stop exposure command error before finishing kV or mA ramp
0x00C0 Error kV or mA ramp change before exposure dead time
0x00C1 Command error with invalid instruction
0x00C2 Command error during ramp
0x00C3 Command error after end of exposure
0x00D0 Head error exited receive loop
0x00D1 Invalid state error during exposure
0x00D2 Head error exited main loop
0x00D3 Not implemented error

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0x00D4 Invalid communication status error
0x00D5 Invalid kV duty cycle error
0x00D6 Invalid mA duty cycle error
0x00D7 Timeout error during exposure
0x00D8 AD reading error
0x00D9 Ramp command error without exposure
0x00DA Command error to start exposure during exposure
0x00DB Command error to end exposure without exposing
0x00DC Command error to update ramp
0x00DD Invalid execution parameter error
0x00DE KV setpoint error greater than maximum value
0X00DF KV setpoint error less than the minimum value
0x00E0 mA setpoint error greater than maximum value
0x00E1 mA setpoint error less than the minimum value
0x00E2 Head error exited exposure loop

BIP CODE ERROR DESCRIPTION


0x0100 Equipment without machine configuration
0x0101 Motor timeout
0x0102 Y Motor timeout
0x0103 X Motor timeout
0x0104 ROT motor timeout
0x0105 CEPH motor timeout
0x0106 HORIZONTAL COLLIMATOR motor timeout
0x0107 VERTICAL COLLIMATOR motor timeout
0x0108 CEPH COLLIMATOR motor timeout
0x0109 CHINREST motor timeout
0x010A RESERVED 9 motor timeouts
0x010B RESERVED 10 motor timeouts
0x010C Y Driver error
0x010D X Driver error
0x010E ROT driver error
0x010F CEPH driver error

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0x0110 Column motor timeout


0x0111 Column motor encoder error
0x0112 The exam was interrupted
0x0113 Shutter error
0x0114 The exam was stopped. The X-ray room door is open
0x0115 3V3 high source voltage
0x0116 Low 3V3 source voltage
0x0117 3V3 MCU source voltage high
0x0118 3V3 MCU source voltage low
0x0119 5V5 high source voltage
0x011A Low 5V5 source voltage
0x011B 12V12 high source voltage
0x011C Low 12V12 source voltage
0x011D 32V32 high source voltage
0x011E Low 32V32 source voltage
0x011F 5V source current high
0x0120 5V source current low
0x0121 12V source current high
0x0122 12V source current low
0x0123 32V source current high
0x0124 32V source current low
0x0125 High slew potentiometer voltage
0x0126 Low slew potentiometer voltage
0x0127 Canine potentiometer voltage high
0x0128 Canine potentiometer voltage low
0x0129 Failed to write to FLASH memory
0x012A Failed to read from FLASH memory
0x012B Failed to clear FLASH memory
0x012C Failed to write to EEPROM memory
0x012D Failed to read from EEPROM memory
0x012E Failed to erase EEPROM memory
0x012F Failed to communicate with head
0x0130 There was no exposure
0x0131 Synchronism failure between column and chinrest

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5.4. BELT REPLACEMENT
5.4.1. SWIVEL BELT
To change the swivel belt, turn off the equipment using the main switch.
Remove the top cover from the equipment.
Disconnect the optical sensors shown in the image below.

Disconnect motor X and potentiometer shown in the image below.

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Remove the clamps shown in the image below.

Disconnect the connectors and ground terminal shown in the image below.

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Disconnect all cables from the main board and remove the screws shown in the image below.

Loosen the swivel belt tensioner screws as shown in the image below, it does not require the
total removal of the screws.

Remove the damaged belt and replace it with the new belt.
Repeat the steps above in reverse order to attach the new belt to the rotation of the equipment.

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5.4.2. TELE BELT


To change the swivel belt, turn off the equipment using the main switch.
Loosen the screws according to the images below, it does not need the total removal of the
screws.

Remove the damaged belt, and replace it with the new belt.
Repeat the steps above in reverse order to attach the new belt to the rotation of the equipment.

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5.5. FUSE CHANGE
5.5.1. INLET FUSES
Input fuses F1 and F2 are located on the lower left side of the equipment.
Push the fuse base inward and turn it counterclockwise with a screwdriver.
The fuse comes out with the base.
Remove the fuse from the base and replace it with a new one. Repeat this procedure for each
blown fuse. Tighten both fuses by pushing the base and turning it clockwise with a screwdriver.
Spare fuses are provided with the product. If necessary, contact an authorized service center.

Supply voltage 110/127V~:


• F1/F2: T 20A L, 250V (Delayed action - 5x20mm)

Supply voltage 220/240V~:


• F1/F2: T 10A L, 250V (Delayed action - 5x20 mm)

F1 F2

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5.5.2. GENERATOR FUSES


Generator fuses are located on the right side of the generator board (F3) and on the front of
the board (F4). Remove the fuse and replace it with a new one.
Spare fuse is provided with the product. If necessary, contact an authorized service center.

• F3: F 5AL, 250V (Fast action - 6.3x32mm)

• F4: F 2AL, 250V (Fast action - 5x20mm)

F3 F4

5.5.3. MAIN BOARD FUSES


The column motor fuse (F5) is located at the top of the equipment, on the main board. Remove
the fuse and replace it with a new one.
Spare fuse is provided with the product. If necessary, contact an authorized service center.

• F5: T 8AL, 250V (Delayed action - 5x20mm)

F5

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5.6. POWER CABLE CHANGE
To change the power cable, disconnect the equipment from the general power board of the
establishment, remove the cable gland, release the cables from the connection terminal.
Arrange the new power cord in the order indicated on the lower right side of the column.
After connecting the cables, secure them with the bracket as shown in the figure below.

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5.7. ELECTRICAL CONNECTIONS


5.7.1. MAIN BOARD

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5.7.2. C-ARM BOARD

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