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Service Manual
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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.
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.
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
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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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
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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.
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Service Manual
Manufacturer Model
Ionizing radiation
Indicates the presence or potential Electrostatic Sensitive Devices
presence of Ionizing Radiation/ (ESD)
Physiological Effect
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Protective ground Hazardous voltage
Two-Phase Configuration:
Phase 2 Conductor
Condutor de fase 1
Single-Phase Configuration:
Neutral Phase
Chinrest Equipment
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Return Ready
Return the equipment to the initial Indicates that the equipment is
position ready to operate
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
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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.
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.
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Service Manual
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.
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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.
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Service Manual
Radiation protection
The lead shot apron and collar are not included with the equipment.
• 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.
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• 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.
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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3
INSTALLATION
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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.
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.
If the equipment was damaged during shipment, document all damage carefully
and contact the responsible shipping agent immediately and file a confidential
damage claim.
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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.
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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.
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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.
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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.
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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.
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3.3. MOVING THE UNIT
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
HOLE HOLE
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.
Position the support, securing with 2 screws and two washers (included with the product).
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Service Manual
For fixing the main unit to the floor, follow the measures provided in the templates that
accompany the equipment.
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PLUMB BOB
WALL WALL
HOLE HOLE
HOLE HOLE
FLOOR DRILLING GUIDE
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.
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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
FOR FIXING THE WALL MOUNT, CONSIDER THE RELATIVE ELEVATION TO THE BASE.
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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
Dispose of the counterweight previously reserved. Position it as shown and secure it to the
main unit using the screws provided.
39
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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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.
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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.
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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
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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.
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.
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
- 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.
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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.
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;
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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
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06) When adjusting on the software screen the APPROVAL of the saved calibration will appear.
Calibration saved
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.
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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.
Analysis Completed
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Service Manual
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)
02) When level access the “Chinrest Position” tab in the calibration software.
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Service Manual
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.
64
screws
Figure 19
05) When the image is approved, proceed “Next” to the next step.
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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
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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
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Service Manual
06) To align the SAGITTAL laser, position the phantom and align the laser according to the software
images.
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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.
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06) Turn the screw indicated below to level the front level.
Back
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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.
74
4.4.3. STARTING THE CALIBRATION
- 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.
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.
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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Service Manual
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.
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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.
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4.4.8. SENSOR
01) Starting sensor calibration.
Awaiting Test
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
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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Cooling
07) When the status is “Analysis completed” click on the “Next” button.
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Analysis Completed
Awaiting test
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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.
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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.
4.4.11. LASER
01) The software indicates the Ear Plugs calibration.
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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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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".
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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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09) On the "Equipment" tab, select the 3D machine configuration, which can be "MFOV", "MFOV
+ TELE”, “SFOV” and “SFOV + TELE”.
11)Check that the door key is installed and select the "Installed" option.
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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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.
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02) Make the 5 shots, according to the Software. If necessary, adjust the collimator, following the
software instructions.
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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.
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02) Fit the geometric calibration phantom into the upper hole of the bracket and position them on
the chinrest.
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04) Check the results obtained and adjust, if necessary.
4.5.8. 2D CALIBRATION
01) To calibrate the center of rotation, check the leveling of the chinrest.
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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
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".
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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.
02) Check the function of the temple support mechanism and adjust.
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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
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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.
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.
This equipment cannot be tilted more than 5°. Risk of tipping over.
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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.
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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.
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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.
Make an exposure.
Check the image shown which lines of the image you can identify the separation.
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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:
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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.
Make an exposure.
Check the image shown which lines of the image you can identify the separation.
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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.
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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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.
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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.
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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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.
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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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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
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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.
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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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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.
F1 F2
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F3 F4
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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5.7.2. C-ARM BOARD
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