Acteon X-MIND trium User manual

Project Name:
X-MIND trium
XMt Installation check list
All. 8 a PR 7.5.3_1
Via Roma, 45
21057 Olgiate Olona (VA)
Rev 6
Rev 6
Issued by: Juri Carlo Cozzi
Reviewed by: Fabio Lissandrello
pag. 1/11
02/03/2018
Approved by : Dario Bandiera
INSTALLATION CHECK LIST
X MIND trium
data
SN
___________________________
UDI
_________________________________
Facility name
___________________________
Facility address
___________________________
State/province
___________________________
City
_________________________________
Nation
___________________________
Zip code
_________________________________
Facility phone
number
___________________________
E-mail
_________________________________

Pag 2 of 11
PLEASE NOTE
After the completion of the installation of the X-MIND trium, the installer technician MUST fill the form
contained in this document to certify that the device has been correctly installed.
The Installation Checklist Form must be completely filled in all the details, signed and stamped by the installer
technician and must be sent by e-mail to de Götzen S.r.l. at [e-mail]
de Götzen S.r.l. reserves the right to reject the filled Installation and start-up checklist Form if not correct
or complete in each part or with any test not passed: in these cases, or if the form has not been sent
to de Götzen, any kind of right of the user will be automatically off, including any kind of
responsibility of the manufacturer. Any future claims and/or complaint will be considered null
and void.
Make 3 copies of the filled form:
o One for de Götzen (soft copy)
o One for the User (keep it with the device documentation)
o One for the Dealer
PLEASE NOTE
If you encounter problems that don’t allow to correctly pass the tests or you have any doubt for the
correct installation of the equipment, contact immediately your referring technician or the
manufacturer: [e-mail]
Since is the authorized installer technician is in charge to perform the installation and tests of the X-
MIND trium, he/she has the full responsibility of the correct installation of the equipment.

Pag 3 of 11
Test
Passed
Failed
Description
Picture
Carry out the following operations while XMIND trium is OFF and disconnected from mains supply
Packaging integrity
□
P
□
F
Verify that the packaging is not damaged
and the impact and tilt indicators (labels)
are not activated (red indicator).
It is recommended to take pictures of the
indicators.
Packaging contents
□
P
□
F
Verify that all the parts are included in the
packaging (See the “XMIND trium
CONTENT PACKAGING” document,
included in the documentation)
Read:
Operator’s manual
Installation and
maintenance manual
AIS operator manual
□
P
□
F
Verify the manuals contained in the
specific folder on the workstation (3D
versions) or in the USB key (PAN, CEPH
versions)
Wall specifications
(for wall versions only)
□
P
□
F
The installation on wall must meet the
requirements specified in the installation
manuals and comply with local standards
Wall specifications
(for self-standing
versions only)
□
P
□
F
The installation must meet the
requirements specified in the installation
manuals and comply with local standards
Floor specifications
□
P
□
F
The installation floor must meet the
requirements specified in the installation
manuals and comply with local standards
Wall mounting
(for wall versions only)
□
P
□
F
Verify the correct fixing of the wall
mounting screws (see installation manual
for tightening torque)
optional for self-standing
versions only
□
P
□
F
Verify the correct fixing of the wall
mounting screws.

Pag 4 of 11
Self-Standing base
□
P
□
F
Verify the correct fixing of the Self-
Standing base screws (see installation
manual for tightening torque)
Column levelling
□
P
□
F
Verify the levelling using a spirit level
U-arm levelling
□
P
□
F
Verify the levelling using a spirit level
Internal cabling
□
P
□
F
Ensure that the internal cabling complies
with identifications on the cable labelling
and the connectors are properly plugged
in
Verify grounding
□
P
□
F
Ensure that the grounding in the pictures
are connected properly
U-arm:
Handling:
Column
motor:
Wires wrapped around
the column
□
P
□
F
Ensure that there are no wires wrapped
around the column during U-arm rotation
Fuse
□
P
□
F
In factory is not installed any fuse
Ensure that the correct fuse is inserted in
the fuse holder, according to power supply
of your country.
20 A. For 100 – 200 V supply voltage
10 A. For 200 – 240 V supply voltage
(See the label on the power board and/or
installation manual)

Pag 5 of 11
WARNING - CAUTION
The fuse is live (mains voltage) also when
the mains switch of trium is OFF: before
handling the fuse be sure that the trium is
disconnected from mains supply
Search for damaged
parts
□
P
□
F
Verify the presence of damaged or ruined
parts
XMIND trium external
connectors
□
P
□
F
Ensure that the main connector, the
Ethernet connector and the power supply
cable are plugged in the socket
U-arm rotation lock
□
P
□
F
Manually rotate the U-arm and identify the
mechanical block. (this operation must
be carried out with XMIND trium off to
prevent damaging the U-arm)
Carry out the next operations with XMIND trium ON and Workstation ON (trium uncovered)
Power supply
Record the measured
value below.
VAC = _______________
□
P
□
F
Ensure that the supply voltage is
compatible with the power supply
requirements (100 - 240 V AC ; 50/60Hz)
Ensure line of supply voltage is
connected to the brown wire of the supply
cable.
Ensure supply voltage stability. Write
down the measured power supply value at
L/N terminal on the power board (See the
installation manual)
WARNING - CAUTION
This part is live (mains voltage) also when
the mains switch of trium is OFF: be
careful handling this part
Check fan operation on
mainboard
□
P
□
F
Verify that the fan located on the
mainboard is in operation when trium is
turned ON
Check vertical movement
of the mobile column
□
P
□
F
Verify the vertical movement of the mobile
column, pressing the Column Up/Down
buttons on the control panel (also from
ceph keypad)

Pag 6 of 11
Check safety stop of the
mobile column when
moving UP
□
P
□
F
Locate the end-switch for UP movement
(close to the column motor).
Move UP the column.
By mean of an appropriate tool (a
screw driver or an Allen key) press the end
run during the column movement UP.
Verify that the vertical movement of the
mobile column stops immediately.
WARNING - CAUTION
Do not act on the end run with finger:
mechanical risk
Check safety stop of the
mobile column when
moving DOWN
□
P
□
F
Locate the end-switch for DOWN
movement (on top of the carriage).
Move DOWN the column.
By mean of an appropriate tool (a
screw driver or an Allen key) press the end
run during the column movement DOWN.
Verify that the vertical movement of the
mobile column stops immediately.
WARNING - CAUTION
Do not act on the end run with finger:
mechanical risk
Check U-Arm motion
□
P
□
F
Carry out the U-arm Demo Rotation
function described in the paragraph
describing the control panel
Verify the U-arm torque
□
P
□
F
Manually stop the U-arm during the Demo
Rotation and it should stop
Local emergency switch
□
P
□
F
Press the local emergency switch while the
system is operating; ensure that X-ray
emission and any column or U-arm
movement promptly stop and display
turns off.
Release the emergency switch and ensure
that the display turns on.
Remote emergency
switch
□
P
□
F
Press the remote emergency switch while
the system is operating; ensure that X-ray
emission and any column or U-arm
movement promptly stop and display
turns off.
Release the emergency switch and ensure
that the display turns on.
Ensure safety key
operation
□
P
□
F
Bring the safety key to position I, select an
exam and proceed until the trium is
armed; carry out an acquisition pressing
the yellow button: verify that the exam is
regularly executed.
Bring the safety key to position O, select
an exam and proceed until the trium is
armed; try to carry out an acquisition
pressing the yellow button: verify that
nothing happens
Check the positioning
lasers with the covers in
□
P
□
F
Verify after positioning in place the x-ray
cover, U-arm bottom covers and patient
arm top cover that the lasers continue to

Pag 7 of 11
place
hit the target as in the previous point of
this check-list
X-ray exposure switch
□
P
□
F
Ensure proper X-ray exposure switch
operation. Release the switch while the
equipment is operating and ensure that
the device stops
X-ray exposure LED
□
P
□
F
Ensure that the X-ray exposure LED is on
during radiation emission
XMIND trium Light
□
P
□
F
Ensure that the light is on:
• Always when trium is ON or
• Only during X-ray emission
depending on the chosen modality of
external light
Ensure collimator
operation
□
P
□
F
Verify that the motors move the X-ray
collimator consequently to the selection of
different FOV.
Arm and perform an
acquisition without
selecting the type of
exam
□
P
□
F
Try to arm the machine and perform an
acquisition without selecting the type of
exam an error message should be
displayed
Ensure key pad panel
operation
□
P
□
F
Ensure proper operation of all the key pad
panel buttons and LEDs, when a CBCT
exam is selected from AIS.
Note that the following keys are inactive
with the exams defined below:
• Bite up/down: inactive for all PAN-TMJ-
SINUS and CEPH exams
• U arm left/right: inactive for all PAN-TMJ-
SINUS and CEPH exams
• U arm forward/backward/right: inactive
for all CEPH exams
Verify the activation
status of the
XMIND trium Imaging
software.
□
P
□
F
Open the XMIND trium Imaging software.
If the software is not activated, proceed
with automatic or manual registration.
Check customization
settings for country
CANADA
□
110X80
Disabled
The FOV 11x8 has been
disabled following the request
of the prescribing dentist,
according to the “Standard of
Practice – Dental CT Scanners”
published in 2011 by the Royal
College of Dental Surgeons of
Ontario that sets out specific
professional and educational
requirements for Craniofacial
CT scans (large field of view
with cylinder height of over 8
centimetres).
“Disab._110x80” flagged
Check customization
settings for country
GERMANY
□
Narrow
Enabled
“narrow vertical collimator (Germany)”
flagged
Check customization
□
“US” flagged – MANDATORY for US

Pag 8 of 11
settings for country US
US
Enabled
market
□
3DApp US
• Uninstall 3DApp
• Clean registry
• Install US version (with US teeth
numbering)
Calibrations:
Perform the next operations with XMIND Trium ON covered with the plastics, except U-ARM
(uncovered)
Collimator calibration
□
P
□
F
See service manual
All models
Kinematic calibration
□
P
□
F
See service manual
All models
CBCT Geometric
calibration
□
P
□
F
See service manual
CBCT model
Laser alignment
□
P
□
F
See service manual
All models
CBCT coronal laser
OFFSET
□
P
□
F
See service manual
CBCT model
Backup XMt
Configuration File
□
P
□
F
See service manual
All models

Pag 9 of 11
Quality assessment checks
Perform the next operations with XMIND Trium ON completely covered with the plastics
PAN Quality Check
" Absence of artifacts
□
P
□
F
Verify that the exposed area is smooth and
without artifacts
see Quality
assessment
manual
PAN Quality Check
" High Contrast
Resolution
□
P
□
F
Verify that the High Contrast resolution is
at least 3.1 Lp/mm
see Quality
assessment
manual
PAN Quality Check
" Low Contrast
Resolution
□
P
□
F
Verify the Low Contrast resolution,
checking that all the four holes are visible.
see Quality
assessment
manual
CEPH Quality Check
" Absence of artifacts
□
P
□
F
Verify that the exposed area is smooth and
without artifacts
see Quality
assessment
manual
CEPH Quality Check
" High Contrast
Resolution
□
P
□
F
Verify that the High Contrast resolution is
at least 3.1 Lp/mm
see Quality
assessment
manual
CEPH Quality Check
" Low Contrast
Resolution
□
P
□
F
Verify the Low Contrast resolution,
checking that all the four holes are visible.
see Quality
assessment
manual
CBCT 80x80 Quality
Check
" Homogeneity
□
P
□
F
Verify that the Homogeneity of the 80x80
FOV Test is in the acceptance range 15.0 ±
5
Measured value (SW output)_______________
see Quality
assessment
manual
CBCT 80x80 Quality
Check
" CNR
□
P
□
F
Verify that the CNR of the 80x80 FOV Test
is > 5.0
Measured value (SW output)_______________
see Quality
assessment
manual
CBCT 80x80 Quality
Check
" V10%
□
P
□
F
Verify that the V10% of the 80x80 FOV Test
is > 1.6 LP/mm
Measured value (SW output)_______________
see Quality
assessment
manual
CBCT 80x80 Quality
Check
" V50%
□
P
□
F
Verify that the V50% of the 80x80 FOV Test
is > 0.5 LP/mm
Measured value (SW output)_______________
see Quality
assessment
manual
CBCT 110x80 Quality
Check
" Homogeneity
□
P
□
F
Verify that the Homogeneity of the 110x80
FOV Test is in the acceptance range 12.0 ±
5
Measured value (SW output)_______________
see Quality
assessment
manual
CBCT 110x80 Quality
Check
" CNR
□
P
□
F
Verify that the CNR of the 110x80 FOV Test
is > 4.0
Measured value (SW output)_______________
see Quality
assessment
manual
CBCT 110x80 Quality
Check
" V10%
□
P
□
F
Verify that the V10% of the 110x80 FOV Test
is in the acceptance range
is > 1.5 LP/mm
Measured value (SW output)_______________
see Quality
assessment
manual

Pag 10 of 11
CBCT 110x80 Quality
Check
" V50%
□
P
□
F
Verify that the V50% of the 110x80 FOV Test
is in the acceptance range
is > 0.4 LP/mm
Measured value (SW output)_______________
see Quality
assessment
manual
Carry out the next operations with XMIND trium OFF and completely covered with the plastics
Translating cassette
assembling (not for TLD
model)
□
P
□
F
Ensure that the covers of the translating
cassette are correctly assembled and the
plastic parts do not interfere with the
movement for the cassette
Translating cassette
assembling (for TLD
model only)
□
P
□
F
Ensure that the covers of the translating
cassette are correctly assembled and the
plastic parts do not interfere with the
movement for the cassette
Laser check with the
plastic mounted
□
P
□
F
See service manual
All models
General covers
inspection
□
P
□
F
Ensure that the covers are correctly
assembled and without any damage
Only for USA installation
Fill out report of
assembly (Form FDA
2579)
□
P
□
F
The report must be filled out to certify that the medical
equipment was assembled according to the instructions
provided by the manufacturer, and meets the requirements of
the applicable Federal standards contained in 21 CFR 1020.30
through 1020.33.
Reports must be filed with FDA's Center for Devices and
Radiological Health (CDRH) within 15 days of completion of the
assembly.
ADDITIONAL NOTES
Commissioning performed in accordance with installation manuals and any specific safety controls implemented
in the country without detection of defects.
The unit including all accessories and documents, in accordance with the manuals, were given in the correct
state.
The undersigned confirms to have the technical knowledge required for the installation.

Pag 11 of 11
DATE____________________
INSTALLATION TECHNICIAN SIGNATURE_______________________________________
NAME AND SURNAME: ___________________________________________________________