Acteon X-MIND trium Installation Checklist Download Page 2

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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 

[email protected]

 

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: 

[email protected]

 

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. 

 

 

Summary of Contents for X-MIND trium

Page 1: ...N CHECK LIST X MIND trium data SN ___________________________ UDI _________________________________ Facility name ___________________________ Facility address ___________________________ State province ___________________________ City _________________________________ Nation ___________________________ Zip code _________________________________ Facility phone number ___________________________ E m...

Page 2: ...he 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 t...

Page 3: ...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 co...

Page 4: ...le 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...

Page 5: ...ation 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 instal...

Page 6: ...orque 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 th...

Page 7: ...tons 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 ...

Page 8: ...N 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 ...

Page 9: ... 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 8...

Page 10: ...ee 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 stand...

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

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