Acteon X-MIND trium Installation Checklist Download Page 1

 

 

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  _________________________________ 

 
 

 

 

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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