Installation Procedure
ESCO MEDICAL MRI-6A10/XQ-1
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Use the user manual as much as possible to get the user well acquainted
with it.
The User/owner is informed that the first VOC filter change is 3 months
after installation and then with 3 months intervals. First service check is under
normal circumstances after 1 year.
6.7 After the Installation
When the installation trip is finished a copy of the original Installation test form must
be sent to AT Medical Ltd.
It will be saved with the device records.
A paper copy of the completed and signed Installation test form is stored in the
device history record of the unique device according to the ISO procedure and
Medical Device Directive.
The date of Installation is written in the Instrument Overview file.
The date of Installation is also written in the Service schedule.
If the MRI-6A10/XQ-1 user or owner make inquiries about a written Installation report
the completed and signed Installation test form must be sent to the clinic.
Any deviations/complains/suggestions from the Installation visit are reported in the
CAPA system.
If a critical error has occurred information about this is to be reported directly to QC
or QA.
If the MRI-6A10/XQ-1 fail any of the Installation test accept criteria or it in
any way suffer from a severe error and incubation parameters is compromised
the MRI-6A10/XQ-1 must be taken out of service until the MRI-6A10/XQ-1 is
repaired/ exchanged or new test approves the MRI-6A10/XQ-1. The MRI-
6A10/XQ-1 user and owner must be informed about this and arrangements to
solve the problems must be initiated.