MIRI
®
II-12 Multiroom IVF incubators User Manual Rev. 4.0
84
written "Installation report". The completed and signed "Installation report" form must be
sent to the clinic. Any deviations/complaints/suggestions from the Installation visit are
reported in the CAPA system. If a critical error has occurred, information about this will be
reported directly to QC or QA.
If the MIRI
®
II-12 multiroom IVF incubator fails any of the "Installation report"
form
acceptance criteria, or it in any way suffer from a severe error and incubation
parameters are compromised, the MIRI
®
II-12 multiroom IVF incubator must be taken
out of service until it is repaired/ exchanged, or anew test approves the MIRI
®
II-12
multiroom IVF incubator. The User and owner must be informed about this and
arrangements to solve the problems must be initiated.
