User's Manual

8
Intended use
The system is designed for the in-line monitoring of morphological cellular parameters via a closed loop
disposable probe that can be sterilized.
The system is referred hereafter as the iLine F Pro (cGMP).
The iLine F Pro is not classified as a medical device and as such ISO-13485 requirements do not apply.
The iLine F Pro is intended to be used standalone, with the delivered power supply unit. Except for the power
supply port which is used to power the device, the various external ports are reserved for debugging and
maintenance purposes only, and shall not be used during nominal use of the system.
The BioConnect cartridge interface and BioConnect pump interface available on the iLine F Pro front are
intended to be used with a genuine BioConnect sold exclusively by Ovizio Imaging Systems S.A.
Ovizio assumes no liability for damage caused by, or any risks arising from the use of the device for purposes
other than those for which it is intended, or use outside the specifications set forth by Ovizio.
In case of violation of the conditions described above, the Declaration of Conformity shall be invalid.