GRIFOLS DG Spin - 8.3 Out-of-Balance Control System Qualification

DG Spin Procedure for Qualification of the Operation (OQ)
8-3
• Verify that the tachometer speed marked is within the speed range
defined in 3.1 “Technical specifications”.
• Furthermore, verify that the speed shown by the Display when
is
pressed, although is not exactly the same than the tachometer speed, is
also within the speed range defined in 3.1 “Technical specifications”.
• Stop centrifugation by keeping
pressed down for a few seconds
until earring a continuous acoustic signal.
• Open the Cover of the centrifuge; remove the
DG Spin Head and the
cards.
• Place the empty
DG Spin Head in the centrifuge and close the Cover.
The verification of centrifuge speed implies verification of the equipment time
basis and therefore, independent verification of the timer is not necessary.
NOTE:
Acceptance of the results enables ensuring
correct function of the
DG Spin centrifuge with
respect to control of speed and time
Otherwise, repeat the procedure. If the results of
the new verification are not accepted, contact
your authorised Technical Service.
8.3 Procedure for qualification of the out-of-balance control system
The DG Spin centrifuge has a system that stops centrifugation if any imbalance
occurs in the
DG Spin Head during centrifugation. The sensor also has an
autoverification system monitored by the program; in case of sensor fault, the
centrifuge stops and indicates the presence of an error in the system.
To verify that this out-of-balance control system is operational, proceed as
described below:
• Open the Cover of the
DG Spin centrifuge and insert 2 adjoining cards.
• Close the Cover.
• Start a centrifugation batch by pressing
.