Spectra Optia Apheresis System Operator’s Manual
13
Preface
1
Collection Set cautions
58
The Collection Set is no longer considered functionally closed if any of the following conditions are true:
•
Inlet needle is not connected.
•
First attempt to insert the inlet needle fails (unless you attach a new needle using a connection device that
maintains the sterility of the tubing set).
•
Inlet needle is disconnected during the procedure.
•
If using the diversion bag to collect a blood sample, the sample is taken before the line to the bag is
sealed.
•
Injection port on the inlet line is accessed.
•
Product bag or the diversion bag is disconnected before the line to the bag is sealed.
•
Product sample is removed from the sample bulb before you permanently seal the line.
•
Sterile barrier filters are damaged.
•
Integrity of the tubing set is compromised for any reason.
59
To correctly lock the needle protector over the inlet needle, you must hold it in place while you pull the
tubing to remove the needle. It will not lock if you use the wings of the needle or the body of the needle
protector to remove the needle. After use, visually confirm that the needle protector is locked over the needle
and that the wings are secured behind the locked prongs.
IDL Set cautions
60
The IDL Set is no longer considered functionally closed if any of the following conditions are true:
•
Inlet needle is not connected.
•
First attempt to insert the inlet needle fails (unless you attach a new needle using a connection device that
maintains the sterility of the tubing set).
•
Inlet needle is disconnected during the procedure.
•
If using the diversion bag to collect a blood sample, the sample is taken before the line to the bag is
sealed.
•
Injection port on the inlet line is accessed.
•
Frangible connector on the replace line is broken for any reason.
•
Product bag or the diversion bag is disconnected before the line to the bag is sealed.
•
Product sample is removed from the sample bulb before you permanently seal the line.
•
Sterile barrier filters are damaged.
•
Integrity of the tubing set is compromised for any reason.
61
To correctly lock the needle protector over the inlet needle, you must hold it in place while you pull the
tubing to remove the needle. The needle protector will not lock if you use the wings of the needle or the
body of the needle protector to remove the needle. After use, visually confirm that the needle protector is
locked over the needle and that the wings are secured behind the locked prongs.
Fluid cautions
62
Hydroxyethyl starch (HES) is not approved or available for use in some countries for apheresis procedures.
Check your country regulations before you consider using HES for a procedure on the Spectra Optia system.
SpectraOptiaOpsManual.book Page 13 Thursday, May 17, 2018 11:24 AM