Spectra Optia Apheresis System Operator’s Manual
7
Preface
1
49
Some secondary plasma devices can remove significant quantities of plasma-circulating proteins, including
important clotting factors and albumin. The attending physician should evaluate each patient and prescribe
replacement proteins, if appropriate.
50
If a TPE-SPD procedure is being performed on a patient who has a TBV of 1 liter or less, Terumo BCT
recommends that the treated plasma bag and the AC container be weighed throughout the TPE-SPD
procedure to assess and manage the fluid balance.
Collection and depletion procedure warnings
51
Platelets are collected with target cells during continuous mononuclear cell collection (CMNC) procedures,
granulocyte (PMN) collection procedures, and white blood cell depletion (WBCD) procedures. If the initial
platelet count is low and the patient is not properly managed, excessive platelet depletion can occur.
52
Red blood cells (RBC) are collected with target cells during granulocyte (PMN) collection procedures, white
blood cell depletion (WBCD) procedures, and platelet depletion (PLTD) procedures. If the procedure is not
properly monitored, excessive RBC depletion may occur. To monitor excessive RBC depletion, consider
testing the patient’s hematocrit throughout the run.
53
Do not use a blood warmer on the replace line during a white blood cell depletion (WBCD) procedure or a
platelet depletion (PLTD) procedure. Using a blood warmer on the replace line slows the flow of
replacement fluid into the reservoir, affecting the system’s management of the fluid balance.
54
During collection and depletion procedures, the operator must monitor the plasma line for hemolysis. The
RBC detector is not used to monitor the plasma line during these procedures. If hemolysis occurs that is not
related to the patient’s condition, the operator should consider consulting the physician to determine
whether or not to continue the procedure and perform rinseback.
55
Before using a granulocyte-colony stimulating factor (G-CSF) or other agents to prepare the patient for a
procedure performed on the Spectra Optia system, consult the manufacturer’s package insert for potential
contraindications and adverse events.
General tubing set warnings
56
Do Not Reuse/Not for Reuse
: Terumo BCT, Inc.(Terumo BCT Ltd) products bearing the “Do Not Reuse”
symbol are intended for single use only and are not intended to be reused or re-sterilized in any manner.
Terumo BCT cannot ensure the functionality or sterility of the product if it is reused or re-sterilized.
Reuse of a single-use product could result in:
•
Product performance issues due to a loss of product integrity, including but not limited to the following:
–
Fluid leaks
–
Parts that are warped or deformed
–
Plastics that are brittle and discolored
–
Filters that have reduced filtration capabilities
•
Exposure to excessive ethylene oxide (EO) residuals
•
Viral infections such as hepatitis or human immunodeficiency virus (HIV)
•
Bacterial infections
•
Cross-contamination
Any of these risks could result in serious injury or death. These risks are shared by product users, donors,
patients, and recipients of end products of the device.
SpectraOptiaOpsManual.book Page 7 Thursday, May 17, 2018 11:24 AM
