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Intended Use
Trima Accel
disposable tubing sets are intended for use with the Trima Accel Automated Blood
®
Collection System. Depending on the tubing set used, platelets, plasma and/or red blood cells may
be collected.
•
Adequate studies have not been performed to evaluate the quality of gamma irradiation or
freezing of ACD-A/AS-3 red blood cell (RBC) products collected with gravity drain
leukoreduction process (TLR filter) on the Trima Accel system.
•
Studies have not been performed to support gamma irradiation or freezing of ACD-A/ AS-3
RBC products collected with an integrated in-line RBC leukoreduction filter(s) (Auto RBC
filter) on the Trima Accel system.
Please refer to the Trima Accel Automated Blood Collection system operator's manual for a
complete listing of warnings, cautions, adverse effects and operating instructions.
Warnings
1.
If the integrity of the tubing set is compromised for any reason, the tubing set is no longer
functionally closed, and the product should not be stored beyond 24 hours.
2.
Check that all pump headers have been properly loaded before beginning a procedure.
Visually inspect each pump and carefully run your finger around the edge of each pump.
3.
This product contains phthalates (DEHP). Whole blood donors are not exposed to DEHP;
the potential health risk to apheresis donors is low, because the time-averaged DEHP dose
exposure is very low. Patient groups that include pregnant or nursing women and children
are considered to be the most at risk to potential harmful effects of exposure to DEHP.
However, regulatory bodies have noted that the benefit of doing a needed procedure is far
greater than the risk associated with exposure to DEHP. It is the responsibility of the treating
physician to balance this risk for the patient.
4.
The blood and fluid pathways of the tubing set are sterilized with ethylene oxide and are
nonpyrogenic. The packaging cover of the tubing set serves to protect the set and keep
contents in place during shipping. Under any of the following conditions, DO NOT use the
set:
•
The end caps are not in place
•
The needle cap plug is not in place
•
Severe kinks in the tubing are apparent
•
The tubing set is incorrectly assembled
•
The tubing set is damaged
•
The clamps are closed on the pre-attached filter tubing assembly
5.
Do Not Reuse/Not for Reuse: Terumo BCT, Inc. 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.
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