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Intended Use
Trima Accel
®
disposable tubing sets are intended for use with the Trima Accel
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.
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.
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 (EtO) residuals
•
Viral infections such as hepatitis or human immunodeficiency virus (HIV)
•
Bacterial infections
•
Cross‑contamination
3
®
Automated Blood
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