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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.
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
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