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Intended Use
The Trima Accel
®
LRS
Blood Collection System to collect platelets and plasma for extended storage (such as, 5-day
platelets).
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.
Check that all pump headers have been properly loaded before beginning a procedure.
2.
Visually inspect each pump and carefully run your finger around the edge of each pump.
This product contains phthalates (DEHP). Whole blood donors are not exposed to DEHP; the
3.
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.
Do Not Reuse/Not for Reuse: Terumo BCT, Inc. products bearing the "Do Not Reuse"
4.
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
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.
Cautions
Each operator should be thoroughly familiar with the Trima Accel system operator's manual.
1.
All procedures should be performed by qualified medical personnel under the supervision of a
physician.
2.
Use aseptic technique throughout all procedures to ensure donor safety and product quality.
®
Platelet, Plasma Set is intended for use with the Trima Accel Automated
2
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