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Intended Use
The Trima Accel LRS Platelet, Plasma Set is intended for use with the Trima Accel Automated
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
If the integrity of the tubing set is compromised for any reason, the tubing set is no longer
1.
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.
Tubing sets manufactured by Terumo BCT contain DEHP. Results from selected studies
3.
of rodents exposed to DEHP (typically via an oral route) have shown potentially harmful
effects to male reproductive organs during fetal development. Because of this, patient
groups that include pregnant or nursing women and children are considered to be most at
risk to potential harmful effects of exposure to DEHP. However, no studies performed to
date involving other mammals and humans exposed to intravenous DEHP have shown
similar results. Regulatory bodies have noted that the risk of not doing a needed procedure
is far greater than the risk associated with exposure to DEHP. It is the responsibility of
treating physicians to balance this risk for their patients.
Cautions
Not for Reuse: Tubing sets manufactured by Terumo BCT bearing the not for reuse
1.
symbol are intended for single use only and are not intended to be reprocessed or reused.
Terumo BCT cannot ensure the functionality or sterility of the set if it is reprocessed or
reused.
Each operator should be thoroughly familiar with the Trima Accel Automated Blood
2.
Collection System Operator's Manual. All procedures should be performed by qualified
medical personnel under the supervision of a physician.
Use aseptic technique throughout all procedures to ensure donor safety and product
3.
quality.
4.
The blood and fluid pathways of the tubing set are sterilized with ethylene oxide and are
nonpyrogenic. Under any of the following conditions, DO NOT use the set:
•
The end caps are 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.
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