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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.
5.
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
Cautions
1.
Each operator should be thoroughly familiar with the Trima Accel system operator's manual.
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.
3.
When loading the channel and the LRS chamber into the centrifuge filler, be careful not to
stretch the tubing, as leaks could develop.
4.
Be careful to press on tubing only with your fingers when loading the channel. To avoid
accidental puncture, never use any sharp object.
5.
When Trima Accel
from certain donors may have the potential for ineffective filtration and leukoreduction. For
TLR Filter sets, filtration times may be extended.
When using MultiPlasma tubing sets, ensure that at least two plasma line clamps are open
6.
for procedures with plasma volumes greater than 600 mL.
Procedures for Use
Refer to the Trima Accel Automated Blood Collection system operator's manual for specifics
regarding the following procedures:
•
Setting up the disposable tubing set
•
Performing a collection procedure
•
Removing products and the disposable tubing set
Storage Conditions
•
Shipping temperature range: –29 °C to 60 °C
•
Long-term storage temperature range: 0 °C to 60 °C
•
The disposable tubing sets are acceptable for use up to 24 hours after the set packaging is
opened (i.e., the Tyvek
®
Auto RBC Sets and TLR Filter Sets are used, RBC products collected
cover is removed, allowing access to the end caps).
®
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