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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 (EO) 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
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.
When loading the channel and the LRS chamber into the centrifuge filler, be careful not to
3.
stretch the tubes, as tubing 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 using the Trima Accel Automated Blood Collection System, Version 5, do not select
a procedure configured with an RBC product when using a disposable tubing set that does
not contain an RBC bag. If a procedure with an RBC product is selected in error, a "centrifuge
pressure high" alert will be displayed when RBC collection begins. Select for rinseback and
continue. Any RBC in the system will be returned to the donor.
6.
When using Trima Accel Auto RBC Sets and TLR Filter Sets, RBC products collected from
certain donors may have the potential for ineffective filtration and leukoreduction. For TLR
Filter sets, filtration times may be extended.
7.
When using MultiPlasma tubing sets, ensure at least two plasma line clamps are open 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
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