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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 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 MultiPlasma tubing sets, ensure that 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 detailed
information regarding the following procedures:
•
Setting up the disposable tubing set
•
Performing a collection procedure
•
Removing products and the disposable tubing set
4
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