Introduction and Safety
X
TRA Operator’s Manual 20077/021 US 1-11
16. Do not completely empty the waste bag until the end of the case. If you empty the waste bag
during the case, leave approximately one liter of fluid in the waste bag to prevent the possibility
of vacuum being generated in the waste bag during the Empty cycle. Vacuum in the waste bag
may prevent complete emptying of the bowl.
17. The waste bag should be replaced with the equipment STOPPED (pump and centrifuge) and the
bowl completely empty. This instruction does not apply if the replacement of the waste bag is
done with a vented waste bag.
18. When cleaning the process air detector, red blood cell detector, Hct indicator, and waste line color
indicator, do not use bleach, abrasive materials, or solvents, as they may damage the sensors.
Use a mild detergent.
19. Do not immerse the rotor in cleaning solution. Do not autoclave. Component damage may result.
20. The fluid collected in the Centrifuge Well Collection may be biohazardous. Handle accordingly and
dispose of the container according to hospital protocol.
21. Prior to first use of the X
TRA, electrical and operational checks should be performed according to
hospital protocol and the company's recommendations.
22. Report immediately to the responsible service personnel any of the following conditions. Do not
use the X
TRA until corrective action has been taken:
• Damaged or worn power cord, plug or receptacle.
• Switches that are loose or do not operate with a positive action.
• A machine that has been subject to significant physical damage.
• A machine that has given anyone an electrical shock while in use.
• A machine that appears to be overheating.
23. It is the responsibility of the health care institution to adequately prepare and identify the product
for return shipment. Do not return products that have been exposed to blood borne infectious
diseases.
24. Federal law (USA) restricts this device to sale by or on the order of a physician.
25. Store plasma products containing platelets at room temperature (20 °C to 24 °C) with
continuous, gentle agitation.
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26. Make sure that you attach both PRP bags included in the XTRA Sequestration Set. Because the
X
TRA does not alert you when a specified volume is collected, you must have sufficient bags
available for the entire amount that can be collected.
27. Air must be collected and be available to be returned to the centrifuge bowl during the Empty
cycle. Otherwise, plasma may be accidentally drawn back into the centrifuge bowl. Ensure that
the bag with the air remains attached to the bowl outlet tubing and OPEN during the Empty cycle.
28. If using the waste bag for air management, the waste line should not be clamped until plasma
starts to exit the bowl during plasma sequestration.
29. Make sure that the waste line is unclamped before starting blood salvage processing.
30. The physician ordering the collection of PRP shall use discretion when any of the following
conditions exist:
•Sepsis
• Preoperative hematocrit less than 30%
• Preoperative platelet count less than 195,000 per µl
• Hemodynamic instability
• Prolonged clotting times
8
American Association of Blood Banks.
Standards for Blood Banks and Transfusion Services
. 18th
ed. Bethesda, MD: American Association of Blood Banks, 1997: G3.300.
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