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Introduction and Safety
X
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Operator’s Manual
20077/021 US
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24. Whole blood must be anticoagulated as it is collected into bags containing appropriate
anticoagulant for plasma sequestration. Inadequate anticoagulation may result in clotting,
interfering with the processing of the blood products.
25. Non-red cell components (e.g., platelet rich/platelet poor plasma intended for transfusion and
platelet rich/platelet poor plasma) shall be used or applied before the patient leaves the operating
room or clinical procedure area.
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26. If plasma is being collected for transfusion, it must be transfused before the patient leaves the
operating room or clinical procedure area.
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27. Do not over anticoagulate collected blood. Plasma Sequestration has no Wash cycle to remove
excess anticoagulant. A part of the anticoagulant used will be returned to the patient.
28. Do not overfill PPP and PRP bags. Overfilling may cause back pressure that would cause fluid to
exit through the bowl seal.
29. Do not reinfuse the PRP back to the patient if the X
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fails to operate as intended.
30. To reduce the possibility of air or particulate embolism, LivaNova STRONGLY RECOMMENDS the
use of reinfusion protection devices, including microfilters, when infusing processed blood.
31. Do not reinfuse under pressure (i.e., do not use a blood pressure cuff on the RBC or plasma/PRP
bags). Reinfusion under pressure could lead to air embolism.
32. Do not use solvents such as alcohol, ether, acetone, etc. to clean the equipment or the disposable
circuits as contact of solvents with the plastic components may cause damage to the equipment
or to the device. In addition to not using solvents, do not otherwise tamper with or alter the
circuit’s configuration.
33. If the rotor of the roller pump has been removed to clean the upper panel, carry out the following
operations to replace it correctly: open the lever, insert the rotor into its seat, turn it until aligns
with the slot of the metal shaft and reposition the white lever into the slot.
34. During the use and transportation of the unit, do not exceed the maximum loading capacity.
35. The program parameters and the buffy-coat level are optimized according to the bowl size. At the
end of the setup, verify that the bowl size automatically recognized by the machine (or manually
selected) corresponds to the bowl size present in the disposable kit.
36. In case of malfunction of the integrated vacuum pump, use an alternate vacuum source, i.e. the
vacuum present in the operating room, possibly connected to a pressure regulator.
37. Whenever the disposable kit is set to start a new case (or, if needed, substituted during the
current case), make sure to conclude the setup by pressing LOAD PUMP; otherwise improper
program parameters could be set, compromising performance.
38. After Setup operations, verify that the size of the bowl used corresponds to that indicated on the
display.
39. The continuation of the current case by pressing RETAIN is under the full responsibility of the
operator.
40. The stand-by function stops the pump for several minutes, but not the centrifuge. Avoid any
improper use. Do not activate the stand-by function for prolonged or repeated periods. Instead,
press the Stop button and restart the case whenever needed.
41. Improper use of RETAIN can lead to the risk of obtaining an inadequate blood product.
42. X
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is provided with an indicator which measures the Hct of the fluid entering and of the RBCs
leaving the bowl. As this system is mainly intended to provide the user with a trending of Hct
values, it is recommended that alternate means of measuring hematocrit be used when it is
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American Association of Blood Banks. Standards for Perioperative Autologous Blood Collection
and Administration . 3rd Edition. Bethesda, MD. 2007 Reference Standard 5.1.8 (Handling,
Storage, Transportation)
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American Association of Blood Banks.
Standards for Blood Banks and Transfusion Services.
18th ed. Bethesda, MD: American Association of Blood Banks, 1997.