sorin 75220, Operator'S Manual, Page: 22 / 304

Introduction and Safety
1-8
20077/021 US
X
TRA
Operator’s Manual
requested to evaluate the final hematocrit in the RBC bag. The same holds true also for volume,
supernatant removal and waste line color monitoring features.
43. The X
TRA
hematocrit sampling system has not been tested for all possible blood conditions.
Conditions may exist which will result in hematocrit readings which differ from Coulter Counter
readings. For example, conditions which result in cellular changes (sickle cell anemia, high
concentrations of anticoagulants which may cause red cell shrinkage, or the use of certain
anticoagulants which may cause red cell volume expansion) or conditions outside of the
applicable ranges may result in Hematocrit readings which differ from Coulter Counter readings.
44. When releasing an IV pole or reservoir pole locking lever, the operator must always hold the pole
and locking mechanism with both hands; otherwise, there is a serious risk of injury.
45. Do not open the lid in the event of a power failure if the centrifuge has not yet come to a stop
(which may take between 50 and 90 seconds).
46. In the event of excess heparin in collection reservoir due to inappropriate ratios, the salvaged
blood may contain residual heparin.
47. In the event of decreased patient antithrombin III levels if using heparin anti coagulation, consult
the physician in order to provide alternate anticoagulation.
48. When the X
TRA
is used alone, the RS422 serial ports used to connect it to the X
VAC
must be
covered and secured with a cap.
49. The use of the Last Bowl function is recommended only to complete the case, with the following
conditions: The reservoir is empty, no more blood is expected to be collected, and sufficient red
cells in saline solution are available in the RBC bag to compete the Concentrate cycle.
50. In case a partial bowl is washed, the hematocrit of the collected blood as well as the removal of
waste components might be lower than expected.
51. The maximum volume in the RBC bag is 1 liter. To avoid explosions, check the level inside the bag
carefully before activating the Last Bowl function.
52. The Last Bowl function automatically activates a second Empty phase at the end of the first
Empty phase. Carefully monitor the air in the RBC bag in case of repeated activation of the Last
Bowl function.
53. The X
TRA
and X
VAC
should not be used adjacent to or stacked with other equipment. However, if
adjacent or stacked use is necessary, the X
TRA
and X
VAC
should be observed to verify normal
operation is occurring in the configuration in which they are used.
54. In order to comply with “General Requirements for basic safety and essential performance of
Medical electrical equipments” (IEC 60601-1, Rules preventing instability), it is requested that the
waste bag not be filled with more than 9 liters of waste liquid.
55. The blood collected with the X
VAC
vacuum module must be processed only with the X
TRA
Autotransfusion System.
56. Use of protocols different from Post-op in postoperative contexts might expose the patient to risks
of tissue damage due to high aspiration level of vacuum module and risks of blood return due to
availability of the Return function.
57. Use of the vacuum pump in INTRA mode while collecting blood postoperatively might expose the
patient to risks of tissue damage.
58. Transport should only be undertaken in a certain condition that is clearly described in Appendix D
of this manual.
59. All contents of the waste bag are not intended for further processing and must be properly
discarded.
60. In the event of large volumes of blood leaking or splashing inside the centrifuge well, the integrity
of the centrifuge plate and centrifuge well gasket could be compromised. In this case please
contact the authorized Services of your LivaNova branch or your local LivaNova representative.