sorin 75220, Operator'S Manual, Page: 27 / 304

Introduction and Safety
X
TRA
Operator’s Manual
20077/021 US
1-13
49. During the execution of emergency protocols, the control that causes a warning of “Minimum
wash quality wash might not be reached yet” is automatically disabled.
50. The use of emergency protocols with the Rapid Transfer option produces an unwashed final
collection in which the removal of contaminants is only possible through the 40-µm filter in the
reservoir. It is the full responsibility of the user to evaluate if the conditions exist to use
emergency protocol with the Rapid Transfer option.
51. The emergency protocols promote fast execution rather than the quality of the final product,
which is reduced compared to that guaranteed by other predefined protocols. Their use is,
therefore, reserved to situations in which there is a preponderant urgent need for blood regarding
the concentration of RBC collected and the wash quality. It is the full responsibility of the user to
evaluate if the conditions exist to use said protocols.
52. The use of emergency protocols with the No Wash option produces an unwashed final collection
in which the removal of contaminants is only possible through the 40-µm filter in the reservoir
and the concentration of the Fill phase. It is the full responsibility of the user to evaluate if the
conditions exist to use an emergency protocol with the No Wash option.
53. Inadequate washing of concentrated red blood cells can lead to an excessive level of
contaminants (i.e. anticoagulants and plasma free hemoglobin) in the treated blood.
54. Use of the vacuum pump in INTRA mode while collecting blood postoperatively might expose the
patient to risks of tissue damage
55. As soon as postoperative drainage operations are completed, the patient must be disconnected
from the reservoir.
56. The use of protocols different from POST-OP in postoperative contexts might expose the patient
to risks of tissue damage due to high aspiration levels of vacuum module and risks of blood return
due to availability of the return function.
57. During setup and unload of the kit, the patient must not be connected to the reservoir through
the drainage line.
58. The deactivation of the RBC Detector is at the full responsibility of the doctor/operator who must
carefully supervise the fill phase (or concentration) and manually touch the Wash button to start
the washing phase (or Spill or Empty to start the phase of the same name during a sequestration
protocol). A delayed procedure might lead to a loss of red blood cells or, in sequestration
procedures to inadequate collections. An early procedure might lead to low quality collection.
59. The repeated use of the Return function on the same red blood cells might lead to them being
damaged and therefore to their loss.
60. The Concentration function reprocesses already collected red blood cells subjecting them again to
the mechanical action of the pump and the centrifuge. The repeated use of the Concentration
function on the same red blood cells might lead to them being damaged and therefore to their
loss.
61. Any modification on the acoustic signals can make the operator take longer to realize that the
machine has made a warning.
62. The deactivation of the alarms “RBC bag full” and/or “Waste bag full” is under the responsibility of
the user who must directly control the fill level of the bags.
63. In the event of replacing a collection bag, verify that the new bags are properly connected and
the manual clamps reopened before restarting the process in order to avoid problems of blood
component leakage and circuit breaks.
64. In the course of preoperative sequestration treatments, it is necessary to open and/or close some
of the manual clamps along the lines. Erroneous execution of these procedures by the operator
might lead to breakage of the disposable, blood component leakage and inadequate collections.
65. The use of the Prime IV function or repeated calibration phases of the HCT sensor can lead to a
dilution of the collection (PPP/PRP).
66. Always close the centrifuge lid before starting any function of the machine that uses the pump
and/or centrifuge action to avoid the risk of touching moving parts of the device.