sorin 75220, Operator'S Manual, Page: 24 / 304

Introduction and Safety
1-10
20077/021 US
X
TRA
Operator’s Manual
17. Connecting electrical equipment to the integral multiple socket-outlet of X
TRA
effectively leads to
creating an ME system, and can result in a reduced level of safety. Connecting of other devices
(which is not allowed according to this user manual), must fulfill all requirements of the standard
IEC 60601-1:Edition 3.1.
18. The only way to separate the equipment from the supply mains on all poles simultaneously is by
disconnecting the POWER CORD from the mains inlet plug. Do not position X
TRA
and X
VAC
in a
way to make it difficult to disconnect the POWER CORD.
19. To isolate X
TRA
and X
VAC
(if connected) electrically from the SUPPLY MAINS on all poles (Line and
Neutral, PE conductor remains connected) simultaneously use the SUPPLY MAINS switch,
Figure 3-2 in this manual.
20. Connecting electrical equipment other than X
VAC
to the integral multiple socket-outlet of X
TRA
can
result in a reduced level of safety.
General Precautions
1. The X
TRA
must be used only with X
TRA
disposables.
2. Due to the possibility of operator exposure to blood borne pathogens (such as HIV, hepatitis
viruses, bacteria, Cytomegalovirus, etc.) when handling extracorporeal blood circuits, adequate
precautions should be taken at all times to prevent the exposure to and transmission of such
agents.
3. An adequate quantity of salvaged, viable, washed, packed red blood cells cannot always be
predicted or depended upon in a blood salvage procedure. Physicians should be prepared to
institute appropriate additional therapy if necessary.
4. Use aseptic technique when installing disposables.
5. Failure to maintain adequate anticoagulation during blood collection can cause excessive clotting
in and possible clogging of the collection reservoir or centrifuge bowl.
6. Incorrect assembly of the vacuum overflow trap or assembly using damaged components could
allow an overflow to enter the machine and damage internal vacuum system parts.
7. The operator is responsible for setting safe parameters for the custom protocols and for the
factory protocols modified during a case.
8. The X
TRA
will always start up with the Wakeup protocol as the Active protocol. Always verify the
Active protocol prior to processing.
9. Sterile 0.9% normal saline, USP (injectable or approved for cell processing) is typically used as a
wash solution. Other solutions intended for intravenous use that have been approved by the FDA
and have documentation available to show the component is safe may be used.
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10. During the Wash cycle, pump speeds lower than those used in the preset X
TRA
protocols may
decrease the wash quality.
11. Inadequate washing of the packed red blood cells may lead to an excessive level of contaminants
(e.g., anticoagulant, plasma free hemoglobin) in the processed blood.
12. The clamp on the inlet port of the waste bag must be open during blood salvage processing.
13. When clearing the line, stop the Empty cycle or manual cranking of the pump before air enters
the primary reinfusion bag. Stop the Empty cycle by pressing the Empty or Stop buttons.
14. Overfilling the reinfusion bag may cause it to rupture.
15. Ignoring a full waste bag may cause back pressure from the waste bag that could result in fluid
leakage around the bowl's rotating seal or waste fluid being returned to the centrifuge bowl.
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American Association of Blood Banks. Standards for Perioperative Autologous Blood Collection
and Administration . 3rd Edition. Bethesda, MD. 2007 Reference Standard 5.4.4 (Addition of
Drugs and Solutions)