
Introduction and Safety
X
TRA
Operator’s Manual
20077/021 US
1-5
12. The American Association of Blood Banks recommends the following guidelines for expiration of
Perioperative Autologous Non-Red-Cell Blood Products:
2
13. To minimize blood cell trauma, LivaNova recommends that vacuum levels no higher than (in
absolute value) 150 mmHg (20 kPa) be used when aspirating fluid from the surgical field.
3
14. Carefully observe the system for leaks before and during use. Leakage may result in loss of
sterility or loss of blood and/or fluid. If leakage is observed before or during use, replace or
retighten the leaking component as appropriate.
15. To prevent interference with anticoagulation when using citrate anticoagulants, do not use wash
solutions containing calcium. Only sterile 0.9% normal saline (injectable or approved for cell
processing) should be used as a wash solution.
16. Be sure that every bowl to be processed is adequately filled and packed before washing.
Otherwise, the Wash cycle will be ineffective and the hematocrit will be low.
17. Washed, packed red cells are depleted of clotting factors. Patients should be monitored for the
presence of clotting abnormalities associated with the transfusion of large volumes of packed red
blood cells without clotting factors. Physicians should be prepared to institute the appropriate
therapy.
18. Do not reinfuse the patient’s blood from the primary RBC bag when it is connected to the X
TRA
autologous transfusion circuit. Reinfusion from the primary reinfusion bag connected to the circuit
could lead to air embolism.
19. To minimize the complications of particulate matter infusion and the risk of air embolism, use of
an in-line microaggregate filter on the patient reinfusion line is STRONGLY RECOMMENDED.
20. Do not reinfuse under pressure (i.e., do not use a blood pressure cuff on the reinfusion bag).
Reinfusion under pressure could lead to air embolism.
21. To reduce risk of air embolism, remove all air from the primary reinfusion bag before handing the
bag over for reinfusion.
22. The physician ordering the use of this system and/or the surgeon operating the suction/collection
wand shall use discretion in the collection of the following substances:
2
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).
Collection Type
Storage temperature
Expiration
Special Conditions
Platelet-rich plasma intended
for transfusion
Room temperature
N/A
Shall be used before the
patient leaves the operating
room or clinical procedure
area
Platelet-rich plasma intended
for topical use
Room temperature
N/A
Shall be used before the
patient leaves the operating
room or clinical procedure
area
Platelet-poor plasma intended
for topical use
Room temperature
N/A
Shall be used before the
patient leaves the operating
room or clinical procedure
area
Thrombin intended for topical
use
Room temperature
Within 6 hours after
component preparation (or
not to exceed device
manufacture’s
recommendations)
Shall be used before the
patient leaves the operating
room or clinical procedure
area
Table 1-2 Guidelines for Expiration of Perioperative Autologous Non-Red-Cell Blood Products
3
Guidelines for blood recovery and reinfusion in surgery and trauma
. Bethesda, MD; American
Association of Blood Banks, 1997: 19-22.
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Страница 1: ...Operator s Manual SOFTWARE VERSION 2 00 20077 021 US FOR US MARKET ONLY...
Страница 70: ...System Description 3 32 20077 021 US XTRA Operator s Manual...
Страница 148: ...Special Cycles 6 10 20077 021 US XTRA Operator s Manual...
Страница 156: ...Automated Functions 7 8 20077 021 US XTRA Operator s Manual...
Страница 178: ...Programmability Option 9 10 20077 021 US XTRA Operator s Manual...
Страница 206: ...Preoperative Sequestration PPP and PRP 10 28 20077 021 US XTRA Operator s Manual...
Страница 232: ...Vacuum Module 13 10 20077 021 US XTRA Operator s Manual...
Страница 260: ...Troubleshooting 14 28 20077 021 US XTRA Operator s Manual...
Страница 270: ...Maintenance 15 10 20077 021 US XTRA Operator s Manual...
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Страница 284: ...B 2 20077 021 US XTRA Operator s Manual...
Страница 286: ...C 2 20077 021 US XTRA Operator s Manual...
Страница 298: ...D 2 20077 021 US XTRA Operator s Manual...
Страница 302: ...E 4 20077 021 US XTRA Operator s Manual...
Страница 304: ...LivaNova Deutschland GmbH Lindberghstrasse 25 D 80939 M nchen Germany Tel 49 0 89 32301 0 Fax 49 0 89 32301 555...