Operation During Bypass; Additional Information - Medtronic Affinity Fusion BB811 Instrucciones De Uso

10.4. Operation During Bypass

1. Arterial PO is controlled by varying the percent concentration of oxygen present in the ventilating
2
gas.
■
To DECREASE the PO
the FiO on your gas blender.
2
■
To INCREASE the PO
the FiO on your oxygen blender.
2
2. PCO is controlled primarily by varying the total gas flow rate.
2
■
To DECREASE PCO
removed.
■
To INCREASE PCO
removed.
3. Patient temperature is controlled by regulating the temperature of the water flow in the heat
exchanger.
Warning: After initiation of bypass, blood flow should circulate through oxygenator at all times
within blood flow range during cardiopulmonary bypass, except during emergency oxygenator
replacement.
Note: Care should be taken to minimize temperature gradient during cooling and warming phases
of bypass.
Note: The premembrane air purge line must remain open to ensure proper air removal when using
the integrated arterial filter function of the oxygenator.
10.5. Termination of Bypass
Terminate bypass per institution CPB protocol as individual case and patient condition indicates.
10.6. Emergency Oxygenator Replacement
A standby oxygenator and venous reservoir should always be available during cardiopulmonary
bypass.
1. Turn off water flow to the heat exchanger, then clamp and remove the water lines.
2. Clamp the venous line at the venous reservoir. Turn off arterial roller pump and clamp arterial line.
(If using a centrifugal pump, clamp the arterial line first, prior to stopping the pump.)
3. Remove oxygen line from the gas inlet port.
4. Clamp all oxygenator blood lines. Leave adequate lengths for reconnections.
5. Remove any monitoring/sampling lines from the oxygenator.
6. Detach the oxygenator from the holder by pressing the release tab.
7. Attach the replacement oxygenator onto the holder.
8. Connect all blood lines to the replacement oxygenator. Ensure all connections are secure.
9. Reconnect the oxygen line to the gas inlet port.
10. Connect and unclamp the water lines, then turn on water source and inspect for water leaks.
Warning: Do not unclamp arterial outlet line or venous return line at this time.
11. With sufficient volume in the venous reservoir, turn on the blood pump and slowly fill the oxygenator.
12. Increase blood flow through the recirculation line.
13. Stop the pump and clamp the recirculation line.
14. Ensure the entire system is free of leaks and gas bubbles.
15. Remove the clamps from venous and arterial lines and reinitiate bypass.

11. Additional Information

The following additional information and data are available upon request: sterilization method, materials
of the blood pathway, plasma leakage across the semipermeable membrane, blood cell damage,
particle release, air handling capacity, and relevant tolerances for specifications in the Instructions for
Use.
12. Important Notice — Limited Warranty (U.S. Customers Only)
A. This LIMITED WARRANTY provides the following assurances to the patient who receives an
Affinity Fusion ® Oxygenator with Integrated Arterial Filter and Balance
referred to as "The Product".
(1) Should the Product fail to function within normal tolerances due to a defect in materials or
workmanship prior to its "Use By" date, Medtronic will, at its option: (a) issue a credit to the
, DECREASE the percent of oxygen in the ventilating gas by adjusting
2
, INCREASE the percent of oxygen in the ventilating gas by adjusting
2
, INCREASE the total gas flow rate to increase the amount of CO
2
, DECREASE the total gas flow rate to decrease the amount of CO
2
® Biosurface, hereafter
Instructions for Use
2
2
English 25