Medtronic Affinity Pixie Gebrauchsanweisung Seite 27

2. Clamp the venous line at the CVR. Turn off the arterial roller pump and clamp the arterial line. (If using a
centrifugal pump, clamp the arterial line first, before stopping the pump.)
3. Remove the oxygen line from the gas inlet port.
4. Remove any monitoring/sampling lines from the oxygenator.
5. Double clamp the recirculation line, oxygenator inlet, and outlet tubing. Cut between the clamps leaving
adequate lengths for reconnections.
6. Detach the oxygenator from the holder by pressing the release tab.
7. Attach the replacement oxygenator onto the holder.
8. Reconnect the recirculation, oxygenator, and outlet tubing. Ensure that 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 the arterial line or venous return line at this time.
11. With sufficient volume in the CVR, 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 that the entire system is free of leaks and gas bubbles.
15. Remove the clamps from the venous and arterial lines and reinitiate bypass.
11. Cardiotomy/venous reservoir, vacuum-assisted venous drainage (VAVD)
11.1. Warnings
■
Do not use a vacuum regulator with maximum negative vacuum pressure greater than –20 kPa
(–150 mmHg). Use of excessive negative pressure may lead to hemolysis.
■ Do not occlude or obstruct the vent port of the CVR during operation (except when using VAVD).
■
Draw only intended drug amounts into the syringe that will be used for drug administration into the CVR
during VAVD. Negative pressure in the CVR could draw more drug from the syringe into the reservoir than
intended and lead to excess drug delivery.
■
All A/V shunt lines must be closed to atmosphere before stopping the pump or using low blood flow rates
during VAVD. Failure to do so may allow air to be drawn into the blood side of the oxygenator from the fiber.
■
Appropriate occlusion of the arterial roller pump head is necessary when using VAVD. Failure to
appropriately occlude the pump may allow air to be drawn into the blood side of the oxygenator from the
fiber.
■
An arterial filter should be used during VAVD techniques to minimize potential delivery of air emboli.
■
Gradually return to atmospheric pressure when ending use of VAVD. A sudden change in pressure may
result in turbulent blood flow inside the CVR.
■
The line between the oxygenator and centrifugal pump (if used) must be clamped before stopping the pump
during use of VAVD. Failure to clamp off the arterial line may result in air drawn into the blood side of the
oxygenator from the fiber. Use of an arterial line one-way valve between the oxygenator and centrifugal
pump is recommended.
11.2. Precautions
■
A controlled vacuum regulator is required during VAVD.
■
A positive/negative pressure relief valve is required during VAVD (included, see Figure 2).
■
Use of a pressure measurement device on the CVR and an additional negative pressure relief valve that
operates at –20 kPa (–150 mm Hg) should be considered.
■
A vapor trap is required during use of VAVD due to condensation development.
11.3. VAVD instructions for use
1. Follow previously listed instructions for use for system setup with the following modifications as listed in
steps 2 through 3.
2. Attach a calibrated means of monitoring pressures to either the venous line or venous reservoir.
3. All manifold sampling ports must have nonvented caps when using VAVD.
4. Follow previously listed instructions for use for priming with the following additions as listed in steps 5
through 8 below.
5. Before initiating bypass, prepare the vacuum portion of the setup. Attach a vented vacuum line to the CVR
vent port and to the vacuum regulator with vapor trap.
Warning: Clamp the quick-prime line before application.
Warning: Do not allow the vapor trap to become completely filled during use. This may allow fluid to enter
the vacuum controller, or may prevent the CVR from being vented to atmosphere when no vacuum is
applied.
Instructions for Use English 25