Additional Information For Products With Balance Biosurface; System Setup; Initiation Of Bypass - Medtronic Affinity Fusion BB811 Instrucciones De Uso

9. Additional Information for Products with Balance Biosurface

The blood-contacting surfaces of the device are coated with Balance Biosurface to reduce platelet
activation and adhesion and preserve platelet function. See Figure 8.
Caution: Appropriate blood anticoagulation protocol should be followed and anticoagulation should be
routinely monitored during all procedures. The benefits of extracorporeal support must be weighed
against the risk of systemic anticoagulation and must be assessed by the prescribing physician.
10. Instructions for Use

10.1. System Setup

Warning: The setup and use of the device is the responsibility of the attending clinician.
1. Remove the device from the packaging carefully to ensure a sterile fluid pathway.
Warning: Ensure aseptic technique is used during all stages of setup and use of this device.
2. Attach the holder mast clamp of the Affinity Orbit Holder System (sold separately) to the heart-lung
machine mast at the desired height and tighten the mast clamp knob.
3. Turn the locking lever perpendicular to the holder arm to unlock it.
4. Slide the oxygenator arm onto the post if it is not already in place.
5. Slide the oxygenator holder connector onto the bottom of the oxygenator arm. A click will indicate
the oxygenator is firmly seated.
Note: To remove the oxygenator, press the holder release tab and pull the oxygenator away from
the connector arm.
6. Position the oxygenator as desired for the procedure. The oxygenator may be rotated clockwise
or counterclockwise and the oxygenator arm may be moved laterally.
7. Turn the locking lever parallel to the holder arm to lock components in place.
8. Turn the holder arm knob to lock the holder arm in place. See Figure 3 for final system assembly.
9. Connect all blood and gas lines to their appropriate connections per institution CPB protocol.
10. If using a recirculation line, connect the recirculation line to the recirculation port on the oxygenator.
Connect the other end of the recirculation line to a barbed port on the venous reservoir used.
11. Connect the quick-connect 1.3 cm (1/2 in) water lines to the inlet and outlet ports on the oxygenator.
Start the water flow and check for leaks from the water compartment to the blood compartment
prior to priming.
Caution: Do not use the oxygenator if water is present in the blood compartment.
10.2. Priming & Recirculation
Note: A CO flush of the circuit prior to priming may improve ease of priming.
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1. Fill the venous reservoir with the appropriate volume of priming solution per institution CPB
protocol.
2. Remove all bubbles in the section of tubing (roller pump head/boot) or centrifugal pump (if used)
from the venous reservoir outlet to the oxygenator inlet.
3. Gravity prime the oxygenator or prime by forward pump flow per institution CPB protocol.
4. Gradually begin recirculation flow using a prebypass filter per institution CPB protocol.
5. Ensure the oxygenator is free of bubbles including unused ports.
Warning: Unused ports should be sealed tightly with the provided caps.
6. Add additional priming solution, if needed, to prime the rest of the extracorporeal circuit.
7. Upon completion of priming and debubbling, gradually reduce flow and stop pump, close all purge
lines, and clamp arterial, venous, and recirculation lines.
8. Ensure the entire extracorporeal circuit is free of bubbles prior to initiating bypass.
Note: Priming solution may be prewarmed using a heat exchanger prior to initiating bypass.

10.3. Initiation of Bypass

Warning: The blood phase pressure should always be greater than the gas phase pressure.
1. Ensure the gas outlet port is not obstructed.
2. Check for adequate levels of anticoagulation prior to initiating bypass.
3. Remove arterial and venous clamps and gradually increase blood flow. If using the integrated
arterial filter of the oxygenator, ensure the premembrane air purge line is open. Then initiate gas
flow with appropriate gas settings per institution CPB protocol and clinical judgment specific to the
patient and procedure.
4. Adjust water temperature to meet clinical demands.
24 Instructions for Use English