System Setup - Medtronic Affinity NT CB511 Mode D'emploi

9. Instructions for use

9.1. System setup

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1. Remove the device from the packaging carefully to ensure sterile fluid pathway.
Warning: Ensure that aseptic technique is used during all stages of setup and use of this system.
Warning: Before removing the device from the packaging, inspect the packaging and product for damage. If
the package or product is damaged, do not use as sterility of the device may have been compromised
and/or performance may be affected.
2. Place the oxygenator securely into its holder. Ensure that the venous reservoir blood outlet is higher than
the oxygenator.
3. Set up the oxygenator, cardiotomy reservoir, venous reservoir, blood lines, and oxygen lines. Do not
occlude tubing in pump raceway.
4. Connect the 1.3 cm (1/2 in) water lines to the inlet and outlet ports on the heat exchanger. Start the heat
exchanger water flow, and check for leaks from the water compartment to the blood compartment. Discard
the oxygenator if water is present in blood compartment, and set up the standby oxygenator.
5. Clamp the tubing at cardiotomy outlet, venous reservoir inlet, venous reservoir outlet, oxygenator arterial
outlet, and oxygenator recirculation line outlet.
Note: A CO flush of the oxygenator is not required, but is recommended before priming.
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9.2. Priming
1. Fill the clamped cardiotomy reservoir with 1.5 to 2 L of priming solution.
2. With the venous reservoir at minimum volume setting, open air purge on the venous reservoir and unclamp
the cardiotomy reservoir outlet line. Allow the solution to slowly gravity prime the venous reservoir while
carefully venting any air from purge port.
Note: Venous reservoir fluid level should always remain above the level of the oxygenator.
3. Open the venous reservoir outlet clamp and allow solution to gravity prime the oxygenator heat exchanger
and fiber bundle. Remove any remaining air from venous reservoir purge port.
Note: Albumin has been reported to reduce the rare instance of transient high inlet pressure phenomenon in
membrane oxygenators. Therefore, albumin in the prime solution should be considered.
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1. Filtered cardiotomy reservoir
2. Venous reservoir
3. Arterial filter
4. Oxygenator
5. Prebypass filter
Figure 6.
Figure 7.
Instructions for Use English 9