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• exsanguination
• hemolysis
• hemolytic anemia
• infection
• ischemia
• neurological dysfunction
• organ dysfunction
7 Information for products with Cortiva bioactive surface
The primary blood-contacting surfaces of the product are coated with Cortiva bioactive surface. This coated surface enhances blood
compatibility and provides a blood-contacting surface that is thromboresistant. Cortiva bioactive surface contains nonleaching
heparin derived from porcine intestinal mucosa
Caution: Product coated with Cortiva bioactive surface is intended for single use only. Resterilization may adversely affect the Cortiva
bioactive surface.
Caution: Follow a strict anticoagulation protocol and routinely monitor anticoagulation during all procedures.
Warning: Do not store product coated with Cortiva bioactive surface above 40°C (104°F).
8 Instructions for use
If using the Affinity CP centrifugal blood pump without the Affinity CP adapter, refer to Section 8.1, Section 8.2, Section 8.7, and
Section 8.8 of these instructions for use.
If using the Affinity CP centrifugal blood pump with the Affinity CP adapter, refer to Section 8.3, Section 8.4, Section 8.5, Section 8.6,
Section 8.7, and Section 8.8 of these instructions for use.
8.1 Installing the Affinity CP centrifugal blood pump on the Medtronic external drive motor model 560A
Connect the external drive motor model 560A to the appropriate Medtronic controller. For complete installation information, refer to the
appropriate Medtronic controller operator's manual.
1. Slide the Affinity CP centrifugal blood pump into the external drive motor model 560A (Figure 2) until the thumb latch pin engages.
Figure 2. Installing and removing the Affinity CP centrifugal blood pump
1 Thumb latch with locking pin on external drive motor model 560A
Note: Whenever possible, install the pump at the lowest point in the circuit, directly below the reservoir.
2. Prime the centrifugal blood pump according to the procedures described in Section 8.7 of these instructions for use.
Caution: Operating the centrifugal blood pump without priming the pump may cause damage to the centrifugal blood pump.
3. Turn the rpm knob to the clicked-off position. As the knob is turned to zero, the user will feel a slight pressure and hear a click. The
black button on the knob serves as the pointer to the rpm settings.
Warning: Use of the Affinity CP centrifugal blood pump beyond the labeled recommendations may result in failure of the
centrifugal blood pump, reduced pumping capacity, leaks, excessive blood trauma, or degradation or corrosion of blood contact
materials that may pass through the blood to the patient.
Caution: Installing the centrifugal blood pump with the drive motor revolving may harm the pump.
4. Proceed with extracorporeal circulation. Refer to the instructions for use supplied with each device.
1
Nonleaching is defined as heparin at a level ≤0.1 IU/mL, as measured through clinically relevant extraction conditions.
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