Adverse Effects - Medtronic Affinity CP BBAP40 Gebrauchsanweisung

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The centrifugal blood pump is sterile and nonpyrogenic. Inspect the device and package carefully prior to use. Do not use if
the unit package or the product has been damaged or soiled, or if caps are not in place.
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The centrifugal blood pump was designed for single patient use only. Do not reuse, reprocess, or resterilize this product.
Reuse, reprocessing, or resterilization may compromise the structural integrity of the device and/or create a risk of
contamination of the device, which could result in patient injury, illness, or death.
■ Follow hospital protocol for maintaining adequate heparinization for a period appropriate to cardiopulmonary bypass (up to
6 hours). Formation of thrombus in the circuit may increase the risk of damage to the perfusion system equipment.
■ Attach tubing in a manner that prevents kinks or restrictions that may alter flow.
■ Do not use excessive force to install tubing on the pump because damage to pump might occur.
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Take care to prevent damage to connectors when repositioning or attaching tubing.
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Do not place the centrifugal blood pump near items adversely affected by magnetic fields.
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A strict anticoagulation protocol should be followed, and anticoagulation should be routinely monitored during all procedures.
The prescribing physician must weigh the benefits of extracorporeal support against the risk of systemic anticoagulation.
Adequate heparinization should be maintained per institution CPB protocol.
■ Refer to the package labeling or instructions for use for storage temperature requirements.
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It is the user's responsibility to dispose of the devices in accordance with local regulations and hospital procedures.
5.2. Affinity™ CP Adapter
■ This device should only be used by clinicians trained in extracorporeal circulation procedures.
■ Use the Affinity CP adapter as described in the instructions for use provided with the adapter.
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Use the Medtronic Affinity CP adapter only with the Medtronic Affinity CP centrifugal blood pumps.
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Use the Stöckert and Sorin centrifugal pump systems and the Sarns and Terumo centrifugal systems as described in the
instructions for use accompanying each device.
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Inspect the adapter for physical damage before use. Do not use the adapter if it appears to be damaged. Return the damaged
product to a Medtronic representative.
■ The adapter contains magnets. Keep the adapter away from metals, magnetic tapes, and magnets.
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Do not strike or drop the adapter. A shock may damage the adapter.
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Do not insert or remove the adapter or the pump until the drive motor has completely stopped.
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When inserting the adapter on the drive motor, make sure that the underside of the adapter is in close contact with the
receptacle of the drive motor and that the receptacle latch is in the locked position.
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During use, do not bump or strike the adapter or the circuit components to reduce the risk of the adapter and pump detaching
from the drive motor or any tubing connections. If detachment occurs, refer to Section 9.
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Do not store at extremes of temperature and humidity. Avoid storing the adapter in direct sunlight.
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For complete installation information, refer to the instructions for use provided with the Stöckert and Sorin centrifugal pump
systems or the Sarns and Terumo centrifugal systems.
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Prime the pump before starting circulation. Operate the pump, coupled to the drive motor with the adapter, at maximum RPM
to check for vibration, unusual noises, lack of flow, and other anomalies. If an anomaly is noted, refer to Section 9.
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When using the Affinity CP centrifugal blood pump and the Affinity CP adapter with a compatible system that displays inlet
pressure, use a measured value for inlet pressure rather than a calculated value. A calculated value is based on characteristic
curves that are not representative of the Affinity CP centrifugal blood pump and may result in inaccurate readings.
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Do not use alcohol-based solutions, other organic solvents, or concentrated acids or bases on the adapter. The adapter may
be damaged by these solutions.
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Do not use the adapter after the Use-by Date on the device label.
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Refer to the package labeling or instructions for use for storage temperature requirements.
■ It is the user's responsibility to dispose of the devices in accordance with local regulations and hospital procedures.

6. Adverse Effects

The following adverse effects are associated with the use of the Affinity CP centrifugal blood pump with Balance biosurface
(BBAP40):
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allergic reaction
12 Instructions for Use English