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Bio-Console 560

Speed Controller System

Indications, Safety, and Warnings

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Affinity® CP Centrifugal Blood Pump

Affinity CP Centrifugal Blood Pump

Contraindication: The Affinity CP Centrifugal Blood Pump is contraindicated for use as a cardiotomy suction device. This device, used for any other purposes than the intended use, is the responsibility of the user.

Indication:The Affinity CP Centrifugal Blood Pump is used to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods appropriate to cardiopulmonary bypass (up to six hours). It is also indicated for use in extracorporeal support systems (for periods up to 6 hours) not requiring complete cardiopulmonary bypass (e.g., valvuloplasty, circulatory support during mitral valve reoperation, surgery of the vena cava or aorta, liver transplants). The Affinity CP Centrifugal Blood Pump is driven by the External Drive Motor or the Emergency Handcrank.

Caution: Federal law (USA) restricts this device to sale by or on the order of a physician. For a complete listing of indications, contraindications, precautions and warnings, please refer to the Instructions for Use which accompany each product.

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