Healthcare Professionals

PBS

Portable Bypass System

Indications, Safety, and Warnings

  

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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BPX-80 Bio-Pump®

BPX-80 Bio-Pump Plus Centrifugal Blood Pump

Contraindication: The Medtronic blood pumping system is contraindicated as a cardiotomy suction device. This device used for any other purposes than for the indicated use is the responsibility of the user.

Indication: The Bio-pump is indicated for use only with the Medtronic Bio-Console pump speed controller to pump blood through the extracorporeal bypass circuit for periods appropriate to cardiopulmonary bypass procedures up to six hours.

Warning: Applying vacuum assisted venous drainage (VAVD) can reduce pump flow. Compensate by increasing pump RMP. Massive air entry into the pump will cause the pump to deprime and blood flow to stop. Stop the pump and remove air prior to resuming circulation. Establish and maintain a minimum pump speed to prevent retrograde flow. Do not operate without flow for more than 30 seconds.

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.

BPX-50 Bio-Pump®

Bio-Console® 560 System

Bio-Probe® Flow Transducer

PBS® Portable Bypass System