Healthcare Professionals

Bio-Probe

Flow Transducer

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.

BIO-CONSOLE 560 SYSTEM

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 Medtronic centrifugal blood pumping system is intended to pump blood through the extracorporeal bypass circuit for extracorporeal support 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. A handcrank must always be available for emergency use. Do not place level sensor below the minimum level recommended by the reservoir manufacturer. Establish pump RPM before releasing the arterial line to prevent retrograde flow.

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.

BIO-PROBE FLOW TRANSDUCER

Contraindication: This device used for any other purposes than for the indicated use is the responsibility of the user.

Indication: The Bio-Probe™ flow monitoring system is to be used with an appropriate Bio-Console™ extracorporeal blood pumping console to measure directly the blood flow in the extracorporeal perfusion circuit.

Warning: Before using this system, read the operators manual for the appropriate model of the Bio-Console blood pumping console.

Use only the Model DP38 disposable insert with the adult transducer, Model TX50. Use only the Model DP38P disposable insert with the Model TX50P.

Make sure the disposable insert pins contact the transducer pins, underneath the transducer cover.

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.