PBS

BPX-50 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.

The use of certain solvents may compromise the integrity of the device.

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.

PBS Portable Bypass System

Contraindication: Patient selection for cardiopulmonary bypass support is based on the medical judgment and discretion of the attending physician. This device is not designed, sold or intended for use except as indicated. The portable bypass system has not been qualified to exceed periods longer than appropriate for cardiopulmonary bypass (6 hours).

Indication: The portable bypass system is indicated only for use in patients needing cardiopulmonary bypass support. With the required addition of an adult pump through membrane oxygenator/heat exchanger (not supplied but a necessary component to make PBS a Portable Bypass System). Cardiopulmonary bypass circuits similar to the PBS system have been used for patients in cardiogenic shock, unresuscitatible cardiac arrest, cardiac failure after cardiac surgery and acute pulmonary insufficiency.

Warning: Use of this system has not been qualified through in vitro, in vivo, or clinical studies for long term use as a bridge to transplant or for pending recovery of the natural heart. Also, use of system for periods longer than appropriate for cardiopulmonary bypass may cause side effects including, but not limited to, infections, mechanical failure, hemolysis and thromboembolic phenomena, degradation of blood contacting materials with possibility of particles passing through PBS circuit to patient, leaks, increased potential for gaseous emboli. These are potential side effects with all extracorporeal blood systems.

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.