Indications For Use - Medtronic BIO-PUMP+ Serie Instrucciones De Uso

1 DESCRIPTION
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The BPX-80 Bio-Pump+
Uncoated (BPX-80)
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®1,2
With Carmeda BioActive Surface (CBBPX-80)
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®3
With Trillium Biosurface (BPX-80T)
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and is intended for use in extracorporeal circulation procedures and is designed to move blood by centrifuge force created
by smooth rotating cones. These smooth cones rotate in a housing designed by computational fluid dynamics (CFD) to
minimize trauma to the blood. Energy is transferred from the cones to the blood in the form of pressure and velocity as
the blood is gently accelerated toward the outlet of the pump. The nonocclusive hemodynamic design of the pump
promotes laminar flow, allowing for improved blood handling capabilities and decreasing trauma that may be associated
with extracorporeal circulatory support during cardiopulmonary bypass.
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The Bio-Pump+ blood pump couples to a safety-locked magnetic drive unit called the Medtronic
speed controller, which serves as the hardware component of the Medtronic extracorporeal blood delivery system. All
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Bio-Pump+ blood pumps are sterilized prior to shipment. Depending on the method of sterilization, a slight amber cast
may be present. This discoloration poses no risks to patient or user.
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The Bio-Pump+ blood pump with Carmeda
surface (heparin) that provides thromboresistance and biocompatibility to blood-contact surfaces.
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The Bio-Pump+ blood pump with Trillium

2 INDICATIONS FOR USE

The Medtronic Bio-Pump+
controller to pump blood through the extracorporeal bypass circuit for extracorporeal circulatory support for periods
appropriate to cardiopulmonary bypass (up to 48 hours). It is also indicated for use in extracorporeal support systems (for
periods up to 48 hours) not requiring complete cardiopulmonary bypass (eg, valvuloplasty, circulatory support during
mitral valve reoperation, surgery of the vena cava or aorta, liver transplants).
3 CONTRAINDICATIONS
The Medtronic blood pumping system is contraindicated as a cardiotomy suction device.
This device used for any other purposes than the intended use is the responsibility of the user.
4 WARNINGS
The pump has not been qualified through in-vitro, in-vivo, or clinical studies for long-term use (longer than 48 hours)
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as a bridge-to-transplant or for pending recovery of the natural heart.
Read all warnings, precautions and instructions for use carefully prior to use. Failure to read and follow instructions or
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failure to observe the stated warnings could cause serious injury or death to the patient.
Possible side effects include, but are not limited to infections, mechanical failure, hemolysis and thromboembolic
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phenomena. These are potential side effects with all extracorporeal blood systems.
Ensure that the pump and circuit have been debubbled and primed properly prior to beginning bypass to minimize the
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risk of air reaching the patient. The use of an arterial filter is recommended.
Massive air entry into the pump will cause the pump to deprime and blood flow to stop. Stop the pump and remove
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air prior to resuming circulation.
Do not expose to chemical agents as they may affect the integrity of this device. Anesthesia solutions such as
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®4
FORANE are known to degrade polycarbonate plastics. Avoid contact of these solutions with the BPX-80 Bio-
®
Pump+ blood pump.
To prevent backflow of the patient's blood when the pump outlet tubing is open, establish and maintain a minimum
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pump speed that overcomes line and patient resistance. Failure to do this could allow retrograde flow and
exsanguinate the patient.
Arterial lines must be clamped when the pump is at rest to prevent retrograde flow.
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The Medtronic Bio-Pump+
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controller. There is no safety or performance data known to Medtronic which establishes compatibility of any other
manufacturer's devices or components to the Medtronic system. Run the Bio-Pump+ blood pump only on a properly
maintained Bio-Console pump speed controller.
Potential risk to the patient should be evaluated prior to changing the pump.
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1. ®
Carmeda is a registered trademark of Carmeda A.B.
2.
This product is coated with the Carmeda
extracorporeal blood circulation system or circuit which includes an oxygenator or blood pump.
3.
Technology licensed under agreement from BioInteractions, Limited, United Kingdom.
4. ®
FORANE is a registered trademark of ATOFINA.
is sold one of three ways:
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BioActive Surface (CBBPX-80) is coated with a nonleaching bioactive
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Biosurface (BPX-80T) is coated with a nonleaching, heparin biosurface.
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centrifugal blood pump is indicated for use only with the Medtronic Bio-Console pump speed
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blood pump is designed to be operated only with the Medtronic Bio-Console pump speed
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BioActive Surface under license from Carmeda A.B. and is licensed for use only as part of an
® ®
Bio-Console pump
Instructions for Use 5