Important Safety Information for Revolution Ph.I.S.I.O. Centrifugal Blood Pump
1. INDICATIONS FOR USE / INTENDED PURPOSE
EU: Devices are intended to perform, control, monitor and support extracorporeal blood circulation replacing the mechanical pumping function of the heart, monitoring and regulating physiologic parameters during procedures requiring extracorporeal circulation.
US: The REVOLUTION Ph.I.S.I.O. Centrifugal Blood Pump utilizes a rotating, vanes impeller design to move blood by centrifugal force. The pump is intended for use only with Sorin Group Deutschland Stöckert Centrifugal Pump Consoles in cardiopulmonary bypass procedures for periods of up to six hours.
2. CONTRAINDICATIONS
There are no known contraindications for the Stöckert S5 System.
3. WARNINGS
The device must be used in accordance with the instructions for use. For a complete listing of warnings, please refer to the Instructions for Use which accompany each product
4. PRECAUTIONS
Federal law (U.S.A.) restricts this device to sale by or on the order of a physician. For a complete listing of precautions/cautions please refer to the Instructions for Use which accompany each product
The devices should be used by qualified and skilled personnel, able to follow the indications and instructions for use contained in the information provided by the manufacturer. Please contact us through our website to receive instructions for use containing full prescribing information including indications, contraindications, warnings, precautions and adverse events.
The information contained in this summary represents partial excerpts taken from the product labeling. The information is not intended to serve as a substitute for a complete and through understanding of the device nor does this information represent full disclosure of all pertinent information concerning the use of this product.
Legal Manufacturer:
LivaNova Deutschland
Lindberghstrasse 25
D-80939 Munich, Germany
Distributed in the USA by:
LivaNova USA
14401 W 65th Way
Arvada, CO 80004
