Summary of Safety & Performance Information for Essenz™ Patient Monitor
1. INDICATIONS FOR USE / INTENDED PURPOSE
EU/US: The ESSENZ™ Patient Monitor Software is a modularly structured software program package that is exclusively used with LivaNova heart-lung machines. The system allows detailed recording of perfusion data during cardiopulmonary bypass procedures as well as the processing and evaluation of this data. The data may be recorded automatically or entered manually.
The LivaNova Perfusion System Monitor is a panel PC intended to be exclusively used with LivaNova heart lung machines as a base and user interface for the ESSENZ™ Patient Monitor Software.
There are no known contraindications for the ESSENZ™ Patient Monitor software or the LivaNova Perfusion System Monitor.
Medical intervention and therapeutic procedure must not be based solely on the perfusion records (reports). The device must be used in accordance with the instructions for use provided in the Instructions for Use. For a complete listing of warnings please refer to the Instructions for Use which accompany each product.
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 risks.
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.
Not approved in all geographies. Consult your labeling.
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