Learn more about the New Era of Pefusion: LivaNova's Essenz Perfusion System is a revolutionary device that couples human skill and advanced technology to create a safe and reliable way to save lives.
Learn more on www.essenzperfusion.com
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IM 7300515 CP B
Important Safety Information
Heart-Lung Machine with Integrated Essenz In-Line Blood Monitor (ILBM) The Essenz Heart-Lung Machine is 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: Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. Essenz ILBM is indicated for supplementary, in-line monitoring of the extracorporeal arterial oxygen partial pressure, venous oxygen saturation, venous hematocrit/hemoglobin, and arterial and venous temperature during cardiopulmonary bypass procedures up to six hours. Essenz Patient Monitor 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.
CONTRAINDICATIONS: No contraindications are known if the devices are used for the purpose described and in accordance with the stated operating conditions. Do not use the devices for any purpose other than indicated.
WARNINGS: The devices must be used in accordance with the instructions for use provided. For a complete listing of warnings please refer to the Instructions for Use. Medical intervention and therapeutic procedure must not be based solely on the Essenz Patient Monitor perfusion records (reports).
PRECAUTIONS: Federal law (U.S.A.) restricts these devices to sale by or on the order of a physician. For a complete listing of precautions/cautions please refer to the Instructions for Use. 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. Essenz In-Line Blood Monitor and B-Capta Blood Gas Monitor are clinically equivalent in terms of safety and performance as they have the same technology and intended use. Not approved in all geographies, consult your labeling. Please visit the LivaNova website to receive instructions for use containing full prescribing information including indications, contraindications, warnings, precautions and adverse.
Legal Manufacturers: LivaNova Deutschland, Lindberghstrasse 25, D-80939, Munich, Germany Sorin Group Italia S.r.l., Via Statale 12 Nord, 86, 41037 Mirandola (MO), Italy Distributed in the US by: LivaNova USA, Inc, 14401 W 65th Way, Arvada, CO 80004, USA