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Indications, Safety, and WarningsIndicationsThe Nautilus™ Smart ECMO module with integrated heat exchanger is intended to provide assisted long-term extracorporeal circulation and physiologic gas exchange (oxygenation and carbon dioxide removal) of the patient’s blood for up to 48 hours in adult and pediatric adolescent patients with acute respiratory failure or acute cardiopulmonary failure where other available treatment options have failed and continued clinical deterioration is expected or the risk of death is imminent. The integrated heat exchanger is intended to heat or cool the blood as needed during use. Integrated fluid path pressure, temperature, and oxygen saturation monitoring are achieved by built-in sensor modules and display.WarningsOnly clinicians thoroughly trained in extracorporeal life support procedures should use this device. Read all warnings, precautions, and instructions for use carefully prior to use. Failure to read and follow all instructions, or failure to observe all stated warnings, could cause serious injury or death to the patient.  Important safety informationFor a list of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the instructions for use.Caution: Federal law (United States) restricts this device to sale by or on the order of a physician.UC202408578 EN

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