Indications, Safety, and Warnings
Potential complications related to the use of ECMO devices include, but are not limited to, heart, vessel, or lung damage, hypoxia, anemia, irritation, toxic reaction, infection, hemorrhage, liver or kidney failure, stroke, and death. The benefits of extracorporeal support must be weighed against the risk of systemic anticoagulation and must be assessed by the prescribing physician.
The VitalFlow™ console
Indication for use: The VitalFlow™ console controls the speed of the VitalFlow™ centrifugal blood pump during extracorporeal cardiopulmonary life support for adult 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 VitalFlow™ centrifugal pump is driven by the VitalFlow™ motor drive or the VitalFlow™ emergency handcrank.
Contraindication: This device is not designed, sold, or intended for use except as indicated.
VitalFlow™ set with Balance™ biosurface
Indication for use: The VitalFlow™ set with Balance™ biosurface is indicated for respiratory/cardiopulmonary support up to 48 hours that provides assisted extracorporeal circulation and physiologic gas exchange of the patient’s blood in adults with acute respiratory failure or acute cardiopulmonary failure, where other available treatment options have failed, and when continued clinical deterioration is expected or the risk of death is imminent.
Contraindication: These devices are intended for use only as indicated in these instructions for use.
For a listing 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. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the instructions for use.
Warning: Only clinicians thoroughly trained in extracorporeal membrane oxygenation (ECMO) procedures should use this device.
Nautilus™ VF oxygenator
Indications for use: The Nautilus™ VF ECMO oxygenator 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 is achieved by built-in sensor modules.
Caution: Federal law (United States) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the instructions for use.
Warning: Only clinicians thoroughly trained in extracorporeal membrane oxygenation (ECMO) procedures should use this device.
VitalFlow™ centrifugal pump
Indication for use: The VitalFlow™ centrifugal pump is intended to pump blood through the extracorporeal circuit for circulatory support up to 48 hours, in adult 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 VitalFlow™ centrifugal pump is driven by the VitalFlow™ console and VitalFlow™ motor drive or the emergency hand crank.
Contraindications: The VitalFlow™ centrifugal pump is contraindicated for use as a cardiotomy suction device. This device, used for any other purposes than the intended use, is the responsibility of the user.
Caution: Federal law (United States) restricts this device to sale by or on the order of a physician. For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the instructions for use.
Warning: Only clinicians thoroughly trained in extracorporeal membrane oxygenation (ECMO) procedures should use this device.
US-CV-2500404 v1.0
