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1. GENERAL STATEMENT
Federal (U.S.A.) law restricts this device to sale, distribution and use by or on the order of a physician.
Any medical techniques described in this document are meant for informational purposes only and do
not replace the expertise of the physician and/or medical protocols.
2. INDICATION FOR USE
The Nautilus™ ECMO Oxygenator with integrated heat exchanger is intended to provide assisted
extracorporeal circulation and physiologic gas exchange of the patient's blood for up to 14 days
in 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.
3. CONTRAINDICATION
This device is not designed, sold, or intended for use except as indicated.
4. DEVICE DESCRIPTION
The Nautilus ECMO diffusion polymethylpentene (PMP) membrane oxygenator with Balance™
Biosurface is used in extracorporeal life support procedures to oxygenate blood, remove carbon
dioxide and regulate blood temperature. Blood enters the device and passes through both the heat
exchange membrane, where temperature is adjusted, and the gas transfer membrane, where oxygen
is added and carbon dioxide is removed.
The device is bonded on its primary blood contacting surfaces with a nonleaching biocompatible
surface to reduce platelet activation and adhesion and preserve platelet function.
The device is single-use, nontoxic, nonpyrogenic, and not made from natural latex rubber materials.
5. ACCESSORIES SOLD SEPARATELY
To ensure a proper connection between the device and holder, the Nautilus ECMO Oxygenator is to
be used with the Nautilus ECMO Oxygenator Holder only. This holder is sold separately.
6. GENERAL WARNINGS AND PRECAUTIONS
Warning: Only use this device in accordance with these instructions for use.
Warning: 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.
Warning: Only clinicians thoroughly trained in extracorporeal life support procedures should use
this device.
Warning: No modification of this equipment is allowed. This device was designed for single
patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing, or
resterilization may compromise the structural integrity of the device and/or create a risk of
contamination of the device which could result in patient injury, illness, or death.
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