SynCardia TAH-t Instructions for Use
SynCardia Systems, Inc.
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Warnings
1)
Setup and operation of this device should only be undertaken by personnel trained
in accordance with the SynCardia training program. A thorough understanding of
the technical principles, clinical applications, and risks associated with the device
is necessary. Prior to use, refer to this IFU and to the Circulatory Support System
(CSS) User’s Manual for important operating instructions.
2)
Sterile components of the SynCardia TAH-t are intended for single use only. Do
not use if package is opened or damaged. Do not re-sterilize or reuse.
3)
Safe use of this system has not been established in pregnant patients.
4)
Do not subject patients implanted with the SynCardia TAH-t to magnetic
resonance imaging (MRI) scans.
5)
Safety and effectiveness in populations other than those of idiopathic and ischemic
cardiomyopathies has not been established.
6)
Do not use this device if the implantable artificial ventricles cannot fit in the chest
area vacated by the natural ventricles. Inferior vena cava and left pulmonary
venous compression are possible consequences.
7)
Do not allow any catheter to get near the inflow valves of the SynCardia TAH-t. If
a catheter gets into an inflow valve, the valve could become stuck, limiting flow.
Confirm by x-ray after catheter insertion. A percutaneously inserted central
catheter may migrate into the inflow valve when the patient raises his/her arm.
8)
There is a potential for air embolism. De-air the artificial ventricles to minimize
the possibility of air inadvertently entering the device.
9)
Do not allow the external drivelines to become kinked. If there is any low cardiac
output alarm, inspect the external drivelines for kinking.
10)
A reduction in the maximum stroke volume on the external console’s monitoring
computer to below 50 milliliters may indicate a failure of one of the diaphragms in
an artificial ventricle of the SynCardia TAH-t.
