SynCardia Companion 2 Driver System, Operator'S Manual

Page: 19 / 134

SynCardia Systems, LLC
Companion 2 Driver System Operator Manual
Page 19 of 132
Chapter 4. Warnings
4.1 Setup and operation of the 50cc or 70cc TAH-t System should only be
performed by personnel certified in accordance with the SynCardia
certification program. A thorough understanding of the technical principles,
clinical applications, and risks associated with the device is necessary.
Prior to use, refer to the
SynCardia temporary Total Artificial Heart (TAH-t)
Instructions for Use with the Companion 2 Driver System for the 50cc or
70cc TAH-t.
4.2 The Drivelines are sterile components and are intended for single use
only. Do not use if package is opened or damaged. Do not re-sterilize or
reuse.
4.3 Safe use of this system has not been established in pregnant patients.
4.4 Do not subject patients implanted with the 50cc or 70cc TAH-t to magnetic
resonance imaging (MRI) scans.
4.5 Do not use the TAH-t System if the implantable artificial ventricles cannot
fit in the chest area vacated by the natural ventricles. Compression of the
inferior vena cava and left pulmonary venous are possible consequences.
4.6 Do not allow any catheter to get near the inflow valves of the TAH-t. If a
catheter migrates into an inflow valve, the valve could become stuck,
limiting flow. Confirm the position of the catheter by x-ray after catheter
insertion and repeat an x-ray immediately if any unexplained sudden drop
in cardiac output occurs. A percutaneously inserted central catheter may
migrate into the inflow valve when the patient raises his or her arm.
4.7 There is a potential for air embolism. De-air the artificial ventricles to
minimize the possibility of air inadvertently entering the device.
4.8 Do not allow the external Drivelines to become kinked. If there is any low
cardiac output alarm, inspect the external Drivelines for kinking.
4.9 A reduction in the maximum stroke volume on the external driver
monitoring computer to below 30 milliliters may indicate a failure of one of
the diaphragms in a ventricle of the 50cc TAH-t.
4.10 A reduction in the maximum stroke volume on the external driver
monitoring computer to below 40 milliliters may indicate a failure of one of
the diaphragms in a ventricle of the 70cc TAH-t.
4.11 Do not administer CPR to TAH-t patients. Defibrillation, cardioversion, and
CPR are ineffective on patients implanted with the 50cc or 70cc TAH-t.
4.12 The graphical user interface software on the Companion 2 Driver requires
two minutes to fully load after the power is turned on with the key switch.
No Driver alarms are active during this time.
4.13 If the Driver is started while undocked from a Hospital Cart and the touch
screen is non-responsive after the graphical user interface is presented on
the display, dock the Driver into the Hospital Cart to recalibrate the Driver