SynCardia Companion 2 Driver System, Operator'S Manual

Page: 9 / 134

SynCardia Systems, LLC
Companion 2 Driver System Operator Manual
Page 9 of 132
Chapter 1. Device Description
The SynCardia temporary Total Artificial Heart (TAH-t) System is comprised of
an implantable TAH-t (50cc or 70cc) and an external driver, such as the
Companion 2 Driver (
Figure 1-1 ) which includes a Hospital Cart and/or Caddy.
Figure 1-1 – 50cc or 70 cc TAH-t with Companion 2 Driver System
The 50cc and 70cc TAH-ts ( Figure 1-2 ) are implantable pulsatile biventricular
devices that temporarily replace a patient's native ventricles and valves, and
pump blood to both the pulmonary and systemic circulation. For more information
on the TAH-t, see the
SynCardia temporary Total Artificial Heart (TAH-t)
Instructions for Use with the Companion 2 Driver System, for the 50cc or 70cc
TAH-t, as appropriate.
The 50cc TAH-t is a smaller version of the PMA approved 70cc TAH-t and is an
Investigational Device Limited by United States Law to investigational use.
The TAH-t cannulae have colored bands on them. The cannula with the red
band is connected to the left ventricle and the cannula with the blue band is
connected to the right ventricle. After implantation, the 50cc TAH-t and 70cc
TAH-t can be differentiated by these colored bands on the cannulae. The 50cc
TAH-t cannulae have two colored bands on each cannula whereas the 70cc
TAH-t cannulae have one colored band on each cannula, as shown in
Figure 1-
2 .