SynCardia TAH-t Instructions for Use
SynCardia Systems, Inc.
Page 4
1.2
The External Console
The external console operates and monitors the SynCardia TAH-t. The console
includes a monitoring computer that provides noninvasive diagnostic and monitoring
information to the user. Device rate, dynamic stroke volumes, and calculated cardiac
outputs are displayed on a beat-to-beat basis. Drive pressure and flow waveforms,
along with cardiac output trends are provided. Patient related alarms (e.g., low cardiac
output) are also displayed on the computer screen.
A separate alarm panel on the console provides information on critical drive pressure
and backup air and battery status. In addition, an alarm is generated if the computer is
not monitoring the patient. All alarms generate audio and visual feedback to the user.
A backup air supply (two air tanks) and electrical power (backup power supply and
console battery) are automatically activated if the external compressed air and/or AC
power are interrupted. This can occur during patient transport or in the event of a
failure in the hospital’s air or electrical supply.
The controller is the major component of the external console, and supplies pulses of
pneumatic pressure to the right and left drivelines, which connect into the air
chambers of the respective implanted artificial ventricles. These pulses cause the
diaphragms to distend and thereby eject blood from the right artificial ventricle into
the pulmonary circulation (typically 50-70mmHg) and from the left artificial ventricle
into the systemic circulation (typically 180-200mmHg).
2.0
Indications for Use
The SynCardia temporary Total Artificial Heart (hereinafter called the TAH-t) is
indicated for use as a bridge to transplantation in cardiac transplant-eligible candidates
at risk of imminent death from biventricular failure. The SynCardia TAH-t System is
intended for use inside the hospital.
3.0
Contraindications
The SynCardia TAH-t is contraindicated for use in:
Patients who are not cardiac transplant eligible.
Patients who do not have sufficient space in the chest area vacated by the natural
ventricles. Generally this includes patients who have body surface areas <1.7m², or
who have a distance between the sternum and the 10
th
anterior vertebral body
measured by computed tomography imaging (CT scan) < 10 cm.
Patients who cannot be adequately anticoagulated on the TAH-t.
