EMS Management of the SynCardia Temporary Total

Artificial Heart (TAH-t) Patient

Clinical-xxx Rev001

Overall Goal of TAH-t Impant

To serve as a bridge to heart transplantation for patients at imminent risk of death from biventricular failure by providing hemodynamic stability and adequate organ perfusion

Clinical Intro -362 Rev 007 3Clinical Intro -362 Rev 007

SynCardia TAH SystemFDA PMA October 2004

Clinical Intro -362 Rev 007 4Clinical Intro -362 Rev 007

Outflow

Inflow

Right Left

Implantable TAH Features• Both Right and Left Both Right and Left

Ventricles RemovedVentricles Removed

• All 4 Heart valves All 4 Heart valves excisedexcised

• Atria left behindAtria left behind

• 70cc Prime Volume70cc Prime Volume

• 27mm Inflow 27mm Inflow

• 25mm Outflow25mm Outflow

• Same blood flow Same blood flow pathway as native heartpathway as native heart

Differences between TAH patients and LVAD patients

TAH patients WILL have a pulse, LVAD patients Usually WILL NOT

TAH patients WILL NOT have a Cardiac Rhythm, Whereas LVAD patients WILL

Clinical Intro -362 Rev 007 6Clinical Intro -362 Rev 007

Operate TAH

Partial Fill

Full Eject

Clinical Relevance in the Field

1) TAH PATIENTS WILL HAVE A PULSE BUT NOT A EKG!!!!!

2) NO CARDIAC MONITOR NEEDED FOR EKG

3) BP CUFF IS ALL THE MONITORING THAT IS NEEDED

4) CPR INEFFECTIVE ON TAH PATIENTS

5) VASOPRESSORS MUST NOT BE GIVEN TO PATIENT IN THE FIELD

6) VASODILATORS MORE BENEFICIAL IN FIELD THAN VASOPRESSORS, PT MAY HAVE RESCUE MED (SL NITRO ETC…)

7) CONTACT VAD COORDINATOR AT HOSPITAL FOR APPROPRIATE CARE INSTRUCTIONS

8) TRANSPORT PATIENTS ASAP TO IMPLANTING HOSPITAL, INTUBATE IF NEEDED

9) CHECK FREQUENTLY THE CARDIAC OUTPUT AND FILL VOLUMES ON FREEDOM DRIVER

Clinical-490 Rev 00210

Exploded View of the Freedom Driver System

Clinical-490 Rev 00211

Freedom Driver Parts

Filter Cover

Power Adaptor

Power Adaptor green receptacle

Drivelines

Power Adaptor green light

Battery Release Button

Driver

Display

Power Adaptor plug

Driver Display Button

Red light Visual Alarm

Yellow light Visual Alarm

Battery Fuel Gauge

Battery Charge Button

Onboard Battery inside Battery Well

Clinical-490 Rev 00212

Connecting to External Power via the AC Power Supply

• Plug the green connector from the AC Power Supply into the

Power Adaptor green receptacle

• Plug one end of the AC Power Supply Cord into the AC Power Supply and the other end of the cord to a grounded wall power

outlet in ambulance

• Confirm that the green light on the AC Power Supply and the Power Adaptor is illuminated

AC Power Supply connected to wall power outlet

AC Power Supply connected to Power Adaptor

Green light illuminated on Power Adaptor

Clinical-490 Rev 00213

Checking Onboard Battery Charge

• Press the Battery Charge Button

• The Battery Fuel Gauge will show green lights on top of the

Onboard Battery

• Each light illuminated represents approximately 20%

charge

• All five lights illuminated indicate approximately 81% to

100% charge

Battery Charge Button

Battery Fuel Gauge

Display Window

Rate, Fill Volumes, Cardiac Output

Display Window Push Button

Clinical-490 Rev 00214

Freedom Driver Alarms

Three Types of Alarms Battery Alarm Temperature Alarm Fault Alarm

Each Alarm indicated by: Visual Alarm and Audible Alarm

Do not ignore Alarms No way to mute Alarms The issue that caused the alarm must

be immediately addressed

Clinical-490 Rev 00215

Battery Alarm

Indicated by:

• Beeping tone Audible Alarm and

• Blinking yellow light Visual Alarm.

(.wav)

Click on speaker icon to hear Battery Alarm

Clinical-490 Rev 00216

Battery Alarm

ALARM HEAR SEE MEANING WHAT YOU SHOULD DO

Battery

Alarm

Loud Intermittent Tone

Yellow Battery LED flashing

One or both of the Onboard Batteries have less than 35% remaining charge (only two green lights display on the Battery Fuel Gauge)

Replace each low Onboard Battery, one at a time, with a charged Onboard Battery or connect to external power (NOTE: Once the batteries are charged above 35% the Battery Alarm will stop)

Onboard Battery is incorrectly installed

Reinsert Onboard Battery until locked in place. If Battery Alarm continues, insert a new Onboard Battery

One Onboard Battery is missing

Insert a charged Onboard Battery into Freedom Driver until locked in place

Clinical-490 Rev 00217

Temperature Alarm

(.wav)

Click on speaker icon to hear Temperature Alarm

Indicated by:

• Beeping tone Audible Alarm and

• Blinking red light Visual Alarm

Clinical-490 Rev 00218

Temperature Alarm

ALARM HEAR SEE MEANING WHAT YOU SHOULD DO

Temperature

Alarm

Loud Intermittent Tone

Red Alarm

LED

flashing

The internal temperature of the Driver is too hot

Remove any objects that are blocking the Filter Cover and / or Fan and check filter

The temperature of the Onboard Batteries is too hot or too cold

Move the Freedom Driver to a cooler or warmer area

Clinical-490 Rev 00219

Fault Alarm

(.wav)

Click on speaker icon to hear Fault Alarm

Indicated by:

• Constant tone Audible Alarm and

• Solid red light Visual Alarm

Clinical-490 Rev 00220

Fault AlarmALARM HEAR SEE MEANING WHAT YOU SHOULD DO

Fault

Alarm

Loud Continuous Tone

Red Alarm

LED solid

Valsalva Maneuver:

Strenuous coughing or laughing, vomiting, straining during a bowel movement, or lifting a heavy weight

Relax/interrupt valsalva maneuver

Kinked or disconnected drivelines

Straighten or connect drivelines

Driver is connected to External Power without at least one correctly inserted Onboard Battery

Insert a charged Onboard Battery into Freedom Driver until locked in place

One or both of the Onboard Batteries have less than 30% remaining charge

Replace each low Onboard Battery, one at a time, with a charged Onboard Battery or connect to external power. (NOTE: the Fault Alarm will continue and will change into a Battery Alarm as the Onboard Batteries recharge. Once the Onboard Batteries are charged above 35%, the Battery Alarm will stop)

Malfunction of the Driver If the above steps do not stop the Fault Alarm, switch to Backup Freedom Driver. Return to implant hospital.