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 0073 SynCardia TAH System FDA PMA October 2004

Clinical Intro -362 Rev 0074 Outflow Inflow RightLeft Implantable TAH Features Both Right and Left Ventricles RemovedBoth Right and Left Ventricles Removed All 4 Heart valves excisedAll 4 Heart valves excised Atria left behindAtria left behind 70cc Prime Volume70cc Prime Volume 27mm Inflow27mm Inflow 25mm Outflow25mm Outflow Same blood flow pathway as native heartSame blood flow pathway 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 0076 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 Exploded View of the Freedom Driver System

Clinical-490 Rev Freedom Driver Parts

Clinical-490 Rev 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 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 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 Battery Alarm Indicated by: Beeping tone Audible Alarm and Blinking yellow light Visual Alarm. Click on speaker icon to hear Battery Alarm

Clinical-490 Rev Battery Alarm ALARMHEARSEEMEANINGWHAT 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 Temperature Alarm Click on speaker icon to hear Temperature Alarm Indicated by: Beeping tone Audible Alarm and Blinking red light Visual Alarm

Clinical-490 Rev Temperature Alarm ALARMHEARSEEMEANINGWHAT YOU SHOULD DO Temperature Alarm Loud Intermitt ent 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 Fault Alarm Click on speaker icon to hear Fault Alarm Indicated by: Constant tone Audible Alarm and Solid red light Visual Alarm

Clinical-490 Rev Fault Alarm ALARMHEARSEEMEANINGWHAT 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 DriverIf the above steps do not stop the Fault Alarm, switch to Backup Freedom Driver. Return to implant hospital.