SynCardia Freedom User manual

Copyright © 2010-2017 by SynCardia Systems, LLC 900212-001 / F-900013-EN Rev 004
Revision Date: 2017-05
SynCardia temporary Total Artificial
Heart (TAH-t) with the
Freedom®Driver System
Operator Manual
SynCardia Systems, LLC
1992 E. Silverlake Road
Tucson, AZ 85713 USA
[phone]
[phone]
www.syncardia.com
CAUTION: The 50cc temporary Total Artificial Heart (TAH-t) is an Investigational
Device - Limited by United States Law to Investigational Use.
CAUTION: In the United States, the use of the SynCardia 70cc TAH-t for destination
therapy is investigational.
CAUTION: In the United States, the use of the Freedom Driver System with the 70cc
TAH-t for the destination therapy indication or with the 50cc TAH-t is
investigational.
CAUTION: Federal (USA) law restricts this device to sale by or on order of a
physician.
0086
15 May 2005

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Table of Contents
1Device Description.................................................................................................9
2Indications for Use...............................................................................................39
3Contraindications.................................................................................................57
4Warnings...............................................................................................................59
5Precautions and Recommendations..................................................................63
6Operating Instructions.........................................................................................65
7Preparing the Freedom Driver for Patient Use ..................................................85
8List of Symbols ....................................................................................................93
9Freedom Driver Operating Cautions ..................................................................95
10 Visual and Audible Alarms..................................................................................99
11 Switch from Primary Freedom Driver to Backup Freedom Driver.................107
12 Switch from CSS Console to Primary Freedom Driver...................................115
13 Switch from Freedom Driver to CSS Console .................................................123
14 Switch from CSS Console with modified Drivelines to Freedom Driver .......129
15 Switch from Companion 2 Driver to Freedom Driver......................................135
16 Switch from Freedom Driver to a Companion 2 Driver...................................141
17 Equipment Maintenance and Care....................................................................147
18 Freedom Driver System Specifications............................................................153
Appendix 1.................................................................................................................163
Appendix 2.................................................................................................................167
Appendix 3.................................................................................................................169

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TABLE OF FIGURES
Figure 1-1 – 50cc or 70cc TAH-t with the Freedom Driver System ...........................9
Figure 1-2 – The SynCardia 70cc TAH-t and 50cc TAH-t .........................................10
Figure 1-3 – Freedom Driver with Attached Power Adaptor and Drivelines
Connected to the Cannulae of a TAH-t......................................................................11
Figure 1-4 Exploded View of the Freedom Driver System.......................................16
Figure 1-5 – Primary Freedom Driver with attached Power Adaptor and Two
Inserted Onboard Batteries........................................................................................17
Figure 1-6 – Backup Freedom Driver with attached Power Adaptor and Inserted
Dummy Battery............................................................................................................20
Figure 1-7 – Power Adaptor........................................................................................21
Figure 1-8 – Onboard Battery.....................................................................................22
Figure 1-9 – Hospital AC Power Supply....................................................................23
Figure 1-10 – Home AC Power Supply ......................................................................24
Figure 1-11 – AC Power Supply and Cord.................................................................25
Figure 1-12 – Car Charger ..........................................................................................26
Figure 1-13 – Battery Charger....................................................................................26
Figure 1-14 – Dummy Battery.....................................................................................28
Figure 1-15 – Filter Pack, Screwdriver and Screws..................................................29
Figure 1-16 – Patient Tool Kit.....................................................................................30
Figure 1-17 – Shoulder Bag........................................................................................31
Figure 1-18 – Backpack ..............................................................................................31
Figure 1-19 – Shoulder Bag with Rain Cover............................................................33
Figure 1-20 – Backpack with Rain Cover ..................................................................33
Figure 1-21 – Accessory Bag .....................................................................................34
Figure 1-22 – Pelican Case.........................................................................................34
Figure 1-23 – Clinician Tool Kit..................................................................................35
Figure 1-24 – Connector Kit .......................................................................................36
Figure 6-1 – Unplugging the Power Adaptor from the Freedom Driver..................69
Figure 6-2 – Removing the Power Adaptor from the Freedom Driver ....................70
Figure 6-3 – Plugging the Green Connector into the Green Power Adaptor
Receptacle...................................................................................................................71
Figure 6-4 – Connection to External Power via the AC Power Supply...................71
Figure 6-5 – Removing the Green Connector from the Green Power Adaptor
Receptacle...................................................................................................................76
Figure 6-6 – Battery Fuel Gauge ................................................................................78
Figure 6-7 – Correct Onboard Battery Insertion into Battery Well..........................79
Figure 6-8 – Battery Charger and Bays.....................................................................80
Figure 6-9 – Connect AC Power Supply and Battery Charger.................................80
Figure 6-10 – Driver LCD Screen ...............................................................................82
Figure 7-1 – Driveline Caps........................................................................................88
Figure 7-2 – Beat Rate Setting Dial on the Back of the Freedom Driver.................89
Figure 10-1 – Illuminated Flashing Yellow Battery Alarm Light..............................99
Figure 10-2 – Illuminated Flashing Red Temperature Alarm Light .......................102
Figure 10-3 – Illuminated Solid Red Fault Alarm Light ..........................................103

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Figure 11-1 – Freedom Drivelines Connected to Cannulae via the CPC Connectors
....................................................................................................................................110
Figure 11-2 – Cutting the Wire Tie with the Wire Cutter Tool................................111
Figure 11-3 – Disconnecting the Drivelines from the Cannulae............................112
Figure 11-4 – Connecting the Drivelines to the Cannulae.....................................112
Figure 11-5 – Inserting Wire Tie under Metal Release Button of CPC connector 113
Figure 12-1 – Inserting Wire Tie under Metal Release Button of CPC Connector116
Figure 12-2 – Wire Ties around CSS Hose Barb Connectors................................117
Figure 12-3 – Metal Hose Barb Connectors Loosened, But Still Connected, to the
Cannulae....................................................................................................................118
Figure 12-4 – Inserting the Freedom Drivelines into the Cannulae.......................118
Figure 12-5 – Securing Cannulae to CPC Connectors with Wire Ties..................119
Figure 12-6 – Cut Driveline Tubing..........................................................................120
Figure 12-7 – Male CPC Connector..........................................................................120
Figure 12-8 – Female CPC Connector .....................................................................120
Figure 12-9 – Driveline End Comparison ................................................................121
Figure 12-10 – Modified CSS Console Driveline.....................................................121
Figure 13-1 – Connection of Driver Connectors to Cannulae ...............................124
Figure 13-2 – Cutting the Wire Tie with the Wire Cutter Tool................................124
Figure 13-3 – Disconnecting Freedom Drivelines from the Cannulae..................126
Figure 13-4 – Connecting the Modified CSS Console Drivelines to the Cannulae
....................................................................................................................................126
Figure 13-5 – Inserting Wire Tie under Metal Release Button of CPC Connector127
Figure 14-1 – Connection of Modified CSS Console Driveline to Cannulae ........130
Figure 14-2 – Cutting the Wire Tie with the Wire Cutter Tool................................131
Figure 14-3 – Disconnecting Modified CSS Console Drivelines from the Cannulae
....................................................................................................................................132
Figure 14-4 – Connecting the Freedom Drivelines to the Cannulae.....................132
Figure 14-5 – Inserting Wire Tie under Metal Release Button of CPC Connector133
Figure 15-1 – Companion Drivelines Connected to Cannulae via the CPC
Connectors ................................................................................................................137
Figure 15-2 – Cutting the Wire Tie with the Wire Cutter Tool................................138
Figure 15-3 – Disconnecting the Companion Drivelines from the Cannulae.......139
Figure 15-4 – Connecting the Freedom Drivelines to the Cannulae.....................139
Figure 15-5 – Inserting Wire Tie under Metal Release Button of CPC Connector140
Figure 16-1 – Freedom Drivelines Connected to Cannulae via the CPC Connectors
....................................................................................................................................142
Figure 16-2 – Cutting the Wire Tie with the Wire Cutter Tool................................143
Figure 16-3 – Disconnecting the Freedom Drivelines from the Cannulae............144
Figure 16-4 – Connecting the Companion Drivelines to the Cannulae.................144
Figure 16-5 – Inserting Wire Tie under Metal Release Button of CPC Connector145
Figure 17-1 – Filter Cover.........................................................................................148

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Table of Tables
Table 2-1 – Key Adverse Event Comparison Stable PMSS to Freedom In-Hospital
Cohort ..........................................................................................................................41
Table 2-2 – Adverse Event Comparison Stable PMSS to Freedom In-Hospital
Experience...................................................................................................................43
Table 2-3 – Adverse Event Comparison Stable PMSS to Cumulative Freedom
Experience...................................................................................................................46
Table 2-4 – Freedom Adverse Event Comparison In-Hospital to Out-of-Hospital.50
Table 2-5 – Adverse Event Comparison Freedom Experience High Volume Sites to
Low Volume Sites........................................................................................................53
Table 7-1 – Normotensive Settings - Patient Simulator ...........................................87
Table 8-1 –Symbols Used in the Freedom Driver System .......................................93
Table 18-1 – Declaration Concerning General Safety Standards for the Freedom
Driver..........................................................................................................................153
Table 18-2 – Declaration Concerning General Safety Standards for the Battery
Charger ......................................................................................................................155
Table 18-3 – Guidance and Manufacturer’s Declaration – Electromagnetic
Emissions ..................................................................................................................156
Table 18-4 – Declaration and Guidance Concerning Electromagnetic Immunity for
the Freedom Battery Charger for IEC 60601-1-2.....................................................157
Table 18-5 – Declaration and Guidance Concerning Electromagnetic Immunity for
the Freedom Battery Charger for IEC 60601...........................................................158
Table 18-6 – Input / Output Characteristics ............................................................160
Table 18-7 – IP Rating Classification.......................................................................162

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1 Device Description
1.1 General Device Information
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 Freedom Driver, that provides pneumatic power to the TAH-t
(Figure 1-1).
NOTE: The Freedom Driver System should be operated only by people
who have been trained and are being supervised by a doctor and Hospital
staff who have been trained in the use of the TAH-t System and the
Freedom Driver System. Data from the 70cc TAH-t and Freedom Driver
clinical trial indicated that certain significant adverse events, such as
Device Malfunction and Infection, occurred more frequently in the out-of-
hospital environment. The Freedom Driver can be managed safely and
effectively by trained patients and caregivers when the recommended
guidelines for use and care are followed. Patients and caregivers should
maintain a heightened level of care for their Freedom Drivers and
accessories at all times. For additional information on out-of-hospital use,
see Section 2.
Figure 1-1 – 50cc or 70cc TAH-t with the Freedom Driver System

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1.2 The TAH-t
NOTE: Throughout this manual, references to the TAH-t apply to both
sizes of the implantable TAH-t (i.e. 50cc and 70cc), unless the size of the
TAH-t is explicitly stated.
The SynCardia TAH-t (Figure 1-2) is an implantable pulsatile biventricular
device that temporarily replaces a patient’s native ventricles and valves
and pumps blood to both the pulmonary and systemic circulation systems.
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.
For more information on the TAH-t, please refer to the SynCardia
temporary Total Artificial Heart (TAH-t) Instructions for Use with the
Companion 2 Driver System or CSS, for the 50cc or 70cc TAH-t, as
appropriate.
Figure 1-2 – The SynCardia 70cc TAH-t and 50cc TAH-t
Two colored bands
on each cannula for
50cc TAH-t
One colored band
on each cannula for
70cc TAH-t

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1.3 The Freedom Driver System
The Freedom Driver System (Figure 1-3) is a multi-component electro-
mechanical unit designed to provide pneumatic power to the implanted
TAH-t.
Figure 1-3 – Freedom Driver with Attached Power Adaptor and
Drivelines Connected to the Cannulae of a TAH-t
The Freedom Driver is the primary component of the Freedom Driver
System. It supplies pulses of pneumatic pressure to the right and left
Drivelines that are directly connected to the TAH-t Cannulae in a manner
consistent with that accomplished by the implant driver (Circulatory
Support System (CSS) Console or Companion 2 Driver). These pulses
cause the diaphragms of the implanted TAH-t to distend, thereby ejecting
blood from the right artificial ventricle into the pulmonary circulation, and
from the left artificial ventricle into the systemic circulation.
The Drivelines are permanently connected to the Freedom Driver. The
distal ends of the Drivelines are connected directly to the TAH-t Cannulae
via CPC connectors.
The Freedom Driver uses visual indicators as well as visual and auditory
alarms to give information about the state of the Driver. It is powered by
two Onboard Batteries that are charged by means of a Power Adaptor that
converts input power from external power sources to DC Power (For more
information on the Power Management, see Section 6.3).
The Freedom Driver System uses materials that are commonly
encountered in medical devices. These materials include Tygon, Lexan,
Nylon and PVC.

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The only adjustable setting in the Freedom Driver is the driver operating
rate (Beat Rate). The Beats per Minute (BPM) can only be adjusted at the
Hospital by a SynCardia trained medical professional with tools designed
specifically for this purpose (provided in the Clinician Tool Kit). The
Clinician Tool Kit should never be given to the patient and the patient
should never adjust his/her Beat Rate.
The Freedom Driver System is designed to have the following
advantages:
•Highly portable, allowing Hospitals to mobilize patients within the
Hospital and discharge patients implanted with the TAH-t
•Simple user interface prevents patient manipulation of any functions,
yet provides key information
•Lightweight, allows patients to leave home and enjoy activities outside
of the Hospital and home environments
The Driver consists of a pneumatic assembly, electronic assemblies,
interfaces to other components, a simple user interface and the ability to
use multiple power sources.
1.3.1 Pneumatics
The pneumatics assembly consists of a compressor assembly and
two fully redundant gearhead motors. The top portion of the
cylinder compresses air routed to the right ventricle, while the
bottom portion of the cylinder routes compressed air to the left
ventricle.
The two stacked subassemblies are driven by a primary gearhead
electric motor. The system includes a second gearhead motor that
provides backup functionality in the event of a fault with the primary
motor.
The gearhead motor drives the compressor assembly to provide
the positive and negative air pressure for the left and right
ventricles. The displacement of air occurs by the movement of the
motor-driven pistons within the compressor assembly. Peak
pressure and peak vacuum are controlled by a valve system within
each chamber of the cylinder.
The pressurized air is routed through the Drivelines to the
implanted TAH-t. Pressure and flow sensors connected to the
pneumatic pathway provide performance information utilized to
verify proper device operation and to calculate cardiac output.
During systole, the Driver supplies compressed air that is pressure
regulated to actuate the left and right TAH-t ventricles, thereby
expelling blood into the arterial and pulmonary systems. In

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diastole, the compressors apply vacuum to the left and right
ventricles to facilitate ventricular filling.
The compressor is driven by independent gearhead motors. The
gearhead motors are governed by motor encoders and motor
controllers. Only one gearhead motor is in use, and the other is
used as a redundant backup.
In a gearhead motor fault condition in which the primary assembly
detects current overload, the Driver will terminate operation of the
faulted gearhead motor, and all functions will be performed by the
remaining redundant gearhead motor. The Driver will then operate
in Backup Mode.
Operation in Backup Mode signals a Fault Alarm condition, but
allows the Driver to continue to provide biventricular support to the
implanted TAH-t while maintaining pressures, vacuums and
operation at the default rate of 125 BPM (+/- 5 BPM) for both the
left and right ventricles. A Fault Alarm must be addressed
immediately as described in Section 10.3.
While each driver has internal redundancy, each patient is issued a
backup Freedom Driver. This backup Driver must accompany the
patient at ALL times whether in the Hospital or out of the Hospital. It
is critical that the backup Driver be available in the event that a
Driver change is needed due to the primary Driver being dropped,
exposed to liquid/debris, subjected to rough handling, or if a Fault
Alarm cannot be resolved within three to four minutes.
1.3.2 Electronics
The electronics assemblies within the Driver route power to the
subassemblies and actuate audible and visual alarm notifications.
Power management electronics automatically prioritize available
power sources in the following order: External power (includes AC
wall power or vehicle battery power) followed by the Onboard
Batteries.
1.3.3 Interfaces
The color-coded TAH-t cannulae and Driveline CPC connectors are
configured to connect only in one direction to ensure that the left
and right ventricles are connected properly.
The Power Adaptor has a fixed power cord that connects to the
Driver. The Power Adaptor cord is inserted into an outlet on the left
side of the Driver.
The Power Adaptor has one input power outlet (green receptacle)
that can be used for either the AC Power Supply or the Car
Charger. The green receptacle is located at the left side of the
Driver and is openly accessible. The Driver has a filter cover that

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can be opened to allow the clinician or the patient to replace the
filters.
The Driver has two battery well doors that conceal the battery wells
when an Onboard Battery is not inserted. The Onboard Batteries
are inserted into the battery wells to power the Driver.
1.3.4 Components of the Freedom Driver System
The Freedom Driver System consists of the following parts:
•One primary Driver with attached Power Adaptor
•One backup Driver with attached Power Adaptor
•One additional Power Adaptor
•Four to Six Onboard Batteries
•Two Hospital AC Power Supplies
•Two Home AC Power Supplies
•One Car Charger
•One Battery Charger (optional)
•Two Handle Straps (one attached to each Driver)
•Two Dummy Batteries (one inserted into each Driver)
•One Filter Pack including Screwdriver
•One Patient Tool Kit: Wire Ties, Wire Cutter Tool, Hook and
Loop cable ties for Drivelines
•One Patient Information Card (Appendix 1) to be filled out by the
Clinician
•One Shoulder Bag, one Backpack and one Accessory Bag
•One Pelican Case
•One Clinician Tool Kit: Slotted Screwdriver, L Torx Wrench, two
Tamper Evident Labels, and one Driveline Retention Bag
•One Connector Kit: Male and Female CPC connectors for the
Cannulae and ten Wire Ties
•One Permanent Center Tool Kit: one Battery Charger, one
additional Dummy Battery, one additional Clinician Tool Kit, one
Wire Cutter Tool, and spare screws for the Setting Dial Cover

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CAUTION
All of the above components of the Freedom Driver System are given to
the patient upon Hospital discharge except the
Freedom Hospital AC
Power Supply, Clinician Tool Kit, the Permanent Center Tool Kit and the
Dummy Battery that was inserted into the primary Freedom Driver.
An exploded view showing the relationship of the main components
of the Freedom Driver System is in Figure 1-4. The Freedom Driver
System should only be operated with the system components and
tools provided by SynCardia Systems, LLC.
If replacement components are needed, please contact SynCardia
directly at [phone] or [phone] or your
Distributor.

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Figure 1-4 Exploded View of the Freedom Driver System

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1.3.5 Primary Driver with attached Power Adaptor
The primary Freedom Driver (Figure 1-5) is the Driver connected to
the implanted TAH-t.
•A Power Adaptor is attached on the side of the primary Freedom
Driver and is needed to connect the Driver to an External Power
source.
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
Figure 1-5 – Primary Freedom Driver with attached Power Adaptor and Two
Inserted Onboard Batteries
The Freedom Driver has the following parts (Figure 1-5):
•Driver Display: displays the Beats per Minute (BPM), Fill Volume
(FV) and Cardiac Output (CO).
•Driver Display Button: when pressed, illuminates the Driver
Display.
•Onboard Battery inside Battery Well: Onboard Batteries are the
batteries that operate the Freedom Driver. They are inserted into

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the compartments (Battery Wells) located on each side of the
Freedom Driver.
•Battery Charge Button: when pressed firmly in the center,
illuminates the Battery Fuel Gauge.
•Battery Fuel Gauge: indicates the amount of remaining charge
for each Onboard Battery.
•Battery Release Button: when pressed, releases the Onboard
Batteries out of the Battery Well.
•Drivelines: flexible tubes that are permanently connected to the
Freedom Driver and connect to the TAH-t Cannulae through
CPC Connectors
•Filter Cover: holds the Filter in place to prevent dirt and dust from
entering the Freedom Driver.
•Yellow Light Visual Alarm: Indicates a Battery Alarm when lit.
The alarm is accompanied by an audible tone.
•Red Light Visual Alarm: Indicates a Temperature Alarm (blinking
light) or Fault Alarm (solid light). The alarm is accompanied by an
audible tone.
•Power Adaptor: converts input power from External Power
sources to DC power for use by the Freedom Driver.
•Power Adaptor green light: when lit, confirms proper connection
of the Freedom Driver to External Power.
•Power Adaptor plug: transmits electrical power from the Power
Adaptor to the Freedom Driver.
•Power Adaptor green receptacle: receptacle into which the green
connector from the AC Power Supply or Car Charger are
plugged in.
When the patient leaves the house, they must always take the
backup Freedom Driver with them as well as all necessary
accessories.

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1.3.6 Backup Driver with Attached Power Adaptor
The backup Freedom Driver is provided to the patient in case the
primary Freedom Driver is dropped, exposed to liquid/debris,
subjected to rough handling or has a Fault Alarm that cannot be
resolved.
Rough handling is defined as knocks, jolts, bumps and falls that
may be received by the Freedom Driver during operational use.
Examples of rough handling are:
•Banging the Freedom Driver against a hard surface (impact)
•Dropping and catching the Driver before it impacts a hard
surface (jerking motion)
See Section 10.3 for information on how to resolve Fault Alarms.
CAUTION
A backup Freedom Driver must always be available for the patient in the
event that the primary Freedom Driver is dropped,
exposed to
liquid/debris, subjected to rough handling or has a Permanent Fault
Alarm.
If the Freedom Driver is dropped, exposed to liquid/debris or subjected to
rough handling, it may sustain damage that will not allow it to provide
life-sustaining functions as designed.
If the primary Freedom Driver is dropped,
exposed to liquid/debris,
subjected to rough handling, or if the Fault Alarm cannot be resolved
within three to four minutes, the patient must switch
to the backup
Freedom Driver.
The backup Freedom Driver (Figure 1-6) is given to the patient with
an orange, nonfunctional Dummy Battery inserted in it.
•The Dummy Battery should only be removed from the backup
Freedom Driver after inserting an Onboard Battery when
switching from the primary Freedom Driver to the backup
Freedom Driver because of a Fault Alarm that cannot be
resolved.
•The Driver has an internal mechanism that locks one Battery in
place, making it impossible for two Batteries to be removed at
the same time. Insert an Onboard Battery to remove the Dummy
Battery.
•A Power Adaptor is attached on the side of the backup Freedom
Driver and is needed to connect the Driver to an External Power
source.