SynCardia Companion 2 Driver System User manual

Copyright © 2011-2017 by SynCardia Systems, LLC 900302-001 / C2-900005 Rev 014
Revision Date: 2017-02
SynCardia
Companion 2 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 Companion 2 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.
STERILE
EO
0086
16 MAY 2005

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Table of Contents
Chapter 1. Device Description .................................................................................... 9
Chapter 2. Indications for Use .................................................................................. 15
Chapter 3. Contraindications .................................................................................... 17
Chapter 4. Warnings .................................................................................................. 19
Chapter 5. Precautions.............................................................................................. 21
Chapter 6. Companion 2 Driver................................................................................. 23
Chapter 7. Air Supply................................................................................................. 31
Chapter 8. Operating Modes – Surgical (O.R.) Environment................................... 33
Chapter 9. Operating Modes – I.C.U. Environment................................................... 57
Chapter 10. Operating Modes – Ambulatory Mode .................................................. 61
Chapter 11. List of Symbols....................................................................................... 67
Chapter 12. Companion 2 Driver Operation Cautions............................................. 69
Chapter 13. Power Management............................................................................... 73
Chapter 14. Alarms and Notifications....................................................................... 81
Chapter 15. Switching from Primary Companion 2 Driver to Backup
Companion 2 Driver............................................................................... 97
Chapter 16. Switching from CSS Console to Companion 2 Driver System .......... 99
Chapter 17. Switching from Companion 2 Driver System to CSS Console ......... 103
Chapter 18. Switching from Companion 2 Driver to Primary Freedom Driver.... 105
Chapter 19. Switching from Freedom Driver to Companion 2 Driver System .... 111
Chapter 20. Equipment Maintenance and Care ..................................................... 113
Chapter 21. Unpacking and System Setup ............................................................ 119
Chapter 22. Companion 2 Driver System Specifications...................................... 121
Appendix A – Companion 2 Driver System Check Form....................................... 131

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Table of Figures
Figure 1-1 – 50cc or 70 cc TAH-t with Companion 2 Driver System.........................9
Figure 1-2 – 70cc TAH-t and 50cc TAH-t ...................................................................10
Figure 1-3 – Companion 2 Driver System Major Components................................10
Figure 1-4 – Companion 2 Driver...............................................................................11
Figure 1-5 – Hospital Cart...........................................................................................12
Figure 1-6 – Driver Caddy...........................................................................................13
Figure 1-7 – Optional Hand Pump..............................................................................13
Figure 6-1 – Display Main Screen in Primary ICU Mode ..........................................25
Figure 6-2 – Driver Alarm and Power Status LED Array..........................................27
Figure 6-3 – Driver External Battery ..........................................................................29
Figure 7-1 – External Air Connection ........................................................................31
Figure 8-1 – Menu Selection in Ambulatory Mode....................................................35
Figure 8-2 – O.R. Mode Entry Screen ........................................................................36
Figure 8-3 – Language Selection Screen ..................................................................37
Figure 8-4 – System Check Menu Screen .................................................................38
Figure 8-5 – Set Date/Time .........................................................................................40
Figure 8-6 – New Patient Setup Screen.....................................................................41
Figure 8-7 – Patient File Copy Screen.......................................................................43
Figure 8-8 – Parameter Adjustment Window ............................................................44
Figure 8-9 – Adjustment of Parameters in O.R. Mode..............................................46
Figure 8-10 – Main O.R. Screen Showing Single Pulse Mode Button.....................47
Figure 8-11 – Flip Screen Menu .................................................................................48
Figure 8-12 – Zoomed View of Pressure Waveform Showing Full Eject Flag........49
Figure 8-13 – Screen Showing Full Fill on the Left and Right Ventricle for a 70cc
TAH-t ............................................................................................................................51
Figure 8-14 – Partial Fill Flow Waveform...................................................................52
Figure 8-15 – Reset Average Hourly Cardiac Output...............................................53
Figure 8-16 – Ambulatory Mode.................................................................................54
Figure 9-1 – I.C.U. Mode Screen – Locked................................................................57
Figure 9-2 – I.C.U. Mode Screen – Unlocked.............................................................58
Figure 9-3 – I.C.U. Mode Parameter Adjustment ......................................................58
Figure 10-1 – Ambulatory Mode.................................................................................61
Figure 10-2 – Ambulatory Mode Maximize Display ..................................................62
Figure 10-3 – Patient File Copy Screen.....................................................................64
Figure 10-4 – Set Date/Time .......................................................................................64

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Figure 13-1 – Locking Connector on the Power Cord..............................................74
Figure 13-2 – Connecting External Power with the Hospital Cart...........................74
Figure 13-3 – Connecting External Power with the Companion Caddy..................74
Figure 13-4 – Releasing the Locking Connector on the Power Cord......................75
Figure 13-5 – Battery Power Status Window ............................................................76
Figure 13-6 – Battery Power Status Window ............................................................77
Figure 13-7 – Battery Latch........................................................................................78
Figure 13-8 – Battery Power Status Window with One Battery Removed..............78
Figure 13-9 – Driver Power Status LED Array...........................................................79
Figure 13-10 – Battery Power Status Window Showing Emergency Battery in Use
......................................................................................................................................80
Figure 14-1 – Alarm Status Screen............................................................................88
Figure 14-2 – Alarm History Screen...........................................................................89
Figure 14-3 – Alarm Settings Screen.........................................................................90
Figure 14-4 – Alarm Configuration Screen................................................................91
Figure 16-1 – Wire Ties around CSS Hose Barb Connectors................................100
Figure 16-2 – Metal Hose Barb Connectors Loosened, but Still Connected, to the
Cannulae....................................................................................................................100
Figure 16-3 – Inserting the Companion 2 Drivelines into the Cannulae...............101
Figure 16-4 – Securing Cannulae to CPC Connectors with Wire Ties..................101
Figure 18-1 – Companion 2 Drivelines Connected to Cannulae via the CPC
Connectors ................................................................................................................107
Figure 18-2 – Cutting the Wire Tie with the Wire Cutter Tool................................108
Figure 18-3 – Disconnecting Companion 2 Drivelines from the Cannulae ..........109
Figure 18-4 – Connecting the Freedom Drivelines to the Cannulae.....................109
Figure 18-5 – Inserting Wire Tie under Metal Release Button of CPC Connector110
Figure 20-1 – Yellow Banner Alarm for Filter Maintenance Required...................114
Figure 20-2 – Driver Side Panel and Filter Cover....................................................114
Figure 20-3 – Driver Side Panel with Filter Cover Removed..................................115
Figure 20-4 – SETUP Menu.......................................................................................116
Figure 20-5 – Verification Screen.............................................................................116
Figure 20-6 – SETUP Menu with Filter Maintenance Alarm Cleared.....................117

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Table of Tables
Table 8-1 – O.R. Mode Parameter Adjustment Range and Increments...................45
Table 9-1 – I.C.U. Mode Parameter Adjustment Range and Increments.................60
Table 11-1 –Symbols Used in Companion 2 Driver System Labeling.....................67
Table 12-1 – List of Locations and Sizes of Fuses...................................................69
Table 14-1 – Alarm Messages and Responses.........................................................81
Table 14-2 – Alarm Configuration Default Settings and Ranges.............................92
Table 14-3 – Notifications...........................................................................................94
Table 22-1 – Declaration Concerning General Safety Standards..........................121
Table 22-2 – Declaration and Guidance Concerning Electromagnetic
Emissions.............................................................................................122
Table 22-3 – Declaration and Guidance Concerning Electromagnetic Immunity
for Companion 2 Driver System .........................................................123
Table 22-4 – Declaration and Guidance Concerning Electromagnetic Immunity
for Life-Sustaining Companion 2 Driver System, including the
TAH-t, Companion 2 Driver and Batteries .........................................124
Table 22-5 – Input/Output Characteristics ..............................................................128

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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.

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Figure 1-2 – 70cc TAH-t and 50cc TAH-t
The implantable 50cc or 70cc TAH-t consists of two artificial ventricles. The
cannula from each artificial ventricle is tunneled through the chest wall. The
cannulae of the right and left artificial ventricles are attached to seven-foot
pneumatic Drivelines that connect to the Companion 2 Driver System.
The Companion 2 Driver System (Figure 1-3) is a multi-component electro-
mechanical unit designed to provide pneumatic power to the implanted 50cc or
70cc TAH-t. The Companion 2 Driver System operates and monitors the 50cc or
70cc TAH-t throughout the implantation, surgical recovery phase and ambulatory
phase of patient support. The Companion 2 Driver System includes a Driver, a
Hospital Cart, and a Caddy and an optional Hand Pump.
Figure 1-3 – Companion 2 Driver System Major Components
Two colored bands
on each cannula for
50cc TAH-t
One colored band
on each cannula for
70cc TAH-t

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1.1 Companion 2 Driver
The Driver (Figure 1-4) powers the TAH-t and docks into the Hospital Cart
or the Driver Caddy. The TAH-t is monitored non-invasively by the Driver
so there are no electrical connections to the patient.
Figure 1-4 – Companion 2 Driver
1.2 Hospital Cart
The Hospital Cart (Figure 1-5) is a large cart with wheels, into which the
Driver docks. It is intended for use in the hospital during the TAH-t implant
procedure and subsequent recovery phase.
oThe Driver docks into the Hospital Cart by placing the Driver
straight into the center of the Hospital Cart so the docking
connectors mate. The Driver must always be put into the Hospital
Cart with the External Batteries facing outward.
oTo remove the Driver from the Hospital Cart, simply lift the Driver
straight up out of the Hospital Cart.
On/Off Switch
Driveline
Connection
External Batteries
Filter Cover
External Air
Connection
Display Screen and
User Interface
LED Array
USB Port

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Figure 1-5 – Hospital Cart
1.3 Caddy
The Driver Caddy (Figure 1-6) is a small cart with wheels, into which the
Driver docks. It is designed to facilitate mobility of ambulatory patients
within the hospital. A tire pump is included in the attached pouch for
inflating the pneumatic tires.
oThe Driver docks into the Caddy by placing the Driver straight into
the center of the Caddy so that the docking connectors mate. The
Driver must always be put into the Driver Caddy with the External
Batteries facing outward.
oThe Driver is removed from the Caddy by depressing the Driver
Release Button found at the back of the Caddy. Once the Driver
Release Button is depressed, the Driver can be removed from the
Caddy by lifting straight up.
Cart LED Array
Accessory Drawer
Locking Casters
Support Handle
Docked Driver
LCD Display and
User Interface

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Figure 1-6 – Driver Caddy
1.4 Hand Pump
The optional Hand Pump (Figure 1-7) is a manually-operated driver that is
intended to provide pulses of pneumatic pressure through the right and left
Drivelines. The Hand Pump is designed for emergency use when a
backup Driver is not immediately available. The Companion Drivelines
connect to the CPC connectors on the Hand Pump. Clinical operators
should pump at 110 strokes per minute to provide adequate Cardiac
Output. See the SynCardia Hand Pump Operator Manual for additional
details.
Figure 1-7 – Optional Hand Pump
Hand
Pump
CPC Connectors
Telescopic Handle
Docked
Driver
Power Inlet
Front Foot
Tires
Handle
Release
Button
Driver
Release
Button

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Chapter 2. Indications for Use
2.1 70cc TAH-t Indication for Use
The SynCardia 70cc temporary Total Artificial Heart (TAH-t) is indicated
for use as a bridge to transplantation in cardiac transplant-eligible
candidates at risk of imminent death from non-reversible biventricular
failure.
The use of the SynCardia 70cc TAH-t for destination therapy (for patients
who are ineligible for cardiac transplantation and for whom clinical indices
indicate a remote likelihood of becoming eligible for a transplant) is
investigational.
2.2 50cc TAH-t Indication for Use
The SynCardia 50cc temporary Total Artificial Heart (TAH-t) is indicated
for use as a bridge to transplantation in cardiac transplant-eligible
candidates at risk of imminent death from biventricular failure.
2.3 Companion 2 Driver System Intended Use
The Companion 2 Driver System, used with the 50cc TAH-t or the 70cc
TAH-t, is intended for use inside the hospital and on the hospital grounds.

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Chapter 3. Contraindications
The 70cc TAH-t System is contraindicated for use in:
•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 < 1.7 m², or who have a distance between the sternum and the 10th
anterior vertebral body measured by computed tomography imaging (CT
scan) < 10 cm.
•Patients who cannot be adequately anticoagulated on the 70cc TAH-t.
The 50cc TAH-t System 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.
•Patients who have a body surface area (BSA) of > 1.85 m2.
•Patients who cannot be adequately anticoagulated on the 50cc TAH-t.

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Chapter 4. Warnings
4.1 Setup and operation of the 50cc or 70cc TAH-t System should only be
performed by personnel certified in accordance with the SynCardia
certification program. A thorough understanding of the technical principles,
clinical applications, and risks associated with the device is necessary.
Prior to use, refer to the SynCardia temporary Total Artificial Heart (TAH-t)
Instructions for Use with the Companion 2 Driver System for the 50cc or
70cc TAH-t.
4.2 The Drivelines are sterile components and are intended for single use
only. Do not use if package is opened or damaged. Do not re-sterilize or
reuse.
4.3 Safe use of this system has not been established in pregnant patients.
4.4 Do not subject patients implanted with the 50cc or 70cc TAH-t to magnetic
resonance imaging (MRI) scans.
4.5 Do not use the TAH-t System if the implantable artificial ventricles cannot
fit in the chest area vacated by the natural ventricles. Compression of the
inferior vena cava and left pulmonary venous are possible consequences.
4.6 Do not allow any catheter to get near the inflow valves of the TAH-t. If a
catheter migrates into an inflow valve, the valve could become stuck,
limiting flow. Confirm the position of the catheter by x-ray after catheter
insertion and repeat an x-ray immediately if any unexplained sudden drop
in cardiac output occurs. A percutaneously inserted central catheter may
migrate into the inflow valve when the patient raises his or her arm.
4.7 There is a potential for air embolism. De-air the artificial ventricles to
minimize the possibility of air inadvertently entering the device.
4.8 Do not allow the external Drivelines to become kinked. If there is any low
cardiac output alarm, inspect the external Drivelines for kinking.
4.9 A reduction in the maximum stroke volume on the external driver
monitoring computer to below 30 milliliters may indicate a failure of one of
the diaphragms in a ventricle of the 50cc TAH-t.
4.10 A reduction in the maximum stroke volume on the external driver
monitoring computer to below 40 milliliters may indicate a failure of one of
the diaphragms in a ventricle of the 70cc TAH-t.
4.11 Do not administer CPR to TAH-t patients. Defibrillation, cardioversion, and
CPR are ineffective on patients implanted with the 50cc or 70cc TAH-t.
4.12 The graphical user interface software on the Companion 2 Driver requires
two minutes to fully load after the power is turned on with the key switch.
No Driver alarms are active during this time.
4.13 If the Driver is started while undocked from a Hospital Cart and the touch
screen is non-responsive after the graphical user interface is presented on
the display, dock the Driver into the Hospital Cart to recalibrate the Driver

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touch screen. This is performed through driver touch screen calibration
procedure (see Section 8.1.10).
4.14 Always keep the Companion 2 Driver System away from any ignition
source including open flame and smoldering cigarettes.
4.15 If a docked Driver user interface displays the following in the Power Status
Window:
- Both External Batteries Missing
- and no AC Power Icon
- and there are External Batteries and/or AC power applied
remove the External Batteries and AC power. Reconnect AC Power and
reinsert the External Batteries.
4.16 Preliminary data on the use of the Companion 2 Driver versus the
Circulatory Support Console (CSS) with the TAH-t for patients who
received circulatory rescue intervention (e.g., extracorporeal membrane
oxygenation [ECMO] or intra-aortic balloon pump [IABP]) prior to implant
suggest a higher mortality for the Companion 2 Driver compared to the
CSS. A mortality difference was not observed among patients not initially
treated with a pre-implant circulatory intervention.
4.17 If upon docking the Driver into a Hospital Cart or Caddy, the Driver screen
flickers, flashes black and white, or turns off, immediately undock the
Driver and DO NOT attempt to dock the Driver again into the same
Hospital Cart or Caddy. A malfunction of the Hospital Cart or Caddy may
exist and it must be returned to SynCardia for evaluation. The Driver
should be docked into another Hospital Cart or Caddy.