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