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SynCardia Companion 2 Driver System Operator's Manual

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Companion 2 Driver System
SynCardia Systems, LLC
1992 E. Silverlake Road
Tucson, AZ 85713 USA
(520) 545-1234
(866) 771-9437
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.
Copyright © 2011-2017 by SynCardia Systems, LLC
SynCardia
Operator Manual
STERILE
16 MAY 2005
900302-001 / C2-900005 Rev 014
Revision Date: 2017-02
EO
0086

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Summary of Contents for SynCardia Companion 2 Driver System

  • Page 1 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.
  • Page 2 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 2 of 132...

  • Page 3: Table Of Contents

    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.
  • Page 4 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 4 of 132...
  • Page 5 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 –...
  • Page 6 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 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 6 of 132...
  • Page 7 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 –...
  • Page 8 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 8 of 132...

  • Page 9: Chapter 1. Device Description

    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.

  • Page 10: Figure 1-2 - 70Cc Tah-T And 50Cc Tah-T

    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.

  • Page 11: Figure 1-4 - Companion 2 Driver

    Cart with the External Batteries facing outward. o To remove the Driver from the Hospital Cart, simply lift the Driver straight up out of the Hospital Cart. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 11 of 132...

  • Page 12: Figure 1-5 - Hospital Cart

    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. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 12 of 132...

  • Page 13: Figure 1-6 - Driver Caddy

    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. Hand...
  • Page 14 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 14 of 132...

  • Page 15: Chapter 2. Indications For Use

    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.
  • Page 16 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 16 of 132...

  • Page 17: Chapter 3. Contraindications

    • 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 m • Patients who cannot be adequately anticoagulated on the 50cc TAH-t. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 17 of 132...
  • Page 18 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 18 of 132...

  • Page 19: Chapter 4. Warnings

    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. The Drivelines are sterile components and are intended for single use only.
  • Page 20 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...

  • Page 21: Chapter 5. Precautions

    Surgical, nursing, and perfusion staff responsible for the SynCardia TAH-t program at each hospital must complete the SynCardia Certification program. The SynCardia TAH-t and Drivelines are provided sterile; caution must be taken in opening the package. Do NOT resterilize. Do NOT use if package is damaged.
  • Page 22 5.16 To facilitate Hospital Cart movement over an obstacle that is 20 mm in height (approximately 0.8”) it is recommended that the user (Clinical Engineer/Nurse) and an assistant, if needed, pull upwards on the Hospital Cart Support Handles. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 22 of 132...

  • Page 23: Chapter 6. Companion 2 Driver

    The power management electronics assembly is designed to continue to route power to the motor assemblies in the event of a loss of one power channel. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 23 of 132...
  • Page 24 Driver is placed in the Hospital Cart or Driver Caddy. There is a port on the right side of the Driver for connecting to External air. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 24 of 132...

  • Page 25: Figure 6-1 - Display Main Screen In Primary Icu Mode

    Chapter 14, Alarms and Notifications, contains additional information. The Graphical Display Window shows pressure and flow waveforms on a beat-to-beat basis and the cardiac output trend SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 25 of 132...
  • Page 26 – I.C.U. Environment, Operating Modes – Ambulatory Mode, respectively. The Air Icon indicates if the Driver is connected to external air or is powered by the compressors. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 26 of 132...

  • Page 27: Figure 6-2 - Driver Alarm And Power Status Led Array

    Solid green indicates the Emergency Battery is not in use. A flashing green emergency LED indicates the Emergency Battery is being charged. Flashing red indicates a very high alarm state. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 27 of 132...
  • Page 28 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.

  • Page 29: Figure 6-3 - Driver External Battery

    (counter will take approximately one minute to update the estimated battery support time based on Driver settings. Battery Release Latch Battery Fuel Gauge Battery Test Button Figure 6-3 – Driver External Battery SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 29 of 132...
  • Page 30 As with all rechargeable batteries, the full capacity of the External Batteries and Emergency Battery will decrease as a result of battery age and charge/discharge cycling. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 30 of 132...

  • Page 31: Chapter 7. Air Supply

    Driver functionality, however, the internal compressor may activate intermittently. When the compressor activates, the external air icon on the display will not be illuminated. Figure 7-1 – External Air Connection SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 31 of 132...
  • Page 32 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 32 of 132...

  • Page 33: Chapter 8. Operating Modes - Surgical (O.r.) Environment

    Driver software has loaded, the system will show the Ambulatory Mode Screen (Figure 8-1). CAUTION Do not rapidly rotate the key between the ON setting and OFF setting. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 33 of 132...
  • Page 34 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.

  • Page 35: Figure 8-1 - Menu Selection In Ambulatory Mode

    CONFIRM to change to O.R. Mode. This can be verified by the Mode Change temporary confirmation window displayed for two seconds and the O.R. Mode descriptor in the upper right corner of the display (Figure 8-2). SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 35 of 132...

  • Page 36: Figure 8-2 - O.r. Mode Entry Screen

    A reminder audible signal will be generated every two hours to indicate that the system is in O.R. Mode. All visual alarm indicators will continue to function SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 36 of 132...

  • Page 37: Figure 8-3 - Language Selection Screen

    Driver. The calibration procedure can be repeated as necessary to improve the touch screen performance. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 37 of 132...

  • Page 38: Figure 8-4 - System Check Menu Screen

    Begin the automated portion of the System Check by navigating to the System Check icon in the menu. Select MENU, SYSTEM then SYSTEM CHECK (Figure 8-4). Figure 8-4 – System Check Menu Screen SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 38 of 132...
  • Page 39 Systems, LLC. Obtain the backup Driver and prepare it for use as indicated in this section. (15) Send a copy of the completed form to SynCardia Systems, LLC by fax at the number indicated on the form. 8.1.12. Set Date and Time...

  • Page 40: Figure 8-5 - Set Date/Time

    Screen displayed when selecting MENU, HELP in order to provide users with access to any contact numbers entered in this screen. Select CONFIRM when entry is completed. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 40 of 132...

  • Page 41: Figure 8-6 - New Patient Setup Screen

    • Patient ID • TAH-t Serial Number • Hospital The following measured or calculated values are recorded in the log file(s): • Time • Rate SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 41 of 132...
  • Page 42 Press COPY to start. o Copying will take a few seconds. o Press DONE, then remove USB device. o To exit at any time, select CANCEL. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 42 of 132...

  • Page 43: Figure 8-7 - Patient File Copy Screen

    Figure 8-7 – Patient File Copy Screen SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 43 of 132...

  • Page 44: Figure 8-8 - Parameter Adjustment Window

    Select “+” to increase the setting and “-” to decrease the setting. Pressing the “+” or “-” button once will change the value by increments of one. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 44 of 132...

  • Page 45: Table 8-1 - O.r. Mode Parameter Adjustment Range And Increments

    All adjustments in O.R. Mode occur without delay when the “+” increase or “-” decrease button is selected. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 45 of 132...

  • Page 46: Figure 8-9 - Adjustment Of Parameters In O.r. Mode

    When the Rate is below 40, “- -” is shown for the Rate and single pulse actuation becomes an option. Select the One Time icon, “1X” (beneath the “+” button) to perform a single pulse actuation (Figure 8-10). SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 46 of 132...

  • Page 47: Figure 8-10 - Main O.r. Screen Showing Single Pulse Mode Button

    TAH-t rate is zero. The stroke volumes will be low until the patient is completely off bypass. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 47 of 132...

  • Page 48: Figure 8-11 - Flip Screen Menu

    MENU, SETUP, FLIP SCREEN (Figure 8-11). This will change the orientation of the Driver display only and will not affect the Hospital Cart display. Figure 8-11 – Flip Screen Menu SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 48 of 132...

  • Page 49: Figure 8-12 - Zoomed View Of Pressure Waveform Showing Full Eject Flag

    Full Eject Flag Figure 8-12 – Zoomed View of Pressure Waveform Showing Full Eject Flag SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 49 of 132...
  • Page 50 65mL or greater (Figure 8-13). An acceptable partial fill for the 70cc TAH-t is fill volume between 50 and 60 cc. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 50 of 132...

  • Page 51: Figure 8-13 - Screen Showing Full Fill On The Left And Right Ventricle For A 70Cc Tah-T

    • Right Fill Volume High Fill volume for the 50cc TAH-t should be monitored and Driver settings adjusted if the patient is experiencing or approaching a full fill condition (> 40cc) SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 51 of 132...

  • Page 52: Figure 8-14 - Partial Fill Flow Waveform

    TAH-t is operating at a partial fill condition. It may not be necessary to adjust all parameters to resolve the issue. • Increase rate • Decrease vacuum • Increase systolic duration SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 52 of 132...

  • Page 53: Figure 8-15 - Reset Average Hourly Cardiac Output

    No password is required to change from O.R. Mode to I.C.U. Mode because there are more restrictions in I.C.U. Mode than in O.R. Mode. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 53 of 132...

  • Page 54: Figure 8-16 - Ambulatory Mode

    Power on the backup Driver. (Note: Alarms are disabled for the first 2 minutes). Once the Driver software has loaded, the system will show the Ambulatory Mode Screen (Figure 8-16). Figure 8-16 – Ambulatory Mode SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 54 of 132...
  • Page 55 Change to I.C.U. Mode by selecting MENU, I.C.U. MODE and enter the password, 9722. Press the LOCK Icon in the lower right corner to unlock the touch screen. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 55 of 132...
  • Page 56 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 56 of 132...

  • Page 57: Chapter 9. Operating Modes - I.c.u. Environment

    Adjustment Locked/Unlocked The default condition for the I.C.U. Mode is “locked,” which is indicated by the LOCK Icon (Figure 9-1). Figure 9-1 – I.C.U. Mode Screen – Locked SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 57 of 132...

  • Page 58: Figure 9-2 - I.c.u. Mode Screen - Unlocked

    The adjustment window in I.C.U. Mode shows both the current setting and the new setting, as shown in Figure 9-3. Figure 9-3 – I.C.U. Mode Parameter Adjustment SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 58 of 132...
  • Page 59 UNLOCKED icon to return to the locked position. 9.2.4. Holding the “+” or “-” button for two seconds will cause the parameter to immediately change by increased increments, as shown in Table 9-1. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 59 of 132...

  • Page 60: Table 9-1 - I.c.u. Mode Parameter Adjustment Range And Increments

    * Actual vacuum achieved is dependent on the patient systemic pressures and resistance and the Driver parameter settings. In general, increasing vacuum increases fill volumes and decreases in vacuum decrease fill volume. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 60 of 132...

  • Page 61: Chapter 10. Operating Modes - Ambulatory Mode

    Once the Driver software has loaded, the system will show the Ambulatory Mode Screen (Figure 10-1). Alarm Alarm Mute Status Bar Button Power Status Window Average Cardiac Output Window Maximize Display Button Figure 10-1 – Ambulatory Mode SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 61 of 132...

  • Page 62: Figure 10-2 - Ambulatory Mode Maximize Display

    • Percent Systole • Left Cardiac Output • Right Cardiac Output • Left Hourly Cardiac Output Average • Right Hourly Cardiac Output Average • Left Fill Volume SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 62 of 132...
  • Page 63 • Press COPY to start. • Copying will take a few seconds. • Press DONE, then remove USB device. • To exit at any time, select CANCEL. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 63 of 132...

  • Page 64: Figure 10-3 - Patient File Copy Screen

    “+” or “-” button to change to the desired value. Select ENTER to accept the change (Figure 10-4). Figure 10-4 – Set Date/Time SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 64 of 132...
  • Page 65 Change the operating mode to I.C.U. Mode by completing the following steps: (1) Select MENU, MODE, and I.C.U. MODE. (2) Enter the I.C.U. Mode password (9722) and press CONFIRM to change to I.C.U. Mode. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 65 of 132...
  • Page 66 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 66 of 132...

  • Page 67: Chapter 11. List Of Symbols

    Chapter 11. List of Symbols Table 11-1 – Symbols Used in Companion 2 Driver System Labeling Symbol Description Symbol Description "OFF" for a part of "ON" (power) equipment Temporary Audible Alarm Audible Alarm Disabled silenced Protected against objects Refer to instruction manual/ IP30 >...
  • Page 68 19: Maximum diameter of cell (in mm) 65: Maximum overall height of the diameter (in mm) 5: Number of battery cells connected in parallel within a cell pack SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 68 of 132...

  • Page 69: Chapter 12. Companion 2 Driver Operation Cautions

    Investigate and correct the cause of any alarm. 12.3. Use of Backup Driver A SynCardia approved Driver must be available as a backup to be used in the event of a failure of the primary Driver. 12.4. Maintenance of Electrical Safety The Companion 2 Driver System is designed to meet AAMI/NFPA electrical safety requirements.
  • Page 70 12.5. Fuses Fuses are user replaceable. 12.6. Reduction of Explosion Hazard Do NOT operate the Companion 2 Driver System in the presence of flammable anesthetics or other flammable gases. 12.7. Maintenance of Patient Safety Verify that all pneumatic and electrical connections are in place, secure, and connected to the Driver in use before attempting to operate the System.
  • Page 71 12.11. Companion 2 Driver System Cleaning Exercise extreme care in cleaning the Companion 2 Driver System. DO NOT soak any item during cleaning or disinfection. DO NOT allow water or solvent to come in direct contact with electrical connectors. See Chapter 20, Equipment Maintenance and Care, for more information.
  • Page 72 • The Companion 2 Driver is docked in either a Hospital Cart or Driver Caddy. • A backup Driver is available that has successfully completed System Check. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 72 of 132...

  • Page 73: Chapter 13. Power Management

    • Make sure that the External Power Indicator on the Driver turns green. If the light does not turn green, the Driver is using battery power. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 73 of 132...

  • Page 74: Figure 13-1 - Locking Connector On The Power Cord

    Hospital Cart Power Inlet Figure 13-2 – Connecting External Power with the Hospital Cart Driver Caddy Power Inlet Figure 13-3 – Connecting External Power with the Companion Driver Caddy SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 74 of 132...

  • Page 75: Figure 13-4 - Releasing The Locking Connector On The Power Cord

    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.

  • Page 76: Figure 13-5 - Battery Power Status Window

    Battery Indicator begins flashing yellow and an alarm sounds every 30 seconds. The Battery symbol in the Power Status Window on the display shows a red battery. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 76 of 132...

  • Page 77: Figure 13-6 - Battery Power Status Window

    Companion 2 Driver display (counter) will take approximately one minute to update the estimated battery support time based on Driver settings. Power Status Window Counter Figure 13-6 – Battery Power Status Window SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 77 of 132...

  • Page 78: Figure 13-7 - Battery Latch

    Symbol with an “X” (Figure 13-8). Battery 2 Removed Battery 1 Full Charge Wall Power Connected Figure 13-8 – Battery Power Status Window with One Battery Removed SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 78 of 132...

  • Page 79: Figure 13-9 - Driver Power Status Led Array

    Figure 13-9, flashes green when the batteries are being charged. Alarm Indicator External Power Indicator External Battery Indicators Emergency Battery Indicator Figure 13-9 – Driver Power Status LED Array SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 79 of 132...

  • Page 80: Figure 13-10 - Battery Power Status Window Showing Emergency Battery In Use

    The system must be reconnected immediately to an alternate power source, such as the wall power or External Batteries or the patient must be switched to a SynCardia approved Backup Driver. SynCardia Systems, LLC Companion 2 Driver System Operator Manual...

  • Page 81: Chapter 14. Alarms And Notifications

    Table 14-1 for alarms and their corrective actions. For alarms observed while the Driver is not supporting a patient, contact SynCardia for additional information. If more than one alarm occurs, the highest priority alarm message is shown first in the Alarm Bar.
  • Page 82 11 hours. Cycle power on the Driver. If Battery Error alarm persists, return the Driver to Emergency Battery 70-80 dBA SynCardia. Indicator: Flashing Red Notify SynCardia at 1-866-771-9437 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 82 of 132...
  • Page 83 Assess patient conditions that may Imbalance contribute to a high Cardiac Output. (high) 70-80 dBA If alarm persists, replace Driver with a SynCardia approved backup Driver. Notify SynCardia at 1-866-771-9437 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 83 of 132...
  • Page 84 Left Ventricle seconds Over Alarm Indicator LED : Red If alarm persists, replace Driver with a Pressure SynCardia approved backup Driver. 70-80 dBA Notify SynCardia at 1-866-771-9437 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 84 of 132...
  • Page 85 Alarm Bar: Flashing 14.4). Right Yellow Pressure If alarm persists, replace Driver with a 70-80 dBA Incorrect Alarm Indicator: Yellow SynCardia approved backup Driver. Notify SynCardia at 1-866-771-9437 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 85 of 132...
  • Page 86 Battery Yellow gauge. Battery Indicator: Yellow 70-80 dBA If alarm persists, replace Driver with a SynCardia approved backup Driver. Notify SynCardia at 1-866-771-9437 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 86 of 132...
  • Page 87 2 beeps every 3½ Replace Driver with a SynCardia Alarm Bar: Yellow Driver minutes approved backup Driver. Requires Alarm Indicator LED: Notify SynCardia at Service Yellow 1-866-771-9437 70-80 dBA SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 87 of 132...

  • Page 88: Figure 14-1 - Alarm Status Screen

    Figure 14-1 – Alarm Status Screen The Alarm Status Screen may be accessed by pressing MENU, ALARMS or by pressing on the alarm bar anywhere other than the Alarm Mute Button. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 88 of 132...

  • Page 89: Figure 14-2 - Alarm History Screen

    The Alarm History can be viewed by touching the Alarm Status Bar and then selecting the Alarm History Tab or by pressing MENU, ALARMS, and ALARM HISTORY. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 89 of 132...

  • Page 90: Figure 14-3 - Alarm Settings Screen

    Scroll Bar Figure 14-3 – Alarm Settings Screen Alarm settings can be adjusted by scrolling up or down, selecting the alarm name and pressing the EDIT button. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 90 of 132...

  • Page 91: Figure 14-4 - Alarm Configuration Screen

    Alarm limits and settings are stored in the Driver and persist during short or extended power interruptions. This allows the user to configure alarm settings on the backup Driver as directed in Section 8.2.8, Setup of Backup Driver. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 91 of 132...

  • Page 92: Table 14-2 - Alarm Configuration Default Settings And Ranges

    Battery Low Left Ventricle 0 to 20 300 mmHg Overpressure mmHg mmHg Right Ventricle 0 to 20 90 mmHg 170 mmHg Overpressure mmHg Very Low External minutes Battery SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 92 of 132...
  • Page 93 Left Fill Volume High alarm and Right Fill Volume High alarm only applies to Driver use with the 70cc TAH-t (this alarm is not present with the 50cc TAH-t). SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 93 of 132...

  • Page 94: Table 14-3 - Notifications

    Solid “X” over the Alarm Disabled in O.R. reminder signal procedure, otherwise change to Mute Button Mode Reminder every 2 hours I.C.U. Mode or Ambulatory Mode to activate audible alarms SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 94 of 132...
  • Page 95 External air Connection No audible signal No action required Connected Icon enabled (black) External air External air Connection No audible signal No action required Disconnected Icon disabled (grey) SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 95 of 132...
  • Page 96 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 96 of 132...

  • Page 97: Chapter 15. Switching From Primary Companion 2 Driver To Backup Companion 2 Driver

    Driveline connector. Attach the Driveline connector to the connection on the backup Driver in the same direction (as shown in Figure 15-1). Figure 15-1 – Properly Connected Drivelines SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 97 of 132...
  • Page 98 Driver. Turn off the primary Driver. The key will lock into place when the primary Driver is set to the OFF position. 15.2.6. Notify SynCardia Systems that the Driver has been switched. Report any alarms or problems at this time.

  • Page 99: Chapter 16. Switching From Css Console To Companion 2 Driver System

    Setup of Backup Driver, including the System Check. If the driver does not pass the Setup, do not connect the patient to the Companion 2 Driver and contact SynCardia immediately. 16.2.2. Connect the Companion Drivelines to the Driver, using the single Driveline connector.

  • Page 100: Figure 16-1 - Wire Ties Around Css Hose Barb Connectors

    Drivelines of the Companion 2 Driver within reach. 16.3.3. Perform steps 16.3.4 and 16.3.5 simultaneously in order to disconnect the Drivelines of the CSS Console and connect the Drivelines of the Companion 2 Driver. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 100 of 132...

  • Page 101: Figure 16-3 - Inserting The Companion 2 Drivelines Into The Cannulae

    The Wire Ties around the Cannulae and CPC connectors must be secured using a Wire Tie Gun. Secure each Cannula with two Wire Ties Figure 16-4 – Securing Cannulae to CPC Connectors with Wire Ties SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 101 of 132...
  • Page 102 16.3.7. It is recommended that the CSS Console Drivelines be retained or disposed of in accordance with hospital procedures. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 102 of 132...

  • Page 103: Chapter 17. Switching From Companion 2 Driver System To Css Console

    NOTE: The procedure described below to switch drivers is the same for both the 50cc TAH-t and 70cc TAH-t. 17.1. Materials Prior to switching from the Companion 2 Driver System to the CSS Console, assemble the following materials: • One set of CSS Console Drivelines •...
  • Page 104 17.3.4. Reinsert a locking tie under the metal release button on the CPC connections to prevent inadvertent disconnect. Note: The TAH-t is now connected to the CSS Console via CPC connectors. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 104 of 132...

  • Page 105: Chapter 18. Switching From Companion 2 Driver To Primary Freedom Driver

    NOTE: The Freedom Driver is set up not to activate a Fault Alarm for low Cardiac Output for 15 minutes after it has been initially turned on, to allow time to connect to a TAH-t. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 105 of 132...
  • Page 106 When performing a switch from the Companion 2 Driver to the Freedom Driver, make certain the Drivelines are properly connected to the TAH-t Cannulae, and do not kink the Drivelines. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 106 of 132...

  • Page 107: Figure 18-1 - Companion 2 Drivelines Connected To Cannulae Via The Cpc Connectors

    CPC Connector that secures TAH-t Cannula to the Companion 2 Driveline (Figure 18-2). Gently pull to remove the Wire Tie and discard. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 107 of 132...

  • Page 108: Figure 18-2 - Cutting The Wire Tie With The Wire Cutter Tool

    • Immediately insert the Cannula into the Freedom Driveline, • Insert until a click is heard. • Lightly tug on the connection to make sure that it is secure. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 108 of 132...

  • Page 109: Figure 18-3 - Disconnecting Companion 2 Drivelines From The Cannulae

    Press Pull Pull Figure 18-3 – Disconnecting Companion 2 Drivelines from the Cannulae Push in Push in Figure 18-4 – Connecting the Freedom Drivelines to the Cannulae SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 109 of 132...

  • Page 110: Figure 18-5 - Inserting Wire Tie Under Metal Release Button Of Cpc Connector

    The patient’s name and the date of the switch must be written on the bag and retained by the Hospital to switch the patient back to the Companion 2 Driver, if necessary. The Hospital should notify SynCardia Systems that the patient has been switched. SynCardia Systems, LLC...

  • Page 111: Chapter 19. Switching From Freedom Driver To Companion 2 Driver System

    Backup Driver, including the System Check. 19.2.2 Connect the Companion Drivelines to the Driver using the single Driveline connector. 19.2.3 Position the Driver that is ON next to the patient. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 111 of 132...
  • Page 112 19.3.4 Cut off the excess ties and cover with Velcro. 19.3.5 The cannulae from the TAH-t are now connected to the Drivelines on the Companion 2 Driver. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 112 of 132...

  • Page 113: Chapter 20. Equipment Maintenance And Care

    Check (Appendix A) upon receipt, prior to use, and every 6 months if the Driver is not in use. In addition, SynCardia will track the Driver runtime and notify the center when a Driver is due for scheduled service. The Driver Caddy may require air to be added to the tires periodically.

  • Page 114: Figure 20-1 - Yellow Banner Alarm For Filter Maintenance Required

    20.4.2 To access the filter, press the Filter Cover Latch (Figure 20-2) and pull the Filter Cover away from the Driver body. Filter Cover Latch Filter Cover Figure 20-2 – Driver Side Panel and Filter Cover SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 114 of 132...

  • Page 115: Figure 20-3 - Driver Side Panel With Filter Cover Removed

    20.4.5 After cleaning or replacing the filter, follow these steps to clear the alarm: (1) Select MENU (2) Select SETUP (3) The FILTER MAINT. REQUIRED button should be active (see Figure 20-4) SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 115 of 132...

  • Page 116: Figure 20-4 - Setup Menu

    (4) Select the FILTER MAINT. REQUIRED button (5) This will bring up a verification screen asking “Has the filter maintenance been completed” (see Figure 20-5). Select YES. Figure 20-5 – Verification Screen SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 116 of 132...

  • Page 117: Figure 20-6 - Setup Menu With Filter Maintenance Alarm Cleared

    (6) Once the alarm has been cleared, the FILTER MAINT. REQUIRED button will be grayed out (see Figure 20-6). Figure 20-6 – SETUP Menu with Filter Maintenance Alarm Cleared SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 117 of 132...
  • Page 118 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 118 of 132...

  • Page 119: Chapter 21. Unpacking And System Setup

    21.1.8 Once the internal Emergency Battery and External Batteries are charged, the system is ready for clinical use. CAUTION Do not rapidly rotate the key between the ON setting and OFF setting. SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 119 of 132...
  • Page 120 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.

  • Page 121: Chapter 22. Companion 2 Driver System Specifications

    Chapter 22. Companion 2 Driver System Specifications 22.1 Safety Standards The Companion 2 Driver System, as part of the SynCardia TAH-t Companion 2 Driver System, has been thoroughly tested pursuant the requirements of European safety standard IEC 60601-1: 2006. This standard requires making the following declarations and stating the type and degree of protection for listed hazards.

  • Page 122: Table 22-2 - Declaration And Guidance Concerning Electromagnetic Emissions

    Guidance Concerning Electromagnetic Emissions The Companion 2 Driver System components are intended for use in the electromagnetic environment specified in Table 22-2. The customer or the user of the device should assure that it is used in such an environment.

  • Page 123: Table 22-3 - Declaration And Guidance Concerning Electromagnetic Immunity For Companion 2 Driver System

    22.1.2 Declaration and Guidance Concerning Electromagnetic Immunity for all Companion 2 Driver System The Companion 2 Driver System components are intended for use in the electromagnetic environment specified in Table 22-3. The customer or the user of the components should assure that they are used in such an environment.
  • Page 124 The customer or the user of either device should assure that they are used in such an electromagnetic environment. 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 60601...
  • Page 125 80 MHz and in the frequency range 80 MHz to 2.5 GHz are intended decrease likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into the patient areas. For this reason, an SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 125 of 132...
  • Page 126 The Companion 2 Driver System has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2:2001 Medical electrical equipment − Part 1-2: General requirements for safety −...
  • Page 127 • Battery Storage Temperature: 0° to 40°C (32° to 104°F) • Transportation/Storage Pressure: 700 to 1060 mBar (525 to 795 mmHg) • Transportation/Storage Humidity: 10 – 100% RH (non- condensing) SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 127 of 132...

  • Page 128: Table 22-5 - Input/Output Characteristics

    Unidirectional USB port protected with a USB Port Driver side panel rubber cap that allows information to be copied from the Driver SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 128 of 132...
  • Page 129 • Externally-Powered Equipment when connected to an external AC (wall) power source The Driver is intended for CONTINUOUS OPERATION 22.10 Software Versions in the Companion 2 Driver System • Embedded Supervisor: v1.25 • Graphical User Interface: v1.0.2160 SynCardia Systems, LLC...
  • Page 130 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 130 of 132...

  • Page 131: Appendix A - Companion 2 Driver System Check Form

    Appendix A – Companion 2 Driver System Check Form SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 131 of 132...
  • Page 132 SynCardia Systems, LLC Companion 2 Driver System Operator Manual Page 132 of 132...
  • Page 133 Verify the system passed all Tests 9. Upon completion of System Check, press “Close” 10. Proceed to Battery Tests on Page 2. Comments: ____________________________________________________________________________ ____________________________________________________________________________ __________ SynCardia Systems, LLC Revision Date: 2017-02 Companion 2 Driver System Check Form: C2-900005 Rev 014 Page 1 of 2...
  • Page 134 Fail  Verify the driver displays and LED lights indicate that the wall power is connected 10. Turn the system off. If the Driver failed any of the above steps, contact SynCardia Systems, LLC Help Line at (866) 771-9437. 11. Sign, date and fax form to 520-903-1782 12.

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