Thoratec HeartMate III Instructions For Use Manual
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Thoratec HeartMate III Instructions For Use Manual

Left ventricular assist system
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Summary of Contents for Thoratec HeartMate III

  • Page 1 Instructions for Use...
  • Page 3 Thoratec Corporation III™ L EART ENTRICULAR SSIST YSTEM Instructions for Use...
  • Page 4 III L EART ENTRICULAR SSIST YSTEM NSTRUCTIONS FOR...
  • Page 5 Thoratec Corporation continually strives to provide the highest quality of products for mechanical circulatory support. Specifications may change without notice. Thoratec and the Thoratec logo are registered trademarks, and HeartMate III, Full MagLev, and HeartLine are trademarks of Thoratec Corporation.
  • Page 6 III L EART ENTRICULAR SSIST YSTEM NSTRUCTIONS FOR...

  • Page 7: Table Of Contents

    System Operations - - - - - - - - - - - - - - - - - 2-1 HeartMate III Left Ventricular Assist Device Overview - - - - - - - - - - - - - 2-3...
  • Page 8 Ongoing Patient Assessment and Care - - - - - - - - - - - - - - - - - - - - 6-7 Important Clinical Considerations for HeartMate III Patients- - - - - - - - - - 6-10...
  • Page 9 Contents Alarms and Troubleshooting - - - - - - - - - - - - 7-1 System Controller Alarms- - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-3 System Monitor Alarms - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-25 Handling Power Module Alarms - - - - - - - - - - - - - - - - - - - - - - - - 7-29 Mobile Power Unit Alarms - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-32...
  • Page 10 Contents viii III L EART ENTRICULAR SSIST YSTEM NSTRUCTIONS FOR...
  • Page 11 INTRODUCTION This section provides an introduction to the HeartMate III Left Ventricular Assist System. Preface - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3...

  • Page 12: Introduction

    1 Introduction HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 13: Preface

    This manual contains information needed to properly and safely operate the HeartMate III™ Left Ventricular Assist System. Users of the HeartMate III Left Ventricular Assist System should have a practical knowledge of the principles of mechanical circulatory support, and should be aware of the physiological and psychological needs of a patient undergoing mechanical ventricular support.

  • Page 14: Overview

    1 Introduction Overview The HeartMate III Left Ventricular Assist System (LVAS) includes equipment and materials that together comprise a medical device designed to provide therapeutic benefit to those affected with advanced heart failure. In service, the LVAS assumes some or all of the workload of the left ventricle, thereby restoring the patient's systemic perfusion while palliating the underlying pathology.
  • Page 15 Rotor, an Outflow Graft, and a Pump Cable (Figure 1.2). Figure 1.2 Left Ventricular Assist Device Components Pump Cable Outflow Graft with Bend Relief Inflow Cannula Rotor Magnet Pump Chamber Rotor Motor Slide Lock HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 16 If necessary, the Modular Cable is readily replaceable without surgery. When connected, the Pump Cable and Modular Cable comprise the Driveline. The Driveline contains duplicate sets of three conductors: two for power and ground, and a third for communication. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 17 HeartMate 14 Volt Lithium-Ion batteries) before use. • Do not use the HeartMate III Left Ventricular Assist Device in pregnant women or in women likely to become pregnant. A growing fetus may dislodge the Pump, which may result in device failure, catastrophic bleeding, or death. Instruct women of childbearing age to use reliable contraception if sexually active.

  • Page 18: Indications

    • Clinical procedures (including LVAS settings) should be conducted under the direction of the prescribing physician (Authorized Personnel) only. • Do not try to repair any of the HeartMate III system components. If components need service, contact the appropriate personnel.

  • Page 19: Adverse Events

    Introduction 1 Adverse Events The following adverse events may be associated with the use of the HeartMate III Left Ventricular Assist System. Adverse events are listed in anticipated decreasing order of frequency, except for death, which appears first as it is a non-reversible complication: •...

  • Page 20: Equipment Overview

    Table 1.1 HeartMate III System Components Left Ventricular Assist Device The HeartMate III Left Ventricular Assist Device (also called the Pump) is implanted in the chest below the heart. One end is inserted into the apex of the left ventricle. The other end connects to the ascending aorta.
  • Page 21 Table 1.1 HeartMate III System Components (Continued) Power Module The Power Module is for clinical use. It provides power to the HeartMate III system. The Power Module is used when the patient is indoors, stationary, or sleeping. The System Controller and the Power Module are connected through the Power Module patient cable.
  • Page 22 1 Introduction Components and Equipment for Implant The HeartMate III LVAS is designed for use both inside and outside of the hospital. Specific system components and equipment may be required for each setting. For a complete list of HeartMate III products and catalog numbers, refer to the HeartMate III™...
  • Page 23 In addition, device malfunction may necessitate emergency treatment. Therefore, patients should not be more than two hours from a healthcare facility that has trained personnel who are capable of treating a HeartMate III patient. Table 1.3 Components and Equipment for Discharged Patients...

  • Page 24: Principles Of Operation

    1 Introduction Principles of Operation The HeartMate III LVAD is a centrifugal pump that produces flow in the patient's circulatory system by angularly accelerating and expelling blood that enters it. From a clinical viewpoint, this mechanical pump works in concert with the native heart to which it is attached. It is a parallel...
  • Page 25 This will result in the collapse of the left ventricle and potential arrhythmia. The HeartMate III LVAS employs a feature called Suction Detection to recognize and avert this condition.

  • Page 26: Explanation Of Parameters

    Explanation of Parameters Speed The HeartMate III Left Ventricular Assist Device operates at a Fixed Speed determined by the physician during a speed ramp study. Refer to Optimal Fixed Speed on page 4-19. Note: The term Fixed Speed is a speed that is fixed (or set) by the clinician (that is, ...
  • Page 27 Under otherwise stable conditions, a significant drop in value may indicate a decrease in circulating blood volume. Pulsatility Index values near or above 10 may indicate potential problems. For PI values near 10 or above, contact Thoratec Corporation. Refer to page iii for Thoratec Corporation contact information.
  • Page 28 1 Introduction 1-18 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 29 Assist System. HeartMate III Left Ventricular Assist Device Overview- - - - - - - - 2-3 System Controller Overview- - - - - - - - - - - - - - - - - - - - - 2-7...

  • Page 30: System Operations

    2 System Operations HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 31: Heartmate Iii Left Ventricular Assist Device Overview

    System Operations 2 HeartMate III Left Ventricular Assist Device Overview The HeartMate III Left Ventricular Assist Device (LVAD) is a centrifugal flow rotary heart pump that is connected in parallel to the native circulation (Figure 2.1). The Inflow Cannula of the LVAD attaches to the apex of the left ventricle.
  • Page 32 2 System Operations Implant Location The HeartMate III Left Ventricular Assist Device is implanted in the chest (Figure 2.2). For more information, refer to Implant Procedures on page 5-30 . Figure 2.2 HeartMate III Implant Configuration Outflow Graft Inflow Cannula The HeartMate III LVAD is part of the Left Ventricular Assist System (Figure 2.3).
  • Page 33 Pump, or may result in death. For information about caring for the Driveline, refer to Care of the Driveline on page 8-5. Figure 2.4 Driveline Pump Cable Modular Cable (Referred to as the Driveline when both cables are connected.) HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 34 • Cessation of pumping WARNING ! If the Driveline or Driveline connector appears damaged, contact Thoratec Corporation for assistance. Refer to page iii for Thoratec Corporation contact information. X-ray images and System Controller log files are useful to assess the extent and location of the damage.

  • Page 35: System Controller Overview

    Readiness on page 2-44). System Controller Overview The HeartMate III System Controller acts as the central power and communication hub for the HeartMate III LVAS. It passes power from the Power Module, the Mobile Power Unit, Lithium-Ion Batteries, or its own integrated emergency backup supply, down to the LVAD via the Driveline.
  • Page 36 The Driveline carries power to the Pump. The Driveline also supplies information from the Pump to the System Controller. Figure 2.5 HeartMate III Left Ventricular Assist System HeartMate III LVAD Driveline System Controller HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 37 (not shown) for at least 15 minutes during a power-loss emergency. System Controller The System Controller Driveline Connector links the Modular Cable Driveline Connector portion of the Driveline to the System Controller. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 38 Run, Sleep, and Charge. System Controller Backup Battery Power This section provides a functional overview with instructions on how to replace the 11 Volt Lithium-Ion backup battery that is inside the System Controller. 2-10 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 39 • If external system components have contact with water or moisture, the Pump may stop. If a HeartMate III patient is approved for showering, he or she must always use the Shower Bag during every shower. The Shower Bag protects external system components from water or moisture.
  • Page 40 • Never use tools to tighten power cable connectors; securely hand tighten only. Using tools may damage the connectors. • Confirm that the patient’s backup System Controller has had the Backup Battery installed, and the time and date have been set. 2-12 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 41 • The System Controller uses lights, sounds, and on-screen messages to communicate with users about system operation. HeartMate III patients with sight or hearing impairment may need extra help using the System Controller. • Do not place the System Controller on bare skin for an extended time.
  • Page 42 (Figure 2.7). HeartMate III patients (and their family members and caregivers) must be thoroughly trained on how to interpret and use the user interface prior to discharge. Refer to Educating and Training Patients, Families, and Caregivers on page 6-12.
  • Page 43 The yellow light near the white power cable connector illuminates when the white power cable becomes loose or disconnects from the System Controller. This is an Advisory alarm. If the white power cable disconnects or becomes loose, promptly restore the connection. HeartMate III Left Ventricular Assist System Instructions for Use 2-15...
  • Page 44 Table 2.3 on page 2-17. Pulse Mode The presence of the black triangle indicates that the HeartMate III system is operating in Pulse Mode. Once every 2 seconds, the HeartMate III Pump will automatically modify its speed to create an artificial pulse.
  • Page 45 Pump speed, power, flow, pulsatility index, and the charge status of the System Controller’s 11 Volt Lithium-Ion backup battery. The Display button is functional only when a System Controller is in use. HeartMate III Left Ventricular Assist System Instructions for Use 2-17...
  • Page 46 Press button Pump flow in liters per minute (LPM) TWO times Press Display Press button Pulsatility Index (PI) THREE times Press Display Press button Power in watts (W) FOUR times 2-18 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 47 This is normal. Note: On-screen messages come in many different languages and can be changed from the System Monitor to support the patient’s needs. Refer to System Controller Language on page 4-42. HeartMate III Left Ventricular Assist System Instructions for Use 2-19...
  • Page 48 Safety Lock (Figure 2.9). If there is a problem with the Driveline connection, the System Controller alarms immediately. Safety Lock Figure 2.9 Moving the Safety Lock to the Unlocked Position 2-20 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 49 Figure 2.10 Unlocking the Safety Lock 3. Align the BLACK arrow/alignment mark on the Driveline Cable Connector with the WHITE arrow on the System Controller socket (Figure 2.11). Figure 2.11 Aligning the Arrows HeartMate III Left Ventricular Assist System Instructions for Use 2-21...
  • Page 50 Do not pull on or bend the Driveline that connects the Pump to the System Controller. Pulling on or bending the Driveline may damage wires inside, even if external Driveline damage is not visible. 2-22 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 51 Grasp the bend relief of the Modular Cable while removing it. Do not pull on or bend the System Controller Driveline Connector (Figure 2.14). Figure 2.14 Removing the Driveline HeartMate III Left Ventricular Assist System Instructions for Use 2-23...
  • Page 52 However, the cable with the white connector transmits signals between the System Controller and System Monitor. Refer to System Monitor Setup on page 4-5. The data link does not work without a white-to-white connection. 2-24 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 53 10–17 hours, depending on the activity level of the patient. Refer to Using HeartMate 14 Volt Lithium-Ion Batteries on page 3-46 for details. Figure 2.16 HeartMate III LVAD on Battery Power (1), Power Module Power (2), and Mobile Power Unit Power (3) Refer to page 3-46...
  • Page 54 Perform the self test at least once a day on the running System Controller. A backup System Controller in Charge Mode can be tested as well, if needed. Consider testing the System Controller at the same time daily to establish a routine. 2-26 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 55 IMPORTANT! If an alarm occurs during a self test, the self test terminates and the alarm’s on-screen indicator remains active. A System Controller self test cannot be initiated during the following alarms: any Hazard alarm, Power Cable Disconnected Advisory alarm, Low Battery Power Advisory alarm. HeartMate III Left Ventricular Assist System Instructions for Use 2-27...
  • Page 56 System Controller’s backup battery (the battery inside the System Controller). To check the status of the System Controller’s backup battery, refer to Viewing Pump and System Information on page 2-18. 2-28 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 57 1 green bar = Running on the Power Module backup battery and less than 25% of battery power remains. Mobile Power Unit Power 4 green bars = Normal Mobile Power Unit operation. HeartMate III Left Ventricular Assist System Instructions for Use 2-29...
  • Page 58 Power Module or Mobile Power Unit. Refer to Switching from Battery Power to the Power Module on page 3-61 or Connecting to the Mobile Power Unit on page 3-42. 2-30 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 59 • Communicates with the System Monitor, if connected • Performs a System Controller self test, when needed For instructions on switching from Run Mode to Sleep Mode, refer to Switching Operating Modes on page 2-34. HeartMate III Left Ventricular Assist System Instructions for Use 2-31...
  • Page 60 • Disconnected from, and not communicating with, the System Monitor For instructions on switching from Sleep Mode to Run Mode or Charge Mode, refer to Switching Operating Modes on page 2-34. 2-32 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 61 • Able to perform a System Controller self test • Disconnected from the Driveline • Displaying charging status or any active alarms • Not responding to silence alarm ( ) or display ( ) buttons HeartMate III Left Ventricular Assist System Instructions for Use 2-33...
  • Page 62 Connect the Driveline to the System Controller. Refer to Connecting the Driveline to the System Controller on page 2-21. The Pump Running symbol is illuminated green ( ) and the System Controller is in Run Mode. 2-34 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 63 When the countdown ends, the screen goes black, the Pump Running symbol is black ( and the System Controller is in Sleep Mode. If this sequence is not fully completed, the System Controller will not enter Sleep Mode. HeartMate III Left Ventricular Assist System Instructions for Use 2-35...
  • Page 64 The 11 Volt Lithium-Ion back up battery inside the System Controller will not by itself start a HeartMate III LVAD if both of the System Controller's power cables are disconnected from a power source. Always ensure that the power cables are connected to a power source to ensure that the HeartMate III Pump will restart during a System Controller exchange.
  • Page 65 6 months remain before the mandatory replacement date. OR THIS TASK YOU NEED • 1 replacement 11 Volt Lithium-Ion backup battery (obtained from Thoratec Corporation) • 1 lever to remove the screw cover of the battery compartment (included with the replacement 11 Volt Lithium-Ion backup battery) •...
  • Page 66 Gently remove the ribbon cable from the battery socket (Figure 2.27 Figure 2.27 Removing the Ribbon Cable From the Battery Socket c. Discard the used battery. For more information, refer to Product Disposal on page 8-8. 2-38 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 67 The words “Charging Complete” appear on the information display screen when the newly-installed 11 Volt Lithium-Ion backup battery has finished charging. Refer to Charge Mode on page 2-33. HeartMate III Left Ventricular Assist System Instructions for Use 2-39...
  • Page 68 1. Use the System Monitor to reset the System Controller clock. Refer to Date and Time on page 4-40. 2. Ensure that the System Monitor clock is correct before relying on it. 2-40 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 69: Backup System Controller Overview

    (backup) in case the running System Controller experiences a failure. Every HeartMate III patient receives a backup System Controller, which is identical to the running System Controller. If a failure occurs on the running System Controller, it may need to be replaced with the backup System Controller.
  • Page 70 Patient Handbook from the System Controller packaging. 2. Connect the backup System Controller to the Power Module (Figure 2.30). The System Controller will alarm. This is normal. Figure 2.30 System Monitor (left) and System Controller (right) 2-42 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 71 Note: The System Monitor will have the PUMP OFF, LOW FLOW, and Driveline Disconnected alarms active. The System Controller will show a red heart alarm ( ) and display a Connect Driveline message. This is normal. HeartMate III Left Ventricular Assist System Instructions for Use 2-43...
  • Page 72 1. Connect the backup System Controller to a power source: Power Module, Mobile Power Unit, or two HeartMate 14 Volt Lithium-Ion batteries (Figure 2.34). Figure 2.34 System Controller on Power Module Power (left) and Battery Power (right) 2-44 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 73 Put the backup System Controller into its Protection Bag (Figure 2.37). For more information, refer to Using the Protection Bag on page 6-62. Figure 2.37 Backup System Controller in Protection Bag HeartMate III Left Ventricular Assist System Instructions for Use 2-45...
  • Page 74 Disconnect the White Power connection from the current System Controller. b. Connect the White Power connection to the replacement System Controller. c. Fully secure the white nut until tight. 2-46 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 75 Connector from the socket. d. Grasp the bend relief of the Driveline while removing it. Do not pull on or bend the Controller Driveline Connector (Figure 2.39). Figure 2.39 Removing the Driveline HeartMate III Left Ventricular Assist System Instructions for Use 2-47...
  • Page 76 Fully secure the black nut until tight. 8. Put the previously running System Controller into Sleep Mode. For further instructions, refer to Turning Off the System Controller (Sleep Mode) on page 2-51. 2-48 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 77 1. If the current System Controller is alarming, press the Silence Alarm button This will silence the audio alarms for 2 minutes. 2. Locate the replacement HeartMate III System Controller and second power source. 3. Complete the following steps to power the replacement System Controller: a.
  • Page 78 Disconnect the White Power connection from the previously running System Controller. c. Put the previously running System Controller into Sleep Mode. For further instructions, refer to Turning Off the System Controller (Sleep Mode) on page 2-51. 2-50 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 79 1. If the current System Controller is alarming, press the Silence Alarm button This will silence the audio alarms for 2 minutes. 2. Gather the replacement Modular Cable and the replacement System Controller. HeartMate III Left Ventricular Assist System Instructions for Use 2-51...
  • Page 80 Note: The Safety Lock cannot move to the locked position unless the Driveline is fully and properly inserted. 5. Move the Safety Lock to the locked position, so that it covers the red button (Figure 2.47). Figure 2.47 Closing the Safety Lock 2-52 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 81 The clicking sound is normal. When the clicking sound has stopped, and the locking nut spins freely, the locking nut has been unlocked. Figure 2.48 Rotating the Locking Nut c. Pull the connectors apart (Figure 2.49) . Figure 2.49 Pulling the Connectors Apart HeartMate III Left Ventricular Assist System Instructions for Use 2-53...
  • Page 82 Figure 2.51 Rotating the Locking Nut 8. Disconnect power and the Modular Cable from the original System Controller. 9. Put the System Controller into Sleep Mode or it will continue to alarm. 2-54 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 83 Listen for a clicking sound as the locking nut is rotated. The clicking sound is normal. When the clicking sound has stopped, and the locking nut spins freely, the locking nut has been unlocked. Figure 2.53 Rotating the Locking Nut HeartMate III Left Ventricular Assist System Instructions for Use 2-55...
  • Page 84 Insert the Driveline Cable Connector into the socket and press firmly until it snaps into place. Note: The Safety Lock cannot move to the locked position unless the Driveline is fully and properly inserted. 2-56 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 85 7. Complete the following steps to connect the replacement Modular Cable to the Pump Cable (which has already been connected to the replacement System Controller): a. Align the white triangles. b. Push the connectors firmly together (Figure 2.58). Figure 2.58 Aligning the White Triangles HeartMate III Left Ventricular Assist System Instructions for Use 2-57...
  • Page 86 8. Rotate the locking nut of the Modular In-Line connector (Figure 2.59). 9. Wait for the clicking sound to stop and ensure that the yellow line is hidden by the locking nut. Figure 2.59 Rotating the Locking Nut 2-58 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 87 POWERING THE SYSTEM This section describes the various methods that can be used to power the HeartMate III Left Ventricular Assist System. Power Overview - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3...

  • Page 88: Powering The System

    3 Powering the System HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 89: Power Overview

    Unit are connected through the Mobile Power Unit patient cable. The cable transfers power from the Mobile Power Unit to the System Controller. Figure 3.1 Power Module and Mobile Power Unit HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 90 The Battery Charger is needed to charge, test, and calibrate the 14 Volt Lithium-Ion batteries. The Battery Charger can accommodate up to four batteries at one time. Figure 3.3 Battery Charger HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 91: Using The Power Module

    The following components are required for connecting the Power Module to the System Controller: • HeartMate Power Module with an installed Power Module backup battery • Power Module patient cable • Power Module power cord • HeartMate III System Controller HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 92 • Do not connect a System Controller to both the Mobile Power Unit and the Power Module at the same time, or damage to the controller and injury to the patient may occur. First connect to HeartMate 14 Volt batteries. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 93 - Connect affected device or devices to an electrical outlet different from the outlet used to power the Power Module and/or the Mobile Power Unit. • Do not use equipment or supplies other than those specified or sold by Thoratec Corporation. The use of unauthorized replacement parts may affect electromagnetic compatibility of the Power Module with other devices.
  • Page 94 • The Power Module has an AC Power Cord and Patient Cable, both of which may be a tripping hazard. Ensure that the patient, caregivers, and all other persons near the Power Module are aware of this potential hazard. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 95 • Connect the Power Module patient cable Installing the Power Module Backup Battery After receiving the Power Module, an individual trained by Thoratec Corporation personnel must open the Power Module to install its backup battery. This must be done prior to using the Power Module.
  • Page 96 9. Place the black battery connector over the metal contact end of the backup battery. The contacts should snap into place. 10. Gently pull on the connection to ensure that it is secure (Figure 3.8). Figure 3.8 Securing the Battery to the Battery Connector 3-10 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 97 Ensure that the white connectors and wires are not trapped under the metal bracket. c. Ensure that the connection is secure (Figure 3.10). Figure 3.10 Reattaching the Metal Bracket HeartMate III Left Ventricular Assist System Instructions for Use 3-11...
  • Page 98 Ensure that the screws are tight and the cover is securely closed (Figure 3.12). Figure 3.12 Tightening the Screws 16. If the Power Module was transported or shipped for service, reconnect the Power Module backup battery. 3-12 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 99 4. Insert the two ends of the clip into the holes and ensure that the clip is securely engaged (Figure 3.14). Figure 3.14 Inserting the Ends of the Clip Into the Holes HeartMate III Left Ventricular Assist System Instructions for Use 3-13...
  • Page 100 • If the green Power On light illuminates (Figure 3.15), the Power Module power cord is connected. • If the light does not illuminate, contact Thoratec Corporation for a replacement, if needed. The device may be defective. Do not use a defective device.
  • Page 101 Power Module, and then insert the patient cable into the socket (Figure 3.17). The cable clicks into place when fully engaged in the socket. Figure 3.17 Aligning the Red Dots HeartMate III Left Ventricular Assist System Instructions for Use 3-15...
  • Page 102 • Ensure that the Power Module patient cable does not become damaged. • Ensure that the Power Module patient cable is placed so that the patient does not trip or fall. 3-16 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 103 Refer to Setting Up the Power Module Before Use on page 3-9. 3. Grasp the single-connector end of the Power Module patient cable (Figure 3.20). Single Connector Figure 3.20 Single-Connector End of the Power Module Patient Cable HeartMate III Left Ventricular Assist System Instructions for Use 3-17...
  • Page 104 ) on the Power Module (Figure 3.22). The connector clicks into place when correctly inserted. Figure 3.22 Aligning the Red Dot on the Connector with the Red Dot on the Power Module 3-18 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 105 (Figure 3.23). Figure 3.23 Black and White System Controller Power Cable Connectors White Connector Black Connector 9. Place the black and white Power Module patient cable connectors within reach (Figure 3.24). HeartMate III Left Ventricular Assist System Instructions for Use 3-19...
  • Page 106 Unscrew and disconnect only the black System Controller power cable connector from the attached battery clip. h. Promptly align opposite half circles inside the black System Controller power cable connector and the black Power Module patient cable connector. 3-20 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 107 Firmly push together the two connectors. j. Securely hand tighten the connector nut. Do not use tools. Figure 3.26 System Controller Power Cables Connected to Power Module Patient Cables HeartMate III Left Ventricular Assist System Instructions for Use 3-21...
  • Page 108 - All the lights remain off - One of the lights does not come on 3. If any of the previous unexpected conditions occur, contact Thoratec Corporation. Refer to page iii for Thoratec Corporation contact information. For guidelines on responding to Power Module alarms, refer to Handling Power Module Alarms on page 7-29.
  • Page 109 The Power Module has an internal backup battery. A new Power Module backup battery provides approximately 30 minutes of backup power to the HeartMate III system if power fails or is disconnected. Over time, the internal battery may provide shorter periods of backup power.
  • Page 110 Yellow Wrench with Red Battery “Hazard” Symbol The Power Module Backup battery is not functioning properly or it is not installed. accompanied by a continuous audio tone 3-24 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 111 Figure 3.27 Green Charge Symbol (Power Module Backup Battery is Charged) Power Module Backup Battery is charging when the battery symbol is yellow. Figure 3.28 Yellow Charge Symbol (Power Module Backup Battery is Charging) HeartMate III Left Ventricular Assist System Instructions for Use 3-25...
  • Page 112 3 Powering the System 3-26 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 113 (Figure 3.30), switch to another Power Source immediately. Figure 3.30 Yellow Wrench and Red Battery Hazard Symbol (Power Module Backup Battery is Not Working) Wrench Malfunction symbol is yellow Battery Hazard symbol is red HeartMate III Left Ventricular Assist System Instructions for Use 3-27...
  • Page 114 • If the Power Module is undamaged, go to Step 5. • If the Power Module is damaged, contact Thoratec Corporation for a replacement if needed. Do not use a Power Module that appears damaged.
  • Page 115 AC power. The alarm is silenced by pressing the Silence Alarm button ) on the user panel. The alarm clears when AC power is applied to the Power Module. HeartMate III Left Ventricular Assist System Instructions for Use 3-29...
  • Page 116 The Power Module backup battery should be reconnected any time it may have been disconnected, such as for annual maintenance. OR THIS TASK YOU NEED • 1 Power Module backup battery installed but not connected • 1 crosshead (Phillips) screwdriver 3-30 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 117 • If the Power Module is undamaged, go to Step 3. • If the Power Module is damaged, contact Thoratec Corporation for a replacement if needed. Do not use a Power Module that appears damaged.
  • Page 118 Use the crosshead (Phillips) screwdriver to tighten the two ¼-turn screws. b. Ensure that the screws are tight and the cover is securely closed (Figure 3.42). Figure 3.42 Tightening the Screws 3-32 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 119 Alarm cannot be silenced if patient is connected to pump. Caring for the Power Module Refer to Cleaning and Maintenance on page 8-4 for warnings, cautions, and instructions on caring for the Power Module. HeartMate III Left Ventricular Assist System Instructions for Use 3-33...

  • Page 120: Using The Mobile Power Unit

    - Increase the distance between the Mobile Power Unit and the affected devices. - Connect the affected devices to an electrical outlet different from the outlet used to power the Mobile Power Unit. 3-34 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 121 • Avoid positioning the Mobile Power Unit where access to the power cord plug into the wall socket is limited or where disconnection of the plug from the wall socket is difficult. HeartMate III Left Ventricular Assist System Instructions for Use 3-35...
  • Page 122 Mobile Power Unit for longer than one minute. The Mobile Power Unit surface temperature can become uncomfortably warm, especially when the room temperature is above 104°F (40°C). Surface temperatures can approach 131°F (55°C). 3-36 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 123 Never change the Mobile Power Unit batteries while the Mobile Power Unit is powering the HeartMate system. Switch to another power source, and then disconnect the Mobile Power Unit power cord from the power socket prior to replacing the batteries. HeartMate III Left Ventricular Assist System Instructions for Use 3-37...
  • Page 124 • If the Mobile Power Unit is undamaged, go to Step 4. • If the Mobile Power Unit is damaged, contact Thoratec Corporation for a replacement if needed. Do not use a Mobile Power Unit that appears damaged.
  • Page 125 Ensure that the screw is tight and the cover is securely closed (Figure 3.47). Figure 3.47 Tightening the Screw 10. Dispose of, or recycle, the depleted batteries in compliance with all applicable local, state, and federal regulations. HeartMate III Left Ventricular Assist System Instructions for Use 3-39...
  • Page 126 • Do not use an outlet that is controlled by a wall switch. • Do not use an adapter; a portable, multiple outlet power strip; a ground fault interrupter (GFI); or a residual current device (RCD) outlet. 3-40 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 127 After the self test is completed, the green Power On light remains illuminated (Figure 3.49). Figure 3.49 Mobile Power Unit Ready for Use 5. If any of the behaviors in Step 4 are not observed, contact Thoratec Corporation. Refer to page iii for Thoratec Corporation contact information. IMPORTANT! The power symbol ( ) is illuminated green when the Mobile Power Unit is powered and functioning properly.
  • Page 128 ONTROLLER TO THE OBILE OWER 1. Gather equipment. 2. Confirm that the Mobile Power Unit is ready for use. Refer to Setting Up the Mobile Power Unit on page 3-37. 3-42 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 129 Mobile Power Unit patient cable connector (Figure 3.52). CAUTION ! Do not try to join together misaligned connectors. Doing so can damage them. Figure 3.52 Carefully Aligning the Connectors HeartMate III Left Ventricular Assist System Instructions for Use 3-43...
  • Page 130 Firmly push together the two connectors. i. Tighten the connector nut until secure. Hand tighten only. Do not use tools. Figure 3.55 System Controller Power Cables Connected to Mobile Power Unit Patient Cable Connectors 3-44 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 131 • Do not put the Mobile Power Unit into water or liquid. • Never clean the Mobile Power Unit while it is providing power to the Pump. Switch to another power source before cleaning the Mobile Power Unit. HeartMate III Left Ventricular Assist System Instructions for Use 3-45...

  • Page 132: Using Heartmate 14 Volt Lithium-Ion Batteries

    3 Powering the System Using HeartMate 14 Volt Lithium-Ion Batteries Using battery power for the HeartMate III LVAS allows for greater patient mobility than when the patient is connected to the Power Module or Mobile Power Unit. When using battery power, a patient can enjoy activities outdoors or away from home, such as gardening or shopping.
  • Page 133 IMPORTANT! HeartMate batteries only work in matching pairs with matching compatible clips. The HeartMate III Left Ventricular Assist System is optimized for operation with two batteries, but the system can run on only one battery for a very short period (minutes). For example, when switching from batteries to the Power Module or Mobile Power Unit (or vice versa), operation will continue on a single battery while connections are made.
  • Page 134 WARNING ! • Use only HeartMate 14 Volt Lithium-Ion batteries supplied by Thoratec Corporation with the HeartMate III Left Ventricular Assist System. Using the wrong batteries may cause the Pump to stop. • HeartMate 14 Volt Lithium-Ion batteries must be charged before use. Before removing a battery from the Battery Charger, make sure that the battery has completed its charge or calibration cycle.
  • Page 135 Batteries are charged in the Battery Charger, which can charge up to four batteries simultaneously. Charging a battery in the Battery Charger is described in more detail in Charging HeartMate Batteries on page 3-72. HeartMate III Left Ventricular Assist System Instructions for Use 3-49...
  • Page 136 5. Press and hold the battery symbol for five seconds. • If all five green power gauge bars light, the battery is between 80–100% charged. • If four or fewer bars light, the battery is not fully charged. 3-50 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 137 If all of the power gauge bars come on except for one in the middle of the sequence, the light emitting diode (LED) for the bar may be broken or burned out. If this happens, contact Thoratec Corporation. Refer to page iii for Thoratec Corporation contact information IMPORTANT! Depending on how long a battery has been in storage, its power gauge may not work until after the battery undergoes its first charge.
  • Page 138 3. Place the batteries with attached battery clips within reach. 4. Place the black and white System Controller power cable connectors within reach (Figure 3.62). Figure 3.62 Black and White System Controller Power Cable Connectors White Connector Black Connector 3-52 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 139 9. Repeat Steps 5 through 8 for the black System Controller power cable connector and the second battery clip connector. Figure 3.64 System Controller Power Cables Connected to Battery Clips HeartMate III Left Ventricular Assist System Instructions for Use 3-53...
  • Page 140 System Controller is connected to the Power Module, Mobile Power Unit, or until no further power remains. When adequate power is supplied, the Pump reverts to the previous mode and speed, and the red battery alarm clears. 3-54 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 141 IMPORTANT! Ensure that a charged battery rather than a depleted battery is used in Step c. Pick up one of the charged batteries and locate the orange arrow on the battery. HeartMate III Left Ventricular Assist System Instructions for Use 3-55...
  • Page 142 10. Return the clips and charged batteries to the holsters or carrying case. 11. Ensure that the Battery Charger is plugged in and turned on. 12. Place the depleted batteries in the pockets for recharging. 3-56 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 143 360 cycles or 36 months from the date of manufacturer, whichever comes first. After this time, battery performance cannot be guaranteed. Call Thoratec Corporation for a replacement when either of these milestones is reached. Refer to Storage and Transport on page 8-3.

  • Page 144: Switching Power Sources

    (Figure 3.66). The alarm will stop when the white System Controller power cable is connected. Figure 3.66 Connecting the System Controller Power Cable Connector to the Battery Clip Connector 3-58 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 145 The cable should be placed so that it will not cause tripping or falling. HeartMate III Left Ventricular Assist System Instructions for Use 3-59...
  • Page 146 IMPORTANT! When not in use, place the Mobile Power Unit where it will not become damaged, dirty, or wet. The cable should be placed so that it will not cause tripping or falling. 3-60 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 147 2. Perform a Power Module self test and complete one of the following steps: • If the Power Module passes the self test, go to Step 3 • If the Power Module fails the self test, contact Thoratec Corporation Refer to Performing a Power Module Self Test on page 3-22.
  • Page 148 • If both batteries are charged equally, disconnect the white connector first. 9. Unscrew the white connector from its battery clip. The Power Cable Disconnect alarm will come on. This is normal. 10. Put aside the battery clip and attached battery. 3-62 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 149 Store the battery clips in a clean, dry location until next use. 17. Place the depleted batteries into the Battery Charger for charging. Refer to Charging HeartMate Batteries on page 3-72. HeartMate III Left Ventricular Assist System Instructions for Use 3-63...
  • Page 150 10. Unscrew the black connector from its battery clip and disconnect the cable. The Power Cable Disconnect alarm will come on. This is normal. 11. Put aside the battery clip and attached battery. 3-64 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 151: Battery Charger Overview

    Battery Charger Overview The Battery Charger (Figure 3.70) is designed to charge the HeartMate 14 Volt Lithium-Ion batteries that are used to power the HeartMate III Left Ventricular Assist System during battery-powered operation. Specifically, the Battery Charger can: • Charge up to four batteries in four hours or less. Refer to Charging HeartMate Batteries on page 3-72.
  • Page 152 • Do not use the Battery Charger in the presence of a flammable anesthetic mixture with air or with oxygen, or nitrous oxide, otherwise an explosion could occur. • Be sure to use only equipment and supplies that are authorized by Thoratec Corporation. If unauthorized parts are used, potential interference may occur between the Battery Charger and other devices.
  • Page 153 Powering the System 3 CAUTION ! • Use only the Battery Charger supplied by Thoratec Corporation to charge HeartMate 14 Volt Lithium-Ion batteries. Other battery chargers may damage HeartMate batteries. • Do not attempt to test or charge non-HeartMate batteries in the Battery Charger. Doing so may damage the charger or the batteries, or injure the user.
  • Page 154 • If the Battery Charger is undamaged, go to Step 4. • If the Battery Charger is damaged, contact Thoratec Corporation for a replacement if needed. Do not use a Battery Charger that appears damaged.
  • Page 155 Note: Any time the words HeartMate CHARGER appear, the display panel slowly dims, turns off for two seconds, and then resumes full brightness. This helps to prolong the life of the display. The Battery Charger may be used during this time. HeartMate III Left Ventricular Assist System Instructions for Use 3-69...
  • Page 156 1 button to set Graphic Symbols as the preferred display mode. IMPORTANT! After releasing the 1 button, the charger conducts a self test. If the test is successful, the words HeartMate CHARGER appear. 3-70 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 157 6. When the preferred display mode appears, press and release the 1 button. IMPORTANT! After releasing the 1 button, the charger conducts a self test. If the test is successful, the words HeartMate CHARGER appear. HeartMate III Left Ventricular Assist System Instructions for Use 3-71...

  • Page 158: Charging Heartmate Batteries

    • Steady yellow light: The battery is actively charging. • Red light: The battery is defective or the charger has a problem. Figure 3.78 Charge Status Lights (Green, Yellow, Red) for Pockets 1 through 4 3-72 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 159 1. Place a battery into one of the four battery charging pockets. The battery power gauge should be at the top and facing forward (Figure 3.79). Figure 3.79 Battery Charger with Batteries Inserted in All Pockets HeartMate III Left Ventricular Assist System Instructions for Use 3-73...
  • Page 160 If the battery cannot be charged in a different pocket, the battery is defective. Do not use the defective battery. Contact Thoratec Corporation for a replacement, if needed. Refer to Using the Charger to Check Battery or Charger Status on page 7-33 for information on advisory messages and troubleshooting, including how to read alarm codes when a red light comes on.

  • Page 161: Calibrating Heartmate Batteries

    O CALIBRATE THE BATTERY WHEN PROMPTED Within ten seconds of the start of the blinking yellow light, press and release the number button for this pocket. The Battery Charger begins calibrating the battery. HeartMate III Left Ventricular Assist System Instructions for Use 3-75...
  • Page 162 Calibration can take up to 12 hours. Therefore, be sure to have enough charged batteries available before calibration begins. Under normal conditions, have four charged batteries available so that batteries can be exchanged twice during a 12-hour calibration cycle. 3-76 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 163: Checking Battery Power

    • Total number or uses/charges for this battery • How much power the battery can potentially hold if fully charged (measured in mAh) After 10 seconds the display panel returns to the default (HeartMate CHARGER) screen. HeartMate III Left Ventricular Assist System Instructions for Use 3-77...

  • Page 164: Care And Maintenance Of The Battery Charger

    Battery Charger after the patient leaves the hospital. Disposing of the Battery Charger Refer to Product Disposal on page 8-8 for information about disposing of the Battery Charger. 3-78 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 165 Using the History Screen - - - - - - - - - - - - - - - - - - - - - -4-38 Admin Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - -4-40 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 166: System Monitor

    4 System Monitor HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 167: Overview

    • Program system parameters, such as Pump speed • Assess and track alarm conditions • View and save performance data • Record data at specific intervals to download for review and analysis HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 168 • Use of equipment and supplies, other than those specified in this manual or sold by Thoratec Corporation for replacement parts, may affect the electromagnetic compatibility of the Left Ventricular Assist System with other devices. This could result in potential interference between the Left Ventricular Assist System and other devices.

  • Page 169: System Monitor Setup

    Figure 4.2 Plugging the System Monitor Data Cable into the Power Module On/Off Switch Service Only: Do Not Use Plug the other end of the System Monitor data cable into the rear of the System Monitor. Check that the connection is secure. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 170 Press the switch to the “on” position. A green light should appear on the front of the System Monitor. If the green light does not appear, contact Thoratec Corporation for assistance. Refer to page iii for Thoratec Corporation contact information.
  • Page 171 • 1 running System Controller connected to the Power Module via Power Module patient cable • 1 working, in-use Power Module • 1 System Monitor • 1 System Monitor data cable • Functioning and grounded (3-prong) AC electrical outlet • 1 AC power cord HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 172 This engages the two feet on the System Monitor into the holding grommets on the Power Module (Figure 4.6). Figure 4.6 Engaging the System Monitor Feet in the Grommets on the Power Module HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 173: System Monitor Interface

    If the icon is not flashing or has disappeared, complete the following steps: 1. Check the System Monitor-Power Module cable connections. 2. Restart the System Monitor. Refer to Setting Up the System Monitor for Use with the Power Module on page 4-5. HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 174: Clinical Screen

    Power Module, the Silence Alarm button on the System Monitor also silences audible alarms on the System Controller. Refer to Silencing Alarms via the System Monitor on page 4-29 for more information. 4-10 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 175 This condition is accompanied by a PUMP OFF Hazard alarm in a red box. A Pump Start button appears in the bottom left corner of the screen (Figure 4.10). Figure 4.10 PUMP OFF Alarm HeartMate III Left Ventricular Assist System Instructions for Use 4-11...
  • Page 176 Driveline is reconnected if one of the following occurs: • The Fixed Speed setting is at least 4,000 rpm • The System Controller’s backup battery is installed and any button is pushed on the System Controller 4-12 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 177 When the Pump is stopped using the Pump Stop button, a zero (0) appears in the Pump Speed box. If a Communication Fault exists, “- - - - “ appears in the pump speed box (Figure 4.14). Figure 4.14 Pump Stopped HeartMate III Left Ventricular Assist System Instructions for Use 4-13...
  • Page 178 The Pump power is displayed in the Pump Power box located below the Pulse Index box. Pump power is the amount of power being provided to the Pump motor. Pump power ranges between 0.0 to 25.5 watts (Figure 4.17). Figure 4.17 Pump Power 4-14 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 179 • LOW VOLTAGE: This text banner appears. • NO EXTERNAL POWER: This text banner appears. Note: A Controller Hardware Fault will not display on the System Monitor. The Monitor will remain on the startup screen. HeartMate III Left Ventricular Assist System Instructions for Use 4-15...
  • Page 180 • All other Advisory alarms with audible tones can be silenced for four hours. The exceptions are Communication Fault, Driveline Power Fault, Driveline Communication Fault, which can be silenced indefinitely or for 24 hours. 4-16 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 181: Settings Screen

    • Status of important parameters such as the set Fixed Speed and Low Speed Limit • Alarm Silence Status: on, off, or extended Figure 4.19 Settings Screen Showing System Status 1 and 2 HeartMate III Left Ventricular Assist System Instructions for Use 4-17...
  • Page 182 Low Speed Limit, or the System Controller is unable to maintain the speed at or above the Low Speed Limit. This Low Speed advisory alarm notification is always provided on the System Monitor (Figure 4.20). Figure 4.20 Settings Screen with Fixed Speed Adjust Box 4-18 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 183 4. Record the patient's current heart rate, blood pressure, and Pump speed. 5. Using echocardiography, record the patient’s left ventricular diameter, septum position, and frequency of aortic valve opening. HeartMate III Left Ventricular Assist System Instructions for Use 4-19...
  • Page 184 System Controller provides 15 minutes of full power before entering Power Saver mode. Note that alarms cannot be silenced while the System Controller is in Power Saver mode. 4-20 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 185 Pump speed. These types of PI events are more likely to be triggered in cases of low pulsatility. HeartMate III Left Ventricular Assist System Instructions for Use 4-21...
  • Page 186 Initially, the WARNING: Low Speed advisory alarm, and then the LOW FLOW Hazard alarm appear. Both alarms appear without an audible alarm (Figure 4.23). Figure 4.23 Pump Stop Countdown in Process 4-22 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 187 5. Press Yes to restart the pump at the previously set mode and speed. IMPORTANT! Auscultation over the pump implant location is recommended to verify that the pump is running. HeartMate III Left Ventricular Assist System Instructions for Use 4-23...
  • Page 188 Periodic assessment of the patient’s hematocrit should be conducted and adjustments made to the stored value in the System Controller as required (that is, during post-operative recovery, pre-hospital discharge, at hospital discharge, periodic clinic visits). Figure 4.26 Settings Screen 4-24 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 189: Alarms Screen

    Alarms screen. There are no adjustable alarm presets, and alarm conditions are not user adjustable in the HeartMate III LVAS. There are no alarm delays in the HeartMate III LVAS. Multiple alarms may be highlighted at the same time.
  • Page 190 14 Volt Lithium-Ion batteries (during battery-powered operation), or the System Controller is receiving inadequate power from the Power Module or Mobile Power Unit. Immediately connect the System Controller to a functioning power source. 4-26 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 191 Modular Cable of the Driveline may resolve the problem. Refer to Replacing the Modular Cable on page 2-51. If exchanging the Modular Cable does not correct the alarm, contact Thoratec Corporation to determine the best next steps. Refer to page iii for Thoratec Corporation contact information.
  • Page 192 • Driveline Power Fault: Indicates that one of the redundant power handling wires inside the Driveline may be damaged or broken. Contact Thoratec Corporation to determine best next steps. Use the System Monitor to silence the alarm while awaiting resolution, if needed.
  • Page 193 The Alarm Silence indicator in the parameters box will display Extended. IMPORTANT! If the Silence Alarm button on the System Controller is pressed, the System Monitor’s extended silence is canceled. HeartMate III Left Ventricular Assist System Instructions for Use 4-29...
  • Page 194 The visual alarm on the System Monitor is maintained. To silence the alarm, access the Alarm screen of the System Monitor and press the Silence Driveline Power Alarm button (Figure 4.30). Figure 4.30 Driveline Fault Alarm Buttons 4-30 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 195 The visual alarm on the System Monitor is maintained. To silence the alarm, access the Alarm screen of the System Monitor and press the Silence Driveline Comm Fault Alarm button (Figure 4.31). Figure 4.31 Driveline Communication Fault Buttons HeartMate III Left Ventricular Assist System Instructions for Use 4-31...

  • Page 196: Save Data Screen

    • Periodic and Event History Figure 4.32 Save Data Screen IMPORTANT! Alarm messages do not appear on the Save Data, History, or Admin Screens. Go to the Alarms screen to view alarm messages. 4-32 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 197 System Controller. Information about events can be viewed on the System Monitor screen. The Controller Event Recorder is always on. It automatically records any alarm. HeartMate III Left Ventricular Assist System Instructions for Use 4-33...
  • Page 198 3. Increase or decrease the Record Interval to the preferred setting. This also enables the data collection. 4. Press Save Changes to confirm the interval. Figure 4.34 System Controller Periodic Log 4-34 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 199 Refer to Date and Time on page 4-40 for specific instructions on setting the clock. 4. Use the on-screen keypad to enter a patient identification description (up to 15 characters). 5. Press Continue to record the event history to the data card. HeartMate III Left Ventricular Assist System Instructions for Use 4-35...
  • Page 200 7. Remove the data card from the System Monitor. Contact Thoratec Corporation regarding questions about accessing or understanding event history data. Refer to page iii for Thoratec Corporation contact information. 4-36 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 201 System Monitor 4 Sending Information to Thoratec Corporation To send data such as log files to Thoratec Corporation for diagnostic purposes, the card reader ® must work with CompactFlash media. A card reader is necessary to transmit data from CompactFlash media to a computer so that the data can then be sent via e-mail. A card reader is available through Thoratec Corporation (Figure 4.38).

  • Page 202: Using The History Screen

    • Command Button: A Save to Card button appears at the bottom left corner of the screen. Refer to Data Card on page 4-33 for specific instructions on saving events to a data card. 4-38 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 203 These events may or may not include alarms. Data without asterisks indicate that those data were recorded at undesignated times due to an event. Pulsatility (PI) Event: indicates a PI event occurred. HeartMate III Left Ventricular Assist System Instructions for Use 4-39...

  • Page 204: Admin Screen

    Logs and event history always reflect the date and time on the System Controller's clock. To synchronize the date and time on the System Controller with the System Monitor, press Synch. 4-40 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 205 5. Press Yes if the date and time are correct. Figure 4.45 Confirm Date and Time IMPORTANT! The System Monitor does not automatically update for Daylight Savings Time. Daylight Savings Time changes must be entered manually. HeartMate III Left Ventricular Assist System Instructions for Use 4-41...
  • Page 206 2. Use the buttons at the bottom of the screen to view and select the preferred language. Available languages are listed in alphabetic order. The first language listed is the one currently in use on the System Controller (Figure 4.46). Figure 4.46 Select Language Screen 4-42 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 207 Items in mixed case are variable and change with backup battery use (Figure 4.47). Figure 4.47 System Controller Information Screen Technical Parameters This screen provides access to the parameters. Access to this screen is restricted to Thoratec Corporation personnel only. HeartMate III Left Ventricular Assist System Instructions for Use 4-43...
  • Page 208 4 System Monitor 4-44 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 209 Postimplant Procedures - - - - - - - - - - - - - - - - - - - - - - -5-51 Device Explant - - - - - - - - - - - - - - - - - - - - - - - - - - -5-55 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 210: Surgical Procedures

    5 Surgical Procedures HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 211: Surgical Considerations

    (Power Module, Mobile Power Unit, Battery Charger, and batteries) before use. • Certain parts of the HeartMate III Left Ventricular Assist System are not compatible with other HeartMate systems (such as the HeartMate II Left Ventricular Assist System). Only use HeartMate III parts with the HeartMate III System.
  • Page 212 • Ensure that apposition between the myocardial tissue and the cuff felt is continuous and sufficiently forceful to prevent bleeding. • If the Slide Lock mechanism on the HeartMate III LVAD fails to engage, do not make further attempts to engage until retracting the Slide Lock mechanism. Evidence of the Slide Lock mechanism failing to engage will be either visual evidence of the yellow “wings,”...

  • Page 213: Equipment And Supplies Required For Implant

    Surgical Procedures 5 Equipment and Supplies Required for Implant The HeartMate III Left Ventricular Assist System Implant Kit is supplied sterile and for single use only. Store components in a cool, dry place away from strong electromagnetic fields. For more information about storing components, refer to Equipment Storage and Care on page 8-1.
  • Page 214 • Backup Battery (packaged with the System Controller) • HeartMate III Tunneler and Handle • User Document: HeartMate III™ Left Ventricular Assist System Instructions for Use Hospital-Supplied Equipment This section describes the components supplied by the hospital. Each site needs to provide a System Monitor and Power Module (Figure 5.1).

  • Page 215: Preimplant Procedures

    Outflow Graft may disrupt or destroy the sealant, and lead to profuse bleeding after implantation. • Do not implant the HeartMate III Left Ventricular Assist Device if it has been dropped. • Never operate the HeartMate III Left Ventricular Assist Device in air, as this will immediately damage the device.
  • Page 216 This section describes how to initialize the Power Module and System Monitor. During implant, the HeartMate III LVAD must be operated with the Power Module and System Monitor (Figure 5.1). Note: If an older model of the System Monitor cable is used, use an adapter to connect the System Monitor to the Power Module.
  • Page 217 • If the logo screen does not appear, perform troubleshooting. Refer to Setting Up the System Monitor for Use with the Power Module on page 4-5. Figure 5.2 HeartMate Logo Screen HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 218: Unpacking The Implant Kit

    5 Surgical Procedures Unpacking the Implant Kit Thoratec Corporation ships the implant kit in a large cardboard box. 1. Remove all the trays from the cardboard box. 2. Place the System Controller backup battery aside for later use. IMPORTANT! Note that the backup battery is not sterile.

  • Page 219: Unpacking The Pump And Accessories Tray

    2. Remove the Pump and accessories trays from the main packaging tray (Figure 5.4). Figure 5.4 Pump and Accessories Trays 3. Peel back and remove the lid from the Pump Tray (Figure 5.5). Figure 5.5 Pump and Accessories Tray HeartMate III Left Ventricular Assist System Instructions for Use 5-11...
  • Page 220 8. Maintaining strict sterile technique, screw the sterile Tunneling Adapter on to the Pump Cable connector. 9. Ensure that the adapter is completely screwed down tight by covering the yellow line on the in-line connector. 5-12 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 221 Figure 5.7 Accessories: Apical Sewing Cuff, Thread Protectors, Coring Knife, and Skin Punch 11. Remove all the sterile components from the Accessories Tray and place them in the sterile work area. HeartMate III Left Ventricular Assist System Instructions for Use 5-13...

  • Page 222: Unpacking The Sealed Outflow Graft

    2. Remove the outer tray from the foil pouch (Figure 5.8). The outer tray is not sterile. Only the innermost tray may be introduced into the sterile field. Figure 5.8 HeartMate III Sealed Graft With Bend Relief 3. Peel back the lid to expose the sealed Outflow Graft.

  • Page 223: Preparing The Sealed Outflow Graft

    Figure 5.9 HeartMate III Sealed Outflow Graft Sealed Graft Screw Ring Prepare a HeartMate III sealed Outflow Graft for implantation, in a sterile environment, using a strict sterile technique. Complete the following procedure: 1. Remove the Bend Relief from the graft.

  • Page 224: Unpacking The System Controller

    Figure 5.11 System Controller 4. Remove the System Controller from the tray and move it to the sterile working area. 5. Secure the power cables so that they stay within the sterile field. 5-16 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 225: Unpacking The Modular Cable

    Figure 5.13 Outer and Inner Plastic Trays with Lids Peeled Back from Modular Cable 3. Remove the sterile Modular Cable and the Modular Cable Cap from the packaging. The Modular Cable Cap protects the connector from fluids and debris. HeartMate III Left Ventricular Assist System Instructions for Use 5-17...
  • Page 226 Wrap a clean and dry sterile towel around the Modular Cable Cap and Modular In-Line Connector. Move the Modular Cable to the sterile work area (Figure 5.14). Figure 5.14 Covering the Modular In-Line Connector with the Modular Cable Cap 5-18 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 227: Connecting And Initializing The Sterile System Controller

    Power Module patient cable, white-to-white and black-to-black. Both the Power Module and System Controller will indicate a hazard alarm condition signifying that the System Controller is powered, but not connected to the HeartMate III LVAD.
  • Page 228 Pulse Mode with dashes “---” in the Setpoint display (Figure 5.15). Figure 5.15 System Monitor Clinical Screen When Initially Connected to the System Controller Active Hazard Alarms Fixed Speed Setpoint 5-20 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 229 System Controller is connected to the LVAD. The Pump Off alarm message will remain active until the LVAD is turned on via the System Monitor pump start command. HeartMate III Left Ventricular Assist System Instructions for Use 5-21...

  • Page 230: Preparing, Operating, And Priming The Pump

    WARNING ! • Only sterile personnel should perform the following procedures. • Never operate the HeartMate III Left Ventricular Assist Device in air, as this will immediately damage the device. Liquid must always be present in the Pump for proper function.
  • Page 231 Visually confirm that the inside of the Modular Cable connector is dry. If the Modular Cable in-line connector is not dry, discard the Modular Cable and obtain a new one. HeartMate III Left Ventricular Assist System Instructions for Use 5-23...
  • Page 232 • Only personnel using sterile technique should touch sterile components such as the Pump, System Controller, and Modular Cable. Note: The sterile personnel may instruct the non-sterile personnel to initiate commands on the System Monitor. 5-24 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 233 During the next five minutes, ensure that the Pump continues to operate. WARNING ! If the Pump fails to operate properly, do not implant it. Utilize the back-up HeartMate III LVAD in its place. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 234 14. Leave the Pump in the sterile graduated pitcher of sterile saline. 15. Maintaining strict sterile technique and using dried gloved hands, attach the sterile Tunneling Adapter to the Pump Cable connector. 5-26 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 235 21. Leave the System Controller power cables connected to the Power Module. If the power cables are disconnected, the extended alarm silence will be reset. HeartMate III Left Ventricular Assist System Instructions for Use 5-27...
  • Page 236 30. Place antibiotic-soaked laps over the Pump and velour portion of the Pump Cable, and then set aside the Pump in a sterile, safe place. 31. Secure the entire length of the Pump Cable so it does not fall out of the sterile field. 5-28 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 237: Preparing The Coring Knife

    Figure 5.25 Assembling the Coring Knife Handle 3. Insert the handle so it creates a "T" handle (Figure 5.26). This enables handling of the tool during surgical procedure. Figure 5.26 Assembled Coring Knife HeartMate III Left Ventricular Assist System Instructions for Use 5-29...

  • Page 238: Implant Procedures

    Outflow Graft attached to the ascending aorta and the Pump Cable exits the right upper quadrant of the abdomen and connects to the external equipment. Figure 5.27 HeartMate III Implantation Configuration 5-30 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 239 System Controller are required at the time of implant to power the LVAS when transporting the patient out of the O.R. • Do not use the HeartMate III Left Ventricular Assist Device in pregnant women or in women likely to become pregnant. A growing fetus may dislodge the Pump, which may result in device failure, catastrophic bleeding, or death.
  • Page 240 • Patients with mitral or aortic mechanical valves may be at added risk of accumulating thrombi on the valve when supported with left ventricular assist devices. • A sealed HeartMate III Outflow Graft must be used. A sealed HeartMate II Outflow Graft is not appropriate for use with the HeartMate III LVAS.
  • Page 241 • The bend relief is in place over the sealed graft and disengaged from the metal fitting. • The Left Ventricular Assist Device is completely primed with Sterile Saline for Injection. • The HeartMate III pump has been run for at least 5 minutes successfully in Sterile Saline for Injection.
  • Page 242 Tunneling Lance and Handle have been cleaned, inspected, and sterilized in accordance with the provided instructions and hospital policy. 1. Place the HeartMate III LVAD in the chest to approximate where the device will be positioned to visualize the path of the Pump Cable.
  • Page 243 Surgical Procedures 5 14. Consideration should also be given to the potential for sharp bends and kinks occurring postimplant with ventricular remodeling during HeartMate III Left Ventricular Assist System support. 15. Ensure that the Pump Cable is clear of anatomical or surgical elements that could cause wear.
  • Page 244 2. Choose the coring location slightly anterior to the apex, a few centimeters lateral to the left anterior descending coronary artery. 3. Ensure that the metal skeletal structure is facing away from the myocardium, and that the black markings are visible on the Apical Cuff. 5-36 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 245 Figure 5.28 Placement of Sutures Between the Metal Ring and the Circumferential Line on the Apical Cuff 5. Ensure that the sutures do not approximate or traverse any of the metallic surfaces. HeartMate III Left Ventricular Assist System Instructions for Use 5-37...
  • Page 246 Ensure that the suture knots are not interfering with the connection. If a sealing agent is used on or near the Apical Cuff, ensure that it does not interfere with the Slide Lock mechanism. 5-38 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 247 Figure 5.30 Coring Ventricular Apex 10. Complete the following steps: Remove the core and inspect the ventricular chamber for mural thrombi and crossing trabeculae. Address one or both, as needed. HeartMate III Left Ventricular Assist System Instructions for Use 5-39...
  • Page 248 1. Remove glove tip. 2. Retract the Slide Lock so that it is in the fully opened position as far as it will go (Figure 5.31). Figure 5.31 Retracting the Slide Lock 5-40 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 249 Push the Slide Lock on the Pump inward to engage and lock the Pump into position (Figure 5.33). Figure 5.33 Pushing the Slide Lock Inward to Engage and Lock the Pump Into Position HeartMate III Left Ventricular Assist System Instructions for Use 5-41...
  • Page 250 7. Gently pull on the Slide Lock to ensure that it is properly engaged. 8. If the Slide Lock mechanism on the HeartMate III LVAD fails to engage, do not make further attempts to engage until retracting the Slide Lock mechanism.
  • Page 251 4. Verify that the graft is not twisted or kinked as follows: • Check the position of the black line on the graft above and below the Bend Relief. • Ensure that the line is straight. HeartMate III Left Ventricular Assist System Instructions for Use 5-43...
  • Page 252 5. Reduce cardiopulmonary bypass flow to allow filling of the left ventricle and Left Ventricular Assist Device by diverting at least two liters per minute (lpm) of blood to the ventricle. 6. Connect the Pump Cable connector to the Modular Cable to initiate HeartMate III Pump operation by completing the following steps: Dry the Pump Cable connector and Tunneling Adapter with a clean and dry sterile towel.
  • Page 253 Press the Pump Start button. The Pump may take up to 10 seconds to start. The PUMP OFF message should disappear and the WARNING: Low Speed Advisory message should appear. HeartMate III Left Ventricular Assist System Instructions for Use 5-45...
  • Page 254 • The estimated pump flow is outside the expected operational range (less than 4000 rpm AND a Pulse Index greater than 9.0). Figure 5.36 Clinical Screen During Initial Pump Startup (typical) Figure 5.37 Settings Screen During Initial Pump Startup (typical) 5-46 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 255 Do not rotate/twist the sealed graft. Check the alignment of the black line on the graft to verify that the sealed graft is not twisted or kinked. Note: The HeartMate III LVAD may create electromagnetic interference with ECG monitoring. Adjustment of ECG lead placement may reduce the level of interference.
  • Page 256 The speed will only change after the Enter button is pressed. The actual flow increase for a given change in speed is dependent on many factors and could vary significantly. 5-48 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 257 Driveline and a power source if one of the following is true: • The Fixed Speed is set to 4,000 rpm or higher. • The System Controller’s backup battery is installed and any button is pushed on the System Controller. HeartMate III Left Ventricular Assist System Instructions for Use 5-49...
  • Page 258 Obtain hemostasis and close all wounds in the standard fashion. Prior to leaving the operating room, immobilize the Driveline and System Controller. CAUTION ! The use of electrocautery devices may temporarily interfere with HeartMate III Pump operation. When electrocautery has been discontinued, there is no interference with Pump operation.

  • Page 259: Postimplant Procedures

    1. Cancel the extended alarm silence by pressing the Silence Alarm button on the System Controller’s user interface panel. 2. Switch the HeartMate III Left Ventricular Assist System from the Power Module to battery power. Refer to Switching from the Power Module to Battery-Powered Operation on page 3-58.
  • Page 260 • Dispose of or recycle an expired battery in accordance with local, state, and federal regulations. Malfunction of the 11 Volt Lithium-Ion backup battery may cause the controller to become excessively hot. If this occurs, switch to the backup System Controller. 5-52 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 261 Figure 5.41 Using the Lever to Lift up the Cover 2. Use the screwdriver to loosen the four captive screws on the battery compartment cover (Figure 5.42). Figure 5.42 Loosening the Screws 3. Lift off the battery compartment cover. HeartMate III Left Ventricular Assist System Instructions for Use 5-53...
  • Page 262 System Monitor to reset the System Controller clock. Refer to Date and Time on page 4-40. Be sure the System Monitor clock is correct before relying on it. 5-54 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 263: Device Explant

    Surgical Procedures 5 Device Tracking and Reporting Requirements The HeartMate III Left Ventricular Assist System is considered a life-sustaining medical device and must be tracked per foreign regulatory agency regulations. Compliance is mandatory. Accordingly, all device-tracking paperwork shipped with the device must be completed and promptly returned to Thoratec Corporation.
  • Page 264 11. Close the site in standard fashion. 12. Remove the sealed Outflow Graft remnant from the aorta and repair the anastomotic site. 13. If returning the device to Thoratec Corporation for disposal, use the HeartMate Explant Kit. 5-56 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 265 Ongoing Patient Assessment and Care - - - - - - - - - - - - - - - 6-7 Important Clinical Considerations for HeartMate III Patients - - - -6-10 Educating and Training Patients, Families, and Caregivers - - - - -6-12...

  • Page 266: Patient Care And Management

    6 Patient Care and Management HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 267: Postoperative Patient Care

    Patient Care and Management 6 Postoperative Patient Care Proper care of a patient who is supported by the HeartMate III Left Ventricular Assist System requires a thorough understanding of the system operation and patient condition. WARNING ! • There is risk of embolism at Pump explant or reoperation if manipulation of the Pump or conduit is performed prior to the initiation of cardiopulmonary bypass and stoppage of Left Ventricular Assist Device pumping.
  • Page 268 • Do not use the HeartMate III Left Ventricular Assist Device in pregnant women or in women likely to become pregnant. A growing fetus may dislodge the Pump, which may result in device failure, catastrophic bleeding, or death.
  • Page 269 Left Ventricular Assist System due to reduced filling of the Pump. • Do not try to fix any of the equipment yourself. If HeartMate III equipment needs service, contact the appropriate personnel trained by Thoratec Corporation.
  • Page 270 • Carefully wash hands every time before and after changing the Driveline exit site bandages, or whenever the Driveline exit site is touched or handled. • Do not place objects other than the HeartMate III system components into the wearable accessories. Placing objects other than HeartMate III components into a wearable accessory may damage the wearable accessory.

  • Page 271: Ongoing Patient Assessment And Care

    Patient Care and Management 6 Ongoing Patient Assessment and Care Patient Assessment HeartMate III patient assessment may include, but is not limited to, assessment of the following: • Pump function • Pump speed, flow, motor power, pulse index (PI), mode of operation •...
  • Page 272 Blood Pressure Management Post-implantation hypertension may be treated at the discretion of the attending physician. Any therapy that consistently maintains mean arterial blood pressure less than 90 mm Hg should be considered adequate. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 273 Consider increasing anticoagulation to upper limits of normal. 2. Risk of bleeding: Consider initiating antiplatelet medications and decreasing heparin/warfarin (INR 1.7–2.3). Antiplatelet effect should be confirmed with lab studies (for example, TEG). HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 274: Important Clinical Considerations For Heartmate Iii Patients

    Pump implantation (prior to mediastinal healing). Defibrillation WARNING ! • If open chest defibrillation is required, be sure to disconnect the HeartMate III Left Ventricular Assist System prior to delivering the shock. • If external defibrillation becomes necessary, do not disconnect the System Controller from the Driveline prior to delivering the shock.
  • Page 275 • Prior to implanting an implantable cardiac defibrillator (ICD) or implantable pacemaker (IPM) in a HeartMate III patient, the ICD or IPM device to be implanted should be placed in close proximity to the Pump (approximately 10 cm) and the telemetry verified. If a patient...

  • Page 276: Educating And Training Patients, Families, And Caregivers

    • Using, charging, testing, and calibrating HeartMate 14 Volt Lithium-Ion batteries • Battery Charger • Mobile Power Unit 4. Using the wear and carry accessories to hold and carry system components. 6-12 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 277 • Emergency telephone contacts • Replacing the running System Controller with the backup System Controller 7. Driveline Exit Site Management 8. Showering 9. Preparing for sleep 10. Travel 11. Warnings and cautions HeartMate III Left Ventricular Assist System Instructions for Use 6-13...

  • Page 278: Ongoing System Assessment And Care

    • Transient alarms due to short or open circuits, often associated with movement of the patient or the lead. • Fluid leakage from the external portion of the Pump Cable. • Pump stopping. 6-14 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 279 Cable. CAUTION ! • The HeartMate III Left Ventricular Assist System uses lights and sounds to indicate how it is working. If the patient has trouble hearing or seeing, he or she may need extra help to hear or see the lights and sounds.
  • Page 280 • When carrying the System Controller in a zippered carrying case, do not snag the power cables in the carrying case zipper. • Do not let the power cables become twisted. Figure 6.1 Do Not Bend System Controller Power Cables 6-16 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 281: Showering

    Warnings and Cautions WARNING ! The HeartMate III System Components must be kept dry. Never expose the System Controller, batteries, Power Module, or Mobile Power Unit to water. If these system components get wet, the Pump may stop. Never take tub baths or go swimming while implanted with the Pump.
  • Page 282 Check all edges and ensure that the sheet completely adheres to the skin with no gaps. Figure 6.3 Tape Used to Seal Around the Edges of the Multi-Purpose Sealing Wrap Sheet 6-18 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 283 As the wrap is removed, be careful to not disturb the driveline management system. Figure 6.4 Multi-Purpose Sealing Wrap and Tape Gently Peel Away From Skin 3. If the driveline management system gets wet, change it as instructed in the previous sections. HeartMate III Left Ventricular Assist System Instructions for Use 6-19...
  • Page 284 6 Patient Care and Management Using the Shower Bag Although the external components of the HeartMate III Left Ventricular Assist System are moisture-resistant (including a properly connected Driveline Modular In-Line connection), they are not waterproof. Take care to protect external system components from water or moisture when the patient is outside in heavy rain or snow, and always for every shower.
  • Page 285 Figure 6.6 shows the Shower Bag in use. IMPORTANT! Figure 6.6 shows an uncovered Driveline exit site. Keep the exit site as clean and dry as possible. Figure 6.6 Using the Shower Bag HeartMate III Left Ventricular Assist System Instructions for Use 6-21...
  • Page 286 6 Patient Care and Management WARNING ! • Do not allow patients to shower without a doctor’s permission. HeartMate III patients may be allowed to shower, but only after sufficient postoperative healing, and only with a doctor’s permission. • Do not allow patients to swim or take tub baths while implanted with the Pump. Patient immersion in water will cause the Pump to stop.
  • Page 287 3. Adjust the shoulder strap so that the Shower Bag fits the patient without pulling on or moving the Driveline. 4. Tighten or lengthen the straps until they are secure, but still comfortable. HeartMate III Left Ventricular Assist System Instructions for Use 6-23...
  • Page 288 3. Unclip the lid of the Shower Bag by squeezing the clip prongs together, and then pulling the slide out of the buckle (Figure 6.10). Figure 6.10 Squeezing the Clip Prongs Together 6-24 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 289 5. Unzip and open the cover of the water-resistant enclosure. 6. Place the batteries, battery clips, and attached power cables into the Shower Bag (Figure 6.12). Figure 6.12 Batteries and Battery Clips in the Shower Bag HeartMate III Left Ventricular Assist System Instructions for Use 6-25...
  • Page 290 10. Ensure that the System Controller power cables are inside the Shower Bag, and that the Driveline exits through the protective red tabs (Figure 6.14). Figure 6.14 Closed and Zipped Cover 6-26 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 291 It also keeps the Shower Bag from swinging away from the patient’s body if he or she bends over. 15. Adjust the shoulder strap so that the Shower Bag does not pull on the Driveline exit site. HeartMate III Left Ventricular Assist System Instructions for Use 6-27...
  • Page 292 Always hang the Shower Bag and allow it to air dry. Ensure that the Shower Bag is completely dry before using it for another shower. Refer to Cleaning and Maintenance on page 8-4 for complete instructions on caring for all wearable accessories, including the Shower Bag. 6-28 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 293: Preparing For Sleep

    Refer to Equipment Storage and Care on page 8-1. Preparing for Sleep HeartMate III patients must be attached to the Power Module or the Mobile Power Unit during sleep or any time when sleep is likely. During sleep, the System Controller and Driveline must be immobilized to reduce movement or pulling on the Driveline exit site.

  • Page 294: Wearing And Carrying System Components

    Mobile Power Unit, or during battery-powered operation. Consolidated Bag Use the Consolidated Bag to carry the System Controller, and two HeartMate 14 Volt Lithium-Ion batteries and attached battery clips in a single bag during battery-powered operation. 6-30 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 295 The Travel Bag stores the Protection Bag (with a backup System Controller) and a spare set of two HeartMate 14 Volt Lithium-Ion batteries and attached battery clips. HeartMate III Left Ventricular Assist System Instructions for Use 6-31...
  • Page 296 The System Controller Neck Strap (Figure 6.17) can be worn around the neck or across the body. It attaches to the System Controller with two small straps. Figure 6.17 System Controller Neck Strap 6-32 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 297 • 1 System Controller Neck Strap O ATTACH AND WEAR THE YSTEM ONTROLLER TRAP 1. Gather the equipment and place within reach. 2. Place the System Controller on a flat, stable surface. HeartMate III Left Ventricular Assist System Instructions for Use 6-33...
  • Page 298 Neck Strap. 5. Slide the rubber strap on the Neck Strap through an attachment point on the System Controller (Figure 6.21). Figure 6.21 Rubber Strap Through the Attachment Point 6-34 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 299 1. Carefully remove the Neck Strap and the System Controller from around the patient’s neck. 2. Place the Neck Strap and the System Controller on a stable surface. 3. Unbuckle the two straps. 4. Remove the Neck Strap from the System Controller. HeartMate III Left Ventricular Assist System Instructions for Use 6-35...
  • Page 300 Figure 6.24 Wearing the Belt Attachment OR THIS TASK YOU NEED • 1 running System Controller • 1 Belt Attachment • 1 personal belt (up to 2” wide) or 1 provided nylon clip belt 6-36 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 301 4. Unclip the two-banded strap on the Belt Attachment. Slide the System Controller, the end without the cable first, into the Belt Attachment with the display screen facing out (Figure 6.27). Figure 6.27 System Controller in Belt Attachment HeartMate III Left Ventricular Assist System Instructions for Use 6-37...
  • Page 302 Figure 6.29 Clip the Strap Into Place 8. Fasten the belt and Belt Attachment around the patient’s waist. 9. Adjust and tighten the belt as necessary, until it is secure but still comfortable. 6-38 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 303 5. Complete the following steps to remove the System Controller from the Belt Attachment: Unclip the two-banded strap from the Belt Attachment. Slide the System Controller out of the Belt Attachment and place both items on a stable surface. HeartMate III Left Ventricular Assist System Instructions for Use 6-39...
  • Page 304 Strap Red Protective Tabs Figure 6.30 Consolidated Bag The Consolidated Bag can be worn across the body using a shoulder strap and supported at the waist using a waist strap. 6-40 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 305 The Consolidated Bag is available in one color (black) and two configurations, depending upon the placement of the patient’s Driveline exit site. One configuration for wearing on the right side and one configuration for wearing on the left side. HeartMate III Left Ventricular Assist System Instructions for Use 6-41...
  • Page 306 5. Adjust the shoulder strap and belt so the bag fits the patient properly. 6. Tighten or lengthen the strap and belt until they are secure but still comfortable. 6-42 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 307 Figure 6.34 System Controller in the Holder in the Consolidated Bag 5. Stretch the two-banded strap over the System Controller, and between the white System Controller power cable and the Driveline connector. HeartMate III Left Ventricular Assist System Instructions for Use 6-43...
  • Page 308 Figure 6.35 Strap Over the System Controller and Between the Cables Place one battery into the Consolidated Bag, with the battery clip and cable facing out (Figure 6.36). Figure 6.36 Battery in the Bag 6-44 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 309 Figure 6.37 Arranging the Cables Around the Edge of the Bag Place the second battery into the Consolidated Bag, with the battery clip and cable facing out (Figure 6.38). Figure 6.38 Placing the Second Battery in the Bag HeartMate III Left Ventricular Assist System Instructions for Use 6-45...
  • Page 310 • The System Controller power cables are inside the Consolidated Bag. • The Driveline exits the Consolidated Bag between the protective red tabs (Figure 6.40). Figure 6.40 Closing the Bag: Driveline Exits Between the Red Tabs 6-46 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 311 • Transfer from battery power to the Power Module or Mobile Power Unit. Refer to Switching from Battery Power to the Power Module on page 3-61. • Remove components from the Consolidated Bag. HeartMate III Left Ventricular Assist System Instructions for Use 6-47...
  • Page 312 The Belt Attachment is designed to conceal and carry the System Controller. The Battery Holster is available in one size and is adjustable to accommodate most HeartMate III patients. Figure 6.42 Battery Holster...
  • Page 313 • 2 fully-charged HeartMate 14 Volt Lithium-Ion batteries • 2 14 Volt battery clips • 1 battery holster • 1 belt attachment • 1 clip-style belt or the patient’s own belt HeartMate III Left Ventricular Assist System Instructions for Use 6-49...
  • Page 314 3. Complete the following steps to insert the batteries and attached battery clips into each holster: Open each hook-and-loop fastener flap on the Battery Holster (Figure 6.44). Figure 6.44 Hook-and-Loop Fastener Flap 6-50 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 315 The clip clicks into place when securely fastened. 10. Transfer from the Power Module or Mobile Power Unit to battery power. Refer to Switching from the Power Module to Battery-Powered Operation on page 3-58. HeartMate III Left Ventricular Assist System Instructions for Use 6-51...
  • Page 316 8. Close the Battery Holster flap. 9. Repeat Step 2 through Step 8 for the second depleted battery. 10. Recharge the depleted batteries in the Battery Charger. Refer to Charging HeartMate Batteries on page 3-72. 6-52 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 317 9. Recharge the low-charged batteries. Refer to Charging HeartMate Batteries on page 3-72. 10. Store the battery holsters in a clean, dry location. Refer to Equipment Storage and Care on page 8-1. HeartMate III Left Ventricular Assist System Instructions for Use 6-53...
  • Page 318 Attachment Figure 6.47 Holster Vest The Holster Vest is designed to distribute the weight of the HeartMate III system components across the patient’s shoulders and back with holsters for the batteries and an optional chest strap. The Holster Vest is available in three sizes: small, medium, and large. A Belt Attachment cover is provided to conceal, protect, and wear the System Controller with the Holster Vest.
  • Page 319 OR THIS TASK YOU NEED • 1 running System Controller on Power Module or Mobile Power Unit power • 1 assembled holster vest with belt attachment • 2 fully-charged HeartMate 14 Volt Lithium-Ion batteries HeartMate III Left Ventricular Assist System Instructions for Use 6-55...
  • Page 320 Insert one battery and attached battery clip into the holster. The clip point should point up and the battery should point down (Figure 6.50). Figure 6.50 Inserting Battery and Clip into Holster 6-56 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 321 The clip will click into place when securely fastened. 8. Transfer from the Power Module or the Mobile Power Unit to battery power. Refer to Switching from the Power Module to Battery-Powered Operation on page 3-58. HeartMate III Left Ventricular Assist System Instructions for Use 6-57...
  • Page 322 (Figure 6.52). Figure 6.52 Hook-and-Loop Fastener Tabs Hold the Power Cables in Place 10. Put the patient’s belt through the hook-and-loop fastener tabs to help secure the holsters in place. 6-58 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 323 The battery clicks into place when fully inserted. The alarm stops when the battery is inserted. 6. Close the flap on the holster. Figure 6.53 Exchanging a Battery 7. Repeat Step 2 through Step 6 to exchange the second depleted battery. HeartMate III Left Ventricular Assist System Instructions for Use 6-59...
  • Page 324 6 Patient Care and Management 8. Recharge the depleted batteries. Refer to Charging HeartMate Batteries on page 3-72. 6-60 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 325 9. Recharge the low-charged batteries. Refer to Charging HeartMate Batteries on page 3-72). 10. Store the Holster Vest in a clean, dry location. Refer to Equipment Storage and Care on page 8-1. HeartMate III Left Ventricular Assist System Instructions for Use 6-61...
  • Page 326 System Controller and attached power cables. IMPORTANT! Do not store or carry the backup System Controller outside of recommended environmental conditions. Refer to Equipment Storage and Care on page 8-1. 6-62 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 327 Figure 6.55 Travel Bag OR THIS TASK YOU NEED • 1 Protection Bag with backup System Controller and cables stored inside • 2 spare fully-charged 14 Volt Lithium-Ion batteries • 1 Travel Bag HeartMate III Left Ventricular Assist System Instructions for Use 6-63...
  • Page 328 4. Place the fully-charged, spare batteries into the side pockets of the Travel Bag (Figure 6.57). Figure 6.57 Inserting Spare Batteries Into Travel Bag 5. Zip close the inner compartment and snap shut the top lid. 6-64 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 329 ALARMS AND TROUBLESHOOTING This section describes the primary alarms and troubleshooting of the HeartMate III Left Ventricular Assist System. System Controller Alarms - - - - - - - - - - - - - - - - - - - - - - 7-3...

  • Page 330: Alarms And Troubleshooting

    7 Alarms and Troubleshooting HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 331: System Controller Alarms

    Figure 7.1 shows the alarm screen layout. Figure 7.1 Alarm Screen Alarm Message Duration Timer HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 332 A dot at the bottom of each screen provides navigational information about which screen is in view (Figure 7.2). Figure 7.2 Sample Alarm History Screen Date (mm-dd-yyyy) and time (hh:mm) of Alarm Alarm Type Duration of Alarm Navigation Information HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 333 Press display button THREE times to display the fourth alarm. Press Press display button FOUR times to display the fifth alarm. Press Press display button FIVE times to display the sixth alarm. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 334 If the audio alarm silence has been activated from either the System Controller or the System Monitor, the System Controller LCD screen will display the alarm silence indicator ( Figure 7.3 Sample Alarm Silence Indicator HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 335 Immediately connect to a working power source (Power extremely low Module, Mobile Power Unit, or two HeartMate 14 Volt minutes with less than Lithium-Ion batteries). Refer to page 7-14. 5 min. remaining HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 336 System the alarm, the System Controller may need to be Controller 4 hours Backup replaced, or additional steps may be required. Battery Fault Call Thoratec with questions. Refer to page 7-21. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 337 4 hours Fault (Driveline resolution, if needed. Comm Fault) Note: The alarm must be active to access the alarm silence for this situation. Refer to page 7-24. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 338 Pump. Refer to page 2-46. 3. Clinically evaluate patient. • 2 minutes or until a new hazard alarm occurs. Alarm silence period: • To silence this alarm, press the Silence Alarm button ( 7-10 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 339 2. Ensure that a power source is connected to the System Controller. 3. Clinically evaluate patient. • 2 minutes or until a new hazard alarm occurs. Alarm silence period: • To silence this alarm, press the Silence Alarm button ( HeartMate III Left Ventricular Assist System Instructions for Use 7-11...
  • Page 340 System Controller with a backup System Controller. • 2 minutes or until a new hazard alarm occurs. Alarm silence period: • To silence this alarm, press the Silence Alarm button ( 7-12 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 341 Pump from stopping. When adequate power is supplied, the Pump reverts to the previous speed and the red battery alarm clears. HeartMate III Left Ventricular Assist System Instructions for Use 7-13...
  • Page 342 (Power Module, Mobile Power Unit, or two HeartMate 14 Volt Lithium-Ion batteries). • 2 minutes or until a new hazard alarm occurs. Alarm silence period: • To silence this alarm, press the Silence Alarm button ( 7-14 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 343 Refer to Backup System Controller Overview on page 2-41 for details about the backup System Controller, including replacement instructions. Refer to page 2-46. HeartMate III Left Ventricular Assist System Instructions for Use 7-15...
  • Page 344 HeartMate 14 Volt Lithium-Ion batteries). • 2 minutes or until a new hazard alarm occurs. Alarm silence period: • To silence this alarm, press the Silence Alarm button ( 7-16 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 345 System Controller and injury to the patient may occur. First connect to HeartMate 14 Volt batteries. To resolve the alarm: 1. Promptly connect to two fully-charged HeartMate 14 Volt Lithium-Ion batteries. HeartMate III Left Ventricular Assist System Instructions for Use 7-17...
  • Page 346 Refer to Connecting to the Mobile Power Unit on page 3-42. Note: This alarm and resolution will not apply for Mobile Power Units with software version 1.02. 7-18 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 347 System Controller Overview on page 2-41 for details about the backup System Controller, including replacement instructions. IMPORTANT! The System Controller will not display all alarms. Certain alarms will be displayed on the System Monitor only. HeartMate III Left Ventricular Assist System Instructions for Use 7-19...
  • Page 348 Alarms via the System Monitor on page 4-29. Note: If EXTENDED ALARM RESET is selected, the System Controller will no longer display this alarm. The visual alarm on the System Monitor is maintained. 7-20 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 349 • To silence this alarm, press the silence alarm button ( IMPORTANT! The System Controller will not display all alarms. Certain alarms will be displayed on the System Monitor only. HeartMate III Left Ventricular Assist System Instructions for Use 7-21...
  • Page 350 Controller, or additional steps may be required for resolution. Call Thoratec with questions. • 4 hours or until any new alarm occurs. Alarm silence period: • To silence this alarm, press the Silence Alarm button ( 7-22 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 351 Fault). Refer to Silencing Alarms via the System Monitor on page 4-29. • If this alarm condition is permanently silenced, it will no longer appear on the System Controller LCD screen. The System Monitor will maintain a visual alarm. HeartMate III Left Ventricular Assist System Instructions for Use 7-23...
  • Page 352 Refer to page 4-30. • If this alarm condition is permanently silenced, it will no longer appear on the System Controller LCD screen. The System Monitor will maintain a visual alarm. 7-24 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 353: System Monitor Alarms

    Refer to page 7-27. LVAD Fault Use the System Monitor to set the System Controller’s internal clock. Refer to page 7-28. Controller Clock Not Set HeartMate III Left Ventricular Assist System Instructions for Use 7-25...
  • Page 354 2. Replace the System Controller. Refer to page 2-46. 3. Clinically evaluate the patient. The Silence Alarm button will appear for this alarm Alarm silence period: condition. In this case, the button will not perform any function. 7-26 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 355 2. Use the System Monitor to silence the alarm while awaiting resolution, if needed. The Silence Alarm button will appear for this alarm Alarm silence period: condition. In this case, the button will not perform any function. HeartMate III Left Ventricular Assist System Instructions for Use 7-27...
  • Page 356 Note: Be sure the System Monitor clock is correct. The Silence Alarm button will appear for this alarm Alarm silence period: condition. In this case, the button will not perform any function. 7-28 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 357: Handling Power Module Alarms

    Refer to Table 7.20 for a description of Power Module alarms and how to respond to them. IMPORTANT! If an audio alarm sounds from the Power Module without an accompanying visual indicator illuminating at the same time, please contact Thoratec Corporation for assistance. Refer to page iii for Thoratec Corporation contact information.
  • Page 358 Advisory Fault yellow wrench indicator Internal malfunction detected Switch to a new set of charged within the Power Module. batteries at earliest convenience. accompanied by beeping audio tone 7-30 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 359 The Power Module backup Immediately switch to a new set of battery is not functioning batteries charged properly or is not installed. accompanied by continuous audio tone HeartMate III Left Ventricular Assist System Instructions for Use 7-31...

  • Page 360: Mobile Power Unit Alarms

    Table 7.21 provides a description of the Mobile Power Unit alarms and how to resolve each alarm. Note: If there is an alarm for the Mobile Power Unit but no light comes on, contact Thoratec Corporation for assistance. Refer to page iii for Thoratec Corporation contact information. Table 7.21 Mobile Power Unit Alarms Alarm Symbol...

  • Page 361: Using The Charger To Check Battery Or Charger Status

    The alarm code appears on the screen. The alarm code is one letter followed by four numbers. Alarm codes related to batteries begin with the letter "B." Record the alarm code and save it for future reference. 6. Remove the defective battery from use. HeartMate III Left Ventricular Assist System Instructions for Use 7-33...
  • Page 362 IMPORTANT! Do not use a damaged or defective Battery Charger until it is repaired or replaced. Until there is a safe and reliable way to recharge batteries, use the HeartMate Power Module or Mobile Power Unit to power the HeartMate system. 7-34 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 363 CALIBRATE? Request Calibration PRESS Y PROGRESS Y: CALIBRATING Accept Calibration CALL SERVICE Charger Fault CALL SERVICE Battery Fault (Button Push) B0001 CALL SERVICE Charger or Pocket S0001 Fault (Button Push) HeartMate III Left Ventricular Assist System Instructions for Use 7-35...

  • Page 364: Guidelines For Power Cable Connectors

    • Never twist connectors or pull them apart at an angle. Figure 7.7 Align Half Circles Connector Nut Figure 7.8 Turn Nut on the Connector 7-36 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 365: What Not To Do: Driveline And Cables

    Left Ventricular Assist Device to stop. If the Driveline or cables become twisted, kinked, or bent, carefully unravel and straighten. CAUTION ! Use care and do not twist, kink, or sharply bend the Driveline. HeartMate III Left Ventricular Assist System Instructions for Use 7-37...
  • Page 366 7 Alarms and Troubleshooting CAUTION ! Use care and do not twist, kink, or sharply bend the System Controller power cables. 7-38 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 367 • Route the patient cable so it will not cause a tripping or falling hazard. • Take care when moving around while connected to the Mobile Power Unit, that it is not inadvertently pulled off of furniture. HeartMate III Left Ventricular Assist System Instructions for Use 7-39...
  • Page 368 Do not connect a System Controller to both the Mobile Power Unit and the Power Module at the same time, or damage to the controller and injury to the patient may occur. First connect to HeartMate 14 Volt batteries. 7-40 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 369 EQUIPMENT STORAGE AND CARE This section provides information on how to store and care for the HeartMate III Left Ventricular Assist System. Storage and Transport - - - - - - - - - - - - - - - - - - - - - - - 8-3...

  • Page 370: Equipment Storage And Care

    8 Equipment Storage and Care HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 371: Storage And Transport

    375 to 795 Lithium-Ion 10% to 93% (-25°C to 40°C) (500 to 1060) Backup Battery Wear and Carry Accessories, -4°F to 131°F 20% to 85% Not applicable including Shower (-20°C to 55°C) HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 372: Cleaning And Maintenance

    8 Equipment Storage and Care Cleaning and Maintenance Although the HeartMate III LVAS does not have external moving components, the external components should undergo routine and periodic inspections, cleaning, and maintenance as prescribed in this section. General Cleaning Guidelines for All Equipment Use a damp cloth to clean exterior surfaces of the system components, as needed.
  • Page 373 • Fluid leakage from the external portion of the Driveline. • Cessation of pumping. If the Driveline is suspected of damage, contact Thoratec Corporation for assistance. Refer to page iii for Thoratec Corporation contact information. X-ray images may be useful to assess the extent and location of the Driveline damage. If damage to the electrical conductors in the Driveline is confirmed, the Left Ventricular Assist Device should be replaced as soon as possible.
  • Page 374 If corrosion is observed, report the condition to Thoratec Corporation. Refer to page iii for Thoratec Corporation contact information. Cleaning and service should be performed only by personnel trained by Thoratec Corporation. Do not attempt to clean or repair equipment. Thoroughly wash any areas where contact with corroded batteries is made.
  • Page 375 For more information, refer to the Safety Checklists on page D-1. Cleaning HeartMate Wear and Carry Accessories HeartMate wear and carry accessories are designed to securely hold or protect HeartMate III components. The accessories include: • Shower Bag •...

  • Page 376: Product Disposal

    Otherwise, dispose of all expired or damaged equipment according to applicable local, state, and federal regulations. For additional product disposal information, please contact Thoratec Corporation for assistance. Refer to page iii for Thoratec Corporation contact information. Batteries HeartMate 14 Volt Lithium-Ion batteries do not contain lead. Dispose of or recycle HeartMate 14 Volt batteries in compliance with all applicable local, state, and federal regulations.

  • Page 377: Technical Specifications

    TECHNICAL SPECIFICATIONS Summary of Clinical Studies This section provides the technical specifications for the HeartMate III Left Ventricular Assist System. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 378 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 379 Specifications The technical specifications for the HeartMate III Left Ventricular Assist System are listed here. For ordering information and catalog numbers, refer to the HeartMate III™ Product List at www.thoratec.com. HeartMate III Left Ventricular Assist System Implant Kit BLOOD VOLUMES-FLUID CAPACITY Dimensions (pump body) 50.3 mm (2.0 in.)
  • Page 380 Advisory Alarms: 85 dB 2300 Hz ± 300 Hz DIMENSIONS Length 12.7 cm (5 in.) Height 3.5 cm (1.375 in.) Width 8.0 cm (3.125 in.) 336 g (12 oz) WEIGHT Three years from date of first use PRODUCT LIFE HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 381 84.6 g (2.98 oz) WEIGHT 10950 cumulative discharge minutes, as tracked by the System Controller and reported on the System Monitor, or 3 years from the date of manufacture, PRODUCT LIFE whichever comes first. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 382 Isolated power to patient during tethered operation Communication interface between System Controller and System Monitor When new, AC power failure backup battery (30 minutes to operate HeartMate III Left Ventricular Assist System) MONITORING FUNCTIONS Isolated bidirectional data link to external System Monitor...
  • Page 383 Height 12.7 cm (5.0 in.) 6.1 m (20 ft) CABLE LENGTH 1.4 kg (3.0 lb) - with three AA (LR6) batteries WEIGHT Two years from date of first use PRODUCT LIFE HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 384 4.8 amp-hour each or 71 watt-hour One pair of new HeartMate 14 Volt Lithium-Ion batteries provides 17 Discharge Time hours of support under nominal operating conditions for a HeartMate III Left Ventricular Assist System (5.4 lpm) Power Gauge 5-LED, button activated...
  • Page 385 Admin Screen • Permits control of date/time and technical parameters. DIMENSIONS Length 305 mm (12.0 in.) Depth 165 mm (6.5 in.) Height 245 mm (10.0 in.) 2.49 kg (5.5 lb) WEIGHT HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 386 HeartMate Consolidated Bag Slim profile shoulder bag for use with HeartMate III Left Ventricular Assist TYPE System Allows patient to wear and carry HeartMate III batteries, battery clips, and FUNCTION System Controller For use with: System Controller PRODUCT Batteries COMPATIBILITY...
  • Page 387 For small users less than 160 lb (73kg) For medium users 160–240 lb (73–109 kg) SIZES For large users greater than 240 lb (109 kg) Two years of continuous use PRODUCT LIFE HeartMate III Left Ventricular Assist System Instructions for Use A-11...
  • Page 388 • System Controller Belt Attachment TYPE • System Controller Protection Bag • System Controller Neck Strap and System Controller Belt Attachment provide options for the patient to wear HeartMate III System Controller FUNCTION • System Controller Protection Bag protects the backup...
  • Page 389 Safety Testing and Classification - - - - - - - - - - - - - - - - - - B-3 Testing and Classification: HeartMate III LVAS - - - - - - - - - - - B-5...
  • Page 390 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 391: Safety Testing And Classification

    Safety Testing and Classification The HeartMate III Left Ventricular Assist System has been thoroughly tested and Classified by Underwriters Laboratories, LLC (UL) to the fire, casualty, and electric shock hazard requirements of the following safety standards, as applicable: • IEC 60601-1:2012 (ed. 3.1) •...
  • Page 392 Performance Determined to be Essential Performance • Alarm for Pump Speed performance outside of the essential performance limits. • Prevent Leakage in Blood Path. HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 393: Testing And Classification: Heartmate Iii Lvas

    Testing and Classification: HeartMate III LVAS The HeartMate III Left Ventricular Assist System has been tested and found to comply with the limits for medical devices to the IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.

  • Page 394: Testing And Classification: Power Module

    Testing and Classification: Power Module Declaration and Guidance for Electromagnetic Disturbances The HeartMate III LVAS (powered by the Power Module) is suitable for use in the following environments: • Hospitals, including ORs and emergency rooms • Treatment areas near active HF Surgical equipment.
  • Page 395 Interference to the HeartMate III LVAS may occur near equipment or areas that are marked with the following symbol: Note: 1,000 MHz = 1.0 GHz [a] – List is not comprehensive. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 396 ± 0.5, ± 1 kV line to line with Power Module is used. Surge Immunity / IEC 61000-4-5 EN 61000-4-5 ± 0.5, ± 1 kV, and ± 2 kV line to earth HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 397 Magnetic Field Immunity / be that of a typical commercial or hospital 30 A/m (50 or 60 Hz) IEC 61000-4-8 environment where the HeartMate III LVAS EN 61000-4-8 with PM is used. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 398 (EMC) “site survey” (measurement) should be considered. If the measured field strength (in Volts per meter, V/m) in the location(s) in which the HeartMate III Left Ventricular Assist System is used exceeds the applicable RF compliance level for the frequency bands above, the HeartMate III LVAS should be observed to verify normal operation.
  • Page 399 CISPR 11 class B is normally required) this equipment might not offer adequate protection to radio-frequency communication services. The user might need to take mitigation measures, such as relocating or re-orienting the equipment. HeartMate III Left Ventricular Assist System Instructions for Use B-11...

  • Page 400: Testing And Classification: Mobile Power Unit

    Testing and Classification: Mobile Power Unit Declaration and Guidance for Electromagnetic Disturbances for the Mobile Power Unit The HeartMate III LVAS (powered by the Mobile Power Unit) is suitable for use in the following environments: • Hospitals, including ORs and emergency rooms •...
  • Page 401 Interference to the HeartMate III LVAS may occur near equipment or areas that are marked with the following symbol: Note: 1,000 MHz = 1.0 GHz [a] – List is not comprehensive. HeartMate III Left Ventricular Assist System Instructions for Use B-13...
  • Page 402 HeartMate III LVAS with Mobile Power Unit is used. Surge Immunity / IEC 61000-4-5 ± 0.5, ± 1 kV line to line EN 61000-4-5 B-14 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 403 (0.5 sec.) EN 61000-4-11 0 % of U ; 250 or 300 cycles (5 sec.) Note – U : A.C. Mains voltage supply, either 50 or 60 Hz (cycles per sec.) HeartMate III Left Ventricular Assist System Instructions for Use B-15...
  • Page 404 Equipment Storage and Care. • Avoid use of the HeartMate III LVAS (and its cables and parts) within 5 cm (2 inches) of a microwave oven or its cord. Keep all HeartMate III LVAS components and their cables away from other electronic devices and their cables/cords.

  • Page 405: Testing And Classification: Battery Charger

    • Increase the separation between the equipment. • Connect the equipment into an outlet on a circuit different from that to which the other devices are connected. • Consult Thoratec Corporation for assistance. HeartMate III Left Ventricular Assist System Instructions for Use B-17...
  • Page 406 Table B.4 Declaration Concerning General Safety Standards for Battery Charger Type Degree of Protection Mode of Operation Continuous Type of protection against mains shock Class I (grounded) Degree of protection against harmful IPX0 ingress of water B-18 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 407 If flooring is synthetic, the relative (ESD) Immunity / humidity should be at least 30%. Higher IEC 61000-4-2 ±8 kV Air relative humidity will reduce the severity EN 61000-4-2 of ESD events. HeartMate III Left Ventricular Assist System Instructions for Use B-19...
  • Page 408 Interference to the HeartMate Battery Charger may occur near equipment or areas that are marked with the following symbol: Note: 1,000 MHz = 1.0 GHz [a] – List is not comprehensive. B-20 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 409 ± 0.5, ± 1 kV line to line Charger is used. Surge Immunity / IEC 61000-4-5 EN 61000-4-5 ± 0.5, ± 1 kV, and ± 2 kV line to earth HeartMate III Left Ventricular Assist System Instructions for Use B-21...
  • Page 410 IEC 61000-4-11 (0.5 sec.) EN 61000-4-11 0 % of U ; 250 or 300 cycles (5 sec.) : A.C. Mains voltage supply, either 50 or 60 Hz (cycles per sec.) B-22 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 411 (EMC) “site survey” (measurement) should be considered. If the measured field strength (in Volts per meter, V/m) in the location(s) in which the HeartMate III Left Ventricular Assist System is used exceeds the applicable RF compliance level for the frequency bands above, the HeartMate III LVAS should be observed to verify normal operation.

  • Page 412: Testing And Classification: Heartmate 14 Volt Lithium-Ion Batteries

    IP24 only when connected to the System Degree of protection against harmful ingress Controller through Clip B-24 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 413 • Commercial aircraft, including helicopters and air ambulances • Public or private passenger watercraft/boats, ferries, etc. Table B.7 Declaration and Guidance for Electromagnetic Disturbances for HeartMate III Powered by 14 V Li-Ion Batteries HeartMate III LVAS Powered By the 14V Li-Ion Batteries...
  • Page 414 Interference to the HeartMate III LVAS may occur near equipment or areas that are marked with the following symbol: Note: 1,000 MHz = 1.0 GHz [a] – List is not comprehensive. B-26 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 415 Note: The recommended minimum separation distance above is a deviation from IEC 60601-1-2 (2014) based on the use-environment of the HeartMate3 LVAS with 14V Batteries. [a] – List is not comprehensive. HeartMate III Left Ventricular Assist System Instructions for Use B-27...
  • Page 416 Magnetic Field Immunity / be that of a typical commercial or hospital 30 A/m (50 or 60 Hz) IEC 61000-4-8 environment where the HeartMate III LVAS EN 61000-4-8 with14V Li-Ion Batteries is used. B-28 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 417 • Avoid use of HeartMate III LVAS (and its cables and parts) within 5 cm (2 inches) of a microwave oven or its cord.
  • Page 418 Thoratec Corporation for replacement parts may affect the electromagnetic compatibility of the Left Ventricular Assist System with other devices, resulting in potential interference between the HeartMate III Left Ventricular Assist System and other devices. B-30 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 419: Symbols

    SYMBOLS This section describes the symbols that are used on the HeartMate III Left Ventricular Assist System components, accessories, or packaging. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 420 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 421 Authorized representative in the European community Temperature limit Sterilized using irradiation Sterilized using ethylene oxide Consult instructions for use Do not use if package is damaged MR Unsafe - Do not subject to magnetic resonance imaging HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 422 Contains Lithium-Ion, recycle in accordance with local, state, and federal regulations. Separate collection for batteries and accumulators Use-by date Keep dry See instructions for use Non-ionizing radiation Fragile, handle with care This end up HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 423 (box and protective bag). Product Use by Specific 11 Volt Lithium-Ion Backup Battery Symbols Symbol Description Backup Battery Use by HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 424 Symbol Description Refer to System Controller User Interface Overview on page On-product symbols 2-14. Indicates the HeartMate III LVAS is operating in Pulse Mode (as shown on the System Controller LCD display). Specific Power Module Symbols Symbol Description • Refer to Handling Power Module Alarms on page 7-29.
  • Page 425 Refer to Mobile Power Unit User Interface Components on page 3-37. Specific System Monitor Symbols Symbol Description Power OFF Power ON Input: System Monitor only. For cable connection from Power Module to port on back of System Monitor. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 426 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 427: Safety Checklists

    SAFETY CHECKLISTS This section provides checklists to assist in performing routine maintenance of the HeartMate III Left Ventricular Assist Device. Daily Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - D-3...
  • Page 428 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 429: Daily Safety Checklist

    Manage the Driveline exit site in accordance with the instructions provided by the clinician. Inspect the Driveline exit site for signs of infection, including redness, tenderness, swelling, discharge, or a foul odor. Use sterile technique to touch or handle the exit site. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 430 Ensure that the Modular In-line Connector is secure and the connector locking nut is in the locked position. Ensure no yellow indicator is seen under the in-line locking nut. Inspect all cables for signs of damage. HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 431: Weekly Safety Checklist

    Power Module patient cable or the Mobile Power Unit patient cable if it shows signs of damage. Obtain a replacement from Thoratec Corporation, if needed. Inspect HeartMate 14 Volt Lithium-Ion batteries for damage. Check the battery contacts for denting or damage.

  • Page 432: Monthly Safety Checklist

    If the pins or sockets are damaged or contaminated, do not attempt to clean them. Report the condition to Thoratec Corporation. Refer to page iii for Thoratec Corporation contact information. Cleaning and service should be performed only by personnel trained by Thoratec Corporation.
  • Page 433 REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. FOR HOSPITAL STAFF ONLY: Use the System Monitor to check the expiration date and battery usage on the 11 Volt Lithium-Ion backup battery. HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 434: Six Month Safety Checklist

    Replace the Mobile Power Unit batteries with three new Alkaline AA batteries. If corrosion is observed, report the condition to Thoratec Corporation. Refer to page iii for Thoratec Corporation contact information. Cleaning and service should be performed only by personnel trained by Thoratec Corporation.
  • Page 435 Review caring for the Driveline exit site including cleansing, dressing, and immobilizing the Driveline. Refer to Caring for the Driveline Exit Site on page 6-8 or Patient Handbook section 4 (if applicable). HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 436: Yearly Safety Checklist

    Yearly Safety Checklist Schedule a Power Module inspection and cleaning with Thoratec-trained personnel. The inspection and cleaning includes (but is not limited to) functional testing, cleaning, inspection, and replacement of the Power Module backup battery. WARNING ! Ensure that the Power Module backup battery is reconnected after service or shipping. Refer to Installing the Power Module Backup Battery on page 3-9.

  • Page 437: As-Needed Safety Checklist

    You may use a mild, non-abrasive cleaner, if necessary. Do not submerge the charger in water or liquid. REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS DAMAGED OR WORN. HeartMate III Left Ventricular Assist System Instructions for Use D-11...

  • Page 438: Clinic Visit Safety Checklist

    Review using the Shower Bag and showering. Refer to page 6-20 or Patient Handbook section 4. Review caring for the Driveline exit site including cleansing, dressing, and immobilizing the Driveline. System Controller must be maintained and assessed for readiness (IFU section 2). D-12 HeartMate III Left Ventricular Assist System Instructions for Use...

  • Page 439: Glossary

    GLOSSARY This section provides a glossary of terms for the HeartMate III Left Ventricular Assist System. Abbreviations - - - - - - - - - - - - - - - - - - - - - - - - - - - - E-2...
  • Page 440 Left Ventricular Assist System Low Molecular Weight Ml/hr Milliliter per hour Magnetic Resonance Imaging O.R. Operating Room Pulsatility Index Partial Thromboplastin time Once daily Revolutions Per Minute Three times daily Volt HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 441 North American households. Apical Cuff: The Apical Cuff is the interface between the heart and the HeartMate III LVAD. It is sewn to the exterior of the heart and anchors it to the LVAD via the Slide Lock.
  • Page 442 System Controller. Direct Current: Abbreviated DC. The type of electricity that comes from a battery. The HeartMate III system uses two types of DC power: either 1) two 14 Volt Lithium-Ion batteries, or 2) an automobile power outlet.
  • Page 443 Driveline. Other terms for the device are Pump, heart pump, or LVAD (the acronym for Left Ventricular Assist Device). Left Ventricular Assist System: The HeartMate III Left Ventricular Assist System includes the implanted pump and all related external equipment. Sometimes the Left Ventricular Assist System is called an LVAS.
  • Page 444 ) on the System Controller. It lights when HeartMate III pump blood flow is critically low. Low Speed Limit: The lowest speed at which the HeartMate III pump can operate while maintaining patient stability. LVAD Fault: An advisory alarm that occurs when the LVAD has determined that one or more internal LVAD operating conditions are out of range.
  • Page 445 Pulsatility Index (PI): Pulsatility Index (PI) is a calculation related to the amount of assistance provided by the pump. PI values typically range from 1 to 10. Pulse Mode: The HeartMate III LVAS automatically develops an induced pulse X times per minute by increasing/decreasing rotor speed in a rapid fashion. The ( ) symbol indicates the pump is operating in Pulse Mode.
  • Page 446 2 minutes to 4 hours. Pressing the Silence Alarm button only silences the alarm. It does not fix the alarm condition. Slide Lock: The mechanical feature on the HeartMate III LVAD that affixes the pump to the Apical Cuff.
  • Page 447 HeartMate 14 Volt Lithium-Ion batteries that are providing power during battery-powered operation. Yellow Wrench Indicator: A yellow-colored symbol ( ) on the System Controller user interface that illuminates during alarm conditions that are important, but not immediately life-threatening. HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 448 E-10 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 449 Power Module, silencing 3-33 admin screen on System Monitor 4-40 pump off 7-8 advisory alarms 4-27 replace controller 7-18, 7-19 backup battery fault 7-21 replace power 7-17 backup battery not installed 7-22 HeartMate III Left Ventricular Assist System Instructions for Use Index-1...
  • Page 450 System Control- blood leak 6-10 ler 2-33 blood pressure, measuring 6-8 environmental requirements 2-7, 8-3 buttons information displayed on System Power Module, silence alarm button Monitor 4-43 3-33 Index-2 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 451 4-40 charging daylight savings time on System Monitor 11 Volt Lithium-Ion battery 2-33 4-41 14 Volt Lithium-Ion batteries 3-72 defibrillation 6-10 backup System Controller 2-44 device tracking and reporting 5-55 HeartMate III Left Ventricular Assist System Instructions for Use Index-3...
  • Page 452 1-13 history screen on System Monitor 4-38 equipment required for implant 1-12 reviewing event log 4-39 event history in System Controller 4-34 holster vest 6-54 event log 4-33 Index-4 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 453 7-11, 7-14 potential complications 6-7 low flow screen 7-8, 7-11, 7-14 potential risks 6-7 low voltage advisory alarm vs. low voltage preimplant preparation 5-8 hazard alarm 3-54 HeartMate III Left Ventricular Assist System Instructions for Use Index-5...
  • Page 454 Run Mode, System Controller 2-31 preparing the sealed outflow graft 5-15 preparing, running, and priming the pump 5-22 safety checklists D-1 unpacking equipment 5-10 Safety Lock on System Controller 2-20 warnings and cautions 5-7 Index-6 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 455 4-11 connecting 2-21 pump power 4-14 disconnecting 2-23 pump speed 4-13 environmental requirements reviewing events 4-39 for operation 2-7 screens for storage and transport 8-3 admin 4-40 HeartMate III Left Ventricular Assist System Instructions for Use Index-7...
  • Page 456 System Controller 2-14 ventricular apex site, preparing 5-36 vest, holster 6-54 warnings, defined 1-3 wear and carry accessories 6-30 battery holster 6-48 belt attachment 6-36 cleaning 8-7 Consolidated Bag 6-40 Index-8 HeartMate III Left Ventricular Assist System Instructions for Use...
  • Page 458 Da Vincilaan 11 Box F1, 1935 Zaventem, Belgium, Tel: +32 2 774 68 11, 24-Hr Tel: +32(0)2 200 66 45 Therefore, please refer to the HeartMate III™ Instructions for Use shipped with the HeartMate III for the most current information regarding indications, contraindications, and cautions.

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