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HeartMate III Instructions for Use
Instructions for Use
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Instructions for Use
Thoratec Corporation HEARTMATE III™ LEFT VENTRICULAR ASSIST SYSTEM
Instructions for Use
ii
HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE
United States & Canada Thoratec Corporation (International Headquarters) 6035 Stoneridge Drive Pleasanton, CA 94588 USA Telephone: (925) 847-8600 Fax: (925) 847-8574 European Authorized Representative St. Jude Medical Coordination Center BVBA The Corporate Village Da Vincilaan 11 Box F1 1935 Zaventem Belgium Telephone: +32 2 774 68 11 24 Hour Number: +32(0)2 200 66 45 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.
Microsoft® and Windows® are registered trademarks of Microsoft Corporation. CompactFlash is a registered trademark of SanDisk Corporation. Tyvek is a registered trademark of E. I duPont de Nemours and Company or its affiliates. Luer-Lok is a trademark of Becton, Dickinson and Company.
©2018 Thoratec Corporation. Document: 10002832.G
Publication Date: 04/2019
HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE
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Contents 1
Introduction - - - - - - - - - - - - - - - - - - - - 1-1 Preface - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Understanding Warnings and Cautions - - - - - - - - - - - - - - - - - - - - 1-3 Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Indications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8 Contraindications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8 Adverse Events - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-9 Pre-Use Requirements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-9 Equipment Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-10 Principles of Operation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-14 Explanation of Parameters - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-16
2
System Operations - - - - - - - - - - - - - - - - - 2-1 HeartMate III Left Ventricular Assist Device Overview - - - - - - - - - - - - - 2-3 System Controller Overview - - - - - - - - - - - - - - - - - - - - - - - - - - 2-7 Backup System Controller Overview - - - - - - - - - - - - - - - - - - - - - - 2-41
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Powering the System - - - - - - - - - - - - - - - - 3-1 Power Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3 Using the Power Module - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5 Using the Mobile Power Unit - - - - - - - - - - - - - - - - - - - - - - - - - - 3-32 Using HeartMate 14 Volt Lithium-Ion Batteries - - - - - - - - - - - - - - - - - 3-44 Switching Power Sources- - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-56 Battery Charger Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-63 Charging HeartMate Batteries - - - - - - - - - - - - - - - - - - - - - - - - - 3-70 Calibrating HeartMate Batteries - - - - - - - - - - - - - - - - - - - - - - - - 3-73 Checking Battery Power - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-75 Care and Maintenance of the Battery Charger - - - - - - - - - - - - - - - - 3-76
HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE
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Contents 4
System Monitor - - - - - - - - - - - - - - - - - - - 4-1 Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3 System Monitor Setup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-5 System Monitor Interface - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-9 Clinical Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-10 Settings Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-17 Alarms Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-25 Save Data Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-32 Using the History Screen- - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-38 Admin Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-40
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Surgical Procedures - - - - - - - - - - - - - - - - - 5-1 Surgical Considerations - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3 Equipment and Supplies Required for Implant - - - - - - - - - - - - - - - - - 5-5 Preimplant Procedures - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-7 Unpacking the Implant Kit - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-10 Unpacking the Pump and Accessories Tray - - - - - - - - - - - - - - - - - - 5-11 Unpacking the Sealed Outflow Graft - - - - - - - - - - - - - - - - - - - - - 5-14 Preparing the Sealed Outflow Graft - - - - - - - - - - - - - - - - - - - - - - 5-15 Unpacking the System Controller - - - - - - - - - - - - - - - - - - - - - - - 5-16 Unpacking the Modular Cable - - - - - - - - - - - - - - - - - - - - - - - - 5-17 Connecting and Initializing the Sterile System Controller - - - - - - - - - - - 5-19 Preparing, Operating, and Priming the Pump - - - - - - - - - - - - - - - - - 5-22 Preparing the Coring Knife - - - - - - - - - - - - - - - - - - - - - - - - - - 5-29 Implant Procedures - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-30 Postimplant Procedures - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-51 Device Explant - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-55
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Patient Care and Management - - - - - - - - - - - - 6-1 Postoperative Patient Care- - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3 Ongoing Patient Assessment and Care - - - - - - - - - - - - - - - - - - - - 6-6 Important Clinical Considerations for HeartMate III Patients- - - - - - - - - - 6-9 Educating and Training Patients, Families, and Caregivers - - - - - - - - - - 6-11 Ongoing System Assessment and Care - - - - - - - - - - - - - - - - - - - - 6-13 Showering - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-16 Preparing for Sleep - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-28 Wearing and Carrying System Components - - - - - - - - - - - - - - - - - 6-29
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HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE
Contents 7
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 Using the Charger to Check Battery or Charger Status - - - - - - - - - - - - 7-33 Guidelines for Power Cable Connectors - - - - - - - - - - - - - - - - - - - - 7-36 What Not to Do: Driveline and Cables - - - - - - - - - - - - - - - - - - - - 7-37
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Equipment Storage and Care - - - - - - - - - - - - 8-1 Storage and Transport - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-3 Cleaning and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - 8-4 Product Disposal - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-8
A
Technical Specifications - - - - - - - - - - - - - - - A-1
B
Safety Testing and Classification
C
Symbols - - - - - - - - - - - - - - - - - - - - - - C-1
D
Safety Checklists - - - - - - - - - - - - - - - - - - D-1
E
Glossary - - - - - - - - - - - - - - - - - - - - - - E-1
- - - - - - - - - - B-1
HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE
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Contents
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HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE
1 INTRODUCTION This section provides an introduction to the HeartMate III Left Ventricular Assist System.
Preface - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3 Understanding Warnings and Cautions - - - - - - - - - - - - - - 1-3 Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4 Indications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8 Contraindications - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8 Adverse Events - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-9 Pre-Use Requirements - - - - - - - - - - - - - - - - - - - - - - - - 1-9 Equipment Overview - - - - - - - - - - - - - - - - - - - - - - - -1-10 Principles of Operation - - - - - - - - - - - - - - - - - - - - - - -1-14 Explanation of Parameters - - - - - - - - - - - - - - - - - - - - -1-16
HeartMate III Left Ventricular Assist System Instructions for Use
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1 Introduction
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HeartMate III Left Ventricular Assist System Instructions for Use
Introduction 1 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. New users should read this document in its entirety before system operation. For experienced practitioners, this manual may serve as a reference. As with all prescription medical devices, clinical procedures should be conducted under the direction of the prescribing physician. The professional staff at Thoratec® Corporation regularly provides laboratory training and on-site, in-service programs.
Understanding Warnings and Cautions In this manual, warnings and cautions that are relevant to a specific procedure or piece of equipment appear at the start of each applicable section. Warnings refer to actions or hazardous conditions that could cause serious injury or death if not avoided. Ignoring a warning can cause sudden and serious injury, life-threatening harm, or death for the user or patient. WARNING ! Warnings appear in the manual in this format. Cautions refer to actions or potentially unsafe conditions that may cause injury to a patient or user, damage the equipment, or affect how the system works. Ignoring a caution can cause the patient or user injury, or result in equipment failure or sub-optimal system operation. Although important for maximum safety and optimal system function, usually cautions do not refer to life-threatening risks. CAUTION ! Cautions appear in the manual in this format.
HeartMate III Left Ventricular Assist System Instructions for Use
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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. The LVAS features a Left Ventricular Assist Device (a blood pump intended for long-term implantation) and an extracorporeal System Controller. Additionally, it includes all of the features, controls, attachments, interfaces, power sources, supporting equipment, labeling, and tools required to achieve therapeutic benefit. The LVAS may be used in any of two configurations: • Line power may be utilized through the Power Module or the Mobile Power Unit™ to run the LVAD indefinitely. This is convenient for sedentary or sleeping periods. Whenever the Power Module is used, a System Monitor may also be used as a means of viewing operating conditions, changing operating parameters, and manipulating stored data. • Portable Battery power may be utilized for limited periods. This is convenient for active periods. The bifurcation of the Patient Cable allows for switching among these configurations, or from a set of depleted batteries to a set of fully-charged batteries, without interrupting LVAS function. A set of user manuals provides instructions at various levels appropriate for users to explain how to use the equipment, and how to interpret and respond to alarms. The LVAS is packaged for safe transport and effective use in an operating room under sterile conditions. The HeartMate III LVAD is part of the LVAS (Figure 1.1).
Figure 1.1 HeartMate III LVAS During Battery-Powered Operation
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HeartMate III Left Ventricular Assist System Instructions for Use
Introduction 1 The LVAD is a blood pump intended for long-term implantation in the thorax of patients affected with advanced heart failure. The LVAD contains the Inflow Cannula, a Motor, a Pump Chamber, a Rotor, an Outflow Graft, and a Pump Cable (Figure 1.2).
3
2
1
4
7
8
6
5
Figure 1.2 Left Ventricular Assist Device Components 1
Pump Cable
2
Outflow Graft with Bend Relief
3
Inflow Cannula
4
Rotor Magnet
5
Pump Chamber
6
Rotor
7
Motor
8
Slide Lock
HeartMate III Left Ventricular Assist System Instructions for Use
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1 Introduction The LVAD is surgically connected to the patient's circulatory system via an Inflow Cannula. It is placed into the left ventricular apex, and an Outflow Graft anastomosed to the ascending aorta. The LVAD is a centrifugal pump. Ventricular blood is drawn into the Inflow Cannula along a central axis and is expelled at right angles by, and between, the impeller blades of a Rotor that is rotating around the central axis. The fluid, thus angularly accelerated, collects and travels around a volute before it is diffused to the preferred pressure and flow rate by being directed tangentially into the Outflow Graft. The Rotor is fully supported by magnetic levitation, obviating mechanical or fluid bearings, and essentially eliminating Rotor mechanical wear as a reliability factor. Both drive (that is, rotation) and levitation of the Rotor is accomplished using a single Stator comprising iron pole pieces, a back-iron, copper coils, and position sensors. By measuring the position of a permanent magnet in the Rotor, and appropriately controlling the current in the drive and levitation coils, the radial position and rotational speed of the Rotor is actively controlled. Because of the permanent magnet's attraction to the iron pole pieces, the rotor passively resists excursion in the axial direction, whether such excursion is translation or tilting. The electronics and software necessary to control motor drive and levitation are integrated into the Pump with the Stator. All of these components, along with the Rotor, comprise the Motor. The Inflow Cannula is a cylindrical conduit with external size and features similar to those of the HeartMate II® LVAD. It is rigidly affixed to the Pump Cover. During the implantation procedure, a Coring Tool is used to resect a plug of myocardium at the left ventricular apex. This allows insertion of the Inflow Cannula into the left ventricle. An Apical Cuff is sewn to the epicardium, and a Slide Lock is used to secure the Inflow Cannula and establish hemostasis. The Outflow Graft assembly consists of a sealed woven polyester graft and the hardware necessary to attach the graft to the Pump Cover. This hardware is similar to that of the HeartMate II LVAD, and can be swiveled to correct any twist that may develop during Pump placement. This type of connection allows the clinician to attach the outflow to the Pump at any time during the implantation procedure and assists with de-airing of the system. The distal end of the graft is designed to be cut to the preferred length, and sutured to the ascending aorta by an end-to-side anastomosis. Only the graft should be cut, not the bend relief. A reinforced tube serves as a bend relief around the Outflow Graft to prevent kinking and abrasion. The bend relief can be attached or removed, and reattached during the implantation procedure. If necessary, the Outflow Graft may be detached from the Pump, permitting Pump replacement without re-anastomosis. A Pump Cable is permanently attached to the Pump to establish electrical connection with the enclosed Motor via a hermetically sealed feed-through. This Pump Cable is tunneled through subdermal abdominal tissue via a Tunneling Tool. It is then exteriorized through a skin wound, prepared with a Skin Punch, at a location deemed optimal for the patient and his or her equipment. The Pump Cable extends only a few inches through this site. It is extended with a Modular Cable, which connects the Pump (through the Pump Cable) to a System Controller. 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.
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HeartMate III Left Ventricular Assist System Instructions for Use
Introduction 1 The HeartMate III System Controller is also part of the Left Ventricular Assist System (LVAS). The System Controller is an extracorporeal interface device that receives power from the Power Module, the Mobile Power Unit, or portable batteries. It appropriately delivers power to the LVAD. It is the primary user interface and has several important functions: • Operating condition display • Source of audible and visible alarms • Communication link for transferring event/period log and alarm information • Battery backup in the case of full power disconnection WARNING ! • A thorough understanding of the technical principles, clinical applications, and risks associated with left ventricular support is necessary before using the HeartMate III Left Ventricular Assist System. Read this entire manual before attempting implantation of the Left Ventricular Assist Device or before caring for HeartMate III patients. Completion of the Thoratec Corporation HeartMate III Surgical Training Program is also required prior to use. • Understanding the operating and safety aspects of the HeartMate III Left Ventricular Assist System is critical for safe and successful use. • All users, including clinicians, patients, and caregivers, must be trained on system operation and safety before use. • All users, including clinicians, patients, and caregivers, must be trained on any HeartMate III power accessories (Power Module, Mobile Power Unit, Battery Charger, or 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. Blood thinners have been associated with birth defects. Anticoagulation regimens are contraindicated during pregnancy. • Do not modify this equipment without authorization from Thoratec Corporation. The use of unauthorized replacement parts may affect the electromagnetic compatibility of the Mobile Power Unit with other devices. Potential interference may occur between the Mobile Power Unit and other devices. • Certain parts of the HeartMate III Left Ventricular Assist System are not compatible with other HeartMate systems. Only use HeartMate III parts with the HeartMate III system. • The HeartMate III Pump may cause interference with implantable cardiac defibrillators (ICD). If electromagnetic interference occurs, it may lead to inappropriate ICD therapy. The occurrence of electromagnetic interference with ICD sensing may require adjustment of device sensitivity and/or repositioning the lead.
HeartMate III Left Ventricular Assist System Instructions for Use
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1 Introduction CAUTION ! • 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. • Notify the appropriate personnel if there is a change in how the Pump works, sounds, or feels. • Counsel the patient to avoid contact sports and jumping activities while implanted with the Pump. Contact sports or jumping can cause bleeding or damage the Pump. • Care should be taken when small children or pets are present. There is a potential for strangulation from the system’s cables. • If HeartMate III patients are approved for showering, they must always use the Shower Bag. When installed properly, the Shower Bag protects external system components from water or moisture. If external system components have contact with water or moisture, the Pump may stop.
Indications The HeartMate III Left Ventricular Assist System is intended to provide long term hemodynamic support in patients with advanced, refractory left ventricular heart failure. It is intended either for temporary support, such as a bridge to cardiac transplantation (BTT), or as permanent destination therapy (DT). The HeartMate III is intended for use inside or outside the hospital.
Contraindications The HeartMate III Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or who are allergic to, anticoagulation therapy.
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HeartMate III Left Ventricular Assist System Instructions for Use
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: • Death • Bleeding (perioperative or late) • Local infection • Cardiac arrhythmia • Respiratory failure • Sepsis • Driveline or Pump pocket infection • Right heart failure • Renal failure • Psychiatric episode • Stroke • Peripheral thromboembolic event • Hepatic dysfunction • Neurologic dysfunction • Hemolysis
Pre-Use Requirements A thorough understanding of the technical principles, clinical applications, and risks associated with left ventricular support is required before using the HeartMate III Left Ventricular Assist System. It is suggested that patients possess a minimum 5th grade educational level and shall be versed in basic computer literacy (that is, Microsoft® Windows® and Office software). This manual contains important warnings, cautions, and instructions for use. Read this entire manual before implanting a HeartMate III Left Ventricular Assist Device or before caring for HeartMate III patients. Completion of the Thoratec Corporation HeartMate III Surgical Training Program is also required. Contact Thoratec Corporation with any questions regarding this manual. Refer to page iii for Thoratec Corporation contact information.
HeartMate III Left Ventricular Assist System Instructions for Use
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1 Introduction Equipment Overview Table 1.1 introduces the main parts of the system. For more information regarding descriptions and use of additional accessories, refer to Patient Care and Management on page 6-1.
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. The Pump diverts blood from the weakened left ventricle and pumps it to the aorta.
System Controller
The System Controller is a small computer that controls and monitors system operation. A Driveline connects the implanted Pump to the System Controller. The System Controller uses lights, sounds, and on-screen messages to communicate with users about operating status and alarm conditions.
14 Volt Lithium-Ion Batteries and 14 Volt Battery Clips Two HeartMate 14 Volt Lithium-Ion batteries power the system during battery-powered operation, such as when AC electricity is not wanted or unavailable. The batteries are used in pairs, and are inserted into a 14 Volt battery clip. Both batteries are discharged together: not one, then the other. Two power cables are required to transfer battery power to the System Controller. When fully charged, a pair of HeartMate 14 Volt Lithium Ion batteries can power the system for up to 10–12 hours, depending on the activity level of the patient.
Modular Cable The Driveline consists of two cables: the Pump Cable and the Modular Cable. One end of the Pump Cable connects to the Pump implanted in the patient’s abdomen. The other end of that cable exits the patient’s body. One end of the Modular Cable is connected to the Pump Cable and the other end connects to the System Controller.
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HeartMate III Left Ventricular Assist System Instructions for Use
Introduction 1 Table 1.1 HeartMate III System Components (Continued) Power Module
The Power Module 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. The cable transfers power from the Power Module to the System Controller.
Power Module Patient Cable The Power Module patient cable connects the Power Module to the System Controller.
Mobile Power Unit
The Mobile Power Unit is for home or clinical use when the patient does not require monitoring using the System Monitor. The Mobile Power Unit is used when the patient is indoors, stationary, or sleeping. The System Controller and the Mobile Power Unit are connected through the Mobile Power Unit patient cable. The cable transfers power from the Mobile Power Unit to the System Controller.
System Monitor
The use of the System Monitor during Left Ventricular Assist Device implantation is required. The System Monitor provides clinicians with the ability to monitor a patient’s HeartMate system, program system parameters (such as pump speed), assess and track alarm conditions, and view and save performance data.
Battery Charger The Battery Charger calibrates, charges, and tests the HeartMate 14 Volt Lithium-Ion batteries that are used to power the system during battery-powered operation.
HeartMate III Left Ventricular Assist System Instructions for Use
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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™ Product List at www.thoratec.com. Table 1.2 lists the components and equipment that are required for implant and ICU transfer.
Table 1.2 Components and Equipment for Implant Components Required for Implantation and ICU Transfer
Primary
Backup
HeartMate III Implant Kit*
Required
Required
System Controller with 11 Volt Lithium-Ion Backup Battery
Required
Required
Power Module with patient cable
Required
Required
System Monitor
Required
Required
One set of 4 rechargeable HeartMate 14 Volt Lithium-Ion batteries
Required
Not required
One set of 2 HeartMate 14 Volt battery clips
Required
Not required
Battery Charger
Required
Not required
HeartMate III Tunneling Lance and Handle**
Required
Apical coring knife**
Optional
Skin coring punch (6 mm)*
Optional
Apical cuff**
Optional
Outflow Graft Thread protectors**
Optional
Modular Cable Cap
Optional
* Some optional items are included in the HeartMate III Implant Kit. ** Also available separately.
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HeartMate III Left Ventricular Assist System Instructions for Use