Abbott HEARTMATE 3 Instruction Manual
Left Ventricular Assist System
Instructions for Use
Abbott
HEARTMATE 3™ LEFT VENTRICULAR ASSIST SYSTEM
Instructions for Use
™ Indicates a trademark of the Abbott group of companies.
‡ Indicates a third party trademark, which is property of its respective owner.
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© 2020 Abbott. All Rights Reserved.
Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc.
iii
Preface - - - - - - - - - - - - - - - - - - - - - - - - - - ix
1 Introduction - - - - - - - - - - - - - - - - - - - - 1-1
Understanding Warnings and Cautions - - - - - - - - - - - - - - - - - - - - - - - 1-2
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3
Indications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7
Contraindications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7
Adverse Events - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8
Pre-Use Requirements - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8
Equipment Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-10
Required, Backup, and Optional Components and Equipment - - - - - - - - - - - - 1-15
Principles of Operation - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-17
Explanation of Parameters - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-19
2 System Operations - - - - - - - - - - - - - - - - - 2-1
HeartMate 3™ Left Ventricular Assist Device Overview- - - - - - - - - - - - - - - - 2-2
System Controller Overview- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-8
The Backup System Controller- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 2-45
3 Powering the System - - - - - - - - - - - - - - - - 3-1
Power Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-2
Using the Power Module - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-4
Using the Mobile Power Unit - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34
Using HeartMate 14 Volt Lithium-Ion Batteries - - - - - - - - - - - - - - - - - - - - 3-51
Switching Power Sources - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-66
Battery Charger Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-73
Charging HeartMate Batteries - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-80
Calibrating HeartMate Batteries - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-84
Using the Charger to Check Battery Power - - - - - - - - - - - - - - - - - - - - - - 3-86
Care and Maintenance of the Battery Charger - - - - - - - - - - - - - - - - - - - - 3-87
4 HeartMate Touch™ Communication System - - - - - 4-1
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-2
Set Up the HeartMate Touch™ Communication System- - - - - - - - - - - - - - - - 4-7
Connect the HeartMate Touch™ Wireless Adapter to the
iv
HeartMate Touch Communication System - - - - - - - - - - - - - - - - - - - - - - 4-11
Interface Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-20
HeartMate Touch™ App Views - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-21
Settings Panel - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-23
Alarms - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-40
Pump Parameters - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-50
Monitor View - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-55
Clinical View - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-56
Historical View - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-62
5 Surgical Procedures - - - - - - - - - - - - - - - - 5-1
Surgical Considerations- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-2
Equipment and Supplies Required for Implant - - - - - - - - - - - - - - - - - - - - 5-4
Preimplant Procedures- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-7
Unpacking - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-10
Unpacking the Pump and Accessories Tray - - - - - - - - - - - - - - - - - - - - - - 5-12
Unpacking the Sealed Outflow Graft - - - - - - - - - - - - - - - - - - - - - - - - - 5-16
Preparing the Sealed Outflow Graft - - - - - - - - - - - - - - - - - - - - - - - - - 5-17
Unpacking the System Controller - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-18
Unpacking the Modular Cable - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-19
Connecting and Initializing the Sterile System Controller to Non-Sterile Equipment - 5-22
Preparing, Running, and Priming the Pump - - - - - - - - - - - - - - - - - - - - - - 5-25
Preparing the Coring Knife - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-34
Implant Procedures - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-35
Postimplant Procedures - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-60
Postimplant Considerations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-66
Device Explant - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-70
6 Patient Care and Management - - - - - - - - - - - 6-1
Postoperative Patient Care - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-2
Ongoing Patient Assessment and Care - - - - - - - - - - - - - - - - - - - - - - - - 6-6
Important Clinical Considerations for HeartMate 3™ Patients - - - - - - - - - - - - 6-9
Using the Shower Bag - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-13
Wearing and Carrying System Components - - - - - - - - - - - - - - - - - - - - - 6-26
Preparing for Sleep - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-63
Ongoing System Assessment and Care - - - - - - - - - - - - - - - - - - - - - - - - 6-64
Educating and Training Patients, Families, and Caregivers- - - - - - - - - - - - - - 6-67
v
7 Alarms and Troubleshooting - - - - - - - - - - - - 7-1
System Controller Alarms - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-2
HeartMate Touch™ App Alarms - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-25
Handling Power Module Alarms - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-37
Mobile Power Unit Alarms - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-40
Using the Charger to Check Battery or Charger Status - - - - - - - - - - - - - - - - 7-42
Guidelines for Power Cable Connectors - - - - - - - - - - - - - - - - - - - - - - - 7-45
What Not To Do: Driveline and Cables- - - - - - - - - - - - - - - - - - - - - - - - 7-46
8 Equipment Storage and Care - - - - - - - - - - - - 8-1
Storage and Transport - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-2
Cleaning and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-4
Product Disposal - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-11
A Summary of the Clinical Study - - - - - - - - - - - A-1
Pediatric Real-World Data - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - A-62
B Technical Specifications - - - - - - - - - - - - - - B-1
C Safety Testing and Classification - - - - - - - - - - C-1
D HeartMate 3™ Product List - - - - - - - - - - - - - D-1
E Symbols - - - - - - - - - - - - - - - - - - - - - - E-1
F Safety Checklists - - - - - - - - - - - - - - - - - - F-1
G Glossary - - - - - - - - - - - - - - - - - - - - - G-1
Index- - - - - - - - - - - - - - -
- -
- - - - - - - Index-1
vi
Preface
This manual contains information needed to properly and safely operate the HeartMate 3™ Left
Ventricular Assist System. Users of the HeartMate 3 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 Abbott regularly provides laboratory training
and on-site, in-service programs.
ix
INTRODUCTION
This section provides an introduction to the HeartMate 3™ Left Ventricular Assist System.
Understanding Warnings and Cautions - - - - - - - - - - - - - - 1-2
1
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-3
Indications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7
Contraindications - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7
Adverse Events - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8
Pre-Use Requirements - - - - - - - - - - - - - - - - - - - - - - - - 1-8
Equipment Overview - - - - - - - - - - - - - - - - - - - - - - - - 1-10
Required, Backup, and Optional Components and Equipment - - - 1-15
Principles of Operation - - - - - - - - - - - - - - - - - - - - - - - 1-17
Explanation of Parameters - - - - - - - - - - - - - - - - - - - - - 1-19
1-1
Chapter 1 Introduction
Understanding Warnings and Cautions
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.
Cautions refer to actions or potentially unsafe conditions that may cause injury, damage the
equipment, or affect how the system works. Ignoring a caution can cause 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.
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.
WARNING !
Warnings appear in the manual in this format.
CAUTION !
Cautions appear in the manual in this format.
1-2
Chapter 1 Introduction
Overview
The HeartMate 3™ Left Ventricular Assist System (LVAS) is a set of 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 (LVAD), a blood pump intended for long-term implantation in
such patients, an extracorporeal Controller, plus all of the features, controls, attachments, interfaces,
power sources, supporting equipment, labeling, and tools required to achieve the desired
therapeutic benefit. The HeartMate 3 Left Ventricular Assist System is intended for use inside or
outside the hospital, or for transportation of LVAD patients via ground ambulance, airplane, or
helicopter.
The LVAS may be used in any of two configurations. First, line power may be utilized through the
Power Module or the Mobile Power Unit (MPU) to run the LVAD indefinitely, convenient for sedentary
or sleeping periods. Second, portable Battery power may be utilized for limited periods, convenient
for active periods. Due to the bifurcation of the Patient Cable, switching among these configurations
or from one set of Batteries to another (as when one set has been depleted and a fully charged set is
available) may be accomplished without interrupting LVAS function. Whenever the Power Module is
used, a HeartMate Touch™ Communication System may also be used as a means of viewing
operating conditions, changing operating parameters, and manipulating stored data.
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 3 LVAD is part of the LVAS. See Figure 1.1.
Figure 1.1 HeartMate 3™ LVAS During Battery-Powered Operation
1-3
Chapter 1 Introduction
Outflow Graft
with Bend Relief
Slide Lock
Motor
Rotor
Pump
Chamber
Rotor Magnet
Inflow Cannula
Pump
Cable
The LVAD is a blood pump intended for implantation in the thorax of patients affected with advanced
heart failure. The LVAD contains an Inflow Cannula, a Pump Cover, a Lower Housing, a Screw Ring
to attach the Pump Cover to the Lower Housing, a Motor, the Outflow Graft, and a Pump Cable.
Figure 1.2 Left Ventricular Assist Device Components
The LVAD is surgically connected to the patient's circulatory system via an Inflow Cannula 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 rotating about the central
axis. The fluid thus angularly accelerated collects and travels around a volute before it is diffused to
a desired 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 (i.e. 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
Lower Housing with the Stator, and all of these plus the Rotor are regarded to comprise the Motor.
1-4
Chapter 1 Introduction
The Inflow Cannula is a cylindrical conduit with external size and features similar to those of the
HeartMate II™. 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 to allow insertion of the Inflow
Cannula into the left ventricle. An Apical Attachment 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. The distal end of the graft is designed to be cut to desired
length and sutured to the ascending aorta by an end-to-side anastomosis (only the graft is to 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 Cover,
permitting pump replacement without re-anastomosis.
A Pump Cable is permanently attached to the Lower Housing 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 and is exteriorized through a skin wound prepared
with a Skin Coring Punch at a location deemed optimal for the patient and his 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 and is readily replaceable
without surgery if necessary. The Pump Cable and Modular Cable, once connected, comprise the
Driveline. The Driveline contains duplicate sets of three conductors: two for power and ground, and
a third for communication.
The HeartMate 3 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, and appropriately delivers that 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, and
• Battery backup in the case of full power disconnection.
1-5
Chapter 1 Introduction
WARNING !
• A thorough understanding of the technical principles, clinical applications, and risks
associated with left ventricular support is necessary before using the HeartMate 3 Left
Ventricular Assist System. Read this entire manual before attempting implantation of the Left
Ventricular Assist Device or before caring for HeartMate 3 patients. Completion of Abbott
HeartMate 3 Surgical Training Program is also required prior to use.
• Understanding the operating and safety aspects of the HeartMate 3 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 3
power accessories (Mobile Power Unit, Battery Charger, or HeartMate 14 Volt Lithium-Ion
batteries) before use.
• Do not use the HeartMate 3 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 Abbott. 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 3 Left Ventricular Assist System are not compatible with other
HeartMate systems. Only use HeartMate 3 parts with the HeartMate 3 system.
• The HeartMate 3 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.
1-6
Chapter 1 Introduction
CAUTION !
• Limited clinical data are available for the HeartMate 3 LVAS in patients with a body surface
area (BSA) less than 1.0 m2 (see HeartMate 3 Pediatric Patients with a BSA below 1.0 m2
on page A-67). The clinical decision to implant the HeartMate 3 in patients with a BSA less
than 1.0 m2 should be based on individualized assessment of body habitus and device fit.
• The HeartMate 3 LVAS sterilant residuals may cause adverse biological effects in patients
with a body mass
carcinogenicity, and reproductive effects.
• Clinical procedures (including LVAS settings) should be conducted under the direction of the
prescribing physician
• Do not try to repair any of the HeartMate 3 system components. If components need service,
contact appropriate
of <25 kg, including irritation, organ damage, mutagenicity,
(Authorized Personnel) only.
personnel.
• Notify 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
strangulation from the system’s cables.
• If HeartMate 3 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.
when small children or pets are present. There is a potential for
Indications
The HeartMate 3 Left Ventricular Assist System is indicated for providing short- and long-term
mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination
therapy) in adult and pediatric patients with advanced refractory left ventricular heart failure and
with an appropriate body surface area.
Contraindications
The HeartMate 3 Left Ventricular Assist System is contraindicated for patients who cannot tolerate, or
who are allergic to, anticoagulation therapy.
1-7
Chapter 1 Introduction
Adverse Events
Adverse events that may be associated with the use of the HeartMate 3™ Left Ventricular Assist
System are listed below. 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
• Cardiac Arrhythmia
• Localized Infection
• Device Malfunctions
• Right Heart Failure
•Respiratory Failure
•Driveline Infection
•Sepsis
•Renal Dysfunction
• Other Neurological Event (not stroke-related)
•Stroke
•Hypertension
• Psychiatric Episode
• Venous Thromboembolism
• Hepatic Dysfunction
• Arterial Non-Central Nervous System (CNS) Thromboembolism
• Pericardial Fluid Collection
• Pump Pocket or Pseudo Pocket Infection
• Myocardial Infarction
• Wound Dehiscence
• Hemolysis (not associated with suspected device thrombosis)
•Pump Thrombosis
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 3™ Left Ventricular Assist System.
1-8
Chapter 1 Introduction
It is suggested that patients possess a minimum 5th grade educational level and shall be versed in
basic computer literacy (i.e., Microsoft‡ Windows
This manual contains important warnings, cautions, and instructions for use. Read this entire manual
before implanting a HeartMate 3 Left Ventricular Assist Device or before caring for HeartMate 3
patients. Completion of Abbott HeartMate 3 Surgical Training Program is also required.
If you have questions after reading this manual, please contact Abbott for assistance. See Abbott
contact information on the Back Cover of this manual.
‡ and Office software).
1-9
Chapter 1 Introduction
Equipment Overview
The table below introduces the main parts of the system, along with useful accessories. All of these
items are described in more detail later in this manual.
Left Ventricular
Assist Device
The HeartMate 3™ Left Ventricular Assist Device
(frequently 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.
For more information, see page 1-17.
System Controller
14 Volt Lithium-Ion Batteries &
14 Volt Battery Clips
The System Controller is a small computer that controls
and monitors system operation. The System Controller
uses lights, sounds, and on-screen messages to
communicate with users about operating status and alarm
conditions. A Driveline, which passes through the
patient’s abdomen, connects the implanted pump to the
System Controller.
For more information, see page 2-8.
Two HeartMate 14 Volt Lithium-Ion batteries are used to
power the system during battery-powered operation, such
as when AC electricity is not wanted or unavailable.
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 10–17 hours,
depending on the activity level of the patient.
1-10
For more information, see page 3-51.
Table 1.1 HeartMate 3™ System Components
Chapter 1 Introduction
Modular Cable
Power Module
Power Module Patient 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.
The Power Module is for clinical use. The Power Module
plugs into an AC to provide power to the HeartMate 3
system. The Power Module is used when the patient is
indoors, stationary, or sleeping. A sleeping patient may
not hear low battery power alarms. 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.
For more information, see page 3-4.
The Power Module patient cable connects the Power
Module to the System Controller. Connections are made
between white-to-white and black-to-black connectors.
Mobile Power Unit
HeartMate Touch
Communication System
For more information, see page 3-15.
The Mobile Power Unit™ is for home or clinical use when
the patient does not require monitoring using the
HeartMate Touch™ Communication System. The Mobile
Power Unit is used when the patient is indoors, stationary,
or sleeping, as a sleeping patient may not hear low
battery power alarms. 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.
For more information, see page 3-34.
The HeartMate Touch Communication System provides
clinicians with the ability to wirelessly monitor a patient’s
HeartMate system, program system parameters such as
pump speed, assess and track alarm conditions, and
view and save performance data. Its use during Left
Ventricular Assist Device implantation is required.
For more information, see page 4-2.
Table 1.1 HeartMate 3™ System Components (Continued)
1-11
Battery Charger
Shower Bag
Chapter 1 Introduction
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.
For more information, see page 3-73.
The Shower Bag is used to protect external system
components from water or moisture—outside in heavy
rain or snow, and always for every shower. HeartMate 3
patients may be allowed to shower when the Driveline
exit site has healed and with permission from their doctor.
If external system components have contact with water or
moisture, the system may fail to operate properly or the
patient may get a serious electric shock.
For more information, see page 6-13.
System Controller Neck Strap
Belt Attachment
The System Controller Neck Strap attaches to the System
Controller and is used to wear the System Controller
around the neck or across the body.
For more information, see page 6-28.
The belt attachment provides another way to wear the
System Controller.
For more information, see page 6-33.
Table 1.1 HeartMate 3™ System Components (Continued)
1-12
Consolidated Bag
Battery Holster
Chapter 1 Introduction
The Consolidated Bag is a convenient way to carry two
HeartMate 14 Volt Lithium-Ion batteries and attached
battery clips during battery-powered operation.
For more information, see page 6-37.
The Battery Holster provides a convenient way to wear
two HeartMate 14 Volt Lithium-Ion batteries and attached
battery clips.
For more information, see page 6-46.
Holster Vest
The Holster Vest provides another way to wear the
HeartMate 14 Volt Lithium-Ion batteries and attached
battery clips.
For more information, see page 6-52.
Table 1.1 HeartMate 3™ System Components (Continued)
1-13
Travel Bag
Protection Bag
Chapter 1 Introduction
The Travel Bag provides a convenient way to carry and
transport the backup System Controller and spare
batteries.
For more information, see page 6-61.
The Protection Bag stores and protects the backup System
Controller.
For more information, see page 6-60.
ICU Cover
The disposable, non-sterile, single-patient use ICU Cover
is a location management accessory to secure the System
Controller to a visible location using the provided Clip.
For more information, see the ICU Cover Instructions for
Use shipped with the ICU Cover.
Table 1.1 HeartMate 3™ System Components (Continued)
1-14
Chapter 1 Introduction
Required, Backup, and Optional Components and Equipment
The HeartMate 3™ Left Ventricular Assist System is designed for use both inside and outside of the
hospital. Specific system components and equipment may be required for each setting. Components
and equipment that are required for implant and ICU transfer are listed in Table 1.2.
.
Components Required for Implantation
and ICU Transfer
HeartMate 3 Implant Kit* Required Required
System Controller with 11 Volt Lithium-Ion
Backup Battery
Power Module with patient cable Required Required
Tablet for use with the HeartMate Touch App
and HeartMate Touch Wireless Adapter
One set of 4 rechargeable HeartMate 14 Volt
Lithium-Ion batteries
One set of 2 HeartMate 14 Volt battery clips and
battery clip cables
Battery Charger Required Not required
HeartMate 3 Tunneling Lance and Handle** Required
Apical coring knife** Optional
Primary Backup
Required Required
Required Required
Required Not required
Required Not required
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 3 Implant Kit.
** Also available separately.
1-15
Table 1.2 Components for Implant
Chapter 1 Introduction
Components and equipment that are required for a discharged patient are listed in
Table 1.3. Patients discharged to a lower care facility or to their homes must be trained in device
use, maintenance, and troubleshooting. 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 3 patient.
Components for a Discharged Patient Primary Backup
Implanted HeartMate 3 Left Ventricular Assist
Device
System Controller with 11 Volt Lithium-Ion
backup battery
Mobile Power Unit Required Not Required
One set of 4 rechargeable HeartMate 14 Volt
Lithium-Ion batteries
One set of 2 HeartMate 14 Volt battery clips Required Not Required
Battery Charger Required Not Required
One set of wear & carry accessories,
including: Shower Bag, Protection Bag for
backup System Controller, holster vest, belt
attachment accessory, and System Controller
Neck Strap
HeartMate 3 Patient Handbook Required Not Required
Required n/a
Required Required
Required Required
Required Not Required
Table 1.3 Components for Discharged Patients
CAUTION !
Confirm that the patient’s backup System Controller has had the 11 Volt Lithium-Ion backup
battery installed and the time and date have been set.
WARNING !
A backup System Controller and charged batteries must remain with the patient at all times
for use in an emergency. Patient and caregiver training must address this crucial need.
1-16
Chapter 1 Introduction
Principles of Operation
The HeartMate 3™ 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
arrangement - ventricular blood may flow either through the LVAD or the aortic valve to reach the
aorta - the proportion of which depends greatly upon the degree of the patient's cardiac function
and the set-speed of the LVAD.
As for any continuous flow pump (axial, centrifugal, or mixed), the volume flow rate through the
pump is directly related to the pressure across the pump and inversely related to the resistance.
Clinically, the volume flow rate through the Pump is the difference between aortic and left ventricular
pressure, and systemic vascular resistance. This relationship can be characterized at any rotor
speed, and the family of curves derived in steady-state at different speeds is commonly termed “H-Q
curves”, or the pressure head (H) - volume flow rate (Q) relationship. HeartMate 3 H-Q curves are
shown in Figure 1.3.
Figure 1.3 Pressure Head-Flow (H-Q) Relationship
Similarly, there is a characteristic relationship between pump power and volume flow rate. Total
power consumption includes hydraulic power (useful blood pressure and flow), viscous losses,
electrical resistance losses, and others. The relationship between hydraulic power and volume flow
1-17
Chapter 1 Introduction
rate is always direct, but the various losses have a multitude of dependencies that make inflections in
the relationship possible.
In general, if the speed is set optimally, LVAD flow will be unidirectional towards the aorta and much
greater than cardiac output, which may be minimal or zero if the presence of the LVAD keeps the
aortic pressure above the ventricular pressure even during systole. If the LVAD speed is set too high,
the inflow pressure may fall to the extent that it attempts to recruit blood from the left ventricle, left
atrium, and pulmonary vasculature that simply is not there, resulting in collapse of the left ventricle
and potential arrhythmia. The HeartMate 3 LVAS employs a feature called Pulsatility Index (PI)
Detection to recognize and avert this condition. When the degree of pulsatility measured in the
electrical current waveform has fallen below a preset value, the system regards this as a risk of
ventricular suction and quickly lowers the rotor speed to a preset, programmable Low Speed Limit,
then immediately but gradually returns the rotor to its original speed. The HeartMate 3 has an
intrinsic limit somewhat above 9000rpm. The system accordingly precludes setting the speed above
9000rpm. Conversely, if the LVAD speed is set too low, support for the failing heart may be
insufficient. The HeartMate 3 LVAS uses the same Low Speed Limit mentioned above to limit how low
the speed may be set. This is to avoid profound retrograde flow (aorto-ventricular shunt). The Low
Speed Limit is settable within a range to accommodate customization for a variety of patients.
The HeartMate 3 employs a feature called Artificial Pulse that adds an element to the discussion
about rotor speed (Figure 1.4). Although the clinician will set only a single speed,
in Figure
c
1.4, the rotor speed will periodically depart from this value in order to contribute a flow disruption
that in some ways mimics native cardiac contractility. This artificial pulse “beats” 30 times per
minute, asynchronously with the heart. The Artificial Pulse mode is indicated on the System Controller
by the use of a ( ) symbol.
1-18
Figure 1.4 Artificial Pulse
Chapter 1 Introduction
Explanation of Parameters
Speed
The HeartMate 3™ Left Ventricular Assist Device operates at a fixed speed (see Optimal Fixed Speed
on page 4-25) determined by the physician during a speed ramp study.
Note: The term “fixed speed” is a speed fixed, or set, by the clinician, i.e.,
Figure 1.4. This should not be confused with the concept of a constant speed mode, as opposed to
an artificial pulse mode. Either mode requires a fixed speed, set by the clinician.
A pre-programmed artificially induced pulse is intermittently generated, changing pump speed. The
“low speed limit” for the device is the lowest speed at which it allowed to operate.
During a suction event, device speed drops to the “low speed limit” and then ramps up to the fixed
speed unless another Pulsatility Index (PI) event is detected. If another PI event is detected, the device
drops to the “low speed limit” again and then ramps back up. This cycle repeats as long as PI events
are detected. Large changes in speed may indicate an abnormal condition that should be evaluated
for cause.
c
in
Power
Device power is a direct measurement of pump motor voltage and current. Changes in pump speed,
flow, or physiological demand can affect pump power. Gradual power increases (over hours or
days) may signal thrombus deposits inside the pump, aortic or insufficiency. Gradual power
decreases may indicate an obstruction of flow and should be evaluated. Depending on the speed of
the pump, power values greater than 10 to 12 watts (W) also can indicate the presence of a
thrombus. Abrupt changes in power should be evaluated for cause.
Flow
Device flow and power generally retain a linear relationship at a given speed. However, while
power is directly measured by the System Controller, the reported flow is estimated, based on
power. Since the flow displayed on the System Controller is a calculated value, it somewhat
underestimates actual flow at high flows.
Any increase in power not related to increased flow (such as thrombus) causes erroneously high flow
readings. Conversely, an occlusion of the flow path decreases flow and causes a corresponding
decrease in power. In either situation, pump output should be assessed.
1-19
Chapter 1 Introduction
Pulsatility Index (PI)
When the left ventricle contracts, the increase in ventricular pressure causes an increase in pump
flow during cardiac systole. The magnitude of these flow pulses are measured and averaged over
15-second intervals to produce a “Pulsatility Index” (occasionally shortened to “PI” for on-screen
messages).
The PI calculation represents cardiac pulsatility. PI values typically range from 1 to 10. In general,
the magnitude of the PI value is related to the amount of assistance provided by the pump. Higher
values indicate more ventricular filling and higher pulsatility (ie, the pump is providing less support to
the left ventricle). Lower values indicate less ventricular filling and lower pulsatility (ie, the pump is
providing greater support and further unloading the ventricle).
PI values should be routinely monitored and should not vary significantly during resting conditions.
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, please contact Abbott. For Abbott contact information, see the Back Cover
of this manual.
IMPORTANT! One single pump parameter is not a surrogate for monitoring the overall clinical
status of the patient. Any change in parameters should be evaluated with all clinical considerations
taken into account.
1-20
SYSTEM OPERATIONS
This section describes the primary system operations of the HeartMate 3™ Left Ventricular Assist
System.
HeartMate 3™ Left Ventricular Assist Device Overview - - - - - - 2-2
2
System Controller Overview - - - - - - - - - - - - - - - - - - - - 2-8
The Backup System Controller - - - - - - - - - - - - - - - - - - - 2-45
2-1
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