Thoratec HeartMate III User manual

Instructions for Use

Thoratec Corporation
HEARTMATE III™ LEFT VENTRICULAR ASSIST SYSTEM
Instructions for Use

HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE
ii

HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE iii
United States & Canada
Thoratec Corporation
(International Headquarters)
6035 Stoneridge Drive
Pleasanton, CA 94588
USA
Telephone: [phone]
Fax: [phone]
European Authorized Representative
St. Jude Medical
Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
Telephone: [phone]
24 Hour Number: [phone]
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.
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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: 100167343.B Publication Date: 03/2019

HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE
iv

Contents
HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE v
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
3 Powering the System - - - - - - - - - - - - - - - - 3-1
Power Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3
Using the Power Module - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-5
Using the Mobile Power Unit - - - - - - - - - - - - - - - - - - - - - - - - - - 3-34
Using HeartMate 14 Volt Lithium-Ion Batteries - - - - - - - - - - - - - - - - - 3-46
Switching Power Sources- - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-58
Battery Charger Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-65
Charging HeartMate Batteries - - - - - - - - - - - - - - - - - - - - - - - - - 3-72
Calibrating HeartMate Batteries - - - - - - - - - - - - - - - - - - - - - - - - 3-75
Checking Battery Power - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-77
Care and Maintenance of the Battery Charger - - - - - - - - - - - - - - - - 3-78

Contents
vi HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE
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
5 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
6 Patient Care and Management - - - - - - - - - - - - 6-1
Postoperative Patient Care- - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3
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
Ongoing System Assessment and Care - - - - - - - - - - - - - - - - - - - - 6-14
Showering - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-17
Preparing for Sleep - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-29
Wearing and Carrying System Components - - - - - - - - - - - - - - - - - 6-30

Contents
HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE vii
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
8 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 - - - - - - - - - - B-1
Testing and Classification: HeartMate 14 Volt Lithium-Ion Batteries - - - - - - B-24
C Symbols - - - - - - - - - - - - - - - - - - - - - - C-1
D Safety Checklists - - - - - - - - - - - - - - - - - - D-1
E Glossary - - - - - - - - - - - - - - - - - - - - - - E-1

Contents
viii HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM INSTRUCTIONS FOR USE

1
HeartMate III Left Ventricular Assist System Instructions for Use 1-1
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

1Introduction
1-2 HeartMate III Left Ventricular Assist System Instructions for Use

Introduction 1
HeartMate III Left Ventricular Assist System Instructions for Use 1-3
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.
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.
WARNING !
Warnings appear in the manual in this format.
CAUTION !
Cautions appear in the manual in this format.

1Introduction
1-4 HeartMate III Left Ventricular Assist System Instructions for Use
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 view-
ing 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

Introduction 1
HeartMate III Left Ventricular Assist System Instructions for Use 1-5
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).
Figure 1.2 Left Ventricular Assist Device Components
2
1
87
65
3
4
1Pump Cable
2Outflow Graft with Bend Relief
3Inflow Cannula
4Rotor Magnet
5Pump Chamber
6Rotor
7Motor
8Slide Lock

1Introduction
1-6 HeartMate III Left Ventricular Assist System Instructions for Use
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.

Introduction 1
HeartMate III Left Ventricular Assist System Instructions for Use 1-7
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.

1Introduction
1-8 HeartMate III Left Ventricular Assist System Instructions for Use
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.
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.

Introduction 1
HeartMate III Left Ventricular Assist System Instructions for Use 1-9
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
•Respiratoryfailure
•Sepsis
•DrivelineorPumppocketinfection
• Right heart failure
•Renalfailure
• 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.

1Introduction
1-10 HeartMate III Left Ventricular Assist System Instructions for Use
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.