Thoratec HeartMate III User manual

Patient Handbook

Thoratec Corporation
HEARTMATE III™ LEFT VENTRICULAR ASSIST SYSTEM
Patient
Handbook
Your guide to understanding the HeartMate III Heart Pump

HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK
ii

HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK 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. Therefore, please refer to the HeartMate III Instructions for Use shipped with the HeartMate III Left Ventricular Assist
System for the most current information regarding indications, contraindications, and cautions. Thoratec and the Thoratec logo are
registered trademarks, and HeartMate III and HeartLine are trademarks of Thoratec Corporation.
©2018 Thoratec Corporation.
Document: 100167342.B Publication Date: 03/2019

HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK
iv

HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK v
EMERGENCY CONTACT LIST
It is very important that you keep a list of emergency contacts with you at all times. You
may need this information if something happens to you or your pump. Before leaving the
hospital, complete the following information.
Call your hospital contact if you think that, for any reason, any portion of your
equipment is not functioning as usual, is broken, or you are uncomfortable with
the operation of the equipment. Your hospital contact can check the equipment
and order replacements, if needed. Do not try to repair anything yourself.
Hospital
Name
Address
Contact Person
Contact Person Telephone Number
Doctor
Name
Address
Telephone Number
Ambulance
Company Name
Address
Telephone Number
Emergency Services
Dial 911 (Confirm 911 is operational in your area.)
Other Important Information
Consider making several copies of this information and leave it in different places for easy access
and reference.

vi HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK

Contents
HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK vii
1 Introduction - - - - - - - - - - - - - - - - - - - - - - 1-1
Why Reading This Handbook is Important - - - - - - - - - - - - - - - - - -1-3
Understanding Warnings and Cautions - - - - - - - - - - - - - - - - - - -1-5
General Warnings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1-6
General Cautions- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1-8
Quick Reference - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1-9
Equipment Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-10
2 How Your Heart Pump Works - - - - - - - - - - - - - 2-1
Your Heart Pump - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -2-3
Driveline Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -2-4
System Controller Overview - - - - - - - - - - - - - - - - - - - - - - - - -2-6
System Controller Backup Power - - - - - - - - - - - - - - - - - - - - - - 2-35
Backup System Controller- - - - - - - - - - - - - - - - - - - - - - - - - - 2-36
3 Powering the System - - - - - - - - - - - - - - - - - - 3-1
Power Source Overview - - - - - - - - - - - - - - - - - - - - - - - - - - -3-3
Using the Mobile Power Unit - - - - - - - - - - - - - - - - - - - - - - - - -3-4
Using HeartMate 14 Volt Lithium-Ion Batteries - - - - - - - - - - - - - - - 3-18
Using the Battery Charger - - - - - - - - - - - - - - - - - - - - - - - - - 3-39
Viewing Battery Information - - - - - - - - - - - - - - - - - - - - - - - - 3-48
Calibrating HeartMate Batteries - - - - - - - - - - - - - - - - - - - - - - 3-49
4 Living with the HeartMate III - - - - - - - - - - - - - - 4-1
Keeping Your Home Safe- - - - - - - - - - - - - - - - - - - - - - - - - - -4-3
Staying Active and Safe - - - - - - - - - - - - - - - - - - - - - - - - - - -4-3
Hand Washing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -4-4
Eating- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -4-5
Caring for the Driveline- - - - - - - - - - - - - - - - - - - - - - - - - - - -4-6
Showering - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -4-9

Contents
viii HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK
Wearing and Carrying the System Controller - - - - - - - - - - - - - - - 4-22
Sleeping - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-62
Traveling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-63
5 Alarms and Troubleshooting - - - - - - - - - - - - - - 5-1
System Controller Alarms- - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3
Mobile Power Unit Alarms - - - - - - - - - - - - - - - - - - - - - - - - - 5-25
Battery Charger Alarms - - - - - - - - - - - - - - - - - - - - - - - - - - 5-27
Guidelines for Power Cable Connectors - - - - - - - - - - - - - - - - - - 5-33
What Not To Do: Driveline and Cables - - - - - - - - - - - - - - - - - - 5-34
6 Equipment Maintenance - - - - - - - - - - - - - - - - 6-1
Cleaning and Maintaining the Equipment - - - - - - - - - - - - - - - - - - 6-4
Product Disposal - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-8
7 Frequently Asked Questions - - - - - - - - - - - - - - 7-1
System Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-3
Showers and Exercise - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-4
Travel- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-5
8 Handling Emergencies - - - - - - - - - - - - - - - - - 8-1
What Is An Emergency? - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-3
How to Handle an Emergency - - - - - - - - - - - - - - - - - - - - - - - - 8-4
9 Testing and Classification- - - - - - - - - - - - - - - - 9-1
Safety Testing and Classification - - - - - - - - - - - - - - - - - - - - - - - 9-3
Acceptable Operating Conditions - - - - - - - - - - - - - - - - - - - - - - 9-4
Declaration Concerning General Safety Standards - - - - - - - - - - - - - 9-5
10 Safety Checklists - - - - - - - - - - - - - - - - - - - 10-1
Daily Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-3

Contents
HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK ix
Weekly Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - - 10-5
Monthly Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - - 10-6
Six Month Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - 10-8
Yearly Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - - - 10-9
As-Needed Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - 10-9
Clinic Visit Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - 10-10
11 Glossary - - - - - - - - - - - - - - - - - - - - - - - 11-1
Abbreviations- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-3
Terms - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 11-4

Contents
x HEARTMATE III LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK

1
HeartMate III Left Ventricular Assist System Patient Handbook 1-1
INTRODUCTION
This section provides some introductory information about the HeartMate III™
Left Ventricular Assist Device and how to use this manual.
Why Reading This Handbook is Important - - - - - - - - - - - - - - -1-3
Understanding Warnings and Cautions - - - - - - - - - - - - - - - -1-5
General Warnings - - - - - - - - - - - - - - - - - - - - - - - - - - -1-6
General Cautions - - - - - - - - - - - - - - - - - - - - - - - - - - - -1-8
Quick Reference - - - - - - - - - - - - - - - - - - - - - - - - - - - -1-9
Equipment Overview - - - - - - - - - - - - - - - - - - - - - - - - - 1-10

1Introduction
1-2 HeartMate III Left Ventricular Assist System Patient Handbook

Introduction 1
HeartMate III Left Ventricular Assist System Patient Handbook 1-3
Why Reading This Handbook is Important
Be Informed
This handbook is about your HeartMate III™ Left Ventricular Assist System. It explains how
the system works. It also describes daily life using the HeartMate III Left Ventricular Assist
System. It explains how to use and care for equipment, and how to take care of yourself.
Emergency procedures are also covered. To lower the risk of complications, you must
closely follow the instructions in this handbook.
Carefully read this handbook before leaving the hospital. Make sure that you understand
it. If you have questions after reading this handbook, ask your doctor or hospital contact.
Be Safe
After healing from the operation to implant the Pump, and with your doctor’s approval,
you can resume many of your favorite activities. Your doctor and hospital contact will
explain what is safe for you.
This handbook can help keep you safe. Use this handbook to:
• Review all warnings and cautions. Refer to the warnings and cautions throughout the
handbook.
• Review and follow steps for equipment storage and care. Refer to Equipment
Maintenance on page 6-1.
• Review and practice emergency steps. Refer to How to Handle an Emergency on page
8-4.
• Keep a list of emergency contacts. Refer to the Emergency Contact List on page v.

1Introduction
1-4 HeartMate III Left Ventricular Assist System Patient Handbook
Figure 1.1 shows the approximate placement of the Pump inside your body. Details
about the Pump function are described in How Your Heart Pump Works on page 2-1.
Figure 1.1 HeartMate III Left Ventricular Assist System on Battery Power
2
1
4
5
3
1HeartMate®14 Volt Lithium-Ion Batteries HeartMate batteries with battery clips
are worn in holsters during
battery-powered operation.
2HeartMate III Left Ventricular Assist Device
The implanted HeartMate III Left
Ventricular Assist Device is also referred
to as the Pump.
3Pump Cable When the Pump Cable and the Modular
Cable are connected by the Modular
In-Line connector, this combined cable is
referred to as the Driveline.
4Modular Cable
5System Controller The System Controller controls and
checks the Pump.

Introduction 1
HeartMate III Left Ventricular Assist System Patient Handbook 1-5
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 handbook, warnings and cautions that are relevant to a specific procedure or piece
of equipment appear at the start of each applicable section.
WARNING !
Warnings in this handbook look like this.
CAUTION !
Cautions in this handbook look like this.

1Introduction
1-6 HeartMate III Left Ventricular Assist System Patient Handbook
General Warnings
WARNING !
• A thorough understanding of the technical principles, clinical applications, and
risks of left ventricular support are necessary before using this product. Read this
entire handbook before use.
• Understanding the operating and the 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.
• The HeartMate III system components must be kept dry. Never expose the
System Controller, Batteries, or Mobile Power Unit to water. If these system
components get wet, your Pump may stop. Never take tub baths or go swimming
while implanted with the Pump. The HeartMate III Shower Bag must be used while
showering to keep the System Controller and Batteries dry.
• Do not take showers unless approved by a doctor for showering. If approved for
showering, the Shower Bag must be used for every shower. The Shower Bag
protects outside parts of the system from water or moisture. If outside parts of the
system get wet, the Pump may stop.
• Do not touch television (TV) or computer screens while you have the Pump.
TV and computer screens have strong static electricity. A strong electrical shock
can damage electrical parts of the system and cause the Pump to stop.
• Avoid activities and conditions that may induce strong static discharges
(for example, touching a television or computer monitor screen) as electrostatic
discharges may damage and/or interfere with the electrical parts of the system,
and may cause the LVAD to perform improperly or stop.
• Do not become pregnant while you have the Pump. A growing fetus may
dislodge the Pump, which may result in device failure, catastrophic bleeding,
or death. If you are a woman of childbearing age, use birth control if you are
sexually active. Blood thinners, which most Left Ventricular Assist Device patients
receive, have been associated with birth defects. Anticoagulation regimens are
contraindicated during pregnancy. If you do become pregnant, immediately tell
your doctor and hospital contact.

Introduction 1
HeartMate III Left Ventricular Assist System Patient Handbook 1-7
• Never have an MRI (magnetic resonance imaging) while you have the
HeartMate III Left Ventricular Assist System, as the device contains Ferromagnetic
components. MRI may cause Pump failure or injury.
• Therapeutic radiation, such as tissue heating therapy that uses Radio Frequency
(RF) energy sources, may damage the device, and damage may not be
immediately detectable. Never have therapeutic radiation while you have the
Pump.
• Do not subject patients implanted with the HeartMate III Left Ventricular Assist
System to magnetic Resonance Imaging (MRI) as the device contains
Ferromagnetic components. MRI can cause Pump failure or patient injury.
• 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.
• Do not try to repair any of the HeartMate III system components. If it seems broken
or in need of service, call your hospital contact.
WARNING ! (Continued)

1Introduction
1-8 HeartMate III Left Ventricular Assist System Patient Handbook
General Cautions
CAUTION !
• Call your hospital contact right away if you notice a change in how your Pump
sounds, feels, or works. Even small changes should be reported.
• Avoid contact sports and jumping activities while implanted with the Pump.
Contact sports or jumping can cause bleeding or damage to the Pump.
• Care should be taken when small children or pets are present. There is a potential
for strangulation from the system’s cables.
• Use of equipment and supplies other than those specified in the handbook or sold
by Thoratec®Corporation for replacement parts may affect the electromagnetic
compatibility of the Left Ventricular Assist System with other devices, resulting in
potential interference between the HeartMate III Left Ventricular Assist System and
other devices.
• The HeartMate III Left Ventricular Assist System uses lights, sounds, and on-screen
messages to tell you how the system is working. If you have trouble hearing or
seeing, you might need extra help to hear or see the sounds and lights. You might
be at higher risk of injury if you have trouble hearing or seeing.
• Always have a backup System Controller, fully-charged spare batteries, battery
cables, and compatible battery clips nearby at all times in case of emergency.
• The Backup Battery within the System Controller should be used only for temporary
support during a power-loss emergency. The Backup Battery will continue to run
the Pump if both power cables are disconnected. However, the Backup Battery will
not start the Pump without external power applied to the System Controller.
• Inappropriate use of the Backup Battery may result in diminished run time during a
power-loss emergency.