Thoratec HEARTMATE II User manual

Thoratec Corporation
HEARTMATE II®LEFT VENTRICULAR ASSIST SYSTEM
Patient
Handbook
Your guide to understanding the HeartMate II heart pump

HeartMate II 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]
Emergency HeartLine™ USA: [phone]
Emergencies outside USA: [phone]
Authorized European Representative
European Authorized Representative:
St. Jude Medical
Coordination Center BVBA
The Corporate Village
Da Vincilaan 11 Box F1
1935 Zaventem
Belgium
[phone]
Website: www.thoratec.com
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 II Instructions for Use shipped with the HeartMate II Left
Ventricular Assist System for the most current information regarding indications, contraindications, and cautions. HeartMate II,
Thoratec, and the Thoratec logo are registered trademarks, and HeartLine is a trademark of Thoratec Corporation.
©2017 Thoratec Corporation.
Document: 10006962.C Publication Date: 05/2019

HeartMate II 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, fill in the list below.
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 list and leave it in different places for easy access and
reference.

HeartMate II Left Ventricular Assist System Patient Handbook
CONTENTS
vii
1 Introduction - - - - - - - - - - - - - - - - - - - - - - - - 1
Why Reading This Handbook is Important- - - - - - - - - - - - - - - - - - - 3
Understanding Warnings & Cautions - - - - - - - - - - - - - - - - - - - - - 5
General Warnings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6
General Cautions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7
Equipment Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8
2 How Your Heart Pump Works - - - - - - - - - - - - - 13
Your Heart Pump - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 15
The Driveline - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 16
The System Controller - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18
System Controller Backup Power - - - - - - - - - - - - - - - - - - - - - - - 51
The Backup System Controller - - - - - - - - - - - - - - - - - - - - - - - - 53
3 Powering the System - - - - - - - - - - - - - - - - - - 57
Power Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 59
Using the Mobile Power Unit - - - - - - - - - - - - - - - - - - - - - - - - - 60
Using HeartMate 14 Volt Lithium-Ion Batteries - - - - - - - - - - - - - - - - 75
Using the Battery Charger - - - - - - - - - - - - - - - - - - - - - - - - - - 97
Battery Charging Overview - - - - - - - - - - - - - - - - - - - - - - - - 103
Viewing Battery Information on the Battery Charger - - - - - - - - - - - 107
Calibrating HeartMate 14 Volt Lithium-Ion Batteries - - - - - - - - - - - - 109
4 Living with the HeartMate II- - - - - - - - - - - - - - 111
Keeping Your Home Safe - - - - - - - - - - - - - - - - - - - - - - - - - 113
Staying Active and Safe - - - - - - - - - - - - - - - - - - - - - - - - - - 114
Hand Washing - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 114
Eating - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 116

Contents
viii HeartMate II Left Ventricular Assist System Patient Handbook
Showering - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 117
Caring for the Driveline Exit Site - - - - - - - - - - - - - - - - - - - - - - 129
Caring for the Driveline - - - - - - - - - - - - - - - - - - - - - - - - - - 131
Using the Stabilization Belt- - - - - - - - - - - - - - - - - - - - - - - - - 134
Wearing and Carrying the System Controller - - - - - - - - - - - - - - - 138
Sleeping - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 179
Traveling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 181
5 Alarms and Troubleshooting - - - - - - - - - - - - - 183
System Controller Alarms- - - - - - - - - - - - - - - - - - - - - - - - - - 185
Mobile Power Unit Alarms - - - - - - - - - - - - - - - - - - - - - - - - - 204
Battery Charger Alarms - - - - - - - - - - - - - - - - - - - - - - - - - - 206
Guidelines for Power Cable Connectors - - - - - - - - - - - - - - - - - - 211
What Not To Do: Driveline and Cables - - - - - - - - - - - - - - - - - - 212
6 Caring for the Equipment - - - - - - - - - - - - - - - 217
Acceptable Operating Conditions - - - - - - - - - - - - - - - - - - - - - 219
Cleaning and Caring for the Equipment - - - - - - - - - - - - - - - - - - 220
Product Disposal - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 226
7 Frequently Asked Questions - - - - - - - - - - - - - 227
Corporate Information - - - - - - - - - - - - - - - - - - - - - - - - - - - 229
System Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 229
Showers and Exercise - - - - - - - - - - - - - - - - - - - - - - - - - - - 231
Travel- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 231
8 Handling Emergencies - - - - - - - - - - - - - - - - 233
What Is An Emergency? - - - - - - - - - - - - - - - - - - - - - - - - - - 235

Contents
HeartMate II Left Ventricular Assist System Patient Handbook ix
9 Testing & Classification - - - - - - - - - - - - - - - - 237
Safety Testing and Classification - - - - - - - - - - - - - - - - - - - - - - 239
Declaration Concerning General Safety Standards - - - - - - - - - - - - 241
Declaration and Guidance for Electromagnetic Emissions - - - - - - - - - 243
Declaration and Guidance for Electromagnetic Immunity - - - - - - - - - 244
Declaration and Guidance for Electromagnetic Emissions for HeartMate
Power Module - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 250
Declaration and Guidance for Electromagnetic Emissions for the Mobile
Power Unit - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 251
Declaration and Guidance for Electromagnetic Emissions for Battery
Charger- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 252
Declaration and Guidance for Electromagnetic Immunity for the Battery
Charger- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 253
Declaration and Guidance for Electromagnetic Emissions - - - - - - - - - 256
Declaration and Guidance for Electromagnetic Immunity for HeartMate
14 Volt Lithium-Ion Batteries - - - - - - - - - - - - - - - - - - - - - - - - 257
10 Safety Checklists - - - - - - - - - - - - - - - - - - - - 261
Daily Safety Checklist- - - - - - - - - - - - - - - - - - - - - - - - - - - - 263
Weekly Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - - 265
Monthly Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - - 266
Six Month Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - 268
Yearly Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - - - 269
As-Needed Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - 270
Clinic Visit Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - 271
11 Survey - - - - - - - - - - - - - - - - - - - - - - - - - 273
12 Glossary - - - - - - - - - - - - - - - - - - - - - - - - 277
Abbreviations- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 279
Terms - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 280

1
HeartMate II Left Ventricular Assist System Patient Handbook 1
INTRODUCTION
This section provides some introductory information about the HeartMate II Left
Ventricular Assist Device and how to use this manual.
Why Reading This Handbook is Important - - - - - - - - - - - - - - - -3
Understanding Warnings & Cautions- - - - - - - - - - - - - - - - - - -5
General Warnings - - - - - - - - - - - - - - - - - - - - - - - - - - - -6
General Cautions - - - - - - - - - - - - - - - - - - - - - - - - - - - - -7
Equipment Overview - - - - - - - - - - - - - - - - - - - - - - - - - - -8

Introduction 1
HeartMate II Left Ventricular Assist System Patient Handbook 3
Why Reading This Handbook is Important
Be Informed
This handbook is about your HeartMate II Left Ventricular Assist System. It explains
how the system works. It also describes what daily life is like. It tells you how to use
and care for equipment and how to take care of yourself. What to do in an
emergency is 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 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 (see the warnings and cautions throughout
the handbook).
• Review and follow steps for equipment storage and care (see Caring for the
Equipment on page 217).
• Review and practice emergency steps (see Handling Emergencies on page
233).
• Keep a list of emergency contacts (see Emergency Contact List on page v).

1Introduction
4 HeartMate II Left Ventricular Assist System Patient Handbook
Figure 1 shows the approximate placement of the pump inside your body. To learn
how the pump works, see How Your Heart Pump Works on page 13.
Figure 1 HeartMate II System on Battery Power
The figure above shows the following:
• Implanted HeartMate II Left Ventricular Assist Device (“heart pump”)
• HeartMate batteries, with battery clips and worn in holsters (during
battery-powered operation)
• Driveline (connects the pump to the System Controller) exiting the body
• HeartMate II System Controller (controls and checks the pump)
HeartMate II
Left Ventricular
Assist Device
HeartMate
14 Volt
Lithium-Ion
Batteries in
Holsters
Driveline
System
Controller

Introduction 1
HeartMate II Left Ventricular Assist System Patient Handbook 5
Understanding Warnings & 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
6 HeartMate II 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 II 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.
• Before using any HeartMate II power accessory (Mobile Power Unit, Battery
Charger, or HeartMate 14 Volt Lithium-Ion batteries), all users (clinicians,
patients, and caregivers) must be trained on their use.
• Do not take showers unless your doctor approves you for showering. If you
are approved for showering, you must use the Shower Bag 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.
• Static electricity can damage the electrical parts of the system and cause the
Left Ventricular Assist Device to stop. Avoid activities that may cause static
electricity, such as vacuuming or touching older style televisions or computer
screens.
• 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.
• Never have an MRI (magnetic resonance imaging) while you have the
HeartMate II Left Ventricular Assist System, as the device contains
Ferromagnetic components. MRI may cause pump failure or injury.
• —MR unsafe. Do not subject to magnetic resonance imaging.

Introduction 1
HeartMate II Left Ventricular Assist System Patient Handbook 7
General Cautions
• 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 try to repair any of the HeartMate II system components. If it seems
broken or in need of service, call your hospital contact.
WARNING ! (Continued)
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 II Left
Ventricular Assist System and other devices.
• The HeartMate II 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 controller, fully-charged spare batteries, battery
cables, and compatible battery clips nearby at all times in case of
emergency.

1Introduction
8 HeartMate II Left Ventricular Assist System Patient Handbook
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 handbook.
• The HeartMate II Left Ventricular Assist System has been extensively tested for
electromagnetic compatibility (EMC). The system will operate under normal
conditions of everyday living. However, conditions and situations that can
generate abnormally high levels of electromagnetic energy should be
avoided. Examples are:
- Very high currents (arc welding, industrial power generation)
- High-powered broadcasting and communication equipment
- High-power antenna systems
- Industrial processes that can generate high levels of electromagnetic
energy
• Risk of static discharge is increased in low humidity environments.
CAUTION ! (Continued)
Left Ventricular
Assist Device
The HeartMate II Left Ventricular Assist Device (often
called the pump) is implanted below the heart. One
end of the pump connects to the heart; the other end
connects to the aorta (the large blood vessel that
sends oxygen-rich blood through the body). A
driveline, that goes through the skin, connects the
pump to the System Controller.
For more information, see page 15.
System Controller 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.
For more information, see page 18.
Table 1 System Components