Thoratec Corporation

HEARTMATE 3TM LEFT VENTRICULAR ASSIST SYSTEM

Patient
Handbook

Your guide to understanding the HeartMate 3 Heart Pump

HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK ii
 United States & Canada
Thoratec Corporation
(International Headquarters)
6035 Stoneridge Drive
Pleasanton, CA 94588
USA
Telephone: (925) 847-8600
Fax: (925) 847-8574

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 3 Instructions for Use shipped with the HeartMate 3 Left Ventricular Assist
System for the most current information regarding indications, contraindications, and cautions. Thoratec and the Thoratec logo are
registered trademarks, and HeartMate 3, Mobile Power Unit, and HeartLine are trademarks of Thoratec Corporation.

©2017 Thoratec Corporation.

Document: 10006136.A Publication Date: 08/2017

iii HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK

iv HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK
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 3 Left Ventricular Assist System Patient Handbook v

vi HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK
 Contents
1 Introduction - - - - - - - - - - - - - - - - - - - - - - - 1
Why Reading This Handbook is Important - - - - - - - - - - - - - - - - - - -3
Understanding Warnings and Cautions - - - - - - - - - - - - - - - - - - - -5
General Warnings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -6
Quick Reference - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -9
Equipment Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 10

2 How Your Heart Pump Works - - - - - - - - - - - - - 15

Your Heart Pump - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17
The Driveline - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18
The System Controller- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 21
System Controller Backup Power - - - - - - - - - - - - - - - - - - - - - - - 56
The Backup System Controller - - - - - - - - - - - - - - - - - - - - - - - - 58

3 Powering the System - - - - - - - - - - - - - - - - - - 75

Power Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 77
Using the Mobile Power Unit - - - - - - - - - - - - - - - - - - - - - - - - - 78
Using HeartMate 14 Volt Lithium-Ion Batteries - - - - - - - - - - - - - - - - 95
Using the Battery Charger - - - - - - - - - - - - - - - - - - - - - - - - - 119
Battery Charging Overview- - - - - - - - - - - - - - - - - - - - - - - - - 125
Viewing Battery Information on the Battery Charger - - - - - - - - - - - - 129
Calibrating HeartMate Batteries - - - - - - - - - - - - - - - - - - - - - - 131

4 Living with the HeartMate 3 - - - - - - - - - - - - - - 133

Keeping Your Home Safe- - - - - - - - - - - - - - - - - - - - - - - - - - 135
Electrostatic Discharge - - - - - - - - - - - - - - - - - - - - - - - - - - - 136
Eating - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 138
Caring for the Driveline- - - - - - - - - - - - - - - - - - - - - - - - - - - 139
Caring for the Driveline Exit Site - - - - - - - - - - - - - - - - - - - - - - 142
Showering - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 144

HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK vii

Contents
Wearing and Carrying the System Controller - - - - - - - - - - - - - - - 159
Sleeping - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 201
Traveling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 203

5 Alarms and Troubleshooting - - - - - - - - - - - - - 207

System Controller Alarms- - - - - - - - - - - - - - - - - - - - - - - - - - 209
Mobile Power Unit Alarms - - - - - - - - - - - - - - - - - - - - - - - - - 231
Battery Charger Alarms - - - - - - - - - - - - - - - - - - - - - - - - - - 233
Guidelines for Power Cable Connectors - - - - - - - - - - - - - - - - - - 238
What Not To Do: Driveline and Cables - - - - - - - - - - - - - - - - - - 239

6 Caring for the Equipment - - - - - - - - - - - - - - - 243

Cleaning and Caring for the Equipment - - - - - - - - - - - - - - - - - - 244
Product Disposal - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 250

7 Frequently Asked Questions - - - - - - - - - - - - - 253

Showers and Exercise - - - - - - - - - - - - - - - - - - - - - - - - - - - 257

8 Handling Emergencies - - - - - - - - - - - - - - - - 259

What Is An Emergency? - - - - - - - - - - - - - - - - - - - - - - - - - - 261
How to Handle an Emergency - - - - - - - - - - - - - - - - - - - - - - - 262

9 Testing & Classification - - - - - - - - - - - - - - - - 265

Safety Testing and Classification - - - - - - - - - - - - - - - - - - - - - - 267
Acceptable Operating Conditions - - - - - - - - - - - - - - - - - - - - - 268
Declaration Concerning General Safety Standards - - - - - - - - - - - - 269

10 Safety Checklists - - - - - - - - - - - - - - - - - - - 293

Daily Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - - - 295
Weekly Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - - 297
Monthly Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - - 298

viii HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK

 Contents
Six Month Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - 300
Yearly Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - - - 301
As-Needed Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - 301
Clinic Visit Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - 302

11 Glossary - - - - - - - - - - - - - - - - - - - - - - - - 303
Abbreviations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 305

HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK ix

Contents

x HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM PATIENT HANDBOOK

 1

INTRODUCTION

This section provides some introductory information about the HeartMate 3 Left
Ventricular Assist Device and how to use this manual.

Why Reading This Handbook is Important - - - - - - - - - - - - - - - -3

Understanding Warnings and Cautions - - - - - - - - - - - - - - - - -5

General Warnings - - - - - - - - - - - - - - - - - - - - - - - - - - - -6
General Cautions - - - - - - - - - - - - - - - - - - - - - - - - - - - - -8

Equipment Overview - - - - - - - - - - - - - - - - - - - - - - - - - - 10

HeartMate 3 Left Ventricular Assist System Patient Handbook 1

1 Introduction

2 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Introduction 1
Why Reading This Handbook is Important

Be Informed
This handbook is about your HeartMate 3 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 243).

• Review and practice emergency steps (see How to Handle an Emergency on

page 262).

• Keep a list of emergency contacts (see Emergency Contact List on page v).

HeartMate 3 Left Ventricular Assist System Patient Handbook 3

1 Introduction
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 15.

Figure 1 HeartMate 3 System on Battery Power

HeartMate HeartMate 3
14 Volt Left Ventricular
Lithium-Ion Assist Device
Batteries in
Holsters
The Pump
Cable and
Modular
Cable, when
Pump Cable connected, are
called the
Driveline

Modular
System Cable
Controller

The figure above shows the following:

• Implanted HeartMate 3 Left Ventricular Assist Device (“heart pump”)

• HeartMate batteries, with battery clips and worn in holsters (during

battery-powered operation)

• The Driveline is the combination of the Pump Cable and the Modular Cable
(when connected by the Modular In-Line connector)

• HeartMate 3 System Controller (controls and checks the pump)

Note: The System Controller is often called Controller.

4 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Introduction 1
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.

HeartMate 3 Left Ventricular Assist System Patient Handbook 5

1 Introduction
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 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 (Power Module, Mobile Power Unit™,
Battery Charger, or HeartMate 14 Volt Lithium-Ion batteries) before use.

• The HeartMate 3 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 3 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.

• High levels of static electricity may damage and/or interfere with the
electrical parts of the system and cause the Left Ventricular Assist Device to
stop. The presence of electrostatic discharge (ESD) may be increased in
environments with a relative humidity less than 30%. Avoid activities that may
cause static electricity and discharge any buildup by touching a metal surface
before handling LVAS components.
• Do not touch television (TV) or computer screens while you have the pump.
TV and computer screens have strong static electricity. A strong electric 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.

6 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Introduction 1
WARNING ! (Continued)
• 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 3 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.

• —MR unsafe. Do not subject patients implanted with the HeartMate 3

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 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.

• Do not try to repair any of the HeartMate 3 system components. If it seems

broken or in need of service, call your hospital contact.

HeartMate 3 Left Ventricular Assist System Patient Handbook 7

1 Introduction
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 3
Left Ventricular Assist System and other devices.
• The HeartMate 3 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 11 Volt Lithium-Ion backup battery within the System Controller should be
used only for temporary support during a power-loss emergency. The 11 Volt
Lithium-Ion backup battery will continue to run the Pump if both power cables
are disconnected. However, the 11 Volt Lithium-Ion backup battery will not
start the Pump without external power applied to the System Controller.

• Inappropriate use of the 11 Volt Lithium-Ion backup battery may result in

diminished run time during a power-loss emergency.

• Some radio devices such as Citizens Band (CB) radios, hand-held

walkie-talkies, cordless phones and radio-controlled toys operating near
27 MHz or 40 MHz may cause interference with the HeartMate 3 LVAS and
such radio device use by, or near, the patient should be avoided. If
interference is suspected, turn off the radio device and/or move away when
possible.

8 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Introduction 1
Quick Reference
There is a Table of Contents at the beginning of this Handbook and an Index at the
end; however, here are a few references that might direct you to sections that may
be more frequently used.

Note: The System Controller is often called the Controller. Please search the Table
of Contents and Index using System Controller.

Task Refer to section

Responding to System Controller

System Controller Alarms on page 209
Alarms

Daily System Controller Self-Test The System Controller Self Test on page 41

Replacing Low Batteries with Replacing Low Batteries with Fully-Charged

Fully Charged Batteries Batteries on page 111

Changing from Mobile Power Changing from Mobile Power Unit Power to
Unit to Batteries Batteries on page 114

Changing from Batteries to Changing from Batteries to Mobile Power Unit

Mobile Power Unit Power on page 117

Charging HeartMate 14 Volt Charging HeartMate 14 Volt Lithium-Ion

Lithium-Ion Batteries Batteries on page 127

Showering Using the Shower Bag on page 147

Caring for the Driveline Caring for the Driveline on page 139

Caring for the Driveline Exit Site Caring for the Driveline Exit Site on page 142

HeartMate 3 Left Ventricular Assist System Patient Handbook 9

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 handbook.

Left Ventricular
Assist Device The HeartMate 3 Left Ventricular Assist Device (often
called the pump) is implanted in the chest 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 connects the pump to the System
Controller.
For more information, see page 17.

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 you about operating
status and alarm conditions.
For more information, see page 21.

HeartMate 14 Volt Lithium-Ion

Batteries & Battery Clips
Batteries are used to power the system when you are
active or outdoors. Special batteries are required.
You always need to use two batteries at a time. Each
battery inserts into a battery clip, which connects the
power cables to the System Controller. Two new
batteries can power your system up to 17 hours.
For more information, see page 93.

Table 1 System Components

10 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Introduction 1
Modular Cable
The Driveline consists of two cables: the Pump Cable
and the Modular cable. One end of the Pump Cable
is connected to the pump, the other end exits your
body. One end of the Modular cable is connected
to the Pump Cable at the Modular In-line Connector,
and the other end connects to the System Controller.

The Mobile Power Unit plugs into an AC outlet to

Mobile Power Unit provide power to the HeartMate 3 system and is
used while indoors, stationary, or sleeping. The
System Controller and the Mobile Power Unit are
connected through the Mobile Power Unit patient
cable. The cable transfers power from the Mobile
Power Unit to the System Controller.
For more information, see page 78.

Battery Charger
The Battery Charger charges, calibrates, and tests
the HeartMate batteries that are used to power the
system during battery-powered operation.
For more information, see page 119.

Shower Bag
The Shower Bag protects external system
components from water or moisture—outside in
heavy rain or snow, and always for every shower.
You may be allowed to shower when the Driveline
exit site has healed and with permission of your
doctor. If external system components have contact
with water or moisture, the system may fail to
operate properly or you may get an electric shock.
For more information, see page 147.

System Controller Neck Strap

The System Controller Neck Strap attaches to the
System Controller and allows you to wear the
System Controller around your neck or across your
body.
For more information, see page 161.

Table 1 System Components (Continued)

HeartMate 3 Left Ventricular Assist System Patient Handbook 11

1 Introduction
Belt Attachment
The belt attachment provides another way to wear
the System Controller.
For more information, see page 166.

Consolidated Bag

The Consolidated Bag is a convenient way to wear

and carry the System Controller and batteries.
For more information, see page 171.

Battery Holster

The Battery Holster provides a convenient way to

wear the batteries and battery clips.
For more information, see page 184.

Holster Vest

The Holster Vest provides another way to wear the

batteries and battery clips.
For more information, see page 192.

Table 1 System Components (Continued)

12 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Introduction 1
Travel Bag

The Travel Bag provides a convenient way to carry

and transport the backup System Controller and
spare batteries.
For more information, see page 182.

Protection Bag
The Protection Bag stores and protects the backup
System Controller.
For more information, see page 182.

Table 1 System Components (Continued)

HeartMate 3 Left Ventricular Assist System Patient Handbook 13

1 Introduction

14 HeartMate 3 Left Ventricular Assist System Patient Handbook

 2

HOW YOUR HEART PUMP WORKS

This section provides information to help you understand how the HeartMate 3 Left
Ventricular Assist Device works.

Your Heart Pump - - - - - - - - - - - - - - - - - - - - - - - - - - - - 17

The Driveline - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 18

The System Controller - - - - - - - - - - - - - - - - - - - - - - - - - - 21

System Controller Backup Power - - - - - - - - - - - - - - - - - - - - 56

The Backup System Controller- - - - - - - - - - - - - - - - - - - - - - 58

HeartMate 3 Left Ventricular Assist System Patient Handbook 15

2 How Your Heart Pump Works

16
HeartMate 3 Left Ventricular Assist System Patient Handbook
 How Your Heart Pump Works 2
Your Heart Pump
Your heart pump is called the HeartMate 3 Left Ventricular Assist Device (Figure 2).
It helps move blood through your body. A small motor inside the pump turns the
rotor that moves the blood. The pump is placed below the heart. One end connects
to the left ventricle (the heart’s main pumping chamber). The other end connects to
the aorta (the large blood vessel that sends blood through the body).

Figure 2 HeartMate 3 Left Ventricular Assist Device

Aorta

Left Ventricle

The pump helps your heart by taking over the work of the left ventricle. The pump
sends oxygen-rich blood from the heart to the aorta. The aorta then sends the blood
to the rest of your body. In this way, your lungs, organs, and cells get the oxygen
they need.

You may feel the pump working. This is normal.

17
HeartMate 3 Left Ventricular Assist System Patient Handbook
2 How Your Heart Pump Works
The Driveline

WARNING !
• Check the System Controller Driveline connector often to confirm that the
Driveline is securely inserted in the socket. If the Driveline disconnects from
the System Controller, the pump will stop.

• Do not open, crush, heat above 104°F (40°C), or incinerate batteries

because of the risk of fire and burns. Follow manufacturer’s instructions.

• Malfunction of internal backup battery may cause the System Controller to

become excessively hot. If this occurs, switch to the backup System Controller.

CAUTION !
• To avoid pulling on or moving the Driveline at the exit site, the patient must
stabilize their Driveline at all times. Pulling on or moving the Driveline can
keep the exit site from healing or damage an already healed exit site. Exit
site trauma or tissue damage can increase the patient’s risk of getting a
serious infection. Emphasize to the patient and/or family member or
caregiver the importance of not pulling on or moving the Driveline.
• Do not twist, kink, or sharply bend the Driveline, System Controller power
cables, or Mobile Power Unit patient cable, which may cause damage to the
wires inside, even if external damage is not visible. Damage to the Driveline
or cables could cause the pump to stop. If the Driveline or cables become
twisted, kinked, or bent, carefully unravel and straighten.

As shown in Figure 3, a thin cable (called a Pump Cable) goes through your
abdomen. It connects to the Modular cable which then connects the pump to the
System Controller. When the Pump Cable and Modular cable are connected, they
are referred to as the Driveline.

18
HeartMate 3 Left Ventricular Assist System Patient Handbook
 How Your Heart Pump Works 2
Figure 3 The Driveline Connects the Pump to the System Controller

Pump Cable

Driveline (both
cables when
Modular Cable connected)

The Driveline sends power and operating signals to the pump. It also supplies
information from the pump to the System Controller.

19
HeartMate 3 Left Ventricular Assist System Patient Handbook
2 How Your Heart Pump Works
Modular In-line Connector

WARNING !
Do not disconnect the Modular In-line Connector or the pump will stop.

There is a Modular In-line Connector that connects your Pump Cable and Modular
Cable. It has a locking nut that keeps both cables connected and secure.

Figure 4 Modular In-line Connector

Locking Nut

The Pump Cable is covered with a special material. It lets skin cells grow into the
cable. Skin growth on the cable is a barrier that can lower the risk of infection.
Keeping the skin clean and dry near the cable exit site also lowers infection risks.

20
HeartMate 3 Left Ventricular Assist System Patient Handbook
 How Your Heart Pump Works 2
The System Controller

WARNING !
• Keep connectors clean and dry and away from water or liquid. If the
connectors come into contact with water or liquid, the system may fail to
operate properly or you may get an electric shock.

• Check the System Controller Driveline connector to confirm that the Driveline
is securely inserted in the socket. If the Driveline disconnects from the System
Controller, the Pump stops. If the Driveline disconnects from the System
Controller, promptly reconnect it to resume Pump operation.
• The pump will stop if the Driveline is disconnected from the System Controller.
If the Driveline disconnects from the System Controller, reconnect it right
away to restart the pump. The pump cannot run without power.
• At least one System Controller power cable must be connected to a power
source (Mobile Power Unit or two HeartMate 14 Volt Lithium-Ion batteries) at
all times.
• Never submerge the Driveline, System Controller, or any external system
components (such as the Mobile Power Unit, batteries, power cables, or
battery clips) in water or liquid. Submersion in water or liquid may cause the
pump to stop.
• Do not swim or take tub baths while implanted with the pump. Immersion in
water may cause the device to stop.
• Do not shower without a doctor’s approval. Showering may be allowed, but
only after sufficient Driveline exit site healing and with a doctor’s permission.
• The Shower Bag protects external system components from water and
moisture. If external system components have contact with water or moisture,
the patient may receive a serious electrical shock or the Pump may stop.
• The 11 Volt Lithium-Ion backup battery inside the System Controller should be
used only for temporary support during a power-loss emergency. The 11 Volt
Lithium-Ion backup battery can provide enough power to run the pump for at
least 15 minutes if the main power source (either the Mobile Power Unit or
two HeartMate 14 Volt Lithium-Ion batteries) disconnects or fails.
Inappropriate use of the 11 Volt Lithium-Ion backup battery may result in
diminished run time during a power-loss emergency.

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CAUTION !
• The System Controller uses lights, sounds, and on-screen messages to tell you
how the system is running. HeartMate 3 users with sight or hearing
impairment may need extra help using the System Controller.
• Do not drop the System Controller or subject it to extreme physical shock.
• The hospital contact should be informed immediately if the System Controller
is dropped. Never delay reporting a dropped System Controller, even if
everything seems fine. Dropping the System Controller can cause trauma or
tissue damage at the Driveline exit site, which can increase your risk of
getting a serious infection. Early treatment of exit site trauma can lower the
risk of infection.
• Never use tools to tighten power cable connectors. Securely hand tighten
only. Using tools may damage the connectors.
• When connecting power cable connectors, do not try to join them together
without first aligning the half circles inside the connectors. Joining together
misaligned power cable connectors may damage them.
• Do not twist, kink, or sharply bend the Driveline, System Controller power
cables, or Mobile Power Unit patient cable, which may cause damage to the
wires inside, even if external damage is not visible. Damage to the Driveline
or cables could cause the pump to stop. If the Driveline or cables become
twisted, kinked, or bent, carefully unravel and straighten.
• Damage to electrical wires inside the Driveline can occur even if not visible
outside. Be alert for signs of Driveline damage, including (but not limited to):

- The System Controller alarming when the Driveline is moved or when you
change position.
- High pulsatility index (PI) readings on the System Controller.
- Occurrence of a Driveline Fault Alarm.
- Feeling pump vibrations.
- Fluid from the external portion of the Driveline.
- Pump stopping.
• The patient should keep a backup System Controller and at least two
fully-charged batteries with him or her at all times for use in an emergency.

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CAUTION ! (Continued)
• The 11 Volt Lithium-Ion backup battery inside the backup System Controller
must be charged at least once every six months. Failure to charge the 11 Volt
Lithium-Ion backup battery inside the backup System Controller may result in
no support during a power-loss emergency when the backup System
Controller is in use.

• Do not place the System Controller on bare skin for an extended time. The
System Controller surface temperature can become uncomfortably warm,
especially when the room temperature is above 104°F (40°C).

The System Controller is a small computer. It controls and checks system operation.
The Driveline going through your skin connects the pump inside of your body with
the System Controller outside of your body (see Figure 5).

Figure 5 HeartMate 3 System Controller

Power Cable User Interface • Controller Driveline Connector:
links the pump to the System
Controller.
• Two Power Cable
Connectors: link external
power source (Mobile Power
Unit or 2 HeartMate 14 Volt
Lithium-Ion Batteries) to the
System Controller.
• User Interface: buttons, lights,
and screen where system
data, alarms, and user
instructions appear.
• Backup battery: located inside
the System Controller, powers
Backup
Controller Driveline the pump for at least 15
Battery
Connector minutes during a power-loss
(inside) emergency.

The System Controller is used to:

• Control system operation.

• Check and respond to system operation.

• Display real-time data on the System Controller user interface.

• Provide a backup system if the main system fails.

• Identify problems with system operation.

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• Alarm with lights, sounds, and on-screen messages.

• Record and store data in its memory.

• Send data to devices that are used by nurses and doctors to control
operation and to find, understand, and fix problems.

Information about the System Controller can be found on the following pages:

The System Controller User Interface

This section describes the visual display of system operations
and on-screen messages.
See page 25.

The System Controller Driveline Connector

This section provides instructions on connecting and
disconnecting the Driveline.
See page 32.

System Controller Power Cable Connectors

This section describes the two power cables on the System
Controller (one white and one black) that connect the System
Controller to either the Mobile Power Unit or two 14 Volt
Lithium-Ion batteries.
See page 38.

The System Controller Self Test

This section provides instructions on how to perform a daily self
test to check the function of the System Controller’s audible and
visual alarms.
See page 41.

Using the Battery Power Gauge on the System Controller

This section describes the battery power gauge function to
show the approximate charge status of the power source that is
connected to the System Controller’s power cables.
See page 44.

System Controller Operating Modes

This section describes the System Controller’s three operating
modes (Run, Sleep, and Charge) and provides an overview
with instructions on how to switch between modes.
See page 47.

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The System Controller User Interface
The user interface on the System Controller (Figure 6) uses sounds, lights, symbols,
and on-screen messages to tell you how the system is working.

Figure 6 System Controller User Interface

Battery Button
Cable Disconnect Pump Running Symbol
Symbols

Display
Button

User
Interface
Screen

Status Symbols Silence Alarm Button

Driveline Cable
Connector White System Controller System Controller Driveline Red Button
Alignment Arrow Driveline Connector Connector Alignment Arrow

Power Cable
Connectors Safety Lock

On-screen messages also tell you how to handle alarms and other situations.

If you have trouble hearing or seeing, you may need extra help using the System
Controller.
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For situations that require attention, and depending on the urgency, the System
Controller issues one of two types of alarms: hazard and advisory. Hazard alarms
occur for conditions that are potentially life threatening for the patient and require
immediate attention. Advisory alarms are important, but not life threatening. For
more information on System Controller alarms and how to resolve them, see System
Controller Alarms on page 209.

Table 2 introduces the main parts of the user interface. These parts are described in
more detail later in this section.

Pump Running
Symbol The green Pump Running light stays on as long as the pump gets
power and remains running.

The red low battery symbol comes on when less than 5 minutes of
power remain for the two in-use HeartMate batteries. This alarm
Low Battery applies only during battery-powered operation. This alarm may
Alarm Symbol also occur when connected to the Mobile Power Unit. If it does,
contact your hospital.
This is a Hazard alarm. When the red low battery symbol comes
on, immediately replace the low batteries with two fully-charged
batteries, or switch to the Mobile Power Unit. Do this immediately
or the pump may stop.
The yellow wrench symbol comes on when the System Controller
Yellow Wrench detects a mechanical, electrical, or software issue with the system.
Alarm Symbol
This is an Advisory alarm. When the yellow wrench symbol
comes on, follow the on-screen instructions. Do this as soon as
possible.
For more information, see page 209.
The red heart symbol comes on for a serious condition. A red
Red Heart heart condition could harm or kill you if it is not fixed.
Alarm Symbol
This is a Hazard alarm. When the red heart symbol comes on,
follow the on-screen instructions. Do this immediately or you could
be seriously harmed or killed.
For more information, see page 209.
Table 2 System Controller User Interface

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Black Power The yellow light near the black power cable connector comes on
Cable when the black power cable is loose or disconnects from the
Alarm Symbol System Controller.
This is an Advisory alarm. If this light comes on, fix the
connection as soon as possible.
For more information, see page 220.
White Power The yellow light near the white power cable connector comes on
Cable when the white power cable is loose or disconnects from the
Alarm Symbol System Controller.
This is an Advisory alarm. If this light comes on, fix the
connection as soon as possible.
For more information, see page 220.
Driveline The red light near the Driveline connector comes on when the
Connector Driveline is loose or disconnects from the System Controller.
Alarm Symbol
This is a Hazard alarm. When the Driveline Disconnected Alarm
comes on, reconnect the Driveline right away. If the Driveline is
not reconnected, the pump will stop.
For more information, see page 219.
Battery Power
Gauge

The battery power gauge shows the approximate charge status of

the power source that is connected to the System Controller’s
white and black power cables—either the 14 Volt Lithium-Ion
batteries or the Mobile Power Unit. The number of green bars
means the more power remaining.
For more information, see page 44.
Yellow diamond = less than 15 minutes of battery power
remain. Appearance of this symbol indicates an Advisory
alarm. If the yellow diamond comes on, promptly replace the low
batteries with two fully-charged batteries, or switch to the Mobile
Power Unit. Do this as soon as possible.
For more information, see page 224.

IMPORTANT! The battery power gauge does not show the

charge status of the System Controller’s backup battery (the
battery inside the System Controller).

Table 2 System Controller User Interface (Continued)

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The battery button is used for the following:
• Operating the battery power gauge: Press and release
the battery button.
For more information, see page 44.
• Starting System Controller self test: Press and hold the
battery button for 5 seconds and then release it. Perform a self
Battery Button test daily on your running System Controller, and every six
months on your backup System Controller, when it is in
Charge Mode.
For more information, see page 42.
• Putting a running System Controller into Sleep
Mode: When a System Controller is no longer in use, it can
be put to sleep by disconnecting the Driveline and power
source, and pressing and holding the battery button for 5
seconds and then releasing it.
For more information, see page 55.

The silence alarm button is used for the following:

• Silencing an active alarm: Press and release the silence
alarm button to silence an active alarm on the System
Controller. How long it is silenced depends on the alarm (see
System Controller Alarms on page 209). You will see the
alarm silence symbol on the LCD screen of the System
Silence Alarm
Controller.
Button
IMPORTANT! Using the silence alarm button only silences
the alarm. It does not fix the alarm condition.

• Viewing the last six System Controller alarms on

the screen: Press and release the silence alarm button ( )
and the display button ( ) at the same time to display the last
six System Controller alarms on the screen.
For more information, see page 210.

Table 2 System Controller User Interface (Continued)

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The display button activates the information display screen. Press
and release the display button to display information about pump
speed, power, flow, pulsatility index, and the charge status of the
System Controller’s 11 Volt Lithium-Ion backup battery. The
Display Button display button is functional only when a System Controller is in
use.
For more information, see page 30.
Press and release the silence alarm button ( ) and the display
button ( ) at the same time to display the last six System
Controller alarms on the screen.
For more information, see page 210.

Table 2 System Controller User Interface (Continued)

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Viewing Pump and System Information on the Screen
Viewing information about the pump is useful when recording daily values or trying
to resolve system problems on the telephone with your hospital contact. When the
System Controller is running, the user interface can display information about the
current system operations:

• Speed

• Flow

• Pulsatility Index (abbreviated as “PI” on the screen)

• Power

• Charge status of the System Controller’s backup battery (11 Volt Lithium-Ion)

To view information on the user interface screen, press and release the display
button ( ). Each push of the display button brings up a new screen. Each screen
comes on for 15 seconds before it goes black, unless another button is pushed. The
screens are always displayed in the same order, starting with the first (Speed)
screen. A dot at the bottom of each screen provides navigational information about
which of the five screens is in view. Table 3 shows the display sequence.

While your pump is operating, an artificial pulse is generated. You can tell that
Pulse Mode is in operation when you see a displayed on the LCD screen of
your System Controller.

Figure 7 shows the LCD screen display if the audio alarms have been silenced.

Figure 7 Silence Alarms

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Screen
Button
Description Displayed Meaning
Press
(Example)

Press
Press display button Pump speed in revolutions per
ONCE minute (RPM)

Press
Press display button Pump flow in liters per minute
TWO times (LPM)

Press
Press display button
Pulsatility Index (PI)
THREE times

Press
Press display button
Power in watts (W)
FOUR times

The System Controller’s backup

battery (located inside the
System Controller and used to
temporarily run the pump
Press
during a power emergency)
has three charge status states:
Press display button
FIVE times 1. Charged (ready for use).
2. Charging (actively
charging).
3. Fault (there is a fault or
problem with the backup
battery that could affect its
reliability).

Press
Press display button Blank screen indicates the
SIX times screen is off, which is normal.

Table 3 System Controller Display Screen Sequence

Note: On-screen messages come in many different languages. Talk with your
hospital contact about selecting the language that is best for your needs.

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The System Controller Driveline Connector
Figure 8 System Controller Driveline Connector

Controller
Driveline
Connector

The Controller Driveline Connector connects the Driveline to the System Controller.
It has a double lock to lower the risk of accidentally detaching the Driveline. The
Driveline is first connected to the running System Controller as one of the steps to
implant the pump. It should remain connected to the same, running System
Controller at all times—unless told by your hospital contact to replace it (see
Replacing the Running System Controller with a Backup Controller on page 63).

It is impossible to connect (or disconnect) the Controller Driveline Connector without

moving the Driveline Safety Lock into the “unlocked” position. When the Controller
Driveline Connector is secure in the socket, the Driveline cannot be removed without
pressing the red button under the raised Safety Lock (Figure 9).

Figure 9 Driveline Safety Lock

System Controller Driveline Connector Alignment Arrow Red Button
Safety Lock
Driveline
Cable
Connector
White
Alignment
Arrow

The System Controller continually monitors the connection status of the Controller
Driveline Connector. If the System Controller detects a problem, it immediately
alarms. For more information, see Driveline Disconnected Alarm on page 219.

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Connecting the Driveline to the System Controller
FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Running System Controller

• Driveline

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Orient the System Controller so the display is facing down.
3. Rotate the Safety Lock to the unlocked position (Figure 10).
Figure 10 Unlock the Safety Lock

CAUTION !
• Do NOT insert a misaligned Driveline Cable Connector.

• When inserting the Driveline Cable Connector, do NOT orient the System
Controller so the display is facing up.

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4. Align the WHITE arrow/alignment mark on the Driveline Cable Connector
with the WHITE arrow on the System Controller Driveline Connector (Figure
11).

Figure 11 Align the Arrows

5. Insert the Driveline Cable Connector into the socket (Figure 12), pressing
firmly until it snaps into place. The Left Ventricular Assist Device immediately
starts running when the cable is fully and properly inserted in the socket
(if pump set speed is set above 4000 rpm).

IMPORTANT! The arrow/alignment mark on the driveline is no longer visible

when properly connected.

Figure 12 Insert and Lock the Driveline Into the Socket

6. Move the Safety Lock to the locked position, so that it covers the red button.
The Safety Lock cannot move to the locked position unless the Driveline is fully
and properly inserted.

IMPORTANT! If the Safety Lock does not fully cover the red button, the driveline is
not connected. Disconnect and reconnect the driveline.

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7. Tug on the inserted metal end of the Modular Cable to check the connection.
Do not pull on or bend the Driveline. If there is a problem with the connection,
the System Controller immediately alarms with a Driveline Disconnected
alarm. This is a Hazard alarm.

CAUTION !
Do not pull on or bend the Driveline that connects the pump to the System Controller.
Pulling on or bending the Driveline may damage wires inside, even if external Driveline
damage is not visible.

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Disconnecting the Driveline from the System Controller
WARNING !
• Failure to connect to a running System Controller may result in serious injury or
death.

• The pump will stop running as soon as the driveline is disconnected.

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Running System Controller

• Driveline that is connected to a running System Controller

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Orient the System Controller so the display is facing down.
3. Rotate the Safety Lock to the unlocked position (see Figure 13).
Figure 13 Unlock the Safety Lock

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4. Firmly press the red button under the Safety Lock, while pulling the Controller
Driveline Connector from the socket. Grasp the bend relief of the Modular
Cable while removing it. Do not pull on or bend the Controller Driveline
Connector (see Figure 14).
Figure 14 Grasp the Metal End and Remove the Driveline

WARNING !
The Left Ventricular Assist Device stops if the Driveline is disconnected from the System
Controller. If the Driveline is disconnected, reconnect it as quickly as possible to restart
the pump. If the System Controller does not work, replace with a backup System Control-
ler.

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System Controller Power Cable Connectors
The pump cannot work without a power source. As long as the pump is connected
to power, it will continue to run.

Two power cables on the System Controller connect to a power source (either the
Mobile Power Unit or two HeartMate 14 Volt Lithium-Ion batteries). One power
cable has a black connector. The other cable has a white connector. (See Figure
15.)

The System Controller continually monitors the connection status of the power cable
connectors. If the System Controller detects a problem, it immediately alarms. For
more information, see Power Cable Disconnected Alarm on page 223.

Figure 15 Power Cable Connectors

White
Connector
Black
Connector

Figure 16 Do Not Sharply Bend the Power Cables

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During routine use, the HeartMate 3 system is powered by one of two power
sources, the Mobile Power Unit or batteries, as described below.

• Mobile Power Unit: The Mobile Power Unit plugs into an AC electrical
outlet. Use it for power when you are indoors relaxing—and always when
sleeping (or when sleep is likely). You must connect to the Mobile Power Unit
when sleeping since you may not hear the System Controller alarms.
Electrical power from the AC outlet is carried to the system through the
Mobile Power Unit patient cable. This cable connects the Mobile Power Unit
to the System Controller. The Mobile Power Unit patient cable is required to
transfer power to the System Controller. Figure 17 shows the Mobile Power
Unit in use.

Figure 17 Mobile Power Unit in Use

Mobile
Power Unit
Power
See page
78.

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• Two HeartMate 14 Volt Lithium-Ion batteries: Use two HeartMate
batteries to power the system when AC power is not wanted or not available
(for example, when being active outdoors). Batteries are used two at a time.
Each battery is inserted into a 14 Volt battery clip. The clips transfer power
to the System Controller through two power cables (one for each battery
clip). Without battery clips, the batteries cannot power the system. When
new, two fully charged HeartMate 14 Volt Lithium-Ion batteries can power
the system for 17 hours. How long the batteries can power the system
depends on your activity level. If you are more active, the run time will be
less. Figure 18 shows the batteries in use.

Figure 18 Batteries in Holsters

Battery Power
See page 95.

WARNING !
The System Controller must be connected to either the Mobile Power Unit or two Heart-
Mate 14 Volt Lithium-Ion batteries at all times.

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The System Controller Self Test
The System Controller self test takes less than a minute and can be run in both Run
and Charge modes. It is brief, but very important. During the self test, the System
Controller checks the lights, symbols, and sounds on the user interface. With the self
test, you can tell if they are working. Performing a self test will not change the speed
at which your pump is running.

The System Controller self test is loud and bright. All of the lights, symbols, and
sounds come on and “Self Test” appears on the screen (Figure 19).

Figure 19 System Controller During Self Test

The self test should be done at least once per day on the running System Controller.
Try to perform the self test at the same time each day so that it becomes part of your
daily routine. When charging the backup System Controller every six months, self
test the backup System Controller when it is in Charge mode.

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Performing a System Controller Self Test

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Running System Controller

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

Note: A self test can only be performed when power is connected to the
System Controller.

IMPORTANT! If an alarm occurs during a self test, the self test ends. The active
alarm overrides the self test. For more information, refer to System Controller Alarms
on page 209. A System Controller self test cannot be initiated during the following
alarms: any Hazard alarm, Power Cable Disconnected Advisory alarm, Low
Battery Power Advisory alarm.

TASK
1. Press and hold the battery button ( ) for five seconds.
2. Check that:

“Self Test” (first briefly white, then black) appears on the screen.
All symbols and indicators on the user interface illuminate at the
same time.
System Controller is making a loud, steady, audio alarm tone.

3. Release the battery button ( ).

One of the following occurs:
• If all the lights, symbols, and sounds remain on for 15 seconds. Then the
lights, symbols, and sounds turn off or stop, and the screen goes black, the self
test is complete and the System Controller has passed.

• If any of the following occur, there is a problem with the System Controller:

• The lights remain off

• The sounds do not work

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• A sound is produced other than a loud steady tone

Do not use a System Controller that fails its self test. It may need to be replaced.
Refer to Replacing the Running System Controller with a Backup Controller on page
63. If the System Controller fails the self test, call your hospital contact.

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Using the Battery Power Gauge on the System Controller
The battery power gauge shows the approximate charge status of the power source
that is connected to the System Controller’s white and black power cables—either
the 14 Volt Lithium-Ion batteries or the Mobile Power Unit. The number of green
bars means the amount of power remaining. The more green bars mean the more
power remaining.

To use the battery power gauge, press and release the battery button ( ) on the
user interface (Figure 20).

Figure 20 Battery Power Gauge Showing Full Charge

Battery Button Battery Power Gauge

IMPORTANT! The battery power gauge does not show the charge status of the
System Controller’s backup battery (the battery inside the System Controller). To
check the status of the System Controller’s backup battery, see Viewing Pump and
System Information on the Screen on page 30.

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On 14 Volt Lithium-Ion battery power:

4 green bars = 75–100% of battery

power remains.

3 green bars = 50–75% of battery

power remains.

2 green bars = 25–50% of battery

power remains.

1 green bar = less than 25% of

battery power remains.

IMPORTANT! Every HeartMate 14 Volt Lithium-Ion battery also has its own
on-battery gauge. It shows the power level for that battery. The on-battery readout
communicates information about a single source using five green bars. The System
Controller battery power gauge communicates information about a combined
source of power using four green bars. For more information, see Checking a
Battery’s Charge Level on page 103.

On Mobile Power Unit power:

4 green bars = Normal Mobile Power

Unit operation.

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Recognizing Low Battery Alarms
If the yellow diamond or the red battery illuminate, the system’s power level is
dangerously low. If either the yellow diamond or the red battery illuminate,
immediately replace the depleted batteries with a fully-charged pair, or switch to
the Mobile Power Unit (see Mobile Power Unit Storage on page 93). When the
system’s power level is dangerously low, it prompts a Low Battery Power alarm
(Figure 21).

Yellow diamond symbol: Less than 15 minutes of battery power

remain. This is an Advisory alarm.
For more information, see Low Battery Power Alarm (less than
15 minutes remain) on page 224.

Red battery symbol: Less than 5 minutes of battery power remain. This
is a Hazard alarm.
For more information, see Low Battery Power Alarm (less than 5
minutes remain) on page 221.

Figure 21 Low Battery Power Alarm (Less Than 5 Minutes of Power Remain)

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System Controller Operating Modes
The System Controller has three operating modes:

• Run Mode—Running and in use.

• Sleep Mode—Not in use, but ready for use (the backup System Controller is
in Sleep Mode until needed).

• Charge Mode—Connected to a power source and charging the System

Controller’s backup battery. (The backup System Controller must be put into
Charge Mode every six months to charge its backup battery).

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Run Mode
Run Mode is the usual mode for the running System Controller. Figure 22 shows
the System Controller in Run Mode.

Figure 22 System Controller in Run Mode While Connected to the Mobile Power Unit (left) and to Batteries
(right)

In Run Mode, the green Pump Running ( ) light is on and the System Controller is:

• Connected to power (either the Mobile Power Unit or two HeartMate 14 Volt
Lithium-Ion batteries).

• Connected to the Driveline.

• Sending power to the pump through the Driveline.

• Controlling and checking operating conditions.

• Using the user interface to show how the system is working.

• Responding to button pushes.

• Charging the backup battery inside the System Controller.

• Able to run a System Controller self test.

For instructions on switching from Run Mode to Sleep Mode, see Switching
Operating Modes on page 51.

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Sleep Mode
This is the usual mode for the backup System Controller. Figure 23 shows the
backup System Controller in Sleep Mode.

Figure 23 System Controller in Sleep Mode

The backup System Controller stays in Sleep Mode until either:

1. It is put into Charge Mode (connected to power) to charge the backup battery.
OR
2. It is put into Run Mode to replace the running System Controller.
In Sleep Mode, the Pump Running symbol ( ) is off and the backup System
Controller is:

• Disconnected from power and off.

• Not connected to the Driveline.

• Not using the user interface to show how the system is working.

• Not responding to button pushes.

• Not charging the backup battery inside the System Controller.

For instructions on switching from Sleep Mode to Run Mode or Charge Mode, see
Switching Operating Modes on page 51.

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Charge Mode
Once every six months, you must put the backup System Controller in Charge
Mode. Figure 24 shows the System Controller in Charge Mode.

Figure 24 System Controller in Charge Mode on Mobile Power Unit Power (left) and Using Fully-Charged
HeartMate Batteries (right)

In Charge Mode, the System Controller’s backup battery will be charged. If the
backup battery is not charged, it may not be able to run the pump if needed (see
System Controller Backup Power on page 56). It can take up to 3 hours for the
backup battery to charge.

In Charge Mode, the Pump Running ( ) is off and the backup System Controller
is:

• Connected to power.

• Charging the 11 Volt Lithium-Ion backup battery inside the System

Controller.

• Able to run System Controller self test.

• Not connected to the Driveline.

• Not using the user interface to show how the system is working.

• Not responding to button pushes.

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Switching Operating Modes
Figure 25 summarizes the steps required to switch between operating modes.

Figure 25 System Controller Operating Modes

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Switching from Sleep Mode to Run Mode

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Sleeping, backup System Controller with a charged backup battery

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Obtain the “sleeping” backup System Controller.
2. Connect the sleeping System Controller to power (either the Mobile Power
Unit or two HeartMate batteries).
3. Connect the Controller Driveline Connector to the System Controller (see
Connecting the Driveline to the System Controller on page 33).
4. The System Controller is now in Run Mode. Confirm that the green Pump
Running light is illuminated on the System Controller.

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Switching from Sleep Mode to Charge Mode

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Sleeping backup System Controller

• Mobile Power Unit or two fully-charged HeartMate 14 Volt Lithium-Ion

batteries

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Connect the sleeping System Controller to a power source (Mobile Power Unit
or two HeartMate 14 Volt Lithium-Ion batteries).
It can take up to 3 hours to charge the 11 Volt Lithium-Ion backup battery.
During this time, “Charging” and five dashes scroll across the bottom of the
screen. This indicates that the 11 Volt Lithium-Ion backup battery is actively
charging.
“Charging Complete” appears on the screen when the battery has finished
charging. After the backup battery is charged, the System Controller can
either be put into Run Mode for immediate use or into Sleep Mode to await
future use.

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Switching from Charge Mode to Run Mode

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Charging backup System Controller with a charged backup battery

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. If the System Controller is in Charge Mode (and already connected to power),
connect the Controller Driveline Connector to the System Controller (see
Connecting the Driveline to the System Controller on page 33). The System
Controller is now in Run Mode. Confirm that the green Pump Running light is
illuminated on the System Controller.

Switching from Charge Mode to Sleep Mode

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Charging backup System Controller with a charged backup battery

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Disconnect the backup System Controller from power (either the Mobile
Power Unit or two HeartMate 14 Volt Lithium-Ion batteries). The System
Controller is now in Sleep Mode.

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Switching from Run Mode to Sleep Mode

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Running System Controller

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Disconnect the Driveline from the System Controller, if connected (see
Disconnecting the Driveline from the System Controller on page 36).
2. Press and release the silence alarm button ( ) to silence the Driveline
Disconnected Alarm.
3. Disconnect the System Controller from power.
4. Press and release the silence alarm button ( ) to silence the Power Cable
Disconnected Alarm.
5. Press and hold the battery button ( ) for 5 seconds. You hear beeps and
the following appears on the screen:
“Hold” and a reverse count down of dots (5 dots, 4 dots, 3 dots, 2 dots,
1 dot)
6. Continue to hold down the battery button ( ) until the countdown ends.
7. After five seconds, the screen goes black. The System Controller is now in
Sleep Mode.

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System Controller Backup Power
An 11 Volt Lithium-Ion backup battery inside the System Controller gives at least
15 minutes of power to the pump if the in-use power source is disconnected or fails.

WARNING !
The 11 Volt Lithium-Ion backup battery should be used only for temporary support
during a power-loss emergency. The 11 Volt Lithium-Ion backup battery inside the
System Controller can provide enough power to run the pump for at least
15 minutes if the main power source (either the Mobile Power Unit or two
HeartMate 14 Volt Lithium-Ion batteries) is disconnected or fails. Inappropriate
use of the 11 Volt Lithium-Ion backup battery may result in diminished run time
during a power-loss emergency.

CAUTION !
• The 11 Volt Lithium-Ion backup battery inside the System Controller must be
charged at least once every six months. Failure to charge the 11 Volt
Lithium-Ion backup battery inside the backup System Controller may result in
diminished or no support during a power-loss emergency when the backup
System Controller is in use. See Maintaining the Backup System Controller’s
Readiness: Six Month Charging and Self Test on page 60 for instructions on
charging the 11 Volt Lithium-Ion backup battery.
• The backup battery inside the backup System Controller is charged only
when the backup System Controller is connected to power. It takes up to
3 hours to charge the 11 Volt Lithium-Ion backup battery inside the backup
System Controller.

To power the pump in an emergency, the backup battery must be fully charged.

The backup battery is only for backup power. It automatically works if the in-use
power disconnects or fails. It should not be used for non-emergencies.
Inappropriate use may leave the pump without power in a real emergency. Backup
battery use is tracked by the System Controller. If your hospital contact sees that the
backup battery is used often, he/she will talk with you about the reasons for this.

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The backup battery is rechargeable. It automatically recharges while the System
Controller is connected to power (either the Mobile Power Unit or two HeartMate
batteries). The backup battery loses power when the System Controller is not
connected to power. That is why the backup System Controller needs to be
connected to power every six months (see Maintaining the Backup System
Controller’s Readiness: Six Month Charging and Self Test on page 60).

Connecting the backup System Controller to a power source recharges its backup
battery. It takes up to three hours to charge a backup battery that is without a
charge.

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The Backup System Controller
HeartMate 3 patients receive two System Controllers: one to actively use (running),
and a reserve (backup) in case the running System Controller experiences a failure.

Backup System Controller Overview

See page 59.

Maintaining the Backup System

Controller’s Readiness: Six Month
Charging and Self Test
Every six months, the backup System
Controller’s backup battery must be charged
and a self test must be performed.
See page 60.

Running
System Controller Replacing the Running System Controller
with a Backup Controller
If the running System Controller experiences a
failure, it must be replaced.
See page 63.
Backup
System Controller

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Backup System Controller Overview
Every HeartMate 3 patient receives a backup System Controller, which is identical
to the running System Controller and is programmed with the same settings as the
running System Controller. If a failure occurs on the running System Controller, it
may need to be replaced with the backup System Controller. For this reason, and in
case of an emergency, the backup System Controller must remain with the patient
at all times.

Running System Controller Backup System Controller

If needed, ready to use

On Mobile Power Unit

Backup is not connected to:

• Power
• Driveline

On Batteries

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Maintaining the Backup System Controller’s Readiness: Six
Month Charging and Self Test
Over time, the backup battery inside the System Controller loses power and must be
recharged. Most of the time, the backup System Controller remains in Sleep Mode.
However, once every six months, you must “awaken” it, connect it to power, and
put it into Charge Mode. Connecting the backup System Controller to power
charges its 11 Volt Lithium-Ion backup battery. While the backup System Controller
is in Charge Mode, you should perform a self test.

Performing Backup System Controller Six Month Charging and Self

Test

FOR THIS TASK YOU NEED:

• 1 backup System Controller

• 1 power source (either Mobile Power Unit or two HeartMate 14 Volt

Lithium-Ion batteries)

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Connect the backup System Controller to a power source (Mobile Power Unit
or two HeartMate 14 Volt Lithium-Ion batteries) (Figure 26).
Figure 26 System Controller on Mobile Power Unit Power (left) and Battery Power (right)

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2. When the System Controller is connected to power, its user display screen
shows “Charging” or “Charging Complete” (Figure 27).
Figure 27 System Controller Charging or Charging Complete

IMPORTANT! Do not remove power until “Charging Complete” is

displayed. It can take up to three hours to charge the System Controller’s
backup battery.

3. Perform a self test on the backup System Controller. Press and hold the battery
button ( ) for five seconds (Figure 28).
For more information, see Performing Backup System Controller Six
Month Charging and Self Test on page 60.
Note: A self test can only be performed when power is connected to the
System Controller.

Figure 28 System Controller Self Test

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4. Disconnect power from the backup System Controller. This will put the backup
System Controller back into Sleep Mode. No further action is needed for one
month.
5. Put the backup System Controller into its Protection Bag (Figure 29).
For more information, see The Travel Bag on page 182.
Figure 29 Backup System Controller in Protection Bag

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Replacing the Running System Controller with a Backup
Controller
WARNING !
Failure to adhere to the following instructions may result in serious injury or death.

There are two ways in which the System Controller can be exchanged. The first
method assumes that only the System Controller is exchanged and that a second
power source is not available. The second exchange method involves exchanging
the System Controller using a second power source.

Replace the System Controller using instructions in either Replacing the Current
System Controller with One Power Source on page 65 or Replacing the Current
System Controller with Multiple Power Sources on page 69.

WARNING !
Failure to connect to a running System Controller may result in serious injury or death.

CAUTION !
Do NOT attempt to change your System Controller without having a trained,
competent caregiver at your side to assist. Follow all alarm instructions, including
calling the hospital.

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Multiple Power Sources Available

With In-use Power Source Only
(Mobile Power Unit AND Batteries and
(Mobile Power Unit OR Batteries and Clips)
Clips)

a. Move the white connector’s a. Connect both the white and

power source from the running black connectors on the
System Controller to the backup System Controller to
backup System Controller. power.
IMPORTANT! Keep the
For more information, see
running System Controller
Powering the System on
connected to power.
page 75.
For more information, see
Powering the System on
page 75.

IMPORTANT! Before IMPORTANT! Before

inserting, align the WHITE inserting, align the WHITE
arrow/ alignment mark on the arrow/ alignment mark on the
Driveline Cable Connector with Driveline Cable Connector with
the WHITE arrow on the System the WHITE arrow on the System
Controller Driveline Connector. Controller Driveline Connector.
b. Promptly move the Controller b. Promptly move the
Driveline Connector from the Controller Driveline Connector
running System Controller to from the running System
the backup System Controller. It Controller to the backup
may take up to 10 seconds for System Controller. It may take
your pump to start. Close the up to 10 seconds for your
Safety Lock. pump to start. Close the Safety
Lock.

For more information, see

The System Controller For more information, see
Driveline Connector on The System Controller
page 32. Driveline Connector on
page 32.

c. Move the black connector’s c. Disconnect the old, replaced

power source from the running System Controller from power.
System Controller to the
backup System Controller.

Table 4 Replacing the System Controller

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Replacing the Current System Controller with One Power Source
To replace the current System Controller with the replacement System Controller:

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• 1 backup System Controller

• 1 running System Controller, connected to a power source (either Mobile

Power Unit or 14 Volt Lithium-Ion batteries and clips)

• Optional: A second power source to power the backup System Controller

(either Mobile Power Unit or 14 Volt Lithium-Ion batteries and clips)

WARNING !
Failure to connect to a running System Controller may result in serious injury or death.

CAUTION !
Do NOT attempt to change your System Controller without having a trained, com-
petent caregiver at your side to assist. Follow all alarm instructions, including call-
ing the hospital.

TASK
1. Place the backup System Controller within reach.
2. Sit or lie down (you may get dizzy if the pump briefly stops).
3. If your current System Controller is alarming, silence the audio alarms for
2 minutes by pressing the silence alarm button ( ).
4. Locate your replacement HeartMate 3 System Controller.
5. Move the white connector’s power source from the running controller to the
backup System Controller. Fully secure the white nut until tight.

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WARNING !
Failure to connect to a running System Controller may result in serious injury or death.

CAUTION !
• Do NOT insert a misaligned Driveline Cable Connector.
• When inserting the Driveline Cable Connector, do NOT orient the System
Controller so the display is facing up.

6. To disconnect the Driveline from the current System Controller:

a. Orient the System Controller so the display is facing down.
b. Rotate the Safety Lock to the unlocked position (see Figure 30).
Figure 30 Unlock the Safety Lock

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c. Firmly press the red button under the Safety Lock, while pulling the
Controller Driveline Connector from the socket. Grasp the bend relief
of the Driveline while removing it. Do not pull on or bend the Controller
Driveline Connector (see Figure 31).
Figure 31 Grasp the Metal End and Remove the Driveline

7. To connect the Driveline to the replacement System Controller:

a. Align the WHITE arrow/alignment mark on the Driveline Cable
Connector with the WHITE arrow on the System Controller Driveline
Connector (Figure 32).
Figure 32 Align the Arrows

b. Insert the Driveline Cable Connector into the socket pressing firmly
until it snaps into place.
Note: The Safety Lock cannot move to the locked position unless the Driveline is
fully and properly inserted.

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8. Move the Safety Lock to the locked position, so that it covers the red button
(Figure 33).
Figure 33 Closing the Safety Lock

9. Orient the System Controller so the display is facing up. Confirm the green
Pump Running symbol ( ) is on.
10. Disconnect the Black Power connection from the previously running System
Controller and connect it to the replacement System Controller (and fully
secure the black nut until tight) which is now supporting the patient.
11. Put the previously running System Controller into Sleep Mode. For further
instructions, refer to Turning Off the System Controller (Sleep Mode) on page
73.

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Replacing the Current System Controller with Multiple Power Sources
To replace the current System Controller with the replacement System Controller
using multiple power sources:

WARNING !
Failure to connect to a running System Controller may result in serious injury or death

CAUTION !
Do NOT attempt to change your System Controller without having a trained, com-
petent caregiver at your side to assist. Follow all alarm instructions, including call-
ing the hospital.

TASK
1. If your current System Controller is alarming, silence the audio alarms for
2 minutes by pressing the silence alarm button ( ).
2. Locate your replacement HeartMate 3 System Controller and second power-
source.
3. Power the replacement System Controller by connecting both the White and
Black Power connections (fully secure both the white and black nuts until
tight).

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WARNING !
Failure to connect to a running System Controller may result in serious injury or death.

CAUTION !
• Do NOT insert a misaligned Driveline Cable Connector.
• When inserting the Driveline Cable Connector, do NOT orient the System
Controller so the display is facing up.

4. To disconnect the Driveline from the current System Controller:

a. Orient the System Controller so the display is facing down.
b. Rotate the Safety Lock to the unlocked position (see Figure 34).
Figure 34 Unlock the Safety Lock

c. Firmly press the red button under the Safety Lock, while pulling the
Controller Driveline Connector from the socket. Grasp the bend relief
of the Driveline while removing it. Do not pull on or bend the Controller
Driveline Connector (see Figure 35).
Figure 35 Grasp the Metal End and Remove the Driveline

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5. To connect the Driveline to the replacement System Controller:
a. Align the WHITE arrow/alignment mark on the Driveline Cable
Connector with the WHITE arrow on the System Controller Driveline
Connector(Figure 36).
Figure 36 Align the Arrows

b. Insert the Driveline Cable Connector into the socket pressing firmly
until it snaps into place. The Left Ventricular Assist Device immediately
starts running when the cable is fully and properly inserted in the
socket (if pump set speed is set above 4000 rpm).
Note: The Safety Lock cannot move to the locked position unless the Driveline is
fully and properly inserted.

6. Move the Safety Lock to the locked position, so that it covers the red button
(Figure 37).
Figure 37 Closing the Safety Lock

7. Orient the System Controller so the display is facing up. Confirm the green
Pump Running symbol ( ) is on.
8. Disconnect the Black Power connection and the White Power connection from
the previously running System Controller.

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9. Put the previously running System Controller into Sleep Mode. For further
instructions, refer to Turning Off the System Controller (Sleep Mode) on page
73.

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Turning Off the System Controller (Sleep Mode)
1. Disconnect the Driveline from the System Controller. Press and release the silence alarm
button ( ) to silence the Driveline Disconnected Alarm.
2. Disconnect the System Controller from its power source (Mobile Power Unit or two
HeartMate 14 Volt Lithium-Ion batteries). Press and release the silence alarm button ( )
to silence the Power Cable Disconnected Alarm.
3. Press and hold the battery button ( ) for five seconds. The following appears on the
screen:
“Hold” accompanied by a reverse countdown from five dots to one dot (5 dots, 4 dots,
3 dots, 2 dots, 1 dot).
When the countdown ends, the screen goes black, the Pump Running symbol is black
( ), and the System Controller is in Sleep Mode. If this sequence is not fully
completed, the System Controller will not enter Sleep Mode.

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HeartMate 3 Left Ventricular Assist System Patient Handbook
 3

POWERING THE SYSTEM

This section provides information about the various ways to power the HeartMate 3 Left
Ventricular Assist System.

Power Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - 77

Using the Mobile Power Unit - - - - - - - - - - - - - - - - - - - - - - 78

Using HeartMate 14 Volt Lithium-Ion Batteries - - - - - - - - - - - - - 95

Using the Battery Charger- - - - - - - - - - - - - - - - - - - - - - - 119

Battery Charging Overview - - - - - - - - - - - - - - - - - - - - - - 125

Viewing Battery Information on the Battery Charger - - - - - - - - - 129

Calibrating HeartMate Batteries - - - - - - - - - - - - - - - - - - - 131

HeartMate 3 Left Ventricular Assist System Patient Handbook 75

3 Powering the System

76 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Powering the System 3
Power Overview

Mobile Power Unit—Use the Mobile Power

Unit when you are indoors, stationary, or
sleeping. The System Controller and the
Mobile Power Unit are connected through the
Mobile Power Unit patient cable. The cable
transfers power from the Mobile Power Unit to
the System Controller.
See page 78.

Two HeartMate 14 Volt Lithium-Ion batteries—

HeartMate batteries are used to power the system during
battery-powered operation when AC electricity is not
wanted or is unavailable. Batteries are used in pairs. Each
battery is inserted into a 14 Volt battery clip. The clips
transfer battery power to the System Controller with two
power cables, one for each clip. Without battery clips, the
batteries cannot transfer power to the system. When fully
charged, a pair of HeartMate 14 Volt Lithium-Ion batteries
can power the system for up to 6–17 hours, depending on
your activity level.
See page 93.

Battery Charger—The Battery Charger

is needed to charge, test, and calibrate the
14 Volt Lithium-Ion batteries. The Battery
Charger can accommodate up to four
batteries at one time.
See page 119.

HeartMate 3 Left Ventricular Assist System Patient Handbook 77

3 Powering the System
Using the Mobile Power Unit
The Mobile Power Unit (Figure 38):

• Provides power to the System Controller and pump.

• Powers the system while you are sleeping or relaxing indoors.

• Echoes System Controller alarms (System Controller Alarms on page 209).

Required Components
The following components are required for connecting the Mobile Power Unit to the
System Controller:

• Mobile Power Unit with batteries inserted

• Mobile Power Unit AC power cord

• Running System Controller

Figure 38 The Mobile Power Unit

Patient Cable

Speakers

Status
Symbols

AC Power
Receptacle

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 Powering the System 3
WARNING !
• The Mobile Power Unit radiates radio frequency energy. If not used
according to instructions, the Mobile Power Unit may cause harmful
interference with nearby devices. To confirm interference, switch to battery
power, and then unplug the Mobile Power Unit and observe the effect on
devices in the area. If interference is detected, switch to another power
source and then:

- Re-orient or move the affected devices.

- Increase the distance between the Mobile Power Unit and the affected
devices.
- Connect the affected devices to an electrical outlet different from the
outlet used to power the Mobile Power Unit.
• Always connect to the Mobile Power Unit when sleeping, or when there is a
chance of sleep. The system alarms may not be heard when asleep, resulting
in injury or death.

• Care should be taken when small children or pets are present. There is a
potential for strangulation from the system’s cables.

• Do not connect a System Controller to both the Mobile Power Unit and the
Power Module at the same time, or damage to the System Controller and
injury to the patient may occur. First connect to HeartMate 14 Volt batteries.

• If there is a power failure, transfer from the Mobile Power Unit to another
power source. The backup battery in the System Controller will temporarily
power the pump while transferring to battery power. Do not rely on the
System Controller’s backup battery as a power source during AC power
failure, as it will only power the pump for a limited amount of time and the
pump will stop.

• Keep the Mobile Power Unit dry and away from water or liquid. If the Mobile
Power Unit comes into contact with water or liquid, it may fail to operate
properly or cause an electrical shock.

• Do not use the Mobile Power Unit in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide, or an explosion could occur.

HeartMate 3 Left Ventricular Assist System Patient Handbook 79

3 Powering the System

CAUTION !
• To avoid the risk of electric shock, the Mobile Power Unit must be plugged
into a properly-tested AC electrical outlet that is dedicated to Mobile Power
Unit use. Do not use portable, multiple outlet (power strip) adapters or
extension cables.

• Do not connect the Mobile Power Unit to electrical outlets that are controlled
by a wall switch, as the Mobile Power Unit may be left inoperable.

• Do not use the Mobile Power Unit with DC to AC inverters, as they may cause
the Mobile Power Unit to fail.

• Avoid positioning the Mobile Power Unit where access to the power cord
plug into the wall socket is limited or where disconnection of the plug from the
wall socket is difficult.

• The Mobile Power Unit has an AC Power Cord and Patient Cable, both of
which may be a tripping hazard. Ensure that the patient, caregivers, and all
other persons near the Power Module are aware of this potential hazard.

• Avoid covering the Mobile Power Unit, such as with a blanket. Covering the
Mobile Power Unit may reduce your ability to hear important system alarms
or may cause the Mobile Power Unit to fail due to overheating.

• Keep the Mobile Power Unit free of excessive lint and dust, and away from
heat or humidity sources such as a fireplace, radiant heater, nebulizer, or
steam kettle, as the Mobile Power Unit may fail to operate properly.
• At least one System Controller power cable must be connected to a power
source (either the Mobile Power Unit or two HeartMate 14 Volt Lithium-Ion
batteries) at all times. Do not rely on the System Controller’s backup battery,
as it will only power the Pump for a limited amount of time.
• When connecting power cable connectors, do not try to join them together
without first aligning the half circles inside the connectors. Joining together
misaligned power cable connectors may damage them.
• Do not carry or touch the Mobile Power Unit for an extended time. To avoid
the risk of burns, do not touch the top surface of the Mobile Power Unit for
longer than one minute. The Mobile Power Unit surface temperature can
become uncomfortably warm, especially when the room temperature is
above 104°F (40°C). Surface temperatures can approach 131°F (55°C).

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 Powering the System 3
CAUTION ! (Continued)
• Do not clean or service the Mobile Power Unit while it is plugged into an AC
electrical outlet, or electrical shock may occur.
• Mobile Power Unit power output may be affected by mobile phones, resulting
in low power alarms on the System Controller, or loss of the green power LED
on the Mobile Power Unit. If either of these conditions is observed, separate
the mobile phone from the Mobile Power Unit by at least .6 meters (24
inches). If the condition persists after separating the devices, switch to two
HeartMate 14 Volt Lithium-Ion batteries.
• Do not incinerate, disassemble, crush, puncture, or otherwise damage
batteries, as this can cause leakage or rupture, resulting in personal injury or
damage to the Mobile Power Unit.
• Do not mix old and new batteries or battery types (such as rechargeable with
non-rechargeable), as this can cause leakage or rupture, resulting in personal
injury or damage to the Mobile Power Unit.
• Do not use equipment or supplies other than those specified or sold by
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.
• Inspect the Mobile Power Unit patient and power cables for damage. Do not
use the Mobile Power Unit if either cable shows signs of damage.
• When moving the Mobile Power Unit to a different location or AC power
source, first connect the System Controller to HeartMate 14 Volt batteries.
• Do not change the Mobile Power Unit batteries while the Mobile Power Unit
is powering the HeartMate system. Switch to another power source and then
disconnect the Mobile Power Unit power cord from the wall socket prior to
replacing the Mobile Power Unit batteries.

Setting Up the Mobile Power Unit for Use

Before using the Mobile Power Unit, you must prepare it for use. This section
provides information about the following:

• Inserting the Mobile Power Unit batteries.

• Connecting the Mobile Power Unit power cord to the Mobile Power Unit and
AC power.

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3 Powering the System
Inserting or Replacing the Mobile Power Unit Batteries
The Mobile Power Unit uses three Alkaline AA batteries to power its alarms. You
must install the Mobile Power Unit batteries before using the Mobile Power Unit. The
batteries power the alarm echo function when an AC power failure occurs or the
power cord is disconnected.

The yellow Mobile Power Unit battery symbol ( ) illuminates and a beeping
audio tone sounds when the Alkaline AA batteries are not installed or are depleted
and need to be changed.

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Mobile Power Unit

• 3 new Alkaline AA batteries

• Flathead screwdriver or coin

CAUTION !
Never change the Mobile Power Unit batteries while the Mobile Power Unit is
powering the HeartMate system. Switch to another power source, and then dis-
connect the Mobile Power Unit power cord from the wall socket prior to replac-
ing the Mobile Power Unit batteries.

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Place the Mobile Power Unit on a flat, sturdy surface.
2. Ensure that the power cord is unplugged from the Mobile Power Unit.
3. Inspect the Mobile Power Unit for dents, chips, cracks, or other signs of
damage. Do not use a Mobile Power Unit that appears damaged. Contact
your hospital contact if a replacement is needed.

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4. Use a flathead screwdriver or coin to loosen the screw from the rear panel.
The screw will remain in the screw hole to ensure it is not lost (Figure 39).
Figure 39 Loosen the Screw

5. Open the battery compartment cover on the rear of the Mobile Power Unit
and dispose of the battery installation reminder tag, if present (Figure 40).
Figure 40 Remove the Battery Compartment Cover

6. If replacing the batteries, pull the ribbon to remove the depleted batteries out
of the case.

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3 Powering the System
7. Lay the ribbon on the bottom of the compartment. Place the Alkaline AA
batteries in the battery compartment. Orient the batteries as shown on the
orientation markings on the battery clip (Figure 41).
Figure 41 Insert AA Batteries

8. Replace the battery compartment cover.

9. Use the flathead screwdriver or coin to tighten the screw. Make sure the screw
is tight and the cover is securely closed (Figure 42).
Figure 42 Tighten the Screw

10. Dispose of or recycle the depleted batteries in compliance with all applicable
local, state, and federal regulations.

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Connecting the Power Cord

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Mobile Power Unit (with 3 AA Alkaline batteries included)

• Black AC power cord to connect the Mobile Power Unit to an AC electrical

outlet

• Functioning AC electrical outlet that is dedicated to Mobile Power Unit use

and not controlled by a wall switch

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Place the Mobile Power Unit on a flat, sturdy surface.
2. Obtain the black AC power cord.
3. Plug the female end of the power cord into the power entry module on the
Mobile Power Unit (Figure 43).
Figure 43 Plug Power Cord into Mobile Power Unit

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3 Powering the System
4. Pull back on the end of the power cord to ensure a secure connection to the
Mobile Power Unit (Figure 44).
Figure 44 Pull Back to Ensure Secure Connection

5. Plug the Mobile Power Unit into an AC electrical outlet that is dedicated to
Mobile Power Unit use.

CAUTION !
• Do not use an outlet that is controlled by a wall switch.
• Do not use portable, multiple outlet (power strip) adapters.

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6. Check the top panel of the Mobile Power Unit. When initially connected to
power, the Mobile Power Unit automatically performs a self test, the green
power symbol is illuminated, and the yellow wrench and Replace MPU
Battery lights flash, and the Mobile Power Unit beeps twice. After the self test,
the green "Power On" light should remain lit (Figure 45). The Mobile Power
Unit is ready for use.
Figure 45 Mobile Power Unit Ready for Use

IMPORTANT! The power symbol ( ) is illuminated green when the Mobile Power
Unit is powered and functioning properly.

7. If the green Power On light does not illuminate, complete the following steps:
a. Plug the Mobile Power Unit into a different AC electrical outlet that is
dedicated to Mobile Power Unit use.

CAUTION !
• Do not use an outlet that is controlled by a wall switch.
• Do not use portable, multiple outlet (power strip) adapters.

b. Observe the top panel of the Mobile Power Unit and complete one of
the following steps:
• If the green light illuminates and the functions described in Step 5
occur, the Mobile Power Unit is ready for use.
• If the green light still does not illuminate, call your hospital contact.
The Mobile Power Unit may have a problem. Do not use it.

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Disconnecting the Power Cord

FOR THIS TASK YOU NEED:

• Mobile Power Unit

• Black AC power cord connected to the Mobile Power Unit.

TO DISCONNECT THE V-LOCK POWER CORD:

TASK
1. Place the Mobile Power Unit on a flat, sturdy surface.
2. Press down and hold the yellow button on the top of the plug to disengage
the locking mechanism (Figure 46).
3. Pull out and unplug the power cord from the Mobile Power Unit.
Figure 46 Press Yellow Locking Button Down and Pull Out

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When to Connect to the Mobile Power Unit
Use the Mobile Power Unit when relaxing indoors and always when sleeping. You
must connect to the Mobile Power Unit when sleeping (or when sleep is likely) since
you may not hear the System Controller’s low battery alarms; the Mobile Power Unit
will echo the System Controller’s alarms. For steps on getting ready for sleep, see
Sleeping on page 201.

You need the Mobile Power Unit patient cable (Figure 47) to connect the System
Controller to the Mobile Power Unit.

Figure 47 Mobile Power Unit Patient Cable

Do not kink or
sharply bend the
Mobile Power Unit
patient cable.

White Black
Connector Connector

CAUTION !
Do not allow the cable to come into contact with sharp edges and use care to
prevent it from being pinched or bent.

Like the power cable connectors on the System Controller, the connectors on the
Mobile Power Unit patient cable are also color coded (see Figure 47). When
connecting the System Controller to the Mobile Power Unit patient cable, always
connect white-to-white and black-to-black. To connect the System Controller to the
Mobile Power Unit, follow the steps below.

Use care when connecting and disconnecting power cables. For more information,
see Guidelines for Power Cable Connectors on page 238.

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3 Powering the System
Connecting the System Controller to the Mobile Power Unit

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Running System Controller

• Mobile Power Unit that is ready for use

• Mobile Power Unit patient cable

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Confirm that the Mobile Power Unit is ready for use (see Setting Up the Mobile
Power Unit for Use on page 81).
3. Place the black and white System Controller power cable connectors within
easy reach (Figure 48).
Figure 48 System Controller Power Cable Connectors

White
Connector

Black
Connector

4. Place the black and white Mobile Power Unit patient cable within easy reach.
5. Place the batteries with their attached battery clips within easy reach.
6. Unscrew and disconnect only the white System Controller power cable
connector from the attached battery clip. Do not remove the black connector!

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7. Promptly align opposite half circles inside the white System Controller power
cable connector and the white Mobile Power Unit patient cable connector
(Figure 49).

CAUTION !
Do not try to join together misaligned connectors. This can damage them.

Figure 49 Carefully Align the Connectors

8. Firmly push together the two connectors (Figure 50).

Figure 50 Push Together the Two Connectors

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3 Powering the System
9. Tighten the connector nut until secure (Figure 51). Hand tighten only—do
not use tools.
Figure 51 Tighten the Connector Nut
Connector Nut

10. Unscrew and disconnect only the black System Controller power cable
connector from the attached battery clip.
11. Promptly align opposite half circles inside the black System Controller power
cable connector and the black Mobile Power Unit patient cable connector.

CAUTION !
Do not try to join together misaligned connectors. This can damage them.

12. Firmly push together the two connectors.

13. Tighten the connector nut until secure. Hand tighten only—do not use tools.
14. Both System Controller power cables are now connected to the Mobile Power
Unit (Figure 52).
Figure 52 System Controller Power Cables Connected to Mobile Power Unit Patient Cable Connectors

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Mobile Power Unit Storage
If the Mobile Power Unit will not be used for an extended time, unplug the AC
power cord from power and detach the power cord from the device. Wrap the
Mobile Power Unit patient cable around the Mobile Power Unit for storage. This
also a convenient way to prepare the device and patient cable for travel.

Figure 53 The Mobile Power Unit

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3 Powering the System
Mobile Power Unit Maintenance
The Mobile Power Unit requires little planned maintenance. However, you need to
inspect it routinely to ensure the safest and best possible performance. For complete
information about caring for the Mobile Power Unit, see Caring for the Mobile
Power Unit on page 247.

Periodically, and as needed, complete the following steps to clean the exterior
surfaces of the Mobile Power Unit.

WARNING !
• Never clean the Mobile Power Unit while it is providing power to the Pump.

• Do not put the Mobile Power Unit into water or liquid.

TASK
1. Change to battery power.
2. Unplug all connections.
3. Clean the exterior surfaces of the Mobile Power Unit using a mild detergent,
and a clean, damp (not wet) cloth.

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Using HeartMate 14 Volt Lithium-Ion Batteries
HeartMate batteries (Figure 54) are the other routine power source for the
HeartMate 3 Left Ventricular Assist System.

Figure 54 HeartMate 14 Volt Lithium-Ion Battery

During battery-powered operation, the Left Ventricular Assist System is powered by

two direct current (DC) batteries that are inserted into battery clips. The battery clips
and attached batteries can be worn in holsters, one under each arm (Figure 55).

Figure 55 HeartMate 3 System on Battery Power

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3 Powering the System
Using batteries to power the system is called mobile operation, since you are not
connected to electricity. Use battery power when you want to be mobile and
relatively active, for example, while shopping, running errands, or performing other
activities outside the home.

Use two HeartMate 14 Volt Lithium-Ion batteries to power the HeartMate 3 Left
Ventricular Assist System. See About the HeartMate 14 Volt Lithium-Ion Batteries on
page 99.

WARNING !
• Use only HeartMate 14 Volt Lithium-Ion batteries supplied by Thoratec
Corporation with the HeartMate 3 Left Ventricular Assist System. Using the
wrong batteries may cause the pump to stop.
• Charge the HeartMate 14 Volt Lithium-Ion batteries before using them.
Before a battery is removed from the Battery Charger, make sure that the
battery has completed its charge or calibration cycle. After the battery is
removed from the Battery Charger, use the battery power gauge to check the
battery charge level.
• Use only 14 Volt battery clips supplied by Thoratec Corporation with
HeartMate 14 Volt Lithium-Ion batteries. Other clips will not transfer electrical
power to the system.
• Always connect to the Mobile Power Unit when sleeping or when there is a
chance of sleep. If you are sleeping, you may not hear System Controller
alarms.
• Do not use damaged, defective, or expired batteries. Using damaged,
defective, or expired batteries may cut operating time.

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 Powering the System 3
CAUTION !
• Use only the Battery Charger supplied by Thoratec Corporation to charge
HeartMate 14 Volt Lithium-Ion batteries. Other battery chargers may damage
HeartMate batteries.
• After approximately 70 uses, HeartMate 14 Volt Lithium-Ion batteries may
need to be re-calibrated. The Battery Charger indicates when a battery needs
to be re-calibrated. Calibration can take up to 12 hours, and only one battery
can be calibrated at a time. Calibrate a battery as soon as possible after
being prompted, to prevent a backlog of uncalibrated batteries.
• Leave a calibrating 14 Volt Lithium-Ion battery in the Battery Charger for the
full calibration cycle. Removing a battery before it is fully calibrated may
result in a depleted battery (the on-battery power gauge will reflect this
status).
• Dirty battery contacts on the 14 Volt Lithium-Ion battery may prevent proper
charging, which can affect operation. Clean the metal contacts on the
batteries and inside the battery clip at least once a month. Use a lint-free cloth
or cotton swab that has been moistened (not dripping) with rubbing alcohol.
Let the alcohol dry before using the batteries or battery clips, or before
placing batteries into the Battery Charger.
• As 14 Volt Lithium-Ion batteries get older, they support the system for shorter
periods of time. If batteries do not give at least four hours of support, take
them out of service.

• If stored and used within recommended guidelines, HeartMate 14 Volt

Lithium-Ion batteries should be usable for approximately 360 use/charge
cycles or for 36 months from the date of manufacture, whichever comes first.
After 360 cycles/36 months, battery performance cannot be guaranteed and
batteries should be replaced.
• If a 14 Volt Lithium-Ion battery leaks, do not touch the leaking fluid. If the fluid
touches skin or eyes, wash the affected area with plenty of water and seek
medical advice.

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3 Powering the System
CAUTION ! (Continued)
• To prevent deterioration or damage to a 14 Volt Lithium-Ion battery:

- Do not store in direct sunlight.

- Do not use in temperatures that are below 32°F (0°C) or above 104°F
(40°C), or the battery may fail suddenly.
- Do not dismantle, open, or shred.
- Do not drop or hit against hard objects or each other.
- Do not leave or store in extremely hot or cold temperatures such as
automobiles or automobile trunks, or battery life will be shortened.
- Do not expose to heat or fire.
- Do not store batteries together with keys, coins, or other loose metallic
objects. Metal objects touching the exposed battery contacts may cause
an accidental short and a rapid discharge of the battery. This can result
in battery overheating that may burn you or damage the batteries.
• Keep batteries out of the reach of children.
• Keep batteries clean and dry.
• Dispose of expired or defective batteries in accordance with local, state, and
federal regulations.
• Avoid touching metal battery contacts with two separate hands, which will
increase the chance that battery energy could pass through your body.
• At least one System Controller power cable must be connected to a power
source (Mobile Power Unit or two HeartMate 14 Volt Lithium-Ion batteries) at
all times. Do not rely on the System Controller’s backup battery, as it will only
power the Pump for a limited amount of time.

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About the HeartMate 14 Volt Lithium-Ion Batteries
Two, new, fully charged HeartMate 14 Volt Lithium-Ion batteries provide 17 hours
of support.

Batteries last for less time if you are active or emotionally stressed. As batteries get
older, they power the system for shorter periods of time. If two HeartMate 14 Volt
Lithium-Ion batteries do not give at least four hours of support, take both batteries
out of service and tell your hospital contact.

Batteries are always used two at a time. However, the system will operate using just
one battery for a very short period (minutes). For example, system operation
continues on a single battery while switching from battery power to Mobile Power
Unit power, or vice versa.

During battery-powered operation, the battery power gauge on the System

Controller shows overall power capacity for both batteries. The battery power
gauge tells you when the batteries are running low. If the current power source is
low, the System Controller prompts you to switch to a different power source (two
new fully-charged batteries or the Mobile Power Unit). To check the status of an
individual battery, press the battery power gauge on that battery (see Checking a
Battery’s Charge Level on page 103).

Charging New Batteries for the First Time

You must charge each HeartMate battery before use, including the very first time
you use a battery. It takes approximately four hours or less to charge a low battery.
Batteries are charged in the Battery Charger, which can charge up to four batteries
at a time.

Depending on how long a battery has been in storage, the on-battery power gauge
may not work until after the battery goes through its first charge cycle (see Checking
a Battery’s Charge Level on page 103).

See Charging HeartMate 14 Volt Lithium-Ion Batteries on page 127 for instructions
on charging HeartMate batteries.

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3 Powering the System
Using Battery Clips
To transfer power to the System Controller, two HeartMate batteries must be placed
into special battery clips (Figure 56). HeartMate 14 Volt Lithium-Ion batteries only
work with 14 Volt battery clips. Other battery clips will not transfer power.
HeartMate batteries cannot power the system without battery clips.

Figure 56 HeartMate 14 Volt Lithium-Ion Battery and 14 Volt Battery Clip

Power cable connectors on the System Controller connect to each battery clip
(Figure 57). In this way, battery power is supplied to the System Controller
through the power cables.

Figure 57 The System Controller Power Cable Attaches to the Battery Clip

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 Powering the System 3
Inserting a HeartMate Battery into a Battery Clip

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• 2 fully-charged HeartMate 14 Volt Lithium-Ion batteries

• 2 14 Volt battery clips

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Hold the battery in one hand and the battery clip in the other hand.
3. Line up the arrows on the battery and battery clip (Figure 58).
Figure 58 Line Up Arrows

4. Insert the battery into the battery clip. The battery clicks into place when fully
and properly inserted.
5. Pull gently on the battery to confirm that the connection is tight.
6. Repeat Steps 2 through 5 for the second battery clip.

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3 Powering the System
Removing a HeartMate Battery from a Battery Clip

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• 2 HeartMate 14 Volt Lithium-Ion batteries

• 2 14 Volt battery clips

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Hold the battery in one hand and the battery clip in the other hand.
3. Press the battery release button on the battery clip (Figure 59) and withdraw
the battery.
Figure 59 Press Battery Release Button and Withdraw Battery
Battery
Release
Button

4. Repeat Steps 2 and 3 for the second battery and attached battery clip.
5. Put the batteries and battery clips in a clean, dry location for safe storage until
next use. Place the batteries in the Battery Charger to recharge, if needed.

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Checking a Battery’s Charge Level
After a HeartMate battery is charged, (see Charging HeartMate 14 Volt Lithium-Ion
Batteries on page 127), it should be ready for use. However, before using the
battery, check the charging pocket to make sure it has finished charging, and then
use the on-battery power gauge to confirm that it is fully charged.

The on-battery power gauge on a HeartMate battery uses five green bars to
indicate available battery power (Figure 60). Each bar represents approximately
20% of available power. When you press the power gauge button on a
fully-charged battery, all five bars turn on, indicating that the battery is 80–100%
charged. Fewer bars illuminate as power is low. When battery power drops below
10%, only one green blinking bar comes on.

IMPORTANT! Depending on how long a battery has been in storage, its power
gauge may not work until after the battery is charged for the first time.

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Battery Charger

• HeartMate 14 Volt Lithium-Ion battery

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Locate a battery in one of the Battery Charger charging pockets.

IMPORTANT! A green light next to the Battery Charger pocket is the only
assurance that a battery in the Battery Charger is 100% charged. If the yellow light
is on, the battery is still charging. If the red light is on, the battery has a problem.
Do not use it.

3. Look at the lights next to the charging pocket for the battery. A green light on
the charger means that the battery is charged and ready for use.
4. Remove the battery from the charging pocket.
5. Find the battery symbol on the battery's power gauge.

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3 Powering the System
6. Press and hold the battery symbol for five seconds.
Figure 60 Press the Power Gauge Button to Check the Battery Charge Level

• If all five green power gauge bars illuminate, the battery power is between
80–100% charged.

• If four or fewer bars illuminate, the battery is not fully charged.

• If all of the battery power gauge bars light up except for one in the middle of
the sequence, the light emitting diode (LED) for the bar may be broken or
burned out. If this happens, contact your hospital contact.

Note: A battery's power gauge may show five bars illuminated, while the Battery
Charger indicates a charging yellow light. This is normal. Five bars illuminated on
the battery do not indicate that the battery is fully charged, but rather that it is 80–
100% charged.

7. If four or fewer bars illuminate, return the battery to the pocket for more
charging.
If the power gauge continues to show four or fewer bars after additional
charging, the battery may be defective. Do not use it.
8. If the battery is defective, obtain a replacement battery, if needed.

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Table 5 describes the on-battery power gauge on a 14 Volt Lithium-Ion battery.

Number of Bars Meaning

Illuminated

Battery is in “sleep” mode, due to being in storage for a

long period of time. Charge battery immediately.
No Bars Illuminated

Approximately 10% or less of power remains. Do not use if

battery has one blinking bar.
1 Bar (blinking)

Approximately 10–20% of power remains.

1 Bar (steady)

Approximately 20–40% of power remains.

2 Bars

Approximately 40–60% of power remains.

3 Bars

Approximately 60–80% of power remains.

4 Bars

Approximately 80–100% of power remains.

5 Bars
Table 5 14 Volt Lithium-Ion Battery On-Battery Power Gauge

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3 Powering the System
When to Connect to Batteries
Use HeartMate batteries for power when active or outdoors, or when electricity fails
or is not available. To connect the System Controller to batteries, follow the steps
below.

Connecting the System Controller to HeartMate Batteries

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Running System Controller

• 2 fully-charged HeartMate14 Volt Lithium-Ion batteries

• 2 HeartMate 14 Volt battery clips

• Battery Holster or other accessory for holding or carrying in-use batteries

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Place two battery clips and two fully-charged batteries within easy reach.
3. To insert a fully-charged battery into a battery clip, line up the arrows on the
battery and battery clip and then push the battery into the clip until the battery
clicks into place (Figure 61).
Figure 61 Insert Battery into Battery Clip

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 Powering the System 3
4. Repeat Step 3 for the second battery and battery clip.
5. Place the black and white System Controller power cable connectors within
easy reach (Figure 62).
Figure 62 System Controller Power Cables with Black and White Connectors

White
Connector

Black
Connector

6. Unscrew and disconnect only the white System Controller power cable
connector from its current power source. Do not disconnect the black
connector!
Note: Alarm will sound.

7. Promptly align the opposite half circles inside the white System Controller
power cable connector and the power cable connector for one of the battery
clips (Figure 63).

CAUTION !
Do not try to join together misaligned connectors. This can damage them.

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3 Powering the System
Figure 63 Carefully Match the Connectors

8. Firmly push together the two connectors.

9. Tighten the connector nut until secure. Hand tighten only—do not use tools.
10. Unscrew and disconnect only the black System Controller power cable
connector from its current power source. Do not disconnect the white
connector!
Note: Alarm will sound.

11. Promptly align the opposite half circles inside the black System Controller
power cable connector and the power cable connector for one of the battery
clips.

CAUTION !
Do not try to join together misaligned connectors. This can damage them.

12. Firmly push together the two connectors.

13. Tighten the connector nut until secure. Hand tighten only—do not use tools.
14. Both System Controller power cables are now connected to battery power
(Figure 64).

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Figure 64 System Controller Connected to Batteries

See Mobile Power Unit Storage on page 93 for information on using HeartMate
14 Volt Lithium-Ion batteries to power the system.

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3 Powering the System
Low Battery Power Operation
When approximately 15 minutes of battery power are left, a yellow battery
advisory will light on the System Controller and an audio beep will sound once
every four seconds. This advisory indicates that the batteries should be changed.
For more information, see Low Battery Power Alarm (less than 15 minutes remain)
on page 224.

When approximately five minutes of operation remain, a red battery hazard

symbol will light and a continuous audio alarm will sound. When this occurs, the
system reverts to Power Saver Mode and gradually ramps down to a lower speed
set by your doctor. This allows the system to operate at a reduced, but adequate,
level of support to provide the maximum amount of operating time from the
remaining battery capacity. Running at reduced speed is a critical situation. It may
cause dizziness or shortness of breath. It is important to immediately change to a
new pair of charged batteries or to the Mobile Power Unit. For more information,
see Low Battery Power Alarm (less than 5 minutes remain) on page 221

The Left Ventricular Assist System remains in Power Saver Mode until one of the
following occurs:

• Charged batteries are installed

• The Mobile Power Unit is connected
• No further power remains

The red battery hazard alarm requires an immediate response. Immediately change
to a reliable alternate power source. When adequate power is supplied, the Pump
reverts to the previous mode and speed, and the red battery alarm clears.
Power Saver Mode
When your batteries have less than five minutes of power remaining, the Pump
automatically slows down and begins pumping at a reduced speed. This is called
Power Saver Mode. When this happens, the System Controller’s red battery light
illuminates and a continuous audio tone sounds.
Running at reduced speed is a critical situation. It may cause dizziness or shortness
of breath. It is important to immediately change power sources to either two new
fully-charged batteries or the Mobile Power Unit. Changing to a different power
source will stop the alarm and return the Pump to its original speed.
Note: If the alarm does not stop after replacing batteries or changing to a different
power source, call your hospital contact. The System Controller or the Mobile Power
Unit patient cable may need to be replaced.

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Replacing Low Batteries with Fully-Charged Batteries

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• 2 low HeartMate 14 Volt Lithium-Ion batteries

• 2 fully-charged HeartMate 14 Volt Lithium-Ion batteries

• 2 14 Volt battery clips

• Running System Controller

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Obtain two fully-charged HeartMate batteries and place them within easy
reach. If you remove batteries from the Battery Charger, make sure that the
light near the charging pocket for each battery is green, indicating that the
battery is charged.
2. To confirm that the battery is fully charged, press and hold the battery symbol
on each battery (Figure 65); make sure each battery is fully charged and
ready for use.
3. Grasp the battery clip and attached battery for one of the batteries that is
currently powering the system and remove the clip and battery from the
holster or carrying case. Do not remove the battery from its clip at this time.
4. Locate the battery power gauge symbol (Figure 65) on the battery.
Figure 65 Battery Power Gauge Symbol on 14 Volt Lithium-Ion Battery

5. Press and hold the battery symbol for five seconds to see how much battery
power remains for this battery (count the number of lights that come on).
6. Repeat Steps 3–5 for the second battery that is currently in use.
7. Determine which battery has the least power.

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3 Powering the System
8. If both batteries have the same amount of power, replace either battery;
otherwise, replace the battery that has the least power first:
a. Press the battery release button on the battery clip.
b. Withdraw the battery from its clip. The System Controller will sound a
once-per-second beep, and the green power symbol and power gauge
lights will flash.
9. Pick up one of the fully-charged batteries; locate the orange arrow on the
battery. Make sure that you pick up a fully-charged battery rather than a low
battery.
10. To insert a fully--charged battery into a battery clip, line up the arrows on the
battery and battery clip, and then push the battery into the clip until the battery
clicks into place (Figure 66).
Figure 66 Align Orange Arrows and then Insert Battery into Battery Clip

11. Pull gently on the battery to confirm that the connection is tight. If the battery
is properly and fully inserted, the battery remains in the clip and the
once-per-second beep stops. (It may take a few seconds for the beeping to
stop.)
12. Remove the other low battery and repeat Steps 9–11.
13. Return the clips and fully-charged batteries to holsters or carrying case.
14. Make sure the Battery Charger is plugged in and turned on ("I"), and then
place the low batteries in the pockets for recharging.

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Maintaining Batteries and Battery Clips
HeartMate batteries require periodic inspection and cleaning to ensure the best
possible performance. For complete information about caring for 14 Volt Lithium-Ion
batteries and battery clips, see Caring for HeartMate 14 Volt Lithium-Ion Batteries
and Battery Clips on page 248.

Monitoring Battery Life

A number of factors influence battery life for a HeartMate battery. The two most
important factors are the number of uses and the number of months since the battery
was manufactured. The month and year of manufacture appears on every
HeartMate battery label.

If a battery is stored and used according to the conditions outlined, the battery
should be usable for approximately 360 cycles OR 36 months from the date of
manufacturer, whichever comes first. After this time, battery performance cannot be
guaranteed. Call your hospital contact when a HeartMate battery reaches either of
these milestones.

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Switching Power Sources

Changing from Mobile Power Unit Power to Batteries

Use care when connecting and disconnecting power cables. For more information,
see Guidelines for Power Cable Connectors on page 238.

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Running System Controller

• Working, in-use Mobile Power Unit with its batteries installed

• 2 fully-charged HeartMate 14 Volt Lithium-Ion batteries

• 2 14 Volt battery clips

• Holster or Carry Accessory

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment listed above; place within easy reach.
2. To insert a fully-charged battery into a battery clip, line up the arrows on the
battery and battery clip, and then push the battery into the clip until the battery
clicks into place.
Figure 67 Insert Battery into Battery Clip

3. Pull gently on the battery to confirm that the connection is tight.

4. Repeat Steps 2–3 for the second battery and battery clip.

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5. Place the batteries with attached battery clips within easy reach.
6. Place the black and white System Controller power cable connectors within
easy reach.
7. Unscrew and disconnect only the white System Controller and white Mobile
Power Unit patient cable connectors. The Power Cable Disconnected alarm
will come on. This is normal.
8. Promptly align the opposite half circles inside the white System Controller
power cable connector and the power cable connector for one of the battery
clips (Figure 68).

CAUTION !
Do not try to join together misaligned connectors. This can damage them.

The alarm will stop when the white System Controller power cable is con-
nected.

Figure 68 Connect Power Cable Connector to Battery Clip Connector

9. Firmly push together the two connectors.

10. Tighten the connector nut until secure. Hand tighten only–do not use tools.

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3 Powering the System
11. Unscrew and disconnect only the black System Controller and black Mobile
Power Unit patient cable connectors. The Power Cable Disconnected alarm
will come on. This is normal.
12. Promptly align the opposite half circles inside the black System Controller
power cable connector and the power cable connector for one of the battery
clips.

CAUTION !
Do not try to join together misaligned connectors. This can damage them.

The alarm will stop when the black System Controller power cable is con-
nected. Tighten the connector nut until secure.

13. Place the batteries and battery clips into a wear and carry accessory, such as
battery holsters or the Consolidated Bag (see Wearing and Carrying the
System Controller on page 159).
14. Place at least two additional fully-charged batteries in your travel case.

CAUTION !
The Mobile Power Unit patient cable should be stored so that it will not get dam-
aged, dirty, or wet, and so it will not cause tripping or falling.

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Changing from Batteries to Mobile Power Unit Power
Use care when connecting and disconnecting power cables. For more information,
see Guidelines for Power Cable Connectors on page 238.

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Running System Controller connected to battery power

• 2 HeartMate 14 Volt Lithium-Ion batteries

• 2 14 Volt battery clips

• Mobile Power Unit power cord

• Mobile Power Unit that is ready for use (see Setting Up the Mobile Power
Unit for Use on page 81)

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Verify that the Mobile Power Unit is plugged into an AC electrical outlet that
meets all of the following criteria:
• Dedicated to Mobile Power Unit use
• Not controlled by a wall switch
• Not connected to an adapter plug or a power strip

WARNING !

Do not use an adapter plug or a power strip with the Mobile Power Unit. Doing
so may cause an electrical shock or may cause the Pump to stop.

3. Place the black and white Mobile Power Unit patient cable connectors and
System Controller power cable connectors within reach.
4. Remove the battery clips and attached batteries from the holsters or carrying
case.

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3 Powering the System
5. Check the charge status of each battery—press the battery power gauge on
each battery to determine which battery has the least power. (See Checking
a Battery’s Charge Level on page 103).
6. If one battery has less charge, start with that battery and disconnect the
connector from the battery; otherwise, disconnect the white connector first.
7. Unscrew the white connector from its battery clip. The Power Cable
Disconnected alarm will come on. This is normal.
8. Put aside the battery clip and attached battery.
9. Connect the white Mobile Power Unit patient cable connector to the white
System Controller connector. The alarm will stop. Tighten the connector nut
until secure.
10. Unscrew the black connector from its battery clip. The Power Cable
Disconnected alarm will come on. This is normal.
11. Put aside the battery clip and attached battery.
12. Connect the black Mobile Power Unit patient cable connector to the black
System Controller connector. The alarm will stop. Tighten the connector nut
until secure.
13. Press the battery release button on one of the battery clips to release its
battery.
14. Repeat Step 13 for the second battery.
15. Store the battery clips in a clean, dry location until next use.
16. Place the used batteries into the Battery Charger for charging (see Charging
HeartMate 14 Volt Lithium-Ion Batteries on page 127).

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Using the Battery Charger
WARNING !
• Before removing a battery from the Battery Charger, make sure that the
battery has completed its charge or calibration cycle. After the battery is
removed from the Battery Charger, use the battery power gauge on the
battery to check the battery’s charge level.

• Be sure to use only equipment and supplies that are authorized by Thoratec
Corporation. If unauthorized parts are used, potential interference may occur
between the Battery Charger and other devices.
• Do not use the Battery Charger next to other equipment. Do not stack the
Battery Charger on top of other equipment.
• The Battery Charger radiates radio frequency energy. If the Battery Charger
is not used according to instructions, it may cause harmful interference with
nearby devices. To confirm if interference is occurring, turn off/on the Battery
Charger and observe the effect on devices in the area. If interference is
detected:

- Re-orient or move the affected devices.

- Increase the distance between the Battery Charger and the affected
devices.
- Connect the affected devices to an electrical outlet that is different from
the outlet that is used to power the Battery Charger.
• To avoid the risk of electrical shock, plug the Battery Charger into a properly
tested and grounded (3-prong) AC electrical power outlet that is dedicated to
Battery Charger use.

- Do not use an outlet that is controlled by a wall switch.

- Do not use an adapter plug for an ungrounded wall outlet.
- Do not use portable, multiple outlet (power strip) adapters.

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WARNING ! (Continued)
• Do not use the Battery Charger in the presence of a flammable anesthetic
mixture with air or with oxygen or nitrous oxide, or an explosion could occur.

• Keep the Battery Charger dry and away from water or liquid. If the
Battery Charger comes into contact with water or liquid, it may fail to operate
properly or cause an electrical shock.

• Do not touch the metal contacts inside the Battery Charger when the charger
is connected to AC power and turned on, or it may cause an electrical shock.

CAUTION !
• Use only the Battery Charger supplied by Thoratec Corporation to charge
HeartMate 14 Volt Lithium-Ion batteries. Other battery chargers may damage
HeartMate batteries.
• Make sure the Battery Charger is plugged in and turned on before placing
batteries into the pockets for charging.
• Do not attempt to test or charge non-HeartMate batteries in the Battery
Charger. Doing so may damage the charger or the batteries, or injure the
user.
• The Battery Charger requires planned maintenance at least once every
12 months for the best possible operation. Planned maintenance includes (but
is not limited to) a functional check of the device and cleaning/inspecting all
internal connections. Service and maintenance of the Battery Charger should
be performed only by service personnel who are trained by Thoratec
Corporation.
• Before inserting a battery into the Battery Charger for charging or
recharging, inspect the battery for signs of damage. Do not use a battery that
appears damaged.
• Dispose of or recycle expired, used, or damaged batteries according to
local, state, and federal regulations. Do not incinerate!

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The Battery Charger (Figure 69) is designed to charge HeartMate 14 Volt
Lithium-Ion batteries. Specifically, the Battery Charger can:

• Charge up to four 14 Volt Lithium-Ion batteries in four hours or less (see

Charging HeartMate 14 Volt Lithium-Ion Batteries on page 127).

• Determine when a 14 Volt Lithium-Ion battery needs calibration.

• Calibrate a 14 Volt Lithium-Ion battery (see Calibrating HeartMate Batteries

on page 131).

• Perform diagnostic testing on up to four HeartMate 14 Volt Lithium-Ion

batteries at a time (see Viewing Battery Information on the Battery Charger
on page 129).

Figure 69 Battery Charger

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3 Powering the System
Setting Up the Battery Charger Before Use
To use the Battery Charger, you must plug it in and turn it on. The display panel on
the front of the charger displays messages during setup and operation. On-screen
messages can be displayed in either English or graphic symbols. Talk with your
hospital contact about selecting the screen display option that is best for your
needs.

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Battery Charger

• AC power cord to connect the Battery Charger to an AC electrical outlet

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. If not already unpacked, carefully remove the charger from its packaging.
Place the charger on a sturdy surface.
2. Inspect the charger for dents, chips, cracks, or other signs of damage. Do not
use a charger that seems damaged. Contact your hospital contact for a
replacement, if needed.
3. Examine the four battery charging pockets. Make sure the pockets are clean
and empty (no batteries), and free of dust or debris.
4. Carefully inspect the metal contacts inside the pockets. Dirt or objects
covering the metal contacts inside the pockets may prevent proper battery
charging, which can affect battery performance.
5. Obtain the grey AC power cord from the product packaging.

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6. Plug the female end of the power cord into the power entry module on the
rear of the charger (Figure 70). Make sure the cord is fully inserted and
secure.
Figure 70 Plug the Power Cord into the Rear of the Battery Charger

7. Plug the battery charger into a functioning AC electrical outlet that is dedi-
cated to battery charger use.

CAUTION !
• Do not use an outlet that is controlled by a wall switch.

• Do not use an adapter plug for an ungrounded wall outlet.

• Do not use portable, multiple outlet (power strip) adapters.

8. Turn on the charger by pressing the on/off switch on the rear of the charger
from the off ("0") to the on ("I") position. When the charger is turned on, all
lights on the front panel turn on (Figure 71). The charger beeps once and
performs a self test for about 10 seconds.
Figure 71 All Lights Turn On When the Charger is Turned On

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3 Powering the System
9. After a successful self test, all lights turn off and "HeartMate CHARGER"
appears on the display panel (Figure 72). The charger is ready for use.
Figure 72 The Battery Charger is Ready to Use

OR

If the charger detects a problem, an error message appears on the display

panel (Figure 73) and/or the lights and beep are not performed as
described above. If an error message appears, or the lights or beep are
missing or do not perform as described, see Battery Charger Display Panel
Messages on page 237 for information on how to respond to advisory mes-
sages.

Figure 73 An Error Message on the Battery Charger

IMPORTANT! If traveling internationally, a Thoratec Corporation power cord set is

needed. This power cord set is compatible with the local voltage and meets
applicable national plug, rated voltage, rated current, and safety agency marks
and specifications. Call your hospital contact for a power cord set, if needed.

Note: Any time the "HeartMate CHARGER" message is displayed, the display
panel slowly dims, turns off for two seconds, and then resumes full brightness. This
helps to prolong the life of the display. You may use the charger during this time.

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Battery Charging Overview
The Battery Charger can charge up to four 14 Volt Lithium-Ion batteries at the same
time. It takes up to four hours to charge from one to four batteries, depending on the
charge status of the batteries. Be sure to plan battery use and charging time with
the four hours in mind.

For best battery performance, leave charged batteries in the charging pockets until
ready for use. Leaving charged batteries in the charger will not damage them.

HeartMate 14 Volt Lithium-Ion batteries use technology that measures available

battery power and counts battery usage/charge cycles. When a battery is placed
in a charging pocket (Figure 74), the charger immediately checks the battery's
status by reading the battery's built-in computer chip. To view information about the
battery’s available power and total number of use/charge cycles, press the button
labeled with the number of the pocket containing the battery you want to check. The
information is displayed on the charger display panel.

Figure 74 Batteries Inserted in Battery Charger Pockets for Charging

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3 Powering the System
Depending on the status of the battery, a green, yellow, or red light is illuminated
next to the pocket (Figure 75). A green light means the battery is charged and
ready for use. A steady yellow light means the battery is actively charging. A red
light means the battery or charger has a problem. See Table 6 for a description of
charger pocket light codes.

Figure 75 A Green Light Indicates that the Battery is Charged

Color Status/Meaning

Green
Battery is charged and ready for use.

Yellow
Battery is undergoing charge, test, or calibration.

Yellow (Blinking)
Battery requires calibration.

Red Battery or charging pocket is defective. Do not use

battery.

Table 6 Description of Battery Charger Pocket Lights

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 Powering the System 3
Charging HeartMate 14 Volt Lithium-Ion Batteries
FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Battery Charger, set up for use (see Setting Up the Battery Charger Before
Use on page 122)

• Up to 4 HeartMate 14 Volt Lithium-Ion batteries

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Place a HeartMate battery into one of the four battery charging pockets, so
the battery power gauge is at the top and faces forward (Figure 76).
Figure 76 The Battery Charger Can Charge Four Batteries at a Time

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3 Powering the System

CAUTION !
Avoid covering or blocking the vents on the top of the Battery Charger during use.
Covering or blocking the vents may affect Battery Charger performance.

Note: Do not force a battery into a charging pocket. A battery only fits in the
pocket with the battery power gauge at the top and facing forward. When
the battery is properly placed in the pocket, a beep sounds and one of the
pocket lights illuminates (green, yellow, or red).

3. Identify which light (green, yellow, or red) comes on for the pocket:
• Green light—The battery is charged and ready for use. Either remove
the battery for immediate use, or leave the battery in the pocket until
needed. Leaving a charged battery in the charger will not damage it.
• Yellow light—The battery is actively charging. Leave the battery in the
pocket to continue charging.
Note: The yellow light remains on until the battery becomes charged.
When the battery is charged, the yellow light turns off and the green
light comes on.

• Blinking yellow light—The battery requires calibration. See

Calibrating HeartMate Batteries on page 131.
• Red light or no light at all—The battery or charger pocket has a
problem. Remove the battery and reinsert it in the same pocket. If the
same condition occurs (red light or no light), insert the battery into a
different pocket. If the battery cannot be charged in a different
pocket, the battery is defective. Do not use the defective battery.
Contact your hospital contact for help and for a replacement, if
needed. See Battery Charger Display Panel Messages on page 237
for information on advisory messages and troubleshooting, including
how to read alarm codes when a red light comes on.
4. After about four hours, check the lights for the charging pocket for the battery.
• If the green light is on, the battery is charged and ready for use.
• If the yellow light is on, the battery is still charging.
• If the red light is on, the battery has a problem or the charger
interrupted the charging cycle for some reason. See Confirming a
Pocket Fault on page 235 for information on how to handle red light
conditions.
5. Repeat Steps 2–4 for up to three more batteries.

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Viewing Battery Information on the Battery Charger
You can use the Battery Charger to check the status of a battery. To check a
battery's charge status, place the battery into a charging pocket, and then press
and release the number button for that pocket. The following information appears
on the charger display panel:

• Pocket number

• Battery symbol

• Percentage of available charge

For example, if approximately 50% of the battery's power is available, half of the
battery symbol is filled and "50%" appears on the screen. In the example below,
90% of the battery’s power is available (Figure 77).

Figure 77 View Battery Charge Level Information on the Battery Charger

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3 Powering the System
After five seconds, the display returns to the default "HeartMate CHARGER" screen.
If you press the button again—while the battery charge level still appears—the
display shows the total number of use/charge cycles. The following information
appears on the display panel (Figure 78):

• Pocket number

• Total number or uses/charges for this battery

• How much power the battery can potentially hold if fully charged (measured
in mAh)

Figure 78 Press the Button a Second Time to Display Battery Charge Cycle Information

After 10 seconds, the display panel returns to the default "HeartMate CHARGER"
screen.

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Calibrating HeartMate Batteries
HeartMate 14 Volt Lithium-Ion batteries use technology that measures available
battery power and counts battery usage/charge cycles. After approximately 70
battery uses, the battery senses that it needs to calibrate its battery power gauge.
Calibration helps keep the battery power gauge accurate.

The battery must be placed in the charger to be calibrated. During calibration, the
charger drains the battery of all electrical energy and then recharges it. Battery
calibration can take up to 12 hours, and only one battery can be calibrated at a
time. While calibrating one battery, the charger can charge three HeartMate
batteries as usual.

When a battery is inserted in the charger, and the charger detects that calibration
is recommended:

• The yellow light for the pocket blinks.

• A split battery symbol and the pocket number for the battery flashes on the
charger display panel (Figure 79). The circled number switches between a
filled and unfilled circle as the display panel screen flashes.

Figure 79 The Battery in Pocket 4 Needs to be Calibrated

You can calibrate a battery when prompted, or wait for a more convenient time,
such as at night.

To calibrate the battery when prompted:

Within ten seconds of the start of the blinking yellow light, press and release the
number button for this pocket. The charger begins calibrating the battery.

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3 Powering the System
During calibration, the yellow light for this pocket remains on and "HeartMate
CHARGER" appears on the display panel screen. If you press the number button for
this pocket while the battery is being calibrated, the calibration status screen
appears (Figure 80).

Figure 80 The Battery in Pocket 4 is Being Calibrated

When calibration is complete, the yellow light turns off and the green light comes
on, indicating that the battery is fully charged and ready for use.

To charge the battery now (and calibrate the battery at a future time):

Do nothing when the yellow light begins blinking. After ten seconds, the charger
continues with a normal charge cycle.

You can skip calibration and instead charge and reuse the battery. However, if you
skip calibration, be sure to do it as soon as possible after the prompt. The Battery
Charger will remind you that the battery needs calibration the next time you insert
the battery into a pocket for charging.

If you choose to calibrate the battery, and then decide to cancel the calibration
after the process has begun, you can cancel calibration by removing the battery
from its pocket. If you remove a battery before calibration is complete, make sure to
recharge and check the battery before using it. If you remove a battery before
calibration ends, the battery may be low (use the on-battery power gauge to check
the battery charge status).

Note: Calibrate a battery as soon as possible after being prompted to do so to

ensure the best possible battery performance. Calibration can take up to 12 hours.
Therefore, be sure to have enough charged batteries available before calibration
begins. Under normal conditions, have four charged batteries available so that
batteries can be exchanged twice during a 12-hour calibration cycle.

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 4

LIVING WITH THE HEARTMATE 3

This section provides information to help you manage daily activities with the
HeartMate 3 Left Ventricular Assist Device.

Keeping Your Home Safe - - - - - - - - - - - - - - - - - - - - - - - 135

Staying Active and Safe - - - - - - - - - - - - - - - - - - - - - - - 136

Hand Washing - - - - - - - - - - - - - - - - - - - - - - - - - - - - 136

Eating - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 138

Caring for the Driveline - - - - - - - - - - - - - - - - - - - - - - - - 139

Caring for the Driveline Exit Site - - - - - - - - - - - - - - - - - - - 142

Showering- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 144

Wearing and Carrying the System Controller- - - - - - - - - - - - - 159

Sleeping- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 201

Traveling - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 203

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4 Living with the HeartMate 3

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 Living with the HeartMate 3 4
Keeping Your Home Safe
You may need to check your home for safety and electrical readiness. Here are
some items to consider checking:

Is the home free of clutter and dangerous objects?

Are there stairs? If so, how many?

Is there a bedroom on the first floor?

Is there a bathroom on the first floor, and does the bathroom have a
shower? Remember, no tub baths while you have the pump, and showers
are allowed only with your doctor’s approval.

Is the home electrically safe, with enough safe and working electric outlets?
(At least one outlet must be dedicated to powering the Mobile Power Unit).

Does the home have adequate telephones for emergency calls (for
example, speed dial for emergency calling)?

Are any occupational or physical therapy aids needed (for example, a

shower chair)?

Has the electric company been notified in writing of the need for priority
power restoration during a power loss?

IMPORTANT! Get a land-line (non-portable) telephone for emergency calls (unless

your hospital contact says not to). Land-lines are often less affected by interference,
interruptions, or power outages.

You are responsible for keeping your home safe after returning from the hospital.
If you are not comfortable testing the electrical system, you can hire an electrician
to do it.

Talk with your hospital contact if you have questions or concerns about home
safety.

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4 Living with the HeartMate 3
Electrostatic Discharge
Electrostatic discharge (ESD) is the release of static electricity when two objects
come into contact. Familiar examples of ESD include the shock received when
walking across a carpet and touching a metal doorknob, and the static electricity
felt after drying clothes in a clothes dryer. The presence of ESD may be increased in
environments with a relative humidity less than 30%. High levels of static electricity
may damage and/or interfere with the electrical parts of the system and cause the
Left Ventricular Assist Device to stop.

WHAT YOU SHOULD DO:

• Avoid activities that may cause static electricity.

• Discharge any built up static electricity by touching a metal surface before

handling LVAS components.

Staying Active and Safe

The HeartMate system was designed to let you stay active. Be sure to tell your
doctor about any changes in activity level or routine. Because each person is
different, your doctor can give the best advice for your needs. To keep safe while
being active, be sure to follow the guidelines in this handbook.

Hand Washing
Why Hand Washing is Important
Proper hand washing is one of the easiest and best ways to lower the spread of
infection.

Wash your hands often, for example, every time you use the bathroom, come in
from outside, after shaking hands or being in public, or anytime you touch dirty
(or maybe dirty) objects. You must also wash your hands every time before and
after changing the exit site bandages or any time you touch the exit site.

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 Living with the HeartMate 3 4
Proper hand washing means using soap and clean, running water. You also need
to wash for at least 15 seconds to get your hands really clean. Follow the steps
below for proper hand washing.

IMPORTANT! Before refilling an empty soap dispenser, wash it first.

Washing Your Hands to Lower Infection

FOR THIS TASK YOU NEED:

• Clean, dry paper towels

• Clean, running water

• Liquid soap (liquid is better than bar soap that can have microbes on it)

TASK
1. Gather supplies; place within easy reach.
2. Use a clean, dry paper towel to turn on the faucet(s) for clean, running water.
3. Wet your hands and wrists with clean, running water.
4. Apply soap to hands.
5. Rub together all parts of both hands (including wrists and backs of hands).
Get under rings, around cuticles, and under fingernails. Rub hard. Friction
helps remove dirt and microbes. Wash for at least 15 seconds.
6. Rinse well under a stream of clean, running water. Point fingers, hands, and
wrists down so water carries away dirt and microbes.
7. Use a new paper towel to dry hands.
8. Use a paper towel to turn off the faucet. Do not touch the faucet with your
clean hands.
9. Repeat steps 1–8 every single time before and after exit site bandage
changes, any time you touch the exit site, or any time your hands are dirty
(or could be dirty).

IMPORTANT! Before refilling an empty soap dispenser, wash it first.

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4 Living with the HeartMate 3
Eating

Why Eating Well is Important

A healthy, well-balanced diet helps you heal from the operation to implant the
pump. It also fuels an active lifestyle that can improve your quality of life.

Because of where the pump is located, some new pump users lose their appetite at
first. This usually goes away over time. If you feel full quickly, try eating smaller
meals more often. Eating more small—but healthy—meals can help you get enough
calories. An easy way to get calories and nutrition is by drinking healthy,
high-calorie drinks and shakes. You can make them yourself or buy them pre-made
at most grocery stores and pharmacies.

Talk with your hospital contact about tips for healthy eating.

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 Living with the HeartMate 3 4
Caring for the Driveline
It is very important to protect the Driveline, especially if you are active. Always keep
the Driveline protected and damage-free. Damage to the Driveline may cause the
pump to stop.

WARNING !
• The Left Ventricular Assist Device stops if the Driveline is disconnected from
the System Controller. If the Driveline is disconnected, reconnect it as quickly
as possible to restart the Pump. If the System Controller does not work,
replace with a backup System Controller.
• At least one System Controller power cable must be connected to a power
source (Mobile Power Unit or two HeartMate 14 Volt Lithium-Ion batteries) at
all times.

• Check the System Controller Driveline connector often to confirm that the
Driveline is securely inserted in the socket. If the Driveline disconnects from
the System Controller, the pump will stop.
• Never put the Driveline, System Controller, or any external equipment (such
as the Mobile Power Unit, batteries, power cables, or battery clips) into water
or liquid. Immersion in water or liquid may cause the pump to stop.

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4 Living with the HeartMate 3
CAUTION !
• Do not twist, kink, or sharply bend the Driveline. Twists, kinks, or sharp bends
can cause damage to the wires inside, even if external damage is not visible.
Damage to the Driveline could cause the pump to stop. If the driveline does
become twisted, carefully turn the System Controller to unravel the Driveline,
turning until the Driveline is no longer twisted.
• Avoid pulling on or moving the Driveline, especially as the skin exit site is
healing. Pulling on or moving the Driveline can damage tissue at the exit site.
Exit site trauma or tissue damage can increase the risk of getting a serious
infection.
• To avoid pulling on or moving the Driveline at the exit site, stabilize the
Driveline at all times.
• Call hospital contact if any change is observed in how the Pump works,
sounds, or feels.
• Never use tools to tighten power cable connectors. Securely hand tighten
only. Using tools may damage the connectors.

• Damage to electrical wires inside the Driveline can occur even if the damage
is not visible. Be alert for signs of Driveline damage, including, but not limited
to:

- The System Controller alarming when the Driveline moves or when body
position changes.
- High pulsatility index (PI) readings on the System Controller.
- Feeling pump vibrations.
- Fluid oozing from the external portion of the Driveline.
- Device stoppage.

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 Living with the HeartMate 3 4
Rules for Driveline Care
• Do not sharply bend or kink the Driveline (see What Not To Do: Driveline
and Cables on page 239).

• If you carry the System Controller in a carrying case, be careful that you do
not “catch” the Driveline in the zipper.

• Allow for a gentle curve for your Driveline. Do not severely bend or kink the
Driveline. Do not wrap the Driveline tightly.

• Keep your Driveline clean. Wipe off any dirt or grime. If the Driveline gets
dirty, use a towel with mild dish soap and warm water to gently clean it.
Never submerge the Driveline or other system components in water or liquid.

• Do not pull on or move the Driveline going through the skin.

• When checking that the Controller Driveline Connector is fully inserted in

the System Controller Driveline Connector, gently tug on the end of the
connector. Do not pull on the Driveline.

• To avoid pulling on or moving the Driveline at the exit site, stabilize the
Driveline at all times.

• Be aware of where your System Controller is at all times. It is important to

protect it from falling. Dropping the Driveline can make it pull on the
Driveline exit site. Report any drops of the System Controller to your hospital
contact. Do this right away, even if everything seems fine.

• If the Driveline is damaged, the pump may need to be replaced. It should be

replaced as soon as possible to prevent serious injury or death.

• Use care to keep the Driveline from snagging or catching on anything that
can pull on or move the Driveline.

• Check the Driveline daily for signs of damage (cuts, holes, tears). Call your
hospital contact right away if the Driveline is damaged (or might be
damaged).

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4 Living with the HeartMate 3
Caring for the Driveline Exit Site
It is very important to keep the Driveline exit site (where the Driveline goes through
the skin) clean and dry at all times. Keeping the exit site clean and dry lowers your
risk for infection.

Sterile technique is a set of specific practices and steps used under carefully
controlled conditions with the goal of minimizing contamination by pathogens.

While you are in the hospital, nurses take care of the exit site. Before leaving, you
are shown how to care for it. This includes learning “sterile technique” for dressing
changes. You are also taught how to recognize signs of infection. After leaving the
hospital, you are responsible for caring for the exit site. Be sure to always follow the
steps provided by your nurse or hospital contact.

Manage the Driveline exit site in accordance with the procedure provided by the
clinician. A driveline management system, supplied by the implanting center,
should be used at all times. The driveline management system should consist of a
dressing and stabilizer.

CAUTION !
• Carefully wash your hands every time before and after changing the exit site
bandages or whenever the exit site is touched and handled. Proper hand
washing is one of the easiest and best ways to reduce the spread of infection.
• To avoid pulling on or moving the Driveline at the exit site, the Driveline must
be stabilized at all times. Pulling on or moving the Driveline can keep the exit
site from healing or damage an already healed exit site. Exit site trauma or
tissue damage can increase the patient’s risk of getting a serious infection.
Emphasize to the patient and/or family member or caregiver the importance
of not pulling on or moving the Driveline.

• Do not twist, kink, or sharply bend the Driveline, System Controller power
cables, or Mobile Power Unit patient cable, which may cause damage to the
wires inside, even if external damage is not visible. Damage to the Driveline
or cables could cause the pump to stop. If the Driveline or cables become
twisted, kinked, or bent, carefully unravel and straighten.
• Keep the Driveline exit site as clean and dry as possible.

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 Living with the HeartMate 3 4
Rules for Exit Site Care
• Refer to the Caring for the Driveline Exit Site section Caring for the Driveline
on page 139.

• Follow strict “sterile technique” every time you change the bandage or touch
the Driveline exit site.

• Wash your hands before and after every bandage change (see Hand
Washing on page 136).

• Keep the Driveline exit site clean and dry.

• Care for your Driveline exit site as your doctor or medical professional tells
you.

• Try to not pull on or move the Driveline that goes through your skin.

• Check the Driveline exit site daily for signs of infection, including:

- Redness
- Swelling
- Drainage or bleeding
- Bad smell
- Feeling feverish, tired, or unwell
If you notice any signs of infection, call your hospital contact right away. Do not
wait! Early treatment makes a difference.

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4 Living with the HeartMate 3
Showering
If your doctor says it is okay for you to shower, follow these instructions each time
you shower.

Keeping your Driveline Exit Site Dry

It is important to keep the Driveline exit site dry while showering. This helps prevent
infection and helps extend the use of the Driveline management system. When
applied correctly, covering the kit with a moisture barrier consisting of multi-purpose
sealing wrap, sealed with adhesive tape on the edges, should keep moisture away.

Warnings and Precautions

WARNING !
The HeartMate 3 System Components must be kept dry. Never expose the System
Controller, Batteries, Mobile Power Unit or Power Base 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® GoGear® Shower Bag
must be used while showering to keep the System Controller and Batteries dry.

CAUTION !
• Do not take a shower until your doctor says you can.

• Refer to the HeartMate 3 Left Ventricular Assist System Patient Handbook for
detailed instructions and information on system function and maintenance.

• The Moisture Barrier is not a replacement for the Driveline management

system. It will only be used to keep the Driveline management system dry
during a shower.
• Apply the Moisture Barrier to clean dry skin. Do not use lotion or cream
before applying.
• Do not lift or attempt to reposition the Moisture Barrier after it is placed.
• Once applied, the Moisture Barrier should only be used one time.

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Applying the Moisture Barrier

TASK
1. Make a sheet of multi-purpose sealing wrap large enough to completely cover
the Driveline management system with at least six inches on all sides.
2. Center sheet of multi-purpose sealing wrap over the Driveline management
system and adhere to skin (see Figure 81).
Figure 81 Center the Multi-Purpose Sealing Wrap Over the Driveline Management System

a. Press the sheet of multi-purpose sealing wrap into place with your
fingers so that it is smooth to the skin with no gaps.
b. If you have difficulties, ask your caregiver or spouse for help.
3. Seal around the edges of the sheet of multi-purpose sealing wrap with the
tape (see Figure 82).
a. Apply the tape to all four edges of the sheet of multi-purpose sealing
wrap so that there are no gaps.
b. Rub the tape into place with fingers so that it is smooth on the skin.
c. Check all edges and make sure the sheet is completely stuck to the skin
with no gaps.
Figure 82 Seal Around the Edges of the Sheet of Multi-Purpose Sealing Wrap with the Tape

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4 Living with the HeartMate 3
Removing After Showering

TASK
1. Towel dry body and the outside of the multi-purpose sealing wrap.
2. Gently peel away the multi-purpose sealing wrap and tape from the skin (see
Figure 83).
a. As you remove, be careful to not disturb the Driveline management
system.
Figure 83 Gently Peel Away Multi-Purpose Sealing Wrap and Tape from Skin

3. If the Driveline management system gets wet, change it as instructed in the

previous sections.

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Using the Shower Bag
Although the external components of the HeartMate 3 Left Ventricular Assist System
are moisture-resistant, they are not waterproof. Take care to protect system
components from water or moisture, whether indoors showering or outdoors in a
heavy rain. If the components have contact with water or moisture, you may receive
a serious electrical shock or the pump may stop.

You cannot take tub baths with the pump, but you may be able to shower after the
Driveline exit site heals. Your doctor decides if you can shower. Do not shower
without your doctor’s approval. After you are approved for showering, you must
use the Shower Bag for every shower. It protects the outside parts of the system from
water and moisture (Figure 84).

Figure 84 Shower Bag

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4 Living with the HeartMate 3
WARNING !
• Never swim or take tub baths. Immersion in water will cause the pump to
stop.

• Showering may be allowed, but only after the exit site has healed and only
with a doctor’s permission. Do not shower without a doctor’s approval.

• If approved for showers, always use the Shower Bag for every shower. Never
shower without the Shower Bag.

• Never expose the System Controller or batteries to water. The System

Controller must be kept dry at all times.

• Do not shower while connected to the Mobile Power Unit. Only shower while
on battery power.
• Do not submerge the Shower Bag in water.

CAUTION !
• To avoid pulling on or moving the Driveline at the exit site, the Driveline must
be stabilized at all times. Pulling on or moving the Driveline can keep the exit
site from healing or damage an already healed exit site. Exit site trauma or
tissue damage can increase the patient’s risk of getting a serious infection.
Emphasize to the patient and/or family member or caregiver the importance
of not pulling on or moving the Driveline.

• Do not twist, kink, or sharply bend the Driveline, System Controller power
cables, or Mobile Power Unit patient cable, which may cause damage to the
wires inside, even if external damage is not visible. Damage to the Driveline
or cables could cause the Left Ventricular Assist Device to stop. If the Driveline
or cables become twisted, kinked, or bent, carefully unravel and straighten.

• Keep the exit site as clean and dry as possible.

• Carefully wash your hands every single time before and after changing the
exit site bandages or whenever you touch or handle the exit site. Proper hand
washing is one of the easiest and best ways to reduce the spread of infection.

• Do not place objects other than HeartMate 3 equipment in the wearable

accessories. Placing objects other than HeartMate 3 equipment in a
wearable accessory may damage the accessory.

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Figure 85 Use the Shower Bag to Shower

IMPORTANT!
Illustration shows
uncovered
exit site. Keep the
exit site as clean
and dry as possible
(see Caring for the
Driveline Exit Site
on page 142).

Shoulder
Strap

See-through
Panel (on top
of bag)

The Shower Bag (Figure 84) has a see-through top panel. This lets you view the
System Controller’s user interface while showering. The Driveline exits the Shower
Bag through double zippers along the side. The Shower Bag has an adjustable
shoulder strap and a waist strap. Adjust the straps as needed. The Shower Bag
should be placed so that it does not pull on or move the Driveline.

Showering is safe when the Shower Bag is used properly. Your hospital contact
may teach you how to use the Shower Bag before leaving the hospital. To keep
safe for showers at home, be sure to follow the guidelines in this handbook,
including the warnings and cautions below.

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Assembling the Shower Bag
FOR THIS TASK YOU NEED:

• 1 Shower Bag

• 1 Shower Bag shoulder strap

• 1 Shower Bag clip-style belt

TASK
1. Gather equipment; place within easy reach.
2. Clip the shoulder strap to the two rings on the top lid of the Shower Bag
(Figure 86).
Figure 86 Attach the Shoulder Strap to the Shower Bag

3. To attach the clip-style belt to the Shower Bag, slide the belt through the loop
on the side of the bag that will be against your body (Figure 87).
Note: The Shower Bag can be worn on your left or right side, depending on
the belt loop chosen.

Figure 87 Slide the Belt Through the Loop on the Side of the Shower Bag

4. Adjust the shoulder strap and belt so that the bag fits properly. Tighten or
lengthen the straps until they are secure, but still comfortable.

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Putting on the Shower Bag
FOR THIS TASK YOU NEED:

• 1 assembled Shower Bag that is clean and dry

• 1 running System Controller on battery power

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Make sure that the System Controller power cables and Driveline are not
twisted (Figure 88).
Figure 88 Make Sure the Power Cables and Driveline are Not Twisted

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4 Living with the HeartMate 3
3. Unclip the top cover of the Shower Bag by squeezing the clip prongs together
and sliding the clip out of the buckle (Figure 89).
Figure 89 Open the Clip and Buckle on the Top of the Shower Bag

4. Pull back the top lid to reveal the double zipper (Figure 90).
Figure 90 Open the Shower Bag

5. Unzip and open the cover of the water-resistant enclosure inside.

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6. Place the batteries and battery clips with attached power cables into the
Shower Bag (Figure 91).
Figure 91 Place Batteries and Clips in the Shower Bag

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4 Living with the HeartMate 3
7. Slide the System Controller into the pocket on the inside cover of the bag,
cable-free end in first and the user interface facing up (Figure 92).
Figure 92 Slide the System Controller into the Pocket

8. Prepare to close the cover by positioning the power cables inside the water
resistant enclosure (Figure 93).
Figure 93 Carefully Position the Power Cables in the Shower Bag

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 Living with the HeartMate 3 4
9. Close and zip the cover. Make sure that both the System Controller’s power
cables are inside the bag with only the Driveline exiting through the protective
red tabs (Figure 94).
Figure 94 Carefully Close the Shower Bag so the Driveline Exits the Bag through the Protective Red Tabs

10. Close the lid over the zippered enclosure, carefully positioning the Driveline
down the side of the bag (Figure 95).
Figure 95 The Driveline Exiting a Closed Shower Bag

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4 Living with the HeartMate 3
11. Snap the clip into the buckle to secure the lid (Figure 96).
Figure 96 Fasten the Clip and Buckle on the Top of the Shower Bag

12. Use the Shower Bag strap to hang the bag over your head and shoulder so
the bag hangs at your side. Adjust the Shower Bag so it does not pull on the
exit site while showering.
13. Clip the belt around your waist and adjust to tighten. The belt secures the
Shower Bag and prevents it from dropping if it slips off your shoulder. It also
keeps the Shower Bag from swinging away from your body if you bend over.
During your shower, keep the Driveline exit site as clean and dry as you can.
Talk with your hospital contact for tips on keeping the exit site dry during showers.

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Taking Off the Shower Bag
FOR THIS TASK YOU NEED:

• Shower Bag loaded with batteries and System Controller

• Large, clean, dry towel to dry your body

• Small, clean, dry towel to dry the Shower Bag

• 4” X 4” (10.2 cm x 10.2 cm) sterile gauze bandages to dry the exit site

• One or more sterile bandages to dress the exit site

• Wearable accessories to hold or carry the System Controller, batteries, and

battery clips after showering

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Unclip the clip-style belt from your waist.
2. Carefully lift and remove the Shower Bag shoulder strap from around your
neck.
3. Place the Shower Bag on a stable surface.
4. Use a clean towel to dry yourself, except the area around the Driveline exit
site.
5. Use a sterile gauze bandage to dry the Driveline exit site.
6. Apply a sterile dressing to the exit site, using an sterile technique (see Caring
for the Driveline Exit Site on page 142).
7. Use a clean, dry towel to dry the Shower Bag’s exterior and strap.

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4 Living with the HeartMate 3
8. Open the Shower Bag using the clip and buckle for the lid, and the left and
right zippers for the top (Figure 97).
Figure 97 Open the Clip and Buckle

9. Remove all equipment from the enclosure; place the equipment in a clean, dry
location.
10. Transfer system components to a wearable accessory, such as the Holster
Vest, Consolidated Bag, Belt Attachment, or Neck Strap (see Wearing and
Carrying the System Controller on page 159).
11. Allow the Shower Bag to drip dry completely before using it again.

Caring for the Shower Bag

Always hang the bag to dry. Allow it to air dry on its own. Never use a clothes
dryer or hair dryer to dry the bag. Make sure the bag is completely dry before
using it again. See Cleaning and Caring for the Equipment on page 244 for
complete instructions on caring for all wearable accessories, including the Shower
Bag.

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Wearing and Carrying the System Controller
Several wear and carry accessories are available for the HeartMate 3 system.

Figure 98 Accessories to Hold or Carry External Parts of the System

Protection Bag
See page 180.

Belt Attachment System

See page 166. Controller
Neck Strap
See page
161.

Battery Holster
See page 184.

Holster Vest
See page 192.

Consolidated Bag
See page 171.

Shower Bag
See page 147.

Travel
Bag
See page
182.

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4 Living with the HeartMate 3
The wear and carry accessories are described in the table below.

Wear and Carry

Use
Accessory

Worn around the neck or across the body; holds the System
System Controller
Controller when connected to the Mobile Power Unit or during
Neck Strap
battery-powered operation.

Worn around the waist, on a belt; holds the System Controller

Belt Attachment when connected to the Mobile Power Unit or during
battery-powered operation.

Protection Bag Stores and protects the backup System Controller.

Travel Bag Worn on a shoulder. Stores the Protection Bag and a spare set
of batteries.

Worn on a shoulder or around the waist; used to carry the

Consolidated Bag System Controller and 2 batteries/battery clips together in a
single bag during battery-powered operation.

Worn around the shoulders and under the arms; holds the
System Controller and 2 batteries/battery clips during
Battery Holster battery-powered operation. Designed to distribute equipment
weight across the shoulders and back. Comes in one size, but
is adjustable to fit most.

Worn around the shoulders and under the arms; holds the
System Controller and 2 batteries/battery clips during
battery-powered operation. Designed to distribute equipment
Holster Vest
weight across the shoulders and back. Includes a chest strap
and works with or without the belt attachment. Comes in 3
sizes (small, medium, and large).

Using these accessories, you can be active because the accessories comfortably
and safely hold/carry the System Controller (and other equipment, at times).

With all of the accessories, you can stand, sit, walk, crouch, bend over, reach, turn,
and lean. Common activities may include (but are not limited to) exercising,
traveling, playing with children, gardening, hiking, cooking, and dancing. Talk
with your doctor about any changes in activity level or routine.

Different accessories provide different wear and carry options.

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The System Controller Neck Strap
The System Controller Neck Strap (Figure 99) allows you to carry the
System Controller around your neck or across your body. It attaches to the
System Controller with two small straps.

Figure 99 Using the System Controller Neck Strap to Carry the System Controller

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4 Living with the HeartMate 3
The System Controller has four attachment points (Figure 100): one in each corner
of the casing. The Neck Strap uses two attachment points for hanging the System
Controller vertically or horizontally (Figure 101).

Figure 100 Attachment Points on System Controller

Attachment
Points

Attachment Points

Figure 101 System Controller Suspended Horizontally (left) and Vertically (right) from Neck Strap

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 Living with the HeartMate 3 4
Putting On the System Controller Neck Strap

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Running System Controller

• System Controller Neck Strap

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Place the System Controller on a flat, stable surface.
3. Make sure the System Controller power cables and Driveline are not twisted
(Figure 102).
Figure 102 Make Sure the Power Cables and Driveline are Not Twisted

4. Choose two attachment points on the System Controller, for either vertical or
horizontal wear.

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4 Living with the HeartMate 3
5. Slide the rubber strap on the Neck Strap through the first attachment point on
the System Controller (Figure 103).
Figure 103 Slide Strap Through Attachment Point

6. To buckle the strap, thread the rubber strap through the metal buckle on the
Neck Strap. Make sure the metal prong on the buckle goes through the strap,
similar to buckling a belt (Figure 104).
Figure 104 Buckle the Strap

7. Hold the System Controller in one hand and give the Neck Strap a tug with
the other hand. This helps to confirm that the buckle is securely connected to
the System Controller (Figure 105).
Figure 105 Give the Neck Strap a Tug

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8. Repeat Steps 5–7 to attach the second strap tab on the System Controller
attachment point.
9. Put on the Neck Strap—around your neck or across your body.
10. Adjust the strap so that the cushioned band on the strap is comfortable on
your body.

Taking Off the Neck Strap

TASK
1. Carefully remove the Neck Strap and attached System Controller.
2. Place Neck Strap and System Controller on a flat, stable surface.
3. Unbuckle the Neck Strap tabs and remove lanyard from the System
Controller.
4. Store the Neck Strap in a clean, dry location.

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The Belt Attachment
The belt attachment accessory (Figure 106) is similar to accessories that are used
to wear or carry a cell phone. You can attach it to your own belt, or attach it to the
provided nylon clip belt.

Figure 106 Belt Attachment

Putting on the Belt Attachment

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Running System Controller on Mobile Power Unit power

• Belt attachment

• Your own belt or the nylon belt that is provided

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Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Make sure the System Controller power cables and Driveline are not twisted
(Figure 107).
Figure 107 Make Sure the Power Cables and Driveline are Not Twisted

3. Slide either your belt or the nylon clip belt through the loop on the back of the
belt attachment (Figure 108).
Figure 108 Slide the Belt Through the Loop on the Belt Attachment

4. Unclip the two-banded strap on the belt attachment.

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4 Living with the HeartMate 3
5. Slide the System Controller, cable-free end first, into the belt attachment with
the display screen facing out (Figure 109).
Figure 109 Slide the System Controller Into the Belt Attachment

6. Place the two-banded strap over the System Controller and between the white
System Controller power cable connector and the Driveline connector
(Figure 110).
Figure 110 Place the Strap Between the Connectors

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7. Clip the two-banded strap into place (Figure 111). Make sure both prongs
are fully engaged in the clip.
Figure 111 Clip the Strap Into Place so the System Controller is Secure

8. Fasten the belt and belt attachment around your waist. Adjust and tighten the
belt as necessary.

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4 Living with the HeartMate 3
Taking Off the Belt Attachment

TASK
1. Hold the belt attachment and System Controller securely in one hand, so that
the System Controller does not fall.
2. If using the nylon clip belt:
a. Unclip the nylon clip belt.
b. Remove the Belt Attachment, System Controller, and belt from around
your waist.
c. Place the Belt Attachment and System Controller on a stable surface.
OR
3. If using your own belt:
a. Unfasten the belt.
b. Slide the Belt Attachment off the belt.
c. Place the Belt Attachment and System Controller on a stable surface.
4. Remove the System Controller from the Belt Attachment:
a. Unclip the two-banded strap from the Belt Attachment.
b. Slide the System Controller out of the Belt Attachment and place the
items on a stable surface.
5. Store the Belt Attachment in a clean, dry location.

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The Consolidated Bag
Use the Consolidated Bag (Figure 112) to carry the System Controller, batteries,
and battery clips together in a single place while using the batteries.

Figure 112 Consolidated Bag

Shoulder Strap

Red Protective Tabs

The Consolidated Bag comes in one color (black) and two designs (for right-sided
carrying or left-sided carrying). A tag on the bag tells you if it is for right- or
left-sided wear.

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4 Living with the HeartMate 3
The Consolidated Bag is worn across the body (see Figure 113) using a shoulder
strap or around the waist using a waist strap. Either strap can be used alone or
together. A double zipper secures the System Controller and batteries in a
compartment inside the bag. The System Controller user interface is visible through
a see-through panel beneath a small flap on the outside of the bag. The Driveline
exits the bag through the protective red tabs on the side.

Figure 113 Wearing the Consolidated Bag

Consolidated Bag
Version for Right-
Sided Wearing

Consolidated Bag
Version for Left-Sided
Wearing

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 Living with the HeartMate 3 4
Assembling the Consolidated Bag

FOR THIS TASK YOU NEED:

• Consolidated Bag with belt

• Consolidated Bag shoulder strap

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Clip the shoulder strap to the Consolidated Bag using the two rings located
on the top of the Consolidated Bag (Figure 114).
Figure 114 Attach the Shoulder Strap

3. Put the bag on to confirm the appropriate placement on your left or right side.
Note: The bag type (left or right) can be found on a tag inside the Consoli-
dated Bag.

4. Adjust the shoulder strap and belt so the bag fits you properly. Tighten or
lengthen the strap and belt until they are secure but still comfortable.

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4 Living with the HeartMate 3
Putting On the Consolidated Bag

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Running System Controller on battery power

• Assembled Consolidated Bag

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Make sure the System Controller power cables and Driveline are not twisted
(Figure 115).
Figure 115 Make Sure the Power Cables and Driveline are Not Twisted

3. Prepare the Consolidated Bag for use. Unzip the double zippers and open
the bag.

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4. Slide the System Controller into its holder so the user interface faces out
(Figure 116).
Figure 116 Slide the System Controller Into the Consolidated Bag

5. Stretch the two-banded strap over the System Controller and between the
white System Controller power cable and the Driveline connector. Fasten the
clip to hold the System Controller in place (Figure 117).
Figure 117 Stretch the Strap Over the System Controller and Between the Cables

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4 Living with the HeartMate 3
6. Place the first battery into the Consolidated Bag, with the battery clip and
cable facing out (Figure 118).
Figure 118 Place Battery and Attached Battery Clip into Consolidated Bag

7. Adjust the power cable so that it lays flat along the edge of the bag
(Figure 119).
Figure 119 Carefully Position the Power Cable Around the Edge of the Bag

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 Living with the HeartMate 3 4
8. Place the second battery into the Consolidated Bag, with the battery clip and
cable facing out (Figure 120).
Figure 120 Insert Second Battery

9. Arrange the power cables so that they lay flat along the edge of the bag
(Figure 121).
Figure 121 Arrange the Cables Around the Inside of the Bag

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4 Living with the HeartMate 3
10. Carefully close the Consolidated Bag, with the System Controller power
cables inside the bag and the Driveline between the protective red tabs
(Figure 122).
Figure 122 Close the Bag so the Driveline Exits Between the Red Tabs

11. Zip the Consolidated Bag closed (Figure 123).

Figure 123 Zip the Consolidated Bag Closed

12. Hold the Consolidated Bag by the handle so it does not drop.
13. To put on the Consolidated Bag, put the shoulder strap over your head and
across your chest, so the bag rests against your body, on the side of your
body for which it was intended. Put the waist belt around your body and clip
it into place. The belt stabilizes the bag and prevents it from moving.

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Taking off the Consolidated Bag

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Running System Controller on battery power, stowed in the Consolidated

Bag

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Unclip the belt.
2. Use the handle on the top of the Consolidated Bag to hold the bag securely
so it does not drop.
3. Take off the shoulder strap—either unclip it at one side, or lift it up and over
your head to take off the Consolidated Bag.
4. Place the bag in front of you on a stable surface.
5. Unzip the bag and open it.
6. Do one of the following:
• Exchange low batteries with fully-charged batteries.
• Transfer from battery power to Mobile Power Unit power (see
Changing from Batteries to Mobile Power Unit Power on page 117).
• Remove the components and transfer to another wearable accessory.
7. Store the Consolidated Bag in a clean, dry location.

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4 Living with the HeartMate 3
The Protection Bag
A special bag protects and stores the backup System Controller while it is in
Sleep Mode. It is called the Protection Bag (Figure 124).

Figure 124 Store Your Backup System Controller in the Protection Bag

The Protection Bag has a clear window for easy viewing of the System Controller
and power cables inside. The bag protects the System Controller from dust, dirt,
moderate water, and debris. It also provides a convenient way to carry the backup
System Controller, which must remain with you at all times. The Protection Bag fits
into the Travel Bag.

Do not store or carry anything in the Protection Bag, except the backup
System Controller and attached power cables.

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Using the Protection Bag for the Backup System Controller

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Protection Bag

• Backup System Controller with attached power cables

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Unzip the Protection Bag.
2. Slide the backup System Controller into the Protection Bag.

IMPORTANT! When placing the System Controller inside the Protection

Bag, do not twist, kink, or sharply bend the System Controller power cables.
This may cause damage to the wires inside, even if external damage is not
visible. Damage to the Driveline or cables could cause the Pump to stop. If
the Driveline or cables become twisted, kinked, or bent, carefully unravel
and straighten.

3. Carefully coil the cables around the System Controller inside the Protection
Bag.
4. Zip the Protection Bag closed.
5. The backup System Controller is now stored in the Protection Bag. Keep the
backup System Controller with you at all times.

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The Travel Bag
The Travel Bag provides an easy way to keep your backup System Controller and
spare batteries with you at all times (see Figure 125).

Figure 125 Travel Bag

Storing Items in the Travel Bag

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Protection Bag with backup System Controller and power cables stored
inside
• 2 fully-charged HeartMate 14 Volt Lithium-Ion batteries

• Travel Bag

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Store the Protection Bag (with backup System Controller and cables inside) in
the Travel Bag (Figure 126).

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 Living with the HeartMate 3 4
Figure 126 Store the Protection Bag with Backup System Controller Inside the Travel Bag

2. Place the spare batteries inside the Travel Bag, on either side of the Protection
Bag (Figure 127).
Figure 127 Store the Batteries Inside the Travel Bag

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4 Living with the HeartMate 3
The Battery Holster
Use the Battery Holster (Figure 128) to hold the System Controller and two
HeartMate batteries (with battery clips) during battery-powered operation. This
accessory distributes equipment weight across the shoulders and back. The Battery
Holster comes in one size. It is adjustable to fit most users.

Figure 128 Battery Holster

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 Living with the HeartMate 3 4
The Belt Attachment can be used with the Battery Holster to protect and cover the
System Controller (Figure 129).

Figure 129 Belt Attachment Used with Battery Holster

When you wear the Battery Holster, you can exchange low-charged batteries for
fully-charged batteries without taking off the holster. See Exchanging Low-Power
Batteries with Two Fully-Charged Batteries on page 189.

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4 Living with the HeartMate 3
Assembling the Battery Holster

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Battery Holster

• Pair of large, sharp scissors

• Small tube of strong epoxy glue

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Place the Battery Holster in front of you on a flat surface, arranged so the
fabric connecting the two straps is in the center.
3. Slide your arms through the straps, so that the fabric connector is between
your shoulder blades on your back.
4. Pull the loose ends of the strap to adjust the fit. The holsters should fit securely
but comfortably against your sides and under your arms.
5. After determining appropriate fit, cut off or trim the extra length from the end
of each strap.
6. Apply a strong epoxy glue to the cut off ends of each strap to reduce fraying.
Allow the glue to dry before wearing the holster.
Note: The straps can also be stitched together through the fabric to prevent the
fabric connector from moving and changing the fit.

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Putting On the Battery Holster

FOR THIS TASK YOU NEED:

• Running System Controller connected on Mobile Power Unit power

• 2 fully-charged HeartMate 14 Volt Lithium-Ion batteries

• 2 14 Volt battery clips

• Battery Holster

• Belt Attachment

• Clip-style belt or your own belt

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Make sure that the System Controller power cables and Driveline are not
twisted (Figure 130).
Figure 130 Make Sure the Power Cables and Driveline are Not Twisted

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4 Living with the HeartMate 3
3. Insert the batteries and attached battery clips into each holster:
a. Open each VELCRO® flap (Figure 131, left).
b. Insert each battery/battery clip into a holster, so the clips point up and
the batteries point down (Figure 131, right).
Figure 131 Open VELCRO Flap and Insert Battery with Attached Battery Clip

4. Close each Battery Holster flap after the battery/battery clip is inside the
holster (Figure 132).
Figure 132 Close VELCRO Flap to Secure Battery/Battery Clip Inside

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5. Put on the Battery Holster with the inserted batteries/battery clips.
6. Put on and secure the Belt Attachment around your waist. Adjust and tighten
the belt as needed (see Putting on the Belt Attachment on page 166).
7. Slide the System Controller into the Belt Attachment.
8. Stretch the two-banded strap on the Belt Attachment over the end of the
System Controller and between the white System Controller power cable
connector and the Driveline connector.
9. Slide the clip ends of the two-banded strap into the clip socket. The clip will
click into place when securely fastened.
10. Transfer from the Mobile Power Unit to battery power (see Changing from
Mobile Power Unit Power to Batteries on page 114).

Exchanging Low-Power Batteries with Two Fully-Charged Batteries

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• To be wearing a battery holster with running System Controller on battery

power

• 2 fully-charged HeartMate 14 Volt Lithium-Ion batteries

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

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4 Living with the HeartMate 3
TASK
1. Gather equipment; place within easy reach.
2. Exchange each battery, one at a time:
a. Open one flap on a Battery Holster.
b. Remove the battery/battery clip from the Battery Holster.
c. Hold the battery while pressing the battery release button on the
battery clip.
d. Withdraw the low battery from its battery clip and put aside the low
battery. Remove only one battery from its clip at this time. A power
cable disconnected advisory will sound. This is normal.
e. Retrieve one of the fully-charged batteries and insert it into the battery
clip. It will click into place when fully inserted. The alarm stops when
the fully-charged battery is properly inserted.
f. Place the fully-charged battery/attached battery clip into the empty
Battery Holster.
g. Close the Battery Holster flap.
h. Repeat Steps a–g for the second low battery.
3. Recharge the low batteries in the Battery Charger (see Charging HeartMate
14 Volt Lithium-Ion Batteries on page 127).

Taking Off the Battery Holster

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• To be wearing a Battery Holster with running System Controller on battery

power

• Mobile Power Unit

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

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TASK
1. Switch from battery power to the Mobile Power Unit (see Changing from
Batteries to Mobile Power Unit Power on page 117). Do this before taking off
the holster.
2. Take off the Battery Holster with batteries.
3. Hold the Belt Attachment and System Controller securely in one hand, so that
the System Controller does not fall.
4. If using the nylon clip belt:
a. Unclip the nylon clip belt.
b. Remove the Belt Attachment, System Controller, and belt from around
your waist.
c. Place the Belt Attachment and System Controller on a stable surface.
OR

5. If using your own belt:

a. Unfasten the belt.
b. Slide the Belt Attachment off the belt.
c. Place the Belt Attachment and System Controller on a stable surface.
6. Remove the System Controller from the Belt Attachment:
a. Unclip the two-banded strap from the Belt Attachment.
b. Slide the System Controller out of the Belt Attachment and place the
items on a stable surface.
7. Remove the batteries and attached battery clips from the holster and place
them on a stable surface.
8. Recharge the low-charged batteries (see Charging HeartMate 14 Volt
Lithium-Ion Batteries on page 127).
9. Store the holster in a clean, dry location (see Caring for the Equipment on
page 243).

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4 Living with the HeartMate 3
The Holster Vest
Use the Holster Vest to hold the System Controller and two HeartMate batteries
(with battery clips) during battery-powered operation (Figure 133).

Figure 133 The Holster Vest

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 Living with the HeartMate 3 4
This accessory distributes equipment weight across the shoulders and back. A chest
strap is also available. Use it to add extra support. The Belt Attachment can be used
with the Holster Vest to protect and cover the System Controller (Figure 134).

Figure 134 Holster Vest with Belt Attachment and Shoulder Strap

Chest
Strap

Belt attachment

The Holster Vest is available in three sizes: small, medium, and large.

When you wear the Holster Vest, you can exchange low-charged batteries for
fully-charged batteries without taking off the vest. See Exchanging Batteries While
Wearing the Holster Vest on page 198.

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4 Living with the HeartMate 3
Assembling the Holster Vest

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Holster Vest with Belt Attachment

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Insert one vest strap through the slot in the top of one of the holsters. The
buckle should be pointing down and the holster should face forward when
you wear the vest (Figure 135).
Figure 135 Insert the Vest Strap Through the Slot in the Top of the Holster

3. Repeat Step 2 for the second holster.

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Putting On the Holster Vest

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Running System Controller on Mobile Power Unit power

• 2 fully-charged HeartMate 14 Volt Lithium-Ion batteries

• Assembled Holster Vest with Belt Attachment

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Gather equipment; place within easy reach.
2. Make sure that the System Controller power cables and Driveline are not
twisted (Figure 136).
Figure 136 Make Sure the Power Cables and Driveline are Not Twisted

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4 Living with the HeartMate 3
3. Place the batteries and attached battery clips into the holsters:
a. Insert one battery and attached battery clip into the holster, with the
battery pointing down and the battery clip pointing up (Figure 137).
Figure 137 Insert Battery and Battery Clip Into Holster

b. Buckle the clip on the holster (Figure 138).

Figure 138 Buckle the Clip on the Holster

c. Repeat Steps a–b for the second battery and battery clip.
4. Put on the Holster Vest with the attached batteries/battery clips.
5. Adjust and tighten the straps as needed.
6. If the chest strap is used, position it higher or lower on the vest as needed, so
it is secure and comfortable.

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7. Put on and secure the belt attachment around your waist. Adjust and tighten
the belt as needed.
8. Slide the System Controller into the Belt Attachment.
9. Stretch the two-banded strap on the Belt Attachment over the end of the
System Controller and between the white System Controller power cable
connector and the Driveline connector.
10. Slide the clip ends of the two-banded strap in to the clip socket. The clip will
click into place when securely fastened.
11. Transfer from the Mobile Power Unit to battery power (see Changing from
Mobile Power Unit Power to Batteries on page 114).
12. Use the VELCRO tabs on the back of the holsters to hold the power cables in
place and to stabilize the holsters (Figure 139).
Figure 139 Use VELCRO Tabs to Hold the Power Cables

13. Put the belt through the VELCRO tabs to help secure the holsters in place.

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4 Living with the HeartMate 3
Exchanging Batteries While Wearing the Holster Vest
The Holster Vest allows you to exchange low-power batteries with two new,
fully-charged batteries, without taking off the Holster Vest or disrupting the power
cables.

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task

• Running System Controller connected to two in-use HeartMate batteries

during battery-powered operation

• 2 fully-charged HeartMate 14 Volt Lithium-Ion batteries

• Holster Vest

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Obtain two fully-charged HeartMate batteries; place them within easy reach.

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 Living with the HeartMate 3 4
2. Exchange the first low-power battery (Figure 140):
a. Open the flap on one of the holsters to access one of the batteries and
its attached battery clip.
b. Hold the battery while pressing the battery release button on the
battery clip.
c. Withdraw the low battery from its battery clip and put aside the lower
battery. Remove only this battery at this time. A Power Cable Discon-
nected advisory will sound. This is normal.
d. Retrieve one of the fully-charged batteries and insert it into the battery
clip. It will click into place when fully inserted. The alarm stops when
the fully-charged battery is properly inserted.
e. Close the flap on the holster.
Figure 140 Exchanging a Battery

f. Repeat Steps a–e to exchange the second low battery.

3. Recharge the low-power batteries (see Charging HeartMate 14 Volt
Lithium-Ion Batteries on page 127).

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4 Living with the HeartMate 3
Taking Off the Holster Vest

TASK
1. Switch from battery power to the Mobile Power Unit (see Changing from
Batteries to Mobile Power Unit Power on page 117). Do this before taking off
the Holster Vest.
2. Take off the Holster Vest with batteries.
3. Hold the Belt Attachment and System Controller securely in one hand, so that
the System Controller does not fall.
4. If using the nylon clip belt:
a. Unclip the nylon clip belt.
b. Remove the Belt Attachment, System Controller, and belt from around
your waist.
c. Place the Belt Attachment and System Controller on a stable surface.
OR

5. If using your own belt:

a. Unfasten the belt.
b. Slide the Belt Attachment off the belt.
c. Place the Belt Attachment and System Controller on a stable surface.
6. Remove the System Controller from the Belt Attachment:
a. Unclip the two-banded strap from the Belt Attachment.
b. Slide the System Controller out of the Belt Attachment and place the
items on a stable surface.
7. Remove the batteries and attached battery clips from the Holster Vest and
place the items on a stable surface.
8. Recharge the low-charged batteries (see Charging HeartMate 14 Volt
Lithium-Ion Batteries on page 127).
9. Store the holster vest in a clean, dry place (Cleaning and Caring for the
Equipment on page 244).

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 Living with the HeartMate 3 4
Sleeping

Pre-Sleep Safety Check

Sleep safety means adding a few extra steps to your routine. For example, before
going to sleep, check all electrical and system connections to make sure they are
tight. See the pre-sleep checklist.

PRE-SLEEP CHECKLIST

Connect to Mobile Power Unit power before going to sleep or any

time you might fall asleep.

Make sure the Driveline is stabilized.

Check all electrical and system connections to make sure they are tight. Check:
Between System Controller and power cables
Between power cables and Mobile Power Unit patient cable
Between Mobile Power Unit and electrical outlet

Check that the bedside flashlight has working batteries.

Place backup equipment nearby:

Backup System Controller
Fully-charged HeartMate batteries (already in their clips)

Make sure your emergency contact list is nearby.

Inspect the Driveline Cable for signs of damage, such as cracking, fraying, wear,
exposed wires, sharp bends or kinks.

Inspect that the Modular In-line Connector is fully connected and the locking nut is
in the fully locked position. Also inspect the Modular In-Line Connector for signs of
damage, such as cracking, fraying, wear, exposed wires, sharp bends, or kinks.

Inspect all cables for signs of damage.

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4 Living with the HeartMate 3
Connect to the Mobile Power Unit
You must always connect to the Mobile Power Unit when sleeping (or when sleep is
likely). This is very important! If you fall asleep on battery power, you might not
hear low power alarms. The batteries could run out of power, and the pump could
stop before you hear the alarms.

Safe Positions
Try to sleep so that you do not bend, pull on, or move the Driveline. Do not sleep on
your stomach. Arrange clothes, sheets, and blankets so they do not pull on or get
tangled in the Driveline. Stabilize the Driveline at all times, including during sleep.

Equipment to Keep Nearby

Keep a flashlight (with well-charged batteries) nearby, along with your emergency
contact list. All backup equipment should also be nearby when sleeping, including
the backup System Controller and fully-charged batteries (already in their clips).
This way, in an emergency, everything you need is nearby.

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 Living with the HeartMate 3 4
Traveling
Being able to travel freely is a big part of everyone’s quality of life. If you want to
enjoy the freedom of travel, it takes some extra planning to do it safely.

Talk with your hospital contact about any travel plans, especially if you will travel
long distances (such as by aircraft).

You need a travel plan and emergency action plan for long-distance trips. Your
hospital contact can help create them. Your hospital contact will also talk with you
about travel safety rules for equipment, like the Mobile Power Unit and its backup
battery.

CAUTION !
For international travel, use a Thoratec Corporation power cord that is compatible
with the local voltage and that meets applicable national plug, rated voltage,
rated current, and safety agency marks and specifications for both the Mobile
Power Unit and Battery Charger. Other power cords must not be used. Contact
your hospital contact for a power cord, if needed.

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4 Living with the HeartMate 3
Always follow these important guidelines for local and long-distance travel:

• Be sure to bring everything you need for battery-powered and

electrical-powered operation at your final destination, including:

- Battery Charger and power cord

- Spare batteries
- Battery clips
- Mobile Power Unit
- Mobile Power Unit patient cable
- Mobile Power Unit power cord for connecting to AC power
- Backup System Controller
• Never leave or store batteries in extremely hot or cold places (such as the
trunk of your automobile), or battery life will be shortened.

• Never carry or store batteries in temperatures below -10°C (14°F) or above

40°C (104°F) or they may fail suddenly.

• Never use batteries in temperatures below 0°C (32°F) or above 40°C

(104°F) or they may fail suddenly.

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 Living with the HeartMate 3 4
Automobile Travel
Automobile airbags deploy with great force. If an airbag hits your abdomen or
chest, the force could cause serious damage or bleeding. For this reason, avoid
riding in the front seat of cars with airbags (also known as supplemental restraint
systems, or “SRS” for short).

Your doctor decides if you can drive an automobile while implanted with the pump.
Some states have laws against letting patients drive if they have a history of
fainting, dizziness, or cardiac arrest. Usually, you need to wait at least 6–8 weeks
after surgery before being considered for driving privileges.

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4 Living with the HeartMate 3

206 HeartMate 3 Left Ventricular Assist System Patient Handbook

 5

ALARMS AND TROUBLESHOOTING

This section describes the primary alarms and troubleshooting of the HeartMate 3 Left
Ventricular Assist System.

System Controller Alarms - - - - - - - - - - - - - - - - - - - - - - - 209

Mobile Power Unit Alarms - - - - - - - - - - - - - - - - - - - - - - 231

Battery Charger Alarms - - - - - - - - - - - - - - - - - - - - - - - - 233

Guidelines for Power Cable Connectors - - - - - - - - - - - - - - - 238

What Not To Do: Driveline and Cables- - - - - - - - - - - - - - - - 239

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5 Alarms and Troubleshooting

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 Alarms and Troubleshooting 5
System Controller Alarms

Alarms that You Can Handle

Many System Controller alarms are easy to resolve. You can expect to troubleshoot
common alarms after you are trained by your hospital contact. Driveline
Disconnected and Power Cable Disconnected alarms are examples of alarms that
are resolvable by users, caregivers, and family members. In most cases, these
alarms are handled by following simple on-screen instructions. Table 7 shows how
to access the alarm history screens.

Alarms for Clinicians to Handle

Other alarms need special help. For most of these cases, “Call Hospital Contact”
appears on the screen. Besides the on-screen message, you will learn from your
hospital contact when to call for help. Depending on the hospital and situation, you
may be told to replace the System Controller (see Replacing the Running System
Controller with a Backup Controller on page 63) or be admitted to the hospital for
testing and care.

Handling System Controller Alarms

System Controller alarms are described on the following pages. Each section gives
the likely cause and typical steps for resolving the alarm. Alarms are listed in order
of priority. Hazard alarms are listed first, followed by Advisories. See Table 8 and
Table 9 on the following pages for a complete list of prioritized System Controller
alarms.

IMPORTANT! System Controller alarms cannot be silenced when the System Controller is
in power saver mode.

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5 Alarms and Troubleshooting
Alarm Screen Overview
When an alarm occurs, messages appear on the System Controller’s user interface
screen to help resolve the problem. These screen messages indicate the alarm type
as well as how long the alarm has been occurring. The timer on the screen counts
up in seconds, indicating how long the alarm has been occurring. Figure 141
shows the alarm screen layout. On-screen messages come in many different
languages. Talk with your hospital contact about selecting the language that is best
for your needs.

Figure 141 Alarm Screen

Alarm Message

Duration Timer

Viewing Alarm History on the User Interface Screen

You can view alarm history on the System Controller user interface. The last six
relevant System Controller alarms are displayed. Only a subset of alarms is
displayed on the System Controller - alarms that are transient, have clinical value,
or that do not interfere with access to more critical alarms. Examples of alarms that
are displayed include:

• Power Cable Disconnected alarm (lasting over 30 seconds)

• External Power Disconnected alarm
• Driveline Disconnected alarm
• Low Battery Power Advisory alarm
• Low Battery Power Hazard alarm
• Low Flow alarm

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 Alarms and Troubleshooting 5
To view the six most recent alarms on the user interface screen, simultaneously press
and release the silence alarm ( ) and display ( ) buttons. Up to six of the most
recent alarms are displayed. The most recent alarm appears first. To view the next
alarm, press and release the display ( ) button. Each push of the display button
brings up a new screen. After the sixth alarm is displayed, the next button push
returns you to the first alarm screen.

Alarm history screens show the date and time of the alarm occurrence at the top of
the screen. A dot at the bottom of each screen provides navigational information
about which screen is in view (see Figure 142).

Figure 142 Sample Alarm History Screen

Date and Time of Alarm
Alarm Type

Duration of Alarm

Navigation Information

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5 Alarms and Troubleshooting
Table 7 shows how to access the alarm history screens.

Alarm
Button Screen
Description
Press Displayed
(Example)
Press

Press display button and silence alarm button at the same time to
AND access the first alarm.

Press

Press display button ONCE to display the second alarm.

Press

Press display button a SECOND time to display the third alarm.

Press

Press display button a THIRD time to display the fourth alarm.

Press

Press display button a FOURTH time to display the fifth alarm.

Press

Press display button a FIFTH time to display the sixth alarm.

Table 7 Viewing Alarm History Screens

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 Alarms and Troubleshooting 5
If the System Controller detects an alarm condition while displaying alarm history,
the screen immediately transitions to the real-time alarm screen. However, you can
still access the alarm history screens during an active alarm by simultaneously
pressing the silence alarm ( ) and display ( ) buttons. To exit from the alarm
history feature, simultaneously press the two buttons again.

Alarms that Do Not Display on the Controller Alarm History Screen

The Driveline Power fault, Driveline Communication fault (Driveline Comm Fault),
Communication fault (Comm fault), Backup Battery fault, and Replace Controller
fault are examples of non-transient alarms that require specific user action to resolve
the alarm condition. These alarms remain on the user interface screen until the
alarm condition is resolved or permanently disabled by a clinician, and therefore
do not appear in alarm history.

In addition, a Power Cable Disconnected advisory (that lasts less than 30 seconds)
and Pulsatility Index (PI) events are examples of routine events that might interfere
with access to more critical information. For this reason, these events also do not
appear in alarm history.

When the audio alarms are silenced, an alarm silence indicator displays (see
Figure 143) on the LCD screen on the System Controller.

Figure 143 Alarm Silence Indicator

IMPORTANT! The green Pump Running ( ) light is always on when the pump is
running

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5 Alarms and Troubleshooting

System Active
Priority Controller Alarm Means To Resolve Alarm
Symbols
Screen

1. Immediately connect to a working power source (Mobile

Power Unit or two HeartMate 14 Volt Lithium-Ion
Pump is off. The batteries).
+ Pump is Running 2. If connecting to power does not resolve the problem,
symbol is black. press any button on the System Controller to attempt
pump start and call your hospital contact immediately.
For more information, see page 217.

Low flow, flow is Call your hospital contact immediately for diagnosis and
+ less than 2.5 instructions.
lpm
D

For more information, see page 218.

1. Immediately reconnect the Driveline to the System

R

Controller and move the Driveline Safety Lock on the

System Controller to the locked position. Also, check
that the Modular In-Line connector is secure.
Driveline is 2. If alarm persists after reconnecting the Driveline, press
disconnected. any button on the System Controller to potentially
The Pump resolve.
A

Running symbol
is black. 3. If Driveline is connected and alarm persists, replace
+ System Controller with a configured backup System
Controller. See page 63.
4. If alarm persists, call your hospital contact immediately.
For more information, see page 219.
Z

+ 1. Immediately connect to a working power source (Mobile

Both power Power Unit or two HeartMate 14 Volt Lithium-Ion
+ cables are batteries).
A

disconnected. 2. If alarm persists, call your hospital contact immediately.

+ For more information, see page 220.
H

System 1. No active symbols (constant audio tone).

Controller 2. Call your hospital contact as soon as possible for
Hardware Fault diagnosis and instructions.
(Microcontroller
Failure) For more information, see page 222.

Low Battery, 1. Immediately connect to a working power source (Mobile

Power input is Power Unit or two HeartMate 14 Volt Lithium-Ion
+ extremely low batteries).
with less than 5 2. If alarm persists, call your hospital contact immediately.
min. remaining. For more information, see page 221.

Table 8 System Controller Hazard Alarms

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 Alarms and Troubleshooting 5

System Active
Priority Controller Alarm Means To Resolve Alarm
Symbols
Screen
1. Promptly connect the disconnected power cable to
One of the two power source (functioning Mobile Power Unit or two
OR power cables is fully-charged HeartMate 14 Volt Lithium-Ion batteries).
disconnected. 2. If alarm persists, call your hospital contact immediately.
For more information, see page 223.
Y

1. Promptly connect to a working or different power

source (Mobile Power Unit or two fully-charged
HeartMate 14 Volt Lithium-Ion batteries).
Low Battery,
2. If alarm persists, call your hospital contact immediately.
R

Power input is
+ low with less For more information, see page 224.
than 15 min.
remaining.
O
S

System Call your hospital contact as soon as possible for

Controller diagnosis and instructions.
Hardware Fault For more information, see page 225.
I

Call your hospital contact as soon as possible for

Communication diagnosis and instructions.
V

Fault (Comm For more information, see page 226.

Fault)
D

System
Controller Call your hospital contact as soon as possible for
Backup diagnosis and instructions.
Battery For more information, see page 227.
A

Fault

Table 9 System Controller Advisory Alarms

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5 Alarms and Troubleshooting

System Active
Priority Controller Alarm Means To Resolve Alarm
Symbols
Screen

System
Controller Call your hospital contact as soon as possible for
+ Backup
Y

diagnosis and instructions.

Battery
Not For more information, see page 228.
R

Installed
O
S

Driveline Call your hospital contact as soon as possible for

Power diagnosis and instructions.
I

Fault For more information, see page 229.

V
D

Driveline Call your hospital contact as soon as possible for

Communication diagnosis and instructions.
Fault (Driveline
A

Comm Fault) For more information, see page 230.

Table 10 System Controller Advisory Alarms continued

IMPORTANT! The Pump Running ( ) light is always green on when the pump is
running.

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 Alarms and Troubleshooting 5
Pump Off Alarm

This is a Hazard alarm

The screens look like this:

(alternating screens)

• Flashing Red Heart ( ) on the user interface.

• The “Pump Running” symbol ( ) is black.
• The Driveline is connected.
Behavior and appearance:
• “Low Flow” and “Call Hospital Contact” alternate on the
screen.
• Alarm tone: Constant tone.
Pump has stopped running, possibly because power has been
Alarm means:
disconnected or failed.
1. Connect to a working power source (Mobile Power Unit or
two HeartMate batteries) right away.

To resolve alarm: 2. If connecting to power does not resolve, press any button on
the System Controller to attempt pump start and call your
hospital contact immediately. It may take up to 10 seconds for
the pump to restart.
• 2 minutes or until a new hazard alarm occurs.
Alarm silence period:
• To silence this alarm, press the silence alarm button.
Table 11 Pump Off Alarm

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5 Alarms and Troubleshooting
Low Flow Alarm

This is a Hazard alarm

The screens look like this:

(alternating screens)

• Flashing Red Heart ( ) on the user interface.

• “Call Hospital Contact” and “Low Flow” alternate on the
Behavior and appearance:
screen.
• Alarm tone: Constant tone.
Alarm means: Pump flow is less than 2.5 lpm.
Call your hospital contact immediately for diagnosis and
To resolve alarm:
instructions.
• 2 minutes or until a new hazard alarm occurs.
Alarm silence period:
• To silence this alarm, press the silence alarm button.
Table 12 Low Flow Alarm

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 Alarms and Troubleshooting 5
Driveline Disconnected Alarm

This is a Hazard alarm

The screen looks like this:

• Flashing Red Heart ( ) on the user interface.

• Green “Pump Running” symbol ( ) is black.
Behavior and appearance: • Flashing red light near Driveline connector.
• “Connect Driveline” flashes on the screen.
• Alarm tone: Constant tone.
Alarm means: The Driveline is disconnected from the System Controller.
1. Immediately reconnect the Driveline to the System Controller
and move the Driveline Safety Lock on the System Controller
to the locked position. (See page 33.) It may take up to 10
seconds for the pump to start.
2. Check that the Modular In-Line connector is secure.
3. If alarm persists after reconnecting the Driveline, press any
To resolve alarm:
button on the System Controller to potentially resolve.
4. If Driveline is connected and alarm persists, replace the
System Controller with a programmed backup System
Controller. See page 63.
5. Immediately call hospital contact if Steps 1–3 do not resolve
the alarm.
• 2 minutes or until a new hazard alarm occurs.
• To silence this alarm, press the silence alarm button.
Alarm silence period:
Note: In some cases, you may have to push the silence
alarm button twice to silence this alarm. This is normal.
Table 13 Driveline Disconnected Alarm

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5 Alarms and Troubleshooting
No External Power Alarm

This is a Hazard alarm

The screens look like this:

(alternating screens)

• Flashing Red Battery ( ) on the user interface.

• “Connect Power Immediately” and Backup Battery
graphic alternate on the screen.
• Yellow light near the black power cable connector is
Behavior and appearance:
flashing.
• Yellow light near the white power cable connector is
flashing.
• Alarm tone: Constant tone.
1. The System Controller is not receiving power from either
power cable.
Alarm means: AND
2. The pump is being powered by the System Controller’s 11
Volt Lithium-Ion backup battery.
1. Immediately connect the System Controller power cables to a
working power source (functioning Mobile Power Unit or two
To resolve alarm: fully-charged HeartMate 14 Volt Lithium-Ion batteries).
2. Call your hospital contact immediately if connecting to power
does not resolve the alarm.
• 2 minutes or until a new hazard alarm occurs.
Alarm silence period:
• To silence this alarm, press the silence alarm button( ).
Table 14 No External Power Alarm
The 11 Volt Lithium-Ion backup battery inside the System Controller provides power to the
pump for at least 15 minutes when fully charged if the main power source is disconnected
or fails.

IMPORTANT! If external power is not restored, the system enters power saver mode. The
pump gradually slows to the low speed limit to save power in an effort to prevent the pump
from stopping. When adequate power is supplied, the pump reverts to the previous speed
and the red battery alarm clears.

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 Alarms and Troubleshooting 5
Low Battery Power Alarm (less than 5 minutes remain)

This is a Hazard alarm

The screens look like this:

(alternating screens)

• Flashing Red Battery ( ) on the user interface.

• “Low Battery” and “Replace Power Immediately” alternate
Behavior and appearance: on the screen.
• Alarm tone: Constant tone.
• The pump will enter Power Save Mode.
1. Low Battery Hazard - there is less than 5 minutes of battery
power remaining (when using battery power).
Alarm means: OR
2. The System Controller is receiving inadequate power from the
Mobile Power Unit.
1. Connect to a working power source (Mobile Power Unit or two
HeartMate batteries) right away. See Connecting the System
To resolve alarm: Controller to the Mobile Power Unit on page 90
2. Call your hospital contact right away if connecting to power
does not resolve the alarm.
• 2 minutes or until a new hazard alarm occurs.
Alarm silence period:
• To silence this alarm, press the silence alarm button( ).
Table 15 Low Battery Power Alarm (< 5 minutes)

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5 Alarms and Troubleshooting
System Controller Hardware Fault

This is a Hazard alarm

The screen looks like this:

• All symbols are off, including the “pump running”

symbol ( ) and wrench( ).
• “Call Hospital Contact; Controller Fault” displayed on
the screen.
Behavior and appearance:
• The Driveline is connected and power is connected.
• Alarm tone: Constant tone.
• All System Controller buttons are non-functional.
A serious internal malfunction has occurred in the System
Controller that requires clinician diagnosis and resolution. The
Alarm means:
pump is still running if the “Call Hospital Contact Controller
Fault” message is displayed.
Call your hospital contact as soon as possible for diagnosis and
To resolve alarm:
instructions.
Alarm silence period: None - the audio tone cannot be silenced

Table 16 System Controller Hardware Fault

IMPORTANT! A backup System Controller is identical to the running System

Controller. It should remain with you at all times for easy access in an emergency.
For instructions on replacing the System Controller, see page 63.

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 Alarms and Troubleshooting 5
Power Cable Disconnected Alarm

This is an Advisory alarm

Screen 1— Black cable

The screens look like this:

(Screen 1 for black cable; Screen 2—White cable

Screen 2 for white cable)

• Flashing yellow light near the black or white power

cable connector, depending on which cable is
disconnected.
Behavior and appearance:
• “Connect Power” appears on the screen.
• Alarm tone: Fast beep.
One of the System Controller power cables is disconnected from
power. If it is the cable with the black connector, the top light
Alarm means:
comes on. If it is the cable with the white connector, the center
light comes on.
1. Promptly connect the disconnected power cable to a working
power source (Mobile Power Unit or two fully-charged
To resolve alarm: HeartMate batteries).
2. Call your hospital contact if reconnecting the power cable
does not resolve the alarm.
Alarm silence period: The alarm cannot be silenced.

Table 17 Power Cable Disconnected Alarm

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5 Alarms and Troubleshooting
Low Battery Power Alarm (less than 15 minutes remain)

This is an Advisory alarm

The screens look like this:

(alternating screens)

• Flashing yellow diamond ( ) on the user interface.

• “Low Battery” and “Replace Power” alternate on the
Behavior and appearance:
screen.
• Alarm tone: Slow beep.
Low Battery Advisory - Low battery, power input to the System
Alarm means:
Controller is low. Less than 15 minutes of battery power remain.
1. Promptly connect to a working or different power source
(Mobile Power Unit or two HeartMate batteries).
To resolve alarm:
2. Call your hospital contact if connecting to power does not
resolve the alarm.
• 5 minutes or until any new alarm occurs.
Alarm silence period:
• To silence this alarm, press the silence alarm button( ).
Table 18 Low Battery Power Alarm (< 15 minutes)

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 Alarms and Troubleshooting 5
System Controller Fault Alarm

This is an Advisory alarm

The screen looks like this:

• Flashing yellow wrench ( ) on the user interface.

Behavior and appearance: • “Call Hospital Contact; Controller Fault” on the screen.
• Alarm tone: Slow beep.
An internal malfunction or other issue has occurred in the System
Alarm means:
Controller that requires clinician diagnosis and resolution.
Call your hospital contact as soon as possible for diagnosis and
To resolve alarm:
instructions.
• 4 hours or until any new alarm occurs.
Alarm silence period:
• To silence this alarm, press the silence alarm button( ).
Table 19 System Controller Fault Alarm
IMPORTANT! A backup System Controller is identical to the running System Controller. It
should remain with you at all times for easy access in an emergency. For instructions on
replacing the System Controller, see page 63.

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5 Alarms and Troubleshooting
Communications Fault (Comm Fault) Alarm

This is an Advisory alarm

The screen looks like this:

• Flashing yellow wrench ( ) on the user interface.

Behavior and appearance: • “Call Hospital Contact; Comm Fault” on the screen.
• Alarm tone: Slow beep.

• Communication between the LVAD and the System Controller

has been lost.
OR
Alarm means: • The primary and back-up communication wires in the
Driveline are not functioning.

In both cases, the pump is still running.

Call your hospital contact immediately for diagnosis and

To resolve alarm:
instructions.

• 4 hours or until any new alarm occurs.

Alarm silence period:
• To silence this alarm, press the silence alarm button ( ).

Table 20 Communication Fault Alarm

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 Alarms and Troubleshooting 5
System Controller Backup Battery Fault Alarm

This is an Advisory alarm

The screen looks like this:

• Flashing yellow wrench ( ) on the user interface.

• “Call Hospital Contact; Backup Battery Fault” on the
Behavior and appearance:
screen.
• Alarm tone: Slow beep.
1. The System Controller’s 11 Volt Lithium-Ion backup battery is
compromised.
OR
Alarm means: 2. It is unable to fully support pump function.
OR
3. There is an issue that requires clinician diagnosis and
resolution.
Call your hospital contact as soon as possible for diagnosis and
To resolve alarm:
instructions.
• 4 hours or until any new alarm occurs.
Alarm silence period:
• To silence this alarm, press the silence alarm button( ).
Table 21 System Controller Backup Battery Fault Alarm

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5 Alarms and Troubleshooting
System Controller Backup Battery Not Installed Alarm

This is an Advisory alarm

The screens look like this:

(alternating screens)

• Flashing yellow wrench ( ) on the user interface.

• "Call Hospital Contact; Backup Battery Fault" and
Behavior and appearance:
"install battery" graphic alternate on the screen.
• Alarm tone: Slow beep.
1. The System Controller’s11 Volt Lithium-Ion backup battery is
not installed.
Alarm means: OR
2. The System Controller’s 11 Volt Lithium-Ion backup battery is
installed incorrectly.
Call your hospital contact as soon as possible for diagnosis and
To resolve alarm:
instructions.
• 4 hours or until any new alarm occurs.
Alarm silence period:
• To silence this alarm, press the silence alarm button( ).
Table 22 System Controller Backup Battery Not Installed Alarm

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 Alarms and Troubleshooting 5
Driveline Power Fault Alarm

This is an Advisory alarm

The screen looks like this:

• Flashing yellow wrench ( ) on the user interface.

Behavior and appearance: • “Call Hospital Contact; Driveline Power Fault” on the screen.
• Alarm tone: Slow beep.

One of the two power handling wires inside the Driveline

Alarm means:
may be damaged or broken. The pump is still running.

Call your hospital contact immediately for diagnosis and

To resolve alarm:
instructions.

• 4 hours or until any new alarm occurs.

Alarm silence period:
• To silence this alarm, press the silence alarm button ( ).

Table 23 Driveline Power Fault Alarm

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5 Alarms and Troubleshooting
Driveline Communication Fault (Driveline Comm Fault) Alarm

This is an Advisory alarm

The screen looks like this:

• Flashing yellow wrench ( ) on the user interface.

Behavior and appearance: • “Call Hospital Contact; Driveline Comm Fault” on the screen.
• Alarm tone: Slow beep.

One of the two communication wires inside the Driveline

Alarm means:
may be damaged or broken. The pump is still running.

Call your hospital contact immediately for diagnosis and

To resolve alarm:
instructions.

• 4 hours or until any new alarm occurs.

Alarm silence period:
• To silence this alarm, press the silence alarm button ( ).

Table 24 Driveline Communication Fault Alarm

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 Alarms and Troubleshooting 5
Mobile Power Unit Alarms
The Mobile Power Unit continually checks the system. The Mobile Power Unit issues
an alarm for the following conditions:

Replace Mobile Power Unit Batteries

Mobile Power Unit Internal Malfunction

Note: If you hear an alarm for the Mobile Power Unit but no light comes on, call
your hospital contact.

All Mobile Power Unit alarms are accompanied by a light (Figure 144) and
sound. Different lights and sounds come on, depending on the alarm.

Figure 144 Indicators on the Mobile Power Unit

Note: When the Mobile Power Unit is connected to the System Controller, the
Mobile Power Unit duplicates any active audio System Controller alarms. See
Handling System Controller Alarms on page 209.

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5 Alarms and Troubleshooting
Note: If you hear an alarm for the Mobile Power Unit but no light comes on, call
your hospital contact.

Alarm Symbol Meaning What You Should Do

1. Promptly switch to two fully-charged

Internal Alkaline AA HeartMate 14 Volt Lithium-Ion batteries.
Advisory Alarm Mobile Power Unit
Yellow Mobile Power batteries need to be 2. Replace Mobile Power Unit batteries (see
Inserting or Replacing the Mobile Power
Unit battery indicator replaced.
Unit Batteries on page 82).
with beeping audio tone

Internal malfunction 1. Promptly switch to two fully-charged

detected within the HeartMate 14 Volt Lithium-Ion batteries.
Advisory Alarm
Yellow wrench light with Mobile Power Unit. 2. Call hospital contact.
beeping audio tone
Table 25 Mobile Power Unit Alarms

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 Alarms and Troubleshooting 5
Battery Charger Alarms
The Battery Charger continually checks its own performance and that of any battery
placed into a slot or pocket. Actual or potential problems, or “faults,” appear as
“advisory messages” on the charger’s display screen.

The Battery Charger can detect a problem or fault condition in up to four charging
pockets at once (with or without batteries inserted), or with the entire charger unit.
The charger alerts you immediately of any problem.

See Table 26 for a summary of English text and graphic symbols that appear on
the Battery Charger’s display screen.

Confirming a Battery Fault

If the Battery Charger detects a problem with a battery, such as battery voltage too
high or too low, or open battery circuit, the red light for the pocket comes on and a
telephone symbol appears on the display panel (Figure 145).

Figure 145 Telephone Symbol and Red Light by Pocket 1 Indicate that the Charger Detects a Problem

Before assuming that the battery is defective, make sure that the connection
between the battery and charging pocket contacts is not blocked by dirt or debris.

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5 Alarms and Troubleshooting
FOR THIS TASK YOU NEED:
• Quiet, well-lighted location where you can focus on the task
• In-use Battery Charger
• Up to 4 HeartMate 14 Volt Lithium-Ion batteries in the charging pockets

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Remove the battery from the pocket. Examine the battery's metal contact and
the contact inside the charging pocket. If there is no dirt, debris, or
obstruction, continue to Step 2.
2. Reinsert the battery into the same pocket.
3. If the red light comes on again, insert the battery into a different pocket.
4. If the red light comes on in a second pocket, the battery is defective. Do not
use it.
5. Obtain the alarm code for the battery, if possible:
a. Press and hold the number button for this pocket. The alarm code
appears on the screen. The alarm code is one letter followed by four
numbers. Alarm codes related to batteries begin with the letter B.
b. Record the alarm code and save it for future reference.
6. Remove the defective battery from use.

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 Alarms and Troubleshooting 5
Confirming a Pocket Fault
When the charger detects a pocket fault, the red light for the affected pocket comes
on, with or without a battery inserted in the pocket. In addition, the charger
immediately stops charging or calibrating the battery in the affected pocket, if one
is present.

FOR THIS TASK YOU NEED:

• Quiet, well-lighted location where you can focus on the task
• In-use Battery Charger
• Up to 4 HeartMate 14 Volt Lithium-Ion batteries in the charging pockets

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Remove the battery from the affected pocket, if one is inserted.
2. Record the alarm code for the defective pocket, if possible:
a. Press and hold the number button for this pocket. The alarm code
appears on the screen. The alarm code is one letter followed by four
numbers. Alarm codes related to pocket problems begin with the letter
S (English only).
b. Record the alarm code and save it for future reference.
3. Call your hospital contact for help. The hospital contact may ask for the alarm
code.
Note: Do not use the defective charging pocket until it is repaired or until the
Battery Charger is replaced. You can continue to use the other pockets.

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5 Alarms and Troubleshooting
Confirming a Battery Charger Fault
If the charger detects a fault with the entire charger, all four red lights come on, and
all charging and calibrating stops.

For this task you need:

• Quiet, well-lighted location where you can focus on the task
• In-use Battery Charger
• Up to 4 HeartMate 14 Volt Lithium-Ion batteries

Remember !
Before starting this task, be sure you know how to do it safely. If you have
questions, call your hospital contact.

TASK
1. Remove all batteries from all pockets.
2. Record the alarm code for the fault condition, if possible:
a. Press and hold the number button for any pocket. The alarm code
appears on the screen. The alarm code is one letter followed by four
numbers. Alarm codes for the entire charger begin with the letter S
(English only).
b. Record the alarm code and save it for future reference.
3. Turn off the charger; unplug it from the electrical outlet.
4. Call your hospital contact for help. The hospital contact may ask for the alarm
code.
Note: Do not use a damaged or defective Battery Charger until it is repaired or
replaced. Until you have a safe and reliable way to recharge batteries, use the
Mobile Power Unit to power your HeartMate 3 system.

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 Alarms and Troubleshooting 5
Battery Charger Display Panel Messages
The English mode always displays first. The following shows the screens to select the mode.

Change Display Mode ENGLISH ENGLISH

to English OK ▼ OK ▼
Change Display Mode GRAPHICS GRAPHICS
to Graphics OK ▼ OK ▼

KEY for Table

Y Battery Charger pocket number
#=X Battery charge cycle count
mAh milliamp-hour
C Battery capacity
B0001 Battery fault with alarm code, example
S0001 Battery Charger pocket (slot) fault with alarm code, example

Table 26 describes the messages that appear on the charger display panel.

Meaning English Mode Graphics Mode

Ready HeartMate HeartMate

CHARGER CHARGER
Battery Charge Status Y: █ █ █ █ █

Battery Information #=X #=X

(3rd screen) X: mAh = C X: mAh = XC

Charge Complete READY

Y: █ █ █ █ █

CALIBRATE?
Request Calibration
PRESS Y

Accept Calibration PROGRESS Y: CALIBRATING

Charger Fault CALL SERVICE

Battery Fault CALL SERVICE

(Button Push) B0001

Charger or Pocket CALL SERVICE

Fault (Button Push) S0001

Table 26 Battery Charger Display Panel Messages

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5 Alarms and Troubleshooting
Guidelines for Power Cable Connectors
Use care when connecting and disconnecting connections to power. Be sure to:

• Line up the half circles inside the connectors, as shown in Figure 146.
• Gently bring the connectors together, turning them slightly to make the connection, if
needed.
• Never pull, turn, or twist the strain relief portion of the connectors (where the connector
and cable meet).
• When you feel the connectors line up, push them together firmly until fully connected,
without twisting or forcing the connectors.
• Tighten the connection between the connectors by turning the nut on the connector
(Figure 147). Hand tighten the nut; do not use tools. Do not twist the connectors
when turning the nut.
• When disconnecting, turn the nut on the connector until the connection is loose and
then gently pull the connectors apart.
• Never twist connectors or pull them apart at an angle.
Figure 146 Carefully Align the Connectors

Figure 147 Tighten the Connector Nut

Connector Nut

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 Alarms and Troubleshooting 5
What Not To Do: Driveline and Cables
Check the Driveline, System Controller power cables, and Mobile Power Unit
patient cable for twisting, kinking, or bending, which could cause damage to the
wires inside, even if external damage is not visible. Damage to the Driveline or
cables could cause the Left Ventricular Assist Device to stop. If the Driveline or
cables become twisted, kinked, or bent, carefully unravel and straighten.

CAUTION !
Do not twist, kink, or sharply bend the Driveline.

HeartMate 3 Left Ventricular Assist System Patient Handbook 239

5 Alarms and Troubleshooting
CAUTION !
Do not twist, kink, or sharply bend the System Controller power cables.

240 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Alarms and Troubleshooting 5
CAUTION !
• Do not twist, kink, or sharply bend the Mobile Power Unit patient cable.

• Route the patient cable so it will not cause a tripping or falling hazard.

• Take care when moving around while connected to the Mobile Power Unit, that it
is not inadvertently pulled off of furniture.

Do not connect a System Controller to both the Mobile Power Unit and the Power Module
at the same time, or damage to the System Controller and injury to the patient may occur.
First connect to HeartMate 14 Volt batteries.

HeartMate 3 Left Ventricular Assist System Patient Handbook 241

5 Alarms and Troubleshooting
Do not insert a misaligned Driveline Cable Connector into the System Controller Driveline
Connector.
Align the WHITE arrow/ alignment mark on the Driveline Cable Connector with the
WHITE arrow on the System Controller Driveline Connector.

Do not orient the System Controller so the display is facing up.

Align the WHITE arrow/ alignment mark on the Driveline Cable Connector with the
WHITE arrow on the rear of the System Controller Driveline Connector.

242 HeartMate 3 Left Ventricular Assist System Patient Handbook

 6

CARING FOR THE EQUIPMENT

This section provides information about how to care for the HeartMate 3 Left
Ventricular Assist System and the wear and carry accessories.

Cleaning and Caring for the Equipment - - - - - - - - - - - - - - - 244

Product Disposal - - - - - - - - - - - - - - - - - - - - - - - - - - - 250

HeartMate 3 Left Ventricular Assist System Patient Handbook 243

6 Caring for the Equipment
Cleaning and Caring for the Equipment
General Cleaning Rules for all Equipment
Use a damp cloth to clean exterior surfaces of the external parts of equipment. Do
this as needed. Water, with or without a mild dish soap, may be used as a surface
cleaner. Do not allow water to enter the interior of devices. Do not put equipment in
water or liquid.

WARNING !
Never submerge the Driveline, Modular Connector, System Controller, or any
external system components (such as the Power Module, the Mobile Power Unit,
batteries, power cables, or battery clips) in water or liquid. Submersion in water
or liquid may cause the Left Ventricular Assist Device to stop.

Cleaning the System Controller

As needed, clean the outside parts of the System Controller with a damp, lint-free
cloth. If more aggressive cleaning is needed, use warm water and a mild dish
soap.

WARNING !
Never put the System Controller into water or liquid. Submersion in water or liq-
uid may cause the Pump to stop.

At least monthly, check the System Controller’s power cable connector pins for dirt
or grease. If you find dirt or damage, do not try to clean or fix the pins yourself. Tell
your hospital contact.

At least monthly, inspect the System Controller’s audio sounders for dirt or grease.
If you notice a change in tone or in loudness during a System Controller self test
(Performing a System Controller Self Test on page 42), the audio speaker sockets
may be obstructed. Audio speaker sockets may be cleaned using a small cotton
swab that is moistened (not dripping) with rubbing alcohol. Never insert anything
sharp (like a toothpick or pin) into the sounder holes. This can damage the speakers
inside.

IMPORTANT! Do not disconnect the System Controller from the Driveline for
cleaning. Disconnecting the Driveline will make the pump stop. The Driveline
connector should be inspected only if the running System Controller is replaced
(see The Backup System Controller on page 58).

244 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Caring for the Equipment 6
Cleaning the System Controller Power Cables
As needed, clean the outside parts of the System Controller power cables with a
damp, lint-free cloth. If more aggressive cleaning is needed, use warm water and
mild dish soap.

Keep the System Controller power cables dry and away from water or liquid. If the
System Controller power cables come into contact with water or liquid, the system
may fail to operate properly or you may get an electric shock.

Driveline Care
Wear and fatigue of the Driveline that connects the pump to the System Controller
may result in damage. Such damage has the potential to interrupt device function.
Resolution of this situation may require reoperation to replace the pump,
replacement of the Modular Cable, or may result in death if not resolved.

Damage due to wear and fatigue of the Driveline has occurred in both the
externalized and implanted portions of the Driveline. Damage to the redundant
wires within the Driveline may or may not be preceded by visible damage to the
outer layer of the Driveline.

HeartMate 3 Left Ventricular Assist System Patient Handbook 245

6 Caring for the Equipment
Driveline damage may be evidenced by the following:

• Driveline faults may occur on Battery or Mobile Power Unit operation.

• Transient alarms due to short or open circuits, often associated with

movement of you or the Driveline.

• High pump power associated with reduced pump speed, as recorded in the
System Controller event log file.

• High pulsatility index (PI) and/or the need for frequent replacement of the
System Controller.

• Feelings of pump vibrations.

• Fluid leakage from the external portion of the Driveline.

• Cessation of pumping.

If you suspect a damaged Driveline, contact your hospital contact immediately.

X-ray images may be useful to assess the extent and location of the Driveline
damage. If damage to the electrical conductors in the Driveline is confirmed, the
Left Ventricular Assist Device should be replaced as soon as possible.

A disruption to the continuity of the wires in the Driveline may cause damage to the
System Controller. If damage to the System Controller occurs and the System
Controller requires replacement, consider using batteries to reduce the potential of
further damaging the System Controller.

246 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Caring for the Equipment 6
Caring for the Mobile Power Unit
Inspect the Mobile Power Unit routinely as described in the Safety Checklists on
page 293 for the safest and best possible performance.

Cleaning the Mobile Power Unit

Periodically, and as needed, unplug the Mobile Power Unit and clean the exterior
surfaces using a clean, damp (not wet) cloth. You may use a mild detergent, if
necessary. Allow the Mobile Power Unit to dry completely before use.

CAUTION !
Do not clean or service the Mobile Power Unit while it is plugged into an AC elec-
trical outlet, or electrical shock may occur.

HeartMate 3 Left Ventricular Assist System Patient Handbook 247

6 Caring for the Equipment
Caring for HeartMate 14 Volt Lithium-Ion Batteries and Battery
Clips
HeartMate batteries require periodic inspection and cleaning to ensure the best
possible performance. Follow the instructions in the Safety Checklists on page 293
to perform routine inspections on the batteries and battery clips.

Cleaning Battery Contacts and Clips

Clean the metal battery contacts and the interior contacts of battery clips monthly
using a cotton swab or lint-free cloth that has been moistened (not dripping) with
rubbing alcohol. Allow the alcohol to dry before using newly cleaned batteries or
clips. Do not clean batteries while the batteries are in use. See Figure 148.

Figure 148 Clean the Contacts on the Batteries and Battery Clips

Caring for the Battery Charger

The Battery Charger requires little maintenance. However, it should be inspected
routinely for the safest and best possible performance. For more information, see
Safety Checklists on page 293.

248 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Caring for the Equipment 6
Caring for the Wear and Carry Accessories
HeartMate wear and carry accessories are designed to securely hold, carry, and
protect HeartMate 3 components. The accessories include:

• Shower Bag

• Consolidated Bag

• Lanyard

• Belt attachment

• Holster vest

• Battery holster

• Protection Bag

If an accessory gets dirty, wash it by hand using mild detergent, a medium-bristle

brush, and cold water. Never use a washing machine to wash a wear and carry
accessory. Hang the accessory to drip dry. Always allow it to air dry on its own.
Never use a clothes dryer or hair dryer to dry a wear and carry accessory.
Mechanical washers and heated dryers can damage the accessories. Make sure an
accessory is completely dry before using it—this includes the Shower Bag.

Periodically inspect the wear and carry accessories for damage or wear. If an
accessory appears damaged or worn, do not use it. Call your hospital contact for a
replacement.

HeartMate 3 Left Ventricular Assist System Patient Handbook 249

6 Caring for the Equipment
Product Disposal
Talk with your hospital contact before throwing away any equipment. Specific
disposal rules for certain equipment appear below. Otherwise, dispose of all
expired or damaged equipment according to applicable local, state, and federal
regulations. If you are unsure how to dispose of something, call your hospital
contact.

Battery Disposal
HeartMate 14 Volt Lithium-Ion batteries do not contain lead. Dispose of or recycle
HeartMate 14 Volt Lithium-Ion batteries in compliance with all applicable local,
state, and federal regulations. Do not incinerate.

Dispose of the Mobile Power Unit batteries in compliance with all applicable local,
state, and federal regulations. Never incinerate discarded Mobile Power Unit
batteries.

Mobile Power Unit Disposal

Dispose of or recycle Mobile Power Unit and Mobile Power Unit electronics in
compliance with all applicable local, state, and federal regulations.

Battery Charger Disposal

Dispose of or recycle the Battery Charger and Battery Charger electronics in
compliance with all applicable local, state, and federal regulations.

250 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Caring for the Equipment 6

HeartMate 3 Left Ventricular Assist System Patient Handbook 251

6 Caring for the Equipment

252 HeartMate 3 Left Ventricular Assist System Patient Handbook

 7

FREQUENTLY ASKED QUESTIONS

This section provided answers to commonly asked questions about the HeartMate 3 Left
Ventricular Assist Device.

System Use - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 255

Showers and Exercise- - - - - - - - - - - - - - - - - - - - - - - - - 257

Travel - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 257

HeartMate 3 Left Ventricular Assist System Patient Handbook 253

7 Frequently Asked Questions

254 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Frequently Asked Questions 7

System Use

Who should I call if I think my equipment is broken?

Call your hospital contact if you think your equipment is broken. Your hospital
contact can check the equipment and order replacements, if needed. Do not try to
repair anything yourself.

Can I use other batteries to power the HeartMate 3 system?

No. Only use the HeartMate 14 Volt Lithium-Ion batteries that you received from the
hospital at discharge. Other batteries will not power the HeartMate 3 system.
Trying to use other batteries for power may cause your pump to stop. If you need
new or extra batteries, call your hospital contact.

Can I charge other batteries in the Battery Charger?

No. Only HeartMate 14 Volt Lithium-Ion batteries can be placed into the Battery
Charger. Inserting other batteries may damage the charger.

What should I do if I drop my System Controller?

If you drop your System Controller, call your hospital contact RIGHT AWAY, even if
everything seems fine. The System Controller casing is tough. A drop is unlikely to
damage the System Controller. However, a drop can move or pull on the Driveline
exit site. This can hurt the skin at the site and increase your risk of infection. Early
treatment can be the key to successful infection control.

HeartMate 3 Left Ventricular Assist System Patient Handbook 255

7 Frequently Asked Questions
What should I do if my System Controller gets wet?

The System Controller is water resistant. It is not waterproof. Placing the System
Controller into water or liquid can damage the System Controller. This can affect
system operation or cause the pump to stop. You may need to replace the System
Controller. Call your hospital contact for instructions if the System Controller gets
wet.

What should I do if the bandages covering the Driveline exit site get
wet?

The Driveline exit site must be kept as clean and dry as possible to lower your risk
of infection. If the bandages covering the exit site get wet, change them right away.
Use the sterile technique that you learned from your hospital contact.

Are there medications that will interfere with my pump?

Consult your doctor before starting any new medications or dietary supplements.

256 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Frequently Asked Questions 7
Showers and Exercise

Can I shower with the HeartMate 3 system?

Maybe. You may be allowed to shower after the Driveline exit site heals, if your
doctor gives approval. Your doctor will decide if you can shower. If approved for
showering, you must use the Shower Bag for every shower. Do not shower without
the Shower Bag.

Can I exercise, play sports, or go to the gym?

Many HeartMate 3 patients enjoy an active lifestyle. However, it is not safe to play
contact sports or engage in jumping activities while you have the pump. These
activities could cause bleeding or could damage the pump. If you have questions
about a specific sport or activity, talk with your hospital contact.

Travel

Can I travel/fly with the HeartMate 3 system?

The HeartMate 3 Left Ventricular Assist System is approved for air travel. Talk with
your physician or hospital contact before traveling, especially if it is a long
distance. He or she can help you with a travel safety plan. If you are going outside
of North America, you need power cords that works with the local voltage and that
meet applicable safety agency marks and standards (for both the Mobile Power
Unit and Battery Charger). Ask your hospital contact for approved power cords, if
needed.

HeartMate 3 Left Ventricular Assist System Patient Handbook 257

7 Frequently Asked Questions
Can I go through a metal detector/body scanner?

No. These devices use types of energy that can interfere with the pump. You should
request a hand search.

For tips on airline travel for passengers with medical conditions, go to the TSA's
website at: http://www.tsa.gov/travelers/airtravel/specialneeds/index.shtm

What if I have a VAD-related problem while I am away from home?

Please call your hospital contact if you have a problem or concern. It is also
advisable to obtain contact information for the nearest VAD center at your travel
destination PRIOR to travelling (and along your travel route, if you are driving).

Can I do anything to hurt or stop the pump?

Many new users worry about doing something that could stop the pump. Try not to
worry. The HeartMate 3 system is designed for safe and easy use at home. It has
built-in backups. As long as the pump is connected to power (the Mobile Power Unit
or two HeartMate batteries), it will continue to run. Over time you will get to know
and trust the system.

258 HeartMate 3 Left Ventricular Assist System Patient Handbook

 8

HANDLING EMERGENCIES

This section provides information to assist you in dealing with an emergency.

IMPORTANT! Make sure you read and understand this information so you are
prepared in case of an emergency.

What Is An Emergency? - - - - - - - - - - - - - - - - - - - - - - - 261

How to Handle an Emergency - - - - - - - - - - - - - - - - - - - - 262

HeartMate 3 Left Ventricular Assist System Patient Handbook 259

8 Handling Emergencies

260 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Handling Emergencies 8
What Is An Emergency?
An “emergency” is any time the heart pump cannot pump enough blood to your
body. Examples of emergencies include (but are not limited to):

• Loss of power to the pump ( symbol appears on the System Controller)

• Broken wires (indicated by Driveline Power or Communication faults or

Communications fault)

• Damage to the pump motor or System Controller (indicated by a Replace

Controller alarm or Low Flow alarm)

• Health changes affecting your heart

If the system is not working right, the System Controller will alarm (see
System Controller Alarms on page 209).

Call your doctor right away if you notice a sudden change in how your pump is
working (even if there is no alarm). Remember, you know best what is normal for
you and your pump.

Note: Consider keeping a land-line (non-portable) telephone in your home for

emergency calls, unless your hospital contact tells you otherwise. Land-line
telephones may be less likely to be affected by interference, interruptions, or power
outages.

Make sure you have completed the Emergency Contact List on page v and keep it
available at all times.

HeartMate 3 Left Ventricular Assist System Patient Handbook 261

8 Handling Emergencies
How to Handle an Emergency
Try to stay calm during an emergency! Most pump problems are easy to solve.

When the Pump is Running

If a problem arises while the pump is running, you should:

1. Check all Driveline connections.

2. Reconnect any loose or disconnected cables.
3. Call your hospital contact if reconnecting the cables does not fix the problem.

Note: See Alarms and Troubleshooting on page 207 for instructions on handling
alarms.

When the Pump has Stopped (Red Heart Alarm)

If the pump stops running, you will see the Red Heart alarm and the pump running
symbol is black:

262 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Handling Emergencies 8
You should:

1. Check the connection between the System Controller and the pump, and
then check the connection between the System Controller and Driveline power
source (Mobile Power Unit or batteries).
2. Check that the Modular In-Line connector on the Driveline is connected and
secure.
3. Fix any loose connections. Loose connections may not resolve the situation if
other Driveline problems exist.
4. Switch to a different power source. If you are on batteries, switch to the Mobile
Power Unit. If you are on Mobile Power Unit power, switch to batteries.
5. Switch to the backup System Controller (see Replacing the Running System
Controller with a Backup Controller on page 63).
6. If checking connections, switching power sources, or changing
System Controllers does not fix the problem, call emergency services right
away (dial 911 if available), and then call your hospital contact.

HeartMate 3 Left Ventricular Assist System Patient Handbook 263

8 Handling Emergencies

264 HeartMate 3 Left Ventricular Assist System Patient Handbook

 9

TESTING & CLASSIFICATION

This section provides information about safety testing and classification for the
HeartMate 3 Left Ventricular Assist System.

Safety Testing and Classification - - - - - - - - - - - - - - - - - - - 267

Acceptable Operating Conditions - - - - - - - - - - - - - - - - - - 268

Declaration Concerning General Safety Standards - - - - - - - - - - 269

HeartMate 3 Left Ventricular Assist System Patient Handbook 265

9 Testing & Classification

266 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Testing & Classification 9
Safety Testing and Classification
The HeartMate 3 Left Ventricular Assist System has been thoroughly tested and
Classified by Underwriters Laboratories, LLC (UL) to the fire, casualty, and electric
shock hazard requirements of the following safety standards, as applicable:
• IEC 60601-1:2012 (ed. 3.1)
• IEC 60601-1:2005 + Corr. 1:2006 + Corr. 2:2007 (ed. 3.0)
• IEC 60601-1-11:2015
• IEC 60601-1-8:2006 + A1:2012
• IEC 60601-1-6:2010 + A1:2013
• IEC 62366:2007 + A1:2014

• EN 60601-1:2012 (ed. 3.1)

• EN 60601-1:2006 +Corr. 2:2010 (ed. 3.0)

• ANSI/AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 +

A2:2010/(R)2012 (ed. 3.1)
• ANSI/AAMI ES60601-1:2005/(R)2012 and C1:2009/(R)2012 and
A2:2010/(R)2012 (ed. 3.0)

• CAN/CSA C22.2 No. 60601-1:14 (ed. 3.1)

• CAN/CSA C22.2 No. 60601-1:08 (ed. 3.0)
• CAN/CSA C22.2 No. 60601-1-11:15
These standards require making the following declarations and stating the type and degree
of protection for listed hazards.
• UL 60601-1, 1st ed., 2006-04-26
• CAN/CSA-C22.2 No. 601.1-M90 (R2005)

HeartMate 3 Left Ventricular Assist System Patient Handbook 267

9 Testing & Classification
Acceptable Operating Conditions
For safe and optimal use of your HeartMate system components, follow the operating
guidelines listed here. If you use the equipment outside these ranges, it may result in a
failure or may impact your LVAD support.

Acceptable
Relative Air Pressure
Equipment Temperature
Humidity mm Hg (hPA)
Range °F (°C)

32°F to 104°F 525 to 795

Mobile Power Unit 15% to 93%
(0°C to 40°C) (700 to 1060)

HeartMate 14 Volt
32°F to 104°F 525 to 795
Lithium-Ion 30% to 75%
(0°C to 40°C) (700 to 1060)
Batteriesa

32°F to 104°F 525 to 795

Battery Charger 30% to 75%
(0°C to 40°C) (700 to 1060)

System Controller,
Backup System 32°F to 104°F 525 to 795
15% to 93%
(0°C to 40°C) (700 to 1060)
Controller a, b

11 Volt
32°F to 104°F 525 to 795
Lithium-Ion 15% to 93%
(0°C to 40°C) (700 to 1060)
Backup Battery

Table 27 Operating Conditions

a. Standby components (extra 14 Volt Lithium-Ion batteries, backup System Controller) should be maintained
at conditions within the acceptable ranges so that they are available for immediate use.
b. Every six months, the “sleeping” backup System Controller must be connected to a power source to
recharge the backup battery inside it. If the 11 Volt Lithium-Ion backup battery inside the backup System
Controller is not charged every six months, it will lose its charge. If this happens, there may not be enough
power to run the pump if the in-use power disconnects or fails. See Maintaining the Backup System
Controller’s Readiness: Six Month Charging and Self Test on page 60.

Note: Patients must maintain the equipment in Table 27 within the stated operating
conditions at all times.

268 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Testing & Classification 9
Declaration Concerning General Safety Standards

Type Degree of Protection

Mode of Operation Continuous/Pulse

Method of Sterilization 100% EtO for blood pump, Controller, and all sterile
accessories
Mobile Power Unit:
• Class II
Type of protection against Lithium-Ion Batteries:
electrical shock • Class II
Battery Charger:
• Class I

Degree of protection against

Type CF (Cardiac Floating)
electric shock

Degree of safety of application in

Equipment not suitable for use in the presence of a
the presence of a flammable
flammable anesthetic mixture with air or with oxygen
anesthetic mixture with air or
or nitrous oxide
with oxygen or nitrous oxide

• System Controller–IP24:Protection against ingress

of solid foreign objects the size of a finger and
from splashing water
• Mobile Power Unit–IP22:Protection against ingress
of solid foreign objects the size of a finger and
from vertically falling water drops when the
enclosure is tilted up to 15°
Degree of protection against • System Monitor–IPX1:Protection against ingress of
harmful ingress of water and vertically dripping water
particulate matter • Shower Bag–IPX3: Protection against ingress of
spraying water
• 14 V Battery and Clip (only when connected to the
System Controller) –IP24: Protection against
ingress of solid foreign objects the size of a finger
and from splashing water
• Battery Charger–IPX0: Non-protected against
ingress of water

Applied parts • HeartMate 3 Left Ventricular Assist Device

• System Controller
Table 28 Declaration Concerning General Safety Standards

HeartMate 3 Left Ventricular Assist System Patient Handbook 269

9 Testing & Classification
Type Degree of Protection

• Maintain Pump Speed (Note: Pump Speed is the

characteristic that the physician uses to set the
Performance Determined to be desired blood flow).
Essential Performance • Alarm for Pump Speed performance outside of the
essential performance limits.
• Prevent Leakage in Blood Path.

Table 28 Declaration Concerning General Safety Standards (Continued)

For additional information on testing and classification for the HeartMate 3 Left
Ventricular Assist System, please see the HeartMate 3 Instructions for Use. Your
hospital contact can get a copy for you.

270 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Testing & Classification 9
Testing and Classification: HeartMate 3 LVAS
The HeartMate 3 Left Ventricular Assist System has been tested and found to comply with
the limits for medical devices to IEC 60601-1-2:2007 Medical electrical equipment—Part
1-2: General requirements for Basic safety and essential performance—Collateral
standard: Electromagnetic compatibility. These limits are designed to provide reasonable
protection against harmful interference in a typical medical installation. The HeartMate 3
Left Ventricular Assist System can generate, use, and radiate radio frequency energy and, if
not installed and used in accordance with the instructions, may cause harmful interference
to other devices in the vicinity. However, there is no guarantee that interference will not
occur in a particular installation. If this equipment does cause harmful interference to other
devices, the user is encouraged to try to correct the interference by one or more of the
following measures:
• Reorient or relocate the equipment.
• Increase the separation between the equipment.
• Connect the equipment into an outlet on a circuit different from that to which the other
device(s) are connected.
• Consult Thoratec Corporation for assistance.
Note: Special precautions are required for installing and using the HeartMate 3 Left
Ventricular Assist System within portable and RF communication environments.

The HeartMate 3 Left Ventricular Assist System is protected against the effects of external
cardiac defibrillation within the limits established per EN 45502-1:1997. However, it is
advised that the HeartMate 3 Left Ventricular Assist System be disconnected from the
System Controller during the use of open-heart defibrillation.

HeartMate 3 Left Ventricular Assist System Patient Handbook 271

9 Testing & Classification
Testing and Classification: Mobile Power Unit

Declaration and Guidance for Electromagnetic Emissions for the

Mobile Power Unit
The HeartMate 3 Left Ventricular Assist System with Mobile Power Unit is intended for use
in the electromagnetic environment specified below. The customer or the user of the
HeartMate 3 Left Ventricular Assist System should assure that it is used in such an
environment.

Electromagnetic
Emissions Test Compliance Environment⎯
Guidance
The HeartMate 3 Left Ventricular Assist
System uses RF energy only for its
RF Emissions
internal function. Therefore, its RF
CISPR 11 Group 1
emissions are very low and are not
EN 55011
likely to cause any interference in
nearby electronic equipment.

RF Emissions
CISPR 11 Class B
EN 55011 The HeartMate 3 Left Ventricular Assist
System is suitable for use in all
Harmonic Emissions
establishments, including domestic
IEC 61000-3-2 Class A
establishments and those directly
EN 61000-3-2
connected to the public low-voltage
Voltage Fluctuations/ power supply network that supplies
Flicker Emissions buildings used for domestic purposes.
Complies
IEC 61000-3-3
EN 61000-3-3

Table 29 Declaration and Guidance Concerning Electromagnetic Emissions for Mobile Power Unit

272 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Testing & Classification 9
Declaration and Guidance for Electromagnetic Immunity
The HeartMate 3 Left Ventricular Assist System (powered by the Mobile Power Unit) is
intended for use in the electromagnetic environment specified below. The customer or the
user of the HeartMate 3 Left Ventricular Assist System should assure that it is used in such
an environment.

Immunity IEC 60601 Electromagnetic

Compliance Level
Test Test Level Environment⎯ Guidance
Electrostatic
discharge
±6 kV contact ±8 kV contact The relative humidity should be at least
(ESD)
±8 kV air ±15 kV air 5%.
IEC 61000-4-2
EN 61000-4-2
Electrical Fast
± 2 kV for power ± 2 kV for power supply
Transient/ Mains power quality should be that of a
supply lines lines
Burst typical commercial or hospital
± 1 kV for ± 1 kV for input/output
IEC 61000-4-4 environment.
input/output lines lines
EN 61000-4-4
Surge Mains power quality should be that of a
± 1 kV line to line ± 1 kV line to line
IEC 61000-4-5 typical commercial or hospital
± 2 kV line to earth Ν/Α
EN 61000-4-5 environment.
<5 % UT <5 % UT
Voltage Dips, (>95 % dip in UT) (>95 % dip in UT) Mains power quality should be that of a
Short for 0.5 cycle for 0.5 cycle typical commercial or hospital
Interruptions 40 % UT 40 % UT environment. If the user of the HM 3 Left
and Voltage (60 % dip in UT) (60 % dip in UT) Ventricular Assist System requires
Variations on continued operation during power
for 5 cycles for 5 cycles
Power supply mains interruptions, it is recommended
70 % UT 70 % UT
Input Lines that the HM 3 Left Ventricular Assist
IEC (30 % dip in UT) (30 % dip in UT) System be powered from an
61000-4-11 for 25 cycles for 25 cycles uninterruptible power supply or a
EN <5 % UT <5 % UT battery.
61000-4-11 (>95 % dip in UT) (>95 % dip in UT)
for 5 s for 5 s
Power
Frequency
Power Frequency Magnetic Field should
(50/60 Hz)
3 A/m 30 A/m be that of a typical commercial or
Magnetic Field
hospital environment.
IEC 61000-4-8
EN 61000-4-8

Table 30 Declaration and Guidance Concerning Electromagnetic Immunity for all HeartMate 3 Left
Ventricular Assist System Equipment including Mobile Power Unit

HeartMate 3 Left Ventricular Assist System Patient Handbook 273

9 Testing & Classification
The HeartMate 3 Left Ventricular Assist Device, System Controller, and Mobile Power Unit
are intended for use in the electromagnetic environment specified below. The customer or
the user of the HeartMate 3, Left Ventricular Assist Device, System Controller, and Mobile
Power Unit should assure that they are used in such an electromagnetic environment.

Immunity IEC 60601 Compliance Electromagnetic

Test Test Level Level Environment⎯Guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the
HeartMate 3 Left Ventricular Assist Device, System
Controller, and Mobile Power Unit, including
cables, than the recommended separation distance
calculated from the equation applicable to the
frequency of the transmitter.
Conducted RF
IEC 61000-4-6 Recommended Separation Distances
EN 61000-4-6 3 Vrms
150 kHz to 80
3 Vrms d = 1.2 P
MHz outside ISM
bandsa
10 Vrms
150 kHz to 80 d = 1.2 P
10 Vrms
MHz in ISM bandsa

d = 1.2 P
Mains Powered 80 MHz to 800 MHz
10 V/m d = 2.3 P
800 MHz to 2.5 GHz

Where P is the maximum output power rating of the

transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended
Radiated RF 10 V/m separation distance in meters (m).b
IEC 61000-4-3 80 MHz to
EN 61000-4-3 2.5 GHz Field strengths from fixed RF transmitters, as
determined by an electromagnetic site surveyc,
should be less than the compliance level in each
frequency ranged.

Interference may occur in the vicinity of equipment

that is marked with the following symbol:

Table 31 Declaration and Guidance Concerning Electromagnetic Immunity for HeartMate 3 Left
Ventricular Assist System Equipment, including Left Ventricular Assist Device, System Controller, and
Mobile Power Unit

274 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Testing & Classification 9
Immunity IEC 60601 Compliance Electromagnetic
Test Test Level Level Environment⎯Guidance
890-940 MHz
Based on 21CFR Chapter 1 performance standard
Radiated RF and
for microwave ovens: field strength at 5 cm from
Microwave N/A 2.4-2.5 GHz
external oven surface. Tested with Mobile Power
Ovens
Unit powered by AC Mains.
137 V/m
825-960 MHz
and
Radiated RF
N/A 1.4-2.0 GHz d = 0.77 P
Cell Phones
30 V/m
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.

a
The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.95 MHz; 13.553
MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.77 MHz.
b
Compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to
2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause
interference if it is inadvertently brought into the patient areas. For this reason, an additional factor of (min. 10/3) is
used in calculating the recommended separation distance for transmitters in these frequency ranges.
c
Field strengths from fixed transmitters, such as base stations for radios (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with accuracy.
To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be
considered. If the measured field strength in the location in which the HeartMate 3 Left Ventricular Assist System is used
exceeds the applicable RF compliance level above, HeartMate 3 Left Ventricular Assist System should be observed to
verify normal operation. If abnormal performance is observed, additional measures may be necessary, such as
re-orienting or relocating the HeartMate 3 Left Ventricular Assist System.
d
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.

Table 31 Declaration and Guidance Concerning Electromagnetic Immunity for HeartMate 3 Left
Ventricular Assist System Equipment, including Left Ventricular Assist Device, System Controller, and
Mobile Power Unit (Continued)

WARNING !
The HeartMate 3 Left Ventricular Assist System should not be used adjacent to or stacked
with other equipment. If adjacent or stacked use is necessary, the HeartMate 3 Left Ven-
tricular Assist System should be observed to verify normal operation in the configuration
in which it will be used.

HeartMate 3 Left Ventricular Assist System Patient Handbook 275

9 Testing & Classification

Recommended separation distances between portable and mobile

RF communications equipment and the HeartMate 3 Left Ventricular
Assist System with the Mobile Power Unit
The HeartMate 3 Left Ventricular Assist System with the Mobile Power Unit is intended for use in an
electromagnetic environment in which radiated RF disturbances are controlled. The customer or the user of
the HeartMate 3 Left Ventricular Assist System can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the HeartMate 3 Left Ventricular Assist System as recommended below, according to the
maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
Rated
maximum m
output
150 kHz to 80 150 kHz to 80 80 MHz to 800 800 MHz to 2,5 Cellular Telephone
power of
MHz outside ISM MHz in ISM MHz GHz 825 MHz to 960 MHz and
transmitter bands bands 1.4 GHz to 2.0 GHz

d = 1.2 P d = 1.2 P d = 1.2 P d = 2.3 P d = 0.77 P

W Mains Mains Mains Mains Mains
Powered Powered Powered Powered Powered

0,01 0.12 0.12 0.12 0.23 0.08

0,1 0.38 0.38 0.38 0.73 0.25
1 1.2 1.2 1.2 2.3 0.77
10 3.8 3.8 3.8 7.3 2.5
100 12 12 12 23 7.7
For transmitters rated at a maximum output power not listed above, the recommended separation distance
d in meters (m) can be determined using the equation applicable to the frequency of the transmitter, where
P is the maximum output power rating of the transmitter in watts (W) according to the transmitter
manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz; 13,553
MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the ISM
frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,5 GHz to decrease the likelihood that
mobile/portable communications equipment could cause interference if it is inadvertently brought into patient areas.
Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects and people.

Table 32 Recommended Separation Distances

276 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Testing & Classification 9
Testing and Classification: Battery Charger
The Battery Charger complies with the following safety standards:
• EN 60950-1: 2006 + A11: 2009 + A1: 2010 + A12: 2011
• IEC 60950-1: 2005, 2nd Edition + Am1:2009
• UL 60950-1, 2nd Edition, 2011
• CSA C22.2 No. 60950-1-07, 2nd Edition, 2011
• IEC 60601-1: 1988, 2nd Edition, A1:1991, A2:1995
• UL 60601-1, 1st Edition, 2003-04-26 (included National Differences for USA)
• EN 60601-1:1990 + A1:1993 + A2:1995 + A13:1996
• CAN/CSA C22.2 No.601.1-M90 (R1997), CAN/CSA C22.2 No.601.1S1-94, and
CAN/CSA C22.2 No.601.1B-98 (National Difference for Canada)
This equipment has been tested and found to comply with the limits for devices to IEC
60601-1-2:2007. These limits are designed to provide reasonable protection against
harmful interference in a typical medical installation. This equipment is an unintentional
radiator of radio frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to other devices in the vicinity. However, there
is no guarantee that interference will not occur in a particular installation. If this equipment
does cause harmful interference to other devices, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or
more of the following measures:
• Reorient or relocate the equipment.
• Increase the separation between the equipment.
• Connect the equipment into an outlet on a circuit different from that to which the other
devices are connected.
• Consult Thoratec Corporation for assistance.

HeartMate 3 Left Ventricular Assist System Patient Handbook 277

9 Testing & Classification
Declaration Concerning General Safety Standards for Battery
Charger

Type Degree of Protection

Mode of Operation Continuous

Type of protection against mains shock Class I (grounded)

Degree of protection against harmful

IPX0
ingress of water

Table 33 Declaration Concerning General Safety Standards for Battery Charger

278 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Testing & Classification 9
Declaration and Guidance for Electromagnetic Emissions for
Battery Charger
The Battery Charger is intended for use in the electromagnetic environment specified
below. The customer or the user of the Battery Charger should assure that it is used in such
an environment.

Electromagnetic Environment⎯
Emissions Test Compliance
Guidance
The Battery Charger uses RF energy only for
RF Emissions its internal function. Therefore, its RF
CISPR 11 Group 1 emissions are very low and are not likely to
EN 55011 cause any interference in nearby electronic
equipment.

RF Emissions
CISPR 11 Class B
EN 55011
The Battery Charger is suitable for use in all
Harmonic Emissions establishments, including domestic
IEC 61000-3-2 Class A establishments and those directly connected
EN 61000-3-2 to the public low-voltage power supply
network that supplies buildings used for
Voltage Fluctuations/ domestic purposes.
Flicker Emissions
Complies
IEC 61000-3-3
EN 61000-3-3

The Battery Charger generates magnetic

fields due to the presence of RF energy
Radiated Emissions,
created by its internal function. Therefore, its
Magnetic Field RE101
magnetic field emissions are very low and
MIL-STD-461F
are not likely to cause any interference in
nearby electronic equipment.

Table 34 Declaration and Guidance Concerning Electromagnetic Emissions for Battery Charger

HeartMate 3 Left Ventricular Assist System Patient Handbook 279

9 Testing & Classification
Declaration and Guidance for Electromagnetic Immunity for the
Battery Charger
The Battery Charger is intended for use in the electromagnetic environment specified
below. The customer or the user of the Battery Charger should assure that it is used in such
an environment.

Immunity IEC 60601 Electromagnetic Environment⎯

Compliance Level
Test Test Level Guidance
Electrostatic
Floors should be wood, concrete, or
discharge
±6 kV contact ±6 kV contact ceramic tile. If floors are covered with
(ESD)
±8 kV air ±8 kV air synthetic material, the relative humidity
IEC 61000-4-2
should be at least 30%.
EN 61000-4-2
Electrical Fast
± 2 kV for power
Transient/Burs ± 2 kV for power
supply lines Mains power quality should be that of a
t supply lines
± 1 kV for typical commercial or hospital environment.
IEC 61000-4-4 Not Applicable
input/output lines
EN 61000-4-4
Surge ± 1 kV differential
± 1 kV differential
mode Mains power quality should be that of a
mode
IEC 61000-4-5 ± 2 kV common typical commercial or hospital environment.
± 2 kV common mode
EN 61000-4-5 mode
<5 % UT <5 % UT
Voltage Dips, (>95 % dip in UT) (>95 % dip in UT)
Short Mains power quality should be that of a
for 0.5 cycle for 0.5 cycle
Interruptions typical commercial or hospital environment.
40 % UT 40 % UT
and Voltage If the user of the Battery Charger requires
(60 % dip in UT) (60 % dip in UT) continued operation during power mains
Variations on
for 5 cycles for 5 cycles interruptions, it is recommended that the
Power supply
70 % UT 70 % UT Battery Charger be powered from an
Input Lines
IEC (30 % dip in UT) (30 % dip in UT) uninterruptible power supply or a battery.
61000-4-11 for 25 cycles for 25 cycles
Note: UT is the AC mains voltage prior to application
EN <5 % UT <5 % UT
of the test level.
61000-4-11 (>95 % dip in UT) (>95 % dip in UT)
for 5 s for 5 s
Power
Frequency Power frequency magnetic fields should be
(50/60 Hz) at levels characteristic of a typical location
3 A/m 30 A/m
Magnetic Field in a typical commercial or hospital
IEC 61000-4-8 environment.
EN 61000-4-8

Table 35 Declaration and Guidance Concerning Electromagnetic Immunity for the Battery Charger

280 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Testing & Classification 9

Immunity IEC 60601 Test Compliance Electromagnetic

Test Level Level Environment⎯Guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the Battery
Charger than the recommended separation
distance calculated from the equation applicable to
the frequency of the transmitter.
Recommended Separation Distances
Conducted
RF
IEC 3 Vrms
3 Vrms d = 1.2 P
61000-4-6 150 kHz to 80 MHz
EN
61000-4-6

d = 1.2 P
80 MHz to 800 MHz

d = 2.3 P
800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended
separation distance in meters (m).
Radiated RF Field strengths from fixed RF transmitters, as
IEC determined by an electromagnetic site surveya,
3 V/m
61000-4-3 3 V/m
80 MHz to 2.5 GHz should be less than the compliance level in each
EN
frequency range.b
61000-4-3
Interference may occur in the vicinity of the
equipment that is marked with the IEC symbol for
non-ionizing radiation:

Note 1: At 80 MHz and 800 MHz, the higher frequency range applies
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
a
Field strengths from fixed transmitters, such as base stations for radios (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the Battery Charger is used exceeds the
applicable RF compliance level above, Battery Charger should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the Battery
Charger
b
Over the frequency range 150 KHz to 80 MHz, field strengths should be less than 3 V/m.

Table 36 Declaration and Guidance Concerning Electromagnetic Immunity for the Battery Charger

HeartMate 3 Left Ventricular Assist System Patient Handbook 281

9 Testing & Classification
WARNING !
• Do not use equipment or supplies other than those specified or sold by Thoratec
Corporation. The use of unauthorized replacement parts may result in increased
emissions or decreased immunity of the HeartMate Left Ventricular Assist System.
• Do not use the Battery Charger next to other equipment.
• Do not stack the Battery Charger on top of other equipment.

• No modification of this equipment is allowed.

282 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Testing & Classification 9
Testing and Classification: HeartMate 14 Volt Lithium-Ion Batteries
HeartMate 14 Volt Lithium-Ion batteries comply with the following safety standards:
• IEC/EN 62133
• UL 2054
• UN 38.3 T1-8

HeartMate 3 Left Ventricular Assist System Patient Handbook 283

9 Testing & Classification
Declaration Concerning General Safety Standards for HeartMate
14 Volt Lithium-Ion Batteries

Type Degree of Protection

Degree of protection against electric
No Applied Part
shock

Degree of safety of application in the

Equipment not suitable for use in the presence of
presence of a flammable anesthetic
a flammable anesthetic mixture with air or with
mixture with air or with oxygen or
oxygen or nitrous oxide
nitrous oxide

Degree of protection against harmful IP24 only when connected to the System
ingress Controller through Clip

Table 37 Declaration Concerning General Safety Standards for HeartMate 14 Volt Lithium-Ion
Batteries

284 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Testing & Classification 9
Declaration and Guidance for Electromagnetic Emissions for
HeartMate 3 Powered by 14 Volt Lithium-Ion Batteries
The HeartMate 3 Left Ventricular Assist System with 14 Volt Lithium-Ion batteries is intended
for use in the electromagnetic environment specified below. The customer or the user of the
HeartMate 3 Left Ventricular Assist System should assure that it is used in such an
environment.

HeartMate 3 Powered by 14 V Lithium-Ion Batteries

Electromagnetic
Emissions Test Compliance
Environment⎯Guidance
The HeartMate 3 Left Ventricular Assist System
with 14 Volt Lithium-Ion batteries uses RF energy
RF Emissions
only for its internal function. Therefore, its RF
CISPR 11 Group 1
emissions are very low and are not likely to
EN 55011
cause any interference in nearby electronic
equipment.
The HeartMate 3 Left Ventricular Assist System
with 14 Volt Lithium-Ion batteries is suitable for
RF Emissions use in all establishments, including domestic
CISPR 11 Class B establishments and those directly connected to
EN 55011 the public low-voltage power supply network
that supplies buildings used for domestic
purposes.
The HeartMate 3 Left Ventricular Assist System
with 14 Volt Lithium-Ion batteries uses RF energy
Radiated Emissions
only for its internal function. Therefore, its RF
Avionics RTCA/DO-160G Cat. M
emissions are very low and are not likely to
Section 21
cause any interference in nearby electronic
equipment.

Table 38 Declaration and Guidance Concerning Electromagnetic Emissions for HeartMate 3 Powered by
14 Volt Lithium-Ion Batteries

HeartMate 3 Left Ventricular Assist System Patient Handbook 285

9 Testing & Classification
Declaration and Guidance for Electromagnetic Immunity for
HeartMate 14 Volt Lithium-Ion Batteries
The HeartMate 3 Left Ventricular Assist System with 14 Volt Lithium-Ion batteries is intended
for use in the electromagnetic environment specified below. The customer or the user of the
HeartMate 3 Left Ventricular Assist System with 14 Volt Lithium-Ion batteries should assure
that it is used in such an environment.

Electromagnetic
IEC 60601
Immunity Test Compliance Level Environment⎯
Test Level
Guidance
Electrostatic
±6 kV contact
discharge (ESD) ±8 kV contact The relative humidity should
IEC 61000-4-2 ±15 kV air be at least 5%.
±8 kV air
EN 61000-4-2

Power frequency magnetic

Power Frequency
fields should be at levels
(50/60 Hz)
characteristic of a typical
Magnetic Field 3 A/m 30 A/m
location in a typical
IEC 61000-4-8
commercial or hospital
EN 61000-4-8
environment.

Table 39 Declaration and Guidance Concerning Electromagnetic Immunity

286 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Testing & Classification 9
The HeartMate 3 Left Ventricular Assist System with 14 Volt Lithium-Ion batteries is intended
for use in the electromagnetic environment specified below. The customer or the user of the
HeartMate 3 Left Ventricular Assist System with 14 Volt Lithium-Ion batteries should assure
that it is used in such an electromagnetic environment.

IEC 60601 Compliance Electromagnetic

Immunity Test
Test Level Level Environment⎯Guidance
Portable and mobile RF communications equipment
should be used no closer to any part of the
HeartMate 3 Left Ventricular Assist Device, System
Controller, and batteries, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Recommended Separation Distances
Min. 3 Vrms
Conducted RF
150 kHz to 3 Vrms ·
IEC 61000-4-6 d = 1.2 P
80 MHz
EN 61000-4-6
outside ISM
bandsa
Min. 10 Vrms

10 Vrms d = 1.2 P
150 kHz to
80 MHz in
ISM bandsa

Table 40 Declaration and Guidance Concerning Electromagnetic Immunity

HeartMate 3 Left Ventricular Assist System Patient Handbook 287

9 Testing & Classification
IEC 60601 Compliance Electromagnetic
Immunity Test
Test Level Level Environment⎯Guidance
Battery Operation
d = 0.6 P
80 MHz to 800 MHz

d = 1.2 P
800 MHz to 2.5 GHz
Where P is the maximum output power rating of the
transmitter in watts (W) according to the transmitter
manufacturer and d is the recommended
separation distance in meters (m).b
Radiated RF 10 V/m
20 V/m Field strengths from fixed RF transmitters, as
IEC 61000-4-3 80 MHz to determined by an electromagnetic site surveyc,
EN 61000-4-3 2.5 GHz should be less than the compliance level in each
frequency range.

Interference may occur in the vicinity of the

equipment that is marked with the IEC symbol for
non-ionizing radiation:

Frequency Range
Radiated RF
890-940 MHz Based on 21 CFR Chapter 1 performance standard
and for microwave ovens: field strength at 5 cm from
Microwave
2.4-2.5 GHz external over surface.
Ovens
137 V/m
Frequency Range
Avionics
Conducted 10 kHz
Radiated and
to 400 MHz
conducted RF
Radiated 100
MHz to 8 GHz
RTCA/DO-160G
Section 20
Cat. R
825-960 MHz and
Radiated RF 1.4-2.0 GHz
N/A d = 0.41 P
Cell Phones
56 V/m

Table 40 Declaration and Guidance Concerning Electromagnetic Immunity (Continued)

288 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Testing & Classification 9
IEC 60601 Compliance Electromagnetic
Immunity Test
Test Level Level Environment⎯Guidance
Note 1: At 80 MHz and 800 MHz, the higher frequency range applies
Note 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and reflection from
structures, objects, and people.
a
The ISM (industrial, scientific, and medical) bands between 150 kHz and 80 MHz are 6.765 MHz to 6.95 MHz; 13.553
MHz to 13.567 MHz; 26.957 MHz to 27.283 MHz; and 40.66 MHz to 40.77 MHz.
b
Compliance levels in the ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to
2.5 GHz are intended to decrease the likelihood that mobile/portable communications equipment could cause
interference if it is inadvertently brought into the patient areas. For this reason, an additional factor of (min. 10/3) is
used in calculating the recommended separation distance for transmitters in these frequency ranges.
c
Field strengths from fixed transmitters, such as base stations for radios (cellular/cordless) telephones and land mobile
radios, amateur radio, AM and FM radio broadcast, and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered. If the measured field strength in the location in which the HeartMate 3 Left Ventricular Assist
System with 14 Volt Lithium-Ion batteries is used exceeds the applicable RF compliance level above, the HeartMate
3 Left Ventricular Assist System with 14 Volt Lithium-Ion batteries should be observed to verify normal operation. If
abnormal performance is observed, additional measures may be necessary, such as re-orienting or relocating the
HeartMate 3 Left Ventricular Assist System with 14 Volt Lithium-Ion batteries.

Table 40 Declaration and Guidance Concerning Electromagnetic Immunity (Continued)

WARNING !
Do not use equipment or supplies other than those specified or sold by Thoratec Corpo-
ration. The use of unauthorized replacement parts may result in increased emissions or
decreased immunity of the HeartMate Left Ventricular Assist System.

HeartMate 3 Left Ventricular Assist System Patient Handbook 289

9 Testing & Classification

Recommended separation distances between portable and mobile RF

communications equipment and the HeartMate 3 Left Ventricular Assist
System with 14 V Li-Ion Batteries
The HeartMate 3 Left Ventricular Assist System is intended for use in an electromagnetic
environment in which radiated RF disturbances are controlled. The customer or the user of the
HeartMate 3 Left Ventricular Assist System can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment
(transmitters) and the HeartMate 3 Left Ventricular Assist System as recommended below, according
to the maximum output power of the communications equipment.
Separation distance according to frequency of transmitter
m
Rated maximum
output 150 kHz to 150 kHz to 80 MHz to 800 MHz to Cellular Telephone
power of transmitter 80 MHz 80 MHz in ISM 800 MHz 2,5 GHz 825 MHz to 960 MHz
outside ISM bands and 1.4 GHz to
bands 2.0 GHz

W d = 1.2 P d = 1.2 P d = 0.6 P d = 1.2 P d = 0.41 P

0,01 0.12 0.12 0.06 0.12 0.04

0,1 0.38 0.38 0.19 0.38 0.13
1 1.2 1.2 0.60 1.2 0.41
10 3.8 3.8 1.9 3.8 1.3
100 12 12 6.0 12 4.1
For transmitters rated at a maximum output power not listed above, the recommended separation
distance d in meters (m) can be determined using the equation applicable to the frequency of the
transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.
Note 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
Note 2: The ISM (industrial, scientific and medical) bands between 150 kHz and 80 MHz are 6,765 MHz to 6,795 MHz;
13,553 MHz to 13,567 MHz; 26,957 MHz to 27,283 MHz; and 40,66 MHz to 40,70 MHz.
Note 3: An additional factor of 10/3 is used in calculating the recommended separation distance for transmitters in the
ISM frequency bands between 150 kHz and 80 MHz and in the frequency range 80 MHz to 2,5 GHz to decrease the
likelihood that mobile/portable communications equipment could cause interference if it is inadvertently brought into patient
areas.
Note 4: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.

Table 41 Recommended Separation Distances

290 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Testing & Classification 9
This equipment has been tested and found to comply with the limits for medical devices to
IEC 60601-1-2:2007. These limits are designed to provide reasonable protection against
harmful interference in a typical medical installation. This equipment generates, uses and
can radiate radio frequency energy and, if not installed and used in accordance with the
instructions, may cause harmful interference to other devices in the vicinity. However, there
is no guarantee that interference will not occur in a particular installation. If this equipment
does cause harmful interference to other devices, which can be determined by turning the
equipment off and on, the user is encouraged to try to correct the interference by one or
more of the following measures:
• Reorient or relocate the equipment.
• Increase the separation between the equipment.
• Connect the equipment into an outlet on a circuit different from that to which the other
device(s) are connected.
• Consult Thoratec Corporation for assistance.

CAUTION !
Use of equipment and supplies other than those specified in the manuals 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 3 Left Ventricular Assist System and
other devices.

HeartMate 3 Left Ventricular Assist System Patient Handbook 291

9 Testing & Classification

292 HeartMate 3 Left Ventricular Assist System Patient Handbook

 10

SAFETY CHECKLISTS

This section provides checklists to assist you in performing routine maintenance of the
HeartMate 3 Left Ventricular Assist Device.

Daily Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - - 295

Weekly Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - 297

Monthly Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - 298

Yearly Safety Checklist - - - - - - - - - - - - - - - - - - - - - - - - 301

As-Needed Safety Checklist- - - - - - - - - - - - - - - - - - - - - - 301

Clinic Visit Safety Checklist - - - - - - - - - - - - - - - - - - - - - - 302

HeartMate 3 Left Ventricular Assist System Patient Handbook 293

10 Safety Checklists

294 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Safety Checklists 10
Daily Safety Checklist

Daytime Checklist:

Perform System Controller self test.

When using a new power source, inspect System Controller power cable
connectors for dirt, grease, or damage.
When changing power sources, inspect connectors on battery clips for dirt,
grease, or damage.
When switching from the battery power to the Mobile Power Unit, inspect the
connector pins and sockets for dirt, grease, or damage.
Ensure that the Modular In-line Connector is secure and the connector locking
nut is in the locked position. Ensure no yellow indicator is seen under the
locking nut.
Manage the Driveline exit site in accordance with the instructions provided
by the clinician.
Inspect the Driveline exit site for signs of infection, including redness,
tenderness, swelling, discharge, or a foul odor. Use sterile technique to touch
or handle the exit site.

HeartMate 3 Left Ventricular Assist System Patient Handbook 295

10 Safety Checklists
Sleep Checklist:
_

Check all electrical connections between the System Controller and power
cables, the power cables and the Mobile Power Unit patient cable, and the
Mobile Power Unit and AC electrical outlet.
Always connect to the Mobile Power Unit for sleeping or when there is a
chance of sleep, as you may not hear System Controller alarms.

Make sure the Driveline is stabilized.

Confirm bedside items are in place:

Working flashlight with charged batteries.

Backup System Controller.

Two charged HeartMate 14 Volt Lithium-Ion batteries and two 14

Volt battery clips.
Inspect the Driveline Cable for signs of damage, such as cracking, fraying,
wear, exposed wires, sharp bends or kinks.
Ensure that the Modular In-line Connector is secure and the connector
locking nut is in the locked position. Ensure no yellow indicator is seen
under the in-line locking nut.

Inspect all cables for signs of damage.

296 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Safety Checklists 10
Weekly Safety Checklist
Review Replacing Running System Controller with a Backup Controller
Instructions in Section 2.

Clean the metal battery terminals and contacts inside the battery clips.
Inspect the Mobile Power Unit power cord, used to connect the Mobile Power
Unit to the AC electrical outlet, for damage or wear. Confirm that the cord is
not kinked, split, cut, cracked, or frayed. Do not use the cord if it shows signs
of damage. Obtain a replacement from your hospital contact, if needed.
Manage the Driveline exit site in accordance with the instructions provided
by the clinician.
Inspect the Mobile Power Unit patient cable, used to connect the System
Controller to the Mobile Power Unit, for damage or wear. Confirm that the
cable is not kinked, split, cut, cracked, or frayed. Do not use the Mobile
Power Unit patient cable if it shows signs of damage. Obtain a replacement
from your hospital contact, if needed.
Inspect HeartMate 14 Volt Lithium-Ion batteries for damage. Check the
battery contacts for denting or damage. Replace damaged batteries. Do not
use batteries that appear damaged.
Inspect the Battery Charger for signs of physical damage, such as dents,
chips, or cracks. Do not use the Battery Charger if it shows signs of damage.
Obtain a replacement from your hospital contact, if needed.
Inspect the power cord that is used to connect the Battery Charger to an AC
outlet. Confirm that the cord is not kinked, split, cut, cracked, or frayed. Do
not use the cord if it shows signs of damage. Obtain a replacement from your
hospital contact, if needed.
Inspect wear and carry accessories (including the consolidation bag, Travel
Bag, Protection Bag, System Controller Neck Strap, Holster Vest, and Belt
Attachment accessory) for damage or wear.
Inspect the Battery Holster for damage or wear.

Inspect the Shower Bag for damage or wear.

Replace any equipment or system component that appears damaged or
worn.

HeartMate 3 Left Ventricular Assist System Patient Handbook 297

10 Safety Checklists
Monthly Safety Checklist

Review Alarms and Troubleshooting Guides in Section 5.

Check the manufacture date on the label of all batteries. If a battery was
manufactured more than three years ago, the battery has expired. Replace
expired batteries. Do not use expired batteries.
Figure 163 Check the Manufacture Date to Determine Battery Expiration

Manufacture
Date

Check the number of use/charge cycles for each battery. Insert a battery into
the Battery Charger to read the number of cycles. The cycle information is
displayed on the charger’s display panel screen (see Battery Charger Display
Panel Messages on page 237). Replace batteries that have exceeded 360
cycles. Do not use batteries that have exceeded 360 cycles.
Clean the metal battery contacts and the interior contacts of battery clips
using a cotton swab or lint-free cloth that has been moistened (not dripping)
with rubbing alcohol. Allow the alcohol to completely air dry before using
newly cleaned batteries or clips. Do not clean batteries while the batteries
are in use.
Inspect the Mobile Power Unit patient cable and power cable connector pins
and sockets for dirt, grease or damage. If the pins or sockets are damaged or
contaminated, do not attempt to clean them. Report the condition to your
hospital contact. Cleaning and service should be performed only by
Thoratec-trained personnel. Do not attempt to clean or repair equipment on
your own.
If the Mobile Power Unit is going to be stored for over 1 month, remove the
Mobile Power Unit batteries.

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 Safety Checklists 10
Unplug the Battery Charger and clean the metal contacts inside all four
charging pockets with a lint-free cloth or swab that has been moistened (not
dripping) with rubbing alcohol. Allow the alcohol to completely air dry
before inserting batteries into the pockets. Do not clean the Battery Charger
while it is plugged in.
Replace any equipment or system component that appears damaged or
worn.

HeartMate 3 Left Ventricular Assist System Patient Handbook 299

10 Safety Checklists
Six Month Safety Checklist
Talk to your hospital contact about maintaining your backup System
Controller and checking it for readiness. To make sure your backup System
Controller is always ready to use in an emergency, once in a six-month
period, your hospital contact will need to charge the backup battery inside
your backup System Controller, perform a self test on the backup System
Controller, and make sure that the backup System Controller’s programmed
settings are identical to the settings in your running System Controller.
Replace the Mobile Power Unit batteries with three new AA Alkaline
batteries. If corrosion is observed, discontinue use of the Mobile Power Unit
and call your hospital contact. (See Inserting or Replacing the Mobile Power
Unit Batteries on page 82).

300 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Safety Checklists 10
Yearly Safety Checklist

Schedule a Battery Charger inspection and cleaning with Thoratec-trained

personnel. The safety inspection and cleaning includes (but is not limited to)
functional testing, cleaning, and inspection.
REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS
DAMAGED OR WORN.

As-Needed Safety Checklist

Manage the Driveline exit site in accordance with the instructions provided
by the clinician.
Clean the exterior surfaces of batteries using a clean, dry cloth. Do not use
liquids such as water or liquid cleaning solvent to clean batteries. Keep the
batteries dry and away from water and liquid.
Unplug the Battery Charger and clean the exterior surfaces using a clean,
damp (not wet) cloth. You may use a mild detergent, if necessary. Do not
immerse the charger in water or liquid.
REPLACE ANY EQUIPMENT OR SYSTEM COMPONENT THAT APPEARS
DAMAGED OR WORN.

HeartMate 3 Left Ventricular Assist System Patient Handbook 301

10 Safety Checklists
Clinic Visit Safety Checklist
Advise your patient to bring his or her Patient Handbook to the clinic visit.
The following safety check should be performed at each clinical follow-up
visit:
Review replacing the running System Controller with a backup System Controller
(Patient Handbook Section 2).
With demonstration equipment, both patient and primary caregiver must be able to
repeatedly demonstrate ability to successfully complete connection of a driveline to
the Pocket Controller in a timely manner (Patient Handbook Section 2).
Evaluate, and if necessary, review your patient’s ability to perform the
following core skills:
Review System Controller alarms and troubleshooting including Hazard and Advisory
alarm handling and accessing alarm history on the System Controller (Patient
Handbook Section 5).

Review Mobile Power Unit alarms and troubleshooting (Patient Handbook Section 5).
Remind the patient to follow all hazard and advisory alarm instructions, for example,
call the hospital when the System Controller instructs the patient to do so.

Review how to identify an emergency (Patient Handbook Section 8).

Review emergency contact lists (Patient Handbook page v).

Review guidelines for connecting power cable connectors (Patient Handbook Section
5).

Review changing power sources (Patient Handbook Section 3).

Review HeartMate 14 Volt Lithium-Ion battery calibration steps (Patient Handbook
Section 3).

Review What Not To Do: Driveline and Cables (Patient Handbook section 5.)

Review using the Shower Bag and showering (Patient Handbook section 4).

Review caring for the driveline exit site including cleansing, dressing, and
immobilizing the driveline (Patient Handbook section 4).

System Controller must be maintained and assessed for readiness.

302 HeartMate 3 Left Ventricular Assist System Patient Handbook

 11

GLOSSARY

This section defines important terms and abbreviations.

Abbreviations - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 305

Terms - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 306

HeartMate 3 Left Ventricular Assist System Patient Handbook 303

11 Glossary

304 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Glossary 11
Abbreviations

Abbreviation Term

AC Alternating Current

CM Centimeter

DC Direct Current

EKG Electrocardiogram

ICU Intensive Care Unit

IMP Implantable Pacemaker

INR International Normalized Ratio

IV Intravenous

LPM Liters Per Minute

LVAD Left Ventricular Assist Device

LVAS Left Ventricular Assist System

LMW Low Molecular Weight

Ml/hr Milliliter per hour

MRI Magnetic Resonance Imaging

OR Operating Room

PI Pulsatility Index
PTT Partial Thromboplastin time

QD Once daily

RPM Revolutions Per Minute

TID Three times daily

V Volt

HeartMate 3 Left Ventricular Assist System Patient Handbook 305

11 Glossary
Terms

A
Advisory Alarm: Alarms that are important, but not life threatening. Advisory
alarms can be silenced for a short time using the Silence Alarm Button that is
found on the System Controller user interface. See System Controller Alarms on
page 209.

Alarm: A sound, light, or lighted symbol that tells you about a problem that may
affect system operation or cause harm. See System Controller User Interface on
page 26.

Alternating Current: Abbreviated AC. The type of electricity that is common for
electrical outlets in North American households.

Apical Cuff: The Apical Cuff is the interface between the heart and the
HeartMate 3 LVAD. It is sewn to the exterior of the heart and anchors it to the
LVAD via the slide lock.

B
Backup Battery: The 11 volt Li-Ion battery inside the System Controller that will
continue to run the pump for a short period of time until the System Controller is
reconnected to external power.

Backup System Controller: A backup System Controller used to replace the

running System Controller, if needed. The backup is identical to the running
System Controller and is pre-set with the same settings. You should keep your
backup System Controller with you at all times (along with other emergency or
backup items). The 11 Volt Lithium-Ion backup battery inside the backup System
Controller must be recharged every six months. See Performing Backup System
Controller Six Month Charging and Self Test on page 60.

The System Controller has an 11 Volt Lithium-Ion battery inside the System
Controller gives at least 15 minutes of backup power to the system if the main
source of power is disconnected or fails. See System Controller Backup Power
on page 56.

306 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Glossary 11
Battery: A device that provides direct current (DC) power to the system. The
HeartMate 3 Left Ventricular Assist System can be powered by two 14 Volt
Lithium-Ion batteries. See Using HeartMate 14 Volt Lithium-Ion Batteries on
page 95. An 11 Volt Lithium-Ion battery inside the System Controller gives at
least 15 minutes of backup power to the system if the main source of power is
disconnected or fails. See System Controller Backup Power on page 56.

Battery button: A button on the System Controller user interface that shows a
small battery symbol ( ). Depending on the mode of operation, pressing this
button either: 1) works the battery power gauge on the System Controller, 2)
starts the System Controller self test, 3) puts the battery to “sleep” for storage
purposes, or 4) recharges the System Controller’s 11 Volt Lithium-Ion backup
battery. See The System Controller User Interface on page 25.

Battery Charger: A device that charges, calibrates, and tests the HeartMate 14
Volt Lithium-Ion batteries that are used to power the HeartMate 3 Left Ventricular
Assist System.

Battery Power Gauge: A set of lighted bars that indicates how much battery
power is available. Each HeartMate 14 Volt Lithium-Ion battery has its own 5-bar
on-board battery power gauge that shows the battery charge level. The System
Controller also has a battery power gauge. The power gauge on the System
Controller has four bars and one diamond-shaped light. The System Controller
battery power gauge is used during battery-powered operation. It shows the
approximate charge level of the two batteries currently in use.

Battery-Powered Operation: Using two HeartMate 14-V Lithium-Ion batteries to

power the system. Using batteries to power the system is appropriate when you
are active, outdoors, or when electrical power is unavailable.

C
Cautions: Actions to avoid that could damage equipment or affect how the
system works. Although important for system function, cautions do not usually
relate to life-threatening risks.

Communication Fault (Comm Fault): An Advisory alarm indicating the

HeartMate 3 LVAD and System Controller cannot properly exchange information.
See System Controller Alarms on page 209.

Controller: See System Controller.

Controller Alarm Fault: An advisory alarm that occurs when an internal

malfunction in the System Controller has occurred that requires clinician
diagnosis and resolution. See “System Controller Alarms” on page 209.

HeartMate 3 Left Ventricular Assist System Patient Handbook 307

11 Glossary
Controller Driveline Connector: Connector permanently attached to the
Driveline that connects the pump to the System Controller.

Controller Hardware Fault Alarm: A hazard alarm that occurs when a serious
internal malfunction occurs in the System Controller that requires clinician
diagnosis and resolution. See “System Controller Alarms” on page 209.

D
Direct Current: Abbreviated DC. The type of electricity that comes from a
battery.

Display Button: A button on the System Controller user interface. Press this
button to bring up data on the user interface’s display screen (such as current
function and alarm history). See The System Controller User Interface on
page 25.

Driveline: The cable that goes through the skin. It links the pump to the System
Controller. The Driveline contains wires that carry power to the pump. Data about
system operation is transferred through the Driveline to the System Controller.

Driveline Communication Fault (Driveline Comm Fault): An Advisory Alarm. It

occurs when one of the two communication wires inside the Driveline is
damaged.

Driveline Power Fault: An Advisory Alarm. It occurs when one of the two power
wires inside the Driveline is damaged.

E
Exit Site: The place where the Driveline goes through the skin. The exit site must
be kept clean and dry to lower the risk of infection.

F
Fixed Speed Mode: An operating mode where the device is set at a constant or
“fixed” speed. Doctor and nurses decide and control pump speed.

G
H

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 Glossary 11
Hazard Alarm: Hazard alarms occur when the pump has stopped working or is
about to stop working. Hazard alarms are serious conditions that require
immediate attention. Hazard alarms are indicated by a red light and continuous
audio tone.

HeartMate 3 Left Ventricular Assist System: Includes the pump and Driveline,
as well as the System Controller, power sources (Mobile Power Unit or batteries),
and accessories. You may sometimes hear the term “LVAS,” which is short for
Left Ventricular Assist System.

I
Inflow Conduit: A small tube that connects the pump to the left ventricle of the
heart.

Intensive Care Unit: Abbreviated ICU. This special hospital unit is where new
Left Ventricular Assist System patients receive intensive care, usually just after
device implant.

J
K
L
Left Ventricular Assist Device: The pump connected to the left ventricle of the
heart that sends blood taken from the inflow conduit through the Outflow Graft
and into the aorta, which sends the blood to the rest of the body. The motor inside
the pump is powered through the Driveline. You may sometimes hear the device
called a “heart pump” or “LVAD,” which is short for Left Ventricular Assist Device.
Left Ventricular Assist System: The HeartMate 3 Left Ventricular Assist System
includes the pump and all related external equipment. Sometimes the Left
Ventricular Assist System is called an “LVAS”. LVAS is NOT the same as LVAD.
LVAD refers only to the pump.

Liters Per Minute: Abbreviate LPM. Blood flow through the pump is measured in
LPMs. “LPM” shows on the System Controller user interface along with blood
flow data.

Low Battery Hazard Alarm: A red battery-shaped symbol ( ) on the System

Controller user interface that illuminates when less than 5 minutes of combined
battery power remain for the in-use HeartMate 14 Volt Lithium-Ion batteries,
during battery-powered operation.

HeartMate 3 Left Ventricular Assist System Patient Handbook 309

11 Glossary
Low Battery Hazard Symbol: Red “battery” light ( ) on the System
Controller. It lights when power to the System Controller is critically low.

Low Flow Alarm: Blood flow is less than 2.5 lpm. This condition is accompanied
by a flashing red heart on the user interface. “Call Hospital Contact” and “Low
Flow” alternate on the screen, and a constant audio tone is emitted from the
System Controllers sounders. This is a Hazard alarm condition that requires
immediate attention.

Low Flow Hazard Symbol: Red “heart” light ( ) on the System Controller.
It lights when HeartMate 3 pump blood flow is critically low.

Low Speed Limit: The lowest speed at which the HeartMate 3 pump can
operate while maintaining patient stability.

LPM: Short for liters per minute (lpm). Blood flow through the pump is measured
in lpm.

LVAS: Short for Left Ventricular Assist System. The HeartMate 3 Left Ventricular
Assist System includes the pump and Driveline, as well as the System Controller,
power sources (Mobile Power Unit or batteries), and accessories.

M
Magnetic Resonance Imaging ( ) MR is unsafe for HeartMate 3 patients. Do
not subject to Magnetic Resonance Imaging.

Mobile Power Unit: The Mobile Power Unit connects to an AC electrical outlet. It
provides AC electrical power to the Left Ventricular Assist System. You must
always connect to the Mobile Power Unit when sleeping (or when sleep is
possible). Connecting to the Mobile Power Unit is also appropriate when you are
stationary or relaxing indoors. See Powering the System on page 75.

Mobile Power Unit Batteries: The batteries inside the Mobile Power Unit power
an alarm if power to the Mobile Power Unit fails or is disconnected. The Mobile
Power Unit batteries work only if they are properly connected and not discharged.
See Inserting or Replacing the Mobile Power Unit Batteries on page 82.

Modular In-line Cable: One of the two cables that make up the Driveline. One
end of the Modular Cable connects to the Pump Cable that exits the patient’s
abdomen. The other end of the Modular Cable connects to the System Controller.

N
O

310 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Glossary 11
Operating Modes: There are three modes of System Controller operation: 1)
Run Mode (actively running), 2) Sleep Mode (off and unused), and 3) Charge
Mode (connected to power and charging the backup battery). See System
Controller Operating Modes on page 47.

Outflow Graft: The polyester tube that connects the pump to the aorta (the large
blood vessel that sends blood through the body).

P
Percutaneous: “Percutaneous” means “through the skin.”

Pump Cable: One of the two cables that make up the Driveline. The Pump Cable
is permanently attached to the pump housing. The other end of the Pump Cable
exits the patient’s abdomen and is connected to the Modular Cable which
connects to the System Controller.

The Pump Cable contains wires that carry power and data to the pump, and that
control and monitor pump operation.

Polyester Velour: A synthetic biocompatible material that lets skin tissue grow
into the soft covering of the Driveline. This material covers the Driveline inside
the body at the exit site and is on the external portion of the Pump Cable. Skin
growth into the velour covering helps create a barrier that reduces the risk of
Driveline infections.

Power Saver Mode: In Power Saver Mode, the System Controller slows pump
speed to save power. If power is removed or fails, the System Controller gives 15
minutes of full power before entering Power Saver Mode. Alarms cannot be
silenced while in Power Saver Mode. See System Controller Alarms on
page 209.

Power Sources: Two power sources can power the HeartMate 3 Left Ventricular
Assist System: 1) two wearable, rechargeable 14 Volt Lithium-Ion batteries worn
in battery clips, or 2) the Mobile Power Unit that plugs into an AC electrical outlet.

Pulsatility Index: Pulsatility Index (PI) is a calculation related to the amount of

assistance provided by the pump. PI values typically range from 1 to 10. Higher
values indicate higher pulsatility (that is, the pump is providing less support and
the heart is providing more support). Lower values indicate lower pulsatility (that
is, the pump is providing more support and the heart is providing less support).

Pulse Mode: Your pump is able to create an artificial pulse while it is operating.
You will know it is operating in Pulse Mode when you see the on the LCD of
the System Controller.

Pump: See Left Ventricular Assist Device.

HeartMate 3 Left Ventricular Assist System Patient Handbook 311

11 Glossary
Pump Running Symbol: A green symbol ( ) on the System Controller user
interface that illuminates when the pump is receiving power and running.

Pump Speed: Pump speed is measured in revolutions per minute (RPM). The
number of RPMs reflects how fast the pump’s internal rotor turns.

Q
R
Red Heart Indicator: A red heart shaped symbol ( ) on the System Controller
user interface that illuminates during a Hazard alarm condition. Red heart alarms
occur for conditions that are immediately life-threatening. Red heart alarms
should prompt an immediate response to avoid serious patient injury or death.

Revolutions Per Minute: Abbreviated RPM. The number of RPMs reflects how
fast the pump’s internal rotor turns.

Running System Controller: The System Controller that is currently in use and
connected to the pump.

S
Safety Lock: The feature on the System Controller that ensures the Controller
Driveline Connector is properly inserted (when the lock can be fully closed).

Self Test: A routine system check that you should perform daily to confirm that
the System Controller’s audio and visual alarms are working properly.

Silence Alarm Button: A button on the System Controller or Mobile Power Unit
( ) that silences an audio alarm. How long the alarm is silenced depends on
the type of alarm. The silence period varies from 2 minutes to 4 hours.
IMPORTANT! Pressing the Silence Alarm button only silences the alarm. It does
not fix the alarm condition. See System Controller Alarms on page 209.

Silence Alarm Screen: When the audio portion of the alarms are silenced, the
symbol will display on the LCD screen of the System Controller.

Slide Lock: The mechanical feature on the HeartMate 3 LVAD that affixes the
pump to the Apical Cuff.

Strap Attachment Points: Four places on the System Controller where straps
can be easily connected. Attachment points allow for holding or carrying the
System Controller. The System Controller can be worn or carried on a belt or
strap, or inside a pocket. See Wearing and Carrying the System Controller on
page 159.

312 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Glossary 11
System Controller: The small computer that controls and checks system
function. It connects the pump to the external power sources and may be worn at
the waist on a belt or in a carrying case around the waist.

System Controller 11 Volt Lithium-Ion Backup Battery: A backup power

source inside the System Controller. It powers the system for up to 15 minutes if
the main power source fails or is disconnected. The 11 Volt Lithium-Ion backup
battery is rechargeable. It charges automatically any time the System Controller
is connected to a power source (Mobile Power Unit or batteries). You need to be
sure to recharge the backup battery inside the backup System Controller every
six months (Performing Backup System Controller Six Month Charging and Self
Test on page 60). Although rechargeable, the 11 Volt Lithium-Ion backup battery
has a limited life (36 months from manufacture date). A message on the System
Controller screen tells you when it is time to replace the 11 Volt Lithium-Ion
backup battery. See System Controller Alarms on page 209.

System Controller Battery Power Gauge: A set of four bars on the System
Controller. The bars show the approximate charge level for two batteries being
used to power the system. Four green bars mean the batteries are between 75–
100% charged. One green bar means the batteries are less than 25% charged. A
yellow diamond-shaped light means that only 15 minutes of battery power
remain. If the yellow diamond comes on, promptly replace the used batteries or
switch to the Mobile Power Unit. Failure to replace batteries or switch to the
Mobile Power Unit may cause the pump to stop. See The System Controller User
Interface on page 25.

System Controller Power Cables: Two power cables (one with a black
connector and one with a white connector) connect the System Controller to its
power source (either batteries or Mobile Power Unit). Both cables provide equal
power. However, the white cable contains a data link that sends information to the
Mobile Power Unit.

T
Tethered Operation: Refers to using the HeartMate 3 Left Ventricular Assist
System while connected to an electrical outlet via the Mobile Power Unit.

U
User Interface: The lights, symbols, and buttons that appear on the front of the
System Controller and provide information about the system.

HeartMate 3 Left Ventricular Assist System Patient Handbook 313

11 Glossary
User Interface Screen: The screen on the System Controller user interface that
provides information about how the system is operating. Alarm information and
instructions also appear on the screen. See The System Controller User
Interface on page 25.

V
W
Warnings: Hazards that could cause serious harm or death if not avoided. If you
ignore a warning, you could be seriously harmed or killed.

Wear and Carry Accessories: Wear and carry accessories are used to safely
hold or carry the System Controller. For example, you can carry the System
Controller with a strap around your neck, on a belt, or in a pocket. A battery
holster is used for carrying batteries and battery clips. See Wearing and Carrying
the System Controller on page 159.

X
Y
Yellow Diamond Indicator: A yellow symbol ( ) on the System Controller user
interface that illuminates when less than15 minutes of combined battery power
remain from the in-use HeartMate 14 Volt Lithium-Ion batteries providing power
during battery-powered operation.

Yellow Wrench Indicator: A yellow symbol ( ) on the System Controller user

interface that illuminates during alarm conditions that are important, but not
immediately life-threatening.

314 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Index
Numerics connect power immediately 220
11 Volt Lithium-Ion backup battery 56 Driveline Communication Fault (Driveline
charging 50, 57 Comm Fault) 230
disposal 250 driveline disconnected hazard 219
environmental requirements Driveline Power Fault 229
for operation 268 low battery advisory 224
fault advisory alarm 228 low battery power hazard 221
14 Volt Lithium-Ion batteries 95 low flow hazard 221
battery life 113 Mobile Power Unit 231
calibrating 131 no external power hazard 220
charging 125 pump off hazard 215
checking charge level 103 replace power advisory 224, 228
connecting to System Controller 106 replace power immediately 221
disposal 250 System Controller 209, 225
environmental requirements backup battery fault 227
for operation 268 backup battery not installed 228
estimating available charge 110 troubleshooting 209
Power Saver Mode 110 B
A backup battery
acceptable environmental conditions for System Controller
for operation 268 backup battery fault alarm 227
accessories 159 battery not installed advisory alarm 228
battery holster 184 environmental requirements 268
belt attachment 166 backup System Controller
cleaning 249 battery 56
consolidated bag 171 Charge Mode 50
holster vest 192 charging 60
lanyard 161 replacing running controller 63
protection bag 180 Sleep Mode 49
Shower Bag 149 storing 180
Stabilization Belt 141 batteries
travel bag 182 11 Volt Lithium-Ion 56
advisory alarms charging 50
11 Volt Lithium-Ion backup battery fault 228 disposal 250
backup battery not installed 228 environmental requirements 268
low battery 224 fault alarm 228
System Controller fault 225 not installed alarm 228
table of 215 14 Volt Lithium-Ion 95
air pressure, acceptable range battery life 113
for operation 268 calibrating 131
alarm history, viewing 210 charging 125
alarm silence indicator 213 checking charge level 103
alarms connecting to System Controller 106
backup battery fault 227 disposal 250
backup battery not installed advisory 228 environmental requirements 268
Communication Fault (Comm Fault) 226 estimating available charge 110
connect driveline 219, 222 Power Saver Mode 110
connect power 223 disposal of 250
Mobile Power Unit 82

HeartMate 3 Left Ventricular Assist System Patient Handbook 315

Index
battery button on System Controller 28 troller 33
Battery Charger 121 disconnecting the driveline from the System
advisory messages 233 Controller 36
charger faults 236 display button 28
display panel messages 237 Driveline Connector 32
environmental requirement 268 hazard alarms 214
information available on display panel 129 operating modes 47
pocket faults 235 overview 23
setting up 122 replacing the current System Controller with
battery holster 184 multiple power sources 69
battery power gauge replacing the current System Controller with
on 14 Volt Lithium-Ion batteries 103 one power source 65
on System Controller 44 run mode 47
belt attachment 166 self test 41
buttons silencing an active alarm 28
System Controller sleep mode 47
battery button 28 symbols 26
display button 29 System Controller power cable connectors
silence alarm button 28 38
turning off the controller (Sleep Mode) 73
C
user interface 25
calibrating batteries 131 yellow diamond 27
call hospital contact screen 217, 218 Controller (see System Controller) 4
backup battery fault 227 Controller Hardware Fault Alarm 308
caring for driveline exit site 142
cautions, defined 5 D
Charge Mode for System Controller 50 daily checklist 295
charging display button on System Controller 29
11 Volt Lithium-Ion backup battery 50, 57 disposing of equipment 250
14 Volt Lithium-Ion batteries 125, 127 driveline 18
backup System Controller 60 care 141
checklist before sleeping 201 cleaning 245
checklists 293 connecting to System Controller 33
cleaning equipment 244 connector 32
Communication Fault Alarm (Comm Fault) 226 disconnected, hazard alarm 219, 222
connect driveline screen 219, 222 disconnecting from System Controller 36
connect power immediately screen 220 evidence of damage 246
connect power screen 223 exit site care 142
connectors Driveline Communication Fault (Driveline Comm
driveline 32 Fault) Alarm 230
Mobile Power Unit patient cable 89 Driveline Disconnected Alarm 219
power cable 38 Driveline Power Fault Alarm 229
consolidated bag 171
E
Controller
advisory alarms 215 emergencies, how to handle 261
backup controller 58 environmental requirements
backup power 56 for operation 268
battery power gauge 44 equipment
charge mode 47 cleaning 244
connecting the driveline to the System Con- disposal 250

316 HeartMate 3 Left Ventricular Assist System Patient Handbook

 Index
overview 10 O
estimating battery time 110 on-battery power gauge 103
G operating modes for System Controller 47
Glossary 303 P
H power cable
cleaning 245
hand washing 136
connectors 38
hazard alarms
power gauge
driveline disconnected 219
on 14 Volt Lithium-Ion batteries 103
low battery power 221
on System Controller 44
low flow 221
Power Module
no external power 220
environmental requirements
pump off 215
for operation 268
table of 214
Power Saver Mode 110
HeartMate 3 Left Ventricular Assist Device 17
pre-sleep checklist 201
HeartMate 3 Left Ventricular Assist System
protection bag for System Controller 180
environmental requirements
pump 17
for operation 268
Pump Off Alarm 217
holster 184
pump off hazard alarm 215
holster vest 192
Pump Running green light 213
humidity, acceptable range
pump running symbol 26
for operation 268
pump status 30
L
R
lanyard 161
red battery symbol
low battery advisory alarm 224
on System Controller 26, 46
low battery power hazard alarm 221
red heart symbol on System Controller 26
low battery screen 221, 224, 228
replace power immediately screen 221
Low Flow Alarm 221
replace power screen 224, 228
low flow hazard alarm 221
replace System Controller
low flow screen 217, 218
instructions 63
M Run Mode for System Controller 48
Mobile Power Unit 78, 89 S
alarms 231
safety checklists 293
connecting to System Controller 90
Safety Lock 32
disconnecting 88
safety testing and classification 267
inserting batteries 82
self test
maintenance 94
for System Controller 41
patient cable connectors 89
Shower Bag 149
power cord 85
showering 147
setting up 81
silence alarm button
storage 93
on System Controller 28
Modular In-line Connector 20
Sleep Mode for System Controller 49
monitoring battery life 113
sleep, preparing for 201
monthly checklist 299
Stabilization Belt 141
N System Controller 23
no external power hazard alarm 220 accessories 159
alarm history 210

HeartMate 3 Left Ventricular Assist System Patient Handbook 317

Index
alarms 209 W
and preparing for sleep 201 warnings, defined 5
backup battery in 56 wear and carry accessories 159
battery button 28 battery holster 184
battery power gauge 44 belt attachment 166
buttons 26 cleaning 249
Charge Mode 50 consolidated bag 171
cleaning 244 holster vest 192
connecting to batteries 106 lanyard 161
connecting to driveline 33 protection bag 180
connecting to Mobile Power Unit 90 travel bag 182
disconnecting from driveline 36
display button 29 X
driveline x-rays, using to determine driveline damage
connecting 33 246
disconnecting 36
environmental requirements Y
for operation 268 yearly checklist 300
fault advisory 225 yellow diamond symbol 46
operating modes 47 yellow wrench symbol
pump status 30 on System Controller 26
red battery symbol 26, 46
red heart symbol 26
Run Mode 48
self test 41
silence alarm button 28
Sleep Mode 49
storing backup 180
user interface 25
when to connect to batteries 106
when to connect to Mobile Power Unit 89
yellow diamond symbol 46
yellow wrench symbol 26
System Controller Fault Alarm 225
T
temperature, acceptable ranges
for operation 268
travel
by automobile 205
general considerations 203
travel bag 182
troubleshooting 209
U
user interface on System Controller 25
V
vest, holster 192

318 HeartMate 3 Left Ventricular Assist System Patient Handbook