Thoratec HEARTMATE II User manual

Instructions for Use
Thoratec Corporation 6035 Stoneridge Drive, Pleasanton, CA 94588
[phone], Fax: [phone], HeartLine™: [phone], www.thoratec.com
Thoratec Corporation continually strives to provide the highest quality products for mechanical circulatory support. Specications may change without notice.
Therefore, please refer to the HeartMate II Instructions for Use shipped with the HeartMate II for the most current information regarding indications, contraindications,
and cautions. HeartMate II, Thoratec, and the Thoratec logo are registered trademarks and HeartLine is a trademark of Thoratec Corporation.
©2017 Thoratec Corporation. 10006960.C 12/2017
Featuring the Mobile Power Unit

Thoratec Corporation
HEARTMATE II®LEFT VENTRICULAR ASSIST SYSTEM
Instructions for Use

HeartMate II Left Ventricular Assist System Instructions for Use iii
Thoratec Corporation
(International headquarters)
6035 Stoneridge Drive
Pleasanton, CA 94588
USA
Telephone: [phone]
Fax: [phone]
Emergency HeartLine™ USA: [phone]
Emergencies outside USA: [phone]
Website: www.thoratec.com
Thoratec Corporation continually strives to provide the highest quality of products for mechanical circulatory support. Specifications
may change without notice. HeartMate II, Thoratec, and the Thoratec logo are registered trademarks, and HeartLine is a trademark
of Thoratec Corporation.
©2017 Thoratec Corporation.
Document: 10006960.C Publication Date: 12/2017

Contents
HeartMate II Left Ventricular Assist System Instructions for Use v
Preface- - - - - - - - - - - - - - - - - - - - - - - ix
1 Introduction - - - - - - - - - - - - - - - - - - - - 1-1
Understanding Warnings and Cautions - - - - - - - - - - - - - - - - - - - - 1-3
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-4
Indications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7
Contraindications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7
Adverse Events - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-7
Pre-Use Requirements- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-8
Equipment Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-9
Required, Backup, and Optional Components & Equipment - - - - - - - - - - 1-13
Principles of Operation- - - - - - - - - - - - - - - - - - - - - - - - - - - - - 1-15
Explanation of Parameters - - - - - - - - - - - - - - - - - - - - - - - - - - 1-17
2 System Operations - - - - - - - - - - - - - - - - - 2-1
HeartMate II Left Ventricular Assist Device Overview - - - - - - - - - - - - - 2-3
System Controller Overview - - - - - - - - - - - - - - - - - - - - - - - - - - 2-10
The Backup System Controller - - - - - - - - - - - - - - - - - - - - - - - - - 2-45
3 Powering the System - - - - - - - - - - - - - - - - 3-1
Power Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-3
Using the Power Module - - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-4
Using the Mobile Power Unit - - - - - - - - - - - - - - - - - - - - - - - - - - 3-30
Using HeartMate 14 Volt Lithium-Ion Batteries - - - - - - - - - - - - - - - - - 3-45
Switching Power Sources- - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-58
Battery Charger Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - 3-65
Charging HeartMate Batteries - - - - - - - - - - - - - - - - - - - - - - - - - 3-71
Calibrating HeartMate 14 Volt Lithium-Ion Batteries - - - - - - - - - - - - - - 3-74
Using the Charger to Check Battery Power - - - - - - - - - - - - - - - - - - 3-76
Care and Maintenance of the Battery Charger - - - - - - - - - - - - - - - - 3-77

Contents
vi HeartMate II Left Ventricular Assist System Instructions for Use
4 System Monitor - - - - - - - - - - - - - - - - - - - 4-1
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-3
System Monitor Setup - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-5
System Monitor Interface - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-9
Clinical Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-10
Settings Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-20
Alarms Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-29
Save Data Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-34
History Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-40
Admin Screen - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 4-42
5 Surgical Procedures - - - - - - - - - - - - - - - - - 5-1
Surgical Considerations - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-3
Equipment and Supplies Required for Implant - - - - - - - - - - - - - - - - - 5-5
Preimplant Procedures - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-7
Implant Procedures - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-24
Postimplant Procedures - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-44
Device Explant- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 5-49
6 Patient Care and Management - - - - - - - - - - - - 6-1
Postoperative Patient Care- - - - - - - - - - - - - - - - - - - - - - - - - - - 6-3
Ongoing Patient Assessment and Care - - - - - - - - - - - - - - - - - - - - 6-7
Unique Treatment Options and Important Clinical Considerations - - - - - - 6-10
Using the Shower Bag - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-14
Using the Stabilization Belt - - - - - - - - - - - - - - - - - - - - - - - - - - 6-24
Wearing and Carrying the System Components - - - - - - - - - - - - - - - 6-27
Preparing for Sleep - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6-62
Ongoing System Assessment and Care - - - - - - - - - - - - - - - - - - - - 6-64
Educating and Training Patients, Families, and Caregivers - - - - - - - - - - 6-67
7 Alarms and Troubleshooting - - - - - - - - - - - - - 7-1
System Controller Alarms - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-3
Power Module Alarms - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-25
Mobile Power Unit Alarms- - - - - - - - - - - - - - - - - - - - - - - - - - - 7-28
Battery Charger Alarms - - - - - - - - - - - - - - - - - - - - - - - - - - - - 7-30
Guidelines for Power Cable Connectors- - - - - - - - - - - - - - - - - - - - 7-33
What Not To Do: Driveline and Cables - - - - - - - - - - - - - - - - - - - - 7-34

Contents
HeartMate II Left Ventricular Assist System Instructions for Use vii
8 Equipment Storage and Care - - - - - - - - - - - - 8-1
Storage and Transport - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-3
Cleaning and Maintenance - - - - - - - - - - - - - - - - - - - - - - - - - - 8-4
Product Disposal - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8-9
A Summary of Clinical Studies - - - - - - - - - - - - A-1
Post-Approval Overview of Risk of Thrombosis- - - - - - - - - - - - - - - - - A-59
B Technical Specifications - - - - - - - - - - - - - - - B-1
C HeartMate II Product List - - - - - - - - - - - - - - C-1
D Safety Testing and Classification - - - - - - - - - - D-1
E Symbols - - - - - - - - - - - - - - - - - - - - - - E-1
F Safety Checklists - - - - - - - - - - - - - - - - - - F-1
G Conversion Patients - - - - - - - - - - - - - - - - G-1
H Survey - - - - - - - - - - - - - - - - - - - - - - H-1
Glossary - - - - - - - - - - - - - - - - - - - Glossary-1
Index - - - - - - - - - - - - - - - - - - - - - Index-1

HeartMate II Left Ventricular Assist System Instructions for Use ix
Preface
This manual contains information needed to properly and safely operate the HeartMate II®
Left Ventricular Assist System. Users of the HeartMate II Left Ventricular Assist System should
have a practical knowledge of the principles of mechanical circulatory support and should
be aware of the physiological and psychological needs of a patient undergoing
mechanical ventricular support. New users should read this document in its entirety, before
system operation. For experienced practitioners, this manual may serve as a reference.
As with all prescription medical devices, clinical procedures should be conducted under the
direction of the prescribing physician. The professional staff at Thoratec regularly provides
laboratory training and on-site, in-service programs. Additional training materials are
available for independent learning.

1
HeartMate II Left Ventricular Assist System Instructions for Use 1-1
INTRODUCTION
This section provides an introduction to the HeartMate II Left Ventricular Assist System.
Understanding Warnings and Cautions - - - - - - - - - - - - - - - -1-3
Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1-4
Indications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1-7
Contraindications - - - - - - - - - - - - - - - - - - - - - - - - - - - -1-7
Adverse Events - - - - - - - - - - - - - - - - - - - - - - - - - - - - -1-7
Pre-Use Requirements - - - - - - - - - - - - - - - - - - - - - - - - - -1-8
Equipment Overview - - - - - - - - - - - - - - - - - - - - - - - - - -1-9
Required, Backup, and Optional Components & Equipment - - - - - 1-13
Principles of Operation - - - - - - - - - - - - - - - - - - - - - - - - 1-15
Explanation of Parameters - - - - - - - - - - - - - - - - - - - - - - 1-17

Introduction 1
HeartMate II Left Ventricular Assist System Instructions for Use 1-3
Understanding Warnings and Cautions
Warnings refer to actions or hazardous conditions that could cause serious injury or death
if not avoided. Ignoring a warning can cause sudden and serious injury, life-threatening
harm, or death for the user or patient.
Cautions refer to actions or potentially unsafe conditions that may cause injury, damage the
equipment, or affect how the system works. Ignoring a caution can cause patient or user
injury, or result in equipment failure or sub-optimal system operation. Although important
for maximum safety and optimal system function, usually cautions do not refer to
life-threatening risks.
In this manual, warnings and cautions that are relevant to a specific procedure or piece of
equipment appear at the start of each applicable section.
WARNING !
Warnings appear in the manual in this format.
CAUTION !
Cautions appear in the manual in this format.

1Introduction
1-4 HeartMate II Left Ventricular Assist System Instructions for Use
Overview
The HeartMate II Left Ventricular Assist System is an axial-flow, rotary ventricular assist
system that generates flows up to 10 liters per minute (lpm). One end of the Left Ventricular
Assist Device is attached to the apex of the left ventricle; the other end of the device
connects to the ascending aorta. The Left Ventricular Assist Device diverts blood from the
weakened left ventricle and propels it to the aorta.
A small external computer, the System Controller, monitors system operation. A driveline,
which passes through the patient’s abdomen, connects the implanted pump to the System
Controller. The system is powered by a Power Module or Mobile Power Unit that is
connected to an AC electrical outlet, or by two HeartMate 14 Volt Lithium-Ion batteries.
Figure 1.1 shows the HeartMate II system during
battery-powered operation.
The HeartMate II Left Ventricular Assist Device
(frequently called the “pump”), is capable of
pumping the entire output delivered to the left
ventricle from the pulmonary circulation.
Improvement in right heart function is common
following pump implant. However, high
pulmonary vascular resistance may limit blood
flow. As a result, patients who develop right heart
dysfunction may require short-term pharmacologic
support and/or a period of right-side circulatory
support (see Postoperative Patient Care on page
6-3).
Figure 1.1 HeartMate II System During
Battery-Powered Operation

Introduction 1
HeartMate II Left Ventricular Assist System Instructions for Use 1-5
WARNING !
• A thorough understanding of the technical principles, clinical applications, and risks
associated with left ventricular support is necessary before using the HeartMate II Left
Ventricular Assist System. Read this entire manual before attempting implantation of
the Left Ventricular Assist Device or before caring for HeartMate II patients.
Completion of Thoratec’s HeartMate II Surgical Training Program is also required
prior to use.
• Understanding the operating and safety aspects of the HeartMate II Left Ventricular
Assist System is critical for safe and successful use.
• All users, including clinicians, patients, and caregivers, must be trained on system
operation and safety before use.
• All users, including clinicians, patients, and caregivers, must be trained on any
HeartMate II power accessories (Power Module, Mobile Power Unit, Battery
Charger, or HeartMate 14 Volt Lithium-Ion batteries) before use.
• Do not use the HeartMate II Left Ventricular Assist Device in pregnant women or in
women likely to become pregnant. A growing fetus may dislodge the pump, which
may result in device failure, catastrophic bleeding, or death. Instruct women of
childbearing age to use reliable contraception if sexually active. Blood thinners have
been associated with birth defects. Anticoagulation regimens are contraindicated
during pregnancy.
• Certain parts of the HeartMate II Left Ventricular Assist System are not compatible
with other HeartMate systems (such as the XVE Left Ventricular Assist System). Only
use HeartMate II parts with the HeartMate II system.
• No modification of this equipment is allowed. Do not use equipment or supplies
other than those specified or sold by Thoratec Corporation.
• Do not modify this equipment without authorization from Thoratec Corporation. The
use of unauthorized replacement parts may affect the electromagnetic compatibility
of the Mobile Power Unit with other devices. Potential interference may occur
between the Mobile Power Unit and other devices.
• Do not try to repair any of the HeartMate II system components. If components need
service, contact appropriate personnel.

1Introduction
1-6 HeartMate II Left Ventricular Assist System Instructions for Use
CAUTION !
• Notify appropriate personnel if there is a change in how the pump works, sounds,
or feels.
• Counsel the patient to avoid contact sports and jumping activities while implanted
with the pump. Contact sports or jumping can cause bleeding or damage the pump.
• Care should be taken when small children or pets are present. There is a potential
for strangulation from the system’s cables.
• If HeartMate II patients are approved for showering, they must always use the
Shower Bag. When installed properly, the Shower Bag protects external system
components from water or moisture. If external system components have contact
with water or moisture, the pump may stop. See Using the Shower Bag on page
6-14 for detailed instructions on using the Shower Bag.

Introduction 1
HeartMate II Left Ventricular Assist System Instructions for Use 1-7
Indications
The HeartMate II Left Ventricular Assist System is indicated for use as a “bridge to
transplantation” for cardiac transplant candidates who are at risk of imminent death from
non-reversible left ventricle failure. It is also indicated for use in patients with New York
Heart Association (NYHA) Class IIIB or IV end-stage left ventricular failure, who have
received optimal medical therapy for at least 45 of the last 60 days, and who are not
candidates for cardiac transplantation. The HeartMate II Left Ventricular Assist System is
intended for use both inside and outside of the hospital, or for transportation of Left
Ventricular Assist Device patients via ground ambulance, airplane, or helicopter.
Contraindications
The HeartMate II Left Ventricular Assist System is contraindicated for patients who cannot
tolerate, or who are allergic to, anticoagulation therapy.
Adverse Events
Adverse events that may be associated with the use of the HeartMate II Left Ventricular
Assist System are listed below. Adverse events are listed in decreasing order of frequency,
except for death, which appears first because it is a non-reversible complication:
•Death
• Bleeding (perioperative or late)
• Cardiac arrhythmia
• Local infection
• Respiratory failure
• Device malfunction
•Sepsis
• Right heart failure
• Driveline or pump pocket infection
•Renalfailure
•Stroke
•Neurologicdysfunction
• Psychiatric episode
• Peripheral thromboembolic event
•Hemolysis

1Introduction
1-8 HeartMate II Left Ventricular Assist System Instructions for Use
• Hepatic dysfunction
• Device thrombosis
• Myocardial infarction
Pre-Use Requirements
A thorough understanding of the technical principles, clinical applications, and risks
associated with left ventricular support is required before using the HeartMate II Left
Ventricular Assist System.
It is suggested that patients possess a minimum 5th grade educational level and shall be
versed in basic computer literacy (ie, Microsoft®Windows®and Office software).
This manual contains important warnings, cautions, and instructions for use. Read this
entire manual before implanting a HeartMate II Left Ventricular Assist Device or before
caring for HeartMate II patients. Completion of Thoratec’s HeartMate II Surgical Training
Program is also required.
If you have questions after reading this manual, please contact Thoratec Corporation for
assistance. See Thoratec contact information on page iii.