Abbott Heartmate 3 User manual

H E A R T M A T E 3 ™
LEFT VENTRICULAR
ASSIST DEVICE
(LVAD)
PATIENT GUIDE
VIVIAN
HeartMate 3™LVAD
Recipient

QUICK START GUIDE
This patient guide is for using the HeartMate 3™ Left Ventricular Assist
Device (LVAD) that both the patient and caregiver will need to be
familiar with upon hospital discharge. Although most of the procedures
can be performed by the patient, a caregiver’s assistance will be needed
in some cases. For more detailed information about monitoring and
maintaining the equipment, consult the complete HeartMate 3™ Left
Ventricular Assist System Patient Handbook.
WARNINGS AND CAUTIONS
Review all the warnings and cautions in the HeartMate 3 Left
Ventricular Assist System Patient Handbook.
WARNINGS refer to actions or hazardous conditions that could cause
serious injury or death.
CAUTIONS refer to actions or potentially unsafe conditions that are
usually not life-threatening risks but may cause injury, damage the
equipment or aect how the system works.

TABLE OF CONTENTS
The HeartMate 3™ LVAD System.................................................... 5
What Should I Know Prior to Hospital Discharge?..................... 6
SYSTEM CONTROLLER
Overview ............................................................................................... 9
Buttons and User Interface Screen................................................ 10
User Interface Screen Display..........................................................11
Lighted Symbols ................................................................................ 12
Alarms.................................................................................................. 14
Changes to Backup System Controller — Multiple Sources......18
Changes to Backup System Controller — Single Source ...........20
Perform a Controller Self Test........................................................22
Driveline Exit Site Care and Stabilization.................................... 23
Backup Battery...................................................................................24
Charging the Backup Battery..........................................................25
POWERING THE SYSTEM
14 V Lithium-ion Batteries............................................................... 27
Universal Battery Charger...............................................................28
Battery Charger Display Messages................................................29
Mobile Power Unit (MPU) Overview............................................30
Switching Power Sources .................................................................31
MPU Alarms and Troubleshooting ............................................... 32
ACCESSORIES ............................................................................... 35

3
2
1
4
4

The HeartMate 3™ LVAD System | 5
5
6
THE HEARTMATE 3™ LVAD SYSTEM
1. HEART PUMP
Connects to the left side of your heart
and moves blood from your heart to the
rest of your body.
2. DRIVELINE: PAGE 23
Transfers power and information between
the controller and the heart pump.
3. SYSTEM CONTROLLER: PAGE 9
Powers and checks the pump and driveline.
The controller uses alerts to tell you how the
system is working and includes 15 minutes of
emergency backup power.
4. BATTERIES AND BATTERY CLIPS: PAGE 27
Powers the system when you are active or
outdoors. You always need to use two batteries
at a time.
5. BATTERY CHARGER: PAGE 28
Charges up to four 14 V lithium-ion batteries at
a time and measures battery charge status.
6. MOBILE POWER UNIT (MPU): PAGE 30
Provides power to the System Controller and
pump. Echoes System Controller alarms.

6 | The HeartMate 3™ LVAD System
• How to switch the power sources, from MPU to
battery to MPU
• How to change the batteries
• How to recharge the batteries
• How to calibrate the batteries
• How to care for the driveline exit site
• How to change the internal MPU battery
• How to change to the backup System Controller
(in case of an emergency)
IMPORTANT:
Be sure to keep a backup System Controller and
charged batteries with you at all times for use in case
of an emergency.
THE HEARTMATE 3™ LVAD SYSTEM:
WHAT SHOULD I KNOW
PRIOR TO HOSPITAL DISCHARGE?

The HeartMate 3™ LVAD System | 7
NOTES

8 | System Controller
SYSTEM CONTROLLER

5
2
System Controller | 9
SYSTEM CONTROLLER: OVERVIEW
The System Controller is a small computer
that controls and checks system information.
It is connected to the pump via the driveline.
It is used to control and respond to system
operation. It identifies and warns of any
problems in the system operation.
The System Controller consists of control
buttons, lighted symbols and a user
interface screen.
1. POWER SOURCE CONNECTIONS
2. DRIVELINE CONNECTION
3. CONTROL BUTTONS
a. Battery button
b. Display button
c. Silence alarm button
4. LIGHTED SYMBOLS
a. Cable disconnect symbols
b. Status symbols
c. Pump running symbol
5. USER INTERFACE SCREEN
4a 4b 4c3a
3c
3b
1

10 | System Controller
1
SYSTEM CONTROLLER:
BUTTONS AND USER INTERFACE SCREEN
1. BATTERY BUTTON
• Displays the battery power
(press and release).
• Tests the controller (press and hold
for 5 seconds).
• Puts the controller into sleep mode
(press and hold for 5 seconds when
nothing is connected to the controller).
2. DISPLAY BUTTON
Activates the user interface screen
(press and release) to display information
about system operation.
3. SILENCE ALARM BUTTON
• Silences an active alarm (press and release).
• Displays previous alarms (press and
release the silence alarm and display
buttons simultaneously).
4. USER INTERFACE SCREEN
Displays information including pump speed,
pump flow, pulsatility index, power and
charge status of the backup battery.
3
2
4

System Controller | 11
SYSTEM CONTROLLER:
USER INTERFACE SCREEN DISPLAY
DISPLAY BUTTON
ACTIONS
SCREEN DISPLAYED
(EXAMPLE) MEANING
Press ONCE Pump speed in revolutions per minute
Press SECOND time Pump flow in liters per minute
Press THIRD time Pulsatility index
Press FOURTH time Power in watts
Press FIFTH time The System Controller’s backup battery (located
inside the System Controller and used to temporarily
run the pump during an emergency) has three
charge status states:
1. Charged (ready for use)
2. Charging (actively charging)
Press SIXTH time Blank user interface screen indicates the screen is o,
which is normal

12 | System Controller
RED LIGHT
Near the driveline connector comes on when the
driveline is not well connected with or is disconnected
from the System Controller.
YELLOW LIGHT
Near the white or black power cables comes on when a
power cable is not well connected with or is disconnected
from the System Controller.
SYSTEM CONTROLLER:
LIGHTED SYMBOLS
The System Controller provides information about the system’s functioning using lighted symbols
on the device. The symbols indicate when the pump is running or when there’s a problem with the
pump’s functioning that needs immediate attention. Other symbols indicate remaining battery power,
problems with the connections to the power cable or driveline, or other issues with the system.

System Controller | 13
BATTERY CAPACITY LIGHT
4 green lights = Approximately 75%–100% of power remains
3 green lights = Approximately 50%–75% of power remains
2 green lights = Approximately 25%–50% of power remains
1 green light = Less than 25% of power remains
Yellow diamond only = Less than 15 minutes of power remains
PUMP RUNNING LIGHT
Stays lit green as long as the LVAD is running.
HAZARD ALARM
When the red heart symbol comes on, follow the on-screen
instructions. Do this immediately.
YELLOW WRENCH
Lights up yellow when the System Controller detects a
mechanical, electrical or software issue with the system.
LOW BATTERY ALERT
Less than 5 minutes of battery power remain. Immediately
replace used batteries with fully charged batteries or switch
to the MPU.
SYSTEM CONTROLLER:
LIGHTED SYMBOLS

14 | System Controller
SYSTEM
CONTROLLER
SCREEN
ACTIVE
SYMBOLS ALARM MEANS TO RESOLVE ALARM
One of two
power cables is
disconnected
1. Promptly connect the disconnected
power cable to the power source
(functioning MPU or two fully charged
HeartMate 3™ LVAD 14 V lithium-ion
batteries).
2. If alarm persists, call your hospital
contact.
Low battery, power
input is low, with
less than 15 minutes
remaining
1. Promptly connect to a working or
dierent power source (MPU or two
fully charged HeartMate 3 LVAD 14 V
lithium-ion batteries).
2. If alarm persists, call your hospital
contact.
System Controller
hardware fault
Call your hospital contact as soon as
possible for diagnosis and instructions.
ADVISORY
OR
SYSTEM CONTROLLER: ALARMS
System Controller advisory and hazard alarms are messages that appear on the user interface screen when
some problem with the system needs immediate attention. Some of the alarms indicate problems you can
address yourself (for example, a disconnected power cable that you should reconnect). But most instruct
you to call your hospital contact for instructions.

System Controller | 15
SYSTEM CONTROLLER: ALARMS
SYSTEM
CONTROLLER
SCREEN
ACTIVE
SYMBOLS ALARM MEANS TO RESOLVE ALARM
System Controller
backup battery fault
Call your hospital contact as soon as possible
for diagnosis and instructions.
System Controller
backup battery
not installed
Call your hospital contact as soon as possible
for diagnosis and instructions.
IMPORTANT: The pump running symbol is always lit green when the pump is running.
ADVISORY

16 | System Controller
SYSTEM
CONTROLLER
SCREEN
ACTIVE
SYMBOLS ALARM MEANS TO RESOLVE ALARM
Pump is o.
The pump running
symbol is black.
1. Immediately connect to a working power
source (MPU or two fully charged
HeartMate 3™ LVAD 14 V lithium-ion
batteries).
2. If connecting to a power source does not resolve
the problem, press any button on the System
Controller to attempt a pump start and call your
hospital contact immediately.
Pump has stopped
running. MPU
power has failed
possibly due to static
electricity.
1. Immediately connect to HeartMate 3 LVAD
14 V lithium-ion batteries.
2. If restoring power does not resolve, press any
button on the System Controller to attempt
pump start.
Driveline is
disconnected.
The pump running
symbol is black.
1. Immediately reconnect the driveline to the System
Controller and move the driveline safety tab on the
System Controller to the locked position.
2. If alarm persists after reconnecting the driveline,
press any button on the System Controller to
potentially resolve.
3. If driveline is connected and alarm persists,
replace System Controller with a programmed
backup System Controller.
4. If alarm persists, call your hospital
contact immediately.
HAZARD
SYSTEM CONTROLLER: ALARMS

System Controller | 17
HAZARD
SYSTEM
CONTROLLER
SCREEN
ACTIVE
SYMBOLS ALARM MEANS TO RESOLVE ALARM
Both power cables
are disconnected.
1. Immediately connect to a working
power source (MPU or two fully charged
HeartMate 3™ LVAD 14 V lithium-ion
batteries).
2. If alarm persists, call your hospital
contact immediately.
Low flow: Flow is
less than 2.5 liters
per minute.
Call your hospital contact immediately for
diagnosis and instructions.
Low voltage: Power
input is extremely
low, with less
than 5 minutes
remaining.
1. Immediately connect to a working power
source (MPU or two fully charged
HeartMate 3 LVAD 14 V lithium-ion batteries).
2. If alarm persists, call your hospital
contact immediately.
SYSTEM CONTROLLER: ALARMS

18 | System Controller
SYSTEM CONTROLLER: CHANGES TO BACKUP
SYSTEM CONTROLLER — MULTIPLE SOURCES
Replace the running System Controller with the backup controller and multiple available power sources.
1. SET UP
This procedure will require assistance
from a caregiver.
1. Place the backup System Controller
within reach.
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.
Always contact your LVAD center before
changing System Controllers.
2. Ensure the patient is sitting or lying down,
as he or she may get dizzy if the pump
stops briefly.
3. Unlock the driveline safety tab for both
controllers (see the image below).

System Controller | 19
SYSTEM CONTROLLER: CHANGES TO BACKUP
SYSTEM CONTROLLER — MULTIPLE SOURCES
2. REPLACE SYSTEM
CONTROLLER
Important: Keep the running System Controller
connected to power.
1. Connect the white and black connectors on
the backup System Controller to power.
2. Promptly move the driveline from the
running controller to the backup controller
(see steps A–C below).
3. Make sure that the green pump running
symbol on the backup System Controller
is illuminated.
Replace the running System Controller with the backup controller and multiple available power sources.
3. FINISH
1. Put the old, replaced System Controller into
sleep mode by disconnecting from the power,
and then pressing and holding the battery
button for 5 seconds.
2. Do not use the old System Controller ever again.
To request a new backup System Controller
and for instructions on returning the old one,
contact the hospital.
A. Align the driveline arrow/alignment mark with
the arrow on the controller.
C. Slide the safety tab over the red button.
B. Push the red button and firmly insert the
driveline until it snaps into place.
Important: If the safety tab does not slide fully
over the red button, the driveline is not connected.
Disconnect the driveline and reconnect it.

20 | System Controller
SYSTEM CONTROLLER: CHANGES TO BACKUP
SYSTEM CONTROLLER — SINGLE SOURCE
Replace the running System Controller with the backup controller and a single available power source
(exchange while on MPU or batteries only).
1. SET UP
This procedure will require assistance from
a caregiver.
1. Place the backup System Controller
within reach.
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.
Always contact your LVAD center before
changing System Controllers.
2. Ensure the patient is sitting or lying down,
as he or she may get dizzy if the pump
stops briefly.
3. Unlock the driveline safety tab for both
controllers (see the image below).