Heartmate 3™ Left Ventricular Assist Device (LVAD) : Patient Guide

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HE A RTM AT E 3™

LEF T VENTRICUL AR
ASSIST DEVICE
( LVA D)
PATIE NT G U ID E

VIVIAN
HeartMate 3™ LVAD
Recipient
Q U I C K S TA R T G U I D E
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.

WA R N I N G S A N D C A U T I O N S
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.

C AUTIONS refer to actions or potentially unsafe conditions that are


usually not life-threatening risks but may cause injury, damage the
equipment or affect how the system works.
TA B L E O F C O N T E N T S
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
1
4

2 4

3
THE HEARTMATE 3™ LVAD SYSTEM

1. HEART PUMP 4. BATTERIES AND BATTERY CLIPS: PAGE 27


Connects to the left side of your heart Powers the system when you are active or
and moves blood from your heart to the outdoors. You always need to use two batteries
rest of your body. at a time.

2. DRIVELINE: PAGE 23
Transfers power and information between 5. BAT TERY CHARGER: PAGE 28
the controller and the heart pump. Charges up to four 14 V lithium-ion batteries at
a time and measures battery charge status.
3. SYSTEM CONTROLLER: PAGE 9
Powers and checks the pump and driveline. 6. MOBILE POWER UNIT (MPU): PAGE 30
The controller uses alerts to tell you how the Provides power to the System Controller and
system is working and includes 15 minutes of pump. Echoes System Controller alarms.
emergency backup power.

The HeartMate 3™ LVAD System | 5


THE HEARTMATE 3™ LVAD SYSTEM:
WHAT SHOULD I KNOW
PRIOR TO HOSPITAL DISCHARGE?

• 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.

6 | The HeartMate 3™ LVAD System


NOTES

The HeartMate 3™ LVAD System | 7


S YSTEM CONTROLLER

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

5. USER INTERFACE SCREEN

4a 4b 3a 4c 3b

2 3c

System Controller | 9
SYSTEM CONTROLLER:
BUTTONS AND USER INTERFACE SCREEN

1. BAT TERY BUTTON 3. SILENCE AL ARM BUT TON


• Displays the battery power • Silences an active alarm (press and release).
(press and release). • Displays previous alarms (press and
• Tests the controller (press and hold release the silence alarm and display
for 5 seconds). buttons simultaneously).
• Puts the controller into sleep mode
4. USER INTERFACE SCREEN
(press and hold for 5 seconds when
Displays information including pump speed,
nothing is connected to the controller).
pump flow, pulsatility index, power and
2. DISPL AY BUT TON charge status of the backup battery.
Activates the user interface screen
(press and release) to display information
about system operation.

3
10 | System Controller
SYSTEM CONTROLLER:
USER INTERFACE SCREEN DISPL AY
DISPLAY BUTTON SCREEN DISPLAYED
ACTIONS (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 off,
which is normal

System Controller | 11
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.

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.

RED LIGHT
Near the driveline connector comes on when the
driveline is not well connected with or is disconnected
from the System Controller.

12 | System Controller
SYSTEM CONTROLLER:
LIGHTED SYMBOLS

PUMP RUNNING LIGHT


Stays lit green as long as the LVAD is running.

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

LOW BATTERY ALERT


Less than 5 minutes of battery power remain. Immediately
replace used batteries with fully charged batteries or switch
to the MPU.

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.

System Controller | 13
SYSTEM CONTROLLER: AL ARMS
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.

ADVISORY
SYSTEM
CONTROLLER ACTIVE
SCREEN SYMBOLS ALARM MEANS TO RESOLVE ALARM

One of two 1. Promptly connect the disconnected


power cables is power cable to the power source
disconnected (functioning MPU or two fully charged
OR HeartMate 3™ LVAD 14 V lithium-ion
batteries).
2. If alarm persists, call your hospital
contact.

Low battery, power 1. Promptly connect to a working or


input is low, with different power source (MPU or two
less than 15 minutes fully charged HeartMate 3 LVAD 14 V
remaining lithium-ion batteries).
2. If alarm persists, call your hospital
contact.

System Controller Call your hospital contact as soon as


hardware fault possible for diagnosis and instructions.

14 | System Controller
SYSTEM CONTROLLER: AL ARMS
ADVISORY
SYSTEM
CONTROLLER ACTIVE
SCREEN SYMBOLS ALARM MEANS TO RESOLVE ALARM

System Controller Call your hospital contact as soon as possible


backup battery fault for diagnosis and instructions.

System Controller Call your hospital contact as soon as possible


backup battery for diagnosis and instructions.
not installed

IMPORTANT: The pump running symbol is always lit green when the pump is running.

System Controller | 15
SYSTEM CONTROLLER: AL ARMS
HAZARD
SYSTEM
CONTROLLER ACTIVE
SCREEN SYMBOLS ALARM MEANS TO RESOLVE ALARM

Pump is off. 1. Immediately connect to a working power


source (MPU or two fully charged
The pump running
HeartMate 3™ LVAD 14 V lithium-ion
symbol is black.
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 1. Immediately connect to HeartMate 3 LVAD


running. MPU 14 V lithium-ion batteries.
power has failed
2. If restoring power does not resolve, press any
possibly due to static
button on the System Controller to attempt
electricity.
pump start.

Driveline is 1. Immediately reconnect the driveline to the System


disconnected. Controller and move the driveline safety tab on the
System Controller to the locked position.
The pump running
symbol is black. 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.

16 | System Controller
SYSTEM CONTROLLER: AL ARMS
HAZARD
SYSTEM
CONTROLLER ACTIVE
SCREEN SYMBOLS ALARM MEANS TO RESOLVE ALARM

Both power cables 1. Immediately connect to a working


are disconnected. 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 Call your hospital contact immediately for


less than 2.5 liters diagnosis and instructions.
per minute.

Low voltage: Power 1. Immediately connect to a working power


input is extremely source (MPU or two fully charged
low, with less HeartMate 3 LVAD 14 V lithium-ion batteries).
than 5 minutes
2. If alarm persists, call your hospital
remaining.
contact immediately.

System Controller | 17
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 2. Ensure the patient is sitting or lying down,
from a caregiver. as he or she may get dizzy if the pump
stops briefly.
1. Place the backup System Controller
within reach. 3. Unlock the driveline safety tab for both
controllers (see the image below).

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.

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.

2. REPL ACE SYSTEM


CONTROLLER
Important: Keep the running System Controller 2. Promptly move the driveline from the
connected to power. running controller to the backup controller
(see steps A–C below).
1. Connect the white and black connectors on
the backup System Controller to power. 3. Make sure that the green pump running
symbol on the backup System Controller
is illuminated.

A. Align the driveline arrow/alignment mark with B. Push the red button and firmly insert the
the arrow on the controller. driveline until it snaps into place.

C. Slide the safety tab over the red button. Important: If the safety tab does not slide fully
over the red button, the driveline is not connected.
Disconnect the driveline and reconnect it.

3. FINISH 2. Do not use the old System Controller ever again.


To request a new backup System Controller
1. Put the old, replaced System Controller into
and for instructions on returning the old one,
sleep mode by disconnecting from the power,
contact the hospital.
and then pressing and holding the battery
button for 5 seconds.

System Controller | 19
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 2. Ensure the patient is sitting or lying down,
a caregiver. as he or she may get dizzy if the pump
stops briefly.
1. Place the backup System Controller
within reach. 3. Unlock the driveline safety tab for both
controllers (see the image below).

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.

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.

2. REPL ACE SYSTEM


CONTROLLER
1. Move the white connector’s power source 3. Make sure that the green pump running
from the running controller to the backup symbol on the backup controller is
System Controller. illuminated.
2. Promptly move the driveline from the 4. Move the black connector’s power source
running controller to the backup controller from the running System Controller to the
(see steps A–C below). backup controller.

A. Align the driveline arrow/alignment mark with B. Push the red button and firmly insert the
the arrow on the controller. driveline until it snaps into place.

C. Slide the safety tab over the red button. Important: If the safety tab does not slide fully
over the red button, the driveline is not connected.
Disconnect the driveline and reconnect it.

3. FINISH 2. Do not use the old System Controller ever again.


To request a new backup System Controller
1. Put the old, replaced System Controller into
and for instructions on returning the old one,
sleep mode by disconnecting from the power,
contact the hospital.
and then pressing and holding the battery
button for 5 seconds.

System Controller | 21
SYSTEM CONTROLLER: PERFORM A
CONTROLLER SELF TEST

Perform a System Controller self test every day 3. Release the battery button . All the
to check the audible and visual alarm indicators audible indicators/lights should remain
on the user interface. The System Controller self on for 15 seconds, after which the audible
test is a loud, bright function. All the audible and indicators/lights stop, the screen goes
visual indicators should come on and “Self Test” black and the self test is complete.
should appear on the screen.

To perform a System Controller self test:

1. Press and hold the battery button for IMPORTANT:


5 seconds.
If an alarm occurs during a self test, the self test
2. Check that: terminates and the alarm’s on-screen indicator
• “Self Test” appears on the screen. remains active. A System Controller self test
cannot be initiated during the following alarms:
• All symbols and indicators on the user
any hazard alarm, power cable disconnected
interface illuminate at the same time.
advisory alarm or low battery power advisory alarm.
• System Controller is making a loud, steady,
audible alarm tone.

22 | System Controller
SYSTEM CONTROLLER: DRIVELINE EXIT SITE
CARE AND STABILIZATION
It is very important to keep the driveline exit site center, should be used at all times. The driveline
(where the driveline goes through the skin) clean management system should consist of a dressing
and dry at all times. Keeping the exit site clean and and stabilizer.
dry lowers your risk for infection. After leaving the
If you notice any signs of infection, call your
hospital, you are responsible for caring for the exit
hospital contact right away. Do not wait!
site. Be sure to always follow the steps provided
Early treatment makes a difference.
by your nurse or hospital contact. A driveline
management system, supplied by the implanting
SYSTEM CONTROLLER: BACKUP BATTERY

An 11 V lithium-ion backup battery inside the The System Controller’s backup battery will be
System Controller provides at least 15 minutes charged once external power is connected
of backup power to the LVAD if the in-use power to the System Controller (batteries or MPU).
source is disconnected or fails.

WARNING:
The 11 V lithium-ion backup battery should be
used only for temporary support during a power-
loss emergency. Inappropriate use of this backup
battery may result in diminished run time during
a power-loss emergency.

24 | System Controller
SYSTEM CONTROLLER: CHARGING THE
BACKUP BATTERY
Charge the backup battery inside the backup
System Controller.

1. Connect the backup System Controller to a


power source (MPU or two HeartMate 3™
LVAD 14 V lithium-ion batteries).

2. When the System Controller is connected


to power, the user interface screen displays
“Charging” or “Charging Complete.”

3. When charging is complete, perform a self test


on the backup System Controller (press and
hold the battery button for 5 seconds).

4. Disconnect power from the backup System


Controller. Place the backup System Controller
back in the protective case. No further action is
needed for 6 months.

CAUTION:
The 11 V lithium-ion backup battery inside the
backup System Controller must be charged once
every 6 months.

IMPORTANT:
Do not remove power until “Charging
Complete” is displayed. It can take
up to 3 hours to charge the System
Controller’s backup battery.

System Controller | 25
POWERING
THE SYS TEM

26 | Powering the System


POWERING THE SYSTEM:
14 V LITHIUM-ION BATTERIES
The HeartMate 3™ LVAD uses 14 V lithium-ion batteries that provide up to 17 hours of support. They require
4 hours to charge. Five lights on each battery indicate the amount of power remaining in the battery.

Align arrows Release button

Battery clip

Battery

SUPPORT TIME
10–17 hours
CHARGING TIME
4 hours

NUMBER OF LIGHTS
ILLUMINATED MEANING

5 lights Approximately 80%–100% of power remains

4 lights Approximately 60%–80% of power remains

3 lights Approximately 40%–60% of power remains

2 lights Approximately 20%–40% of power remains

1 light steady Approximately 10%–20% of power remains

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


1 light blinking has one blinking light. The HeartMate 3 LVAD System Controller will
indicate a power advisory

Powering the System | 27


POWERING THE SYSTEM:
UNIVERSAL BATTERY CHARGER

BATTERY CHARGER
DISPL AY

Slot number and


LED indicators

LED INDICATORS
LED LIGHT COLOR STATUS/MEANING

Green Battery is charged and ready for use.

Yellow Battery is undergoing test, charging or calibration.

Yellow blinking Battery requires calibration cycle (see the example on the next page).

Red Battery or charging system is defective. DO NOT USE BATTERY.

28 | Powering the System


POWERING THE SYSTEM:
BATTERY CHARGER DISPL AY MESSAGES

MESSAGES GENERATED BY PRESSING THE SLOT NUMBER


Available power Cycle count and charger capacity

AUTOMATIC MESSAGES
Call hospital for service

For example, slot 4 Press 4 Calibration is in progress


needs calibration for 12 hours

Powering the System | 29


POWERING THE SYSTEM:
MOBILE POWER UNIT (MPU) OVERVIEW

The MPU plugs into an AC outlet to provide power 2. AC POWER RECEPTACLE


to the HeartMate 3™ LVAD System and is used For plugging unit into AC power outlet.
while indoors, stationary or sleeping. The MPU
transfers power to the System Controller through 3. STATUS SYMBOLS
the patient cable. Provide information about the system status.

1. SPEAKERS 4. PATIENT CABLE


Sound alarm in case of system problems that Connects to the System Controller to
need attention. transfer power.

4
2

30 | Powering the System


POWERING THE SYSTEM:
SWITCHING POWER SOURCES

FROM MPU TO BATTERIES

FROM BATTERIES TO MPU

CONNECT
Black to black
White to white

Powering the System | 31


POWERING THE SYSTEM:
MPU AL ARMS AND TROUBLESHOOTING

ADVISORY

STATUS SYMBOLS ALARM MEANS TO RESOLVE ALARM


Internal fault 1. Promptly connect to two fully charged
HeartMate 3™ LVAD 14 V lithium-ion batteries.
2. Call your hospital contact as soon as
possible for diagnosis and instructions.

Replace MPU batteries Replace the AA batteries


in the MPU.

CHANGING THE ALK ALINE A A BATTERIES


1. Loosen the screw from the rear panel. 2. Open the battery compartment and pull the red
ribbon to remove the batteries.

3. Place the alkaline AA batteries in the compartment. 4. Close the compartment and tighten the screw.

32 | Powering the System


NOTES

Powering the System | 33


ACCESSORIES

34 | Accessories
ACCESSORIES

Shower Bag
Keeps the controller and the batteries
dry when you shower.

Battery Holster
Allows the batteries to be carried
in shoulder straps.

Consolidated Bag Belt Attachment Holster Vest


Holds both the controller and the An alternative way of wearing A mesh vest that carries the
batteries in one bag. the controller. batteries and spreads their weight
across the torso.

Accessories | 35
Abbott
One St. Jude Medical Dr., St. Paul, MN 55117 USA, Tel: 1 651 756 2000
HeartMate3.com

Rx Only
Important Safety Information
Brief Summary: Prior to using these devices, review the Instructions for Use for a complete listing of indications,
contraindications, warnings, precautions, potential adverse events and directions for use.

Indications: The HeartMate 3™ Left Ventricular Assist System is indicated for providing short- and long-term
mechanical circulatory support (e.g., as bridge to transplant or myocardial recovery, or destination therapy) in
patients with advanced refractory left ventricular heart failure.

Contraindications: The HeartMate 3 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 3 Left Ventricular Assist
System are: death, bleeding, cardiac arrhythmia, localized infection, right heart failure, respiratory failure, device
malfunctions, driveline infection, renal dysfunction, sepsis, stroke, other neurological event (not stroke-related),
hepatic dysfunction, psychiatric episode, venous thromboembolism, hypertension, arterial non-central nervous
system (CNS) thromboembolism, pericardial fluid collection, pump pocket or pseudo pocket infection, myocardial
infarction, wound dehiscence, hemolysis (not associated with suspected device thrombosis) or device thrombosis.

™ Indicates a trademark of the Abbott group of companies.


© 2020 Abbott. All Rights Reserved.
MAT-2002480 v2.0 | Item approved for U.S. use only.

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