Heartmate 3™ Left Ventricular Assist Device (LVAD) : Patient Guide
Heartmate 3™ Left Ventricular Assist Device (LVAD) : Patient Guide
Heartmate 3™ Left Ventricular Assist Device (LVAD) : Patient Guide
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.
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
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
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.
IMPORTANT:
Be sure to keep a backup System Controller and
charged batteries with you at all times for use in case
of an emergency.
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
4a 4b 3a 4c 3b
2 3c
System Controller | 9
SYSTEM CONTROLLER:
BUTTONS AND USER INTERFACE SCREEN
3
10 | System Controller
SYSTEM CONTROLLER:
USER INTERFACE SCREEN DISPL AY
DISPLAY BUTTON SCREEN DISPLAYED
ACTIONS (EXAMPLE) MEANING
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
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
14 | System Controller
SYSTEM CONTROLLER: AL ARMS
ADVISORY
SYSTEM
CONTROLLER ACTIVE
SCREEN SYMBOLS ALARM MEANS TO RESOLVE ALARM
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
16 | System Controller
SYSTEM CONTROLLER: AL ARMS
HAZARD
SYSTEM
CONTROLLER ACTIVE
SCREEN SYMBOLS ALARM MEANS TO RESOLVE ALARM
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.
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.
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.
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.
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.
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.
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
Battery clip
Battery
SUPPORT TIME
10–17 hours
CHARGING TIME
4 hours
NUMBER OF LIGHTS
ILLUMINATED MEANING
BATTERY CHARGER
DISPL AY
LED INDICATORS
LED LIGHT COLOR STATUS/MEANING
Yellow blinking Battery requires calibration cycle (see the example on the next page).
AUTOMATIC MESSAGES
Call hospital for service
4
2
CONNECT
Black to black
White to white
ADVISORY
3. Place the alkaline AA batteries in the compartment. 4. Close the compartment and tighten the screw.
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.
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.