ReliantHeart CTL002 Controller for HeartAssist 5 Left Ventricular Assist Device User Manual user guide

Download:
Mirror Download [FCC.gov]
Document ID	2809278
Application ID	qy1+WJ1Z9Y2lc/Bff+NevA==
Document Description	user guide
Short Term Confidential	No
Permanent Confidential	No
Supercede	No
Document Type	User Manual
Display Format	Adobe Acrobat PDF - pdf
Filesize	235.31kB (2941355 bits)
Date Submitted	2015-11-11 00:00:00
Date Available	2015-11-11 00:00:00
Creation Date	2015-01-14 14:47:26
Producing Software	Acrobat Distiller 11.0 (Windows)
Document Lastmod	2015-09-04 16:56:32
Document Title	user guide
Document Creator	PScript5.dll Version 5.2.2
Document Author:	bswift

HeartAssist 5®
VAD System
Patient User's
Manual
For use with Controller Model: CTL002
L00088-01 Rev R 12/2014
The HeartAssist 5® VAD is a miniaturized ventricular assist technology co-developed
with Dr. Michael E. DeBakey, Dr. George P. Noon and the National Aeronautics and
Space Administration (NASA).
Federal (USA) law limits the sale and use of HeartAssist 5® VAD to
investigational use only.
HeartAssist 5® and HeartAttendant® are registered trademarks of ReliantHeart Inc.
0086 CE marked since November 2013
Copyright © 2001 – 2014 by ReliantHeart as an unpublished work. All rights reserved.
ii
HeartAssist 5® VAD System Patient User's Manual
Customer support
Use the contact information below to reach ReliantHeart.
International
 ReliantHeart (Distributor)
Erfstraat 10A
5405 BE
Uden, The Netherlands
Phone +31 413 245 107
Fax +31 413 270 504
 MedPass International Limited (Authorized Representative)
Windsor House
Bretforton
Evesham
Worcs, WR117JJ
United Kingdom
 Emergency technical and clinical support for medical professionals
(24/7 Urgent Support)
+44 132-386-2836
 Emergency help for patients
Contact your health care provider. (See page 1-2.)
 Non-emergency technical and clinical support
support@reliantheart.com
United States
 ReliantHeart (Manufacturer)
8965 Interchange Drive
Houston, TX 77054
Phone: 713-592-0913
Fax: 713-665-0963
 Emergency technical and clinical support for medical professionals
877-332-2539
 Emergency help for patients
Call 911, or contact your health care provider. (See page 1-2.)
 Non-emergency technical and clinical support
support@reliantheart.com
ReliantHeart Confidential – Patient and Heath Care Provider Use
iii
iv
HeartAssist 5® VAD System Patient User's Manual
Contents
Figures ............................................................................................................................................. x
Tables.............................................................................................................................................. xii
Warnings ........................................................................................................................................ xiii
Cautions ..........................................................................................................................................xv
Chapter 1
Emergency Information
Introduction ................................................................................................................................... 1-2
Support team phone numbers quick reference ............................................................................. 1-2
Conditions for calling emergency assistance ................................................................................ 1-2
Call 911 ............................................................................................................................ 1-2
Call your doctor ................................................................................................................ 1-3
Chapter 2
About This Manual
Introduction ................................................................................................................................... 2-2
Purpose of this manual ................................................................................................................. 2-2
Scope of this manual..................................................................................................................... 2-2
Intended audience......................................................................................................................... 2-2
How to use this manual ................................................................................................................. 2-2
Text conventions .............................................................................................................. 2-3
Tips, notes, cautions, and warnings................................................................................. 2-3
Description of chapters ................................................................................................................. 2-4
Chapter 3
Description of the HeartAssist 5® VAD System
Introduction ................................................................................................................................... 3-2
Indications and contraindications for use ...................................................................................... 3-2
Potential complications ................................................................................................................. 3-3
Maintenance .................................................................................................................................. 3-3
System components...................................................................................................................... 3-3
Implantable components .................................................................................................. 3-4
Wearable components ..................................................................................................... 3-5
Accessories ................................................................................................................................... 3-7
Patient accessories .......................................................................................................... 3-7
Hospital accessories ........................................................................................................ 3-8
Symbols used in labeling .............................................................................................................. 3-8
Documentation ............................................................................................................................ 3-11
Chapter 4
Getting Started with Your HeartAssist 5® VAD System
Introduction ................................................................................................................................... 4-2
General considerations ................................................................................................................. 4-2
Controller ....................................................................................................................................... 4-2
ReliantHeart Inc. Confidential – Patient and Heath Care Provider Use
Contents
Overview .......................................................................................................................... 4-3
Controller display ............................................................................................................. 4-3
Controller sounds ............................................................................................................. 4-4
Controller messages and alarms ..................................................................................... 4-4
Battery indicators ............................................................................................................. 4-5
Flow sensor ...................................................................................................................... 4-5
Wireless radio antenna .................................................................................................... 4-5
Automatic fail-safe mode ................................................................................................. 4-6
VAD restart algorithm ....................................................................................................... 4-6
Controller replacement ..................................................................................................... 4-7
Controller safety check .................................................................................................. 4-14
Battery pockets ........................................................................................................................... 4-15
VADPAK ...................................................................................................................................... 4-16
VADPAK components .................................................................................................... 4-16
Setting up the VADPAK Insert ....................................................................................... 4-16
Connecting to external power ........................................................................................ 4-21
Power supply............................................................................................................................... 4-22
Batteries ......................................................................................................................... 4-22
LVAD Battery Charger ................................................................................................... 4-28
Independent Power Supply ............................................................................................ 4-31
Connecting the Independent Power Supply to the Controller ........................................ 4-32
Chapter 5
Everyday Use and Self Care
Introduction ................................................................................................................................... 5-2
Daily status checks ....................................................................................................................... 5-2
Upon waking .................................................................................................................... 5-2
Before sleeping ................................................................................................................ 5-2
Daily operation .............................................................................................................................. 5-3
Tethered operation ........................................................................................................... 5-3
Untethered operation ....................................................................................................... 5-3
Switching from tethered to untethered operation ............................................................. 5-4
Switching from untethered to tethered operation ............................................................. 5-5
Leaving the home............................................................................................................. 5-6
Showering with the VADPAK Insert and shower bag ...................................................... 5-6
Activity restrictions ........................................................................................................... 5-8
Self care at home .......................................................................................................................... 5-9
Caring for the exit site ...................................................................................................... 5-9
Caring for the percutaneous cable ................................................................................. 5-10
Caring for the VADPAK .................................................................................................. 5-10
Taking medications ........................................................................................................ 5-10
Emergencies ............................................................................................................................... 5-11
Local emergency services ............................................................................................. 5-11
vi
Contents
HeartAssist 5® VAD System Patient User's Manual
CPR and defibrillation .................................................................................................... 5-11
Power outages ............................................................................................................... 5-11
Chapter 6
Equipment Care and Maintenance
Introduction ................................................................................................................................... 6-2
All HeartAssist 5® VAD System components ............................................................................... 6-2
Environmental conditions ................................................................................................. 6-2
Contact with liquids .......................................................................................................... 6-3
Electromagnetic disturbances .......................................................................................... 6-3
Service ............................................................................................................................. 6-4
Controller ....................................................................................................................................... 6-4
LVAD Battery Charger .................................................................................................................. 6-4
Independent Power Supply ........................................................................................................... 6-5
Chapter 7
The Pediatric Patient on HeartAssist 5® LBSA VAD Support
Introduction ................................................................................................................................... 7-2
Implant surgery ............................................................................................................................. 7-2
System description ........................................................................................................................ 7-2
Environmental conditions .............................................................................................................. 7-2
Temperature..................................................................................................................... 7-2
Contact with liquids .......................................................................................................... 7-3
Electromagnetic disturbances .......................................................................................... 7-3
Electrostatic discharge ..................................................................................................... 7-4
Operating the HeartAssist 5® LBSA VAD system ........................................................................ 7-4
Batteries ........................................................................................................................... 7-4
VADPAK ........................................................................................................................... 7-4
Percutaneous cable ......................................................................................................... 7-5
Daily operation for the pediatric patient ........................................................................................ 7-5
Leaving the home............................................................................................................. 7-5
Returning to school .......................................................................................................... 7-5
Activities ........................................................................................................................... 7-6
Travel ............................................................................................................................... 7-6
Sleeping ........................................................................................................................... 7-6
Showering and cleansing ................................................................................................. 7-6
Emergencies ................................................................................................................................. 7-6
Local emergency services ............................................................................................... 7-6
CPR and defibrillation ...................................................................................................... 7-7
Power outages ................................................................................................................. 7-7
Prevention ........................................................................................................................ 7-7
Appendix A Troubleshooting
Emergencies .................................................................................................................................A-2
ReliantHeart Inc. Confidential – Patient and Heath Care Provider Use
Contents
vii
Controller troubleshooting .............................................................................................................A-3
Non-VAD related troubleshooting .................................................................................................A-6
Appendix B Controller Messages and Alarms
Standard message screens ..........................................................................................................B-2
Emergency alarms ........................................................................................................................B-4
Emergency alarm 1: PUMP STOPPED ...........................................................................B-4
Emergency alarm 2: BOTH BATTERIES DISCONNECTED ...........................................B-5
Emergency alarm 3: VAD DISCONNECTED ..................................................................B-5
Diagnostic alarms..........................................................................................................................B-6
Diagnostic alarm 1: EXCESS CURRENT ........................................................................B-6
Diagnostic alarm 2: REDUCED FLOW RATE .................................................................B-7
Diagnostic alarm 3: REDUCED MOTOR SPEED ............................................................B-7
Diagnostic alarm 4: PUMP RESTARTING ......................................................................B-7
Diagnostic alarm 5: BATTERY 1 DISCONNECTED........................................................B-8
Diagnostic alarm 6: BATTERY 1 DISCHARGED ............................................................B-8
Diagnostic alarm 7: BATTERY 1 EXPIRED .....................................................................B-9
Diagnostic alarm 8: BATTERY 2 DISCONNECTED........................................................B-9
Diagnostic alarm 9: BATTERY 2 DISCHARGED ..........................................................B-10
Diagnostic alarm 10: BATTERY 2 EXPIRED .................................................................B-10
Controller failure alarms ..............................................................................................................B-11
Controller failure alarm 1: fail-safe alarm .......................................................................B-11
Controller failure alarm 2: Controller failure alarm .........................................................B-12
Appendix C System Specifications
Introduction .................................................................................................................................. C-2
HeartAssist 5® VAD specifications .............................................................................................. C-2
Controller specifications ............................................................................................................... C-3
General specifications ..................................................................................................... C-3
Interface features ............................................................................................................ C-3
Safety features ................................................................................................................ C-3
Wireless antenna specifications................................................................................................... C-4
HeartAttendant® specifications.................................................................................................... C-4
General specifications ..................................................................................................... C-4
Safety features ................................................................................................................ C-4
Electrical specifications ................................................................................................... C-4
Replacement and accessory part list (fuses) .................................................................. C-5
VADPAK and VADPAK Insert specifications ............................................................................... C-5
Independent Power Supply specifications ................................................................................... C-5
General specifications ..................................................................................................... C-5
Safety features ................................................................................................................ C-6
Electrical specifications ................................................................................................... C-6
viii
Contents
HeartAssist 5® VAD System Patient User's Manual
Lithium ion battery specifications ................................................................................................. C-6
General specifications ..................................................................................................... C-6
Safety features ................................................................................................................ C-6
Electrical specifications ................................................................................................... C-6
LVAD Battery Charger specifications........................................................................................... C-7
General specifications ..................................................................................................... C-7
Electrical specifications ................................................................................................... C-7
Connecter cables, power cords, and fuses .................................................................................. C-7
Essential performance of the HeartAssist 5® VAD...................................................................... C-8
Appendix D Manufacturer Guidance for Environmental Conditions
Introduction .................................................................................................................................. D-2
Electromagnetic emissions .......................................................................................................... D-2
Electromagnetic immunity ............................................................................................................ D-2
Recommended separation distance between portable and mobile RF communications
equipment and the Controller, HeartAttendant®, battery pockets, Independent Power
Supply, and batteries ............................................................................................................. D-5
Requirements applicable to ME EQUIPMENT and ME SYSTEMS that
intentionally receive RF electromagnetic energy for the purpose of their
operation (60601-1-2, 5.2.2.5) .................................................................................. D-6
Requirements applicable to ME EQUIPMENT and ME SYSTEMS that include RF
transmitters (60601-1-2, 5.2.2.6) .............................................................................. D-7
FCC statements ........................................................................................................................... D-8
Statement according to FCC part 15.19 ......................................................................... D-8
Statement according to FCC part 15.21 ......................................................................... D-8
Statement according to FCC part 15.105 ....................................................................... D-8
R&TTE Declaration of Conformity.............................................................................................. D-10
Index
ReliantHeart Inc. Confidential – Patient and Heath Care Provider Use
Contents
ix
Figures
Figure 3-1.
The HeartAssist 5® VAD System ................................................................. 3-2
Figure 4-1.
Controller ...................................................................................................... 4-3
Figure 4-2.
Controller front panel .................................................................................... 4-4
Figure 4-3.
Backup equipment for replacing the Controller ............................................ 4-7
Figure 4-4.
Removing the VADPAK Insert from the VADPAK ........................................ 4-8
Figure 4-5.
Arranging the components for easy access ................................................. 4-8
Figure 4-6.
Unscrewing the defibrillation cover ............................................................... 4-9
Figure 4-7.
Disconnecting one battery pocket from the Controller ................................. 4-9
Figure 4-8.
Connecting the first battery pocket to the backup Controller ..................... 4-10
Figure 4-9.
Disconnecting the percutaneous cable ...................................................... 4-10
Figure 4-10.
Aligning the driveline cable to the backup Controller ................................. 4-10
Figure 4-11.
Disconnecting the second battery pocket from the Controller.................... 4-11
Figure 4-12.
Connecting the second battery pocket to the backup Controller ............... 4-12
Figure 4-13.
Removing the SIM card cover with the ReliantHeart screwdriver .............. 4-12
Figure 4-14.
SIM card covers removed from both Controllers ........................................ 4-13
Figure 4-15.
Removing the SIM card from the Controller ............................................... 4-13
Figure 4-16.
Inserting the SIM card into the backup Controller ...................................... 4-13
Figure 4-17.
Replacing the SIM card cover .................................................................... 4-14
Figure 4-18.
Battery pocket............................................................................................. 4-15
Figure 4-19.
VADPAK ..................................................................................................... 4-16
Figure 4-20.
VADPAK Insert ........................................................................................... 4-17
Figure 4-21.
Securing the battery pockets in the VADPAK Insert .................................. 4-17
Figure 4-22.
Securing the Controller into the VADPAK Insert with the Controller
display facing upward ................................................................................. 4-18
Figure 4-23.
Securing the battery connectors in the VADPAK Insert ............................. 4-18
Figure 4-24.
Placing the VADPAK Insert in the VADPAK............................................... 4-19
Figure 4-25.
Viewing the Controller in the clear window of the VADPAK ....................... 4-19
Figure 4-26.
Routing the driveline cable in the VADPAK................................................ 4-20
Figure 4-27.
Zipping up the VADPAK completely ........................................................... 4-20
Figure 4-28.
Exposing the battery pocket external power connector ............................. 4-21
Figure 4-29.
Aligning the arrow on the power source connector with the square on
the battery pocket external power connector ............................................. 4-21
Figure 4-30.
Routing the cables in the VADPAK ............................................................ 4-22
Figure 4-31.
HeartAssist 5® VAD battery ....................................................................... 4-23
Figure 4-32.
Battery charge level LED indicators ........................................................... 4-23
Figure 4-33.
Aligning the arrow on the battery pocket connector with the square
on the Controller connector ........................................................................ 4-24
Figure 4-34.
Batteries connected to the Controller ......................................................... 4-25
Figure 4-35.
Removing the battery from the battery pocket ........................................... 4-27
Figure 4-36.
LVAD Battery Charger ................................................................................ 4-29
Figures
HeartAssist 5® VAD System Patient User's Manual
Figure 4-37.
Independent Power Supply ........................................................................ 4-31
Figure 4-38.
Independent Power Supply connection diagram........................................ 4-32
Figure 5-1.
Standard message screen 1 display on the Controller front panel
when using external power ........................................................................... 5-2
Figure 5-2.
Standard message screen 1 display on the Controller front panel
when using battery power ............................................................................ 5-4
Figure 5-3.
Properly inserting the Controller, battery pockets, batteries, and
cables in the VADPAK Insert into the shower bag ....................................... 5-7
Figure 5-4.
Securing the percutaneous cable to the side of the shower bag ................. 5-7
Figure 5-5.
Properly closing and securing the lid of the shower bag .............................. 5-8
Figure 6-1.
MRI warning and safety seal ........................................................................ 6-3
Figure B-1.
Standard message screen 1: battery status .................................................B-2
Figure B-2.
Standard message screen 2: current VAD parameters ...............................B-2
Figure B-3.
Standard message screen 3: wireless antenna status.................................B-3
Figure B-4.
Standard message screen 4: flow probe received amplitude ......................B-3
Figure B-5.
Standard message screen 5: flow sensor status .........................................B-3
Figure B-6.
Standard message screen 6: battery capacity .............................................B-3
Figure B-7.
Standard message screen 7: not used.........................................................B-4
Figure B-8.
Emergency alarm 1: PUMP STOPPED........................................................B-4
Figure B-9.
Emergency alarm 2: BOTH BATTERIES DISCONNECTED .......................B-5
Figure B-10.
Emergency alarm 3: VAD DISCONNECTED ...............................................B-5
Figure B-11.
Diagnostic alarm 1: EXCESS CURRENT ....................................................B-6
Figure B-12.
Diagnostic alarm 2: REDUCED FLOW RATE ..............................................B-7
Figure B-13.
Diagnostic alarm 3: REDUCED MOTOR SPEED ........................................B-7
Figure B-14.
Diagnostic alarm 4: PUMP RESTARTING ...................................................B-8
Figure B-15.
Diagnostic alarm 5: BATTERY 1 DISCONNECTED ....................................B-8
Figure B-16.
Diagnostic alarm 6: BATTERY 1 DISCHARGED .........................................B-9
Figure B-17.
Diagnostic alarm 7: BATTERY 1 EXPIRED .................................................B-9
Figure B-18.
Diagnostic alarm 8: BATTERY 2 DISCONNECTED ..................................B-10
Figure B-19.
Diagnostic alarm 9: BATTERY 2 DISCHARGED .......................................B-10
Figure B-20.
Diagnostic alarm 10: BATTERY 2 EXPIRED .............................................B-11
Figure B-21.
Controller failure alarm 1: fail-safe alarm (display frozen)..........................B-11
Figure B-22.
Controller failure alarm 2: (no display) .......................................................B-12
ReliantHeart Inc. Confidential – Patient and Heath Care Provider Use
Figures
xi
Tables
Table 1-1.
Support team phone numbers ...................................................................... 1-2
Table 2-1.
Text conventions used in this manual .......................................................... 2-3
Table 2-2.
The HeartAssist 5® VAD System Patient User’s Manual chapter
descriptions .................................................................................................. 2-4
Table 3-1.
Implantable components .............................................................................. 3-4
Table 3-2.
Wearable components.................................................................................. 3-5
Table 3-3.
Patient accessories ...................................................................................... 3-7
Table 3-4.
Hospital accessories..................................................................................... 3-8
Table 3-5.
Product labeling symbols ............................................................................. 3-8
Table 3-6.
HeartAssist 5® VAD System documentation set ....................................... 3-11
Table 4-1.
Battery charge level LED indicators ........................................................... 4-24
Table 4-2.
Controller battery indicator descriptions ..................................................... 4-26
Table 4-3.
LVAD Battery Charger status lights description ......................................... 4-30
Table 5-1.
Prohibited activities....................................................................................... 5-8
Table 5-2.
Restricted activities....................................................................................... 5-9
Table 5-3.
Permitted activities ....................................................................................... 5-9
Table A-1.
Troubleshooting guide for Controller alarms ................................................A-3
Table A-2.
Troubleshooting guide for non-VAD issues ..................................................A-6
Table C-1.
HeartAssist 5® VAD general specifications ................................................ C-2
Table C-2.
Controller general specifications ................................................................. C-3
Table C-3.
HeartAttendant® general specifications ...................................................... C-4
Table C-4.
HeartAttendant® electrical specifications .................................................... C-4
Table C-5.
HeartAttendant® part list ............................................................................. C-5
Table C-6.
VADPAK specifications ............................................................................... C-5
Table C-7.
Independent Power Supply general specifications ..................................... C-5
Table C-8.
Independent Power Supply electrical specifications ................................... C-6
Table C-9.
Lithium ion battery general specifications ................................................... C-6
Table C-10.
Lithium ion battery electrical specifications ................................................. C-6
Table C-11.
LVAD Battery Charger general specifications ............................................. C-7
Table C-12.
LVAD Battery Charger electrical specifications ........................................... C-7
Table D-1.
Electromagnetic emissions guidance and manufacturer’s declaration
for all ME equipment and ME systems ........................................................ D-2
Table D-2.
Electromagnetic immunity guidance and manufacturer’s declaration
for all ME equipment and ME systems ........................................................ D-2
Table D-3.
< Radio Frequency Susceptibility (Radiated and Conducted) .................... D-3
and Electrostatic Discharge > ..................................................................... D-3
xii
Table D-4.
Electromagnetic immunity guidance and manufacturer’s declaration
for all life supporting ME equipment and ME systems ................................ D-4
Table D-5.
Recommended separation distance between portable and mobile RF
communications equipment and the life-supporting ME equipment
and ME systems .......................................................................................... D-5
Tables
HeartAssist 5® VAD System Patient User's Manual
Warnings
General warnings
The following warnings do not appear elsewhere in this manual.
Warnings indicate possible bodily injury or death.
 Do not disconnect the HeartAssist 5® VAD (VAD) from the Controller. The VAD
will stop. The Controller must be reconnected as quickly as possible to resume
VAD function.
 The Controller’s internal capacitors only run the CPU and alarms for approximately
three minutes. They do not run the VAD. If both of the batteries are disconnected or
depleted, the VAD stops.
 Do not use the Independent Power Supply with ventricular assist devices (VADs) other
than the HeartAssist 5® VAD System.
 The Independent Power Supply should not be used in the presence of a flammable
anesthetic mixture with air, oxygen, or nitrous oxide.
 The VAD should not be used adjacent to other equipment or in a stacked configuration
with other equipment. The normal operation of the VAD must be verified when used in
these configurations.
 Avoid unnecessary pulling or moving of the external portion of the percutaneous lead,
especially as the exit site is healing. Pulling on or moving the lead could prolong the
healing process or disrupt an already healed exit site. Disruption of the percutaneous
lead exit site increases the patient's risk of acquiring a serious infection.
 Avoid prolonged direct contact between the Controller and battery pockets and your
skin. The Controller and batteries emit heat that could potentially cause harm if left in
direct contact with skin. Limit direct contact with skin to less than one minute.
 Always place the Controller (with battery) in the VADPAK Insert to promote proper
cooling of the Controller and to eliminate potential bodily harm.
 Exercise diligent care throughout the course of VAD support to prevent infection and
sepsis. Systemic infections and localized infection of the percutaneous lead exit site
can occur with use of this device. Infection can contribute to patient morbidity and
death.
 Be cautious in the presence of young children as they may not understand the life
supporting nature of the system and could damage cables, connectors, or other
system components.
 Keep pets and pests away from all HeartAssist 5® VAD System components as they
could damage cables, connectors, or other system components.
ReliantHeart Inc. Confidential – Patient and Heath Care Provider Use
Warnings
xiii
List of warnings
The following warnings appear sequentially in this manual on the pages indicated.
xiv
Warnings

Read this entire manual before handling the VAD without supervision.

Do not store or use the Independent Power Supply near water or any liquid
(for example, in the bathroom or kitchen) due to the risk of electrical shock. ........... 2-4

Only use the power cables supplied by ReliantHeart................................................ 4-2

Plug this equipment into grounded outlets only to reduce the risk of shock. If
the power outlets are not grounded, an electrician must install grounded
outlets before you can use this equipment outside of the hospital. .......................... 4-2

Only attempt to manually restart the VAD one time. If the VAD does not
successfully restart, immediately begin the procedure detailed in the next
section, “Controller replacement.” ............................................................................. 4-7

You must periodically (every two to three hours) visually inspect the front
panel of the Controller to verify battery status in case of a diagnostic audible
alarm failure. ............................................................................................................ 4-26

Only remove one battery at a time from the battery pockets. Removing both
batteries simultaneously causes the VAD to stop (unless you are in tethered
mode). The batteries must be reconnected as quickly as possible to resume
VAD function. ........................................................................................................... 4-27

Do not store or use the Independent Power Supply near water or any liquid
(for example, in the bathroom or kitchen) due to the risk of electrical shock. ......... 4-31

Use the Independent Power Supply only with a properly grounded plug. To
reduce the risk of electrical shock, plug this equipment into grounded outlets
only. If your power outlets are not grounded, an electrician must install
grounded outlets before you can use this equipment outside of the hospital. ........ 4-32

Only use batteries supplied by ReliantHeart. ............................................................ 5-3

Only remove one battery at a time from the battery pockets. Removing both
batteries simultaneously causes the VAD to stop (unless you are in tethered
mode). The batteries must be reconnected as quickly as possible to resume
VAD function. ............................................................................................................. 5-4

If a power failure is expected to last for an extended period of time, take the
Independent Power Supply, the LVAD Battery Charger, and all batteries to
the nearest location with suitable mains power. ........................................................ 5-5

Do not shower with the VAD connected to the Independent Power Supply (in
tethered mode). Showering in untethered mode reduces the risk of electrical
shock. ........................................................................................................................ 5-6

Keep all liquids away from equipment to avoid accidental spills. Do not put
any part of this equipment under water or in other liquids. Contact with liquids
increases the risk of electrical shock and of damage to the equipment. ................... 6-3

Do not subject patients implanted with the VAD to magnetic resonance
imaging (MRI). The VAD contains ferromagnetic components, and MRI can
cause device failure or patient injury. ........................................................................ 6-3

Do not modify this equipment. No modification of this equipment is allowed. .......... 6-4

Do not open the back cover of any ReliantHeart device. .......................................... 6-4

You must always have extra batteries, a backup battery pocket, and a
backup Controller. .....................................................................................................A-7
HeartAssist 5® VAD System Patient User's Manual
Cautions
General cautions
The following cautions do not appear elsewhere in this manual.
Cautions indicate possible data loss or equipment damage.
 Federal law restricts this device to sale or to use by or on the order of a physician or
properly licensed practitioner.
 Implantable parts of this system must not be reused.
 Do not drop the LVAD Battery Charger, Independent Power Supply, batteries, or the
Controller on any hard surface. Dropping these components might damage internal
parts causing the device to malfunction.
 Do not expose the LVAD Battery Charger, Independent Power Supply to moisture.
 Do not store the HeartAssist 5® VAD System in environments where temperatures are
less than –20 °C (–4 °F) or greater than 55 °C (131 °F).
 Do not store or leave batteries in hot or cold areas (e.g., car trunks, dashboards,
window sills, and so forth). These temperatures can damage the battery.
 Do not attempt to make any changes to system software or to use the device as a
laptop computer. Any modification of, or attempt to modify, the operating system
software could result in rendering this device nonfunctional for its intended use.
 Disconnect the Controller from the Independent Power Supply before unplugging the
Independent Power Supply from the power source.
 The percutaneous cable from the patient to the Controller must be handled with care
to prevent damage.
 All connectors must be handled with care and kept free of liquid, dust, and debris.
 Clean the LVAD Battery Charger, Independent Power Supply by first disconnecting the
equipment from the power source and then wiping it with a damp cloth. Complete the
cleaning process by wiping the equipment with isopropanol alcohol to remove
contaminants.
 Do not invert the cabinet of the LVAD Battery Charger while installing batteries.
 A spare Controller, a spare battery pocket, and additional batteries must be accessible
to the patient at all times.
 When connecting the Controller to the Independent Power Supply, ensure that mains
(AC) power is available or that fully charged batteries are installed in the battery
pockets.
 Do not obstruct the fan on the back of the LVAD Battery Charger. Obstructing the fan
can prevent the batteries from charging properly or cause the LVAD Battery Charger
to overheat.
 Using expired or defective batteries can result in reduced operating time or abrupt loss
of VAD function.
 Do not set alarm thresholds to extreme values that can render the alarm system
useless.
ReliantHeart Inc. Confidential – Patient and Heath Care Provider Use
Cautions
xv
 Do not dispose of any ReliantHeart equipment. Return all equipment to your support
team for proper return to ReliantHeart.
 Do not use a battery suspected to be malfunctioning. In the event of a possible battery
failure, please remove the faulty battery from battery pocket or charger and replace
with a working battery. Contact ReliantHeart if a battery error is suspected.
List of cautions
The following cautions appear sequentially in this manual on the pages indicated.
xvi
Cautions

Connecting batteries other than as described can result in permanent
damage to the unit. .................................................................................................... 2-4

Ensure that the mains (AC) input voltage is appropriate for the local power
source. Do not use extension cords. ......................................................................... 4-2

Do not block fans or ventilation holes of the equipment. Blocking these
openings can cause heat to build up inside and damage the equipment. ................ 4-2

Align the driveline connector and Controller connector properly. Forcing the
connectors with improper alignment can damage the equipment. Do not twist
a connector plug while inserting it after the connectors are aligned. ...................... 4-11

Align all connectors properly. Forcing connectors without proper alignment
can damage the equipment. Do not try to force a power source connector
into the battery pocket external power connector. When removing a cable,
hold the connector, and pull it out. Do not twist the connectors while inserting
them or removing them after the connectors are aligned........................................ 4-25

Do not handle batteries by the connector pins. A strong static discharge can
cause the charge level indicator to temporarily malfunction. If the charge
level indictor ceases to function, place the battery into a ReliantHeart
charger, and recharge the battery. .......................................................................... 4-28

Even when they are connected to an external power source (such as the
Independent Power Supply), the batteries located inside the battery pockets
drain and lose charge over time. Verify that the two batteries in the battery
pockets have sufficient charge levels prior to disconnecting the system from
an external power source. ....................................................................................... 4-28

Obtain replacement batteries from ReliantHeart after the battery capacity
indicates less than 6,000 milliamp hours. Only use batteries supplied by
Reliant Heart. ........................................................................................................... 4-28

Connection other than indicated can result in permanent damage to the
LVAD Battery Charger. ............................................................................................ 4-30

Avoid placing or operating the LVAD Battery Charger in areas or near
appliances that expose it to temperatures outside of the operating range of
the device, which is 0 °C (32 °F) to 50 °C (122 °F). ................................................ 4-30

The Independent Power Supply contains no user-serviceable parts. Do not
open the back cover of the Independent Power Supply. Only qualified
ReliantHeart personnel can service this equipment. If service is required,
contact your support team. ...................................................................................... 4-31

Avoid placing or operating the Independent Power Supply in areas or near
appliances that expose it to temperatures outside the operating range of the
device, which is 0 °C (32 °F) to 40 °C (104 °F) or where relative humidity is
noncondensing, less than 10% Rh or greater than 75% Rh. .................................. 4-31

Do not trip over the power cord. Instruct persons in the area to prevent
tripping. .................................................................................................................... 4-31
HeartAssist 5® VAD System Patient User's Manual

Contact your support team if any of the Controller alarms are not working.
Every two – three hours when you are awake (whether you are attached to
the Independent Power Supply or not), check the battery status on the
Controller front panel. ................................................................................................ 5-2

You can damage the connectors if you force them without proper alignment.
After the connectors are aligned, do not twist the power source connector
while connecting it. .................................................................................................... 5-5

Ensure that batteries that are not being used in the battery pockets are
always charging in the LVAD Battery Charger while you are in the tethered
mode of operation...................................................................................................... 5-5

Do not submerge the Controller in liquid. Submerging the Controller in liquid
might damage internal parts, causing the device to malfunction. Showers and
washing are permitted when the clinician approves wound site readiness.
During showers, you must use the shower bag. Do not expose the Controller
to moisture. ................................................................................................................ 5-6

Do not submerge batteries in liquid or expose them to heat or moisture.
Submerging the batteries in liquid or exposing them to heat might cause
them to malfunction. During showers, you must use the shower bag to
prevent exposure to moisture. ................................................................................... 5-6

Ensure that the VADPAK Insert is properly encased in the provided shower
bag before showering. ............................................................................................... 5-6

Do not use the VADPAK Insert and Controller in the shower bag longer than
30 minutes because the Controller requires air circulation for proper cooling. ......... 5-8

Position the shower bag so that it does not tip or drop. Do not allow the
shower bag to sit in liquid. ......................................................................................... 5-8

The system has not been tested with each possible brand of device, and the
possibility of electromagnetic disturbances exists. If you experience
unexpected changes in the speed of the VAD, investigate potential sources
of electromagnetic disturbances (such as cellular phones, radio transmitters,
or microwave ovens) within a few feet. If you discover disturbances, move
away from the potential source, and determine if the VAD operation returns
to normal. If it does not return to normal, contact your support team. ...................... 6-3

Do not service this equipment yourself. Only qualified personnel can service
this equipment. If service is required, contact your support team. ............................ 6-4

Do not drop the Controller on any hard surface. Dropping the Controller can
damage internal parts causing the device to malfunction. ........................................ 6-4

Do not attempt to wipe liquid from the inside of the LVAD Battery Charger
battery bays as this action might bend or otherwise damage the connector
pins. ........................................................................................................................... 6-5

Do not operate the Controller where temperatures are less than –10 °C (14
°F) or greater than 40 °C (104 °F) or where the relative humidity is
noncondensing, <10% Rh or >75% Rh. .................................................................... 7-2

The batteries, Controller, battery pockets, VADPAK, and VADPAK Insert
must not be exposed to moisture or heat. ................................................................. 7-3

Never spray water or detergent directly onto the Controller. Always apply
water or detergent to a soft cloth, wring it out until just slightly damp, and
wipe the Controller.....................................................................................................A-6

You can damage the connectors if you force them without proper alignment.
Do not twist the connectors while inserting them after the connectors are
aligned. ......................................................................................................................A-8
ReliantHeart Inc. Confidential – Patient and Heath Care Provider Use
Cautions
xvii

xviii
Cautions

The HeartAttendant® is intended for use in an electromagnetic environment
in which radiated RF disturbances are controlled. The user of the
HeartAttendant® can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF
communications equipment (transmitters) and the HeartAttendant® as
recommended in Table D-4, according to the maximum output power of the
communications equipment. ..................................................................................... D-6

Use of equipment and supplies other than those specified in this manual or
sold by ReliantHeart for replacement parts could affect the electromagnetic
compatibility of the HeartAssist 5® VAD with other devices, resulting in
potential interference between the HeartAssist 5® VAD and other devices. ........... D-6

The HeartAttendant® must be kept at least one foot away from electrical
appliances (such as kitchen appliances). ................................................................. D-6

The HeartAssist 5® VAD System requires special precautions regarding
electromagnetic compatibility (EMC), and you must install it and put it into
service according to the EMC information provided in this appendix. ..................... D-8

Portable and mobile RF communications equipment can affect the
HeartAssist 5® VAD System. ................................................................................... D-8

Radio frequency radiation exposure information: For body worn operation,
this phone has been tested and meets the FCC RF exposure guidelines
when used with the ReliantHeart accessories supplied or designated for this
product. Use of other accessories may not ensure compliance with FCC RF
exposure guidelines.................................................................................................. D-9
HeartAssist 5® VAD System Patient User's Manual
Chapter 1
Emergency Information
In this chapter
Introduction ................................................................................................................................... 1-2
Support team phone numbers quick reference ............................................................................. 1-2
Conditions for calling emergency assistance ................................................................................ 1-2
Call 911 ............................................................................................................................ 1-2
Call your doctor ................................................................................................................ 1-3
ReliantHeart Confidential – Patient and Heath Care Provider Use
1–1
Introduction
This chapter provides a quick reference of your support team’s contact information and
examples of conditions for calling your doctor or emergency assistance.
Read this entire manual before handling the VAD without supervision.
Support team phone numbers quick reference
Keep a record of your support team’s contact information in Table 1-1. To reach
ReliantHeart, see “Customer support” on page iii.
Table 1-1.
Title
Support team phone numbers
Name
Phone Number
Emergency assistance
Cardiologist
Cardiothoracic surgeon
Nurse
Technical assistance
You should always have access to someone trained in the use of and
troubleshooting for the HeartAssist 5® VAD System. Your medical care should be
monitored by a qualified doctor or medical staff trained in the operation of the
HeartAssist 5® VAD System. The name and phone number of this person, your
medical doctor, and heart surgeon are listed above.
ReliantHeart recommends that patients who have a limited ability to care for
themselves or communicate clearly have a trained companion available.
Conditions for calling emergency assistance
Use the following guidelines to determine whether to call for emergency help.
Your physician’s instructions supersede these guidelines. Always follow your
physician's orders regarding your care.
Call 911
Call 911 or your local emergency number when any of the following symptoms occur:
 Loss of consciousness
 Seizures or convulsions
 Inability to move or speak
 Sudden collapse
1–2
HeartAssist 5® VAD System Patient User's Manual
Call your doctor
Call your doctor immediately if you have any of the following symptoms:
 Numbness, tingling or weakness
 Pain
 Redness, swelling, or drainage at the exit site of the percutaneous cable
 Blurred vision
 Speech problems
 Shortness of breath
 Dizziness
 Temperature higher than 38 °C (100.4 °F)
 Unusual bleeding
 Unusual bruising
ReliantHeart Confidential – Patient and Heath Care Provider Use
1–3
1–4
HeartAssist 5® VAD System Patient User's Manual
Chapter 2
About This Manual
In this chapter
Introduction ................................................................................................................................... 2-2
Purpose of this manual ................................................................................................................. 2-2
Scope of this manual..................................................................................................................... 2-2
Intended audience......................................................................................................................... 2-2
How to use this manual ................................................................................................................. 2-2
Text conventions .............................................................................................................. 2-3
Tips, notes, cautions, and warnings................................................................................. 2-3
Description of chapters ................................................................................................................. 2-4
ReliantHeart Confidential – Patient and Heath Care Provider Use
2–1
Introduction
This manual is intended to supplement formal training provided by your clinician and VAD
support team. The VAD should only be operated and monitored by properly trained
personnel. Adjustment, maintenance, and repair of this equipment should only be carried
out by qualified personnel.
Use this manual as a reference after leaving the hospital.
Purpose of this manual
The purpose of the HeartAssist 5® VAD System Patient User’s Manual is to serve as a
guide for the HeartAssist 5® VAD System for the patient and patient’s caregiver.
Scope of this manual
This manual includes information on operating the HeartAssist 5® VAD System, including
the Controller, VADPAK, VADPAK Insert, LVAD Battery Charger, Independent Power
Supply, and other components.
Intended audience
This manual is intended for the HeartAssist 5® VAD System patients and their
caregivers. Medical personnel should refer to the HeartAssist 5® VAD System Operator’s
Manual.
How to use this manual
This manual contains features to assist the reader in finding and comprehending
information. These features include a table of contents, a list of figures, a list of tables, an
index, chapter-level tables of content, chapter-level numbering, headings and
subheadings in the body text, and running headers above the body text that indicate your
location in the manual.
This manual uses certain conventions to enhance usability. A description of each of these
conventions follows in Table 2-1.
2–2
HeartAssist 5® VAD System Patient User's Manual
Text conventions
Table 2-1 explains the conventions used in the text of this document.
Table 2-1.
Text conventions used in this manual
Format
Meaning
Example
Boldface
The text on the equipment display
appears exactly as written in the manual.
The LCD alternates between PUMP
STOPPED and PUMP RESTARTED while
restarting.
Boldface Italic
The emphasized words are particularly
important.
Do not open the inner package outside of
the sterile field.
Blue, 10-point text and
blue, 10-point initial
capped text
 The formatted text is a file format, file
 YY-MM-DD hh-mm-ssSegX.hol
name, or file extension.
 The formatted, initial capped text
indicates a control or window that
does not appear on the display as it
is written in the manual. (For
example, the control or window is not
titled on the display or is graphical.)
 The emphasized words have special
Italic
meaning.
 The emphasized words indicate a
book title.
Magenta text
The formatted text is a link. In the PDF
version of the manual, the text is a
hyperlink.
 11-05-25 10_40_33Seg1.hol
 *.hol
 Press the Alarm Silence button.
 This method is called tethered
operation.
 Refer to The HeartAssist 5® VAD
System Operator’s Manual for more
information.
www.reliantheart.com
Tips, notes, cautions, and warnings
This manual uses special notices including tips, notes, cautions, and warnings to call out
important information. The following sections describe the meaning of these notices.
Tips
Tips convey helpful hints and shortcuts.
Example:
You can only adjust the motor speed (increase or decrease) when the VAD is
running.
Notes
Notes convey important information that does not pertain to data loss, equipment
damage, or personal injury.
Example:
ReliantHeart Confidential – Patient and Heath Care Provider Use
2–3
The power adapter is universal for both domestic and European AC input voltages.
Cautions
Cautions indicate possible data loss or equipment damage.
Example:
Connecting batteries other than as described can result in permanent damage
to the unit.
Warnings
Warnings indicate possible bodily injury or death.
Example:
Do not store or use the Independent Power Supply near water or any liquid (for
example, in the bathroom or kitchen) due to the risk of electrical shock.
Description of chapters
This manual gives you and your caregiver the information that you need to use and
manage the HeartAssist 5® VAD System. The manual covers normal use and also
explains how to handle emergencies. Read the entire manual before using the
HeartAssist 5® VAD System without supervision.
Table 2-2 describes the type of information contained in each chapter. For more
information, refer to the appropriate chapter.
Table 2-2.
Chapter
The HeartAssist 5® VAD System Patient User’s Manual chapter descriptions
Title
Description
Contents
Sequential reference of chapters, headings, and subheadings in
this manual
Figures
Sequential reference of graphics in the manual
Tables
Sequential reference of tables in the manual
Warnings
 General warnings for VAD patients
 Sequential reference of the warnings that appear in the
chapters and appendices of this manual
Cautions
 General cautions for VAD patients
 Sequential reference of the cautions that appear in the chapters
and appendices of this manual
Chapter 1
Emergency information
 Who to call for emergencies, equipment service, or general
health concerns
 When to call for help
2–4
HeartAssist 5® VAD System Patient User's Manual
Chapter
Title
Description
Chapter 2
About this manual
 How the manual is arranged and what information is presented
in each chapter
 The conventions used in this manual
Chapter 3
Description of the HeartAssist
5® VAD System
 Why patients need the HeartAssist 5® VAD System and what it
does
 Names and images of the HeartAssist 5® VAD System
components
Chapter 4
Getting started with your
HeartAssist 5® VAD System
 Managing the Controller, VADPAK, and power supply
 General information about the HeartAssist 5® VAD System
Chapter 5
Everyday use and self care




Verifying that the VAD is working properly
Steps to perform every day
Allowed and prohibited activities while using this device
Patient care away from the hospital
Chapter 6
Equipment care and
maintenance
 Maintaining the VAD and components
 Cleaning the components
Chapter 7
The pediatric patient on
HeartAssist 5® LBSA VAD
support
 Information specific to pediatric patients on HeartAssist 5®
LBSA VAD support
 Special considerations for children using the HeartAssist 5®
LBSA VAD
Appendix A
Troubleshooting
 Appropriate action take in an emergency
 Troubleshooting the HeartAssist 5® VAD System
Appendix B
Controller messages and
alarms
 Information on the Controller message screens
 Controller alarm meanings
Appendix C
System specifications
 General specifications for the HeartAssist 5® VAD system
components
 Information on the use of connecter cables and power cords,
the proper replacement of fuses, and the essential performance
of the HeartAssist 5® VAD
Appendix D
Manufacturer guidance for
environmental conditions
 Operating temperatures and other environmental conditions for
the HeartAssist 5® VAD System
 Conditions to avoid while using the HeartAssist 5® VAD System
Index
Alphabetical reference of major concepts, processes, and system
components
ReliantHeart Confidential – Patient and Heath Care Provider Use
2–5
2–6
HeartAssist 5® VAD System Patient User's Manual
Chapter 3
Description of the HeartAssist 5® VAD System
In this chapter
Introduction ................................................................................................................................... 3-2
Indications and contraindications for use ...................................................................................... 3-2
Potential complications ................................................................................................................. 3-3
Maintenance .................................................................................................................................. 3-3
System components...................................................................................................................... 3-3
Implantable components .................................................................................................. 3-4
Wearable components ..................................................................................................... 3-5
Accessories ................................................................................................................................... 3-7
Patient accessories .......................................................................................................... 3-7
Hospital accessories ........................................................................................................ 3-8
Symbols used in labeling .............................................................................................................. 3-8
Documentation ............................................................................................................................ 3-11
ReliantHeart Confidential – Patient and Heath Care Provider Use
3–1
Introduction
The VAD is a miniaturized, auxiliary heart pump, or ventricular assist device (VAD). The
VAD is 30 mm x 76 mm, weighs 92 grams (less than 4 ounces), and is designed to
provide increased blood flow to patients who suffer from heart failure. It is capable of
pumping in excess of 10 liters per minute.
The HeartAssist 5® VAD is intended for patients with a BSA > 1.5, and the HeartAssist
5® LBSA VAD is intended for patients with a BSA < 1.5. All of the material presented in
the HeartAssist 5® VAD System Operator’s Manual is true for both devices.
Figure 3-1.
The HeartAssist 5® VAD System
Outflow Graft
Flow Probe
Pump
Inflow Cannula
Battery Pockets
and Batteries
Percutaneous
Cable
Controller
Indications and contraindications for use
The VAD is intended for use in patients with end stage heart failure who would benefit
from the implantation of a left ventricular assist device and in whom the device's
implantable components fit properly. The HeartAssist 5 VAD is intended for use in the
hospital and outside of the hospital, or for transportation of VAD patients via ground
ambulance, fixed wing aircraft, or helicopter. .
The VAD is contraindicated in patients who cannot tolerate anticoagulation therapy.
3–2
HeartAssist 5® VAD System Patient User's Manual
Potential complications
The medical risks associated with the use of the HeartAssist 5® VAD System include the
following adverse events:
 Bleeding
 Re-operation
 Hemolysis
 Infection (all causes)
 Renal dysfunction
 Hepatic dysfunction
 Right ventricular dysfunction
 Neurological dysfunction
 Thromboembolism
 Mechanical or electrical failure
Maintenance
The HeartAssist 5® VAD System does not require any user maintenance other than
charging batteries. The individual life of a fully charged battery is approximately 4.5 – 7
hours depending on pump speed. Patients must recondition batteries occasionally and
recharge batteries regularly.
System components
The HeartAssist 5® VAD System consists of implantable components, wearable
components, and accessories as well as patient and hospital documentation.
Tables 3-1 through 3-4 list the components that are used throughout your time on VAD
support.
ReliantHeart Confidential – Patient and Heath Care Provider Use
3–3
Implantable components
Table 3-1 lists the implanted HeartAssist 5® VAD System components.
Table 3-1.
Implantable components
Component
Description
HeartAssist 5®
VAD (VAD)
The VAD with inflow cannula, wedge nut, flow
probe, and percutaneous cable attached. The
VAD is connected to the heart via the inflow
cannula, which is inserted into the apex of the left
ventricle.
A three-phase electric motor is integrated in the
VAD and driven by the Controller. The VAD is
connected to the Controller via the percutaneous
cable that is passed through the skin at the exit
site.
The VAD is fully implanted in the patient (with the
exception of a portion of the percutaneous cable),
and thus does not have a user interface.
The VAD is the CF Applied part.
Outflow graft
The outflow graft consists of a pre-clotted gelatin
weave graft. It is attached to the distal end of the
VAD with the wedge nut and is anastomosed to
the ascending aorta.
Graft protector
The graft protector is a plastic cover that attaches
to the flow probe and protects the outflow graft.
Flow probe
The flow probe is a custom ultrasonic real-time
flow sensor. It accurately measures the flow
passing through the graft.
Sewing ring
The sewing ring is a silicone ring wrapped in
polyester with drawstring Prolene “0” sutures
used to attach the inflow cannula to the apex of
the left ventricle.
3–4
Example
HeartAssist 5® VAD System Patient User's Manual
Wearable components
Table 3-2 lists the HeartAssist 5® VAD System components that you wear.
Table 3-2.
Wearable components
Component
Description
Controller
The Controller regulates the speed and supply of
power to the VAD, displays current operating
parameters, and provides visual and audible
alarms.
The Controller contains the power management
system, the motor controller, data acquisition
memory, software, a microprocessor, and
ultrasonic flow measurement system, and a
system to provide GSM cell phone connectivity to
transmit pump data for remote monitoring.
The Controller includes two battery cables and
one driveline cable for the VAD connection.
ReliantHeart supplies a spare Controller with
each patient to allow for Controller exchange in
emergency situations.
Lithium ion
Each battery supplies power to the VAD for up
7.5 hours. The battery includes a button indicator
consisting of LEDs which indicate the charge
level of the battery.
VADPAK
The VADPAK carries the VADPAK Insert, which
contains the Controller and two battery pockets
with batteries inserted.
ReliantHeart Confidential – Patient and Heath Care Provider Use
Example
3–5
Component
Description
VADPAK Insert
The VADPAK Insert is a reinforced fabric
organizer for the Controller, battery pockets,
batteries, and associated cables. It allows you to
easily manage and transport the HeartAssist 5®
VAD System during everyday use.
Defibrillation
cover
The defibrillation cover protects the patient from
harm if defibrillation is needed. It is not intended
to secure the percutaneous cable to the
Controller cable. The defibrillation cover does not
protect against fluid ingress.
Battery pockets
The battery pockets connect the batteries and all
external power sources to the Controller. The
battery pockets have an integrated quick release
feature to allow for easy removal of the batteries.
3–6
Example
HeartAssist 5® VAD System Patient User's Manual
Accessories
Tables 3-3 and 3-4 describe the patient and hospital accessories available for the
HeartAssist 5® VAD System.
Patient accessories
Table 3-3 lists the HeartAssist 5® VAD System patient accessories.
Table 3-3.
Patient accessories
Component
Description
LVAD Battery
Charger
The LVAD Battery Charger charges and
reconditions the system batteries. The charger
contains LED status indicators. The charger
requires up to 3.5 hours to fully charge a battery
and between 10 – 14 hours to recondition a
battery.
Independent
Power Supply
The Independent Power Supply provides mains
(AC) electricity to the Controller. When you are
using the Independent Power Supply, the VAD
is not consuming battery power, and the
Controller displays the external power indicator
(a plug symbol) on the front panel. This symbol
indicates that the system is using an external
power source:
Shower bag
The shower bag protects the VADPAK Insert,
Controller, cables, battery pockets, and batteries
while you shower.
ReliantHeart Confidential – Patient and Heath Care Provider Use
Example
3–7
Hospital accessories
Table 3-4 lists the components used by the hospital staff.
Table 3-4.
Hospital accessories
Component
Description
Example
HeartAttendant®
The HeartAttendant® is used to program the
Controller, displays VAD performance and data,
and provide mains (AC) power to the Controller.
It can transmit data via an internet connection.
This device is password protected. It is
connected to the Controller via the
HeartAttendant® connector cable.
Surgery pouch
The surgery pouch is a non-sterile, disposable
pouch that holds the Controller during surgery.
Symbols used in labeling
Table 3-5 lists the symbols used in ReliantHeart product labeling and provides a
description of their meaning.
Table 3-5.
Symbol
Product labeling symbols
Description
Authorized EC representative in the European Community
Batch code
Batteries enclosed
Battery connection – battery 1
Battery connection – battery 2
Catalog or reference number
3–8
HeartAssist 5® VAD System Patient User's Manual
Symbol
Description
Caution; consult accompanying documents
CE mark
Consult operating instructions
Danger; risk of electrical shock
Defibrillation proof – type CF applied part
Diameter
Do not reuse; applies to single-use devices
Do not discard in trash
Do not use if damaged
Double insulated
Fire hazard
For use within temperature limits
ReliantHeart Confidential – Patient and Heath Care Provider Use
3–9
Symbol
Description
Fragile
General caution
General warning
Item showing sterilization method: ethylene oxide
Latex free
Manufactured on YYYY-MM
or
Manufactured on YYYY-MM-DD
Manufacturers name and address
Nationally recognized safe testing lab label
Serial number
Use by YYYY-MM
or
Use by YYYY-MM-DD
3–10
HeartAssist 5® VAD System Patient User's Manual
Documentation
Table 3-6 lists the documentation available for the HeartAssist 5® VAD System.
Table 3-6.
HeartAssist 5® VAD System documentation set
Document
Audience
Description
The HeartAssist 5® VAD System
Patient User’s Manual
(this book)
Patients and caregivers
This manual is a user guide intended for
HeartAssist 5® VAD System patients and
caregivers. It contains descriptions and usage
information for the end user of the HeartAssist 5®
VAD System.
The HeartAssist 5® VAD System
Operator’s Manual
Medical personnel and
technical staff
This manual is a user guide intended for
HeartAssist 5® VAD System surgeons, technical
support staff, and other medical personnel. It
contains detailed instructions for surgical
procedures and system setup for HeartAssist 5®
VAD System medical and technical staff.
ReliantHeart Confidential – Patient and Heath Care Provider Use
3–11
3–12
HeartAssist 5® VAD System Patient User's Manual
Chapter 4
Getting Started with Your HeartAssist 5® VAD System
In this chapter
Introduction ................................................................................................................................... 4-2
General considerations ................................................................................................................. 4-2
Controller ....................................................................................................................................... 4-2
Overview .......................................................................................................................... 4-3
Controller display ............................................................................................................. 4-3
Controller sounds ............................................................................................................. 4-4
Controller messages and alarms ..................................................................................... 4-4
Battery indicators ............................................................................................................. 4-5
Flow sensor ...................................................................................................................... 4-5
Wireless radio antenna .................................................................................................... 4-5
Automatic fail-safe mode ................................................................................................. 4-6
VAD restart algorithm ....................................................................................................... 4-6
Controller replacement ..................................................................................................... 4-7
Controller safety check .................................................................................................. 4-14
Battery pockets ........................................................................................................................... 4-15
VADPAK ...................................................................................................................................... 4-16
VADPAK components .................................................................................................... 4-16
Setting up the VADPAK Insert ....................................................................................... 4-16
Connecting to external power ........................................................................................ 4-21
Power supply............................................................................................................................... 4-22
Batteries ......................................................................................................................... 4-22
LVAD Battery Charger ................................................................................................... 4-28
Independent Power Supply ............................................................................................ 4-30
Connecting the Independent Power Supply to the Controller ........................................ 4-32
ReliantHeart Confidential – Patient and Heath Care Provider Use
4–1
Introduction
You should practice connecting the components of the HeartAssist 5® VAD System with
your support team personnel before you attempt to connect them on your own. This
practice allows you to become familiar with each part of your system, how they connect,
and what they do. If you have any questions during the system connection, ask your
support team personnel for more information.
General considerations
The Controller has alarm sounds and light indicators to alert you about important system
conditions and a display that provides textual information about these conditions. For a
complete description of these messages and alarms, see Appendix B, “Controller
messages and alarms.”
Protect the power cords and equipment cables. Do not put them where people walk. Do
not allow anything heavy to rest on top of or roll over the cables. Avoid pinching cables in
doors, drawers, and so forth. To avoid the possibility of electrical shock, contact the
support team regarding the replacement of frayed or damaged cords and plugs.
Only use the power cables supplied by ReliantHeart.
Ensure that the mains (AC) input voltage is appropriate for the local power
source. Do not use extension cords.
All equipment should sit on a hard, flat, stable surface. Do not place them on surfaces
that could allow them to tip over.
Plug this equipment into grounded outlets only to reduce the risk of shock.
If the power outlets are not grounded, an electrician must install grounded
outlets before you can use this equipment outside of the hospital.
To avoid accidentally switching off the power to your VAD, use outlets that are not
connected to any wall or light switches. Set up your equipment near outlets that meet
these requirements.
Do not block fans or ventilation holes of the equipment. Blocking these
openings can cause heat to build up inside and damage the equipment.
Controller
The Controller provides power to run the VAD, and it displays VAD operating parameters
such as speed, flow, and power usage. It also displays remaining battery life and wireless
4–2
HeartAssist 5® VAD System Patient User's Manual
antenna status. The Controller is equipped with an internal radio for one-way wireless
transmission of data from the Controller to a secure server.
The Controller is designed to be reliable and easy to operate.
Users can choose the Controller option to transmit pump data by radio frequency
transmission, but activating this option is not required for the device to fulfill its
intended use or to meet the indications for use.
Overview
The Controller has two battery cables and one driveline cable for VAD connection. (See
Figure 4-1.) A liquid crystal display (LCD) is integrated into the Controller to display the
operational parameters of the VAD as well as any emergency or diagnostic alarms that
might occur. (See Figure 4-2 on page 4-4.)
Figure 4-1.
Controller
Controller display
The Controller front panel allows you manage alarms and to monitor system status.
Controller front panel features
The front panel of the Controller contains the following features:
 LCD display
 Two battery indicator light emitting diodes (LEDs)
 Fail-safe and emergency mode indicator LED
The indicator LED is red when it activates. It is a solid red for fail-safe alarms, and it
flashes red for emergency alarms.
 Alarm Silence button
 Scroll Display button
Figure 4-2 shows an example of the Controller front panel display.
ReliantHeart Confidential – Patient and Heath Care Provider Use
4–3
Figure 4-2.
Controller front panel
Battery 2
Indicator
Battery 1
Indicator
LCD Display
Alarm Silence
Button
Fail-safe and emergency
mode indicator LED
Scroll Display Button
Adjusting Controller front panel brightness
Use the following steps to adjust the Controller backlight display brightness:
1.
On the Controller, press the Scroll Display button, and hold it for five seconds.
The Controller display flashes when five seconds has passed.
2.
Release the Scroll Display button.
The Controller front panel displays the + and – buttons and a slider, indicating the
current brightness level.
3. Press the + button to increase the brightness, or press the – button to decrease the
brightness.
The brightness slider indicates the new brightness level.
Controller sounds
The Controller emits three distinct sounds:
 A diagnostic alarm is indicated by a slower beeping sound.
 An emergency alarm is indicated by a faster, loud, ringing two-tone sound.
 A Controller failure is indicated by a continuous tone.
Controller messages and alarms
The LCD screen on the front panel of the Controller displays three types of messages:
 Standard messages
 Diagnostic alarms
 Emergency alarms
Standard messages
You can review seven standard information messages on the front panel of the Controller
by pressing the Scroll Display button. With the first press of the Scroll Display button, the
LCD backlights, and each subsequent press changes the display from one message to
the next in a continuous loop.
4–4
HeartAssist 5® VAD System Patient User's Manual
Emergency alarms
When the Controller displays an emergency alarm, the pump is stopped, the back light
automatically lights, an audible alarm sounds, and the emergency alarm indicator flashes
red. The Controller continues to audibly and visually alarm until you resolve the condition
causing the alarm. Pressing the Alarm Silence button has no effect. After you resolve the
condition causing the emergency alarm, the alarm automatically clears.
Diagnostic alarms
When the Controller displays a diagnostic alarm message, the back light automatically
lights, and an audible alarm sounds. Pressing the Alarm Silence button silences the
alarm.
Normal mode
In normal operating conditions with no alarms, the Controller LCD back light is off, and
the Controller displays standard message screen 1: battery status.
Battery indicators
The battery indicators on the top corners of the Controller front panel indicate three
different conditions for each battery.
For a description of these indicators, see Table 4-2, “Controller battery indicator
descriptions,” on page 4-26.
Flow sensor
The Controller contains an integrated flow sensor board that works with the implantable
flow probe. The quality of the flow signal is indicated by the received amplitude shown on
one of the screens of the Controller. See Figure B-4, “Standard message screen 4: flow
probe received amplitude,” on page B-3 as an example.
Any voltage above one volt on either channel A or B indicates that the flow signal quality
is acceptable.
Wireless radio antenna
The Controller contains an internal wireless radio antenna for one-way, wireless,
machine-to-machine transmission of data from the Controller to a secure server. You can
disable the wireless antenna (the equivalent of placing the unit in airplane mode) as
needed.
Users have the option to allow the Controller to transmit pump data by radio
frequency transmission, but this option is not required for the device to fulfill its
intended use or to meet the indications for use.
Use the following steps to enable and disable the wireless antenna:
1. On the Controller, press Alarm Silence button, and hold it for five seconds.
The Controller display flashes when five seconds has passed.
2. Release the Alarm Silence button.
The Controller front panel displays the + and – buttons and a wireless antenna
symbol. If the wireless radio antenna is disabled, the front panel also displays a
circle-backslash symbol.
ReliantHeart Confidential – Patient and Heath Care Provider Use
4–5
3. Press the + button to activate the wireless antenna, or press the – button to disable
the antenna.
See Figure B-3, “Standard message screen 3: wireless antenna status,” on page B-3 for
examples of the wireless antenna Controller display.
Always disable the wireless radio antenna prior to boarding an aircraft.
Automatic fail-safe mode
ReliantHeart equips the Controller with features to provide fail-safe operation in the event
of failure of the internal central processing unit (CPU). The fail-safe mode operation
bypasses the CPU entirely and runs the HeartAssist 5® VAD at the last set speed. Failsafe mode operation activates automatically. In this situation, the Fail-safe and
emergency mode indicator LED on the Controller front panel changes from off to solid
red, and the Controller sounds a continuous high-pitched tone alarm. If these conditions
exist, replace the Controller, and contact your support team immediately for instructions.
VAD restart algorithm
The Controller contains a sophisticated restart algorithm that attempts to restart the VAD
in case of desynchronization or a VAD stoppage.
Automatic restart
If the VAD becomes desynchronized due to the loss of the back-EMF signal or other
momentary VAD stoppage, the Controller attempts to restart the VAD in approximately
two seconds. If this attempt occurs, the LCD displays PUMP STOPPED then PUMP
RESTARTING (only while the VAD is attempting to restart).
If the VAD restarts on the first attempt, the LCD screen clears and returns to the standard
message screen 1: battery status. If the VAD does not restart on the first attempt, the
PUMP STOPPED emergency alarm sounds as well as any additional alarms that can
diagnose why the VAD has stopped. (Examples of additional alarms include BOTH
BATTERIES DISCONNECTED or VAD DISCONNECTED.)
The Controller attempts to restart the VAD for approximately 60 seconds. First, the
Controller attempts to restart the VAD three times with a four-second pause between
each attempt. If these initial attempts are unsuccessful, the cycle is repeated two more
times with a 10-second pause between each set of attempts. The Controller attempts to
automatically restart the VAD up to nine times.
Manual restart
If the nine attempts to automatically restart the VAD are unsuccessful, the Controller
ceases any further attempts to restart the VAD. Initiate manual restarts with the following
method:
1. Disconnect the battery pockets from any external power sources (such as the
Independent Power Supply).
2. Briefly remove both batteries from the battery pockets.
3. Re-insert one of the charged batteries into one of the battery pockets.
This action activates the restart algorithm, which triggers an additional nine automatic
restart attempts.
4–6
HeartAssist 5® VAD System Patient User's Manual
Only attempt to manually restart the VAD one time. If the VAD does not
successfully restart, immediately begin the procedure detailed in the next
section, “Controller replacement.”
When the pump restarts, the PUMP STOPPED emergency alarm automatically
clears.
Controller replacement
Replace the Controller only when it is absolutely clear that the existing Controller has
malfunctioned.
Read all instructions thoroughly before replacing the Controller.
Setting up the equipment
Use the following steps to replace the Controller.
1. Locate the necessary backup equipment:
 Backup Controller
 Independent Power Supply or at least one charged battery
Figure 4-3.
Backup equipment for replacing the Controller
2. Remove the VADPAK Insert from the VADPAK.
ReliantHeart Confidential – Patient and Heath Care Provider Use
4–7
Figure 4-4.
Removing the VADPAK Insert from the VADPAK
3. Arrange all of the components in the VADPAK Insert and all of the backup equipment
so that they are easy to access.
Figure 4-5.
Arranging the components for easy access
Ensure that there is at least one charged battery or an external power source
available.
4–8
HeartAssist 5® VAD System Patient User's Manual
Connecting the backup Controller
The patient must sit or recline for this procedure.
1. Unscrew the defibrillation cover, by turning it counter-clockwise, to access the
driveline connector.
Figure 4-6.
Unscrewing the defibrillation cover
2. Slide the defibrillation cover back along the driveline toward the patient.
3. Disconnect one battery pocket (with charged battery) from the Controller.
Figure 4-7.
Disconnecting one battery pocket from the Controller
4. Connect the battery pocket to the backup Controller.
The backup Controller begins to alarm.
ReliantHeart Confidential – Patient and Heath Care Provider Use
4–9
Figure 4-8.
Connecting the first battery pocket to the backup Controller
5. Pull the ribbed section of the driveline connector to disconnect it from the
malfunctioning Controller.
Figure 4-9.
Disconnecting the percutaneous cable
6. Align the arrow on the driveline connector to the groove on the backup Controller
connector.
Figure 4-10. Aligning the driveline cable to the backup Controller
7. Firmly press the connectors together to connect the backup Controller to the VAD.
A slight click sounds as the connectors snap into place and become fully seated.
4–10
HeartAssist 5® VAD System Patient User's Manual
Align the driveline connector and Controller connector properly. Forcing the
connectors with improper alignment can damage the equipment. Do not twist a
connector plug while inserting it after the connectors are aligned.
The VAD should now be running using the backup Controller.
8. Screw the defibrillation cover to the Controller cable by turning clockwise.
9. Press the Alarm Silence button.
10. Disconnect the second battery pocket from the malfunctioning Controller.
Figure 4-11. Disconnecting the second battery pocket from the Controller
11. Connect the second battery pocket to the backup Controller.
ReliantHeart Confidential – Patient and Heath Care Provider Use
4–11
Figure 4-12. Connecting the second battery pocket to the backup Controller
The malfunctioning Controller continues to alarm for approximately three minutes
after you disconnect the power. You cannot silence this alarm.
Replacing the SIM card
When you replace the Controller, you must transfer the SIM card from the malfunctioning
Controller to the backup Controller. Continue with the following steps to replace the SIM
card.
1. Locate and use the screwdriver supplied by ReliantHeart to remove the SIM card
cover located on both Controllers.
Figure 4-13. Removing the SIM card cover with the ReliantHeart screwdriver
4–12
HeartAssist 5® VAD System Patient User's Manual
Figure 4-14. SIM card covers removed from both Controllers
2. Remove the SIM card from the malfunctioning Controller.
Figure 4-15. Removing the SIM card from the Controller
3. Insert the SIM card into the backup Controller.
The SIM card clicks when it is properly seated.
Figure 4-16. Inserting the SIM card into the backup Controller
4. Reattach the SIM card cover on both Controllers, and secure the cover using the
screwdriver.
ReliantHeart Confidential – Patient and Heath Care Provider Use
4–13
Figure 4-17. Replacing the SIM card cover
5. Contact your support team immediately.
The Controller replacement is now complete.
Controller safety check
ReliantHeart recommends a periodic safety check of the Controller to ensure continued
proper operation.
Perform the following steps to verify the safety of the Controller.
1. Verify that all three connections to the Controller are secure and undamaged.
2. Disconnect the Independent Power Supply from the battery pocket (if connected).
3. Verify that the percent charge of both batteries as displayed on the Controller LCD
indicates a charge level above 25%.
4. Remove battery 1 from the battery pocket.
5. Verify that the % charge of battery 1 displays a line: — and that the LED for battery
1 is a flashing amber light.
6. Reinstall battery 1.
7. Verify that the Controller emits three audible beeps and that the Controller LCD
displays the % charge for battery 1.
8. Remove battery 2 from the battery pocket.
9. Verify that the % charge of battery 2 displays a line: — and that the LED for battery
2 is a flashing amber light.
10. Reinstall battery 2.
11. Verify that the Controller emits three audible beeps and that the Controller LCD
displays the % charge for battery 2.
If the Controller is functioning improperly during the safety check, replace the
Controller using the procedure defined in “Controller replacement” on page 4-7,
repeat the steps in “Controller safety check,” and contact your support team
immediately.
4–14
HeartAssist 5® VAD System Patient User's Manual
Battery pockets
The battery pockets securely hold the lithium ion batteries that power the HeartAssist 5®
VAD System.
Figure 4-18. Battery pocket
Each battery pocket is comprised of the following components:
 Green and amber LED indicators that indicate the status of the battery.
 External interface port that facilitates convenient connection to external power sources
(such as the Independent Power Supply).
 Metal belt clip that allows you to rotate the battery pocket 360° for comfortable
positioning and for attaching to a belt or the VADPAK Insert for easy mobility.
 Retention clip that safely secures the battery in the battery pocket while providing easy
access for battery insertion and removal.
ReliantHeart Confidential – Patient and Heath Care Provider Use
4–15
VADPAK
The VADPAK is an ergonomic storage system that allows the patient to carry the
Controller, battery pockets, and batteries (Figure 4-19).
Figure 4-19. VADPAK
VADPAK components
The VADPAK is comprised of three components:
 A removable VADPAK Insert that organizes the Controller, battery pockets, batteries,
and cables.
 A protective pouch with a padded shoulder strap.
 An emergency information card with appropriate contact information.
Setting up the VADPAK Insert
The VADPAK Insert is a reinforced fabric organizer for the Controller, battery pockets,
batteries, and associated cables. It is designed to allow easy management and transport
of the HeartAssist 5® VAD System during everyday use.
4–16
HeartAssist 5® VAD System Patient User's Manual
Figure 4-20. VADPAK Insert
Use the following steps to set up the VADPAK insert.
1. Place the VADPAK Insert on a secure surface near the percutaneous cable exit site.
2. Slide the battery pockets side by side onto the matching fabric straps on the
VADPAK Insert using the battery pocket belt clips.
Figure 4-21. Securing the battery pockets in the VADPAK Insert
3. Slide the Controller onto the fabric strap using the Controller belt clip so that the
Controller display is facing upward.
ReliantHeart Confidential – Patient and Heath Care Provider Use
4–17
Figure 4-22. Securing the Controller into the VADPAK Insert with the
Controller display facing upward
4. Secure the battery connectors and cables below the Controller using the Velcro®
straps.
Figure 4-23. Securing the battery connectors in the VADPAK Insert
5. Grasp the VADPAK Insert by the handle, and place it in the VADPAK with the
Controller display visible in the clear window of the VADPAK.
4–18
HeartAssist 5® VAD System Patient User's Manual
Figure 4-24. Placing the VADPAK Insert in the VADPAK
Figure 4-25. Viewing the Controller in the clear window of the VADPAK
6. Route the driveline cable to the opening below the end of the zipper in the VADPAK.
ReliantHeart Confidential – Patient and Heath Care Provider Use
4–19
Figure 4-26. Routing the driveline cable in the VADPAK
7. Zip the VADPAK all the way to the end of the zipper to prevent the VADPAK Insert
from falling out of the VADPAK.
Figure 4-27. Zipping up the VADPAK completely
The VADPAK is now ready to carry using the handle or the shoulder strap.
You can easily remove the VADPAK Insert to aid in replacing batteries or connecting
to external power sources.
4–20
HeartAssist 5® VAD System Patient User's Manual
Connecting to external power
Use the following instructions to connect the Controller to external power sources using
the battery pocket’s external power connector. These steps are performed while the
Controller is in the VADPAK Insert.
These instructions apply to all external power supply sources. All external power
sources share identical connectors.
1. Open the VADPAK to expose the external power connector on the bottom of the
battery pocket.
Figure 4-28. Exposing the battery pocket external power connector
2. Visually align the arrow on the power source connector (such as the Independent
Power Supply) with the square on the battery pocket external power connector on the
bottom of the battery pocket.
Figure 4-29. Aligning the arrow on the power source connector with the
square on the battery pocket external power connector
3. Once the arrow and the square are aligned, firmly push the power source connector
straight into the battery pocket external power connector.
ReliantHeart Confidential – Patient and Heath Care Provider Use
4–21
A slight click sounds, and the connectors snap into place as they become fully
seated.
4. When you are connected to a single external power source, the following indications
verify your external power connection:
 The Controller emits three audible beeps.
 The Controller screen and the connected battery pocket both display a solid green
light.
 The external power indicator (a plug symbol) displays on the Controller screen in
place of the charge time remaining for the connected battery pocket.
5. Route the connector cable and the percutaneous cable to the opening below the end
of the zipper.
Figure 4-30. Routing the cables in the VADPAK
6. Zip the VADPAK all the way to the end of the zipper to prevent the VADPAK Insert
from falling out of the VADPAK.
See Figure 4-27, “Zipping up the VADPAK completely” on page 4-20.
The VADPAK is now ready to carry using the handle or the shoulder strap.
Power supply
While you are away from home, the HeartAssist 5® VAD System can draw power from a
variety of sources including batteries, the Independent Power Supply.
Batteries
The batteries that power the VAD are lithium ion smart batteries. Each battery powers the
VAD for approximately 4.5 – 7.5 hours, providing a combined battery time of
approximately 9 – 15 hours.
Figure 4-31 displays an example of a HeartAssist 5® VAD battery.
4–22
HeartAssist 5® VAD System Patient User's Manual
Figure 4-31. HeartAssist 5® VAD battery
Figure 4-32 displays an example of the charge level indicators on a battery.
Figure 4-32. Battery charge level LED indicators
Each battery contains an integrated charge level indicator display consisting of four LEDs
on the face of the battery. The LEDs represent the maximum charge level the battery
contains in 25% increments. Table 4-1 describes the LED battery charge level indicators.
 To activate the charge level indicator display on the battery, press the circular Check
button above the indicator LEDs.
ReliantHeart Confidential – Patient and Heath Care Provider Use
4–23
Table 4-1.
Battery charge level LED indicators
Charge level indicator LEDs on battery
Percent charged
75% – 100%
50% – 75%
25% – 50%
1 red
10% – 25%
1 flashing red
Below 10%
The battery in Figure 4-32 is 25% – 50% charged.
Battery time can vary from patient to patient depending on the set VAD speed.
Connecting a battery pocket to the Controller
The Controller connects to the battery pockets with connectors that are on the end of
cables extending from the units. The Controller has two connectors that connect to the
battery pockets, and these connectors are designed for ease of use.
Use the following steps to connect the battery pocket connectors to the Controller
connectors.
1. Visually align the arrow on the battery pocket connector with the square on the
Controller connector.
Figure 4-33. Aligning the arrow on the battery pocket connector with the
square on the Controller connector
2. After you align the arrow and the square, firmly push the battery pocket connector
straight into the Controller connector.
4–24
HeartAssist 5® VAD System Patient User's Manual
 A slight click sounds, and the connectors snap into place as they become fully
seated.
 The Controller emits three audible beeps, and the Controller LCD displays the
percent charge for the connected battery pocket.
 If the connected battery is either discharged or expired, the battery indicator LED
for that battery pocket flashes an amber light, and the Controller emits audible
alarms and displays visual alarms.
Figure 4-34. Batteries connected to the Controller
 Alternately, if you cannot visually align the arrow and the square, use the following
steps:
a. Gently insert the battery pocket connector 2mm (1/16 of an inch).
b. With very little pressure applied, rotate the battery pocket connector until it
mates with the Controller connector and no longer rotates freely.
c.
Firmly push the battery pocket connector straight into the Controller connector
until they are fully seated.
Align all connectors properly. Forcing connectors without proper alignment
can damage the equipment. Do not try to force a power source connector into
the battery pocket external power connector. When removing a cable, hold the
connector, and pull it out. Do not twist the connectors while inserting them or
removing them after the connectors are aligned.
Both battery pocket connectors are identical. The Controller automatically switches
to draw power from the appropriate battery.
When an external power source (such as the Independent Power Supply) is
connected to the battery pocket external power connector, the power source
bypasses the battery in the battery pocket and supplies power directly to the
Controller port. The Controller displays the external power indicator (a plug symbol)
in place of the battery charge percentage.
ReliantHeart Confidential – Patient and Heath Care Provider Use
4–25
Interpreting Controller battery indicators
The battery indicators on the top corners of the Controller front panel indicate three
different conditions for each battery. See Figure 4-2, “Controller front panel,” on page 4-4
for an example of the battery indicators.
Table 4-2.
Controller battery indicator descriptions
Indicator condition
Meaning
Solid green
This battery pocket is connected to external power, and the
Controller is using external power from this battery pocket to run
the VAD.
Flashing ambera
This battery pocket contains either a discharged, an expired, or no
battery.
Off
This battery pocket contains a battery with an adequate charge
level, which is correctly installed and is in use or is ready for use.
Flashing amber lights indicate batteries that should be changed. Always change batteries
with flashing amber lights before batteries with no lights.
The Controller always uses the battery with the lower charge and continues to use
the battery down to a 25% charge level, thus preserving the battery with the highest
charge for later use.
You must periodically (every two to three hours) visually inspect the front
panel of the Controller to verify battery status in case of a diagnostic audible
alarm failure.
Changing a battery
Use the following steps to change a battery.
1. Determine which battery to change by selecting the one with the lower charge using
one of the following methods:
 Use the LCD display on the Controller.
See Figure B-1, “Standard message screen 1: battery status,” on page B-2.
 Use the battery indicator LED on the Controller or battery pockets.
See Table 4-2, “Controller battery indicator descriptions,” on page 4-26.
 Press the battery charge level indicator Check button on each battery to determine
its charge level.
Batteries with adequate charge levels have no indicator lights on the Controller
and battery pockets. Batteries with flashing amber indicator lights on the Controller
and battery pockets have less than a 25% charge level and should be changed
first. See Table 4-2, “Controller battery indicator descriptions,” on page 4-26 for
other battery conditions and Figure 4-32, “Battery charge level indicators,” on page
4-23.
2. Ensure that the remaining battery indicates adequate charge on the Controller LCD
display.
3. Remove the battery with the lower charge from the battery pocket.
4–26
HeartAssist 5® VAD System Patient User's Manual
Figure 4-35. Removing the battery from the battery pocket
4. Verify that the battery to be inserted is fully charged by pressing the battery level
charge indicator Check button on the battery itself.
See Table 4-1, “Battery charge level LED indicators,” on page 4-23. All four LEDs on
the battery should illuminate, indicating a charge between 75% and 100%.
5. Align the connector on the battery with the receptacle in the pocket, and insert the
charged battery into the pocket until it clicks.
 The Controller emits three audible beeps, and the Controller LCD displays the
percent charge for the connected battery. Any flashing amber indicator lights turn
off.
 The BATTERY DISCHARGED and BATTERY DISCONNECTED alarms clear
automatically.
6. Verify the percent charge of the replaced battery on the Controller LCD display.
See the following section, “Verifying battery charge status.”
Only remove one battery at a time from the battery pockets. Removing both
batteries simultaneously causes the VAD to stop (unless you are in tethered
mode). The batteries must be reconnected as quickly as possible to resume
VAD function.
ReliantHeart Confidential – Patient and Heath Care Provider Use
4–27
Do not handle batteries by the connector pins. A strong static discharge can
cause the charge level indicator to temporarily malfunction. If the charge level
indictor ceases to function, place the battery into a ReliantHeart charger, and
recharge the battery.
Verifying battery charge status
Use one of the following methods to check the charge status of either battery:
 Look at the Controller LCD display.
 Press the Check button on the battery, adjacent to the battery charge indicator LEDs.
See Table 4-1, “Battery charge level LED indicators,” on page 4-23 for a description of
the LED meanings.
Even when they are connected to an external power source (such as the
Independent Power Supply), the batteries located inside the battery pockets
drain and lose charge over time. Verify that the two batteries in the battery
pockets have sufficient charge levels prior to disconnecting the system from
an external power source.
Verifying battery capacity
Battery capacity number refers to the total power available from the battery when fully
charged. As the battery ages with normal use, this number decreases.
Verify the total battery capacity using standard message screen 6: battery capacity on the
Controller. (See Figure B-6 on page B-3.) The screen displays the maximum battery
capacity in milliamp hours. Once a battery displays a total capacity of 6000 milliamp
hours or less, contact your support team for a replacement battery.
Obtain replacement batteries from ReliantHeart after the battery capacity
indicates less than 6,000 milliamp hours. Only use batteries supplied by
Reliant Heart.
A battery that displays less than 6000 milliamp hours is still a good battery; however,
the battery might not provide as much total support time as a new battery.
LVAD Battery Charger
Figure 4-36 displays the LVAD Battery Charger. It charges and reconditions batteries
used with the HeartAssist 5® VAD System. Table 4-3, “LVAD Battery Charger status
lights description,” on page 4-30 describes the charge indicator lights.
With batteries, the LVAD Battery Charger weighs approximately 3.6 pounds (1.7 kg). It is
enclosed in a durable case that is both moisture and flame resistant.
4–28
HeartAssist 5® VAD System Patient User's Manual
Figure 4-36. LVAD Battery Charger
Certain battery charger can only charge or recondition one battery at a time. This is
denoted by the recondition arrow solely indicating the left bay as the reconditions lot.
Please verify the proper model before following the steps for charging or
reconditioning of batteries..
Connecting to a power source
Use the following steps to connect the LVAD Battery Charger to wall power.
1. Plug the main power cord into the AC power input on the LVAD Battery Charger.
2. Connect the plug to an AC power source.
The power adapter is universal for both domestic and European AC input voltages.
Charging batteries
Use the following steps to charge the batteries.
1. Identify the appropriate model, before attempting reconditioning or charging.
2. Inspect the connector end of each battery to ensure that it is clean.
3. Insert one or two batteries into the two bays of the LVAD Battery Charger.
4. Allow 5 – 10 seconds for the LVAD Battery Charger to recognize the battery.
Depending on model type, the charger can charge one or two batteries
simultaneously.. The charging process can take up to 3.5 hours per battery. If the
battery status light below the battery bay flashes green, the battery is charging. If a
battery status light flashes red, the battery charger is in error mode.
If the battery status lights flash a red color, you must remove both batteries and
unplug the power cord. Wait 15 seconds, reinsert the batteries, and reconnect the
power cord. If the batteries are warm, wait for 30 minutes before reinserting them.
ReliantHeart Confidential – Patient and Heath Care Provider Use
4–29
Always check batteries by pushing the charge level indicator Check button on the
battery to verify charge level when removing batteries from the LVAD Battery
Charger.
Using a battery charger that is not supplied by ReliantHeart could result with
batteries that could be charged inappropriately causing an over or under charged
condition resulting in discharge times that are noticeably shorter than intended.
Table 4-3 describes the LVAD Battery Charger status lights.
Table 4-3.
LVAD Battery Charger status lights description
Light status
Battery status
Off
No battery
Green flashing
Fast charging
Green solid
Fully charged
Amber flashing
Reconditioning
Amber and green
Reconditioned
Amber solid
Standby or Suspend
Red flashing
Error
Reconditioning batteries
To maintain the accuracy of the battery indicators, batteries must occasionally run
through a recondition cycle. Use the following steps to recondition batteries.
1. Place the battery into the left bay, for chargers with only one reconditions slot. Use
either slot with the charger capable of reconditioning in either position.
2. Press the Recondition button on the front label of the charger, directly below the
battery slot. The reconditioning process can take up to 9 hours.
Connection other than indicated can result in permanent damage to the LVAD
Battery Charger.
Avoid placing or operating the LVAD Battery Charger in areas or near
appliances that expose it to temperatures outside of the operating range of the
device, which is 0 °C (32 °F) to 50 °C (122 °F).
Independent Power Supply
The Independent Power Supply is a portable power supply that supplies AC power to the
VAD via the battery pocket external power connector.
Use this power supply as a backup power source in conjunction with the two battery
pockets containing charged batteries.
4–30
HeartAssist 5® VAD System Patient User's Manual
Figure 4-37. Independent Power Supply
The Independent Power Supply is for use only by patients who are implanted with
the HeartAssist 5® VAD System.
Do not store or use the Independent Power Supply near water or any liquid (for
example, in the bathroom or kitchen) due to the risk of electrical shock.
The Independent Power Supply contains no user-serviceable parts. Do not
open the back cover of the Independent Power Supply. Only qualified
ReliantHeart personnel can service this equipment. If service is required,
contact your support team.
Avoid placing or operating the Independent Power Supply in areas or near
appliances that expose it to temperatures outside the operating range of the
device, which is 0 °C (32 °F) to 40 °C (104 °F) or where relative humidity is
noncondensing, less than 10% Rh or greater than 75% Rh.
Do not trip over the power cord. Instruct persons in the area to prevent
tripping.
ReliantHeart Confidential – Patient and Heath Care Provider Use
4–31
Connecting the Independent Power Supply to the Controller
Figure 4-38 and the following instructions serve as a guide for connecting the
Independent Power Supply to an AC power source and to the Controller.
Figure 4-38. Independent Power Supply connection diagram
Use the following instructions to connect the Independent Power Supply to the Controller.
1. Plug the power cord of the Independent Power Supply into the wall plug. See “1” in
Figure 4-38.
2. Plug the power cord into the Independent Power Supply. See “2” in Figure 4-38.
3. Plug the Independent Power Supply connector into the battery pocket external power
connector (which is already connected to the Controller; see “Connecting a battery
pocket to the Controller” on page 4-24). See “3” in Figure 4-38.
If all connections are secure, and the components are working properly, the Controller
emits three audible beeps, the Controller front panel displays the external power indicator
(a plug symbol), and the battery indicator LED on the Controller’s front panel displays a
solid green light for the connected battery pocket.
When you are using the Independent Power Supply, the Controller uses power from the
grounded AC wall outlet. The Controller can also receive backup power from the two
charged batteries in the battery pockets if the wall outlet fails. If a power failure occurs,
the Controller sounds an audible alarm, notifying you that it is using backup battery
power.
Use the Independent Power Supply only with a properly grounded plug. To
reduce the risk of electrical shock, plug this equipment into grounded outlets
only. If your power outlets are not grounded, an electrician must install
grounded outlets before you can use this equipment outside of the hospital.
4–32
HeartAssist 5® VAD System Patient User's Manual
Chapter 5
Everyday Use and Self Care
In this chapter
Introduction ................................................................................................................................... 5-2
Daily status checks ....................................................................................................................... 5-2
Upon waking .................................................................................................................... 5-2
Before sleeping ................................................................................................................ 5-2
Daily operation .............................................................................................................................. 5-3
Tethered operation ........................................................................................................... 5-3
Untethered operation ....................................................................................................... 5-3
Switching from tethered to untethered operation ............................................................. 5-4
Switching from untethered to tethered operation ............................................................. 5-5
Leaving the home............................................................................................................. 5-6
Showering with the VADPAK Insert and shower bag ...................................................... 5-6
Activity restrictions ........................................................................................................... 5-8
Self care at home .......................................................................................................................... 5-9
Caring for the exit site ...................................................................................................... 5-9
Caring for the percutaneous cable ................................................................................. 5-10
Caring for the VADPAK .................................................................................................. 5-10
Taking medications ........................................................................................................ 5-10
Emergencies ............................................................................................................................... 5-11
Local emergency services ............................................................................................. 5-11
CPR and defibrillation .................................................................................................... 5-11
Power outages ............................................................................................................... 5-11
ReliantHeart Confidential – Patient and Heath Care Provider Use
5–1
Introduction
Hospital staff should initially supervise system management, and then, as appropriate,
transfer management to the patient.
Daily status checks
Check the Controller, the primary and reserve batteries, the Independent Power Supply,
and the LVAD Battery Charger every day as described below.
Contact your support team if any of the Controller alarms are not working.
Every two – three hours when you are awake (whether you are attached to the
Independent Power Supply or not), check the battery status on the Controller
front panel.
Upon waking
When you awaken in the morning, check the front panel display of the Controller for
lighted symbols and messages. If the Controller is displaying alarm messages, see
“Emergency alarms” on page B-4 and “Diagnostic alarms” on page B-6.
Before sleeping
Before you go to sleep, ensure that you verify the following statuses:
 Verify that the battery status lights are lit for all reserve batteries in the LVAD Battery
Charger.
 Verify that you have two fully charged batteries in the battery pockets.
 Verify that the Independent Power Supply is supplying power to the Controller by
performing the following steps:
a. Verify that the battery LED on the Controller’s front panel is solid green for the
battery pocket connected to the Independent Power Supply.
b. Press the Scroll Display button on the front panel of the Controller to verify that the
battery percentage is displaying the external power indicator (a plug symbol) for
the battery pocket connected to the Independent Power Supply.
Figure 5-1.
Standard message screen 1 display on the Controller front panel
when using external power
Battery 2 External
Power Indicator
5–2
HeartAssist 5® VAD System Patient User's Manual
Daily operation
Always connect the Controller to two power sources. The VAD draws power from one
source at a time. The second source serves as backup power. When you are using the
two batteries in the battery pockets as the primary and backup power sources, ensure
that you check the remaining charge in each battery every hour.
While you are relaxing or sleeping, use the Independent Power Supply in the tethered
mode of operation (described in the following section).
When you are active, you usually use the batteries in the battery pockets in the
untethered mode of operation. The system is not connected to the Independent Power
Supply during this time.
Tethered operation
During times of little activity, such as when you are sleeping or relaxing, you should use
the Independent Power Supply. This method is called tethered operation. The
HeartAttendant® is only used while you are in the hospital and the physician wants to
monitor your condition.
The system must be in tethered mode whenever you think you might fall asleep or if
charged batteries are not available for use in the battery pockets.
When you use the Independent Power Supply the Controller uses power from the
grounded AC wall outlet. The Controller can also receive backup power from the batteries
in the battery pockets if the wall fails.
Untethered operation
When active, most patients prefer using the batteries in the battery pockets (untethered
operation) instead of having the system plugged into the Independent Power Supply in
tethered mode.
The battery pockets must contain two fully charged batteries before you switch to
untethered mode. The Controller draws power from one battery before drawing power
from the second battery. This design ensures that the second battery will have energy
remaining when the first battery falls below a 25% charge level.
Each fully charged battery powers the VAD for approximately 4.5 – 7.5 hours, giving a
combined battery time of approximately 9 – 15 hours. Higher VAD speeds can reduce
battery charge levels. The Controller front panel displays the percent charge level for
each battery.
A fully charged battery provides adequate power to run the VAD for 4.5 – 7.5 hours.
If the VAD speed is set high, it reduces the amount of time the battery can operate
the VAD.
The amount of time that you stay in untethered operation depends on the set VAD
speed and the number of reserve batteries available.
Only use batteries supplied by ReliantHeart.
ReliantHeart Confidential – Patient and Heath Care Provider Use
5–3
Switching from tethered to untethered operation
Use the following steps to change the power source from tethered to untethered
operation.
Verifying battery charge
Use the following steps before you disconnect from the Independent Power Supply.
Verify that the charge level of the two batteries connected to the Controller is nearly full
(>80%) on the Controller front panel.
Figure 5-2.
Standard message screen 1 display on the Controller front panel
when using battery power
Battery 2 Percent
Charge Remaining
Battery 1 Percent
Charge Remaining
Battery 1 Charge
Time Remaining
hh:mm
Battery 2 Charge
Time Remaining
hh:mm
If one or both batteries are not near charge capacity, proceed as follows:
1. Remove one or two fully charged batteries from the LVAD Battery Charger.
2. Check the batteries by pushing the charge indicator button on each battery to verify
charge level.
3. Remove only one discharged battery from the battery pocket and insert the fully
charged battery.
4. Remove the second discharged battery from the battery pocket and insert the fully
charged battery.
Only remove one battery at a time from the battery pockets. Removing both
batteries simultaneously causes the VAD to stop (unless you are in tethered
mode). The batteries must be reconnected as quickly as possible to resume
VAD function.
5. Check the charge level of the new battery connected to the Controller on the
Controller front panel.
Disconnecting from the Independent Power Supply
Use the following steps to disconnect the battery pocket from the Independent Power
Supply and complete the process of switching to untethered operation.
Disconnect the Independent Power Supply from the battery pocket external power
connector as follows:
1. With one hand, firmly hold the battery pocket external power connector.
2. With the other hand, pull the power source connector from the battery pocket external
power connector.
This connection might be tight and might take some force to pull loose.
5–4
HeartAssist 5® VAD System Patient User's Manual
Do not twist the connector while removing it. Do no pull on the cables..
During untethered operation, check the charge level of both batteries in the battery
pockets every hour to ensure that enough power is available..
Always disconnect the Independent Power Supply connector from the battery pocket
external power connector before removing power to or turning off the Independent
Power Supply.
Switching from untethered to tethered operation
Use the following steps to change the power source from untethered to tethered
operation.
Verifying Readiness
Ensure that the Independent Power Supply is ready to be used.
 Verify that the system status light of the Independent Power Supply is a steady green.
Connecting to the battery pocket external power connector
Use the following general steps to connect the power source connector (Independent
Power Supply connector) to the battery pocket external power connector.
1. Visually align the arrow on the power source connector with the square on the battery
pocket external power connector.
2. Once the arrow and square are aligned, firmly push the power source connector into
the battery pocket external power connector.
You hear a slight click as the connectors become fully seated.
You can damage the connectors if you force them without proper alignment.
After the connectors are aligned, do not twist the power source connector
while connecting it.
If all connections are tight and the components are working properly, the Controller
emits three audible beeps, the Controller front panel displays the external power
indicator (a plug symbol), and the battery indicator LED on the Controller’s front
panel displays a solid green light for the connected battery pocket.
If a power failure is expected to last for an extended period of time, take the
Independent Power Supply, the LVAD Battery Charger, and all batteries to the
nearest location with suitable mains power.
Ensure that batteries that are not being used in the battery pockets are always
charging in the LVAD Battery Charger while you are in the tethered mode of
operation.
ReliantHeart Confidential – Patient and Heath Care Provider Use
5–5
Leaving the home
Always travel with fully charged batteries, a spare Controller, a spare battery pocket, the
Independent Power Supply, extra batteries and the LVAD Battery Charger. You might
need these components in an emergency.
When you travel away from home, carry a card, letter or other medical notification that
identifies you as a left ventricular assist device (HeartAssist 5® VAD) patient. This
notification should include the name and telephone number of your doctor in case of an
emergency.
Before going on extended trips, notify your support team.
Showering with the VADPAK Insert and shower bag
Your doctor will provide instructions for the exit site care before, during, and after
showering.
Do not shower with the VAD connected to the Independent Power Supply (in
tethered mode). Showering in untethered mode reduces the risk of electrical
shock.
Do not submerge the Controller in liquid. Submerging the Controller in liquid
might damage internal parts, causing the device to malfunction. Showers and
washing are permitted when the clinician approves wound site readiness.
During showers, you must use the shower bag. Do not expose the Controller
to moisture.
Do not submerge batteries in liquid or expose them to heat or moisture.
Submerging the batteries in liquid or exposing them to heat might cause them
to malfunction. During showers, you must use the shower bag to prevent
exposure to moisture.
Ensure that the VADPAK Insert is properly encased in the provided shower
bag before showering.
Use the following instructions to encase the VADPAK Insert with components into the
shower bag for showering.
1. Open the top cover of the shower bag.
2. Insert the VADPAK Insert, containing the Controller, battery pockets, two charged
batteries, and cables into the shower bag with the VAD percutaneous cable pointing
towards the left (as viewed facing the shower bag).
The percutaneous cable connection must remain dry in the shower bag.
5–6
HeartAssist 5® VAD System Patient User's Manual
Figure 5-3.
3.
Properly inserting the Controller, battery pockets, batteries, and
cables in the VADPAK Insert into the shower bag
Secure the percutaneous cable to the side of the shower bag using the Velcro® strap
attached to the left side of the shower bag.
Figure 5-4.
Securing the percutaneous cable to the side of the shower bag
4. Close the lid of the shower bag, and carefully press the sides of the cover inward to
secure the Velcro® fasteners located along each face of the shower bag.
ReliantHeart Confidential – Patient and Heath Care Provider Use
5–7
Figure 5-5.
Properly closing and securing the lid of the shower bag
5. When you are finished showering, carefully dry off the outside of the shower bag,
open the top cover of the shower bag, and remove the VADPAK Insert. If water has
leaked into the shower bag, contact your support team immediately.
Do not use the VADPAK Insert and Controller in the shower bag longer than 30
minutes because the Controller requires air circulation for proper cooling.
Position the shower bag so that it does not tip or drop. Do not allow the
shower bag to sit in liquid.
Activity restrictions
The HeartAssist 5® VAD System lets you move around and be active; however, there are
some restrictions associated with the device. The following tables describe prohibited
activities.
The activities described in Table 5-1 are always prohibited for your safety and for the
function of the device. Ask the doctor what types of activities you are allowed to perform.
Table 5-1.
5–8
Prohibited activities
Activity
Notes
Total body submersion
(swimming or bathing)
Do not submerge the Controller or batteries in water. Submerging
these components can cause the device to malfunction.
Steam bath or dry saunas
Do not operate the system in environments where the temperature
is less than 10 °C or greater than 40 °C.
Participation in contact
sports
Hard physical contact with other people or objects could damage
the external HeartAssist 5® VAD System hardware, injure internal
organs, or interfere with the tissue healing at the exit site.
HeartAssist 5® VAD System Patient User's Manual
Consult the doctor and gain prior approval before engaging in the activities described in
Table 5-2.
Table 5-2.
Restricted activities
Activity
Notes
Showering
Obtain approval from the doctor. A shower bag is also required.
Driving an automobile
Obtain approval from the doctor. In addition, local laws may
prohibit persons in your condition from operating motor vehicles.
Flying
Obtain approval from the doctor. In addition, check with the airlines
about possible special requirements.
Non-contact sports
(golfing, jogging, tennis)
You and your doctor can determine whether participation in a
certain sport could cause equipment damage or bodily harm.
The activities described in Table 5-3 have no known risks.
Table 5-3.
Permitted activities
Activity
Notes
Careful sponge baths
No total submersion
Sexual activity
Housework
Moderate exercise
Walking, gardening, cycling, and so forth
Shopping
Self care at home
Use the following instructions to care for yourself and HeartAssist 5® VAD System while
you are away from the hospital.
Caring for the exit site
The tube (percutaneous cable) that protrudes from your skin contains wires that connect
the HeartAssist 5® VAD to the Controller and allow the VAD and Controller to
communicate. The area where the percutaneous cable comes out of your skin is called
the exit site.
The physician’s orders supersede these cleaning instructions. You should always
follow the physician’s orders regarding the care of the exit site and other surgical
locations.
Change the percutaneous cable exit site dressing daily using strict aseptic technique
(sterile gloves minimally).
1. Gently cleanse the site with a mild disinfectant soap (preferably chlorhexidine
solution).
2. Rinse with sterile normal saline solution.
3. Dry the cleansed site using a sterile 4” x 4” gauze pad.
4. Cover the cleansed and dried site with a dry, sterile dressing.
ReliantHeart Confidential – Patient and Heath Care Provider Use
5–9
Do not apply prophylactic topical agents to the exit site wound unless ordered by the
physician.
As you clean the exit site each day, examine it for signs of infection such as the following:
 Redness
 Swelling
 Drainage
 Open sores or ulcers
 Pain
 Skin that is warm to the touch
If any sign of infection or break in the tissue is present, contact the doctor immediately.
Caring for the percutaneous cable
It is extremely important that the percutaneous cable is protected from extreme or
frequent bending or kinking. Damage to the percutaneous cable, depending on the
degree, can cause the VAD to stop.
Follow these recommendations to reduce damage to the percutaneous cable:
 Do not severely bend or kink the percutaneous cable.
 Do not let the percutaneous cable become twisted.
 Allow for a gentle curve of the percutaneous cable.
 Do not severely bend the percutaneous cable multiple times or wrap it tightly.
 Keep the percutaneous cable clean. Wipe off any dirt or grime that appears. If
necessary, use a towel with soap and warm water to gently clean the percutaneous
cable. However, never submerge the cable or other system components in water or
liquid.
 Do not pull on or move the cable going through the skin.
 Be aware of the location of the Controller at all times.
 Protect the Controller from falling or from pulling on the percutaneous cable.
 Do not allow the percutaneous cable to catch or snag on anything that will pull on or
move the cable.
 Check the percutaneous cable daily for signs of damage (such as cuts, holes, or
tears).
Caring for the VADPAK
The VADPAK is an ergonomic storage system that allows you to carry the Controller,
battery pockets, and batteries. If you are going for a walk, disconnect the Independent
Power Supply (possibly the HeartAttendant® if in the hospital).
Taking medications
Your doctor might prescribe an anticoagulant such as warfarin (Coumadin®) and might
prescribe other drugs to take while you are on the HeartAssist 5® VAD support. It is
important that you take these and other medications according to your doctor’s
instructions.
Contact your doctor if you have questions about your medications.
5–10
HeartAssist 5® VAD System Patient User's Manual
Emergencies
An emergency situation can be caused by medical conditions or by mechanical problems
that interfere with the pumping ability of the HeartAssist 5® VAD. You and your
caregivers must learn how to identify and respond to emergencies. The most important
action is to restore power to your HeartAssist 5® VAD.
Local emergency services
You or your caregivers should brief local emergency services about your HeartAssist 5®
VAD, and your caregivers should establish a plan to activate these emergency services
when needed.
CPR and defibrillation
If defibrillation is required, you can be connected either to battery power, the
HeartAttendant®, or the Independent Power Supply. While you are implanted with the
HeartAssist 5® VAD, you can receive cardiopulmonary resuscitation (CPR).
Caregivers and health care providers might not be able to feel your pulse, even if the
HeartAssist 5® VAD is operating normally, so CPR and defibrillation should not be
performed if you are awake and responsive, even if a pulse is not apparent.
Power outages
If your current location loses power, and you are not certain when it will be restored, you
must temporarily move to a location with power as soon as possible to prevent the
HeartAssist 5® VAD from stopping. Bring your Independent Power Supply, LVAD Battery
Charger, and reserve batteries with you to the new location.
ReliantHeart Confidential – Patient and Heath Care Provider Use
5–11
5–12
HeartAssist 5® VAD System Patient User's Manual
Chapter 6
Equipment Care and Maintenance
In this chapter
Introduction ................................................................................................................................... 6-2
All HeartAssist 5® VAD System components ............................................................................... 6-2
Environmental conditions ................................................................................................. 6-2
Contact with liquids .......................................................................................................... 6-3
Electromagnetic disturbances .......................................................................................... 6-3
Service ............................................................................................................................. 6-4
Controller ....................................................................................................................................... 6-4
LVAD Battery Charger .................................................................................................................. 6-4
Independent Power Supply ........................................................................................................... 6-5
ReliantHeart Confidential – Patient and Heath Care Provider Use
6–1
Introduction
The HeartAssist 5® VAD System is made of tough, durable materials, but it does require
some basic care as described in the following sections. In addition, support team
personnel should perform periodic safety and function checks of your HeartAssist 5®
VAD System equipment.
All HeartAssist 5® VAD System components
The following subsections “Environmental conditions,” “Contact with liquids,”
“Electromagnetic disturbances,” and “Service” apply to all HeartAssist 5® VAD System
components.
Environmental conditions
The HeartAssist 5® VAD System components operate under the following environmental
conditions.
 Do not operate the Controller where temperatures are less than -10 °C (14 °F) or
greater than 40 °C (104 °F), or where the relative humidity is non-condensing, less
than 10% Rh or greater than 75% Rh.
 Do not operate the Independent Power Supply where temperatures are less than 0 °C
(32 °F) or greater than 40 °C (104 °F) or where the relative humidity is noncondensing, less than 10% Rh or greater than 75% Rh.
 Do not operate the LVAD Battery Charger where temperatures are less than 0 °C (32
°F) or greater than 50 °C (122 °F), or where the relative humidity is non-condensing,
less than 10% Rh or greater than 75% Rh.
 Do not store the system in environments where temperatures are less than –20 °C
(–4 F) or greater than 55 °C (131 °F).
 Do not expose the batteries to moisture or heat.
 Do not expose the Controller, VADPAK, VADPAK Insert, battery pockets, Independent
Power Supply to moisture.
 The VADPAK carry bag is flame retardant, but you must be careful when using the
bag near open flame or embers. Any hot item that falls onto or within the bag must be
removed as quickly as possible to prevent scorching or marring of the materials.
 The Controller meets the IP32 rating as designated in IEC 60529 Degrees of
protection provided by enclosures. This rating signifies that the Controller case
protects the Controller hardware and software from dripping fluid and solid foreign
objects ≥ 2.5 mm in diameter.
 Do not transport the HeartAssist 5® VAD System in environments where
temperatures are less than 0 °C (32 °F) or greater than 55 °C (122 °F).
 Travel should be limited to pressure altitude of 0 – 2000 m (6500 ft).
 The altitude specification does not limit use of the device on fixed wing aircraft, since
commercial planes utilize pressurized cabins. For example, when a plane is traveling
at 35,000 feet altitude, the pressurized altitude inside the cabin is equivalent to 5,400
feet above sea level.
6–2
HeartAssist 5® VAD System Patient User's Manual
Contact with liquids
All HeartAssist 5® VAD System components (with the exception of the shower bag) are
susceptible to damage by liquids. Keep all liquids away from HeartAssist 5® VAD System
components.
Keep all liquids away from equipment to avoid accidental spills. Do not put any
part of this equipment under water or in other liquids. Contact with liquids
increases the risk of electrical shock and of damage to the equipment.
Electromagnetic disturbances
Laboratory testing suggests that patients have little risk from most devices that might
produce electromagnetic disturbances (such as metal detectors, microwave ovens, and
cellular phones). However, such devices can affect electronic equipment at very close
range. For this reason, observe the recommended separation distances in Tables D-1
through D-4 beginning on page D-2 in Appendix D, “Manufacturer guidance for
environmental conditions.”
The HeartAssist 5® VAD has been shown to have acceptable risk regarding
electromagnetic disturbances, as specified by international standard IEC 60601-12:2007.
The system has not been tested with each possible brand of device, and the
possibility of electromagnetic disturbances exists.
If you experience unexpected changes in the speed of the VAD, investigate
potential sources of electromagnetic disturbances (such as cellular phones,
radio transmitters, or microwave ovens) within a few feet. If you discover
disturbances, move away from the potential source, and determine if the VAD
operation returns to normal. If it does not return to normal, contact your
support team.
Do not subject patients implanted with the VAD to magnetic resonance
imaging (MRI). The VAD contains ferromagnetic components, and MRI can
cause device failure or patient injury.
Figure 6-1.
MRI warning and safety seal
MR unsafe
ReliantHeart Confidential – Patient and Heath Care Provider Use
6–3
VAD support equipment was assessed for basic electrical and constructional safety
with respect to IEC/EN 60601-1/A2: 1995
UL2601-1: 1997 (North American Deviations to IEC 60601-1)
UL60601-1: 2003 (HeartAttendant®)
CAN/CSA-C22.2 No. 601.1-M90 (with updates 1 and 2 for HeartAttendant®) Service
Service
There are no user-serviceable parts in the Controller, LVAD Battery Charger, or
Independent Power Supply. Contact your support team for service of this equipment.
Do not service this equipment yourself. Only qualified personnel can service
this equipment. If service is required, contact your support team.
Do not modify this equipment. No modification of this equipment is allowed.
Do not open the back cover of any ReliantHeart device.
Controller
The Controller does not require routine maintenance. You can wipe dust off of the
surface of the device with a clean, dry, lint-free cloth, and you can clean spills from the
cover with a dampened cloth.
Do not drop the Controller on any hard surface. Dropping the Controller can
damage internal parts causing the device to malfunction.
LVAD Battery Charger
The LVAD Battery Charger does not require routine maintenance. You can wipe dust off
of the surface of the device with a clean, dry, lint-free cloth, and you can clean spills from
the cover with a dampened cloth.
6–4
HeartAssist 5® VAD System Patient User's Manual
Do not attempt to wipe liquid from the inside of the LVAD Battery Charger
battery bays as this action might bend or otherwise damage the connector
pins.
Independent Power Supply
The Independent Power Supply does not require routine maintenance. You can wipe dust
off of the surface of the device with a clean, dry, lint-free cloth, and you can clean spills
from the cover with a dampened cloth.
ReliantHeart Confidential – Patient and Heath Care Provider Use
6–5
6–6
HeartAssist 5® VAD System Patient User's Manual
Chapter 7
The Pediatric Patient on HeartAssist 5® LBSA VAD Support
In this chapter
Introduction ................................................................................................................................... 7-2
Implant surgery ............................................................................................................................. 7-2
System description ........................................................................................................................ 7-2
Environmental conditions .............................................................................................................. 7-2
Temperature..................................................................................................................... 7-2
Contact with liquids .......................................................................................................... 7-3
Electromagnetic disturbances .......................................................................................... 7-3
Electrostatic discharge ..................................................................................................... 7-4
Operating the HeartAssist 5® LBSA VAD system ........................................................................ 7-4
Batteries ........................................................................................................................... 7-4
VADPAK ........................................................................................................................... 7-4
Percutaneous cable ......................................................................................................... 7-5
Daily operation for the pediatric patient ........................................................................................ 7-5
Leaving the home............................................................................................................. 7-5
Returning to school .......................................................................................................... 7-5
Activities ........................................................................................................................... 7-6
Travel ............................................................................................................................... 7-6
Sleeping ........................................................................................................................... 7-6
Showering and cleansing ................................................................................................. 7-6
Emergencies ................................................................................................................................. 7-6
Local emergency services ............................................................................................... 7-6
CPR and defibrillation ...................................................................................................... 7-7
Power outages ................................................................................................................. 7-7
Prevention ........................................................................................................................ 7-7
ReliantHeart Confidential – Patient and Heath Care Provider Use
7–1
Introduction
All of the material previously presented in the HeartAssist 5® VAD System Patient User's
Manual is true for the pediatric patient. It is expected that pediatric patients between 5
and 16 years of age will encounter situations similar to the adult patient as described in
this manual. This chapter provides guidance for situations that pediatric patients,
especially younger children, might encounter and is written for the child’s parents or
caregivers.
Parents or caregivers of pediatric patients of any age and children or adolescents with
the appropriate skills should read the HeartAssist 5® VAD System Patient User's Manual
thoroughly before working with the HeartAssist 5® LBSA VAD.
This chapter does not repeat all of the cautions and instructions contained elsewhere
in this manual, and this chapter should not be substituted for reading the entire
manual.
Implant surgery
The HeartAssist 5® LBSA VAD is placed in your child’s chest during surgery. Your child’s
doctor explains the surgery to both of you. When you and your child are ready after the
implant operation, the hospital staff trains you and your child, if he or she is old enough,
on how to operate the HeartAssist 5® LBSA VAD.
System description
The Controller, VADPAK, VADPAK Insert, battery pockets, batteries, LVAD Battery
Charger, and Independent Power Supply that the pediatric patient uses are the same as
described in Chapter 3, “Description of the HeartAssist 5® VAD System.”
The VAD your child receives is designed to fit properly in a child’s smaller chest. The
HeartAssist 5® LBSA VAD operates exactly like the adult HeartAssist 5® VAD. Chapter
3, “Description of the HeartAssist 5® VAD System” describes how the HeartAssist 5®
LBSA VAD operates.
Environmental conditions
HeartAssist 5® LBSA VAD system operation and storage is not recommended in certain
environmental conditions, as explained in the following subsections.
Temperature
The following guidelines describe temperature controls for the Controller.
Do not operate the Controller where temperatures are less than –10 °C (14 °F)
or greater than 40 °C (104 °F) or where the relative humidity is noncondensing,
<10% Rh or >75% Rh.
7–2
HeartAssist 5® VAD System Patient User's Manual
Your child must wear the Controller at all times, or your child’s HeartAssist 5® LBSA VAD
will not run. Therefore, you must not allow your child to spend time in areas with
temperatures outside of the specified range of –10 °C (14 °F) or greater than 40 °C (104
°F) or to place the Controller in locations where this temperature range can be exceeded
(for example, near heaters, radiators, or air conditioners).
The batteries, Controller, battery pockets, VADPAK, and VADPAK Insert must
not be exposed to moisture or heat.
The batteries must not be exposed to extreme heat. You must monitor his or her
temperature when your child is playing in very hot environments such as the beach.
Children on HeartAssist 5® LBSA VAD support must not stand in front of or come in
contact with sources of heat such as fireplaces, space heaters, stoves, and so forth. As a
reminder, your child’s LVAD Battery Charger or Independent Power Supply should never
be placed close to these types of heat sources.
The VADPAK carry bag is flame retardant, but you must exercise care when using
the bag near open flame or embers. Remove any hot item that falls onto or within the
bag as quickly as possible to prevent scorching or marring of the materials.
Take special care if your child is around campfires or other sources of open flame. Teach
your child to stay a safe distance away from them.
Contact with liquids
All forms of liquid must be kept away from the equipment in order to prevent accidental
spills. For example, you might want your child to wear an apron or bib while eating so that
food or drinks don’t spill on the VADPAK or its components. The equipment must never
be submerged in any liquid. Young children might need to be watched carefully when
they are near sources of water, such as the bathroom, as they might attempt to put their
equipment in places like the toilet. Your child will not be able to swim or take a full bath
while supported by the HeartAssist 5® LBSA VAD. Bathing while wearing the HeartAssist
5® LBSA VAD is described in “Showering with the VADPAK Insert and shower bag” on
page 5-6.
Whenever your child is mobile or operating in the untethered mode (operating the
HeartAssist 5® LBSA VAD on batteries alone), he or she will have two batteries, two
battery pockets, and the Controller in the VADPAK, using the VADPAK Insert. The
batteries, the battery pockets, and the Controller must not get wet. You must not allow
your child to swim or play in water in a way that allows moisture to enter the VADPAK
and come in contact with the batteries, the battery pockets, or the Controller.
On days with heavy rains, it might be helpful to ensure that your child is wearing rain gear
or the shower bag to protect the VADPAK, the Controller, the batteries, and the battery
pockets when he or she goes outside.
Limit the time that the Controller and accessories are in the shower bag and the shower
to 30 minutes.
Electromagnetic disturbances
Laboratory testing suggests that there is little risk from most devices that can produce
electromagnetic disturbances (such as metal detectors, microwave ovens, and cellular
phones) with the HeartAssist 5® LBSA VAD. However, these types of devices can affect
electronic equipment at very close range. For this reason, observe the recommended
ReliantHeart Confidential – Patient and Heath Care Provider Use
7–3
separation distances in Table D-4, “Recommended separation distance between portable
and mobile RF communications equipment and the life-supporting ME equipment and ME
systems,” on page D-5. The system has not been tested with each possible brand of
these devices, and the possibility of electromagnetic disturbances might exist.
You must observe your child’s HeartAssist 5® LBSA VAD functions, such as flow and
speed, closely anytime your child is in the presence of devices that might cause
electromagnetic disturbances, including toys that use wireless or radio-controlled
technology. If an unexpected change occurs, tell your child to move away from the
potential source of interference. If the HeartAssist 5® LBSA VAD function does not
immediately return to normal when the source is removed, contact your support team.
Electrostatic discharge
Testing has demonstrated that the HeartAssist 5® LBSA VAD has an acceptable risk
regarding electrostatic discharge. However, children often come in close contact with
television screens or computer monitors. Although this contact should not affect the
operation of the HeartAssist 5® LBSA VAD, consider teaching your child to stay a safe
distance from television screens and other sources of electrostatic discharge as an
added measure of safety.
Operating the HeartAssist 5® LBSA VAD system
Chapters 4 – 6 explain how to operate and manage your child’s HeartAssist 5® LBSA
VAD system. The following additional information is specific to device management for
the pediatric patient.
As appropriate for his or her age, help your child to understand the device that is
supporting his or her life; in particular, your child should understand that the Controller
and other components of the system are not toys and should be handled carefully. Put
precautions in place to minimize your child’s ability to play with cables and connections.
Teach your child to recognize alarms and to immediately go to you or another caregiver
when an alarm occurs. If your child is too young to detect audible alarms reliably,
ReliantHeart recommends that your child always be within hearing distance of you or
another caregiver.
Batteries
If your child is old enough to participate in his or her care and to understand what to do,
you should encourage your child to be responsible for changing batteries. Since the
charge duration of the batteries varies according to the HeartAssist 5® LBSA VAD speed,
you can only estimate the time interval between battery changes. If your child cannot
change his or her batteries, you or another caregiver must always be available around
the time that batteries must be changed. If you cannot reasonably estimate the battery
charge duration, keep your child within hearing distance so that you can detect the
battery discharged alarm. You must make a rule with your child that he or she will always
have two charged batteries in the battery pockets.
VADPAK
The VADPAK might be large for your child. Adjust the shoulder strap so that the VADPAK
fits securely on your child. If the weight of the VADPAK pulls on your child’s shoulder,
additional padding may be placed beneath the shoulder strap to reduce the force. Your
child should be taught to keep the VADPAK closed at all times, except when changing a
battery or checking the Controller.
7–4
HeartAssist 5® VAD System Patient User's Manual
Caution active children against upside-down maneuvers on jungle gyms or other
apparatus because the VADPAK Insert might come loose from the VADPAK if the
zippers are unzipped.
Your child will almost certainly get the VADPAK dirty. You can wipe the exterior of the
bag with a slightly damp cloth to clean it, taking care not to get water inside the VADPAK.
If your child would like, you can apply stickers to the exterior of the VADPAK, but nothing
should be placed in the interior of the bag where equipment is placed. Because sand or
dirt particles could easily get into the VADPAK and potentially interfere with connections,
keep your child from sitting and playing in sand or dirt. Your child’s VADPAK should be
exposed to ambient air to allow proper cooling and to prevent the alarms from being
muffled. Do not allow your child to wear the VADPAK beneath clothing for extended
periods of time.
Percutaneous cable
The percutaneous cable connection to the Controller should be protected because it links
the HeartAssist 5® LBSA VAD inside your child’s chest to the equipment that runs that
VAD on the outside of your child’s body. Even though the HeartAssist 5® LBSA VAD is
designed to prevent the cable from catching on objects and being pulled, you should
make sure that your child’s percutaneous cable is not prone to pulling or disconnection at
any point while your child is active. Teach your child not to play with the percutaneous
cable or its connection to the Controller because doing so might increase the risk of injury
or infection at the exit site or disturb connections.
Daily operation for the pediatric patient
“Daily operation” on page 5-3 discusses the normal, daily use for both the HeartAssist 5®
VAD (for adult patients) and the HeartAssist 5® LBSA VAD. The following subsections
provide more information that is specific to children on HeartAssist 5® LBSA VAD
support.
Leaving the home
Your child must have fully charged batteries whenever he or she leaves the house, and
you or your child should always carry a spare Controller, spare battery pocket, and spare
batteries. If your child will be away from home for extended periods of time, he or she
must travel with an LVAD Battery Charger, reserve batteries, and an Independent Power
Supply to charge his or her batteries and provide backup wall power.
If you do not accompany your child, it is very important to teach him or her to carry the
required backup equipment. Your child should also have a card, letter, bracelet, or other
medical identification that shows that he or she has a HeartAssist 5® LBSA VAD left
ventricular support device. This identification should also include your name or another
caregiver’s name and a method of contact, as well as the name and phone number of
your child’s physician.
Returning to school
Some children return to school while on HeartAssist 5® LBSA VAD support. Before your
child returns to school, the school nurse and classroom teacher or teachers should
receive training in the management of your child’s device. It is helpful to provide a copy of
The HeartAssist 5® VAD System Patient User's Manual to school staff. You and your
child’s teachers should evaluate playground and classroom areas to identify any
situations that might cause harm to your child or his or her device.
ReliantHeart Confidential – Patient and Heath Care Provider Use
7–5
It is useful to discuss your child’s device with his or her classmates before he or she
returns to school. Other children who play with your child should be cautioned not to pull
your child’s VADPAK, straps, or percutaneous cable during play. Classmates and
playmates should be reminded to seek adult help as soon as possible if your child
doesn’t feel well or loses consciousness.
Activities
While on HeartAssist 5® LBSA VAD support, your child may not participate in swimming
or contact sports. This restriction is to protect the safety and function of your child’s
device. With the doctor’s permission, your child may participate in moderate activities like
jogging, golfing, walking, shopping, and so forth with a low risk of harm to the device.
Travel
Consult your doctor about whether or not your child may travel by car or plane. If your
child requires a car seat during travel, you must position the VADPAK to eliminate pulling
on the cables or on your child’s shoulder. Seat belts should not interfere with travel for
older children; however, children might be more comfortable riding on the right side of the
vehicle where the belt buckles connect on the left side (because the percutaneous cable
and VADPAK are located on the right side of the body).
Sleeping
When sleeping, your child should be tethered to the Independent Power Supply, which
provides a continuous power supply and prevents the necessity of waking your child to
change batteries. Arrange your child’s room so that he or she can take the VADPAK off
while sleeping, yet keep it close by so that the percutaneous cable connection is not
stretched. You should put things your child might need at night in
Showering and cleansing
Children supported by the HeartAssist 5® LBSA VAD may not take a bath because the
VADPAK, VADPAK Insert, Controller, battery pockets, and batteries would be fully
submerged in water. Careful sponge baths are suggested in children not yet old enough
to shower. If your child showers with the device, the VADPAK Insert must be fully
enclosed in the shower bag as described in the section “Showering with the VADPAK
Insert and shower bag” on page 5-6.
Emergencies
An emergency situation can be caused by medical conditions or by mechanical problems
that interfere with the pumping ability of the HeartAssist 5® LBSA VAD. You and your
child must learn how to identify and respond to emergencies. The most important action
is to restore power and function to your child’s HeartAssist 5® LBSA VAD.
Local emergency services
Local emergency services should be briefed about your child’s HeartAssist 5® LBSA
VAD, and you should have a plan established with your family to activate these
emergency services when needed.
7–6
HeartAssist 5® VAD System Patient User's Manual
CPR and defibrillation
If defibrillation is required, your child can be connected either to battery power, the
HeartAttendant®, or the Independent Power Supply. Children on HeartAssist 5® LBSA
VAD support can receive cardiopulmonary resuscitation (CPR). You might not be able to
feel your child’s pulse even if the HeartAssist 5® LBSA VAD is operating normally, so
CPR and defibrillation should not be performed if your child is awake and responsive,
even if a pulse is not apparent.
Power outages
If your child’s current location loses power, and you are not certain when it will be
restored, you must temporarily move your child to a location with power as soon as
possible to prevent the HeartAssist 5® LBSA VAD from stopping. Bring your child’s
Independent Power Supply, LVAD Battery Charger, and reserve batteries with you and
your child to the new location.
Prevention
Prevention is the key to handling emergencies with children on HeartAssist 5® LBSA
VAD support, especially children who are old enough to sometimes be without a parent
or caregiver.
Your child should always carry identification as a left ventricular assist device patient with
contact information for the caregiver and physician. Your child’s teachers, coaches,
classmates, friends, and siblings should be educated about the HeartAssist 5® LBSA
VAD and taught what to do in the case of emergency.
If your child is not with you, he or she should be accompanied by a responsible person
such as a friend or an older sibling, so that someone is available to immediately seek
help for your child in the case of an emergency. Children who are too young or unable to
respond to device alarms, change batteries, or seek help should always be accompanied
by a parent, other caregiver, or an individual knowledgeable in the operation of the
HeartAssist 5® LBSA VAD.
ReliantHeart Confidential – Patient and Heath Care Provider Use
7–7
7–8
HeartAssist 5® VAD System Patient User's Manual
Appendix A
Troubleshooting
In this appendix
Emergencies .................................................................................................................................A-2
Controller troubleshooting .............................................................................................................A-3
Non-VAD related troubleshooting .................................................................................................A-6
ReliantHeart Confidential – Patient and Heath Care Provider Use
A–1
Emergencies
Emergency situations can be caused by medical conditions or by mechanical problems
that interfere with the pumping ability of the HeartAssist 5® VAD. You must learn how to
identify and respond to emergencies. The most important action is to restore power and
function to the HeartAssist 5® VAD.
You or your caregiver must call 911 or the local emergency number when any of the
following symptoms occur:
 Loss of consciousness
 Seizures or convulsions
 Inability to move or speak
 Sudden collapse
If you lose AC power, ensure that fully charged batteries are installed in the battery
pockets, disconnect the Controller from the Independent Power Supply, and travel to the
nearest source of correct AC power with the Independent Power Supply, reserve
batteries, and the LVAD Battery Charger.
A–2
HeartAssist 5® VAD System Patient User's Manual
Controller troubleshooting
Table A-1 describes troubleshooting for alarm messages displayed on the Controller
LCD. For examples of these messages, see “Emergency alarms” on page B-4 and
“Diagnostic alarms” on page B-6.
Table A-1.
Troubleshooting guide for Controller alarms
Alarm or error
Associated event
Troubleshooting
PUMP STOPPED
alarm
The VAD has stopped.
The Controller
automatically tries
restarting nine times
within approximately 60
seconds.
The LCD alternates
between PUMP
STOPPED and PUMP
RESTARTING while
restarting.
If the first three methods fail to restart the VAD, you can force
the VAD to restart by removing both batteries and re-inserting
one battery into a battery pocket while not tethered to wall
power as described in “Manual VAD restart” below.
 Check for flashing alarms, which can indicate why the VAD
has stopped. For example: VAD DISCONNECTED or
BOTH BATTERIES DISCONNECTED.
 Check for system damage.
 Attempt to verify that an unknown electrical disturbance is
not affecting the Controller by moving to another location.
See “Emergency alarm 1: PUMP STOPPED” on page B-4.
Manual VAD restart
If the VAD did not restart, perform the manual restart procedure
described below:
1. Disconnect the battery pockets from any external power
source.
2. Briefly remove both batteries from the battery pockets.
3. Re-insert one of the batteries into one of the battery
pockets.
 This procedure activates the restart algorithm, which
triggers an additional nine automatic restart attempts.
 If the VAD does not restart, continue with step 4.
 If the VAD restarts, disregard the remaining steps.
4.
5.
When the VAD restarts, the emergency alarm clears.
If the VAD does not restart after you have performed the
manual restart procedure, replace the Controller with the
backup Controller.
Contact emergency medical services and your support
team.
The impeller and the motor Controller can
occasionally lose synchronization. When this
event occurs, the LCD displays the PUMP
STOPPED then PUMP RESTARTING alarms,
then it returns to the default display (assuming
no other alarms are present). The audible
emergency alarm does not sound for this
event, but the event memory is captured. The
resynchronization event typically allows the
VAD to stop for approximately two seconds.
PUMP
RESTARTING
alarm
The VAD is attempting to
restart.
1.
2.
See “Diagnostic alarm 4: PUMP RESTARTING” on page
B-7.
Contact your support team.
ReliantHeart Confidential – Patient and Heath Care Provider Use
A–3
Alarm or error
Associated event
Troubleshooting
REDUCED FLOW
RATE alarm
The flow rate measured
by the implanted flow
probe has dropped below
the programmed alarm
threshold.
Contact your support team.
EXCESS
CURRENT alarm
The VAD is drawing
current in excess of the
programmed alarm
threshold.
Contact your support team.
Fail-safe LED
display frozen
The fail-safe LED is lit, the
Controller is emitting a
high-pitched continuous
alarm, the LCD display is
frozen, and the battery
LEDs are lit. The VAD is
running at the last set
speed.
1.
2.
Replace the Controller with the backup Controller.
Contact your support team.
No display
The LCD is off, the LEDs
are off, and the Controller
is emitting a high-pitched
continuous emergency
alarm.
The Controller has failed
internally. Due to potential
processor failure, no
display is associated with
this alarm.
1.
Replace the Controller with the backup Controller
immediately.
Contact your support team.
Both batteries are
disconnected.
If the emergency alarm
clears, the batteries are
connected; disregard
further steps. If the alarm
does not silence, continue
with step 5.
1.
BOTH
BATTERIES
DISCONNECTED
alarm
VAD
DISCONNECTED
alarm
The VAD has become
disconnected from the
Controller.
2.
2.
3.
4.
5.
6.
1.
2.
3.
4.
5.
6.
A–4
Verify that all batteries are fully seated into the battery
pockets.
Verify that the battery pocket connectors are correctly
inserted into the Controller connectors.
Verify that the battery pocket cables are not cut or
damaged.
Verify that at least one of the batteries is charged.
Replace the Controller with the backup Controller.
Contact your support team.
Verify that the percutaneous cable is not damaged.
Unscrew the white defibrillation cover from the
percutaneous cable.
Disconnect the driveline from the percutaneous cable and
verify that the pins inside the VAD connector are straight
and free from debris or liquid.
Plug the driveline connector back into the percutaneous
cable ensuring that the driveline connector is fully seated
with the percutaneous cable connector.
If the emergency alarm silences, the VAD is running.
If the VAD does not restart, and the message does not
clear when the alarm silence button is pressed, replace the
Controller with the backup Controller.
Screw the white defibrillation cover onto the driveline
cable.
Contact emergency medical services and your support
team.
HeartAssist 5® VAD System Patient User's Manual
Alarm or error
Associated event
Troubleshooting
Continuous audible
alarm
The Controller is
malfunctioning.
1.
2.
3.
You must seek immediate medical assistance if the VAD
has stopped.
Replace the Controller with the backup Controller.
Contact your support team.
REDUCED
MOTOR SPEED
alarm
The RPM of the VAD has
fallen below the
programmed alarm
threshold.
Contact your support team.
BATTERY 1 OR 2
DISCHARGED
alarm
The battery in port 1 or 2
has discharged below
25%.
Replace the discharged battery with a charged battery.
BATTERY 1 OR 2
DISCONNECTED
alarm
Either battery 1 or 2 has
been disconnected.
1.
2.
3.
BATTERY 1 OR 2
EXPIRED alarm
The battery in port 1 or 2
has discharged below
15%, or the battery
voltage is too low.
1.
2.
Verify that the battery is firmly seated into the battery
pocket.
Verify the battery plug is properly seated into battery port
of alarm Controller.
If alarm does not clear, contact your support team.
Replace the expired battery with a charged battery.
If the battery expired alarm occurred prior to a battery
discharged alarm for that battery, contact your support
team for a replacement battery.
ReliantHeart Confidential – Patient and Heath Care Provider Use
A–5
Non-VAD related troubleshooting
The following tables describe troubleshooting information for the HeartAssist 5® VAD
System.
Table A-2.
Troubleshooting guide for non-VAD issues
Situation or error
Troubleshooting
The Controller LCD display is unreadable, the
battery LEDs respond to battery changes, and
the fail-safe mode LED is off.
It is likely that the VAD is still running normally.
1.
2.
3.
Verify the functionality of the battery LEDs by inserting and
removing a fully charged battery into one of the battery
ports while the other battery port contains a charged
battery.
If the LCD is not functional but the battery and fail-safe
mode status indicators are still functional and you feel no
adverse effects, the VAD is probably still functioning
correctly.
Replace the Controller with the backup Controller.
Contact your support team.
The Controller LCD display is unreadable, the
battery LEDs respond to battery changes, and
the fail-safe mode LED is on (solid red).
It is likely that the VAD is still running in fail-safe
mode at the last set speed. Because the motor
Controller is separate circuitry from the CPU,
the VAD could continue to run in the event of a
Controller failure. However, the circuitry that
verifies the functionality of the CPU detects a
failure in the CPU and sets the motor controller
to the last set speed.
1.
2.
Replace the Controller with the backup Controller.
Contact your support team.
The Controller LCD display is unreadable; the
battery LEDs do not respond to battery
changes.
It cannot be determined whether or not the VAD
is operational.
1.
2.
Replace the Controller with the backup Controller.
Contact your support team.
The Controller is splashed with liquid.
Wipe the liquid from the case of the Controller.
The Controller becomes soiled.
Wipe the Controller with a slightly damp cloth with mild
detergent (for example, dishwasher soap).
Never spray water or detergent directly
onto the Controller. Always apply water or
detergent to a soft cloth, wring it out until
just slightly damp, and wipe the Controller.
The Controller becomes submerged in liquid.
1.
2.
A–6
Replace the Controller with the backup Controller
immediately.
Contact your support team.
HeartAssist 5® VAD System Patient User's Manual
Situation or error
Troubleshooting
A VADPAK with VADPAK Insert is submerged
in liquid.
1.
2.
3.
4.
5.
Locate your backup Controller, backup battery pocket, a
charged battery, and the Independent Power Supply.
Insert a charged battery into the backup battery pocket.
Power up and connect the Independent Power Supply to
the backup battery pocket.
Connect the backup battery pocket to the backup
Controller. Perform the Controller replacement with the
backup.
Contact your support team.
If the backup battery pocket and the Independent Power
Supply are not available, do not disconnect the Controller.
Try to drain liquid, and contact your support team
immediately.
You must always have extra batteries, a
backup battery pocket, and a backup
Controller.
A battery is submerged in liquid.
If the battery is in the battery pocket, replace both the battery
pocket and battery with a backup battery pocket and a spare
battery.
If the battery is not in the battery pocket, do not attempt to use
or recharge this battery.
Do not attempt to use or recharge any battery that becomes
submerged in liquid.
Contact your support team for a replacement battery and
battery pocket.
ReliantHeart Confidential – Patient and Heath Care Provider Use
A–7
Situation or error
Troubleshooting
An external power source, such as the
Independent Power Supply (IPS), is connected
to the battery pocket external power connector,
but the power source is not indicated on the
Controller display.
1.
2.
3.
4.
Verify that the connector cable is correctly inserted in the
battery pocket connector. If the Controller display does not
indicate that the IPS or APS is connected, continue with
steps 2–5.
Using the Controller display, check the battery status for
both battery pocket batteries to ensure adequate charge
levels.
See Figure B-1 on page B-2.
With the IPS or APS connected to the battery pocket,
disconnect the battery pocket from the Controller.
See “Disconnecting from the Independent Power Supply”
on page 5-4.
Press the Alarm Silence button on the Controller front
panel.
If you do not press the Alarm Silence button on the
sounds, notifying you that it is disconnected.
5.
Disconnect the IPS or APS from the battery pocket
connector, and connect the IPS or APS directly into the
Controller connector.
You can damage the connectors if you
force them without proper alignment. Do
not twist the connectors while inserting
them after the connectors are aligned.
 If the Controller front panel displays the external power
indicator (a plug symbol), the battery pocket external
power connector is malfunctioning. Replace the battery
pocket with a backup battery pocket, and contact your
support team for a replacement.
 If the Controller front panel is not displaying the external
power indicator, the IPS or APS is malfunctioning.
Reconnect the battery pocket, and contact your support
team for a replacement IPS or APS.
A–8
HeartAssist 5® VAD System Patient User's Manual
Appendix B
Controller Messages and Alarms
In this appendix
Standard message screens ..........................................................................................................B-2
Emergency alarms ........................................................................................................................B-4
Emergency alarm 1: PUMP STOPPED ...........................................................................B-4
Emergency alarm 2: BOTH BATTERIES DISCONNECTED ...........................................B-5
Emergency alarm 3: VAD DISCONNECTED ..................................................................B-5
Diagnostic alarms..........................................................................................................................B-6
Diagnostic alarm 1: EXCESS CURRENT ........................................................................B-6
Diagnostic alarm 2: REDUCED FLOW RATE .................................................................B-7
Diagnostic alarm 3: REDUCED MOTOR SPEED ............................................................B-7
Diagnostic alarm 4: PUMP RESTARTING ......................................................................B-7
Diagnostic alarm 5: BATTERY 1 DISCONNECTED........................................................B-8
Diagnostic alarm 6: BATTERY 1 DISCHARGED ............................................................B-8
Diagnostic alarm 7: BATTERY 1 EXPIRED .....................................................................B-9
Diagnostic alarm 8: BATTERY 2 DISCONNECTED........................................................B-9
Diagnostic alarm 9: BATTERY 2 DISCHARGED ..........................................................B-10
Diagnostic alarm 10: BATTERY 2 EXPIRED .................................................................B-10
Controller failure alarms ..............................................................................................................B-11
Controller failure alarm 1: fail-safe alarm .......................................................................B-11
Controller failure alarm 2: Controller failure alarm .........................................................B-12
ReliantHeart Confidential – Patient and Heath Care Provider Use
B–1
Standard message screens
The Controller has seven standard message screens that continuously display
information while scrolling with the Scroll Display button.
Figures B-1 – B-6 display the seven messages shown on the Controller.
Figure B-1.
Standard message screen 1: battery status
Battery 1 Percent
Charge Remaining
Battery 2 Percent
Charge Remaining
Battery 1 Charge Time
Remaining hh:mm
Battery 2 Charge Time
Remaining hh:mm
Using battery power
Battery 2 Percent
Charge Remaining
Battery 1 Percent
Charge Remaining
Battery 2 External
Power Indicator
Battery 1 Charge Time
Remaining hh:mm
Using external power
Figure B-2.
VAD Motor Power in
WATTS, 0 – 24 W
Standard message screen 2: current VAD parameters
Flow rate in liters per
minute
VAD Speed (kRPM) 7.5 kRPM to
12.5 kRPM
When the system is plugged in to external AC or DC power (for example with the
Independent Power Supply), the battery charge time remaining that is displayed in
standard message screen 1 is replaced by the external power indicator (a plug
symbol), as shown in Figure B-1.
B–2
HeartAssist 5® VAD System Patient User's Manual
Figure B-3.
Standard message screen 3: wireless antenna status
Wireless Antenna Enabled
Wireless Antenna Disabled
Wireless Antenna Disabled with
Adjust Controls
Figure B-4.
Standard message screen 4: flow probe received amplitude
Flow Probe Received Amplitude:
A & B Channels 1 - 5 Volts
Figure B-5.
Standard message screen 5: flow sensor status
Flow Probe/Meter ENABLED or
DISABLED
Figure B-6.
Standard message screen 6: battery capacity
Battery 1 and 2 Capacity
Remaining in Milliamp Hours
(mAh)
ReliantHeart Confidential – Patient and Heath Care Provider Use
B–3
Figure B-7.
Standard message screen 7: not used
Emergency alarms
The following subsections describe emergency alarms.
The Controller indicates an emergency alarm with a fast, loud, two-tone ringing
sound.
Emergency alarm 1: PUMP STOPPED
The VAD has stopped. The Controller immediately activates the restart algorithm for
approximately 60 seconds. The LCD alternates between PUMP STOPPED and PUMP
RESTARTING while the restart algorithm is activated.
If the pump successfully restarts, the emergency alarm automatically clears.
Example
Figure B-8 displays an example of emergency alarm 1, PUMP STOPPED. This alarm
indicates that the VAD is not running.
Figure B-8.
Emergency alarm 1: PUMP STOPPED
PUMP STOPPED
User response
If the PUMP STOPPED alarm displays, take the following actions:
1. Allow the automatic restart algorithm to complete its cycle (within 60 seconds).
2. If the VAD does not restart automatically after 60 seconds, perform the following
manual restart procedure:
a. Disconnect the battery pockets from any external power sources (such as the
Independent Power Supply).
b. Briefly remove both batteries from the battery pockets.
c.
B–4
Re-insert one of the batteries into one of the battery pockets.
HeartAssist 5® VAD System Patient User's Manual
This procedure activates the restart algorithm, which triggers an additional nine
automatic restart attempts.
3. If the VAD does not restart after performing the manual restart procedure, replace the
Controller with the backup Controller.
4. Contact your support team immediately.
Emergency alarm 2: BOTH BATTERIES DISCONNECTED
The Controller is not receiving power from either of the batteries.
Example
Figure B-9 displays an example of emergency alarm 2, BOTH BATTERIES
DISCONNECTED.
This alarm indicates that either the batteries are not properly inserted in the battery
pockets, the cables connecting the battery pockets and Controller are not secure or are
damaged, or that the Controller is malfunctioning. The VAD is not running when this
alarm is present.
Figure B-9.
Emergency alarm 2: BOTH BATTERIES DISCONNECTED
BOTH BATTERIES
DISCONNECTED
User response
If the BOTH BATTERIES DISCONNECTED alarm displays, take the following actions:
1. Confirm that both batteries are properly inserted into the battery pockets.
2. Verify all cable connections.
3. If the VAD does not start, and the alarm does not clear automatically, replace the
Controller with the backup Controller.
This alarm clears automatically when the VAD restarts.
A Controller that is not receiving power alarms for approximately three minutes. This
alarm cannot be silenced.
Emergency alarm 3: VAD DISCONNECTED
The VAD is not connected to the Controller.
Example
Figure B-10 displays an example of emergency alarm 3, VAD DISCONNECTED. This
alarm indicates that the VAD is not running and is not connected to the Controller.
Figure B-10. Emergency alarm 3: VAD DISCONNECTED
ReliantHeart Confidential – Patient and Heath Care Provider Use
B–5
VAD
DISCONNECTED
User response
If the VAD DISCONNECTED alarm displays, take the following actions:
1. Unscrew the white defibrillation cover from the driveline cable.
2. Verify and, if necessary, reconnect the driveline cable to the Controller.
3. Verify that the VAD has restarted successfully.
4. If VAD does not restart, and the alarm does not clear automatically, replace the
Controller with the backup Controller.
5. Contact your support team immediately.
Diagnostic alarms
The following subsections describe diagnostic alarms.
The Controller indicates a diagnostic alarm with a slow beeping sound.
Diagnostic alarm 1: EXCESS CURRENT
The VAD is drawing current in excess of the programmed alarm threshold.
This alarm does not silence or clear automatically. Press the Controller Alarm
Silence button to clear this alarm.
Example
Figure B-11 displays an example of diagnostic alarm 1, EXCESS CURRENT.
Figure B-11. Diagnostic alarm 1: EXCESS CURRENT
EXCESS CURRENT
User response
If the EXCESS CURRENT alarm displays, contact your support team immediately.
B–6
HeartAssist 5® VAD System Patient User's Manual
Diagnostic alarm 2: REDUCED FLOW RATE
The flow rate measured by the implanted flow probe has decreased below the
programmed alarm threshold.
This alarm does not silence or clear automatically. Press the Controller Alarm
Silence button to clear this alarm.
Example
Figure B-12 displays an example of diagnostic alarm 2, REDUCED FLOW RATE.
Figure B-12. Diagnostic alarm 2: REDUCED FLOW RATE
REDUCED
FLOW RATE
User response
If the REDUCED FLOW RATE alarm displays, contact your support team immediately.
Diagnostic alarm 3: REDUCED MOTOR SPEED
The speed (RPM) of the VAD has fallen below the programmed alarm threshold.
This alarm does not clear automatically. Press the Alarm Silence button to clear this
alarm.
Example
Figure B-13 displays an example of diagnostic alarm 3, REDUCED MOTOR SPEED.
Figure B-13. Diagnostic alarm 3: REDUCED MOTOR SPEED
REDUCED
MOTOR SPEED
User response
If the REDUCED MOTOR SPEED alarm displays, contact your support team
immediately.
Diagnostic alarm 4: PUMP RESTARTING
The VAD has stopped and is attempting to restart. The message PUMP RESTARTING
displays briefly during the restart attempt alternating with the PUMP STOPPED message.
ReliantHeart Confidential – Patient and Heath Care Provider Use
B–7
Example
Figure B-14 displays an example of diagnostic alarm 4, PUMP RESTARTING.
Figure B-14. Diagnostic alarm 4: PUMP RESTARTING
PUMP
RESTARTING
User response
If the PUMP RESTARTING alarm displays, take the following actions:
1. Every two to three seconds, press the Alarm Silence button on the Controller, and
verify that the flow rate, RPM, and power are normal.
See Figure B-2 on page B-2. If the alarm silences, the VAD has restarted
successfully.
2. Contact your support team immediately.
Diagnostic alarm 5: BATTERY 1 DISCONNECTED
Battery 1 is disconnected from the battery pocket as indicated on the Controller with a
blinking amber light and an audible diagnostic alarm.
Example
Figure B-15 displays an example of diagnostic alarm 5: BATTERY 1 DISCONNECTED.
Figure B-15. Diagnostic alarm 5: BATTERY 1 DISCONNECTED
BATTERY 1
DISCONNECTED
User response
If the BATTERY 1 DISCONNECTED alarm displays, take the following actions:
1. Verify that the battery is firmly seated into battery pocket 1.
2. Verify that the battery pocket connector is firmly inserted into the Controller connector
for battery 1. This alarm clears automatically after you reconnect battery 1.
3. If alarm does not clear, contact your support team.
Diagnostic alarm 6: BATTERY 1 DISCHARGED
The battery plugged into battery pocket 1 has discharged below a 25% charge level, as
indicated on both the Controller and the battery pocket with a blinking amber light and an
audible diagnostic alarm.
B–8
HeartAssist 5® VAD System Patient User's Manual
Example
Figure B-16 displays an example of diagnostic alarm 6, BATTERY 1 DISCHARGED.
Figure B-16. Diagnostic alarm 6: BATTERY 1 DISCHARGED
BATTERY 1
DISCHARGED
User response
If the BATTERY 1 DISCHARGED alarm displays, take the following actions:
1. Replace the battery in battery pocket 1 with a fully charged battery.
2. Recharge the discharged battery.
This alarm clears automatically when you replace the discharged battery with a charged
battery.
Diagnostic alarm 7: BATTERY 1 EXPIRED
The battery plugged into battery pocket 1 has discharged below 15%, or its voltage is too
low, as indicated on both the Controller and battery pocket with a blinking amber light and
an audible diagnostic alarm.
Example
Figure B-17 displays an example of diagnostic alarm 7, BATTERY 1 EXPIRED.
Figure B-17. Diagnostic alarm 7: BATTERY 1 EXPIRED
BATTERY 1
EXPIRED
User response
If the BATTERY 1 EXPIRED alarm displays, take the following actions:
1. Replace the expired battery in battery pocket 1 with a fully charged battery.
2. Recharge the expired battery.
This alarm clears automatically after you replace the expired battery with a charged
battery.
Diagnostic alarm 8: BATTERY 2 DISCONNECTED
Battery 2 is disconnected from the battery pocket as indicated on the Controller with a
blinking amber light and an audible diagnostic alarm.
Example
Figure B-18 displays an example of diagnostic alarm 8, BATTERY 2 DISCONNECTED.
ReliantHeart Confidential – Patient and Heath Care Provider Use
B–9
Figure B-18. Diagnostic alarm 8: BATTERY 2 DISCONNECTED
BATTERY 2
DISCONNECTED
User response
If the BATTERY 2 DISCONNECTED alarm displays, take the following actions:
1. Verify that the battery is firmly seated into battery pocket 2.
2. Verify that the battery pocket connector is firmly inserted into the Controller connector
for battery 2.
This alarm clears automatically after you reconnect battery 2.
Diagnostic alarm 9: BATTERY 2 DISCHARGED
The battery plugged into battery pocket 2 has discharged below a 25% charge level, as
indicated on both the Controller and the battery pocket with a blinking amber light and an
audible diagnostic alarm.
Example
Figure B-19 displays an example of diagnostic alarm 9, BATTERY 2 DISCHARGED.
Figure B-19. Diagnostic alarm 9: BATTERY 2 DISCHARGED
BATTERY 2
DISCHARGED
User response
If the BATTERY 2 DISCHARGED alarm displays, take the following actions:
1. Replace the battery in battery pocket 2 with a fully charged battery.
2. Recharge the discharged battery.
This alarm clears automatically when you replace the discharged battery with a
charged battery.
Diagnostic alarm 10: BATTERY 2 EXPIRED
The battery plugged into battery pocket 2 has discharged below 15%, or its voltage is too
low, as indicated on both the Controller and the battery pocket with a blinking amber light
and an audible diagnostic alarm.
Example
Figure B-20 displays an example of diagnostic alarm 10: BATTERY 2 EXPIRED.
B–10
HeartAssist 5® VAD System Patient User's Manual
Figure B-20. Diagnostic alarm 10: BATTERY 2 EXPIRED
BATTERY 2
EXPIRED
User response
If the BATTERY 2 EXPIRED alarm displays, take the following actions:
1. Replace the expired battery in battery pocket 2 with a fully charged battery.
2. Recharge the expired battery.
This alarm clears automatically when you replace the expired battery with a charged
battery.
Controller failure alarms
The following section describes alarms that occur when the Controller ceases to function.
Controller failure alarms are indicated by a continuous tone.
Controller failure alarm 1: fail-safe alarm
The fail-safe LED is lit solid red, a high-pitch continuous alarm sounds, the LCD display is
frozen, and battery LEDs are lit. The VAD continues to run at the last set speed.
Example
When this alarm sounds, the Controller continues to display the same screen that was
present when the fail-safe alarm began to sound.
Figure B-21. Controller failure alarm 1: fail-safe alarm (display frozen)
FLOW SENSOR
ENABLED
The Controller screen is
frozen to the last screen
displayed before the alarm
began to sound
User response
1. Replace the Controller with the backup Controller.
2. Notify your support team of this event, and request a Controller replacement.
ReliantHeart Confidential – Patient and Heath Care Provider Use
B–11
Controller failure alarm 2: Controller failure alarm
The LCD is off, the LEDs are off, and the Controller emits a high-pitch continuous alarm
(not a beeping alarm). The Controller has failed internally. The VAD has stopped.
Example
Figure B-22 displays an example of the Controller failure alarm. The Controller has a
blank display when emitting this alarm.
Figure B-22. Controller failure alarm 2: (no display)
User response
1. Replace the Controller with the backup Controller immediately.
2. Notify your support team of this event immediately, and request a Controller
replacement.
B–12
HeartAssist 5® VAD System Patient User's Manual
Appendix C
System Specifications
In this appendix
Introduction .................................................................................................................................. C-2
HeartAssist 5® VAD specifications .............................................................................................. C-2
Controller specifications ............................................................................................................... C-3
General specifications ..................................................................................................... C-3
Interface features ............................................................................................................ C-3
Safety features ................................................................................................................ C-3
Wireless antenna specifications................................................................................................... C-4
HeartAttendant® specifications.................................................................................................... C-4
General specifications ..................................................................................................... C-4
Safety features ................................................................................................................ C-4
Electrical specifications ................................................................................................... C-4
Replacement and accessory part list (fuses) .................................................................. C-5
VADPAK and VADPAK Insert specifications ............................................................................... C-5
Independent Power Supply .......................................................................................................... C-5
General specifications ..................................................................................................... C-5
Safety features ................................................................................................................ C-6
Electrical specifications ................................................................................................... C-6
Lithium ion battery ........................................................................................................................ C-6
General specifications ..................................................................................................... C-6
Safety features ................................................................................................................ C-6
Electrical specifications ................................................................................................... C-6
LVAD Battery Charger ................................................................................................................. C-7
General specifications ..................................................................................................... C-7
Electrical specifications ................................................................................................... C-7
Connecter cables, power cords, and fuses .................................................................................. C-7
Essential performance of the HeartAssist 5® VAD...................................................................... C-8
ReliantHeart Confidential – Patient and Heath Care Provider Use
C–1
Introduction
This chapter presents information on the specifications for the HeartAssist 5® VAD
System components. This chapter also presents information on the use of connecter
cables and power cords, the proper replacement of fuses, and the essential performance
of the HeartAssist 5® VAD.
The service life of the Controller and all accessories is three years.
HeartAssist 5® VAD specifications
Table C-1 describes the general specifications of the HeartAssist 5® VAD.
Table C-1.
HeartAssist 5® VAD general specifications
General property
Specific property
Specification
Weight (without cannula)
92 grams
Size
30 mm x 76 mm
Material
VAD and internal components
Titanium
Bearings
Ceramic
Graft
Vascutek Gel Weave® (with titanium ring)
Flow probe
Titanium, polyurethane, epoxy, polycarbonate
polyurethane
Percutaneous cable
Polycarbonate-polyurethane
Graft protector
Ultra-high molecular-weight polyethylene
Flow accuracy
±10% when flow > 3 L/min; 0.3 L/min when flow is
< 3 L/min
Range
–4.0 L/min to 10.0 L/min
C–2
HeartAssist 5® VAD System Patient User's Manual
Controller specifications
The following subsections describe the properties of the Controller.
General specifications
Table C-2 describes the general specifications of the Controller.
Table C-2.
Controller general specifications
Property
Specification
Classification
Internally powered, type CF, defibrillation proof
Ingress protection
IP32
Weight
2.7 kg (6 lbs) – (with two battery pockets & two batteries)
Dimensions
16.5 cm x 8.9 cm x 5.1 cm
(6.5 in x 3.5 in x 2.0 in)
Programmed pump speed
7500 (±200) to 12500 (±200) RPM
Battery type
Lithium Ion (Li-ON)
Power required
Range: 0 – 40 W ±10%
Alarm sound pressure
60 – 80 db
Interface features
Patients, caregivers, and support staff use the Controller by interacting with the following
features.
 Battery indicators
 Fail-safe and emergency mode indicator LED
 LCD display
 Programmable language
 Real-time clock
 Alarm Silence button
 Scroll Display button
 Battery status indicators
Safety features
The Controller includes the following features to ensure patient safety.
 Automatic fail-safe and emergency mode LED (with status)
 Automatic pump restart algorithm
 Automatic diagnostic tests at start-up
 Diagnostic visual and audible alarms
 Emergency visual and audible alarms
 Built-in data acquisition
 Patient information stored in nonvolatile memory
ReliantHeart Confidential – Patient and Heath Care Provider Use
C–3
Wireless antenna specifications
You can use the wireless antenna in all markets where Quadband GSM (850/900/
1800/1900 MHz) is available.
The wireless transmission of data is not a requirement for the Controller to fulfill its
intended use or to meet its indications for use.
HeartAttendant® specifications
The following subsections describe the HeartAttendant® properties.
General specifications
Table C-3 describes the general specifications of the HeartAttendant®.
Table C-3.
HeartAttendant® general specifications
Property
Specification
Weight
11.34 kg (25 lbs)
Dimensions
55.88 cm x 48.25 cm x 45.72 cm (22 in x 19 in x 18 in)
External indicators
LED display
External control
Touch screen
Safety features
The HeartAttendant® includes the following features to ensure patient safety.
 Fault tolerant operating system
 5,000 volt defibrillation protection
 Password protection to VAD controls and operating system
Electrical specifications
Table C-4 describes the HeartAttendant® electrical specifications.
Table C-4.
C–4
HeartAttendant® electrical specifications
Property
Specification
Input voltage
120/240 VAC 60/50 Hz
Maximum current
3.0/1.5 A
Equipment type
Type CF, defibrillation proof, Class 1
EMI/RFI
Class A device
Operation
Continuous duty
HeartAssist 5® VAD System Patient User's Manual
Replacement and accessory part list (fuses)
Table C-5 lists the HeartAttendant® replacement and accessory parts and their part
numbers. See “Connecter cables, power cords, and fuses” for instructions on obtaining
replacement fuses.
Table C-5.
HeartAttendant® part list
Part description
Part number
Fuse (US)
5 x 20 mm 120 V / 4 AMP slow blow
Fuse (Europe)
5 x 20 mm 240 V / 3 AMP slow blow
VADPAK and VADPAK Insert specifications
Table C-6 describes VADPAK and VADPAK Insert properties.
Table C-6.
VADPAK specifications
Property
Specification
VADPAK Bag
Weight
1.81 kg (4.0 lb) (with batteries, battery pockets and controller)
Dimensions
27.94 cm x 10.16 cm x 21.59 cm (11 in x 4.0 in x 8.5 in)
Materials
Cordura 500D Black, Cordura 500D Foliage, Soft Tex Skid
Resistant
VADPAK Insert
Weight
1.81 kg (4 lb) (with batteries, battery pockets and controller)
Dimensions
25.4 cm x 20.32 cm x 17.78 cm (10 in x 8 in x 7 in)
Materials
Cordura 500D Black, 0.125 Corrugated Plastic
Independent Power Supply specifications
The following subsections describe the Independent Power Supply properties.
General specifications
Table C-7 describes the general properties of the Independent Power Supply.
Table C-7.
Independent Power Supply general specifications
Property
Specification
Weight
0.45 kg (1 lb)
Dimensions
4.80 cm × 12.07 cm × 7.62 cm (1.89 in × 4.75 in × 3.00 in)
External indicators
Power indicator light (green LED)
ReliantHeart Confidential – Patient and Heath Care Provider Use
C–5
Property
Specification
Ingress protection
IPX1
Safety features
The Independent Power Supply includes output protection from short circuit and overload
to ensure patient safety.
Electrical specifications
Table C-8 describes the Independent Power Supply electrical specifications.
Table C-8.
Independent Power Supply electrical specifications
Property
Specification
Input voltage
90-264 VAC; 47-63 Hz; 60 W
Maximum voltage
13.5 Vdc; 4.3 A
Equipment type
Type CF; Defibrillation proof; Class 1
EMI/RFI
Class B device
Operation
Continuous duty
Lithium ion battery specifications
The following subsections describe the lithium ion battery properties.
General specifications
Table C-9 describes the general properties of the lithium ion battery.
Table C-9.
Lithium ion battery general specifications
Property
Specification
Weight
0.45 kg (1 lb)
Dimensions
14.05 cm × 8.86 cm × 2.00 cm (5.53 in × 3.49 in × 0.79 in)
External indicators
LED indicator icon (fuel gauge)
Charge percentage
Range: 0 – 100% ±10%
Charge time remaining
Range: 0:00 – 7:30 hours ±10%
Battery capacity
Range: 6000a – 7800 mAh ±10%
Recommended battery replacement level specified by ReliantHeart.
Safety features
The lithium ion battery includes a discharge cutoff of 9.0 V to ensure patient safety.
Electrical specifications
Table C-10 describes the lithium ion battery electrical specifications.
Table C-10. Lithium ion battery electrical specifications
C–6
HeartAssist 5® VAD System Patient User's Manual
Property
Specification
Input voltage
10.8 V
Maximum voltage
4000 mA (under 30 °C)
3000 mA (over 30 °C)
Equipment type
Type BF
Operation
Continuous duty
LVAD Battery Charger specifications
The following subsections describe the LVAD Battery Charger properties.
General specifications
Table C-11 describes the general properties of the LVAD Battery Charger.
Table C-11. LVAD Battery Charger general specifications
Property
Specification
Weight
0.71 kg (1.56 lb)
Dimensions
17.15 cm × 11.05 cm × 5.03 cm (6.75 in × 4.35 in × 1.98 in)
External indicators
LED indicators (green and amber)
External control
Recalibration button
Electrical specifications
Table C-12 describes the LVAD Battery Charger electrical specifications.
Table C-12. LVAD Battery Charger electrical specifications
Property
Specification
Input voltage
18 VDC
Maximum current
1.8 A
Equipment type
Type BF, Class III
EMI/RFI
Class III
Operation
Intermittent duty
Connecter cables, power cords, and fuses
Only use ReliantHeart-supplied power cords and connecter cables with the HeartAssist
5® VAD System. Contact ReliantHeart to obtain the proper replacement power cords or
connecter cables for your geographical area.
Ensure appropriate fuse usage by obtaining replacement fuses from ReliantHeart. See
“Customer support” on page iii for contact information.
ReliantHeart Confidential – Patient and Heath Care Provider Use
C–7
Essential performance of the HeartAssist 5® VAD
The HeartAssist 5® VAD operates, without stoppage, at the preset speed.
C–8
HeartAssist 5® VAD System Patient User's Manual
Appendix D
Manufacturer Guidance for Environmental Conditions
In this appendix
Introduction .................................................................................................................................. D-2
Electromagnetic emissions .......................................................................................................... D-2
Electromagnetic immunity ............................................................................................................ D-2
Recommended separation distance between portable and mobile RF communications equipment
and the Controller, HeartAttendant®, battery pockets, Independent Power Supply, and
batteries ................................................................................................................................. D-5
Requirements applicable to ME EQUIPMENT and ME SYSTEMS that intentionally
receive RF electromagnetic energy for the purpose of their operation (60601-1-2,
5.2.2.5)...................................................................................................................... D-6
Requirements applicable to ME EQUIPMENT and ME SYSTEMS that include RF
transmitters (60601-1-2, 5.2.2.6) .............................................................................. D-7
FCC statements ........................................................................................................................... D-8
Statement according to FCC part 15.19 ......................................................................... D-8
Statement according to FCC part 15.21 ......................................................................... D-8
Statement according to FCC part 15.105 ....................................................................... D-9
R&TTE Declaration of Conformity................................................................................................ D-9
ReliantHeart Confidential – Patient and Heath Care Provider Use
D–1
Introduction
The following sections outline the ReliantHeart manufacturer’s guidance and declarations
for the components of the HeartAssist 5® VAD System.
Electromagnetic emissions
The HeartAssist 5® Controller, HeartAttendant®, battery pockets, batteries, Independent
Power Supply, and Controller connector cable are intended for use in the electromagnetic
environment specified in Table D-1. The customer or the user of these components must
ensure that they are used in such an environment.
Table D-1.
Electromagnetic emissions guidance and manufacturer’s declaration for all ME
equipment and ME systems
Emissions test
Compliance
Electromagnetic environment—guidance
RF emissions
CISPR 11
Group 1
These components use RF energy only for their internal
functions. Therefore, RF emissions are very low and are not
likely to cause any interference in nearby electronic equipment.
RF emissions
CISPR 11
Class B
Harmonic emissions
IEC 61000-3-2
Class A
These components are suitable for use in all establishments,
including domestic establishments and those directly connected
to the public low-voltage power supply network that supplies
buildings used for domestic purposes.
Voltage fluctuations/flicker
emissions
IEC 61000-3-3
Complies
Electromagnetic immunity
The Controller, HeartAttendant®, battery pockets, batteries, Independent Power Supply
and Controller connector cable are intended for use in the electromagnetic environment
specified in Table D-2 and Table D-3. The customer or the user of these components
must ensure that they are used in such an environment.
Table D-2.
Electromagnetic immunity guidance and manufacturer’s declaration for all ME
equipment and ME systems
IEC 60601 test
level
Compliance
Electromagnetic environment—guidance
Electrostatic
discharge (ESD)
IEC 61000-4-2
±6 kV contact
±8 kV air
±6 kV contact
±15 kV air
The relative humidity should be at least 10%.
Electrical fast
transient/ burst
IEC 61000-4-4
±2 kV for power
supply lines
±1 kV for input/
output lines
±2 kV for power
supply lines
±1 kV for input/
output lines
Mains power quality should be that of a typical
commercial or hospital environment.
Surge
IEC 61000-4-5
±1 kV line(s) to
line(s)
±2 kV line(s) to
earth
±1 kV differential
mode
±2 kV common
mode
Mains power quality should be that of a typical
commercial or hospital environment.
Immunity test
D–2
HeartAssist 5® VAD System Patient User's Manual
Immunity test
IEC 60601 test
level
Compliance
Electromagnetic environment—guidance
Voltage dips,
short
interruptions, and
voltage variations
on power supply
input lines
IEC 61000-4-11
<5% UTa
(>95% dip in UT)
for 0.5 cycles
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
<5% UT
(>95% dip in UT)
for 5 sec
<5% UT
(>95% dip in UT)
for 0.5 cycles
40% UT
(60% dip in UT)
for 5 cycles
70% UT
(30% dip in UT)
for 25 cycles
<5% UT
(>95% dip in UT)
for 5 sec
Mains power quality should be that of a typical
commercial or hospital environment. If the user of
this equipment requires continued operation during
power mains interruptions, ReliantHeart
recommends powering this equipment from an
uninterruptible power supply (UPS) or a battery.
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
10 A/m
60 A/m
Based on the compliance level of 60 A/m for power
frequency magnetic field, the appropriate
separation distance can be calculated based upon
the current in the power risers using the following
formula:
r=
Where I is the maximum current in amperes in the
mains cable, and r is the recommended minimum
separation distance (in meters).
An example for calculating the separation distance
for a 100 power bus would be as follows:
r=
In the example above, the recommended
separation distance would be about 27 cm.
UT is the AC mains voltage prior to application of the test level.
Table D-3.
< Radio Frequency Susceptibility (Radiated and Conducted)
and Electrostatic Discharge >
Immunity Test
RTCA/DO 160F Test Level
Compliance
Radiated Susceptibility
RTCA/DO-160F Section 20
20V/m 100 to 400 MHz
Yes
Radiated Susceptibility
RTCA/DO-160F section 20
150V/m 400 MHz to 8 GHz
Yes
Air Discharge
RTCA/DO-160F Section 25
15kV
Yes
Compliance indicates that the device did not malfunction while subjected to the listed
test levels.
ReliantHeart Confidential – Patient and Heath Care Provider Use
D–3
Table D-4.
Immunity test
Electromagnetic immunity guidance and manufacturer’s declaration for all life
supporting ME equipment and ME systems
IEC 60601 test
level
Compliance
Electromagnetic environment—guidance
Portable and mobile RF communications equipment
should be used no closer to any part of this
equipment, including cables, than the
recommended separation distance calculated from
the equation applicable to the frequency of the
transmitter.
Conducted RF
IEC 61000-4-6
Radiated RF
IEC 61000-4-3
3 Vrms
150 kHz to 80 MHz
Outside ISM bandsa
3V
10 Vrms
150 kHz to 80 MHz
in ISM bandsa
10 V
10 V/ m
80 MHz to 2.5 GHz
Recommended Separation Distance
1.2√
Recommended Separation Distance
1.2√
10 V/ m
80 MHz to 400
MHz
Recommended Separation Distance: 80 MHz to
400 MHz
20 V/ m
400 MHz to 3.5
GHz
Recommended Separation Distance: 400 MHz to
800 MHz
1.2√
1.2√
Recommended Separation Distance: 800 MHz to
3.5 GHz
0.6√
Recommended Separation Distance: 800 MHz to
3.5 GHz
1.2√
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
Field strengths from fixed RF transmitters, as
determined by an electromagnetic site survey c;
should be less than the compliance level in each
frequency ranged.
Interference can occur in the vicinity of equipment
marked with the following symbol:
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; 27,957 MHz to 27,283 MHz; and 40.66 MHz to 40.70 MHz.
The 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 patient areas. For this reason, an additional factor of
10/3 is used in calculating the recommended separation distance for transmitters in these frequency ranges.
D–4
HeartAssist 5® VAD System Patient User's Manual
IEC 60601 test
level
Immunity test
Compliance
Electromagnetic environment—guidance
No accurate theoretical prediction of field strength from fixed transmitters such as base stations for radio,
cellular and cordless telephones, land mobile radios, amateur radios, AM and FM radio broadcasts, and TV
broadcasts is possible. To assess the electromagnetic environment due to fixed RF transmitters, consider an
electromagnetic site survey. If the measured field strength in the location in which this equipment is used
exceeds the applicable RF compliance level listed in Table D-3, observe the equipment to verify normal
operation. If you observe abnormal performance, additional measures might be necessary, such as
reorienting or relocating this equipment.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 10 V/m.
At 400 MHz and 800 MHz, the higher frequency range applies.
These guidelines might not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
Recommended separation distance between portable and mobile RF
communications equipment and the Controller, HeartAttendant®,
battery pockets, Independent Power Supply, and batteries
This equipment is intended for use in an electromagnetic environment in which radiated
RF disturbances are controlled. The customer or the user of this equipment can help
prevent electromagnetic interference by maintaining a minimum distance between
portable and mobile communications equipment (transmitters) and this equipment as
recommended in Table D-4, according to the maximum output power of the
communications equipment.
Table D-5.
Recommended separation distance between portable and mobile RF
communications equipment and the life-supporting ME equipment and ME
systems
Separation distance according to frequency of transmitter
Rated maximum
output power of
transmitter
150 kHz to 80
MHz outside
ISM bands
150 kHz to 80
MHz in ISM
bands
80 MHz to 400
MHz
400 MHz to 800
MHz
800 MHz to 3.5
GHz
. √
. √
. √
. √
. √
0.01
0.12
0.12
0.12
0.06
0.12
0.1
0.38
0.38
0.38
0.19
0.38
1.2
1.2
1.2
0.6
1.2
10
3.8
3.8
3.8
1.9
3.8
100
12
12
12
12
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
ReliantHeart Confidential – Patient and Heath Care Provider Use
D–5
the frequency transmitter, where P is the maximum output power rating of the transmitter
in watts (W) according to the transmitter manufacturer.
At 400 MHz and 800 MHz, the separation distance for the higher frequency range
applies.
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.
An additional factor of 10/3 has been incorporated into the formula 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 or portable communications
equipment could cause interference if it is inadvertently brought into patient areas.
These guidelines might not apply in all situations. Electromagnetic propagation is
affected by absorption and reflection from structures, objects, and people.
The HeartAttendant® is intended for use in an electromagnetic environment in
which radiated RF disturbances are controlled. The user of the
HeartAttendant® can help prevent electromagnetic interference by maintaining
a minimum distance between portable and mobile RF communications
equipment (transmitters) and the HeartAttendant® as recommended in Table
D-4, according to the maximum output power of the communications
equipment.
Use of equipment and supplies other than those specified in this manual or
sold by ReliantHeart for replacement parts could affect the electromagnetic
compatibility of the HeartAssist 5® VAD with other devices, resulting in
potential interference between the HeartAssist 5® VAD and other devices.
The HeartAttendant® must be kept at least one foot away from electrical
appliances (such as kitchen appliances).
Requirements applicable to ME EQUIPMENT and ME SYSTEMS that intentionally
receive RF electromagnetic energy for the purpose of their operation (60601-1-2,
5.2.2.5)
For ME EQUIPMENT and ME SYSTEMS that intentionally receive FR electromagnetic
energy for the purpose of their operation, the ACCOMPANYING DOCUMENTS shall
include the following information:
a. Each frequency or frequency band of reception; the preferred frequency or
frequency band, if applicable, and the bandwidth of the receiving section of the
ME EQUIPMENT or ME SYSTEM in those bands.
The conquest controller may receive the following frequency ranges:
 869.2 MHz to 894.2 MHz
D–6
HeartAssist 5® VAD System Patient User's Manual
 935 MHz to 960 MHz
 1805.2 MHz to 1879.8 MHz
 1930.2 MHz to 1989.8 MHz
For operation in North America, the conquest controller will be fitted with an antenna
which is optimized to receive frequencies in the GSM 850 and GSM 1900 frequency
bands which have a range of 869.2 to 894.2 MHz and 1930.2 to 1989.8 MHz.
Use of equipment and supplies other than those specified in this manual or sold by
ReliantHeart for replacement parts could affect the electromagnetic compatibility
of the HeartAssist 5® VAD with other devices, resulting in potential interference
between the HeartAssist 5® VAD and other devices.
Requirements applicable to ME EQUIPMENT and ME SYSTEMS that include RF
transmitters (60601-1-2, 5.2.2.6)
For (Conquest Controller) ME EQUIPMENT and (VAD System) ME SYSTEMS that
include RF transmitters, the ACCOMPANYING DOCUMENTS shall include each
frequency or frequency band of transmission, the type and frequency characteristics of
the modulation and the EFFECTIVE RADIATED POWER.
RF Power Output 850MHz band
Limit: FCC: Nominal Peak Output Power < 38.45 dBm (7W)
IC: Nominal Peak Output Power < 40.60 dBm (11.5W) GSM Cellular 850 (GMSK Mode)
Frequency (MHz)
Radiated Power ERP (dBm)
824.2
30.5
836.6
31.2
848.8
30.3
RF Power Output 1900MHz band
Limit: Nominal Peak Output Power < 33 dBm (2W) GSM PCS 1900 (GMSK Mode)
Frequency (MHz)
Radiated Power EIRP (dBm)
1850.2
29.1
1880.0
29.3
1909.8
27.7
The HeartAssist 5® VAD System has been tested and found to comply with IEC 60601-12:2007 Medical Electrical Equipment - Part 1-2 General Requirements for Safety Collateral Standard: Electromagnetic Compatibility. This testing shows the device
provides reasonable protection against interference in a typical medical installation.
The HeartAssist 5® VAD can generate, use, and radiate radio frequency energy and, if
not installed and used in accordance with the instructions, can cause 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 interference to other
devices or is negatively impacted by other devices, the user is encouraged to attempt to
correct the interference by one or more of the following measures:
 Reorient or relocate devices.
 Increase the separation between devices.
ReliantHeart Confidential – Patient and Heath Care Provider Use
D–7
 Connect the equipment to an outlet on a different circuit.
 Consult the manufacturer or technical support engineer for help.
The HeartAssist 5® VAD System requires special precautions regarding
electromagnetic compatibility (EMC), and you must install it and put it into
service according to the EMC information provided in this appendix.
Portable and mobile RF communications equipment can affect the HeartAssist
5® VAD System.
FCC statements
ReliantHeart has issued the following statements regarding the HeartAssist 5® VAD
System wireless transmitter.
The following FCC statements apply to Model: CTL002
FCC ID: 2AB4ZCTL002.
Statement according to FCC part 15.19
This device complies with Part 15 of the FCC Rules. Operation is subject to the following
two conditions: (1) this device may not cause harmful interference, and (2) this device
must accept any interference received, including interference that may cause undesired
operation.
Statement according to FCC part 15.21
Modifications not expressly approved by, ReliantHeart could void the user’s authority to
operate the equipment.
D–8
HeartAssist 5® VAD System Patient User's Manual
Statement according to FCC part 15.105
This equipment has been tested and found to comply with the limits for a Class B
digital device, pursuant to Part 15 of the FCC Rules. These limits are designed to
provide reasonable protection against harmful interference in a residential
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 radio communications. However, there is no guarantee that
interference will not occur in a particular installation. If this equipment does cause
harmful interference to radio or television reception, 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 receiving antenna.
 Increase the separation between the equipment and receiver.
 Connect the equipment into an outlet on a circuit different from that to which the
receiver is connected.
 Consult the dealer or an experienced radio/TV technician for help.
Radio frequency radiation exposure information:
This phone has been tested and meets the FCC RF exposure guidelines for body
worn operations with zero distance. It shall be used with the ReliantHeart
accessories supplied or designated for this product and as documented within this
manual. Use of other accessories may not ensure compliance with the FCC RF
exposure guidelines.
R&TTE Declaration of Conformity
Hereby, ReliantHeart declares that the Controller is in compliance with the essential
requirements and other relevant provisions of Directive 1999/5/EC.
To obtain an English copy of the Declaration of Conformity, write to the address below:
ReliantHeart
8965 Interchange Drive
Houston, TX 77054
ReliantHeart Confidential – Patient and Heath Care Provider Use
D–9
D–10
HeartAssist 5® VAD System Patient User's Manual
Index
Accessories, 3-7
activity restrictions, 7-6
Daily operation, 5-3
Activity restrictions, 5-8
Daily status checks, 5-2
Automatic restart, 4-6
defibrillation, 5-11, 7-7
diagnostic alarms
BATTERY 1 DISCHARGED, B-8
backup
BATTERY 1 DISCONNECTED, B-8
power, 5-3
BATTERY 1 EXPIRED, B-9
bathing, 7-6
BATTERY 2 DISCHARGED, B-10
battery
BATTERY 2 DISCONNECTED, B-9
changing, 4-26
BATTERY 2 EXPIRED, B-10
charging, 4-28
EXCESS CURRENT, B-6
Battery pockets, 4-15
PUMP RESTARTING, B-7
REDUCED FLOW RATE, B-7
REDUCED MOTOR SPEED, B-7
controller
Documentation, 3-11
Automatic fail-safe mode, 4-6
Battery indicators, 4-5
display, 4-3
electrical shock, avoiding, 4-2
Flow sensor, 4-5
Electromagnetic disturbances, 6-3
messages and alarms, 4-4
Emergencies, 5-11, 7-6, A-2
replacement, 4-7
emergency alarms
Replacing the SIM card, 4-12
BOTH BATTERIES DISCONNECTED, B-5
safety check, 4-14
PUMP STOPPED, B-4
sounds, 4-4
VAD DISCONNECTED, B-5
Standard message screens, B-2
emergency assistance, 1-2
troubleshooting, A-3
Environmental conditions, 6-2
VAD restart algorithm, 4-6
exit site, how to care for, 5-9
Wireless radio antenna, 4-5
Controller, 4-2
controller failure alarms
graft protector, 3-4
Controller failure alarm, B-12
fail-safe alarm, B-11
CPR, 5-11
Independent Power Supply, 4-31
disconnecting, 5-4
ReliantHeart Confidential – Patient and Heath Care Provider Use
Index
LVAD Battery Charger, C-7
Indications and contraindications for use, 3-2
VAD, C-2
VADPAK, C-5
Leaving the home, 5-6
wireless antenna, C-4
liquids, contact with, 6-3, 7-3
specifications
independent power supply, C-5
Maintenance, 3-3
surgery pouch, 3-8
Symbols used in labeling, 3-8
System components, 3-3
no display, A-4
television screens, 7-4
outflow graft, 3-4
tethered operation
Independent Power Supply, 5-5
switching from unthethered operation, 5-5
pediatric patient
Tethered operation, 5-3
daily operation, 7-5
percutaneous cable
caring for, 5-10
untethered operation
switching to unthethered operation, 5-4
securing to the showerbag, 5-7
Percutaneous cable, 7-5
Potential complications, 3-3
power
cables, 4-2
outages, 5-11, 7-7
Untethered operation, 5-3
VADPAK, 4-16
Connecting to external power, 4-21
outlets, 4-2
Power supply, 4-22
prohibited activities, 7-6
pulse, 7-7
separation distance, D-5
shower bag, 5-6
Showering, 5-6, 7-6
specifications
controller, C-3
HeartAttendant, C-4
lithium ion batteries, C-6
Index
HeartAssist 5® VAD System Patient User's Manual
ReliantHeart Confidential – Patient and Heath Care Provider Use
Index-3

---

Source Exif Data:

File Type                       : PDF
File Type Extension             : pdf
MIME Type                       : application/pdf
PDF Version                     : 1.5
Linearized                      : No
Warning                         : Invalid secondary xref table
Author                          : bswift
Create Date                     : 2015:01:14 14:47:26-06:00
Creator                         : PScript5.dll Version 5.2.2
Modify Date                     : 2015:09:04 16:56:32-05:00
Producer                        : Acrobat Distiller 11.0 (Windows)
Title                           : 

EXIF Metadata provided by EXIF.tools