HeartWare Ventricular Assist System User manual

HeartWare®Ventricular Assist System
Patient Manual
CAUTION: Federal law restricts this device to sale by or on the order of a physician.
Leading a small revolution

IMPORTANT
Please read this enre manual before using the HeartWare® Ventricular Assist System
outside of the hospital. It is not safe to use the system away from trained professionals
unl you understand the informaon in this manual.
CONTACT INFORMATION
All problems should be promptly reported to medical or technical personnel. Before you leave
the hospital, add names and contact informaon below. It is very important to keep this
informaon available in case something happens to you or to your HeartWare® System.
TECHNICAL ASSISTANCE FOR HEARTWARE® VENTRICULAR ASSIST SYSTEM
_______________________ _______________ _______________ _____________
Name    Oce   Pager   Mobile
_______________________ _______________ _______________ _____________
Name    Oce   Pager   Mobile
MEDICAL ASSISTANCE
_______________________ _______________ _______________ _____________
Name    Oce   Pager   Mobile
_______________________ _______________ _______________ _____________
Name    Oce   Pager   Mobile
AMBULANCE
_______________________ ________________
Company   PhoneNumber

HeartWare®VentricularAssistSystemPatientManual
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QUICKREFERENCEGUIDEFORALARMS
Whenanalarmoccurs,twolinesoftextappearintheControllerDisplay.Thefirstlinetellsyou
whatthealarmis,andthesecondlinetellsyouwhattodo.Thechartbelowshowsallpotential
alarmsyoumayseeonyourcontroller.
AlarmTypeAlarmDisplay(line1)Action(line2)
“NoPower”Alarm
<nomessage><nomessage>
Whenbothpowersources(2batteriesor1batteryandanAC
adapterorDCadapter)areremoved,NOmessagewilldisplayon
thecontroller.The“NoPower”alarmwillsoundbuttheAlarm
IndicatoronthecontrollerWILLNOTlight.Thisindicatesyourpump
hasstopped.Youshouldimmediatelyconnecttwopowersources.
High‐Critical
(FlashingRed)
VADStoppedConnectDriveline
VADStoppedChangeController
CriticalBattery1ReplaceBattery1
CriticalBattery2ReplaceBattery2
ControllerFailedChangeController
Medium
(FlashingYellow)
ControllerFaultCall
ControllerFaultCall:ALARMSOFF
HighWattsCall
ElectricalFaultCall
LowFlowCall
SuctionCall
Low
(SolidYellow)
LowBattery1ReplaceBattery1
LowBattery2ReplaceBattery2
PowerDisconnectReconnectPower1
PowerDisconnectReconnectPower2

HeartWare®VentricularAssistSystemPatientManual
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TABLEOFCONTENTS
1GLOSSARYOFTERMS.........................................................................................................................................1
2INTRODUCTION..................................................................................................................................................4
2.1WHENVENTRICULARASSISTDEVICESAREINDICATED.....................................................................................................4
2.2WHYYOUSHOULDREADTHISMANUAL......................................................................................................................4
2.3UNDERSTANDINGHOWYOURHEARTWARE®VENTRICULARASSISTSYSTEMWORKS............................................................4
2.4HEARTWARE®VENTRICULARASSISTSYSTEMCOMPONENTS............................................................................................5
3WARNINGSANDPRECAUTIONS..........................................................................................................................7
3.1WARNINGS............................................................................................................................................................7
3.2PRECAUTIONS.........................................................................................................................................................9
4POTENTIALCOMPLICATIONSANDRISKS...........................................................................................................10
5POTENTIALBENEFITS........................................................................................................................................12
5.1HOWTODECIDEIFAHEARTWARE®SYSTEMISTHERIGHTTREATMENTFORYOU..............................................................12
5.2THEOPERATIONTOPLACETHEHEARTWARE®SYSTEM.................................................................................................12
5.3SUMMARYOFCLINICALSTUDYINFORMATIONUSINGTHEHEARTWARE®SYSTEM..............................................................13
6HEARTWARE®SYSTEM.....................................................................................................................................13
6.1HVAD®PUMP.....................................................................................................................................................13
6.2HEARTWARE®CONTROLLER....................................................................................................................................14
6.2.1USINGTHECONTROLLER.........................................................................................................................................15
6.2.2HOWTOCHANGETHECONTROLLER..........................................................................................................................17
6.3POWERSOURCESFORTHEHEARTWARE®CONTROLLER................................................................................................19
6.3.1CONNECTINGPOWERSOURCES................................................................................................................................20
6.3.2DISCONNECTINGPOWERSOURCES............................................................................................................................21
6.3.3CHANGINGPOWERSOURCES...................................................................................................................................21
6.3.4USINGBATTERYPOWER.........................................................................................................................................21
6.3.5RECOMMENDEDPRACTICESFORPOWERMANAGEMENT...............................................................................................23
6.3.6CHANGINGABATTERY............................................................................................................................................24
6.3.7CAREOFBATTERIES................................................................................................................................................24
6.4HEARTWARE®BATTERYCHARGER............................................................................................................................25
6.4.1CONNECTINGBATTERIESTOTHEBATTERYCHARGER.....................................................................................................26
6.4.2DISCONNECTINGBATTERIESFROMTHEBATTERYCHARGER............................................................................................26
7ALARMS...........................................................................................................................................................26
7.1NOPOWERALARM................................................................................................................................................27
7.2HIGHALARMS.......................................................................................................................................................27
7.3MEDIUMALARMS.................................................................................................................................................28
7.4LOWALARMS.......................................................................................................................................................29
7.5MULTIPLEALARMS................................................................................................................................................29
7.6HOWTOSILENCE(MUTE)ALARMS...........................................................................................................................30
8EQUIPMENTCAREANDMAINTENANCE............................................................................................................31
8.1HOWLONGHEARTWARE®EQUIPMENTSHOULDLAST.................................................................................................31
8.2GENERALCARE.....................................................................................................................................................31
8.3CONTROLLER........................................................................................................................................................31
8.4BATTERIES............................................................................................................................................................32
8.5BATTERYCHARGER................................................................................................................................................32
9ACTIVITIESOFDAILYLIVING.............................................................................................................................33

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9.1ELECTROSTATICDISCHARGE(ESD)............................................................................................................................34
9.2DRIVELINEEXITSITECARE.......................................................................................................................................35
9.3SHOWERING.........................................................................................................................................................36
9.4MEDICATIONS.......................................................................................................................................................36
10DISCHARGEINSTRUCTIONS..............................................................................................................................37
10.1DAILYCARE..........................................................................................................................................................37
10.2CAREOFEQUIPMENT.............................................................................................................................................37
10.3PAIN...................................................................................................................................................................37
10.4DIET....................................................................................................................................................................38
10.5TOBACCOPRODUCTS..............................................................................................................................................38
10.6ALCOHOL.............................................................................................................................................................38
10.7WEATHER............................................................................................................................................................38
10.8LIMITATIONS.........................................................................................................................................................38
10.9MISCELLANEOUS...................................................................................................................................................38
11EQUIPMENTNEEDEDFORHOMEUSE...............................................................................................................39
11.1HOMEDISCHARGEEQUIPMENTREQUIREMENTS..........................................................................................................39
11.2CARRYINGCASES...................................................................................................................................................39
11.2.1HEARTWARE®SHOULDERPACK..........................................................................................................................39
11.2.2HEARTWARE®WAISTPACK................................................................................................................................41
11.2.3CAREOFTHEHEARTWARE®SHOULDERPACKANDWAISTPACK:...............................................................................43
11.3HEARTWARE®SHOWERBAG...................................................................................................................................44
11.3.1GETTINGREADYTOSHOWER..............................................................................................................................44
11.3.2AFTERSHOWERING...........................................................................................................................................46
11.3.3CARINGFORYOURHEARTWARE®SHOWERBAG....................................................................................................46
12HANDLINGANEMERGENCY.............................................................................................................................47
13TRAVELINGANDTRANSPORT...........................................................................................................................47
14ADDITIONALINFORMATIONABOUTHEARTFAILURE........................................................................................48
APPENDIXA:PATIENTANDCAREGIVERTRAINING.....................................................................................................49

HeartWare®VentricularAssistSystemPatientManual
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1GLOSSARYOFTERMS
Ifyouhaveanyquestionsorneedmoreinformationaboutthetermsdefinedbelow,pleaseaskyour
doctororVADcoordinator.
A
ACAdapter:Anadapterthatusespowerfromanelectricaloutlettorunthecontroller.
AlarmAdapter:Asmallredadapter,thatwheninsertedintothecontroller,willsilencethe“No
Power”alarmifpowerisremovedfromacontrollerthatisnolongerinuse.
AlarmMuteButton:Abuttononthefrontofthecontrollerthatsilenceslowandmediumlevel
alarms.Whenpressedandheldfor5secondssimultaneouslywiththeScrollButton,itwillalso
silencethe“NoPower”alarmifpowerisremovedfromacontrollerthatisnolongerinuse.
AlarmIndicator:Abuttononthefrontofthecontrollerthatlightswhenoneormorealarm
conditionsoccur.Theindicatorchangescolorsdependingontheseverityofthealarmandalways
displaysthemostseverealarminthecaseofmultiplealarms.
Anticoagulants:Drugsthatincreasethetimeittakesbloodtoclot.
B
Battery:Oneofthepowersourcesusedtorunthepump.TwobatteriesoronebatteryandanAC
adapterorDCadapterarerequiredatalltimes.
BatteryCharger:Unitusedtochargebatteries.Uptofourbatteriesmaybechargedatatime.
BatteryCapacityDisplay:TheBatteryCapacityDisplayonthebatteryusesfourgreenlightstoshow
howmuchpowerremainsinthebattery.Eachgreenlightrepresentsapproximately25%ofavailable
power.Whenabatteryischargedandreadyforuse,allfourlightswillbeon.Asthebatteryloses
charge,fewerlightswillappear.
C
Cardioversion:Controlledelectricalshockusedtoreturnthehearttoanormalbeatingpattern.
Controller:Asmallcomputerthatoperatesthepumpandmakessureitisworkingcorrectly.It
warnstheuserwithwords,lightsandsoundsifthereisaproblem.
ControllerAC/DCIndicator:TheControllerAC/DCIndicatorwillbegreenifyouareusingthe
ACadapterorDCadaptertopowerthecontroller.
ControllerBatteryIndicators: TheControllerBatteryIndicatorsarelocatedonthetopof
thecontrollerandarelabeled“1”and“2”.Eitherthe“1”or“2”lightwillbelit,dependingupon
whichportisprovidingprimarybatterypowertothecontroller.TheControllerBatteryIndicators
tellyouapproximatelyhowmuchpowerremainsineachbattery.Whenabatteryisfullycharged,all
fourlightswillbeon.Asthebatterylosescharge,fewerlightsappear.

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D
DCAdapter:Anadapterthatusespowerfromanelectricaloutletinanautomobiletorunthe
controller.
Driveline:Thecablethatpassesthroughtheskinandconnectstotheimplantedpumpandtothe
externalHeartWare®Systemcomponents.
DrivelineCover:Asmall,whitecoverthatslidesoverthepump/controllerconnectiontoprotectit
andkeepitclean.
E
ESD:Electrostaticdischarge(staticelectricity)
ExitSite:Locationwherethedrivelinepassesthroughtheskin.
H
HeartWare®System:Allofthecomponents,bothinternalandexternal,neededtoimplantandrun
theHVAD®Pump.
HighAlarm:Themostseriousaudioandvisual(flashingred)alarm.Highpriorityalarmsrequire
immediateattention.
HVAD®Pump:Apumpingdevicethatsitsinsideyourchestandisconnecteddirectlytoyourheart.
Ithelpsyourheartpumpbloodthroughouttherestofyourbody.
I
Impeller:Theonlymovingpartofthepump.Astheimpellerspinsitmovesbloodfromtheheartto
therestofthebody.
L
LowAlarm:Anaudioandvisual(solidyellow)alarmthatinstructsyoutoeitherreplacealow
batteryortoreconnecttoapowersource(battery,ACadapterorDCadapter).
L/min:Litersperminute.Measurementofhowmuchbloodthepumpispumpingthroughthebody
inaminute.ShownontheControllerDisplay.
LVAD:Leftventricularassistdevice.Amechanicalpumpthathelpstheleftsideoftheheartpump
bloodthroughtherestofthebody.
LVAS:Leftventricularassistsystem.Aheartassistsystemthatincludesanimplantedpumpaswell
asanexternalcontrollerwithassociatedpowersources(batteries,ACadapter,andDCadapter)and
accessories.
M
MediumAlarm:Anaudioandvisual(flashingyellow)alarmthatrequiresyoutonotifyyourdoctor
orVADcoordinator.
MultipleAlarms:Conditioninwhichtherearetwoormorealarmsoccurringatthesametime.

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N
NoPowerAlarm:Anaudibleonlyalarmthatsoundswhenbothpowersourcesareremovedfrom
thecontroller.
P
Pump:Adevice(alsoknownasanLVAD)thatmovesbloodfromyourhearttootherpartsofyour
body.Thepumpisimplantedatthebaseofyourheartduringsurgery.
R
RPM:Revolutionsperminute.Thenumberoftimestheimpellerinthepumpspinsinaminute.
ShownontheControllerDisplay.
S
ScrollButton:Locatedontherightsideofthecontroller,theScrollButtonisusedtoseeallactive
alarmsandpumpinformation(RPM,L/min,Watts)ontheControllerDisplay.TheScrollButtonwill
alsoclearresolvedmediumalarmsfromtheControllerDisplay,willsilencea“NoPower”alarm
whenpressedwiththeAlarmMuteButton(seeAlarmMuteButton),andwillbrightenthe
ControllerDisplay.
ShowerBag:Abagthatholdsthecontrollerandtwobatteriesduringashower.
T
TestButton:Abuttononthebatterythatdisplaysbatterycapacitywhenpressed.
V
VAD:VentricularAssistDevice.Amechanicaldevicethatassiststheheart.
W
Watts:Measurementoftheamountofelectricityusedtorunthepump.ShownontheController
Display.
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2INTRODUCTION
Congestiveheartfailureisaconditioninwhichaheartcannotpumpenoughbloodtomeetthe
body'sneeds.Afailingheartworks,butnotasefficientlyasitshould.Asbloodflowleavingthe
heartslows,bloodflowreturningtotheheartwillback‐up,causingcongestioninthetissues.Along
withcongestioninthetissues,swelling(edema)oftenresults.Swellingmostoftenoccursinthelegs
andanklesbutitcanhappeninotherpartsofthebody,too.Fluidmaycollectinthelungsand
interferewithbreathing,causingshortnessofbreath,especiallywhenapersonislyingdown.Heart
failurealsoaffectsthekidneys'abilitytodisposeofwasteandextrafluid.Fluidretainedbythe
kidneysincreasesswelling.Peoplewithheartfailurecannotexertthemselvesbecausetheybecome
shortofbreathandtired.Withadvancedheartfailure,symptomsoftissuewastingandweightloss
canoccur.Severeheartfailurecanprogresstoshock(shockduetoinadequateoxygenandnutrients
deliveredbytheheart)andeventualdeath.
2.1 WhenVentricularAssistDevicesareIndicated
DoctorsuseVADssuchastheHeartWare®Systemtotreatpatientswhoarewaitingtoreceivea
hearttransplantandhavesevereheartfailurethathasnotimproveddespiteusingallother
treatmentmethodsavailable.
TheHeartWare®Systemshouldnotbeusedinpatientswhocannottakebloodthinning
medications.
2.2 WhyYouShouldReadthisManual
ThisPatientManualwilltellyouaboutyourHeartWare®Systemandexplainhowitworks.Italso
providesinformationaboutpropercareoftheHeartWare®Systemandwhattodoincaseofan
emergency.
Inadditiontothismanual,yourphysician,nurseorVADcoordinatorwillprovideyouwith
instructionsonoperatingtheHeartWare®Systemandonnecessarymedicalcare.Priortoleaving
thehospitalyoushouldunderstandhowtheHeartWare®Systemworks,howtocareforthe
equipmentandwhattodoinemergencysituations.Ifyouhaveanyquestionsafterreadingthis
manual,pleaseaskyourphysician,nurseorVADcoordinator.
2.3 UnderstandingHowYourHeartWare®VentricularAssistSystemWorks
TheHeartWare®Systemhelpsyourweakenedheartpumpbloodthroughoutyourbody.Thepump,
calledtheHVAD®Pump,circulatesbloodbyremovingitfromtheleftsideofyourheartand
pumpingitintoyouraorta(largebloodvesselthatcarriesbloodfromyourhearttotherestofyour
body).Thepumprestsinsideyourchestandtwosmallmotorsinsidethepumpcirculatetheblood
(Figure1).Adriveline(electricalwire)exitsyourskinandconnectsthepumptoacontroller.The
controllerispoweredbytwobatteriesorabatteryandelectricityfromthewallorcaroutlet.The
controlleroperatesthepumpandtellsyouifthereareanyproblemswithyoursystem.The
controllerandbatteriesarecontainedinaCarryingCase.
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Figure1:IllustrationofanImplantedHVAD®Pump
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2.4 HeartWare®VentricularAssistSystemComponents
HVAD®
Pump

Thepumpmovesbloodfromyourheart
tootherpartsofyourbody.Thepump
isimplantedatthebaseofyourheart
duringsurgery.
HeartWare®
Controller

Thecontrolleroperatesthepumpand
makessureitisworkingcorrectly.It
warnsyouwithwords,lightsand
soundsifthereisaproblem.
HeartWare®
Battery

Thebatteryisusedtopowerthe
controllerandthepump.Twobatteries
oronebatteryandanACadapterorDC
adapterareALWAYSrequired.
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RecommendedenvironmentalconditionsforgeneraluseoftheHeartWare®System:
Temperaturerangewithin10°Cto31°C(50°Fto88°F)
Relativehumidityrangewithin30%to75%
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HeartWare®
Battery
Charger
Thebatterychargerchargesandtests
thebatteries.
Driveline
Cover

Asmall,whitecoverthatslidesoverthe
pump/controllerconnectionand
protectsthecontrollerandpump
connector.
HeartWare®
Controller
ACAdapter

TheACadapterusespowerfroman
electricaloutlettopowerthecontroller
andpump.
HeartWare®
Controller
DCAdapter

TheDCadapterusespowerfroman
electricaloutletinamotorvehicleto
powerthecontrollerandpump.
Alarm
Adapter

Theredalarmadapterisforemergency
useonly.Theadapterisusedtosilence
the“NoPower”alarmwhenpoweris
removedfromacontrollerthatisno
longerinuse.

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3WARNINGSandPRECAUTIONS
3.1 Warnings
1. WARNING!Seriousandlifethreateningadverseevents,includingstroke,havebeenassociated
withuseofthisdevice.Ausermustfullyconsidertherisksofthisdevicewiththatofother
treatmentmodalitiesbeforedecidingtoproceedwithdeviceimplantation.
2. WARNING!PleasereadthisentiremanualbeforeusingtheHeartWare®Systemoutsideofthe
hospital.Itisnotsafetousethesystemawayfromtrainedprofessionalsuntilyouunderstand
theinformationinthismanual.
3. WARNING!DONOTbecomepregnantwhileyouhavetheHeartWare®System.Ifyouarea
womanofchildbearingage,usebirthcontrolifyouaresexuallyactive.Bloodthinners(which
mostLVASpatientsreceive)havebeenassociatedwithbirthdefects.Ifyoudobecome
pregnant,tellyourphysicianandhospitalcontactpersonimmediately.
4. WARNING!DONOToperatethecontrollerintemperatureslessthan‐4°F(‐20°C)orgreaterthan
122°F(50°C)orthecontrollermayfail.
5. WARNING!DONOTdisconnectthedrivelinefromthecontrollerorthepumpwillstop.Ifthis
happens,reconnectthedrivelinetothecontrollerassoonaspossibletorestartthepump.
6. WARNING!ALWAYSinvestigate,andifpossible,correctthecauseofanyalarm.Silencingan
alarmdoesnotresolvethealarmcondition.
7. WARNING!ALWAYSkeepasparecontrollerandfully‐chargedsparebatteriesavailableatall
timesincaseofanemergency.
8. WARNING!DONOTattachthealarmadaptertoacontrollerthatisconnectedtoarunning
pump.Thealarmadaptersilencesthe“NoPower”alarmandshouldonlybeattachedtoa
controllerthathasfailedormalfunctionedandisnolongerconnectedtoapump.
9. WARNING!DONOTplugtheACadapterintoanelectricaloutletthatisnotproperlygrounded
oryoumayreceiveaseriouselectricalshock.
10. WARNING!ALWAYSreplaceacontrollerwithablankdisplayand/ornoaudiblealarms.
11. WARNING!NEVERdisconnectbothpowersources(batteries,ACadapter,DCadapter)atthe
sametimesincethiswillstopthepumpandactivatetheNoPoweralarm.Atleastonepower
sourcemustbeconnectedatalltimes.
12. WARNING!ALWAYSswitchtothebackupcontrollerifthereisa“ControllerFailed”alarm.
13. WARNING!DONOTdropthecontrollerorotherequipment.Droppingthecontrollercould
causesuddenstoppageofthepump.Droppedequipmentshouldbereportedandinspected.
14. WARNING!ALWAYScheckthecontrollerdisplayforanyinformationregardinganalarmwhen
usingloudmachineryorinthevicinityofloudnoisessinceundertheseconditions,thecontroller
andbatteryalarmsmaynotbeaudible.
15. WARNING!DONOThaveamagneticresonanceimaging(MRI)procedurewhileimplantedwith
theHVAD®System.Doingsocouldharmyouorcausethepumptostop.

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16. WARNING!Keepmobilephonesatleast20inches(50centimeters)awayfromthecontroller,as
mobilephonesmayinterferewithcontrolleroperation.
17. WARNING!DONOTundergoproceduresrequiringhighpowerelectricaltreatment(e.g.
applicationofdiathermy)whilethepumpisimplanted.
18. WARNING!AVOIDexposuretotherapeuticlevelsofultrasoundenergy.Consultyourphysician
beforehavinglithotripsyprocedurestotreatkidneystonesoranytreatmentsinvolvinghigh
intensityultrasound.Theimplanteddevicemayinadvertentlyconcentratetheultrasoundfield
andcauseharm.
19. WARNING!AVOIDtherapeuticionizingradiation.Consultyourphysicianbeforehavingany
nuclearmedicineproceduresorradiationtherapyforcancer.Radiationmaydamagethedevice
andmaynotbeimmediatelydetectable.
20. WARNING!Avoiddevicesandconditionsthatmayinducestrongstaticdischarges(e.g.,
televisionorcomputermonitorscreens)aselectrostaticdischargescandamagetheelectrical
partsofthesystemandcausetheLVADtoperformimproperlyorstop.
21. WARNING!Alwayshaveabackupcontrollerhandyand,wheneverpossible,acaregivernearby
whenchangingpowersourcesorcontrollers.Bewatchfulforunusualchangesinpowerorflow
alarmsforaperiodoftimefollowingequipmentchanges.
22. WARNING!DONOTshoweruntilyourphysiciantellsyouitissafetodoso.Ifyoureceive
permissiontoshower,youmustusetheHeartWare®ShowerBag.Ifyourhearingisimpaired
and/oryoucannothearthecontrolleralarmswithouttheuseofahearingaid,makesureyour
caregiverwillbeclosebytohearalarms.
23. WARNING!DONOTplugthecontrollerintoanACwalloutletduringshowers;itshouldbe
connectedtotwobatteries.
24. WARNING!DONOTtakeabathorswim.
25. WARNING!DONOTsubmergeanyHeartWare®Systemcomponentinwater.
26. WARNING!DONOTallowwaterorotherfluidstoenterthecontroller,power(AC/DC)adapters,
batteries,batterycharger,orconnectors.Ifthishappens,contactyourphysician,nurseorVAD
coordinator.
27. WARNING!AVOIDareaswithhighmagneticforcessuchastheftdetectiondevices,airport
securitysystemsorinductioncooktops,asthesemayaffectHeartWare®Systemsoperation.
28. WARNING!DamagedequipmentshouldbereportedtoyourVADcoordinatorandinspected.
29. WARNING!DONOTuseanycomponentsotherthanthosesuppliedbyHeartWarewiththe
HeartWare®System,asthismayaffectHeartWare®Systemoperation.
30. WARNING!DONOTdisconnectthedrivelineorpowersourcesfromthecontrollerwhile
cleaningitorthepumpwillstop.Ifthishappens,reconnectthedrivelinetothecontrolleras
soonaspossibletorestartthepump.
31. WARNING!NEVERcleanthebatterychargerwiththepoweron,asthismayleadtoanelectrical
shock.

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3.2 Precautions
1. CAUTION:Tellyourphysicianifyouhavesightorhearingproblems.Thecontrolleruseswords,
lightsandsoundstotellyouhowthesystemisoperatingandwhentoseekadditionalhelp.
2. CAUTION:ALWAYSconfirmthatthepowercablesareproperlylockedtothecontrollerbygently
pullingthecableneartheconnector.
3. CAUTION:DONOTforceconnectorstogetherwithoutproperalignment.Forcingtogether
misalignedconnectorsmaydamagetheconnectors.
4. CAUTION:ALWAYSkeepallconnectorsfreeofliquid,dustanddirt,ortheHeartWare®System
maynotfunctionasintended.
5. CAUTION:DONOTpull,twistorkinkthedrivelineorpowercables,especiallywhilesitting,
gettingoutofbed,adjustingthecontrollerorpowersources,orwhenusingtheshowerbag.
6. CAUTION:ALWAYSchecktobesuretheDCadapterworksinyourmotorvehicle.TheDC
adapterisforuseinmotorvehiclesonlyandmaynotfitallmotorvehicles.
7. CAUTION:UseonlyHeartWare‐suppliedpoweradapterswiththeHeartWare®System.
8. CAUTION:ALWAYSrechargecompletelydepletedbatterieswithin24hourstoavoidpermanent
batterydamage.
9. CAUTION:DONOTplacebatteriesinwaterorliquid.
10. CAUTION:DONOTexposebatteriestotemperatureslessthan32°F(0°C)orgreaterthan113°F
(45°C)orthebatterymayrunthepumpforlesstimethanusual.Topreservebatterylife,
batteriesshouldbestoredatroomtemperature.
11. CAUTION:DONOTexposebatteriestoexcessiveshockorvibration.
12. CAUTION:DONOTdisassemble,crush,orpunctureabattery.
13. CAUTION:DONOTshorttheexternalcontactsonabattery.
14. CAUTION:ALWAYSkeepbatteriesawayfromchildren.Childrenmaybeharmedbydamaged
batteriesorcomponents.
15. CAUTION:DONOTuseadamagedbattery.
16. CAUTION:DONOTtouchthefluidifabatterypackisleakingfluid.Disposeofaleakingbattery
pack.Incaseofeyecontactwithfluid,DONOTrubeyes.Immediatelyflusheyesthoroughlywith
waterforatleast15minutes,liftingupperandlowerlids,untilnoevidenceofthefluidremains.
Seekmedicalattention.
17. CAUTION:DONOTdisposeofabatteryinfireorwater.Disposeofbatteriesaccordingto
federal,state,andlocalregulations.
18. CAUTION:NEVERuseotherbatterychargerstochargeHeartWare®Batteries.Otherbattery
chargersmaydamagethebatteries.
19. CAUTION:ALWAYSwaituntilthe“Ready”lightturnsontodisconnectthebatteryfromthe
batterycharger.Ifthisisnotfollowedoverconsecutivechargingcycles,theBatteryCapacity
Displaywillnotfunctionproperlyandmayconveymisleadingbatterycapacity.

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20. CAUTION:ALWAYScallyourclinicianforappropriateactionifthereisa“ControllerFault”alarm.
Thecontrollermayneedtobereplacedwiththeback‐upcontroller.
21. CAUTION:DONOTattempttorepairorserviceHeartWare®Systemequipment.Ifserviceis
required,contactyourphysician,nurseorVADcoordinator.
22. CAUTION:UseonlyHeartWare‐suppliedcomponentswithyourHeartWare®System.
23. CAUTION:DONOTplaycontactsports.Youmaystartbleedingorcoulddamageyour
equipment.
24. CAUTION:DONOTpull,kinkortwistthedrivelineorthepowercables.Specialcareshouldbe
takennottotwistthedrivelinewhilesitting,gettingoutofbed,adjustingcontrollerorpower
sources,orwhenusingtheshowerbag.
25. CAUTION:ALWAYSkeepextradrivelinelengthtuckedunderclothingorsecuredwithan
abdominalbinderordressing.Donotletanyportionofdrivelinehangfreelywhereitmightget
caughtonexternalitemssuchasdoorknobsorthecornersoffurniture.
26. CAUTION:ALWAYSnotifyyourphysicianpromptlyifthereisdrainage,swellingorreddenedskin
aroundthedrivelineexitsite,thesemayindicateaninfection.
27. CAUTION:DONOTuseprophylactictopicalantibioticointmentssuchassilversulfadiazine,
betadine,orpolymyxin‐neomycin‐bacitracinointment.Theseointmentscaninjurethetissue
adjacenttotheexitsite.
28. CAUTION:ALWAYSexaminethedrivelineforevidenceoftears,puncturesorbreakdownofany
ofthematerialduringexitsitedressingchanges.Reportanydamagetoyourphysician,nurseor
VADcoordinator.
29. CAUTION:ALWAYSnotifyyourphysicianpromptly,ifyounoticebloodorfluidinthedriveline.
ThesectionofthedrivelineinsideyourbodymayhavebeendamagedduringHVAD®Pump
implantationorduringanotheroperation.Thedrivelinehasbuiltinfeaturesthatminimizethe
effectofbloodorfluidenteringit,sotheHVAD®Pumpshouldcontinuetooperatenormally.
However,yourphysicianshouldexaminethedrivelinetofullyevaluatethesituation.
30. CAUTION:TheHeartWare®WaistPackandtheHeartWare®ShoulderPackcontainmagnetic
closures.Patientswithaninternalcardiacdefibrillator(ICD)orpacemakershouldkeepthepack
awayfromtheirchestandshouldnotsleepwiththepacktoavoidproximitytotheICDor
pacemaker.ThePatientPackwithoutmagnetsshouldbeusedwhensleeping.Perpacemaker
andICDmanufacturerguidelines,magnetsshouldbekeptatleast6inches(15cm)awayfrom
thepacemakerorICD(pleaserefertomanufacturerguidelinesforadditionalinformation).
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4POTENTIALCOMPLICATIONSANDRISKS
Duringthetwoclinicalstudiesavarietyofpotentialcomplicationswereidentified.Manyofthese
complicationswerewellknownfrompriorexperiencewithotherventricularassistdeviceshowever,
itisimportantthatyouunderstandallofthepotentialcomplicationsthatmayoccurwiththe
HeartWare®VentricularAssistSystem.Implantationofanyventricularassistdeviceisamajor
operationrequiringgeneralanesthesia,anincisionthatsplitsthebreastbone,beingonaheart‐lung

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machineandabreathingmachine.Eachoftheseproceduresmayleadtoseriouscomplications.
ComplicationsassociatedwithHeartWare®Systemuseandthepercentagesofpatientswho
developthesecomplicationsareshowninthetablebelow.Itispossiblethatacomplicationnot
listedinthistablemayoccur.
WARNING!Seriousandlifethreateningadverseevents,includingstroke,havebeen
associatedwithuseofthisdevice.Ausermustfullyconsidertherisksofthisdevicewith
thatofothertreatmentmodalitiesbeforedecidingtoproceedwithdeviceimplantation.
ComplicationsThatMayOccurwiththeHeartWare®System:
Complication
PercentChancefor
PatientstoHave
thisComplication
ResultofHavingaComplication
Infection40%Hospitalization,medication,death
Bleeding39%Hospitalization,bloodtransfusion,surgery,
death
IrregularHeartBeat

32%Hospitalization,medication,
cardioversion*,death
FailureoftheRightSideof
theHeart22%Hospitalization,medication,pumpforright sideofheart,death
LungProblems18%Hospitalization,medication,ventilator,
death
HeartWare®System
Malfunction/Failure16%Hospitalization,medication,surgery,death
NervousSystem(brainor
nerve)Problems15%Confusion,lossofmemory,pain,death
Stroke12%Hospitalization,medication,surgery,
rehabilitation,death
BloodClotsinthe
Bloodstream10%Hospitalization,medication,death
PsychologicalProblems8%Hospitalization,medication,depression
KidneyProblems8%Hospitalization,medication,dialysis,death
LiverProblems5%Hospitalization,medication,death

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Complication
PercentChancefor
PatientstoHave
thisComplication
ResultofHavingaComplication
DamagetoBloodCells3%Hospitalization,medication
HeartAttack0.3%Hospitalization,medication,death
*Cardioversion:Controlledelectricalshockusedtoreturnthehearttoanormalbeatingpattern

5POTENTIALBENEFITS
TheHeartWare®Systemwasdesignedtoassistafailingheart.Thepotentialbenefitofhavingthe
HeartWare®Systemisthereliefofthesymptomsofadvancedheartfailurewhileyouarewaitingfor
ahearttransplant.However,thereisnoguaranteeofthisandyoursymptomsmayremain
unchanged.Asaresultofthereliefofsymptomsofheartfailureyouwillfeelstrongerandhavethe
abilitytobemoreactive.
5.1 HowtoDecideifaHeartWare®SystemistheRightTreatmentforYou
Onlyyou,inconsultationwithyourdoctorcandecideifhavingtheHeartWare®Systemisrightfor
you.Yourdoctorwilltalkwithyouaboutthepotentialbenefitsandrisksofsurgeryandimplantation
oftheHeartWare®System.Besuretotalktoyourdoctoraboutanyconcernsorquestionsyoumay
have.
5.2 TheOperationtoPlacetheHeartWare®System
PlacementoftheHeartWare®Systemrequiresamajoroperation.Anincisionwillbemadeonthe
breastbonesothesurgeonscangainaccesstoyourheart.Youwillbetemporarilyplacedonaheart‐
lungmachinethatwilldotheworkofyourheartandlungswhilethesurgeonsareplacingthe
HVAD®Pump.PartoftheHVAD®Pumpwillbeinsidetheheartandpartwillsitinthechestcavity,
rightnexttotheheart.Anelectricalwirecalledadrivelinewillbetunneledundertheskinandcome
outthroughtheskinjustabovetheabdomen.Thedrivelinewirewillconnecttheexternalcomputer
(controller)thatrunsthepumpandthepowersourcestotheimplantedpump.Afterthepumpisin
placeandworking,youwillbeweanedfromtheheart–lungmachineandtheincisionswillbe
suturedclosed.
OncetheHVAD®Pumphasbeenimplanted,youwillbetakentotheIntensiveCareUnitwhere
nursesanddoctorswillprovideyouwiththelevelofcareyouneed.Youwillbeonabreathing
machinefor12‐24hoursandwillhavetospendsometimeintheIntensiveCareUnit.Youwillalso
beconnectedtoseveralintravenouslinesanddrainagetubes.Duringthistimeyouwillreceive
antibioticstoreducetheriskofinfectionandmedicationstohelpkeepyourheartbeatingregularly.
Youmayalsoneedtogetsomebloodtransfusions.Noneofthesetreatmentsareunusual;theyare
allintendedtoreducethechancesthatacomplicationmayoccur.Asyouregainyourstrength,you
willbetakenoffthebreathingmachineandtheintravenouslinesandthetubeswillberemoved.
YoumayalsobemovedfromtheIntensiveCareUnittoageneralhospitalfloor.Whileyouareinthe

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hospital,youwillbeginarehabilitationprogramdesignedtohelpyoureturntoamoreactive
lifestyle.Aspartofthisprogram,youandyourcaregiverwillbegiventrainingontheHeartWare®
System.Forexample,youwillbetrainedonhowtouseyourHeartWare®Systemathomeandhow
tointerpretandhandlethemessagesandalarmsthatmayappearonyourcontroller.
5.3 SummaryofClinicalStudyInformationusingtheHeartWare®System
TheHeartWare®Systemwhenusedtobridgepatientstohearttransplantationhasbeenevaluated
intwoclinicalstudies.ThefirstclinicalstudywasconductedinEuropeandAustralia.Thisstudy
included50patientsofwhich90%successfullyreachedthestudysuccesspoint.Thedefinitionof
successwas:
BeingaliveontheHeartWare®Systemfor180daysor
Receivingahearttransplantwithin180daysofhavingtheHVAD®Pumpimplantedor
HavingtheHVAD®Pumpsuccessfullyremovedafterthepatient’sownheartrecovered
within180daysofHVAD®Pumpimplant.
SixpatientsfromthisstudystillhavetheHeartWare®System;withthelongestpatientbeingonthe
system4.5years.
Asecond,largerbridgetohearttransplantationstudywasperformedintheUnitedStates.This
studyincluded140patients.Ofthe140patientswhoreceivedtheHeartWare®Systemasbridgeto
hearttransplantationintheUnitedStates,91%reachedthestudysuccesspoint.Inboththese
studies,therewereimprovementsinthepatients’qualityoflifeandtheirabilitytobetterperform
physicalactivitieswithatleast92%ofthepatientsbeingabletoreturnhomeaftertheHeartWare®
Systemwasplaced.TherisksidentifiedintheclinicaltrialsaredescribedinSection4,“Potential
ComplicationsandRisks”.
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6HEARTWARE®SYSTEM
TheHeartWare®Systemincludesthefollowingmajorcomponents:
1. HVAD®Pump
2. Controller
3. Externalpower–battery,ACadapterandDCadapter
4. Batterycharger
6.1 HVAD®Pump
TheHVAD®Pump(alsoknownasanLVAD)issmallandhasonemovingpart,calledanimpeller
(Figure2).Astheimpellerspinsitmovesbloodfromthehearttothebody.Theamountofblood
flowingthroughyourpumpdependsonthespeedoftheimpellerandyourbloodpressure.The
drivelinepassesthroughyourskinandconnectsthepumptothecontroller.

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Figure2:HVAD®PumpwithImpeller
6.2 HeartWare®Controller
Thecontroller(Figure3)operatesyourpumpandmakessurethatitisworkingcorrectly.The
controllerisconnectedtoyourdrivelineandshouldhavetwopowersupplies(batteries,ACadapter
orDCadapter)connectedatalltimes.Thedisplayonthecontrollergivesinformationaboutpump
performancethatincludesthebloodflowthroughthepump(L/min),impellerspeed(RPM)andthe
amountofpowerconsumed(Watts).Thecontrolleralsowarnsyouifthereisaproblemwithyour
pumporwiththepowersuppliesconnectedtoyourcontroller.
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Figure3:Controller
1. MonitorConnection
2. PowerConnection
3. DrivelineConnection
4. PowerConnection
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CAUTION:Tellyourphysicianifyouhavesightorhearingproblems.Thecontroller
useswords,lightsandsoundstotellyouhowthesystemisoperatingandwhento
seekadditionalhelp.
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