Abiomed AbioCor User manual

AbioCor
HandheldMonitor
INSTRUCTIONSFOR USE
®
®

CAUTION:
IMPORTANTNOTICE: Readthe entire InstructionsforUse beforeusingtheHandheldMonitor.
The HandheldMonitoristobe usedonlyinaccordancewiththe InstructionsforUse.
Manufacturedby:
ABIOMED, Inc.
22 CherryHill Drive
Danvers, MA01923USA
N.America:800-422-8666 (24-Hour EmergencyHotline)
or 978-777-5410
Document No.0034-0980-00006Rev. ADRAFT
July2004

©2004 ABIOMED, Inc. All rightsreserved.
Informationcontainedinthisdocument issubjecttochange withoutnotice.
ABIOMED, AbioCor,andtheABIOMEDlogoareregisteredU.S.trademarks of ABIOMED, Inc.
The AbioCor®ImplantableReplacement HeartSystemiscoveredbyoneormoreUnitedStates
Patentsandpatentspending.

Contents
Cautions..............................................................................................................1
Overview.............................................................................................................2
Componentsof theHandheldMonitor................................................................3
ControlsandFeatures........................................................................................5
Resolving Alarms................................................................................................7
Checking AbioCor®Status................................................................................13
Checking AbioCor®Settingsand AlarmHistory...............................................15
Chargingthe Battery.........................................................................................19
Troubleshooting................................................................................................21
CareandCleaning............................................................................................23
Appendix:FederalCommunicationsCommission (FCC)Notice...................A.1

About ThisManual
Thismanualprovidesthe InstructionsforUse fortheHandheldMonitorusedbypatientswhohave
receivedtheAbioCor®ImplantableReplacementHeartSystem.
These InstructionsforUse areintendedtobeusedbyclinicians, caregivers, andAbioCorpatients.
FormoreinformationabouttheAbioCorSystem, refertothe AbioCorImplantableReplacement
HeartSystem- Operator’sManual;the AbioCorConsoleAlarms-User’sGuide;andthe Patient-
CarriedElectronics [PCE] -Instructions forUse.

1
Cautions
NOTE:Acaution indicatesasituation inwhichequipmentmaymalfunction, bedamaged,orcease
tooperate.
•Do not usetheHandheldMonitorclosetoanoperatingAbioCor®Console. TheRFsignalsfrom
theAbioCorConsoleandtheHandheldMonitorwillinterferewitheachotherand notallow
adjustmentstobemadetotheImplantedSystem.IfRFinterference occurs,turnoffthe
HandheldMonitor.
•TheHandheldMonitordoes not useanindicatortodisplaythestatus ofitsbattery. However,the
alarmmessage“HandheldBattery”isdisplayedwhenthebatteryislow. Youshouldchargethe
HandheldMonitorbatteryeverynight, whetheritisusedornot.

Overview
2
Overview
TheHandheldMonitorisaPersonalDigitalAssistant(PDA)thatcommunicateswiththeAbioCor®
ImplantedController. Thisallowsyoutoquicklyaccess importantinformationabouttheAbioCor
withoutusingtheConsole. YoucanusetheHandheldMonitorto:
•RespondtoaHeartAlarmonthePCE Module.
•CheckAbioCor®status.
•CheckAbioCor®settingsandalarmhistory.
You cannot makechangestoBeatRate,MotorSpeed,orBalance settingsusing theHandheld
Monitor.Thesechangesmustbemadeusing theConsole.
BeforeusingtheHandheldMonitor, youmustbetrainedintheoperationofthePCE andtheConsole.

3
Componentsof theHandheldMonitor
•RFExpansionModule –allows theHandheldMonitortocommunicatewiththe
ImplantedController;draws powerfromtheHandheldMonitor’s battery(evenwhen
theunit is off).
•Handspring™Personal DigitalAssistant(PDA) –standardPDAusedas the
interface componentoftheHandheldMonitor.
•Stylus –usedtoselectitems onthescreen(fingers canalsobeused).
•Charger –plugsintoanACoutlettochargetheHandheldMonitor’s battery.

Componentsof theHandheld
Monitor
4
RFExpansion
Module
Charger
Handspring
™
PDA
Stylus

5
Controlsand Features
•Life-ThreateningAlarm Light –flashes whenalife-threateningalarmcondition
exists;italsoflashes brieflywhentheRFExpansionModuleisinserted.
•ApplicationButton –usedtoaccess theAbioCor®Settings Screens and Alarm
HistoryScreen.
•PowerButton –turns theHandheldMonitoronandoff;thescreenautomatically
turns off(tosavepower)iftheunit has notbeenusedfor2minutes.
•Touch-SensitiveScreen –displaysinformation;responds tothestylus.
•Scroll Buttons, Up/DownArrows,andScroll Bar –usedtomovethrough
informationonthescreen.

Controlsand
Features
6
Life-
Threatening
Alarm Light
Application
Button
Up/Down
Arrows
Scroll
Buttons
Scroll Bar
Touch-
Sensitive
Screen
(Not used)
Power
Button

7
Resolving Alarms
1TheHandheldMonitor’s AbioCor®Alarms screenallows youtoviewtwotypes of
alarms: active and inactive.
•Active alarm –anexistingalarmthathas not beenacknowledged(“silenced”);
indicatedbya flashing alarmmessage.
•Inactive alarm –anexistingalarmthathas beenacknowledged;becomes active
againifit isnotresolvedwithin2minutes;indicatedby a solid (notflashing)
alarmmessage.
NOTE:
Alarmsthat havebeen resolved without action oracknowledgementmaybe displayed as
solidalarmmessages.

Resolving
Alarms
8
2Alarms aredividedintothree levels: LifeThreatening, Serious, andAdvisory. The
followingmessagedisplaymethods areusedtodistinguisheachlevel:
•LifeThreatening –Active:flashes betweenblacktext
onlightbackground and lighttextonblackbackground.
Inactive:solidlighttextwithblackbackground.
•Serious –Active:flashes betweenblacktextandtexturedtext.
Inactive:solidblacktext.
•Advisory –Active:flashes “INFO”betweenblacktextandtexturedtext.
Inactive:solidblacktext.
Life-Threatening
Alarm Light
NOTE:The Life-Threatening AlarmLightalsoflashes red forActiveand Inactive.

9
Resolving Alarms(continued)
3WhentheHeartAlarm(visibleandaudible)onthePCEModuleis activated,move
theHandheldMonitorclosetotheImplantedController(stomacharea)andturnit
on. TheAbioCor®Alarms screenappears.
Heart
Alarm
PCE
Module

Resolving
Alarms
10
4Alarms arelistedinorderofimportance. Themostimportantalarmis atthetop of
thelist.
a. Usingthestylus (oryourfinger), tapthealarm
atthetop ofthelist. TheAlarmInfoscreen
appears.
b. Followtheinstructionsinthe firststeponly.
c. Taptoacknowledgethealarm. This
returnsyoutotheAbioCor®Alarms screen.
Checkwhetherthealarmis stilllisted.
Alarm
Info
Screen

11
Resolving Alarms (continued)
5Ifthealarmis stilllisted:
a. Tapthealarm.TheAlarmInfoscreenappears.
b. Followtheinstructionsinthe nextsteponly.
c. TaptoreturntotheAbioCor®Alarms screen.
d. Continueinthismanner, performing onestepat
atime,untilthealarmhas cleared.
Ifthealarmis nolongerlisted, tapthealarmthatisnowatthetop ofthelist. Begin
againwiththeproceduredescribedontheprevious page.
NOTE:
Besuretousethescrollbarto
viewadditionalinstructionsthatdonot fit
on asinglescreen.
Scroll
Bar

Resolving
Alarms
12
6Whenallalarms areresolved, theAbioCor®Status
screenappears, andtheHeartAlarmindicatoron
thePCEModuleturns off.
AbioCor
Status
Screen
Heart
Alarm
PCE
Module

13
Checking AbioCor®Status
1TurnontheHandheldMonitor. EithertheAbioCorStatus screenortheAbioCor
Alarms screenappears:
•IftheAbioCorStatus screenappears, proceedtothefollowingpage.
•IftheAbioCorAlarms screenappears (displayinga“CheckRF”alarm),move
theHandheldMonitorclosertotheImplantedController(stomacharea). The
“CheckRF”alarmshouldclear.
CAUTION: Do not use the Handheld Monitor close toan operating AbioCor®Console.
The RFsignals from the Console and the Handheld Monitor will interfere with each
other and not allow adjustments to be made to theImplanted System. If RFinterference
appears, turn off the Handheld Monitor.

Checking
AbioCor
®
Status
14
2TheAbioCor®Status screenprovides thefollowing
information:
•CO –indicates AbioCorblood flowinliters per
minute(L/min).
•TET –indicates systemvoltageinVDC.
•ABIOMED®logo –appears torotatewhenthe
programis operating.
TET ABIOMED
logo
CO