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LF524950

Medtronic LF524950, LF524955, MyCareLink 24950, MyCareLink Patient Monitor User manual

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MyCareLink™ Patient
Monitor
Model 24950
Caution: Federal Law (USA)
restricts this device to sale by
or on the order of a physician.
Patient Manual
Thefollowinglistincludestrademarksor
registeredtrademarksofMedtronicintheUnited
Statesandpossiblyinothercountries.Allother
trademarksarethepropertyoftheirrespective
owners.
MedtronicandMyCareLink
Explanation of Symbols
Conformité Européenne (European
Conformity).This symbol means that the
device fully complies with European
Directives.
This symbol means that the device fully
complies with the AIMD Directive
90/385/EEC (as amended by
2007/47/EC)(NB 0123) and R&TTE
1999/5/EC
(Reader) This product complies with
international electrical safety rating IP22 with
regard to ingress of dust, other foreign
objects, and water as required by IEC
60601-11.
(Monitor base) This product complies with
international electrical safety rating IP21 with
regard to ingress of dust, other foreign
objects, and water as required by IEC
60601-11.
Keep dry
Use only with provided power supply
Type BF applied part
Caution
Consult instructions for use
Package contents
Home monitor
Product documentation
Accessories
MyCareLink Patient Monitor
Non-ionizing electromagnetic radiation
Caution: Federal Law (USA) restricts this
device to sale by or on the order of a
physician.
Do not dispose of this product in the unsorted
municipal waste stream. Dispose of this
product according to local regulations. See
http:// recycling.medtronic.com for
instructions on proper disposal of this
product.
Reorder number
Serial number
Temperature limitation
Humidity limitation
For US audiences only
Manufacturer
Date of manufacture
Authorized representative in the European
community
Medical equipment with respect to electric
shock, fire, and mechanical hazards, only in
AAMI/ES 60601-1(2006) / A2 (2010) and
CSA 22.2 NO 60601-1 CAN/CSA:2008
China RoHS
USB port
Direct current. 5V 0.3A
Refer to instruction manual
7
Contents
Introduction 9
Aboutyourmonitor 9
Indicationsforuse 11
Contraindications 11
Warnings 11
Precautions 14
Contentsofthemonitorpackage 15
Aboutthemonitor 16
Choosingaplacetosetupthe monitor 18
Settingupthemonitor 19
Sendinginformationusingthemonitor 20
Start‐upscreeninformation 27
ReaderLEDindicatorlights 29
Troubleshootingerrormessages 30
Travelingwithyourmonitor 37
Monitorcare 38
HowtocontactMedtronic 39
Monitorspecifications 40
9
Introduction
Thismanualisintendedtohelpyouusethe
MyCareLinkPatientMonitorModel 24950.
Ifyouhaveanyquestionssettinguporusingthe
monitor,orifyouhaveproblemswiththemonitor,
pleasecontactMedtronic.See“Howtocontact
Medtronic”onpage 40,orusetheinformation
foundonthebackcoverofthismanual.
Ifyouhavequestionsaboutyourmedical
condition,talktoyourdoctor.Yourdoctorknows
yourmedicalhistory.
About your monitor
Themonitorisanelectronicdevicethatprovides
aneasywayforyourdoctortoobtaininformation
aboutyourheartdevice.Themonitorgathersthis
informationtoallowyourdoctortomanageyour
care.
Howyourmonitorgathersinformationfromyour
heartdeviceisdeterminedbythekindofheart
device
youhave.
10
Someheartdevicescommunicatewirelesslywith
yourmonitor.Onceyouhavesetupyourmonitor
andcompletedaninitialmanualtransmission,the
monitorisdesignedtoautomaticallygather
informationfromyourimplantedheartdevice.
Thisautomaticwirelesscommunicationbetween
yourheartdeviceandthemonitortakesplaceat
timesscheduledbyyourdoctororclinic.Sending
heartdeviceinformationtoyourclinicusing
wirelesstechnologydoesnotrequireyouto
interactwithyourmonitor.Theprocessissilent
andinvisible.
Clinicstypicallyscheduletheautomaticprocessto
occurwhileyousleep.Forthisreason,themonitor
mustremainpluggedintoapoweroutlet.The
heartdeviceinformationissenttoyourclinicusing
thecellularphonenetwork.
Otherheartdevicesrequireyoutouseyour
monitor’sreadertogatherinformationfromyour
heartdevicesoyourmonitorcansendthe
informationtoyourclinic.
Tofindoutwhichkindofdeviceyouhave,see
yourheartdevicepatientmanual,ortalktoyour
doctor.
11
Themonitorisintendedspecificallyforyouruse
only.Itwillnotworkwithotherimplanteddevices
andshouldonlybeusedbyyouasdirectedby
yourdoctor.Unauthorizedusebyotherswith
implanteddevicescouldinterrupttheprescribed
operationoftheirdevice.
Sending information at the request of your
doctor or clinic
Youwillsometimesneedtosendinformationat
timesotherthanthosescheduledbyyourdoctoror
clinic.Thesetimesare:
•Whencompletingfirst‐timesetup,toallow
automaticwirelesscommunicationbetween
yourmonitorandyourheartdevice
•Attherequestofyourdoctororclinic
See“Sendinginformationusingthemonitor”on
page 21ofthismanual.
Indications for use
Themonitorisanexternalelectronicdevicethat
interfaceswithMedtronicimplantedheartdevices
andatelecommunicationsconnectiontotransmit
12
storedimplantedheartdevicedatatothe
physicianorclinician.
Contraindications
Therearenoknowncontraindicationsforthe
monitor.
Warnings
Warning: Ifyouarefeelingill,seekimmediate
medicalattention.Donotusethemonitorunless
directedbyyourdoctor.Ifthereisanemergency,
callyourlocalemergencynumber.Ifyourdoctor
hasprovidedinstructions,followthem.Waitingto
seekmedicalattentioncouldbedangeroustoyour
health.
Warning: Toensure
thesafeoperationofthe
monitorandyourimplantedheartdevice,follow
theseinstructions:
Usethemonitorasdescribedinthismanual.Save
thismanual.
Usethemonitoronlyatthetimesprescribedby
yourdoctor.
13
Ifyouneedfurtherassistance,pleasecontact
Medtronic.See“HowtocontactMedtronic”on
page 40,orusetheinformationfoundontheback
coverofthismanual.
Warning: Donotusethemonitorifthemonitor
doesnotoperateasdescribedin“Sending
informationusingthemonitor”onpage 21.To
ensureproperoperationofyourimplantedheart
device,followtheinstructionsinthismanual
aboutpositioningthereaderoveryourimplanted
heartdevice.Ifyoudonotfollowthese
instructions,themonitormaynotberecordingor
sendinginformationfromyourimplantedheart
device.Ifyouneedfurtherassistance,please
contactMedtronic.See“Howtocontact
Medtronic”onpage 40,orusetheinformation
foundonthebackcoverofthismanual.
Warning: Donotmodifythisequipment.
Modificationsmayimpactmonitoreffectiveness,
andadverselyaffectyoursafety.
Warning: Donottouchopenportsorplugs,or
insertyourfingeroranyobjectsintotheopenports
onthemonitor.Insertingyourfingerorobjectsinto
anopenportmayresultinelectricalshock.
14
Warning: Importantsafetyinstructions.When
usingthemonitor,basicsafetyprecautionsshould
alwaysbefollowedtoreducetheriskoffire,
electricshock,andinjurytopersons,includingthe
following:
•Donotusethemonitornearwater,for
example,nearabathtub,washbowl,kitchen
sinkorlaundrytub,ina
wetbasement,or
nearaswimmingpool.
•Ifyoususpectagasleak,donotusethe
monitoranddonotuseatelephoneinthe
vicinityoftheleaktoreportagasleak.
15
Precautions
•Useonlythesuppliedpowercordwiththis
monitor.Usingadifferentpowercordcould
damagethemonitorandadverselyaffect
yoursafety.
•Donotusethemonitorwithintwometers
(six feet)ofatelevision,computermonitoror
screen,orwirelesscommunications
equipmentsuchaswirelesshomenetwork
devices,mobilephones,cordlesstelephones
andtheirbasestations,or‘walkie‐talkies.’
Usingyourmonitornearthesedevicescould
interferewithcommunicationbetweenyour
implantedheartdeviceandthemonitor.
16
Contents of the monitor package
Youshouldreceivethefollowing:
•OneMedtronicMyCareLinkPatientMonitor
Model 24950base
•OneMedtronicMyCareLinkModel24955
removablereader
•OneMedtronicMyCareLinkModel24956
powercord
•OnePatientManual
•OneQuickStartGuide
•Onesetof‘ForYourRecords’labels
•OneCellularModemsafetymanual
17
About the monitor
Figure 1: Monitor base and removable reader (front
view)
Themonitor(Figure 2)consistsofthree
components:
1 Reader 4 Power LED
2 Accept Button 5 Power port
3 Monitor screen
1
2
3
4
5
18
•Amonitorbase
•Aremovablereadertogatherinformationfrom
yourimplantedheartdevice
•Apowercord
Figure 2: Components
1 Power cord 2 Reader 3 Base
1
2
3
19
Figure 3: Monitor reader (front and back view,
approximately 1/3 actual size)
Choosing a place to set up the monitor
Considerthefollowingrecommendationsfor
choosingaplacetosetupthemonitor:
•Placethemonitornearwhereyousleep,
preferablyonanightstandoratable.Your
monitoriscapableofreceivingsignals from
yourheartdeviceupto3meters(10feet)away,
butyoushouldconsultyourheart
device
manualforrecommendeddistancesspecificto
yourdevice.
20
•Placethemonitorwhereyoucansitcomfortably
andseethefrontofthemonitor.
•Placethemonitorinalocationthatreceivesan
adequatecellularsignal.
•Placethemonitorwithinreachofapower
outlet,andpositionitsothatitcanbe
unpluggedfromthepoweroutletifnecessary.
•Donotplacethemonitoranywhereitcouldget
wet.
Setting up the monitor
Beforeyouusethemonitoryouwillneedtoplug
themonitorintoapoweroutlet.
Topluginyourmonitor,locatethepowercord
portontheleftsideofthemonitorbase.Insertthe
powercordendintothemonitorsideport,then
plugthewallplugintoa
walloutlet.
Caution: Useonlythesuppliedpowercordwith
thismonitor.Usingadifferentpowercordcould
damagethemonitorandadverselyaffectyour
safety.
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