iHealth ECG3 User manual

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iHealth
Portable ECGmonitor(ECG3)
OWNER S MANUAL
TableofContents
INTRODUCTION................................................................................................................. 2
PACKAGECONTENTS...................................................................................................... 2
INTENDEDUSE ................................................................................................................. 2
CONTRAINDICATION........................................................................................................ 2
PARTS AND DISPLAYINDICATORS................................................................................. 3
SETUP AND OPERATINGPROCEDURES ....................................................................... 3
DownloadTheFreeiHealthECG3App............................................................................ 3
Add newuseritemin iHealthECG3App........................................................................... 3
ActivatetheECG3............................................................................................................. 3
Updatethefirmware of ECG3............................................................................................. 3
OPERATIONINSTRUCTIONS........................................................................................... 4
SPECIFICATIONS.............................................................................................................. 5
GENERAL SAFETY ANDPRECAUTIONS......................................................................... 5
BATTERY HANDLINGAND USAGE.................................................................................. 7
TROUBLESHOOTING....................................................................................................... 8
CARE AND MAINTENANCE............................................................................................... 9
WARRANTY INFORMATION.............................................................................................. 9
EXPLANATIONOFSYMBOLS......................................................................................... 10
OTHERSTANDARDS AND COMPLIANCES................................................................... 12
ELECTROMAGNETICCOMPATIBILITYINFORMATION................................................ 12

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INTRODUCTION
Thankyouforselecting theECG3.TheECG3 isanautomaticsingle -leaddynamic
electrocardiogram(ECG)recorder,whichcan recordand store 72hourECGdataatmost.
ECG3 cantransmit currentECGdatatoaniOS device withBluetooth on whichusercan
watch thecurrentECGwaveform and heartrate.The ECGdatastored inECG3can be
uploadedon aniOSdevice with adatacable,which willbeautomaticallyanalyzedand
displayed.The heartrate iscalculatedbycounting the heartbeatsineach 30sandthe
maximumand minimumheartrateiscalculated ineveryhour.
PACKAGECONTENTS
•1 ECGRecorder
•1 Owner sManual
•3 Electrodes
•1 Data cable
•1 Chargingcable
Cable
Max. cable length,
Shielded/unshielded Number Cable classification
DCPower Line (USBCable) 0.26m Unshielded
1Set DCPower
Signal Line(USB Cable) 0.26m Unshielded
1Set Datatransition
INTENDEDUSE
The ECG3 isintendedforuseinacommunityhospitalorathomeand itisa dynamic
electrocardiogrammeasurementsystem.It isdesignedto measureand record ECGdata
ofanadult individualinthelongterm byusinga technique in whichan electrode was
pastedon thechest.
CONTRAINDICATION
People wearing acardiacpacemakershould notusethisproduct.
People with sensitive skin orskinallergiesare notsuggested tousethisproduct.

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PARTS AND DISPLAYINDICATORS
IndicatorLED
Userkey
Base
Electrode Bside
Electrode Aside
Electrode
Contracts
SETUP AND OPERATINGPROCEDURES
DownloadTheFreeiHealthECG3App
Priortofirst use,download andinstall the iHealthECG3App fromthe App Store(iOS
device). Usekeywordsearchterms iHealth”or ECG3”.
Note:TheiHealthECG3 Appisonlysupported iniPadmini4,iPadAir2,iPad mini3,
iPadAir,iPad mini2,iPad miniand iPad(4thgeneration).The systemversionshouldbe
above 10.0.0.
Add newuseritemin iHealthECG3App
Userneedtoadd a newuseritemin iHealth ECG3App tostorethemeasuringhistory.
Do the followingstepsto createa newuseritem:
a. Press the button togetintothe userlist.
b. Click the “Add”button atthe bottomofthispage to enterthe “Add User”page.Input
the information ofthe patientaccording tothe prompt.
c. Click the “Save”button to savethe newuseritem.
ActivatetheECG3
ECG3shouldbeactivatedonfirstuse,oryouwill notbeabletousethisunit.
ConnectingECG3toan ACadapteroraUSB porton PCusingthe chargingcable,the
green indicatorLEDon the ECG3beginsto blink.DisconnectingECG3withcharging cable,
the green indicatorLEDblinks4timesindicating thatthe devicehasbeen activated.
Updatethefirmware of ECG3
If anewversion of theECG3’sfirmwareisreleased, the iHealthECG3Appwill inform
usertoupdatewhen theECG3isconnected totheiOS devicewiththe datacable. User
can choosewhethertoupdatethisversion ofthe ECG3’sfirmware,but it isstrongly
recommendedtodothisupdatingtoget abetterexperience. Dothefollowingstepsto
updatethefirmwareofECG3:
a.Connect ECG3totheiOS devicewiththe data
cableand launchthe iHealthECG3App.Ifthereis

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anewversion offirmware, theApp will prompt userasisshowninthefigureat
right side.
b.Click the Install”buttontodo theupdating, keep theconnectionbetween ECG3
and iOS deviceand wait until thefirmwaredownload finish,then disconnect ECG3
withthe iOS device.
c.ECG3will updateautomaticallyandthegreenLEDwill blinks during updating.The
green LEDwill lighten When updatingfinish.
d.Press thebuttontoreset ECG3, thegreenLEDwill blink4times, whichindicates
updatingsuccess.
Note: Theclock inECG3will reset aftereachupdatingfinish,sopleasecalibratethe
clock intheECG3bywatchingthecurrentECG waveformintroduced inthefollowing
introductionsaftereachupdating.
OPERATIONINSTRUCTIONS
a. RemovethereleasepaperatAsideoftheelectrode,
andpastetheelectrodeatthepositionofchest
shown in the figure onthe rightside (Note:Clean skin
beforepastingtheelectrodeif possible,whichis
conducivetotheaccuracy ofmeasurement).Then
removethereleasepaperatBsideoftheelectrode.
The electrodeisdisposableand donottrytouse itagain.
b. Fasten ECG3withthebase on the electrodeand ensure thatthe ECG3hasagood
contactwiththeelectrode.Press the UserkeyonECG3forabout2s,the ECG3
will vibrateonce,whichindicatethe measurementbeginning.And the green
indicatorLEDon ECG3will blinkoncein3s.The blinkingwill lastuntil
measurementstopped.
c. Usercan watchthecurrentECGwaveformduringmeasurementprocessing.
Please do thefollowing stepsto watch currentECGwaveform:
1)OpenBluetoothofthe iOS device.
2)LaunchtheiHealth ECG3App,waituntil the icon turnsblue.Press this
icon, the iHealth ECG3Appwill showanewpage.The currentECGwaveform,
heart rateandbatteryvolumeareshowninthispage.
3)WhenseveralECG3areworkingatthe sametime,the iHealth ECG3App will
showadevicelist. UserneedstochooseadeviceinthelistaccordingtotheMAC
printed at the bottomoftheECG3.
4)IftheECG3doesnotcontactwell withthe electrode,
the iHealth ECG3Appwill promptalead offmessage
showninthefigureattherightsideandtheECG3will
vibratecontinuously(4timesvibration ineach5s).Please
check the contact between skinand the electrode andthe
contact between theECG3andthe electrode.
d.Ifuserfeelsuncomfortableinheart duringmeasurement
processing,pleasepress the userkeytomarkthistime
point, whichisconducivetothe diagnosisoftheheart
abnormality.

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e. If userwantstofinishthe measurement,takedowntheECG3fromtheelectrode,
theECG3willbegintovibrateandwillstopworking30slater.Usercanalsostop
the ECG3workingbycharging it.
f. If userneedstowatch the ECGdatastored inthe ECG3,pleaseconnecttheECG3
toaniOSdevicewiththe datacable.Launchthe iHealthECG3App and the App
will showthe pageindicatingthatthe ECG3beginstouploadtheECGdatatothe
iOS device.Waitinguntil the ECGdatauploadingfinish,usercan watchthe
recordedECGwaveformandthetimepointsadded byuseroranalyzed
automaticallybythe iHealthECG3Appindicatingthe heartabnormality.
Note: TheiHealthECG3Appwill calibratetheclock inECG3whichisusedtorecord
the start time, stoptimeandtimepointsthatusermarks whilethe ECG3is
transmitting thecurrentECG data.So itisstronglysuggested towatchthecurrent
ECG waveformineachmeasurement.
SPECIFICATIONS
1. Productname:Portable ECGmonitor
2. Model:ECG3
3. Classification:Internallypowered,TypeBFapplied part,IP22,Continuousoperation
4. Machinesize:approx.45mm ×45mm ×14mm
5. Weight:approx.17g
6. Memoryvolume:more than72 hourECGdata
7. Power:
DC:5V 500mA
Battery:1*3.7V Li-ion 165mAh
8. Measurementrange:
Heartrate:30 -280BPM
9. Heartrate Accuracy: 2BPMor 5%(which islarger)
10.Wireless communication:
Bluetooth lowenergy
11.StorageCondition (recorder):-20 ℃～65℃(-4 ℉～149 ℉)+0 ～95%RH without
condensation
12.Operationcondition:10℃～40℃(50℉～104℉)+10～95%RH withoutcondensation
13.Environmentalpressure:700hPa-1060hPa
14.Batterylife: 300 charge/ dischargecycles,72hourcontinuousmeasurementonafull
charge
Note:Thesespecificationsare subjectto changewithoutnotice.
GENERAL SAFETY ANDPRECAUTIONS
1. Read allofthe informationinthe OwnersManualandotherprovidedinstructions
beforeoperatingthe unit.
2. Pleasecontactthe manufacturertogetinformation in maintainingand using ECG3orto
reportunexpected operationorevents.
3. ThisECGRecorderisdesigned foradultsand should neverbe used on infants
weighinglessthan10kg.
4. Do notdiagnosebyyourselfaccordingtothe measurementresults,pleasealways
consultyourdoctor.Self-diagnosismaylead to deterioration in yourcondition.
5. KeeptheECG3andotheraccessoriesoutofreachofyoung children and petsto
preventtheunitbeingswallowedorcausing contactinjuries.

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6. Use ofECG3adjacenttoorstacked with otherequipmentshouldbe avoided
becauseit could result in improperoperation.If such use isnecessary,ECG3and the
otherequipmentshould be observed to verifythattheyareoperating normally.
7. Portable RFcommunicationsequipment(includingperipheralssuchasantenna
cablesand externalantennas)should beused no closerthan30 cm(12 inches)toany
partoftheECG3,includingcablesspecified bythemanufacturer.Otherwise,
degradationofthe performanceofthisequipmentcouldresult.
8. The useofaccessories,transmittersandcablesotherthanthose specifiedbyAndon
Health,with the exception ofaccessoriesand cablessoldbyAndonHealthof
PORTABLEECGMONITORasreplacementpartsforinternalcomponents,mayresult
inincreased EMISSIONSordecreased IMMUNITYofthePORTABLE ECGMONITOR.
9. FollowingESSENTIALPERFORMANCE isintendedused in Homecare environment.
ESSENTIALPERFORMANCE: Heartrate Accuracy: 2BPMor 5%(whichislarger)
10.The ECG3 can beusedathomeandin a communityhospital.IfuseECG3 inahospital,
keepthe unitawayfromactiveHFSURGICAL EQUIPMENTandthe RFshieldedroom
ofan MESYSTEMformagneticresonanceimaging,where theintensityofEM
DISTURBANCES ishigh.If useECG3athome,keeptheunit awayfromdevices
emitting strongelectromagneticradiosuchasmobile phone and microwave.
11.Uploadingand watching theECGdatarecorded in theECG3inaniOS deviceisthe
onlyoperation thatusercan doinanambientcondition with highintensityofEM
DISTURBANCES.
12. Donotusethisproductwithadefibrillator,whichwillbe dangerous.Removethe
ECG3 before usingadefibrillator.
13.The skin which theelectrodesare contactedorpastedshouldbe clean,because
excessivebodyhairwillinfluencethe ECGmeasurement.
14. If a skinallergyorotherunfitted symptomshappenedduringmeasurement, stop
measuringimmediately.
15. Please donotshare the unitwithanyinfectiouspersontoavoidcross-infection.
16.Sweatandsteamhavenoharmfuleffecton ECG3,butyoushouldkeepthisunitdryas
possible.Avoidactivitiesinwetenvironmentsuchastaking ashower.
17.The ECG3 willnotsend warning message touserwhena heartabnormalityoccurs
duringtakingmeasurement.
18. Wrong operationandinappropriatepositionofelectrode will lead toanunreliable
measuringresult. Please read the Owner sManualcarefullyandoperatetheECG3
cautiouslywhiletaking measurement.
19.Avoidstrenuousexercise while taking measurement,whichmaycause awrong
measuringresult.
20.The devicewouldnotapplytothepatientswho useanartificialheartandlung(there
will be no ECGwaveform).
21.The patientcanbeanintendedoperator.Allfunctionsoftheunitcanbeusedsafelyby
patient.Chargingisthe onlymaintenance can be operatedbypatient.
22.Pleasedon tuseaccessories(e.g.electrode,datacable,etc.)thatarenotdescribedin
the instructions.Dothe opposite willpossiblydamage thisunitand causedangers.
23.Thisproductshouldnotbeused asa USBdevice.
24. Thisproductmightnotmeetitsperformancespecificationsif stored orused outside
the specified temperature and humidityranges.
25. No maintenancecanbe carried onwhentheECG3isworking ona patient.

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26. Donotbenervousoranxiouswhen taking measurement, anunreliablewilloccur
otherwise.
27.Electrode ofECG3 shouldnotcontactotherconductivepartsincluding earth.
28.ThisequipmentcomplieswithFCC RFradiation exposurelimitssetforthforan
uncontrolled environment.
29.Thisdevicecomplieswith part15ofthe FCCrules.Operationissubjecttothe following
twoconditions:(1)thisdevicemaynotcauseharmfulinterference,and (2)thisdevice
mustacceptanyinterference received,including interference thatmaycauseundesired
operation.
30.The manufacturerisnotresponsibleforanyradioorTVinterferencecausedby
unauthorized modificationstothisequipment.Suchmodificationscouldvoidthe users
authoritytooperatethe equipment.
31.Thisequipmenthasbeentestedandfoundto complywiththelimitsforaClassB digital
device,pursuanttopart15oftheFCC Rules.Theselimitsaredesignedtoprovide
reasonableprotectionagainstharmfulinterferenceinaresidentialinstallation.This
equipmentgeneratesusesand canradiateradiofrequency energyand,if notinstalled
and usedinaccordancewiththe instructions,maycauseharmfulinterferencetoradio
communications.However,thereisno guaranteethatinterferencewill notoccurina
particularinstallation.If thisequipmentdoescauseharmfulinterferencetoradioor
television reception,whichcanbedeterminedbyturningtheequipmentoffand on,the
userisencouragedtotrytocorrecttheinterferencebyoneormoreofthe following
measures:
-Reorientorrelocatethe receivingantenna.
-Increase the separation betweenthe equipmentandreceiver.
-Connecttheequipmentintoan outleton acircuit differentfromthattowhichthe
receiverisconnected.
-Consult thedealeroranexperiencedradio/TV technician forhelp.
-Thisdeviceand itsantenna(s)mustnotbeco-located oroperatingin conjunction with
anyotherantennaortransmitter.
BATTERY HANDLINGAND USAGE
Donotchange the battery.Ifthebatterycan nolongerbecharged,pleasecontact
CustomerService.
•Please ensurethe ECG3 hasatleast40%powerbeforea 24hourmeasurement. If
an ECG3doesnothave enough powertostartameasurement,itwillstop recording
ECGdataand willpromptuser.Pleasecharge thisunitforatleast1 hour.
•When chargingisneeded,pleaseconnectECG3 toanACadapterora USBporton
PCwith thechargingcable.TheECG3willnotworkwhilecharging,pleasewait until
charging iscomplete.
•AmedicalACadapterwithanoutputofDC5.0V,above500mAandcomplieswith
IEC60601-1/UL60601-1andIEC60601-1-2/EN60601-1-2issuitableforthisunit.
Please notethatthejack sizeisUSBmicro-B.
•When charging theECG3,theECG3willshowwithdifferentindicatorindicatingthe
powerstatus.See thetablebelowfordetails.
•It issuggested thatyou charge thebatterywhenthe batteryisless than20%.
Overchargingthebatterymayreduce itslifetime.
Lithiumbatteryreplacementbyinadequatelytrained personnelcould resultina
hazardsuchasa fireorexplosion.

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Do notplugorunplugtheACadapterinto the electricaloutletwithwethands.
If theACadapterisabnormal, pleasechangetheadapter.
When batterycharging,the ACinputvoltageisinterrupted,ECG3 will stopbattery
charging,and ifthepowersupplyrestored,batterychargingrecovered automatically,
thisdegradationcould be acceptedbecause itwill notleadtounacceptablerisks andit
will notresultinthelossofbasicsafetyoressentialperformance
The ECG3,data cable,chargingcable, battery and electrodesmustbe
disposedofaccording to localregulationsatthe endoftheirusage.
Note:Thebatteryhaslimited charge cyclesand mayeventuallyneed tobe
replacedbyan iHealthservice provider.Batterylifeand chargecyclesvarybyuse
andsettings.
ECG3 Status StatusIndicator
Charging The green indicatorLEDbreathes(Theprocess thatLED turnsdimtobrilliantgraduallyandthendotheopposite)
continuously
Fullycharged The greenindicatorLEDlightsup constantly
Lowbattery ECG3vibrates2timesandtheredindicatorLEDbreathes
for10times
TROUBLESHOOTING
PROBLEM POSSIBLECAUSE SOLUTION
LowBattery Batteryistoolow Charge thebattery
ECG3 vibrates
continuouslyduring
measurement
ECG3 andelectrode do not
contactwell
Check andensure thatthe
ECG3 andthe electrode,the
electrode and skin have agood
contact
ECG3 cannotconnect
to iOSdevicethrough
Bluetooth
The iHealth ECG3 App
occursan errororthe
BluetoothoftheiOSdevice
isnotopen
Check andensure the
BluetoothoftheiOSdeviceis
open andlaunchthe App again
The iHealth ECG3 App
showswrong
waveform when
watching thecurrent
ECGwaveform orthe
uploadedECG
waveform
ECG3 andelectrode do not
contactwell
Check andensure thatthe
ECG3 andthe electrode,the
electrode and skin have agood
contact
ECG3 isexposeinstrong
electromagneticfield
KeeptheECG3awayfrom
unitsemittingstrong
electromagneticradio during
measurement

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CARE AND MAINTENANCE
1. Donotattempttodisassemble,repairormodifythisunit. Todootherwisewill
possiblydamage thisunit orcausedangers.
2. Avoidstrong shocks orvibrations,ordroporsteponthe ECG3.
3. Do notexpose the unittostaticelectricity.Always disperseanystaticelectricity
fromyourbodybefore usingthisunit.
4. Avoidhigh temperatureanddirectsunlight.Donotimmersetheunit intowateror
anyotherliquidasthiswill resultin damage toECG3.
5. Do notkeepthisunit in the followingambientconditions:
-Exposed todirectsunlight.
-Subjecttohigh temperaturesorhighhumidity.
-Wetordamplocationswhere watermaygeton theunit.
-Dustylocations.
-Nearfiresoropen flames.
-Locationsexposed to strong vibration.
-Locationsexposed to strong electromagneticfields.
Keepthisunitinaboveambientconditionsmaycausedamage tothisunit.
6. Wipe theECG3withamoistened and wellwrungsoftclothusing warm watertoclean
the unit. Thenairdrythe unit.
ECG3 hasa hardware
problem Contactcustomerservice
The time anddate
recordedinECG3is
notaccurate
The clock in ECG3needsto
be calibratedortheECG3
wasrestarted before
Starta measurementand
watch thecurrentECG
waveform,which will calibrate
the clock inECG3
ECG3 cannotupload
ECGdatathroughthe
datacable The datacableisdamaged Contactcustomerservice to
getanotherdata cable
Red indicatorLED
lightsup for10s when
ameasurement starts Firmware error Starta measurementagain
The greenindicator
LEDblinks
continuouslyafter
updating thefirmware
Updatingisfailed andthe
previousfirmwarehasbeen
damaged Contactcustomerservice
Red indicatorLED
lightsup constantly Firmware faultorhardware damage
Pushtheuserkeyforabout8s
to resetthedeviceorcontact
customerservice
No response Firmware faultorhardware
damage
Pushtheuserkeyforabout8s
to resetthedeviceorcontact
customerservice

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7. Do notsterilizethisunit inan autoclaveorgassterilizers,whichwilldodamageto
the unit.
8. The ECG3 can maintain the safetyand performance characteristics fora minimumof
three yearsofusage.
9. The electrodeissingle use only.Pleaseusetheelectrode inthe validityperiod on
the packingof the electrode.
10. The ECG3 willnotmeasure theECGdataand willpromptuserwhen theelectrodeis
loosened.Usinga degradedelectrode willlead toan unreliable measuring result.
11. Do notuse immediatelyif theunit isstored attemperaturebelow0℃orabove45℃.
Leave thisunit atroomtemperature foratleastonehour.
12. The batterycanmaintainthe performancecharacteristics foraminimumof300charge
cycles.Batteryreplacementshould onlybe performed bya qualified iHealth technician.
To dootherwisewillvoid yourwarrantyand possiblydamageyourunit.
13. If ECG3 isnotusedfora long time,please sure tofullychargeit every2 months.
14. Nocomponentcanbe maintainedbyuserintheunit.Thecircuit diagrams,
componentpartlists,descriptions,orotherinformationwhichwill assistthe
appropriatelyqualifiedtechnicalpersonneltorepairthosepartsoftheunitdesignated
reparablycan be supplied bythemanufacturer.
15. It isrecommendedthatproductperformancebecheckedevery2yearsoraftereach
repair.Please contactthe service center.
16. The ECG3canonlyconnecttoaniOSdevicewiththedatacableorconnecttoaUSB
portonPCoran ACadaptorwiththe charging cable.It willbeunsafetoconnectthis
unittootherequipmentnotdescribed in the instructions,pleasedon tdothis.
17. The electrode andotherconductivepartson ECG3shouldnotcontactother
conductiveparts.Dootherwise maycausedamage totheECG3.
18. Donottouchtheelectrodesonthebackside oftheunit.Todootherwisemay
causedamagetothisunit.
WARRANTY INFORMATION
The PortableECGmonitoriswarrantedtobefreefromdefectsin materialsand
workmanshipwithinone yearfromthedateofpurchase whenused in accordance with the
provided instructions.The warrantyextendsonlytotheend user.We will,atouroption,
repairorreplacewithoutcharge the PortableECGmonitorcovered bythewarranty.Repair
orreplacementisouronlyresponsibilityandyouronlyremedyunderthewarranty.
EXPLANATIONOFSYMBOLS
Symbolfor “THE OPERATIONGUIDE MUSTBE READ”
The sign background color:blue.
The sign graphicalsymbol: white.
Symbolfor “WARNING”
Symbolfor “TYPE BFAPPLIEDPARTS”
Symbolfor “INGRESSPROTECTION”–“IP22”indicatesthatthe levelofingressof
solidforeignobjectsis2 and thelevelofingress ofwateris2.

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Symbolfor “ENVIRONMENTPROTECTION”–Wasteelectricalproductsshould
notbedisposedofwithhouseholdwaste.Please recycle wherefacilitiesexist.
Check with yourlocalauthorityorretailerforrecyclingadvice.
Symbolfor “MANUFACTURER”
Symbolfor “COMPILES WITHMDD93/42/EECREQUIREMENTS”
Symbolfor “DATEOFMANUFACTURE”
Symbolfor “SERIAL NUMBER”
Symbolfor “EUROPEANREPRESENTATIVE”
Symbolfor “DONOTCONTAINAND NOPRESENCE OFNATURAL RUBBER
LATEX”
Symbolfor “KEEP DRY”
Symbolfor “KEEP AWAY FROMSUNLIGHT”
Symbolfor “MATERAL OFELECTRODE”
Symbolfor “USE-BYDATE”
Symbolfor “BATCH CODE”
Symbolfor “CATALOGUE NUMBER”
Symbolfor “DONOTRE-USE”
Symbolfor “TEMPERATURE LIMIT”
Symbolfor “STOREDHERMETICALLY”
Symbolfor “PRESCRIPTION”
Symbolfor “MAGNETICRESONANCE(MR) UNSAFE”
“Made foriPad,”mean thatanelectronicaccessoryhasbeen designed to connect
specificallytoiPad,respectively,and hasbeen certifiedbythedeveloperto meetApple
performance standards.Appleisnotresponsiblefortheoperationofthisdeviceorits

compliance with safety and regulatory standards. Please note that the use of this
accessory with iPad may affect wireless performance.
iHealth is a trademark of iHealth Labs Inc.
Manufactured for iHealth Labs Inc.
120 Sun Lucar Ct., Sunnyvale, CA 94086, USA
[phone]
www.ihealthlabs.com
iHealthLabs Europe SARL
EC REP 3 Rue Tronchet,75008,Paris,France
[e-mail] www.ihealthlabs.eu
ANDON HEALTH CO., LTD.
No. 3 Jinping Street, Ya An Road, Nankai District, Tianjin 300190, China
Tel: [phone]
OTHER STANDARDS AND COMPLIANCES
The Portable ECG monitor corresponds to the following standards: IEC 60601-1:2005
+A1:2012(E)/EN 60601-1:2006/A1: 2013 (Medical electrical equipment -- Part 1: General
requirements for basic safety and essential performance), IEC 60601-1-2:2014(Medical
electrical equipment -- Part 1-2: General requirements for basic safety and essential
performance - Collateral standard: Electromagnetic compatibility - Requirements and
Tests), ISO60601-2-47:2001 ( Medical Electrical Equipment -- Part 2-47: Particular
Requirements For The Basic Safety And Essential Performance Of Ambulatory
Electrocardiographic).
ELECTROMAGNETIC COMPATIBILITY INFORMATION
This product is applicable to the equipment and system requirements for the purpose of
receiving radio frequency energy for the purpose of the work, Bluetooth low energy receive
bandwidth 2M. This product can also be used to include RF transmitter equipment and
system requirements and emission frequency of 2.4GHz ISM band, BLE modulation types:
GFSK, effective radiated power: < 0dBm
Table 1 - Emission
Phenomenon
Compliance
Electromagnetic environment
RF emissions
CISPR 11
Group 1, Class
B
Home healthcare environment
Harmonic
distortion
IEC 61000-3-2
Class A
Home healthcare environment
Voltage
fluctuations and
flicker
IEC 61000-3-3
Compliance
Home healthcare environment
12

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Table2-EnclosurePort
Phenomenon BasicEMC
standard Immunitytestlevels
HomeHealthcareEnvironment
Electrostatic
Discharge IEC61000-4-2 ±8kV contact ±2kV, ±4kV, ±8kV, ±15kV air
RadiatedRFEM
field
IEC61000-4-3
10V/m 80MHz-2.7GHz
80%AMat 1kHz
Proximityfields
fromRFwireless
communications
equipment
IEC61000-4-3
Refertotable3
Rated power
frequency
magneticfields
IEC61000-4-8 30A/m
50Hzor60Hz
Table3 ProximityfieldsfromRF wirelesscommunicationsequipment
Testfrequency
(MHz) Band (MHz) Immunitytestlevels
Professionalhealthcarefacilityenvironment
385 380-390 Pulsemodulation18Hz, 27V/m
450 430-470 FM, 5kHzdeviation, 1kHzsine, 28V/m
710 704-787 Pulsemodulation217Hz, 9V/m
745
780
810 800-960 Pulsemodulation18Hz, 28V/m
870
930
1720 1700-1990 Pulsemodulation217Hz, 28V/m
1845
1970
2450 2400-2570 Pulsemodulation217Hz, 28V/m
5240 5100-5800 Pulsemodulation217Hz, 9V/m
5500
5785
Table4 Inputa.c.powerPORT
Phenomenon BasicEMC
standard Immunitytestlevels
Homecareenvironment
Electricalfast
transients/burst IEC61000-4-4 ±2kV 100kHzrepetitionfrequency
Surges
Line-to-line IEC 61000-4-5 ±0.5kV, ±1 kV
Conducted
disturbances
inducedbyRF IEC61000-4-6 3V, 0.15MHz-80MHz
6V inISMbandsandand amateurradio
bandsbetween 0.15MHzand 80MHz

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fields 80%AMat 1kHz
Voltagedips IEC61000-4-11
0%UT;0.5cycle
At 0º, 45º,90º, 135º,180º, 225º, 270ºand
315º
0%UT;1cycle
and
70%UT;20/30 cycles
Singlephase: at 0°
Voltage
interruptions IEC61000-4-11
0%UT; 250/300cycles
Dateofissue:Nov10,2016
ECG3-SMSY01 V1.0