BORSAM Biomedical Instruments Co.,Ltd. ECG-Check ECG-Check ECG-Check ECG-Check UserUserUserUser Manual Manual Manual Manual User Manual ECG-Check - OTC R E S T R I C T I O N O N U S E , D U P L I C A T I O N , O R DISCLOSURE OF PROPRIETARY INFORMATION This document contains proprietary information, which is the sole property of the company. The document is submitted to the recipient for his use only. By receiving this document the recipient undertakes not copy or disclose part of, or the whole of the information contained herein to any third party without receiving beforehand, written permission from submitting company. WRITTEN BY APPROVED BY Name SHUIBINGYAN MAODINGHONG Title TEAM LEADER MANAGING DIRECTOR Signature Date This document contains proprietary information of BORSAM Biomedical Instruments Co.,Ltd. Document No. ECGC-70-003 Rev. 02 Page 1 of 23 BORSAM Biomedical Instruments Co.,Ltd. ECG-Check ECG-Check ECG-Check ECG-Check UserUserUserUser Manual Manual Manual Manual Version Version Version Version DateDateDateDate NameNameNameName 01 02 1/16/2013 C. Pillar 1/18/2013 M. Jandes Description Description Description Description Initial Document Added screen shots of progress bar This document contains proprietary information of BORSAM Biomedical Instruments Co.,Ltd. Document No. ECGC-70-003 Rev. 02 Page 2 of 23 ECGCheckWireless 1-LeadCardiacMonitor OTCUse Check DearDearDearDear ECGECGECGECG Check Owner:
Check Owner:
Check Owner:
Owner:
ThankyouforselectingtheECGCheckcardiacmonitor. ThisuserguideincludesinformationandinstructionsaboutyournewECGCheck andwillhelpfamiliarizeyouwiththebasicskillsofusingyourECGCheck,soplease takeamomenttoreaditcarefullybeforeyoubegintesting. Wehaveincludedawarrantyregistrationcard. Pleasecompleteandreturnitpromptlytoenableustoprovideyouthefullbenefits regardingyourECGCheckproduct. Forthemostup-to-datelistofcompatibledevices,pleaserefertothesupportedlist athttp://www.bioxtime.com. Wecareaboutwhatyouthinkandwanttokeepyouinformedaboutitsuseandcare. IfyouhaveanyquestionsaboutyournewECGCheck,pleasecontact:
BORSAMBiomedicalInstrumentsCo.,Ltd. Rm.502,UniversityInnovationPARK Lishanroad XiliTown 518055Shenzhen PEOPLESREPUBLICOFCHINA Email:sale@bioxtime.com Website:www.bioxtime.com ii Copyright Declaration Copyright Declaration Copyright Declaration Copyright Declaration CopyrightBORSAMBiomedicalInstrumentsCo.,Ltd. Allrightsreserved. iPhone,iPad,iPod,iOSandtheApplelogoareeitherregisteredtrademarksor trademarksofAppleCorporationintheUnitedStatesand/orothercountries. BORSAMBiomedicalInstrumentsCo.,Ltd.,BORSAMlogo,andECGCheckandECG WebCenteraretrademarksorregisteredtrademarksofBORSAMBiomedical InstrumentsCo.,Ltd. Allotherbrandnamesandproductnamesusedinthisdocumentaretrade names,servicemarks,trademarks,orregisteredtrademarksoftheirrespective owners. Theinformationandscreensprovidedinthismanualaresubjecttochangewithout notice. BORSAMBiomedicalInstrumentsCo.,Ltd.SHALLNOTBELIABLEFORTECHNICAL OREDITORIALERRORSOROMISSIONSCONTAINEDHEREIN;NORFOR INCIDENTALORCONSEQUENTIALDAMAGESRESULTINGFROMTHE FURNISHING,PERFORMANCE,ORUSEOFTHISMATERIAL. AuthorizedRepresentatives:
CHINA BORSAMBiomedicalInstrumentsCo.,Ltd. Rm.502,UniversityInnovationPARK Lishanroad XiliTown 518055Shenzhen 86-755-86325336 ConformancetoStandardsnon-clinicaltestingdemonstratedconformance tovoluntarysafetyIEC60601-1andtoIEC60601-1-2-2001ClassB Declaration ofofofof Conformity Declaration Conformity Declaration Conformity Declaration Conformity iii Warning:Changesormodificationstothisunitnotexpresslyapprovedbytheparty responsibleforcompliancecouldvoidtheusersauthoritytooperatetheequipment. NOTE: Thisequipmenthasbeentestedandfoundtocomplywiththelimitsfora ClassBdigitaldevice,pursuanttoPart15oftheFCCRules. Theselimitsare designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequencyenergyand,ifnotinstalledandusedinaccordancewiththeinstructions, maycauseharmfulinterferencetoradiocommunications. However,thereisnoguaranteethatinterferencewillnotoccurinaparticular installation.Ifthisequipmentdoescauseharmfulinterferencetoradioortelevision reception,whichcanbedeterminedbyturningtheequipmentoffandon,theuseris encouragedtotrytocorrecttheinterferencebyoneormoreofthefollowing measures:
Reorientorrelocatethereceivingantenna. Increasetheseparationbetweentheequipmentandreceiver. Connecttheequipmentintoanoutletonacircuitdifferentfromthatto whichthereceiverisconnected. Consultthedealeroranexperiencedradio/TVtechnicianforhelp. ThisdevicecomplieswithPart15oftheFCCRules. Operationissubjecttothe followingtwoconditions:
(1)thisdevicemaynotcauseharmfulinterference,and
(2)thisdevicemustacceptanyinterferencereceived,includinginterference thatmaycauseundesiredoperation. BORSAMBiomedicalInstrumentsCo.,Ltd.sQualitySystemconformsto21CFR820 andISO13485:2003 Equipmentnotsuitableforuseinthepresenceofflammableanestheticmixturewith airorwithOxygenorNitrousOxide. Thissymbolisintendedtoalerttheusertothepresenceof importantoperatingandmaintenance(servicing)instructions intheliteratureaccompanyingtheappliance. Symbols onononon ECGECGECGECG Check Symbols Graphic Check Graphic Symbols Check Graphic Symbols Graphic Check Danger Danger Danger Danger iv ThissymbolindicatestypeBFequipmentclassifiedin accordancewithIECPublication601-1Safetyofmedical electricalequipment. Intended Intended UseUseUseUse Intended Intended TheECGCheckisintendedforusewheneveryouareinterestedinyourcardiac activity.Itcanbeusedanytime,includingduringorafterstrenuousactivity(i.e., duringorafterexercise)orifyouexperiencethefollowingsymptomsthatare suggestiveofabnormalheartrhythms:
SkippedBeats PoundingHeart(Palpitations)HeartRacingorIrregularPulse LightheadednessorFaintness HistoryofArrhythmias TheECGCheckisnotintendedfordiagnosticuseanddoesnotprovidediagnostic qualityECGdata. TherearenopotentialadverseeffectsoftheECGCheckonhealth. Contraindications Contraindications Contraindications Contraindications v Should NOTNOTNOTNOT UseUseUseUse thethethethe ECGECGECGECG Check Should WhoWhoWhoWho Should Check Should Check Check Inordertousethisdevice,youmustbeabletoperformallofthefollowing:
Understandprincipleofoperationdescribedinthismanual SpeakandunderstandEnglish PlacetheECGCheckinyourhandsoronyourchestandholditforatleast30 seconds OperateaECGCheckandtheWebCenterapplication Operatesimplepush-buttons Duetothepossibleseriousnessoftheabnormalheartrhythmsthatcanbe associatedwiththeseconditions,personswiththefollowingconditionsshould consulttheirphysicianbeforeusingthisdevice:
Coronaryheartdisease Valvularheartdisease Hearttransplant Heartfailure vi Warning Warning Warning Warning TheECGCheckisnotadiagnosticdevice. Thisnon-standard1-leadelectrocardiogram(ECG),whichismeasuredusingthe ECGCheck,shouldnotbeusedfordiagnosticsincomparisontothestandard12lead ECGobtainedwithstandardelectrodeplacement. Thisdeviceshouldnotbeusedwithpacemakersorimplanteddefibrillatorsand cannotpredictordiagnoseaheartattackorbeusedforchestpainmonitoring. TheECGCheckisnotadefibrillation-proofdevice. Topreventfireorshockhazard,donotexposetheunittorainormoisture.Refer servicingtoqualifiedpersonnelonly. WhenusedasanOver-the-Counterdevice,thedisplayfunctionforactualECG waveformsandECGreportsisdisabled.Toaccessthedisplayfeatureforviewing yourECGdate,contactyourphysicianandobtainaprescription.Onlypatients underthecareofaphysicianwithaprescriptionforthisservicemayviewECGdata andECGreports. vii Table ofofofof Contents Table Contents Table Contents Table Contents
...................................................................................................... ..................................................................................................... Owner:...................................................................................................... .....................................................................................................iiiiiiii Check DearDearDearDear ECGECGECGECG Check Owner:
Check Owner:
Check Owner:
........................................................................................................ ....................................................................................................... Declaration........................................................................................................ .......................................................................................................iiiiiiiiiiii Copyright Declaration Copyright Declaration Copyright Copyright Declaration
................................................................................................. ................................................................................................ ................................................................................................ iiiiiiiiiiii Conformity................................................................................................. Declaration ofofofof Conformity Declaration Conformity Declaration Conformity Declaration
................................................................................................................................ ............................................................................................................................... ............................................................................................................................... iiiiiiiiiiii Danger................................................................................................................................ Danger Danger Danger
......................................................................................... ........................................................................................ Check......................................................................................... ........................................................................................ iviviviv Symbols onononon ECGECGECGECG Check Graphic Symbols Check Graphic Symbols Check Graphic Graphic Symbols
...................................................................................................................... ..................................................................................................................... ..................................................................................................................... iviviviv Intended UseUseUseUse...................................................................................................................... Intended Intended Intended
............................................................................................................... .............................................................................................................. Contraindications............................................................................................................... ..............................................................................................................iviviviv Contraindications Contraindications Contraindications
................................................................................. ................................................................................ Check................................................................................. ................................................................................vvvv WhoWhoWhoWho Should Check Should NOTNOTNOTNOT UseUseUseUse thethethethe ECGECGECGECG Check Should Should Check
.............................................................................................................................. ............................................................................................................................. ............................................................................................................................. vivivivi Warning.............................................................................................................................. Warning Warning Warning
................................................................................................................ ............................................................................................................... Guide................................................................................................................ ............................................................................................................... 1111 Start QuickQuickQuickQuick Start Guide Start Guide Start Guide
...................................................................................................... ..................................................................................................... Introduction...................................................................................................... ..................................................................................................... 4444 Introduction Check ECGECGECGECG Check Introduction Check Check Introduction GeneralDescription........................................................................................................................4 TheECGCheckKit..........................................................................................................................4 General............................................................................................................................................5 BeforeTesting.................................................................................................................................6 Recording........................................................................................................................................6 MedicalRecords..............................................................................................................................8 BatteryReplacement......................................................................................................................9 ConditionsofUse............................................................................................................................9 CaringforyourECGCheck.............................................................................................................9 Environment...................................................................................................................................9 Precautions...................................................................................................................................10 PreventiveMaintenance..............................................................................................................10
........................................................................................................... .......................................................................................................... Check........................................................................................................... .......................................................................................................... 5555 Check UsingUsingUsingUsing thethethethe ECGECGECGECG Check Check
....................................................................................................................... ...................................................................................................................... Maintenance....................................................................................................................... ...................................................................................................................... 9999 Maintenance Maintenance Maintenance MechanicalInspection..............................................................................................................10 Cleaning.....................................................................................................................................10
................................................................................................................ ............................................................................................................... Troubleshooting................................................................................................................ ...............................................................................................................11111111 Troubleshooting Troubleshooting Troubleshooting
............................................................................................................................. ............................................................................................................................ Glossary............................................................................................................................. ............................................................................................................................12121212 Glossary Glossary Glossary
.................................................................................................... ................................................................................................... Specifications.................................................................................................... ...................................................................................................13131313 Specifications Technical Technical Specifications Technical Specifications Technical
..................................................................................................... .................................................................................................... Information..................................................................................................... .................................................................................................... 14141414 Additional Information Additional Information Additional Additional Information viii Start QuickQuickQuickQuick Start Guide Start Guide Start Guide Guide 1. InstalltheECGCheckApplicationontheiPhoneviatheiPhoneAppStoreor visithttp://aircardio.comfromyouriPhoneforadirectlink(firsttimeuse). 2. EnsuredataandBluetoothcommunicationsareenabled. a. ConfiguretheoutgoingcommunicationtotheECGCheckWebCenter byenablingeithercellulardataorWifi(orboth--SeeyouriPhone documentationformoreinformation). b. ConfiguretheECGcommunicationtotheECGCheckdeviceby ensuringyourBluetoothradioisenabled. 3. StarttheECGCheckApplicationontheiPhonebypressingtheECGCheck icon. 4. Setuptheuserprofile(firsttimeuseorwhennecessary). 5. PlaceyourfingersonthesilverpadsoftheECGCheckdevicetostarttheECG recording. 6. Oncetheprogressbarisfull,therecordingwillbeautomaticallystoredand sentforanalysis.Uponcompletion,youwillseethescreenbelow. 2 Check ECGECGECGECG Check Introduction Check Introduction Check Introduction Introduction General Description General Description General Description General Description TheECGCheckisamedicaldevicethatallowsrecordingandsendingofanECG recording(usingBluetoothtechnology).Therecordingissenttoadevice(ECGCheck ApplicationcompatibleiPhone).Thisallowsyouandyourphysiciantomonitoryour healthinformation(ECG)fromanywhereanytimeyouwish. 1. ECGCheckMonitor Check TheTheTheThe ECGECGECGECG Check Check KitKitKitKit Check 2. (1)CR2032Battery 3. QuickUserGuide(thisdocument) 3 UsingUsingUsingUsing thethethethe ECGECGECGECG Check Check Check Check General General General General TheECG-CheckisasingleleadECGrecordingdevicethatusesthe2built-in electrodes(silverpads)ontheundersideofthedevicetorecordandtransmityour ECGtoanapplicationviaBluetoothfordisplayandanalysis. Placeyourfingersontheelectrodesorplacethedeviceonyourchesttostartthe recording. DeviceFunctions 1. On/Record Ifthedeviceisoff,pressingyourfingerstotheelectrodeswillturnthedevice onandbeginrecordingoncethedevicehasinitiatedcommunicationwiththe iOSapplication. 4 IftheiOSapplicationisnotloaded,pleasestarttheiOSapplicationpriorto initiatingarecordingonthedevice.Thedevicewillnotbeginrecordingdata untiltheiOSapplicationhasbeenstarted. 2. Standby/PowerOff Thedevicewillturnoffautomaticallyafterthedevicehasdetectednoskin contactfor4seconds.Iftherewasanon-goingtest,thetestwillbe invalidatedandneedtoberestarted Note:Thedevicestartsrecordingwhenthereiselectrodecontactwiththeskin ANDtheiOShascommunicatedwiththedeviceviaBluetoothtobegin recording Readthetestinginstructionsbeforeattemptingatest.Paycarefulattentiontothe electrodepositionsasinstructed. Makesureyouhaveallitemsneededtotest:
ECGCheck ECGCheckApplicationcompatibleiPhone(withapplicationinstalled) 1. VerifythatBluetoothisonandcellulardataisenabledontheiPhone. Before Testing Before Testing Before Testing Before Testing Recording Recording Recording Recording 5 2. StarttheECGCheckapplicationbytappingtheECGCheckicon. 3. Logintoyouruseraccount. 4. Pressyourfingerstotheelectrodestoinitiatearecording. 5. WaitfortheprogressbartofillupwhilethesystemrecordsyourECG.You willseethescreenshownbelowasitisrecording. 6. ThesystemwillautomaticallysendtheECGforanalysis. Toexaminealistofpreviousrecordingsstoredonthedevice,tapthemedical historyicontoopenthemedicalhistoryscreen;hereyouwillseealistofthe previoustestsstoredonyourdevice. Medical Records Medical Records Medical Records Medical Records 6 7 Maintenance Maintenance Maintenance Maintenance Conditions Conditions ofofofof UseUseUseUse Conditions Conditions Battery Replacement Battery Replacement Battery Replacement Battery Replacement Caution:UseonlyCR2032lithiumionbatteries. 1. PlacetheECGCheckdevicewithelectrodepadsdownonastablesurface 2. UsingaPhillipsheadscrewdriver,unscrewthescrewsecuringthebattery cover. 3. Slideouttheusedbattery 4. SlideinthenewCR2032lithiumionbattery 5. Replacethebatterycoverandsecurewiththecoverscrew YourECGCheckconformstointernationalregulationsinsofarasitisusedunder normalconditionsandinaccordancewiththefollowinginstructions. DonotopenorattempttorepairyourECGCheckyourself.Onlyauthorizedservice personnelmayrepairtheproduct. DonotdropyourECGCheckorsubjectittosevereimpacts.Bendingthebodycan damagethecircuitry.Donotuseextremeforcewhenpressingthedisplayorkeys. DonotusesolventstocleanyourECGCheck.Useonlyasoft,drycloth. Keepawayfromextremeheat.Donotleaveitonthedashboardofacarorneara heater.Donotleaveitinanyplacethatisextremelydampordusty. 8 your ECGECGECGECG Check your Caring forforforfor your Caring Check Caring your Check Caring Check Environment Environment Environment Environment Precautions Precautions Precautions Precautions Preventive Maintenance Preventive Maintenance Preventive Maintenance Preventive Maintenance Asthisproductisnotwaterproof,donotuseitorstoreitwherefluidssuchaswater cansplashontoit.Raindrops,waterspray,juice,coffee,steam, perspiration,etc.mayalsocauseamalfunction. Keepaccessoriesthatmightbeswallowedawayfromchildren. Warning:Disposeofallusedbatteriesinaproperwastedisposalinaccordancewithlocal regulation.Usedbatteriesmustnotbediscardedinthenormaltrash. Thefollowingsimplepreventivemaintenancetasksshouldbeperformedmonthlyto ensurecontinuedperformanceofthedeviceatmaximumcapacity,andtoreducethe possibilityofafailure. Checkforsplits,cracks,orimperfectionsinthecase.Ifyouhaveanyquestionsor doubts,callyourserviceprovider. Cleantheoutsideofthedeviceonly,usingalint-freedrycloth. Donotallowanyliquidtoenterthecase,andavoidpouringwaterorotherliquidson thedevicewhilecleaning. Neveruseabrasivessuchaswirewoolormetalpolish. Duringcleaning,makesureyoudonotexposethedevicetotemperaturesinexcessof 45C(113F). Mechanical Inspection Mechanical Inspection Mechanical Inspection Mechanical Inspection Cleaning Cleaning Cleaning Cleaning 9 Troubleshooting Troubleshooting Troubleshooting Troubleshooting Problem DevicedoesnotsendECG toapplication ECGDataisnotbeing analyzed ECGanalysiscomesback withabadrecording iPhoneisrunningslowly ECGCheckapplication doesnotlaunch Solution PossibleCause(s) Replacebattery Thebatteryisverylowor depleted enabledonthehostdevice TurnontheBluetooth TheBluetoothradioisnot radiointheiPhone Ensurebothelectrode Theuserhasnottouched padsareincontactwith bothelectrodes. theusersskin Thereisnoconnectionto Turnonyourcellulardata theinternet orconnecttoawifiaccess point Donotmove&remain Toomuchnoiseor movementinthe stillwhilethedeviceis recording recording Keepthedeviceincontact NotenoughECGdatawas collected withtheskinfor30 seconds ManuallyclosetheiOS Toomanyapplications open applicationsorrestart yourphone. Toomanyapplications ManuallyclosetheiOS applicationsnotinuseor open restartyourphone. 10 Glossary Glossary Glossary Glossary ECG HeartRate Bluetooth(BT) ECGCheck PC ECGCheckApplication ECGCheckHomepage ECGCheckWebCenter Electrocardiogram;arepresentationoftheheart's electricalactivityrecordedfromelectrodesonthebody surface. Numberofbeatsperminute,measuredasbpm. Wirelesscommunicationprotocol. ECGCheckwirelessECGmonitor. Personalcomputer. BORSAMBiomedicalInstrumentsCo.,Ltd.proprietary iPhoneprogramformeasuring,storing,displaying,and transmittingdatagatheredfromtheECGCheckmedical device. ECGCheckApplicationmainpage. BORSAMBiomedicalInstrumentsCo.,Ltd.proprietary internet-enabledprogramforstoringandretrievalof patientrecords.Forusebyphysiciansandmedical professionals. 11 Technical Specifications Technical Specifications Technical Specifications Technical Specifications InputImpedance Inputdynamicrange MaximumCurrentconsumption CMRR DCoffsetcorrection Bandwidth Recording SampleRate TransmissionPeriod Transmissionmode BatteryType BatteryLife OperatingTemperature Transport&storagetemperature Relativehumidity Dimensions NetWeight 1.1mohm
+/-3.5mV 55mA 75db
+/-200mV 0.5Hz25Hz 30seconds,single-leadECG 200Hz Instant,dependentoniPhone BluetoothLowEnergy 3VCR2032Lithiumionbattery 8hours(approximately480recordings)
+10to+40oC(50to104oF)
-20to+65oC(-4to149oF) 30to85%
118x62x17mm 40(grams) 12 Additional Information Additional Information Additional Information Additional Information SeetheECGCheckApplicationInstallationGuideavailableattheBORSAM BiomedicalInstrumentsCo.,Ltd.website. ManufacturedBy:
BORSAMBiomedicalInstrumentsCo.,Ltd. Rm.502,UniversityInnovationPARK Lishanroad XiliTown 518055Shenzhen Tel:86-755-86325336 Fax:86-755-86325336 Email:sale@bioxtime.com Website:www.bioxtime.com ECGC-70-003,Rev.A,January16,2013 13