FCC ID: 2ASBD-WM-3000 Wearable ECG Recorder

Wearable ECG Recorder Model: WM-3000 User manual I Instruction Thanks for purchased Mr. Wear Wearable ECG Recorder Please read the contents of this instruction manual carefully before using the product in order to use the product correctly. Please keep this instruction manual after reading so that you can check it whenever you need it. Specificationmodel: WM3000 Productname: WearableECGRecorder RegistrationCertificateNumber:

Producttechnicalrequirementnumber:

Productionlicensenumber: FoodandDrugAdministrationProductionNo.20150055 Applicationscopeofproducts: TheproductconsistsofawearableECGrecorder,anECGsensor andamobileplatformECGapplicationsoftware. Registrant/manufacturername: DamingIndustrial(Suzhou)Co.,Ltd. Registrant/ProductionEnterpriseResidence:SuhuaiwestRoad,EconomicandTechnologicalDevelopmentZone, SuzhouCity,AnhuiProvince Manufacturingdate: atthebackofproduct Periodofvalidity: Reusable500times Dateofpublicationofthisusermanual: June2018 Intellectual property The intellectual property rights of this instruction manual and its corresponding products belong to Daming Industrial(Suzhou)Co.,Ltd.(hereinafterreferredtoasDamingCompany). 20052013DamingIndustrial(Suzhou)Co.,Ltd.,copyrightowned.NopartofthisUser'sGuidemaybecopied, modified,ortranslatedwithoutthepriorwrittenconsentofDamingCorporation. ItisaregisteredtrademarkofDamingCompany. Daming company is responsible for the safety, reliability and performance of the product only if all of the followingrequirementsaremet:

Assembly operations, expansion, readjustment, improvement and repair are carried out by professionals recognizedbyDamingCompany;

All repairs involving replacement parts and accessories and consumables used are all original (original) or approvedbyDamingCompany;

Therelevantelectricalequipmentcomplieswiththenationalstandardsandtherequirementsofthisinstruction manual;

Productoperationiscarriedoutinaccordancewiththeseinstructions. II Warranty and repair services Thewarrantyperiodofthepurchasedproductissubjecttothesalescontract.Consumablesrefertodisposable consumables thatneedtobereplacedaftereachuseorregularlyreplacedconsumables,theconsumablesare notwarranted. The warranty period begins with the installation date on the <equipment warranty card> attached to the product.The<equipmentwarrantycard>istheonlycertificateforcalculatingthewarrantyperiod.Inorderto protectyourrightsandinterests,pleasefillinthecardaftertheinstallationoftheequipment,andhandoverthe secondcardoftheinsurancecard("DaMingcompanyretention")totheinstallerormailbacktothecustomer servicedepartmentofDamingCompany. Pleasenotethatthefollowingconditionswillnotbecoveredbythewarranty:

Thecustomerdidnotfillinandreturnthe<equipmentwarrantycard>within30daysafterthecompletionofthe installationacceptance;

Theserialnumberoftheequipmentprovidedbythecustomerisincorrect(ourcompanyconfirmsthewarranty withtheequipmentserialnumber). Duringthewarrantyperiod,theproductscanenjoyfreeaftersalesservice;however,pleasenotethatevenifthe productneedstoberepairedduetothefollowingreasonsduringthewarrantyperiod,Damingwillimplement thefeebasedrepairservice,youneedtopaythemaintenancefeeandaccessoriesfee.:

Manmadedamage;

misuse;

Irresistiblenaturaldisasters;

Replace or use parts, accessories, consumables that have not been approved by Da Ming Company, or be repairedbyanonDaMingcompanyauthorizedpersonnel;

Otherfailurescausedbynonproductsthemselves. Aftertheexpirationofthewarrantyperiod,DamingCompanycancontinuetoprovidefeebasedrepairservices. Ifyoudonotpayordelaythepaymentoftherepairservicefee,DaMingwilltemporarilysuspendtherepair serviceuntilyoupay. After sales service office Companyname: DamingIndustrial(Suzhou)Co.,Ltd. Address: SuhuaiwestRoad,EconomicandTechnologicalDevelopmentZone,SuzhouCity,Anhui Province Postalcode: 234099 Website: http://www.dmsyjt.com 24hoursservicehotline: 4001819566 Tel: +865573152888 Fax: +865573698899 III Foreword Instruction Thismanualdescribesindetailtheuse,functionandoperationoftheproduct.Beforeusingthisproduct,please read and understand thecontents of this manual to ensure thecorrect use of this product and to ensure the safetyofpatientsandoperators. This manual describes the product in its most complete configuration, so some of the content may not be applicabletotheproductyoupurchased.Ifyouhaveanyquestions,pleasecontactus. Keepthismanualneartheproductsothatitcanbeeasilyandtimelyobtainedwhenneeded. Suitable Thismanualisintendedforprofessionalclinicalstafftoread. Illustration Allillustrationsprovidedinthismanualareforreferenceonly,andthesettingsordataintheillustrationsmaynot exactlymatchtheactualdisplayyouseeontheproduct. Convention ItalicThissectionusesbolditalicstoindicatethequotedchapter. The terms danger, warning, caution and attention are used in this manual to indicate the hazard informationanditsseverity. IV Index Safety.1 Safetyinformation Danger Warning Caution Attention Devicesymbol Overview Productintrouction Scopeofuse Contraindications Productcomposition Productexterior Installationandmaintenance Installation Unpackinginspection Environmentalrequirements Powerrequirement Installationmethod Cleaninganddisinfection Cleaning Disinfection Useinstructions WearableECGrecorderoperationflow Mountingaccessories Pastetherecordertothemeasurementsite Startrecorder Wirelesstransmission Handlingofcommonproblems Handlingofcommonproblems Battery Accessories Accessories Productspecification 1 Safetyspecification Environmentalspecifications PowerSpecifications Wearablerecorderspecifications Recordingandstoragespecifications ECGspecification EMCandradiomanagementcompliance EMC Radiomanagementcompliance Symbolsandterms Unitlist Symbollist Toxicorharmfulsubstancesorelements 2 Safety Safety information Thissectionlistsbasicsafetyinformationthatusersshouldbeawareofandfollowwhenusing the product. Other safety information that is the same, similar, or related to the specific operationwillappearineachchapter. Danger Indicatesanimminentdangerthat,ifnotavoided,couldresultindeath,serious personalinjuryorpropertydamage. caveat Promptforpotentiallydangerousorunsafepracticesthat,ifnotavoided,couldresultin deathorseriouspersonalinjuryorpropertydamage. Caution Indicatesapotentiallyhazardousorunsafeoperationthat,ifnotavoided,couldresult inminorpersonalinjury,productmalfunction,damage,orpropertydamage. Attention Emphasizeimportantconsiderations,provideinstructionsorexplanationstobetteruse theproduct. 1 Danger Therearenosafetyinformationforhazardlevelsinthismanual. Warning Warning Thisproductisnotsuitableforinfantsweighinglessthan10Kg. Beforeusingthisproduct,theusermustchecktheproductanditsaccessoriestoensure thattheyworkproperlyandsafely. Skinisallergictotheaccesoryofthisproduct Donotusethisproductinanenvironmentwhereflammableorexplosivematerials suchasanesthesiaareplacedtopreventfireorexplosion. Theproducthasabuiltinbatteryandmustnotbeopenedtotheoutercasingofthe product.Repairsorupgradestotheproductmustbeperformedbyservice personneltrainedandauthorizedbythecompany. Thisproductdoesnothaveantidefibrillationcapability.Whendefibrillation,the wearableECGrecordermustbedisconnectedfromthepatient.Otherwise,the devicemaybedamaged. Thisproductmaynotbeusedinconjunctionwithelectrosurgicalequipment.When usingelectrosurgicalequipment,thedeviceandthepatientmustbedisconnected asthismayresultinequipmentdamage. Whenhandlingpackagingmaterials,youmustcomplywithlocalregulationsorthe hospital'swastedisposalsystem.Packagingmaterialsmustbeplacedoutofreach ofchildren. ThisproductgeneratesRFradiationenergyand,ifnotinstalledandusedinaccordance withthemethodsgiveninthismanual,maycauseconflictsinRFcommunications. Thisproducttransmitswirelesssignalsthroughspace.Duringsignaltransmission,the signalmaybeinterferedbymultiplesourcesofRFinterference.Althoughthis producthasacertainantiinterferenceability,transmissionfailuremay occasionallyoccur. 2 Warning Warning Whenusingthisproduct,itisimportanttoensurethattheenvironmentinwhichitis usedmeetstheenvironmentalspecificationsclaimedbytheproduct. Toensurethesafetyoftheuser,pleaseusetheaccessoriesspecifiedinthismanual. Disposableofdevicescanonlybeusedonce,andrepeatedusecanresultin performancedegradationorcrosscontamination. Whenthisproductanditsaccessoriesareabouttoexpire,theymustbedisposedofin accordancewiththerelevantlocalregulationsorthehospital'ssystem.Ifyouhave anyquestions,pleasecontactus. Electromagneticfieldscanaffecttheperformanceoftheproduct,soequipmentused neartheproductmustmeettheappropriateEMCrequirements.Mobilephones, XrayorMRIequipmentareallpossiblesourcesofinterferencebecausetheyemit highintensityelectromagneticradiation. Attention Attention Keepthismanualnearthisproductsothatitcanbeeasilyandpromptlyobtainedwhen needed. 3 Device symbol WarningSeerandomdata(Inthismanual) Dateofmanufacturing Serialnumber Environmentalprotectionlifeofelectronicproducts(20years) Waterproofratingis7 Referencemanualorrandominformation CFtypeapplicationpart Nonionizingradiationsymbol 4 Overview Product introduction The wireless singlelead ECG collecting and recorder is composed of a wearable electrocardiograph (hereinafter referred to as an electrocardiograph), an electrocardiograph sensor and a mobile platform ECG application software. The ECG recorder collects the ECG signal through the ECG sensor. The collected signal is stored in the recorder and can be transmitted to the protocolcompatible device via Bluetooth. The acquired signal can also be displayedonthemobileplatformECGapplicationsoftware. Wearableelectrocardiographrecorder electrocardiographsensor Scope of use For human body dynamic singlelead ECG data acquisition, recording and storage, does not includeautomaticanalysisanddiagnosis. warning AsinglewearableECGrecordercanonlymonitorasingleuser. 1 Contraindications 1.Thisproductisnotsuitableforinfantsweighinglessthan10Kg;

2.Theskinisallergictothisproduct;

3.Donotusethisproductinanenvironmentwhereflammableorexplosive materialssuchasanestheticareplaced. 4.Thisproductcannotbeusedtogetherwithelectrosurgicalequipment. Product composition The wireless singlelead ECG collecting and recorder is composed of a wearable electrocardiograph (hereinafter referred to as an electrocardiograph), an electrocardiograph sensorandamobileplatformECGapplicationsoftware. Product exterior Picture01Frontofproduct Picture02Backofproduct 2 Installation and maintenance Installation Warning Thecopyrightofthesoftwareofthisproductbelongstothecompany.Anyorganization orindividualmaynottamperwith,copyorexchangeanyinfringementbyany meansorformwithoutpermission. open box to check Beforeunpacking,pleasechecktheboxcarefullytodetermineiftheproductisdamagedduring transportation.Ifyoufindanydamage,pleasecontactthecarrierorthecompanyimmediately. Ifthepackagingisintact,pleaseunpackthepackageinthecorrectway,carefullyremovethe productandothercomponentsfromthebox,andcheckthepackinglistonebyone.Checkthe product for any mechanical damage and complete items. If you have any questions, please contactourCustomerServiceDepartmentimmediately. Warning Theusershouldplacethepackagingmaterialsoutofreachofchildren;whenhandling packagingmaterials,theymustcomplywithlocalregulationsorthehospital's wastedisposalsystem. Theequipmentmaybecontaminatedbymicroorganismsduringstorage,transportation anduse.Pleaseconfirmthatthepackagingisingoodconditionbeforeuse, especiallytheonetimeuseaccessories.Ifdamageisfound,pleasedonotuseit. 1 Environmental requirements The environment in which this product is used must comply with the environmental specificationsinAppendixB,ProductSpecifications. Power requirement ThepowersupplyusedinthisproductshouldmeetthepowersupplyspecificationsinAppendix BProductSpecifications. Warning Pleaseensurethattheproductworkswithinthespecifiedenvironmentalrequirements andpowerrequirements,otherwiseitwillnotmeetthetechnicalspecifications statedintheAppendixBproductspecifications,andmayleadtounforeseen consequencessuchasequipmentdamage. Installationmethod FortheinstallationofthewearableECGrecorder,seeChapter4,OperatingInstructions. 2 Cleaning and disinfection ThecleananddisinfectionisonlyforECGrecorders.Theaccessoriesaresingleusesingleuse, noneedtocleananddisinfect. Cleaning Theproductshouldbecleanedbeforeandafteruse.Pleaseconsultorunderstandthehospital's regulationsonequipmentcleaning,disinfectionandsterilizationbeforecleaning. When cleaning the surface of the product, use a clean, soft cloth, sponge or cotton ball to absorbthenonerosioncleaner,wringitoutandgentlywipeit.Thefollowingcleaningagents areavailable:

Water 70%Ethano(70%)l 70%Isopropanol(70%) Topreventdamagetothedevice,pleaseobservethefollowingrules:

Some clean agent need to be diluted before use. Please dilute the clean agent in strict accordancewiththemanufacturer'sinstructions;

Aftercleaning,useadryclothtodryexcessdetergent;

Donotimmersethedeviceinwateroranycleaningagent,orspillwaterordetergentonthe surfaceofthedevice;

Donotuseabrasivematerials(suchassteelwoolorsilverpolish),andanystrongsolvents(such asacetoneordetergentscontainingacetone);

Warning Failuretofollowthoseinstructionsmayresultincorrosion,wearorblurringofthe casingorlabel,ormayresultinequipmentfailure. Disinfection Disinfection may result in a degree of damage to the equipment. Therefore, this equipment is not recommended for customers to disinfect. 3 Use instructions WearableECGrecorderoperationflow TheoperationalflowchartofthewearableECGrecorderisasfollows:

Figure01OperationalflowchartofthewearableECGrecorder Attention ThewearableECGrecorderiswaterproofIPX7andcanbeusedintheshowerand soakinginashorttime. Mounting accessories When you start using the wearable ECG recorder, you need to attach the recorder to the accessory.TheoperationmodeisshowninFigure02. Figure02Attachmentinstallationdiagram Theinstallationstepsareasfollows:

1.Uncovertheadhesivebackingoftheupperpartoftheattachment. 2.Pastethehosttotheattachment. 3.Removethelowerbackingoftheattachment. 4.Pastetheproductontothehumanbody. 5.Removethepaperbackingfromthefrontoftheattachment. 1 Attention Donotusetheaccessoryifitisfoundtobedamagedornot. Paste the recorder to the measurement site ThequalityofthedynamicECGdependsonthequalityoftheelectricalsignalsobtainedbythe electrodes on the accessory. In order to ensure the quality of the electrical signal, proper treatmentoftheskinatthepatient'splacementelectrodeisnecessary. Thestepsforinstallingandpastingthepadsareasfollows:

1.Preparetherecorderwiththeattachedaccessoriesandputthemnexttothem. 2.Ifnecessary,removethechesthairandwipetheskinwith75%alcoholtoremovethe oil. 3.Ifnecessary,useamedicalsandpapertoproperlypolishtheskinwheretherecorderis attached. 4.Attachtherecordertothecleanedskinaccordingtothespecifiedlocation. Fortheinstallationlocationoftherecorder,pleaserefertoFigure03:

Figure03Recorderinstallationdiagramwhenusingasinglechannelaccessory 2 Attention Whenplacingtheelectrodeorconnectingthecable,makesurethatitisnotincontact withanyotherconductivepartsorground.Inparticular,ensurethatallECG electrodes,includingneutralelectrodes,areattachedtothepatienttoprevent themfromcomingintocontactwithconductivepartsorground. Start recorder Therecorderisinstalledandattachedtotheanthropometricpart,andtherecorderwill wakeup.Iftherecorderislow,itneedstobechargedbeforeitcanwakeup. Wireless transmission This product has the wireless transmission function of data, compatible with Android system version 4.3 and above, iOS system version 7.1 and above, and builtin Bluetooth 4.0 versionandabovemobilecommunicationequipment 3 Handling of common problems Handling of common problems Faultphenomenon Possiblereason Solutions After booting, display shows battery the low Recording time is not enough, it may only be a few hours or a fewminutes Bluetooth connection isnotavailable Lowpower Chargetherecorder Lowpower There is a problem with therecorderitself. Lowpower There is a problem with therecorderitself. ECG Mobile platform application software Bluetoothisnotturnedon Useaftercharging;

Return it to the manufacturer or contact the factory service personnelforprocessing. Useaftercharging;

Return it to the manufacturer or contact the factory service personnelforprocessing. Turn on the Bluetooth of Mobile ECG application platform 4 Battery The wearable ECG recorder has a builtin rechargeable lithium battery as the working powersourcefortherecorder. Whenthebatteryisbelow10%,thewearableECGwillflasharedlightandthebatteryshould becharged. Warning Thebuiltinlithiumbatterycannotbereplaced. Keeptheproductoutofthereachofchildrenwhencharging. Onlyusethechargerspecifiedbythemanufacturer,thechargershouldmeetGB 9706.12007. Inordertoincreasethebatterylife,pleasechargeitwhenpromptedlowbatteryorlow battery. ChargetheECGrecordertomorethan80%beforelongtermstorageandchargeitonce amonth. Whenthebatteryisabouttoexceeditslifespan,itmustbedisposedofinaccordance withrelevantlocalregulationsorhospitalregulations.Ifyouhaveanyquestions, pleasecontactus. 1 Accessory Warning Whenusingthisproduct,pleaseusetheaccessoriesspecifiedinthischapter.The attachmentsaresingleuseforasinglepatient.Usingothertypesofaccessories mayreduceproductperformanceordamagetheproduct. Donotusetheaccessoryifitisfoundtobedamagedornot. Theaccessoriesinthischapterareincompliancewithbiocompatibilityrequirements andmeetthestandardYY/T01962005. Accessory name Model / material code Type Manufacturer ECG single lead ECG sensor EPA001 Dispose user Daming

(Suzhou)Co.,Ltd. Industrial 2 Product specifications Safety specification Parameter specification Authority ChinaNationalFoodandDrug Supervisory Classification Electricshockprotectiontype Electricshockprotectionlevel Workmodel Explosionprotectionrating IPprotectionlevel Equipmenttype flammable Safety when using anesthetic gas mixed with air or flammable anesthetic gas mixed withoxygenornitrousoxide ClassII Internalpowersupply CFtype continuouslyworking IPX7 Portable Equipment that cannot be used in the presence of flammableanestheticgasesmixedwithairorflammable anestheticgasesmixedwithoxygenornitrousoxide Environmental specifications Parameter Specification Workingtemperature Workinghumidity Workingaltitude Storagetemperature Storagehumidify Storagealtitude 045 1095%,Noncondensing 86106kPa 2045 1095%,Noncondensing 57107kPa Power specification Parameter Specification Batteryvoltageinputrange Typeofbattery Life

(continuous measurementtypicalvalue) time 34.2V Rechargeablebuiltinlithiumbattery(ratedvoltage3.7V) 30hours 1 Wearable recorder specification Parameter Size Weight Interface Specification length:875mm Width:323mm Height:61mm 101g StandardinterfacewithleadsignalandBluetoothsignal Recording and storage specification Parameter Recordingmethod Storagemethod Storagecapacity Specification Realtimerecording Chipstorage Storagetime30hours ECG Specification ECG Leadsystem SamplingRate Dynamicinputrange PACEdetectioncapability SupportIlead 125Hz Inputsignalrangeisnotlessthan8mVwith500mVDCbias voltagesuperimposed Has the ability to detect the following pacing pulses and correctlydisplaytheECGsignal:

Pulseamplitude:2~200mV Pulsepulsewidth:0.1~2.0ms Common mode ratio Bandwidth(3dB) Gainsetting Wavespeed Inputresistance rejection 96dB When the sampling rate is 125Hz, the bandwidth is 0.05~40Hz. Error 5%

Error 5%

20M@10Hz 2 EMC and radio management compliance EMC This device complies with EMC standard YY 0505. All accessories listed in the attached chapter of this manual comply with the requirements of YY 0505 when used in conjunction with this equipment. Attention Use of accessories, sensors and cables outside the specified range may increase the electromagnetic emissions of the device and/or reduce the electromagnetic immunity of the device. This device cannot be used in close proximity or stacked with other devices. If necessary, observe the device closely to ensure it is functioning properly in the configuration used. EMC is required to be specifically protected against this equipment and needs to be installed and repaired in an environment that meets the following EMC information. Even if other devices meet the CISPR emission requirements, they may cause interference to the device. When the input signal amplitude is lower than the minimum amplitude specified in the technical specifications, the measurement may be inaccurate. Portable and mobile communication devices can affect the performance of this device. Other devices that contain RF radio transmissions may affect the device

(for example, mobile phones, PADs, wireless-enabled computers) Electromagnetic emission guidelines and statements This equipment should be used in the specified electromagnetic environment, and the customer or user should ensure that the equipment is used in the electromagnetic environment specified below. Launch test Compliance Electromagnetic environment - guide Radio frequency emission Group 1 GB 4824 This device uses RF energy only for its internal functions. Therefore, its RF emissions are low and there is little possibility of interference with nearby electronic equipment. 1 Radio frequency emission Class B GB 4824 This equipment is suitable for use in all facilities, including domestic facilities and residential public low-voltage power supply networks that are directly connected to the home. Harmonic emission GB 17625.1

/

Not applicable Voltage fluctuations and flicker Not applicable GB 17625.2 This equipment provides the following basic features and remains safe in the guidelines and manufacturer's statement - electromagnetic immunity environment. Operating mode Precision Function Attachment identification Data storage Prompt Connection detection (accessory) Electromagnetic Immunity Guidelines and Statements This equipment should be used in the specified electromagnetic environment, and the customer or user should ensure that the equipment is used in the electromagnetic environment specified below. Immunity test IEC60601 test level Compliance level Electromagnetic environment - guide Electrostatic discharge (ESD) 6 kV contact discharge 6 kV contact discharge GB/T 17626.2 8 kV air discharge 8 kV air discharge The floor must be wood, concrete or tile. If the floor is covered with synthetic materials, the relative humidity is at least 30%

Electrical Fast Pulse Group (EFT) GB/T 17626.4 Surge GB/T 17626.5 2 kV power cord Not applicable

/

1kV to input/output line 1 kV differential mode voltage 2 kV common Not applicable 2 dips, Voltage short interruptions, and changes voltage GB/T 17626.11 Power frequency magnetic field

(150Hz/180Hz) GB/T 17626.8 Not applicable

/

mode voltage

<5% UT (drop > 95%

UT) 0.5 cycle 40% UT (drop 60%

UT) 5 cycles 70% UT (drop 30%

UT) 25 cycles

<5% UT (drop > 95%

UT) 5 seconds 3 A/m 3 A/m The power frequency magnetic field should have the characteristics of the power frequency magnetic field in a typical place in a typical commercial or hospital environment. Note 1: UT refers to the AC network voltage before the test voltage is applied. Electromagnetic Immunity Guidelines and Statements This equipment should be used in the specified electromagnetic environment, and the customer or user should ensure that the equipment is used in the electromagnetic environment specified below. Immunity test IEC60601 test level Complian ce level Electromagnetic environment - guide 3 Vrms 150k80MHz Conducted immunity GB/T 17626.6 Not applicab le 2.1 P d Portable and mobile RF communications equipment must be used at specified distances from any component of the equipment and/or system, including the cable. This isolation distance is calculated by selecting the appropriate equation based on the transmitter frequency. The recommended calculation for the isolation distance is:

d 2.1 P 17626.3 3V/m 3 V/m 80MHz2.5GHz The recommended calculation for the isolation distance is:

80 MHz to 800 MHz:

d 800MHz to 2.5GHz:

2.1 P 3 P 3.2 Where P is based on the d transmitter's maximum output rated power, in watts (W), and d is the recommended isolation distance in meters (m). The field strength of a fixed RF transmitter is determined by surveying the electromagnetic field a, and each frequency range b should be lower than the compliance level. Interference may occur near devices marked with the following symbols:

Note 1: At 80MHz and 800MHz frequencies, the formula for the higher frequency band is used. Note 2: The above guidelines may not be applicable in all cases. Electromagnetic wave propagation is affected by absorption and reflection from buildings, objects and the human body. Note 3: This equipment is intended to receive RF electromagnetic energy and is free of basic performance requirements in the occupied frequency band (2400MHz-2483.5MHz), but remains safe. a. Fixed launch emission is strong, such as: wireless (cellular / cordless) telephone and ground mobile radio base station, amateur radio, AM (amplitude modulation) and FM (frequency modulation) radio broadcast and television broadcast, etc., its field strength in theory Can not accurately predict. In order to assess the electromagnetic environment of a fixed RF transmitter, an electromagnetic field survey should be considered. If the field strength of the location where the [device or system] is located is higher than the RF compliance level of the above application, the [device or system] should be observed to verify that it is functioning properly. If abnormal performance is observed, additional measures may be necessary, such as reorienting and relocating [device or system]. b. The field strength should be less than 3V/m over the entire frequency range from 150kHz to 80MHz. Recommended distance between wearable ECG recorders and portable/mobile RF communication devices This device can be used in an electromagnetic environment where RF interference is controlled. To avoid electromagnetic interference, the customer or user should maintain a minimum recommended distance between the device and the portable/mobile RF communication device. Transmitter rating Maximum output power

(W) Calculate the isolation distance based on the frequency of the transmitter (m) 150 kHz 80 MHz 80 MHz 800 MHz 800 MHz 2.5 GHz d 2.1 P d 2.1 P d 3.2 P 4 0.01 0.12 0.1 0.38 1 10 1.20 3.80 100 12.00 0.12 0.38 1.20 3.80 12.00 0.23 0.73 2.30 7.30 23.00 For the rated maximum output power of the transmitter not listed above, the recommended isolation distance d, in meters (m), can be determined using the formula in the corresponding transmitter frequency column, where P is provided by the transmitter manufacturer. Transmitter maximum output rated power in watts (W). Note 1: At 80 MHz and 800 MHz frequencies, the formula for the higher frequency range is used. Note 2: These guidelines may not be suitable for all situations. Electromagnetic propagation is affected by the absorption and reflection of buildings, objects and human bodies. 5 EMC Wireless Management Compliance RF parameters Items Description Bluetooth low energy 4.1 Working frequency band (MHz) 2402 - 2480 Modulation Transmit power (mW) GFSK 2.5 This device with the Panlink II Wireless Module complies with Part 15 of the FCC Rules. The premise of this operation is that this device will not cause harmful interference. FCC and Industrial Canada radio regulatory compliance for this device including the Panlink II wireless module: This device complies with Part 15 of the FCC Rules and RSS-210 of Industrial Canada. Operation is subject to the following two conditions: (1) this device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Any modifications and alterations to this equipment not expressly approved by the company could cause harmful radio frequency interference and void your authority to operate the equipment. The maximum allowed antenna gain is in accordance with the e.i.r.p. limit specified in RSS-210. The maximum allowed antenna gain is in accordance with the e.i.r.p. limit specified for peer-to-peer work in RSS-210. 6 Symbols and terms Unit list Abbreviation English A dB g Hz k kPa m mm ms mV mW s V W ampere decibel gram hertz kilo kilopascal meter millimeters millisecond millivolt milliwatt second volt ohm watt Symbol list Symbol

%

/

^

English minus percent per;divide;or to power plus equalto lessthan greaterthan lessthanorequalto greaterthanorequalto plusorminus multiply copyright 1 Toxic or harmful substances or elements Accessoryname Pb Hg Cd Cr(VI) PBB PBDE Main device Package Battery Accessor y Remarks of Casing PCBA Material package Lithium battery ECG accessories Indicates that the content of this toxic and hazardous substance in all homogeneous materials of this part is below the limit requirement specified in SJ/T113632006. Indicates that the toxic or hazardous substance contains at least a certain homogeneousmaterialcontentofthepartexceedingthelimitrequirementspecified inSJ/T113632006. FCCWarningStatement Changesormodificationsnotexpresslyapprovedbythepartyresponsibleforcompliancecouldvoidtheusersauthorityto operatetheequipment.ThisequipmenthasbeentestedandfoundtocomplywiththelimitsforaClassBdigitaldevice, pursuanttoPart15oftheFCCRules.Theselimitsaredesignedtoprovidereasonableprotectionagainstharmfulinterference inaresidentialinstallation.Thisequipmentgeneratesusesandcanradiateradiofrequencyenergyand,ifnotinstalledand usedinaccordancewiththeinstructions,maycauseharmfulinterferencetoradiocommunications.However,thereisno guaranteethatinterferencewillnotoccurinaparticularinstallation.Ifthisequipmentdoescauseharmfulinterferenceto radioortelevisionreception,whichcanbedeterminedbyturningtheequipmentoffandon,theuserisencouragedtotryto correcttheinterferencebyoneormoreofthefollowingmeasures:

Reorientorrelocatethereceivingantenna. Increasetheseparationbetweentheequipmentandreceiver. Connecttheequipmentintoanoutletonacircuitdifferentfromthattowhichthe receiveris connected. Consultthedealeroranexperiencedradio/TVtechnicianforhelp. This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and

(2) this device must accept any interference received, including interference that may cause undesired operation. 1