2ADXK-8326Pulse Oximeter

PulseOximeter InstructionforUse 1.Introduction 1.1Intendeduse ThisPulseOximeterisintendedtobeusedfor measuring,displayingandstoringofpulseoxygen saturation(SpO 2 ),pulserateofadultsinhomeor healthcarefacilitiesenvironment. 1.2Contraindications Nocontraindications. 1.3WarningsandCautions DONOTsqueezethesensorpartorapplyexcessive forceonit. DonotusethisdeviceduringMRIexamination. Donotusethisdevicewithadefibrillator. Donotstorethedeviceinthefollowinglocations: locationsinwhichthedeviceisexposedtodirect sunlight,hightemperaturesorlevelsofmoisture,or heavycontamination;locationsneartosourcesof waterorfire;orlocationsthataresubjecttostrong electromagneticinfluences. Donotusethedeviceinacombustibleenvironment (i.e.,oxygen-enrichedenvironment). Neversubmergethedeviceinwaterorotherliquids. Donotcleanthedevicewithacetoneorothervolatile solutions. Donotdropthisdeviceorsubjectittostrongimpact. Thedeviceandaccessoriesareprovidednon-sterile. Donotplacethisdeviceinpressurevesselsorgas sterilizationdevice. Donotdismantlethedevice,asthiscouldcause damageormalfunctionsorimpedetheoperationofthe device. Consultyourdoctorimmediatelyifyouexperience symptomsthatcouldindicateacutedisease. Donotself-diagnoseorself-medicateonthebasisof thisdevicewithoutconsultingyourdoctor.Inparticular, donotstarttakinganynewmedicationorchangethe typeand/ordosageofanyexistingmedicationwithout priorapproval. Useonlycables,sensorsandotheraccessories specifiedinthismanual. Prolongedcontinuousmonitoringmayincreasetherisk ofundesirablechangesinskincharacteristics,suchas irritation,reddening,blisteringorburns. Donotopenthedevicecoverwithoutauthorization. Thecovershouldonlybeopenedbyaqualifiedservice personnel. Thebiocompatibilitytestinghasbeenperformedonthe materialsincontactwiththepersoninaccordancewith ISO10993. DonotplacetheSpO 2 probeonafingerwithedemaor fragiletissue. ChecktheSpO 2 sensorandcablebeforeuse.Donot useadamagedSpO 2 sensor. ChecktheSpO 2 sensorapplicationsiteevery6-8hours todeterminethepositioningofthesensorandthe circulationandskinsensitivityofthepatient.Patient sensitivityvariesdependingonmedicalstatusorskin condition.Forpatientswithpoorperipheralblood circulationorsensitiveskin,inspectthesensorsite morefrequently. Thefunctionaltestercannotbeusedtoassessthe accuracyoftheSpO 2 sensororadevice. Thedevicehasnoalarmsystem. Continuoususeforalongtimemaycauseallergies, redness,blisteringorburns.Checkthewearing positionevery6-8hours. Thelocallawsandregulationsshouldbefollowed whendisposingofthedeviceandaccessories. Thebatteryinsidethisproductcannotbereplaced. 1.4GuidetoSymbols SymbolDescription TypeBF-AppliedPart Manufacturer Dateofmanufacture AuthorizedRepresentativeinthe EuropeanCommunity FollowInstructionsforUse. MRIunsafe.Presentshazardsin allMRenvironmentsasdevice containsstronglyferromagnetic materials. IP22 Protectedagainstsprayingwater andagainstaccesstohazardous partswithatool,perIEC60529. SNSerialnumber Noalarmsystem Temperaturelimitation Humiditylimitation Atmosphericpressurelimitation Indicateseparatecollectionfor electricalandelectronicequipment (WEEE). 1.5Unpacking Device UserManual Data/ChargingCable 2Overview Name:PulseOximeter Model:PO2 1.TouchSwitch: Wakeupthescreenandswitchtheinterface. 2.BacklitScreen: ShowSpO 2 valueandpulseratevalue. 3.USBChargingPort: Canbechargedanddatatransmission. 4.Sensor: Thedeviceturnson/offautomaticallyinamomentafter youtakeon/offthesensor. ThebloodSpO 2 andpulseratecanbemeasured. 3UsingtheDevice 3.1Charging UsetheUSBcabletochargetheproduct.Connect theUSBcabletoaUSBchargerortothePC. Therewillbeabatterylogoflashonthedevice whencharging. Afullychargewillneed2-3hours.Afterfully charged,thedevicewillpoweroffautomatically. Note:Thedevicecannotbeusedduringcharging, andifchoosingathirdpartychargingadaptor (ClassII),selectonethatcomplieswithIEC60950 orIEC60601-1. 3.2POWERON/OFF POWERON: Wearthedevice,itwillturnonautomatically. POWEROFF: Thedeviceturnsoffautomaticallyinamoment afteryoutakeoffthesensor. 3.3Typicalsteps 1)START.Afterchargethebattery,wearthe devicetopoweron. 2)STOP.Takeoffthedevice,therecordingwill beoverafterthecountdown. 3)DATAUploading.Runyourphoneto downloaddata. 3.4Startworking 1)Wearthedeviceonindexfinger.Tryto movethedevicealongtheforefingertofind outabestfit.Avoidbeingloose.Loose wearingcausesinaccuratemeasure. 2)Devicewillturnonautomatically.Afterafew seconds,thedevicewillbegintowork. Notice: Iftheworkingtimeislessthan2minute,the datawillnotbesaved. Pleaseavoidexcessivemotion. Pleaseavoidstrongambientlightcondition. SpO 2 measurementprinciple: ThePulseOxiemterisalightweight,portable healthoximeterforuseinthehomeorin Sensor healthcarefacilities.SpO2measurement technologyisbasedondevelopedphotoelectron method,thecircuitdesignandcalculationsoftware wasdevelopedbyShenzhenViatomTechnology Co.,Ltd.TheSpO2sensorreceivestheoptical signalfromtheredlightandinfra-redlightthrough thefinger.Insertthefingerintotheoximeter,there aretwoemittingtube(redlightdiodesandinfrared diodes)locatedontheinnerupsideofthesensor andtheycanemitredlightandinfrared;Thereis thereceivingendlocatedontheinnerdownsideof thesensor,anditcantransmittheredlightand infraredintothepulsesignalthroughfinger.The MCUreceivesthepulsesignal,getsthefrequency signalbycounting,processesitsdigitalsignal,and finallygetsthemeasuredSpO2value.ThePRis averagelycalculatedbyabovepeakintervalsofPR waveform. 3.5Stopworking&Uploaddata Takeoffthedevice,thecountdown willbegin. (Iftheworkingtimeislessthan2minute,therewill benocountdown) Duringthecountdown,ifyouwearthedeviceagain, therecordwillberesumed. Afterthecountdown,thedatawillbereadyfor uploading. Notice:Thebuilt-inmemorycanstore4records. Theoldestwillbeoverwrittenbythe5th.Please uploaddatatoyourphoneintime. 3.6ScreenWakeup Thescreenwillgooffautomaticallyforsaving powerinStandardMode;youcantouchthekeyon toptowakeupthescreen. 3.7HowtoCheckBattery Touchthekeyontop,youcanswitchdisplay betweenreadingsandbattery. 3.8UnavailableSymbol Whenthissymbol…

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Report No.: EED32M00325601Page 44 of 50 PHOTOGRAPHS OF EUT Constructional Details Test model No.: PO2 View of Product-1 View of Product-2 Report No.: EED32M00325601Page 45 of 50 View of Product-3 View of Product-4 Report No.: EED32M00325601Page 46 of 50 View of Product-5 View of Product-6 Report No.: EED32M00325601Page 47 of 50 View of Product-7 View of Product-8

FCC-ID：2ADXK-8326

Report No.: EED32M00325601Page 47 of 50 View of Product-7 View of Product-8 Report No.: EED32M00325601Page 48 of 50 View of Product-9 Report No.: EED32M00325601Page 49 of 50 View of Product-10 View of Product-11 Report No.: EED32M00325601Page 50 of 50 View of Product-12 View of Product-13 The test report is effective only with both signature and specialized stamp, The result(s) shown in this report refer only to the sample(s) tested. Without written approval of CTI, this report can’t be reproduced except in full. *** End of Report ***

Report No.: EED32M00325602Page 1 of 8 1 COVER PAGE RF Exposure Evaluation Report Product:Pulse Oximeter Trade mark:N/A Model/Type reference :PO2 Serial Number:N/A Report Number:EED32M00325602 FCC ID:2ADXK-8326 Date of Issue:Nov. 09, 2020 Test Standards: 47 CFR Part 1.1307 47 CFR Part 2.1093 KDB447498D01 General RF Exposure Guidance v06 Test result:PASS Prepared for: Shenzhen Viatom Technology Co., Ltd. 4E, 3#, Tingwei Industrial Park, Honglang North 2nd Road, Baoan District, Shenzhen, China. Prepared by : Centre Testing International Group Co., Ltd. Hongwei Industrial Zone, Bao’an 70 District, Shenzhen, Guangdong, China TEL: +86-755-3368 3668 FAX: +86-755-3368 3385 Compiled by:Reviewed by: Sunlight SunWare Xin Approved by:Date:Nov. 09, 2020 Aaron Ma Check No.: 3970366882 Report No.: EED32M00325602Page 2 of 8 2Version Version No.DateDescription 00Nov. 09, 2020Original Report No.: EED32M00325602Page 3 of 8 3 Contents Page 1 COVER PAGE.................................................................................................................................................................... 1 2 VERSION.............................................................................................................................................................................2 3CONTENTS.........................................................................................................................................................................3 4 GENERAL INFORMATION..............................................................................................................................................4 4.1 C LIENT I NFORMATION ................................................................................................................................................... 4 4.2 G ENERAL D ESCRIPTION OF EUT ................................................................................................................................ 4 4.3 P RODUCT S PECIFICATION SUBJECTIVE TO THIS STANDARD ....................................................................................... 4 4.4 T EST L OCATION ............................................................................................................................................................ 5 4.5 D EVIATION FROM S TANDARDS ..................................................................................................................................... 5 4.6 A BNORMALITIES FROM S TANDARD C ONDITIONS ......................................................................................................... 5 4.7 O THER I NFORMATION R EQUESTED BY THE C USTOMER ............................................................................................. 5 5 SAR EVALUATION........................................................................................................................................................... 6 5.1 RF E XPOSURE C OMPLIANCE R EQUIREMENT .............................................................................................................. 6 5.1.1 Standard Requirement ...................................................................................................................................... 6 5.1.2 EUT RF Exposure .............................................................................................................................................. 7 PHOTOGRAPHS OF EUT CONSTRUCTIONAL DETAILS.......................................................................................... 8 Report No.: EED32M00325602Page 4 of 8 4 General Information 4.1 Client Information Applicant: Shenzhen Viatom Technology Co., Ltd. Address of Applicant: 4E, 3#, Tingwei Industrial Park, Honglang North 2nd Road, Baoan District, Shenzhen, China. Manufacturer: Shenzhen Viatom Technology Co., Ltd. Address of Manufacturer: 4E, 3#, Tingwei Industrial Park, Honglang North 2nd Road, Baoan District, Shenzhen, China. Factory: Shenzhen Viatom Technology Co., Ltd. Address of Factory: 4E, 3#, Tingwei Industrial Park, Honglang North 2nd Road, Baoan District, Shenzhen, China. 4.2 General Description of EUT Product Name:Pulse Oximeter Model No.(EUT): PO2 Trade Mark: N/A EUT Supports Radios application: 2402MHz to 2480MHz 4.3 Product Specification subjective to this standard FrequencyRange:2402MHz~2480MHz Modulation Type:GFSK Test Power Grade:Default Test Software of EUT:DTM Tester Antenna Type:Chip antenna Antenna Gain:3.45dBi Power Supply:DC5V Max Conducted Peak Output Power: -11.247 dBm The Max Conducted Peak Output Power data refer to the report EED32M00325601 Sample Received Date: Oct. 24, 2020 Sample tested Date: Oct. 24, 2020 to Nov. 5, 2020 Company Name and Address shown on Report, the sample(s) and sample Information was/ were provided by the applicant who should be responsible for the authenticity which CTI hasn’t verified. Report No.: EED32M00325602Page 5 of 8 4.4 Test Location All tests were performed at: Centre Testing International Group Co., Ltd Building C, Hongwei Industrial Park Block 70, Bao'an District, Shenzhen, China Telephone: +86 (0) 755 33683668 Fax:+86 (0) 755 33683385 No tests were sub-contracted. FCC Designation No.: CN1164 4.5 Deviation from Standards None. 4.6 Abnormalities from Standard Conditions None. 4.7 Other Information Requested by the Customer None. Report No.: EED32M00325602Page 6 of 8 5 SAR Evaluation 5.1 RF Exposure Compliance Requirement 5.1.1 Standard Requirement According to KDB447498D01 General RF Exposure Guidance v06 Standalone SAR test exclusion considerations Unless specifically required by the published RF exposure KDB procedures, standalone 1-g head or body and 10-g extremity SAR evaluation for general population exposure conditions, by measurement or numerical simulation, is not required when the corresponding SAR Exclusion Threshold condition, listed below, is satisfied. Limits The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test s…

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Report No.: EED32M00325601Page 42 of 50 PHOTOGRAPHS OF TEST SETUP Test model No.: PO2 Radiated spurious emission Test Setup-1(Below 30MHz) Radiated spurious emissionTest Setup-2(Below 1GHz) Report No.: EED32M00325601Page 43 of 50 Radiated spurious emissionTest Setup-3(Above 1GHz) Radiated spurious emissionTest Setup-4(Above 1GHz) There are absorbing materials under the ground.