2ADXK-4708Pulse Oximeter

PulseOximeter InstructionforUse 1.Introduction 1.1Intendeduse ThisPulseOximeterisintendedtobeusedformeasuring, displayingandstoringofpulseoxygensaturation(SpO 2 ), pulserateofadultsinhomeorhealthcarefacilities environment. 1.2Contraindications Nocontraindications. 1.3WarningsandCautions  DONOTsqueezethesensorpartorapplyexcessive forceonit.  DonotusethisdeviceduringMRIexamination.  Donotusethisdevicewithadefibrillator.  Donotstorethedeviceinthefollowinglocations: locationsinwhichthedeviceisexposedtodirect sunlight,lint,dust,hightemperaturesorlevelsof moisture,orheavycontamination;locationsnearto sourcesofwaterorfire;orlocationsthataresubjectto strongelectromagneticinfluences.  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. Donotmaintainthedevicewhileitischarging. Pleasekeepthecableawayfromchildren.Itcancause strangulation. Keepthedeviceoutofreachofpets,pestsand children. ThePULSEOXIMETEREQUIPMENTiscalibratedto displayFUNCTIONALOXYGENSATURATION. 1.4GuidetoSymbols SymbolDescription TypeBF-AppliedPart Manufacturer Dateofmanufacture AuthorizedRepresentativeinthe EuropeanCommunity FollowInstructionsforUse. MRIunsafe.PresentshazardsinallMR environmentsasdevicecontainsstrongly ferromagneticmaterials. IP22 Protectedagainstsprayingwaterand againstaccesstohazardouspartswitha tool,perIEC60529. SNSerialnumber Noalarmsystem Temperaturelimitation Humiditylimitation Atmosphericpressurelimitation Indicateseparatecollectionforelectrical andelectronicequipment(WEEE). 1.5Unpacking Device UserManual ChargingCable 2Overview Name:PulseOximeter Model:PO6，PO6A ModelandConfigurationseethetablebelow. 3UsingtheDevice 3.1Charging UsetheUSBcabletochargetheproduct.Connect theUSBcabletoaUSBchargerortothePC. Therewillbeabatterylogoflashonthedevice whencharging.Whenthebatteryislow,thedisplay screenwilldisplayalowpowerprompt. 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.Chargethebattery.Wearthedevice topoweron. 2)STOP.Takeoffthedevice,therecordingwill beoverafterthecountdown. 3)DATAUploading.Runyourphonetodownloaddata. 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 healthcarefacilities.SpO2measurement technologyisbasedondevelopedphotoelectron method,thecircuitdesignandcalculationsoftware wasdevelopedbyShenzhenViatomTechnology Co.,Ltd.TheSpO2sensorreceivestheoptical signalfromtheredlightandinfra-redlightthrough thefinger.Insertthefingerintotheoximeter,there No.Model Appearance color 1PO6Blue 2PO6AGray are two emitting tube (red light diodes and infrared diodes) located on the inner upside of the sensor and they can emit red light and infrared; There is the receiving end located on the inner downside of the sensor, and it can transmit the red light and infrared into the pulse signal through finger. The MCU receives the pulse signal, gets the frequency signal by counting, processes its digital signal, and finally gets the measured SpO2 value. The PR is averagely calculated by above peak intervals of PR waveform. 3.5 Stop working & Upload data Take off the device, the countdown will begin. (If the working time is less than 2 minute, there will be no countdown) During the countdown, if you wear the device again, the record will be resumed. After the countdown, thedata will be ready for uploading. Notice:The built-in memory can store 1 records. The oldest will be overwritten by the 2th. Please upload data to your phone in time. 3.6 How to Check Battery Press the …

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ReportNo.:EED32M00324201Page 44 of 53 PHOTOGRAPHSOFEUTConstructionalDetails TestmodelNo.:PO6 ViewofProduct-1 ViewofProduct-2 ReportNo.:EED32M00324201Page 45 of 53 ViewofProduct-3 ViewofProduct-4 ReportNo.:EED32M00324201Page 46 of 53 ViewofProduct-5 ViewofProduct-6 ReportNo.:EED32M00324201Page 47 of 53 ViewofProduct-7 ViewofProduct-8

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Report No.: EED32M00324201Page 47 of 52 View of Product-7 View of Product-8 Report No.: EED32M00324201Page 48 of 52 View of Product-9 View of Product-10 Report No.: EED32M00324201Page 49 of 52 View of Product-11 View of Product-12 Report No.: EED32M00324201Page 50 of 52 View of Product-13 View of Product-14 Report No.: EED32M00324201Page 51 of 52 View of Product-15 View of Product-16 Report No.: EED32M00324201Page 52 of 52 View of Product-17 View of Product-18 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.: EED32M00324202Page 1 of 8 1 COVER PAGE RF Exposure Evaluation Report Product:Pulse Oximeter Trade mark:N/A Model/Type reference :PO6, PO6A Serial Number:N/A Report Number:EED32M00324202 FCC ID:2ADXK-4708 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.: 3970389710 Report No.: EED32M00324202Page 2 of 8 2Version Version No.DateDescription 00Nov. 09, 2020Original Report No.: EED32M00324202Page 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.: EED32M00324202Page 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): PO6, PO6A Test Model No.: PO6 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 Suppl y:DC5V Max Conducted Peak Output Power: -7.546dBm The Max Conducted Peak Output Power data refer to the report EED32M00324201 Sample Received Date: Oct. 22, 2020 Sample tested Date: Oct. 22, 2020 to Oct. 30, 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. ModelNo.:PO6,PO6A Only the model PO6 was tested, Their electrical circuit design, layout, components used and internal wiring are identical only the color of silicon finger-cot appearance is different. Report No.: EED32M00324202Page 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.: EED32M00324202Page 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 cond…

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Report No.: EED32M00324201Page 1 of 52 1 COVER PAGE TEST REPORT Product:Pulse Oximeter Trade mark:N/A Model/Type reference :PO6, PO6A Serial Number:N/A Report Number:EED32M00324201 FCC ID:2ADXK-4708 Date of Issue:Nov. 09, 2020 Test Standards: 47 CFR Part 15 Subpart C 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.: 3970389710 Report No.: EED32M00324201Page 2 of 52 2Version Version No.DateDescription 00Nov. 09, 2020Original Report No.: EED32M00324201Page 3 of 52 3TestSummary Test ItemTest RequirementTest methodResult Antenna Requirement 47 CFR Part 15 Subpart C Section 15.203/15.247 (c) ANSI C63.10-2013PASS AC Power Line Conducted Emission 47 CFR Part 15 Subpart C Section 15.207 ANSI C63.10-2013PASS Conducted Peak Output Power 47 CFR Part 15 Subpart C Section 15.247 (b)(3) ANSI C63.10-2013PASS 6dB Occupied Bandwidth 47 CFR Part 15 Subpart C Section 15.247 (a)(2) ANSI C63.10-2013PASS Power Spectral Density 47 CFR Part 15 Subpart C Section 15.247 (e) ANSI C63.10-2013PASS Band-edge for RF Conducted Emissions 47 CFR Part 15 Subpart C Section 15.247(d) ANSI C63.10-2013PASS RF Conducted Spurious Emissions 47 CFR Part 15 Subpart C Section 15.247(d) ANSI C63.10-2013PASS Radiated Spurious Emissions 47 CFR Part 15 Subpart C Section 15.205/15.209 ANSI C63.10-2013PASS Restricted bands around fundamental frequency (Radiated Emission) 47 CFR Part 15 Subpart C Section 15.205/15.209 ANSI C63.10-2013PASS Remark: Test according to ANSI C63.4-2014 & ANSI C63.10-2013. 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. Model No.: PO6, PO6A Only the model PO6 was tested, Their electrical circuit design, layout, components used and internal wiring are identical only the color of silicon finger-cot appearance is different. Report No.: EED32M00324201Page 4 of 52 4 Content 1 COVER PAGE..................................................................................................................................................................... 1 2 VERSION..............................................................................................................................................................................2 3 TEST SUMMARY................................................................................................................................................................3 4CONTENT.............................................................................................................................................................................4 5 TEST REQUIREMENT.......................................................................................................................................................5 5.1 T EST SETUP ................................................................................................................................................................... 5 5.1.1 For Conducted test setup ................................................................................................................................... 5 5.1.2 For Radiated Emissions test setup ................................................................................................................... 5 5.1.3 For Conducted Emissions test setup ............................................................................................................... 6 5.2 T EST E NVIRONMENT ...................................................................................................................................................... 6 5.3 T EST C ONDITION ........................................................................................................................................................... 6 6 GENERAL INFORMATION...............................................................................................................................................7 6.1 C LIENT I NFORMATION ....................................................................................................................................................7 6.2 G ENERAL D ESCRIPTION OF EUT..................................................................................................................................7 6.3 P RODUCT S PECIFICATION SUBJECTIVE TO THIS STANDARD ........................................................................................7 6.4 D ESCRIPTION OF S UPPORT U NITS ...............................................................................................................................8 6.5 T EST L OCATION .............................................................................................................................................................8 6.6 D EVIATION FROM S TANDARDS ......................................................................................................................................9 6.7 A BNORMALITIES FROM S TANDARD C ONDITIONS ..........................................................................................................9 6.8 O THER I NFORMATION R EQUESTED BY THE C USTOMER ..............................................................................................9 6.9 M EASUREMENT U NCERTAINTY (95% CONFIDENCE LEVELS , K =2)..............................................................................9 7EQUIPMENTLIST............................................................................................................................................................ 10 8 RADIO TECHN…

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Report No.: EED32M00324201Page 42 of 52 PHOTOGRAPHS OF TEST SETUP Test model No.: PO6 Radiated spurious emissionTest Setup-2(Below 30MHz) Radiated spurious emissionTest Setup-1(Below 1GHz) Report No.: EED32M00324201Page 43 of 52 Radiated spurious emissionTest Setup-2(Above 1GHz) Radiated spurious emissionTest Setup-3(Above 1GHz) There are absorbing materials under the ground.