U7I-PF200BPeak flow meter

Instructions for Use: Model Number [Category] [Status] [Keywords] 1 Microlife Corporation Instructions for Use: Digital Peak Flow Meter Product Model #: PF200B Introduction Document Scope Please read this Instructions for Use, the device label, and all other information provided with this product, before using the device. This instruction of Use contains important information about the device safety, performance, and operation. Disclaimers The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks on this device is under license. Apple, the Apple logo, iPad, and iPhone are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc. Android and Google Play are both trademarks of Google Inc. Other trademarks and trade names are those of their respective owners. Important Information Device Description Microlife digital peak flow meter is a medical device that utilizes the principles of flow turbine with optical interruption detection and digital signal processing to compute and provide a measurement of peak expiratory flow and other pulmonary functional parameters. Measuring your pulmonary functions, as instructed by your physician or other qualified healthcare professionals, is useful for monitoring your airway and lung conditions or diseases. Instructions for Use: Model Number [Category] [Status] [Keywords] 2 Microlife Corporation Intended Purposes This device is intended to measure the following pulmonary function parameters: Peak Expiratory Flow (PEF): the maximum flow rate a person can exhale forcibly after taking a deep as possible breathe. Forced Expiratory Volume 1-Second (FEV1): the air volume of forcible exhalation a person can exhale in 1 second after taking a deep as possible breathe. Intended User The device is intended to be operated by adult users with the vision and motor functions as well as the literacy and basic educations capable of understanding the content of this instructions for use and operating general household electrical appliances, for use of self-monitoring or monitoring of other subjects. Intended Patient The device is intended for measurements of pediatric and adult subjects. Intended Use Environment & Conditions The device is intended for use in a home healthcare environment (for example general household) by patients (for self measurement) or by a care giver. The device is intended for use by a single patient. Indications This device has the indications of: ◼ Asthma ◼ Chronic bronchitis ◼ Chronic Obstructive Pulmonary Disease (COPD) ◼ Other respiratory diseases or conditions affecting airway flow, as instructed by healthcare professionals. Contra-Indications & Limitations The device is not suitable for subjects who are unable to conduct the measurement correctly, for example: Patients unconscious or in disabling conditions that does not allow correct self-measurement operating conditions. Bedridden patients unable to stand or sit upright as required for correct measurement. Patients whose mouth cannot cover the mouthpiece as required for correct measurement, for infants and neonates. Instructions for Use: Model Number [Category] [Status] [Keywords] 3 Microlife Corporation Warning WARNING: Indicates a potentially hazardous situation, which if not avoided, could result in death or serious injury. DO NOT use this device for purposes beyond described in this Instructions for Use. The manufacturer cannot be held liable for damage caused by incorrect application. Inspect the device, cuff, and other parts for damage. DO NOT use the device, cuff or parts if they appear damaged or operating abnormally. DO NOT use this device in oxygen rich environment or near flammable gas. Keep the device away from children and people incapable of operating the device. Beware of the risks of accidental ingestion of small parts and of strangulation with the cables of this device and accessories. DO NOT let children operate the device alone. DO NOT use this device in proximity of equipment that may cause electromagnetic disturbance (EMD), such as high frequency (HF) surgical equipment, magnetic resonance imaging (MRI) equipment, and computerized tomography (CT) scanners. This may cause device malfunction and measurement inaccuracies. Caution CAUTION: Indicates a potentially hazardous situation which, if not avoided, may result in minor or moderate injury to the user or patient, or cause damage to the device or other property. Protect the device & accessories from the following to avoid damaging the device: • Water, other liquids, and moisture • Extreme temperatures • Impacts and vibrations • Direct sunlight • Contamination and dust Stop using this device and consult with your doctor if you experience skin irritation or discomfort. DO NOT use this device or parts after the expiration of its stated service life. Instructions for Use: Model Number [Category] [Status] [Keywords] 4 Microlife Corporation DO NOT dissemble or attempt to service the device, accessory and parts, during use or in storage. Access to the device internal hardware and software is prohibited. Unauthorized access and servicing of the device, during use or in storage, may compromise the safety and performance of the device. Electromagnetic Compatibility Information This device is compliant with EN60601-1-2: 2015 Electromagnetic Disturbances standard. DO NOT use this device close to strong electromagnetic fields and portable radio frequency communication devices (for example microwave oven and mobile devices). Keep a minimum distance of 0.3 m from such devices when using this device. This device features Bluetooth that emits radio frequency (RF) in the 2.4GHz band. Do not use this device in locations where RF is restricted (for example, on a aircraft). Turn off the device and remove the power source if necessary when in RF restricted locations. This device operates in an unlicensed ISM band at 2.4GHz. In case t…

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Applicant FRN: 0016306045

ReportNo.:EED32P80872501Page 31 of 39 10PHOTOGRAPHSOFEUTConstructionalDetails ViewofProduct-1 ViewofProduct-2 ReportNo.:EED32P80872501Page 32 of 39 ViewofProduct-3 ViewofProduct-4 ReportNo.:EED32P80872501Page 33 of 39 ViewofProduct-5 ViewofProduct-6 ReportNo.:EED32P80872501Page 34 of 39 ViewofProduct-7 ViewofProduct-8 ReportNo.:EED32P80872501Page 35 of 39 ViewofProduct-9 ViewofProduct-10

PF200B FCC label and size The label is located in the red box on the back of the product

ReportNo.:EED32P80872501Page 36 of 39 ViewofProdct-11 ViewofProduct-12 ReportNo.:EED32P80872501Page 37 of 39 ViewofProduct-13 ViewofProduct-14 ReportNo.:EED32P80872501Page 38 of 39 ViewofProduct-15 ViewofProduct-16 ReportNo.:EED32P80872501Page 39 of 39 ViewofProduct-17 Thetestreportiseffectiveonlywithbothsignatureandspecializedstamp,Theresult(s)showninthis reportreferonlytothesample(s)tested.WithoutwrittenapprovalofCTI,thisreportcan’tbereproduced exceptinfull. ***EndofReport***

ReportNo.:EED32P80872502Page1of7 1COVERPAGE RFExposureEvaluationReport Product:Peakflowmeter Trademark:Mircrolife Model/Typereference:PF200B SerialNumber:N/A ReportNumber:EED32P80872502 FCCID:U7I-PF200B DateofIssue:Jun.25,2023 TestStandards: 47CFRPart1.1307 47CFRPart1.1310 47CFRPart2.1093 447498D04InterimGeneralRF ExposureGuidancev01 Testresult:PASS Preparedfor: MicrolifeCorporation 9F,431,RuiGuangRoad,NeiHuTaipei11492,Taiwan,China Preparedby : CentreTestingInternationalGroupCo.,Ltd. HongweiIndustrialZone,Bao’an70District, Shenzhen,Guangdong,China TEL:+86-755-33683668 FAX:+86-755-33683385 Compiledby:Reviewedby: MarkChenTomChen Approvedby:Date:Jun.25,2023 AaronMa CheckNo.:4455130623 ReportNo.:EED32P80872502Page2of7 2Version VersionNo.DateDescription 00Jun.25,2023Original ReportNo.:EED32P80872502Page3of7 3Contents Page 1COVERPAGE....................................................................................................................................................................1 2VERSION............................................................................................................................................................................2 3CONTENTS........................................................................................................................................................................3 4GENERALINFORMATION..............................................................................................................................................4 4.1C LIENT I NFORMATION ...................................................................................................................................................4 4.2G ENERAL D ESCRIPTIONOF EUT...................................................................................................................................4 4.3P RODUCT S PECIFICATIONSUBJECTIVETOTHISSTANDARD ...........................................................................................4 4.4T EST L OCATION .............................................................................................................................................................5 4.5D EVIATIONFROM S TANDARDS ......................................................................................................................................5 4.6A BNORMALITIESFROM S TANDARD C ONDITIONS ..........................................................................................................5 4.7O THER I NFORMATION R EQUESTEDBYTHE C USTOMER ................................................................................................5 5SAREVALUATION...........................................................................................................................................................6 5.1RFE XPOSURE C OMPLIANCE R EQUIREMENT .................................................................................................................6 5.1.1Limits....................................................................................................................................................................6 5.1.2TestProcedure....................................................................................................................................................6 5.1.3EUTRFExposureEvaluation..........................................................................................................................7 ReportNo.:EED32P80872502Page4of7 4GeneralInformation 4.1ClientInformation Applicant: MicrolifeCorporation AddressofApplicant: 9F,431,RuiGuangRoad,NeiHuTaipei11492,Taiwan,China Manufacturer: ONBOElectronic(Shenzhen)Co.,Ltd. AddressofManufacturer: No.138,HuashengRoad,LangkouCommunity,DalangStreet,LonghuaDistrict, Shenzhen,China Factory: ONBOElectronic(Shenzhen)Co.,Ltd. AddressofFactory: No.138,HuashengRoad,LangkouCommunity,DalangStreet,LonghuaDistrict, Shenzhen,China 4.2GeneralDescriptionofEUT ProductName:Peakflowmeter ModelNo.(EUT): PF200B TradeMark: Mircrolife Devicetype: Portable 4.3 ProductSpecificationsubjectivetothisstandard FrequencyRange:2402MHz~2480MHz ModulationType:GFSK TestPowerGrade:Default TestSoftwareofEUT:nRF_DTM AntennaType: Chipantenna AntennaGain: 3dBi PowerSupply:Battery3.0V SampleReceivedDate: Jun.13,2023 SampletestedDate: Jun.13,2023toJun.16,2023 Remark: CompanyNameandAddressshownonReport,thesample(s)andsampleInformationwas/wereprovided bytheapplicantwhoshouldberesponsiblefortheauthenticitywhichCTIhasn’tverified. ReportNo.:EED32P80872502Page5of7 4.4TestLocation Alltestswereperformedat: CentreTestingInternationalGroupCo.,Ltd BuildingC,HongweiIndustrialParkBlock70,Bao'anDistrict,Shenzhen,China Telephone:+86(0)75533683668Fax:+86(0)75533683385 Notestsweresub-contracted. FCCDesignationNo.:CN1164 4.5DeviationfromStandards None. 4.6AbnormalitiesfromStandardConditions None. 4.7OtherInformationRequestedbytheCustomer None. ReportNo.:EED32P80872502Page6of7 5SAREvaluation 5.1RFExposureComplianceRequirement 5.1.1Limits TheSAR-basedexemptionformulaof§1.1307(b)(3)(i)(B),repeatedhereasFormula(B.2),appliesfor singlefixed,mobile,andportableRFsourceswithavailablemaximumtime-averagedpoweroreffective radiatedpower(ERP),whicheverisgreater,oflessthanorequaltothethresholdPth(mW). Thismethodshallonlybeusedatseparationdistancesfrom0.5cmto40cmandatfrequenciesfrom 0.3GHzto6GHz(inclusive).PthisgivenbyFormula andfisinGHz,distheseparationdistance(cm),andERP20cmisperFormula(B.1). The1mWBlanketExemptionof§1.1307(b)(3)(i)(A)appliesforsinglefixed,mobile,andportableRF sourceswithavailablemaximumtime-averagedpowerofnomorethan1mW,regardlessofseparation distance. 5.1.2TestProcedure SoftwareprovidedbyclientenabledtheEUTtotransmitandreceivedataatlowest,middleandhighest channelindividually. ReportNo.:EED32P80872502Page7of7 5.1.3EUTRFExposureEvaluation ForStandalone: ForBLE Frequency (MHz) Separation distance (cm) Max. Conducted Output power (dBm) Antenna Gain (dBi) EIRP (dBm) ERP (dBm) ERP (mW) Limit (m…

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ReportNo.: EED32P80872501 Page1of24 Appendix:BluetoothLE ReportNo.: EED32P80872501 Page2of24 Contents Contents.....................................................................................................................................................................................................2 DutyCycle..................................................................................................................................................................................................3 MaximumPeakConductedOutputPower..................................................................................................................................................6 -6dBBandwidth..........................................................................................................................................................................................9 OccupiedChannelBandwidth..................................................................................................................................................................12 MaximumPowerSpectralDensityLevel..................................................................................................................................................15 BandEdge................................................................................................................................................................................................18 ConductedRFSpuriousEmission............................................................................................................................................................21 ReportNo.: EED32P80872501 Page3of24 DutyCycle ConditionModeFrequency(MHz)AntennaDutyCycle(%)CorrectionFactor(dB)1/T(kHz) NVNTBLE1M2402Ant168.961.612.32 NVNTBLE1M2440Ant168.961.612.32 NVNTBLE1M2480Ant168.641.632.33 ReportNo.: EED32P80872501 Page4of24 TestGraphs DutyCycleNVNTBLE1M2402MHzAnt1 DutyCycleNVNTBLE1M2440MHzAnt1 ReportNo.: EED32P80872501 Page5of24 DutyCycleNVNTBLE1M2480MHzAnt1 ReportNo.: EED32P80872501 Page6of24 MaximumPeakConductedOutputPower ConditionModeFrequency (MHz) AntennaConductedPower (dBm) Limit (dBm) Verdict NVNTBLE1M2402Ant1-0.4130Pass NVNTBLE1M2440Ant1-2.1530Pass NVNTBLE1M2480Ant1-3.8130Pass ReportNo.: EED32P80872501 Page7of24 TestGraphs PeakPowerNVNTBLE1M2402MHzAnt1 PeakPowerNVNTBLE1M2440MHzAnt1 ReportNo.: EED32P80872501 Page8of24 PeakPowerNVNTBLE1M2480MHzAnt1 ReportNo.: EED32P80872501 Page9of24 -6dBBandwidth ConditionModeFrequency(MHz)Antenna-6dBBandwidth(MHz)Limit-6dBBandwidth(MHz)Verdict NVNTBLE1M2402Ant10.7260.5Pass NVNTBLE1M2440Ant10.7160.5Pass NVNTBLE1M2480Ant10.6950.5Pass ReportNo.: EED32P80872501 Page10of24 TestGraphs -6dBBandwidthNVNTBLE1M2402MHzAnt1 -6dBBandwidthNVNTBLE1M2440MHzAnt1 ReportNo.: EED32P80872501 Page11of24 -6dBBandwidthNVNTBLE1M2480MHzAnt1 ReportNo.: EED32P80872501 Page12of24 OccupiedChannelBandwidth ConditionModeFrequency(MHz)Antenna99%OBW(MHz) NVNTBLE1M2402Ant11.049 NVNTBLE1M2440Ant11.044 NVNTBLE1M2480Ant11.04 ReportNo.: EED32P80872501 Page13of24 TestGraphs OBWNVNTBLE1M2402MHzAnt1 OBWNVNTBLE1M2440MHzAnt1 ReportNo.: EED32P80872501 Page14of24 OBWNVNTBLE1M2480MHzAnt1 ReportNo.: EED32P80872501 Page15of24 MaximumPowerSpectralDensityLevel ConditionModeFrequency (MHz) AntennaConductedPSD (dBm/3kHz) Limit (dBm/3kHz) Verdict NVNTBLE1M2402Ant1-158Pass NVNTBLE1M2440Ant1-16.378Pass NVNTBLE1M2480Ant1-17.718Pass ReportNo.: EED32P80872501 Page16of24 TestGraphs PSDNVNTBLE1M2402MHzAnt1 PSDNVNTBLE1M2440MHzAnt1 ReportNo.: EED32P80872501 Page17of24 PSDNVNTBLE1M2480MHzAnt1 ReportNo.: EED32P80872501 Page18of24 BandEdge ConditionModeFrequency(MHz)AntennaMaxValue(dBc)Limit(dBc)Verdict NVNTBLE1M2402Ant1-41.33-20Pass NVNTBLE1M2480Ant1-40.36-20Pass ReportNo.: EED32P80872501 Page19of24 TestGraphs BandEdgeNVNTBLE1M2402MHzAnt1Ref BandEdgeNVNTBLE1M2402MHzAnt1Emission ReportNo.: EED32P80872501 Page20of24 BandEdgeNVNTBLE1M2480MHzAnt1Ref BandEdgeNVNTBLE1M2480MHzAnt1Emission ReportNo.: EED32P80872501 Page21of24 ConductedRFSpuriousEmission ConditionModeFrequency(MHz)AntennaMaxValue(dBc)Limit(dBc)Verdict NVNTBLE1M2402Ant1-47.78-20Pass NVNTBLE1M2440Ant1-46.04-20Pass NVNTBLE1M2480Ant1-44.38-20Pass ReportNo.: EED32P80872501 Page22of24 TestGraphs Tx.SpuriousNVNTBLE1M2402MHzAnt1Ref Tx.SpuriousNVNTBLE1M2402MHzAnt1Emission ReportNo.: EED32P80872501 Page23of24 Tx.SpuriousNVNTBLE1M2440MHzAnt1Ref Tx.SpuriousNVNTBLE1M2440MHzAnt1Emission ReportNo.: EED32P80872501 Page24of24 Tx.SpuriousNVNTBLE1M2480MHzAnt1Ref Tx.SpuriousNVNTBLE1M2480MHzAnt1Emission ***EndofReport***

ReportNo.:EED32P80872501Page1of39 1 COVERPAGE TESTREPORT Product:Peakflowmeter Trademark:Mircrolife Model/Typereference:PF200B SerialNumber:N/A ReportNumber:EED32P80872501 FCCID: U7I-PF200B DateofIssue:Jun.25,2023 TestStandards: 47CFRPart15SubpartC Testresult:PASS Preparedfor: MicrolifeCorporation 9F,431,RuiGuangRoad,NeiHuTaipei11492,Taiwan,China Preparedby : CentreTestingInternationalGroupCo.,Ltd. HongweiIndustrialZone,Bao’an70District, Shenzhen,Guangdong,China TEL:+86-755-33683668 FAX:+86-755-33683385 Compiledby:Reviewedby: MarkChenTomChen Approvedby:Date:Jun.25,2023 AaronMa CheckNo.:4455130623 ReportNo.:EED32P80872501Page 2 of 39 2Content 1COVERPAGE.....................................................................................................................................................................1 2CONTENT............................................................................................................................................................................2 3VERSION.............................................................................................................................................................................3 4TESTSUMMARY...............................................................................................................................................................4 5GENERALINFORMATION...............................................................................................................................................5 5.1C LIENT I NFORMATION ....................................................................................................................................................5 5.2G ENERAL D ESCRIPTIONOF EUT.................................................................................................................................5 5.3T EST C ONFIGURATION ..................................................................................................................................................6 5.4T EST E NVIRONMENT .....................................................................................................................................................7 5.5D ESCRIPTIONOF S UPPORT U NITS ...............................................................................................................................7 5.6T EST L OCATION .............................................................................................................................................................7 5.7M EASUREMENT U NCERTAINTY (95% CONFIDENCELEVELS , K =2).............................................................................8 6EQUIPMENTLIST..............................................................................................................................................................9 7TESTRESULTSANDMEASUREMENTDATA.........................................................................................................12 7.1A NTENNA R EQUIREMENT ............................................................................................................................................12 7.2DTSB ANDWIDTH ........................................................................................................................................................14 7.3M AXIMUM P OWER S PECTRAL D ENSITY .....................................................................................................................15 7.4B AND E DGEMEASUREMENTSAND C ONDUCTED S PURIOUS E MISSION ...................................................................16 7.5R ADIATED S PURIOUS E MISSION &R ESTRICTEDBANDS ...........................................................................................17 8APPENDIXBLE................................................................................................................................................................28 9PHOTOGRAPHSOFTESTSETUP..............................................................................................................................29 10PHOTOGRAPHSOFEUTCONSTRUCTIONALDETAILS...................................................................................31 ReportNo.:EED32P80872501Page 3 of 39 3Version VersionNo.DateDescription 00Jun.25,2023Original ReportNo.:EED32P80872501Page 4 of 39 4TestSummary TestItemTestRequirementResult AntennaRequirement 47CFRPart15SubpartCSection 15.203/15.247(c) PASS ACPowerLineConducted Emission 47CFRPart15SubpartCSection 15.207 N/A DTSBandwidth 47CFRPart15SubpartCSection 15.247(a)(2) PASS MaximumConductedOutput Power 47CFRPart15SubpartCSection 15.247(b)(3) PASS MaximumPowerSpectral Density 47CFRPart15SubpartCSection15.247(e)PASS BandEdgeMeasurements 47CFRPart15SubpartCSection 15.247(d) PASS ConductedSpurious Emissions 47CFRPart15SubpartCSection 15.247(d) PASS RadiatedSpuriousEmission& Restrictedbands 47CFRPart15SubpartCSection 15.205/15.209 PASS Remark: N/A:Onlybatterysupplyissupportedandthisitemisnotconsidered. CompanyNameandAddressshownonReport,thesample(s)andsampleInformationwereprovidedbythe applicantwhoshouldberesponsiblefortheauthenticitywhichCTIhasn’tverified. ReportNo.:EED32P80872501Page 5 of 39 5GeneralInformation 5.1ClientInformation Applicant:MicrolifeCorporation AddressofApplicant:9F,431,RuiGuangRoad,NeiHuTaipei11492,Taiwan,China Manufacturer:ONBOElectronic(Shenzhen)Co.,Ltd. AddressofManufacturer:No.138,HuashengRoad,LangkouCommunity,DalangStreet,Longhua District,Shenzhen,China Factory:ONBOElectronic(Shenzhen)Co.,Ltd. AddressofFactory:No.138,HuashengRoad,LangkouCommunity,DalangStreet,Longhua District,Shenzhen,China 5.2GeneralDescriptionofEUT ProductName: Peakflowmeter ModelNo.: PF200B Trademark: Mircrolife Devicetype: Portable OperationFrequency:2402MHz~2480MHz ModulationType:GFSK TransferRate: 1Mbps NumberofChannel:40 AntennaType:Chipantenna AntennaGain:3dBi PowerSupply:Battery3.0V TestVoltage:DC3.0V SampleReceivedDate:Jun.13,2023 SampletestedDate:Jun.13,20…

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ReportNo.:EED32P80872501Page 29 of 39 9PHOTOGRAPHSOFTESTSETUP RadiatedspuriousemissionTestSetup-1 (Below1GHz) RadiatedspuriousemissionTestSetup-2( Above1GHz) ReportNo.:EED32P80872501Page 30 of 39 RadiatedspuriousemissionTestSetup-3( Above1GHz) Thereareabsorbingmaterialsundertheground.