U7I-BP3T01-1BDigital Blood Pressure Monitor

BP Progress BP3T01-1B Symbols & Definitions Manufacturer Catalog Number Serial Number Caution Type BF Applied part IP22 Protected against solid objects with a diameter of ≧12.5mm. ; Protected against vertically falling water drops when enclosure tilted up to 15 ̊ Temperature limit Humidity limitation Follow instructions for use. This document provides important product operation and safety information regarding this device. Please read this document thoroughly before using the device and keep for future reference. WEEE symbol: Dispose or recycle this product in accordance with local laws or regulations that apply Device Illustration Device Illustration Legend Device 1 Display 2 O/I Button 3 Select Button 4 + & - touch pad 5 Battery compartment Important Information Read the important information in this Instructions for use before using this device. Follow the instructions for use for your safety and keep it for future reference. Indication for Use This device is a non-invasive automatic blood pressure monitor. The intended purpose of this device is described in this section. ◼ This device is intended to measure blood pressure (systole and diastole) and pulse rate of an adult individual with arm circumference between 22 cm – 40 cm ◼ The device detects the appearance of irregular heartbeat during measurement and gives a warning signal with the reading once the irregular heartbeat is detected. ◼ The device is intended to be reusable: single patient multiple use or multiple patient multiple use depending on the specific variant. ◼ The device can be used in connection with a smart phone via Bluetooth. The measurement data can be transferred to a smart phone running the Microlife Connected Health+ mobile software (App). Intended User, Patient, and Use Environment This device is only intended to be used by user on patients in environments described in this section. ◼ The device is intended to be used by patients (self-measurement) or on a third person in a home healthcare environment (such as general household use). ◼ 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. ◼ The intended patients are normotensive and hypertensive adults and adolescents (aged 12 years or older) of the general population. Indication & Clinical Benefits This device is suitable for use for the following conditions and clinical benefits described in this section. ◼ The device is intended to measure human brachial blood pressure non-invasively for monitoring of the systolic and diastolic pressures, to support the diagnosis medical conditions or diseases related to blood pressure, including: ◼ Diagnosis white-coat hypertension and masked hypertension and identifying white-coat effect and masked uncontrolled hypertension. ◼ Evaluate blood pressure in response to treatment ◼ Confirming the diagnosis of resistant hypertension ◼ Detecting morning hypertension Contra-indications Do not use this device if the patient’s condition meets the following contra-indications, to avoid inaccurate measurements or injuries. ◼ The device is not intended for measuring blood pressure in pediatric patients of age younger than 12 years old (children, infant, or neonates). ◼ Presence of significant cardiac arrhythmia during measurement may interfere with blood pressure measurement and affect the reliability of blood pressure readings. Consult with your doctor about whether the device is suitable for use in this case. ◼ The device is not intended for measuring blood pressure in adults with conditions of diabetes, pregnancy, or pre-eclampsia. ◼ The device measures brachial blood pressure using pressured cuff over upper arm. If the measuring arm suffers from injuries (for example open wounds) or under conditions or treatments (for example intravenous drip) making it unsuitable for surface contact or pressurization of the arm, DO NOT use the device, to avoid worsening of the injuries or conditions. ◼ Patient motions during measurement may interfere with the measurement process and influence results. Avoid taking measurements of patients with conditions, diseases, and susceptible to environment conditions that lead to incontrollable motions (e.g. trembling or shivering) and inability to communicate clearly (for example children and unconscious patients). ◼ The device uses oscillometric method to determine blood pressure, and requires the measured arm with normal perfusion. The device is not intended to be used on an arm with restricted or impaired blood circulation. Consult with your doctor if you severer perfusion or blood disorders before using the device. ◼ Avoid taking measurement on the arm on the side of a mastectomy or lymph node clearance. ◼ The device is not intended to measure pulse rate to check the frequency of pacemaker. ◼ Do not use this device in a moving vehicle (for example in a car or on an aircraft). Side Effects Use of the device may be accompanied by minor side effects. ◼ In some cases, slight bruising may result after measurement due to pressurization of the arm. Warning Indicates a potentially hazardous situation, which if not avoided, could result in death or serious injury. ◼ A self-measurement reading is not a medical diagnosis or treatment. Always consult with your physician. Under no circumstances should you diagnose or alter your prescribed medication by yourself. ◼ Consult your physician before using this device if any of the following or similar conditions are present: arrhythmias such as atrial or ventricular premature beats or atrial fibrillation, arterial sclerosis, poor perfusion, diabetes, pregnancy, preeclampsia, or renal diseases. ◼ Motion during measurement, including trembling or shivering may affect the measurement. Keep the device away from children! The device and its accessories contain small parts, tubes …

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ReportNo.:EED32Q80680701Page 35 of 41 ViewofProduct-09 ViewofProduct-10 ReportNo.:EED32Q80680701Page 36 of 41 ViewofProduct-11 ViewofProduct-12 ReportNo.:EED32Q80680701Page 37 of 41 ViewofProduct-13 ViewofProduct-14 ReportNo.:EED32Q80680701Page 38 of 41 ViewofProduct-15 ViewofProduct-16 ReportNo.:EED32Q80680701Page 39 of 41 ViewofProduct-17 ViewofProduct-18 ReportNo.:EED32Q80680701Page 40 of 41 ViewofProduct-19 ViewofProduct-20 ReportNo.:EED32Q80680701Page 41 of 41 ViewofProduct-21 Thetestreportiseffectiveonlywithbothsignatureandspecializedstamp,Theresult(s)showninthis reportreferonlytothesample(s)tested.WithoutwrittenapprovalofCTI,thisreportcan’tbereproduced exceptinfull. ***EndofReport***

A T 5 0 2 0 S e r i e s F e a t u r e s M o n o l i t h i c S M D w i t h s m a l l , l o w - p r o f i l e a n d l i g h t - w e i g h t t y p e . W i d e b a n d w i d t h A p p l i c a t i o n s ^ B l u e t o o t h / W i r e l e s s L A N H o m e R F I S M b a n d 2 . 4 G H z a p p l i c a t i o n s S p ec i f i c a t i o n Ceramic Antenna s O p e r a t i n g A v e r a g e G a i n P e a k G a i n I m p e d a n ce V S W R F r e q u e n c y P a r t N u m b e r ( X Z - V ) ( X Z - V ) ( M H z ) A T 5 0 2 0 5 0 Ω - 1 d B i t yp . 2 m a x 2 4 0 0 ～ 2 5 0 0 0 d B i t y p . - B 2 R 8 H A A a t y / R e e l ( p cs ) O p e r a t i n g T e m p e r a t u r e R a n g e S t o r a g e T e m p e r a t u r e R a n g e S t o r a g e P e r i o d P o w er C a p a c i t y : 2 , 0 0 0 p c s - 4 0 ～ + 8 5 °C : + 5 ~ + 3 5 °C , H u m i d i t y 4 5 ~ 7 5 % R H 1 2 m o n t h s m a x : 2 W m a x P a r t N u m b e r H A A □ 旦 A I 5 0 2 0 - B 2 R 8 ⑥ ② ③ ⑤ ① ⑦ ④ ② D i m e n s i o n s ( L × W ) 5 . 0 × 2 . 0 mm | T y p e 2 R 8 = 2 8 0 0 M H Ceramic Antenna z ④ I n i t i a l c e n t er f r e q u e n c y ③ M a t e r i a l C o d e B T : T a p e & R ee l P a c k a g i n g H AA ⑤ S p e c i f i c a t i o n C o d e B : B u l k = l e a d - c o n t a i n i n g | S o l d e r i n g / L F = l ea d - f r e e T e r m i n a l C on f i g u r a t i o n 0 0 T e r m i n a l N a m e T e r m i n a l N a m e N o . N o . ① ② ② N C F e e d i n g P o i n t ① A T 5 0 2 0 - B 2 R 8 H A A T / L F R E V : 2 P A G E : 1 / 8

ReportNo.:EED32Q80680701Page1of25 Appendix:BluetoothLE ReportNo.:EED32Q80680701Page2of25 Contents AppendixA:DTSBandwidth.......................................................................................................3 TestResult .........................................................................................................................3 TestGraphs .......................................................................................................................4 AppendixB:OccupiedChannelBandwidth................................................................................6 TestResult .........................................................................................................................6 TestGraphs .......................................................................................................................7 AppendixC:Maximumconductedoutputpower......................................................................9 TestResultPeak ..............................................................................................................9 TestGraphsPeak ..........................................................................................................10 AppendixD:Maximumpowerspectraldensity.......................................................................12 TestResult .......................................................................................................................12 TestGraphs .....................................................................................................................13 AppendixE:Bandedgemeasurements...................................................................................15 TestResult .......................................................................................................................15 TestGraphs .....................................................................................................................16 AppendixF:ConductedSpuriousEmission..............................................................................17 TestResult .......................................................................................................................17 TestGraphs .....................................................................................................................18 AppendixG:DutyCycle............................................................................................................23 TestResult .......................................................................................................................23 TestGraphs .....................................................................................................................24 ReportNo.:EED32Q80680701Page3of25 AppendixA:DTSBandwidth TestResult TestModeAntennaFrequency[MHz] DTSBW [MHz] FL[MHz]FH[MHz]Limit[MHz]Verdict BLE_1MAnt1 24020.732401.622402.350.5PASS 24400.712439.632440.340.5PASS 24800.712479.642480.360.5PASS ReportNo.:EED32Q80680701Page4of25 TestGraphs BLE_1M_Ant1_2402 BLE_1M_Ant1_2440 ReportNo.:EED32Q80680701Page5of25 BLE_1M_Ant1_2480 ReportNo.:EED32Q80680701Page6of25 AppendixB:OccupiedChannelBandwidth TestResult TestModeAntennaFrequency[MHz] OCB [MHz] FL[MHz]FH[MHz]Limit[MHz]Verdict BLE_1MAnt1 24021.2212401.4322402.652------ 24401.1782439.4472440.626------ 24801.0892479.4772480.566------ ReportNo.:EED32Q80680701Page7of25 TestGraphs BLE_1M_Ant1_2402 BLE_1M_Ant1_2440 ReportNo.:EED32Q80680701Page8of25 BLE_1M_Ant1_2480 ReportNo.:EED32Q80680701Page9of25 AppendixC:Maximumconductedoutputpower TestResultPeak TestModeAntennaFrequency[MHz] Conducted Peak Power[dBm] Conducted Limit[dBm] Verdict BLE_1MAnt1 2402-9.46≤30PASS 2440-10.94≤30PASS 2480-12.22≤30PASS ReportNo.:EED32Q80680701Page10of25 TestGraphsPeak BLE_1M_Ant1_2402 BLE_1M_Ant1_2440 ReportNo.:EED32Q80680701Page11of25 BLE_1M_Ant1_2480 ReportNo.:EED32Q80680701Page12of25 AppendixD:Maximumpowerspectraldensity TestResult TestModeAntennaFrequency[MHz]Result[dBm/3kHz]Limit[dBm/3kHz]Verdict BLE_1MAnt1 2402-24.3≤8.00PASS 2440-25.87≤8.00PASS 2480-26.6≤8.00PASS ReportNo.:EED32Q80680701Page13of25 TestGraphs BLE_1M_Ant1_2402 BLE_1M_Ant1_2440 ReportNo.:EED32Q80680701Page14of25 BLE_1M_Ant1_2480 ReportNo.:EED32Q80680701Page15of25 AppendixE:Bandedgemeasurements TestResult TestModeAntennaChNameFrequency[MHz]RefLevel[dBm]Result[dBm]Limit[dBm]Verdict BLE_1MAnt1 Low2402-9.73-47.84≤-29.73PASS High2480-12.44-50.89≤-32.44PASS ReportNo.:EED32Q80680701Page16of25 TestGraphs BLE_1M_Ant1_Low_2402 BLE_1M_Ant1_High_2480 ReportNo.:EED32Q80680701Page17of25 AppendixF:ConductedSpuriousEmission TestResult TestModeAntenna Frequency [MHz] FreqRange [MHz] RefLevel [dBm] Result[dBm]Limit[dBm]Verdict BLE_1MAnt1 2402 Reference-9.78-9.78---PASS 30~1000-9.78-65.62≤-29.78PASS 1000~26500-9.78-49.01≤-29.78PASS 2440 Reference-11.17-11.17---PASS 30~1000-11.17-64.01≤-31.17PASS 1000~26500-11.17-40.48≤-31.17PASS 2480 Reference-12.38-12.38---PASS 30~1000-12.38-63.37≤-32.38PASS 1000~26500-12.38-45.35≤-32.38PASS ReportNo.:EED32Q80680701Page18of25 TestGraphs BLE_1M_Ant1_2402_0~Reference BLE_1M_Ant1_2402_30~1000 ReportNo.:EED32Q80680701Page19of25 BLE_1M_Ant1_2402_1000~26500 BLE_1M_Ant1_2440_0~Reference ReportNo.:EED32Q80680701Page20of25 BLE_1M_Ant1_2440_30~1000 BLE_1M_Ant1_2440_1000~26500 ReportNo.:EED32Q80680701Page21of25 BLE_1M_Ant1_2480_0~Reference BLE_1M_Ant1_2480_30~1000 ReportNo.:EED32Q80680701Page22of25 BLE_1M_Ant1_2480_1000~26500 ReportNo.:EED32Q80680701Page23of25 AppendixG:DutyCycle TestResult TestModeAntennaFrequency[MHz] ONTime [ms] Period [ms] DutyCycle [%] DutyCycle Factor [dB] BLE_1MAnt1 24020.430.6368.251.66 24400.430.6368.251.66 24800.430.6368.251.66 ReportNo.:EED32Q80680701Page24of25 TestGraphs BLE_1M_Ant1_2402 BLE_1M_Ant1_2440 ReportNo.:EED32Q80680701Page25of25 BLE_1M_Ant1_2480 ***EndofReport***

ReportNo.:EED32Q80680701Page1of41 1 COVERPAGE TESTREPORT Product:DigitalBloodPressureMonitor Trademark:Mircrolife Model/Typereference:BP3T01-1B SerialNumber:N/A ReportNumber:EED32Q80680701 FCCID:U7I-BP3T01-1B DateofIssue:Jul.08,2024 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: ZhenxiaWenFrazerLi Approvedby:Date:Jul.08,2024 AaronMa CheckNo.:5352210524 ReportNo.:EED32Q80680701Page 2 of 41 2Version VersionNo.DateDescription 00Jul.08,2024Original ReportNo.:EED32Q80680701Page 3 of 41 3Content 1COVERPAGE.....................................................................................................................................................................1 2VERSION.............................................................................................................................................................................2 3CONTENT............................................................................................................................................................................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 7.2M AXIMUM C ONDUCTED O UTPUT P OWER ..................................................................................................................13 7.3DTSB ANDWIDTH ........................................................................................................................................................14 7.4M AXIMUM P OWER S PECTRAL D ENSITY .....................................................................................................................15 7.5B AND E DGEMEASUREMENTSAND C ONDUCTED S PURIOUS E MISSION ...................................................................16 7.6R ADIATED S PURIOUS E MISSION &R ESTRICTEDBANDS ...........................................................................................17 8APPENDIXBLUETOOTHLE.........................................................................................................................................28 9PHOTOGRAPHSOFTESTSETUP..............................................................................................................................29 10PHOTOGRAPHSOFEUTCONSTRUCTIONALDETAILS...................................................................................31 ReportNo.:EED32Q80680701Page 4 of 41 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:TheproductispoweredbyDCbatteriesandhasnoACpowersupplyport. CompanyNameandAddressshownonReport,thesample(s)andsampleInformationwereprovidedbythe applicantwhoshouldberesponsiblefortheauthenticitywhichCTIhasn’tverified. ReportNo.:EED32Q80680701Page 5 of 41 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: DigitalBloodPressureMonitor ModelNo.: BP3T01-1B Trademark: Mircrolife ProductType: MobilePortableFixLocation OperationFrequency: 2402MHz~2480MHz M…

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ReportNo.:EED32Q80680701Page 29 of 41 9PHOTOGRAPHSOFTESTSETUP RadiatedspuriousemissionTestSetup-1 (Below1GHz) RadiatedspuriousemissionTestSetup-2( Above1GHz) ReportNo.:EED32Q80680701Page 30 of 41 RadiatedspuriousemissionTestSetup-3( Above1GHz) Thereareabsorbingmaterialsundertheground.