2AXH5002Continuous Glucose Monitoring System

三诺生物传感股份有限公司 Page( 1 )of(5) NPI031-持续葡萄糖监测系统 使用说明书 NPI031-ContinuousGlucoseMonitoring System(CGMS) UserManual 文件编号DocumentNo.：NPI031-UM-001F 版本Version：A.6 DraftedbyRADate Reviewed by MechanicalEngineerDate SystemEngineerDate HardwareEngineerDate SoftwareEngineerDate SensorEngineerDate IndustrialDesignDate ProjectManagerDate DQADate RADirector Approved by CGMR&DDeputy Director Date 三诺生物传感股份有限公司 Page( 2 )of(5) DocumentChangeHistory RevisionSubjectDraftedbyDate A.1InitialReleaseAoGao2022-02-25 A.2 1.Changethenameof“Howtousethisguide”to “GettingstartedwithTrueViecontinuousglucose monitoring(CGM)”; 2.Changethenameof“Introduction”to“System Overview”andaddpackagingillustrations; 3.Usedifferentsignfordifferenttypeofnotice,caution, warning; 4.MovetheTableofContentstothebeginningofthe document; 5.Movetheinformationinthesecondtwoparagraphs ofIndicationsforUsetotheSystemDescription; 6.RewordChapter2:ChooseaSite; 7.MovetheProfilesectiontoChapter2:App installationandsetup. AoGao2022-08-25 A.3 1.ChangetheproductsnametoTRUEVIEi3CGM 2.UpdatethenewestUIpictures 3.IncreasetheUIpictureof“Access” AoGao2023.01.17 A.4 1.UpdatethenewestUIpictures,descriptionsandtable ofcontents 2.ChangetheproductsnametoTRUEVIEI3CGM 3.Changetheagegroupto “ 2-6years/7yearsand older ” 4.Changethepairingdescriptionbetweensensorand transmitterpack(TheSensorPackandTransmitterPack arepackagedtogetherandsharethesamefirst8digitsin theirrespectiveserialnumbers.) 5.TheREACHAPPuser’snames“CarePartner” 6.UpdatetheD.2ProductSpecifications 7.UpdatetheAttachmentELabelSymbols 8.UpdatetheAttachmentFAlertsVibrationsand Sounds 9.Changethedescriptionof“sensorglucose“to “glucose”. ZiaoQin2023-03-24 A.5 1.Added“1.3.4RadioFrequency(RF)communication” aspatientinstructionsagainstpotentialinterference. 2.Updated“D.7FCCComplianceStatements”to includeharmfulinterferencesfromFCC 3.Updatethenameof“Section2.1.3Profile”toSystem SettingsandupdatetheUIofAttachmentF EchoYu2023-05-11 三诺生物传感股份有限公司 Page( 3 )of(5) A.6 1.Changetheguidancepicturetoguidancevideo 2.Correctspellingandgrammarerror 3.Adddescriptionof“DataConsent” 4.UpdatetheAPP’sUI 5.Update“AttachmentFAlerts,Vibrationsand Sounds” 6.Updatetheagegroupandinsertsites ZiaoQin 三诺生物传感股份有限公司 Page( 4 )of(5) 目录 1.Purpose目的...............................................................................................................................0 2.Scope范围..................................................................................................................................0 3.Terms,Definitions,Abbreviations术语、定义、缩略语.........................................................0 4.ReferenceDocument参考文件..................................................................................................0 5.Procedure 程序 ...........................................................................................................................0 6.Attachment 附件 .........................................................................................................................0 三诺生物传感股份有限公司 Page(5)of(5) 产品使用说明书（UM） Purpose目的 按照法规要求输出 TRUEVIEI3 实时持续葡萄糖监测系统产品使用说明书。 OutputtheTRUEVIEI3ContinuousGlucoseMonitoringSystemUserManual. Scope范围 本文件适用于本公司生产的在美国上市销售的TRUEVIEI3实时持续葡萄糖监测系统。 ThisdocumentappliestotheTRUEVIEI3ContinuousGlucoseMonitoringSystemmanufacturedbySinocare andmarketedintheUnitedStates. Terms,Definitions,Abbreviations术语、定义、缩略语 详见说明书。 SeetheUserManualfordetails. ReferenceDocument参考文件 NPI031-DP-001F_A.1CGMSDocumentationPlan(DP) 21CFRPart801Labeling 21CFR862.1355iCGMSpecialControl FDAGuidance-PatientLabeling FDAGuidance-DesignConsiderationsforDevicesIntendedforHomeUse ISO15223-1:2021 FCCCertification IEC60601-1:2005+AMD1:2012+AMD2:2020 IEC60601-1-2:2014 FDAGuidance-TestingLabelingMRIEnvironment 1.Procedure程序 N/A 2.Attachment 附件 附件ATRUEVIEI3CGMUserGuide。 AttachmentATRUEVIEI3CGMUserGuide 0 TRUEVIEI3CGM InstructionsforUse 1 TableofContents TableofContents................................................................................................................1 IMPORTANTSAFETYINFORMATION........................................................................4 Section1:SystemOverview...............................................................................................7 1.1SystemDescription...............................................................................................8 1.2IntendedPurpose.................................................................................................10 1.3UserSafety..........................................................................................................10 Section2:StartYourSensor.............................................................................................15 2.1PreparetheSensor...............................................................................................16 2.2ChooseaSite.......................................................................................................20 2.3PairYourSensorwiththeTransmitter................................................................21 2.4ApplyYourSensor..............................................................................................22 2.5SensorWarmup...................................................................................................26 Section3:UnderstandyourTRUEVIEI3CGMResults................................................27 3.1HomeScreenOverview.......................................................................................28 3.2GlucoseInformation............................................................................................28 3.3NavigationandStatusBar...................................................................................32 3.4Events..................................................................................................................33 3.5Alerts...................................................................................................................35 3.6Access............................…

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Sinocare Inc. Attestation Statements Not Covered Entity Applicant To: Federal Communications Commission Date: 03-25-2023 7435 Oakland Mills Road, Columbia, MD 21046, USA Ref: Information Required by Section 2.911(d)(5)(ii) filing FCC ID: 2AXH5002 [TCL Communication Ltd.] (“the applicant”) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List (as a specifically named entity or any of its subsidiaries or affiliates) as an entity producing “covered” equipment. Sincerely yours, Applicant Signature Printed Name: Annie Jiang Title: Jiangfeng Fei Address: 11 Qingshan West Road, Yuelu District, Changsha, Hunan, China 410205 Tel.: +86 13521316621 Email: [email protected]

Sinocare Inc. Attestation Statements Not Covered Equipment To: Federal Communications Commission Date: 03-25-2023 7435 Oakland Mills Road, Columbia, MD 21046, USA Ref: Information Required by Section 2.911(d)(5)(i) filing FCC ID: 2AXH5002 [TCL Communication Ltd.] (“the applicant”) certifies that the equipment for which authorization is sought is not “covered” equipment prohibited from receiving an equipment authorization pursuant to section § 2.903 of the FCC rules. Sincerely yours, Applicant Signature Printed Name: Jiangfeng Fei Title: Director of CGM Department Address: 11 Qingshan West Road, Yuelu District, Changsha, Hunan, China 410205 Tel.: +86 13521316621 Email: [email protected]

TCB Authority to Act as Agent Number: MS-0045317 Revision: 0 Effective date: Oct 8, 2021 Page 1 of 1 Authority to Act as Agent Date: 27 März 2023 TUV Rheinland of North America, Inc. 1279 Quarry Lane., Suite. A Pleasanton, CA 94566 To Whom It May Concern: I appoint TUV Rheinland (Shenzhen) Co., Ltd. to act as our agent in the preparation of this application for equipment certification. I certify that submitted documents properly describe the device or system for which equipment certification is sought. I also certify that each unit manufactured, imported or marketed, as defined in the FCC or Industry Canada’s regulations will have affixed to it a label identical to that submitted for approval with this application. For instances where our authorized agent signs the application for certification on our behalf, I acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by TUV Rheinland Group, still resides with Sinocare Inc. / 11 Qingshan West Road, Yuelu District, Changsha, China For TCB applications, We certify that we are not subject to denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 862. Further, no party, as defined in 47 CFR 1.2002 (b), to the application is subject to denial of federal benefits, that includes FCC benefits. Thank you, Agency Agreement Date: 12 Months Agreement is valid for 12 months from the above date. By: __________________________ Jiangfeng Fei (Signature) (Print name) Director of CGM Department Tel:+8613521316621 (Title) (Telephone) On behalf of: Sinocare Inc. (Company Name)

（2） Transmitter Pack

RF ANT

DATA SHEET WIRELESS COMPONENTS Ceramic Chip Antenna ANT3216LL00R2400A 2.4 - 2.5 GHZ 3216 Serie s Product Specification – March 27, 2013 V.0 www.yageo.com Mar. 27, 2013 V0 WIRELESS COMPONENTS 2 6 Product specification Ceramic Chip Antenna FEATURES z Compact size z Omni-directional radiation z Tape & reel automatic mounting z Reflow process compatible z RoHS compliant APPLICATIONS z 2.4 GHz WiFi device z Bluetooth gadget z Zigbee device z ISM band equipment ORDERING INFORMATION All part numbers are identified by the series, packing type, material, size, antenna type, working frequency and packing quantity. PART NUMBER ANT 3216 L L00 R 2400A (1) (2) (3) (4) (5) (6) ( 1 ) PRODUCT ANT = Antenna ( 2 ) SIZE 3216 = 3.2 × 1.6 mm ( 3 ) ANTENNA TYPE L,F,A = Chip Antenna ( 4 ) SERIAL NO. L00 ( 5 ) PACKING TYPE R = Tape and Reel ( 6 ) WORKING FREQUENCY 2400 = 2.4GHz PHYCOMP CTC CAN4311712002453K 12NC 431171200245 www.yageo.com Mar. 27, 2013 V0 WIRELESS COMPONENTS 3 6 Product specification Ceramic Chip Antenna SPECIFICATION DESCRIPTION VALUE Working Frequency 2.4 - 2.5 GHz Bandwidth 160 MHz Polarization Linear Azimuth Beamwidth Omni-directional Peak Gain 5.05 dBi (Typ.) Impedance 50Ω Operating Temperature -40 ~105°C Maximum Power 1W Termination Ni / Sn (Environmentally-Friendly Leadless) Resistance to Soldering Heats 260°C , 10sec. NOTE 1. The specification is defined on Yageo evaluation board Ta b l e 1 O O U U T T L L I I N N E E S S YNH0010 Side ViewTop View Bot t om View T W L C S1S2 Fig. 1 Antenna outlines DIMENSIONS DIMENSION L (mm) 3.20 ±0.15 W (mm) 1.60 ±0.15 T (mm) 1.20 ±0.15 C (mm) 0.40 ±0.20 Table 2 Machinical Dimension TERMINAL NAME FUNCTION S1 Feeding Point S2 Soldering Point Table 3 Termination configuration www.yageo.com Mar. 27, 2013 V0 WIRELESS COMPONENTS 4 6 Product specification Ceramic Chip Antenna YNH0011 Bottom Layer Top Layer 2.5 2.0 3.5 0.4 Matching Circuit 1.8 Unit : mm Unit : mm 1030 18 Fig. 2 Outlook and dimension of evaluation board REFERENCE DESIGN OF EVALUATION BOARD Fig. 3 Details of soldering Pad www.yageo.com Mar. 27, 2013 V0 WIRELESS COMPONENTS 5 6 Product specification Ceramic Chip Antenna 2.0 2.13.0 f (GHz) Return loss (dB) −50 −30 −10 10 30 50 2.2 2.3 2.4 2.5 2.6 2.7 2.8 2.9 YNH0012 1 2 3 Fig. 4 Return loss ELECTRICAL PERFORMANCES YNH0013 Y X Z Z axle X axleY axle Gain (dBi) 5.00 − 0.00 − − 5.00 − − 10.00 − − 15.00 − − 20.00 − − 25.00 − − 30.00 − − 35.00 − Fig. 5 Radiation pattern Max gain = 5.05 dBi, at (180, 60) MEG (mean effective gain)= 0.45dBi Directivity (dB) = 7.15 Efficiency = -1.50dB, 70.74% Evaluation board and XYZ direction Marker data 1. 2.37GHz, -10dB 2. 2.45GHz, -27.3dB 3. 2.53GHz, -10dB www.yageo.com Mar. 27, 2013 V0 WIRELESS COMPONENTS 6 6 Product specification Ceramic Chip Antenna REVISION HISTORY REVISION DATE CHANGE NOTIFICATION DESCRIPTION Version 0 Mar. 27, 2013 - - New datasheet for Ceramic Chip Antenna, 2.4-2.5 GHz application, size 3216 series

Prüfbericht - Produkte Test Report - Products Prüfbericht-Nr.: Test report no.: CN22SJQA 002 Auftrags-Nr.: Order no.: 168393288 Seite 1 von 3 Page 1 of 3 Kunden-Referenz-Nr.: Client reference no.: N/A Auftragsdatum: Order date: 2022-10-08 Auftraggeber: Client: Sinocare Inc. 11 Qingshan West Road, Yuelu District, Changsha, Hunan, China 410205 Prüfgegenstand: Test item: TRUE VIE I3 Continuous Glucose Monitoring System Bezeichnung / Typ-Nr.: Identification / Type no.: I3 Auftrags-Inhalt: Order content: Test Report Prüfgrundlage: Test specification: CFR47 FCC Part 2: Section 2.1093 CFR47 FCC Part 1: Section 1.1310 KDB 447498 D01 General RF Exposure Guidance v06 Wareneingangsdatum: Date of sample receipt: 2022-10-26 Please refer to Photo Document Prüfmuster-Nr.: Test sample no: A003354144-009~011 A003363063-001~002 Prüfzeitraum: Testing period: 2022-11-04 – 2022-11-15 Ort der Prüfung: Place of testing: TÜV Rheinland (Shenzhen) Co., Ltd. Prüflaboratorium: Testing laboratory: TÜV Rheinland (Shenzhen) Co., Ltd. Prüfergebnis*: Test result*: Pass geprüft von: tested by: X Signed by: Breeze Jiang genehmigt von: authorized by: X Signed by: Lin Lin Datum: Date: 2022-12-07 Ausstellungsdatum: Issue date: 2022-12-07 Stellung / Position: Assistant Project Manager Stellung / Position: Reviewer Sonstiges / Other: FCC ID: 2AXH5002 Zustand des Prüfgegenstandes bei Anlieferung: Condition of the test item at delivery: Prüfmuster vollständig und unbeschädigt Test item complete and undamaged * Legende: P(ass) = entspricht o.g. Prüfgrundlage(n) F(ail) = entspricht nicht o.g. Prüfgrundlage(n) N/A = nicht anwendbar N/T = nicht getestet * Legend: P(ass) = passed a.m. test specification(s) F(ail) = failed a.m. test specification(s) N/A = not applicable N/T = not tested Dieser Prüfbericht bezieht sich nur auf das o.g. Prüfmuster und darf ohne Genehmigung der Prüfstelle nicht auszugsweise vervielfältigt werden. Dieser Bericht berechtigt nicht zur Verwendung eines Prüfzeichens. This test report only relates to the a. m. test sample. Without permission of the test center this test report is not permitted to be duplicated in extracts. This test report does not entitle to carry any test mark. TÜV Rheinland (Shenzhen) Co., Ltd. 1601 R&D Room, 1602-1604, 17-18F, Building 7 Site C, Vanke Cloud City Phase I, Xingke First Street, Xili Street, Xili Community, Nanshan District, Shenzhen 518052, P.R. China Mail: [email protected] · Web: www.tuv.com Prüfbericht - Produkte Test Report - Products CN22SJQA 002 Page 2 of 3 1. Radio Frequency Exposure RESULT: Pass Test standard : FCC Part 2: Section 2.1093 CFR47 FCC Part 1: Section 1.1310 KDB 447498 D01 General RF Exposure Guidance v06 1.1 Product Technical Information The EUT is a TRUE VIE I3 Continuous Glucose Monitoring System which supports Bluetooth Low Energy wireless technology. For details refer to the User Manual, Technical Description and Circuit Diagram. General Information of EUT Value Kind of Equipment TRUE VIE I3 Continuous Glucose Monitoring System Type Designation I3 Operating Voltage Battery operated (1.5Vdc, Alkaline Manganese Button Cell) FCC ID 2AXH5002 Technical Specification of Bluetooth Operating Frequency 2402-2480MHz Type of Modulation GFSK Data Rate 1Mbps Channel Number 40 channels Channel Separation 2MHz Antenna Type Ceramic Chip Antenna Antenna Number 1 Antenna Gain 5.05 dBi The type of wideband data transmission equipment FHSS Prüfbericht - Produkte Test Report - Products CN22SJQA 002 Page 3 of 3 1.2 Result: According to the KDB 447498 D1 v06 section 4.3.1: The maximum conducted output power for the EUT is 0.1dBm=1.02mW. The SAR Exclusion Threshold Level for 1-g extremity SAR: = 3.0 * (min. test separation distance, mm) / sqrt(freq. in GHz) = 3.0 * 5 / sqrt (2.480) mW = 9.53 mW Since the max. conducted output power is well below the SAR low threshold level, so the EUT is considered to comply with SAR requirement without testing.

Prüfbericht - Produkte Test Report - Products Prüfbericht-Nr.: Test report no.: CN22SJQA 001 Auftrags-Nr.: Order no.: 168393288 Seite 1 von 18 Page 1 of 18 Kunden-Referenz-Nr.: Client reference no.: N/A Auftragsdatum: Order date: 2022-10-08 Auftraggeber: Client: Sinocare Inc. 11 Qingshan West Road, Yuelu District, Changsha, Hunan, China 410205 Prüfgegenstand: Test item: TRUE VIE I3 Continuous Glucose Monitoring System Bezeichnung / Typ-Nr.: Identification / Type no.: I3 Auftrags-Inhalt: Order content: Test Report Prüfgrundlage: Test specification: CFR47 FCC Part 15: Subpart C Section 15.247 CFR47 FCC Part 15: Subpart C Section 15.209 Wareneingangsdatum: Date of sample receipt: 2022-10-26 Please refer to Photo Document Prüfmuster-Nr.: Test sample no: A003354144-009~011 A003363063-001~002 Prüfzeitraum: Testing period: 2022-11-04 – 2022-11-15 Ort der Prüfung: Place of testing: TÜV Rheinland (Shenzhen) Co., Ltd. Prüflaboratorium: Testing laboratory: TÜV Rheinland (Shenzhen) Co., Ltd. Prüfergebnis*: Test result*: Pass geprüft von: tested by: X Signed by: Breeze Jiang genehmigt von: authorized by: X Signed by: Lin Lin Datum: Date: 2023-03-31 Ausstellungsdatum: Issue date: 2023-03-31 Stellung / Position: Assistant Project Manager Stellung / Position: Reviewer Sonstiges / Other: FCC ID: 2AXH5002 Zustand des Prüfgegenstandes bei Anlieferung: Condition of the test item at delivery: Prüfmuster vollständig und unbeschädigt Test item complete and undamaged * Legende: 1 = sehr gut 2 = gut 3 = befriedigend 4 = ausreichend 5 = mangelhaft P(ass) = entspricht o.g. Prüfgrundlage(n) F(ail) = entspricht nicht o.g. Prüfgrundlage(n) N/A = nicht anwendbar N/T = nicht getestet * Legend: 1 = very good 2 = good 3 = satisfactory 4 = sufficient 5 = poor P(ass) = passed a.m. test specification(s) F(ail) = failed a.m. test specification(s) N/A = not applicable N/T = not tested Dieser Prüfbericht bezieht sich nur auf das o.g. Prüfmuster und darf ohne Genehmigung der Prüfstelle nicht auszugsweise vervielfältigt werden. Dieser Bericht berechtigt nicht zur Verwendung eines Prüfzeichens. This test report only relates to the a. m. test sample. Without permission of the test center this test report is not permitted to be duplicated in extracts. This test report does not entitle to carry any test mark. TÜV Rheinland (Shenzhen) Co., Ltd. 1601 R&D Room, 1602-1604, 17-18F, Building 7 Site C, Vanke Cloud City Phase I, Xingke First Street, Xili Street, Xili Community, Nanshan District, Shenzhen 518052, P.R. China Mail: [email protected] · Web: www.tuv.com jjj Prüfbericht - Produkte Test Report - Products Prüfbericht - Nr.: Test Report No.: CN22SJQA 001 Seite 2 von 18 Page 2 of 18 Test Summary 5.1.1 ANTENNA REQUIREMENT RESULT: Pass 5.1.2 MAXIMUM PEAK CONDUCTED OUTPUT POWER RESULT: Pass 5.1.3 CONDUCTED POWER SPECTRAL DENSITY RESULT: Pass 5.1.4 6DB BANDWIDTH RESULT: Pass 5.1.5 99% BANDWIDTH RESULT: Pass 5.1.6 CONDUCTED SPURIOUS EMISSIONS MEASURED IN 100 KHZ BANDWIDTH RESULT: Pass 5.1.7 RADIATED SPURIOUS EMISSION RESULT: Pass Prüfbericht - Produkte Test Report - Products Prüfbericht - Nr.: Test Report No.: CN22SJQA 001 Seite 3 von 18 Page 3 of 18 Contents 1 GENERAL REMARKS ........................................................................................................................... 4 1.1 COMPLEMENTARY MATERIALS ............................................................................................................ 4 2 TEST SITES ........................................................................................................................................ 5 2.1 TEST FACILITIES ................................................................................................................................. 5 2.2 LIST OF TEST AND MEASUREMENT INSTRUMENTS................................................................................. 5 2.3 TRACEABILITY .................................................................................................................................... 6 2.4 CALIBRATION ..................................................................................................................................... 6 2.5 MEASUREMENT UNCERTAINTY............................................................................................................. 6 2.6 LOCATION OF ORIGINAL DATA ............................................................................................................. 6 2.7 STATUS OF FACILITY USED FOR TESTING ............................................................................................. 6 3 GENERAL PRODUCT INFORMATION ...................................................................................................... 7 3.1 PRODUCT FUNCTION AND INTENDED USE ............................................................................................. 7 3.2 RATINGS AND SYSTEM DETAILS .......................................................................................................... 7 3.3 INDEPENDENT OPERATION MODES ...................................................................................................... 8 3.4 NOISE GENERATING AND NOISE SUPPRESSING PARTS ......................................................................... 8 3.5 SUBMITTED DOCUMENTS..................................................................................................................... 8 4 TEST SET-UP AND OPERATION MODES ................................................................................................ 9 4.1 PRINCIPLE OF CONFIGURATION SELECTION ......................................................................................... 9 4.2 TEST OPERATION AND TEST SOFTWARE .............................................................................................. 9 4.3 SPECIAL ACCESSORIES AND AUXILIARY EQUIPMENT ............................................................................ 9 4.4 COUNTERMEASURES TO ACHIEVE EMC COMPLIANCE ..........…

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Prüfbericht - Produkte Test Report - Products Appendix B CN22SJQA 001 Page 1 of 2 Appendix B: Photographs of the Test Set-Up APPENDIX B: PHOTOGRAPHS OF THE TEST SET-UP ....................................................................................................... 1 PHOTOGRAPH 1: SET-UP PHOTO FOR RADIATED SPURIOUS EMISSION, BELOW 1GHZ ......................................................................... 2 PHOTOGRAPH 2: SET-UP PHOTO FOR RADIATED SPURIOUS EMISSION, ABOVE 1GHZ ......................................................................... 2 Prüfbericht - Produkte Test Report - Products Appendix B CN22SJQA 001 Page 2 of 2 Photograph 1: Set-up photo for Radiated Spurious Emission, Below 1GHz Photograph 2: Set-up photo for Radiated Spurious Emission, Above 1GHz