2AHV9-UB2550UbiqVue 2A Wearable Biosensor using UbiqVue 2A Wireless Patient Monitoring System

UbiqVue TM 2AWirelessPatientMonitoringSystem (UX2550)UserManual ii UbiqVue TM 2AWirelessPatientMonitoringSystem|UserManual Publishedon:02Feb,2023 DocumentID:1000001974A Copyright Copyright©2023LifeSignals,Inc.AllRightsReserved. ContainsinformationownedbyLifeSignals,Inc.and/oritsaffiliates.Donotcopy,store,transmitordiscloseto anythirdpartywithoutpriorwrittenpermissionfromLifeSignals,Inc..Otherproductandcompanynamesmay betrademarksorregisteredtrademarksofothercompanies,andarethepropertyoftheirowners.Theyare usedonlyforexplanation,withoutintenttoinfringe. Patentprotectionandtrademarks LifeSignals®,LifeSignals,LifeSignalsEnabled,UbiqVue TM 2AWirelessPatientMonitoringSystemare trademarksofLifeSignals,Inc..Allproductnames,brands,logos,andtrademarksarethepropertyoftheir respectiveowners.Formoreinformation,seehttps://lifesignals.com/patents/ Intendedpurpose ThismanualdescribestheintendeduseoftheUbiqVue TM 2AWirelessPatientMonitoringSystemand observanceofthemanualisaprerequisiteforproperperformance,correctoperationandensurespatientand usersafety.Theintendedaudienceareclinicalprofessionalswhoareexpectedtohaveaworkingknowledge ofmedicalprocedures,practices,andterminologytoprovidepatientcare. Safetynotices Thefollowingsafetynoticeformatsareusedinthismanual.Safetynoticesareusedatthestartofsectionsor embeddedinoperatinginstructions. Ensureyoufullyunderstandandcomplywiththenoticesinthismanual. Warning Indicatesapotentialhazardoussituationwhich,ifnotavoided,couldresult inseriousinjury. Caution Indicatesapotentiallyhazardoussituationwhich,ifnotavoided,could resultinminorormoderateinjury. Notice Indicatesanimportantsituationwhich,ifnotavoided,mayseriouslyimpair operations. Tip Additionalinformationrelatingtothecurrentsection. Contactaddress LifeSignals,Inc. 426SHillviewDr., Milpitas,CA95035,USA SupportEmail:[email protected] Website:www.lifesignals.com CustomerService(USA):+1510.770.6412 UbiqVue TM 2AWirelessPatientMonitoringSystem|UserManual iii Glossary TermDefinition AlertCombinationofphysiological(clinical)andtechnicalalarm conditionsthatgeneratealertnotifications. BiosensorSingle-usemedicalwearabledevicethatacquiresand wirelesslytransmitspatient'sphysiologicalsignalstopaired UbiqVue™PatientRelayApporMPRdevice. BiosensorIDAfiveorseven-characteralphabeticalcode(uniqueidentifier) printedontheBiosensorandBiosensorpackaging. CentralServerManagesthedecryption,uploadingandstorageofBiosensor datafrommultipleauthenticatedrelaydevices.Allowsaccess toderivedparameterandBiosensordatausingtheUbiqVue™ ActiveMonitoringPortal.Cansendalertnotificationsto configuredusersthroughE-mail,SMS,orWhatsAppfromany clinical(physiological),technical,ormanualalertconditions. ClinicalFacilityOrganizationthatprovideshealthcareservicesandutilizes monitoringservicee.g.hospitalormedicalfacility. ClinicalFacilityAdministrator (CFA) Multiplefunctionsassociatedwithoverallsetupand configurationofActiveMonitoringPortalfortheclinical facility.Forexample,createsassignroles (SC/Clinician/Physician)fornewusers,resetuserspassword, selectspatientidentificationmethodforthefacility(MRNor PatientID),createslocation/medicalgroupsandconfigures alertdefaultsforentireclinicalfacility. DenotesClinicianrole-canadmitpatients,assignnew patientstoanylocationormedicalgroup,set/editdefault alertlimitsforanyassignedpatients,viewdataand acknowledgealertsofmultipleassignedpatients,enter manualevents,BPvaluesandperformEWSusingtheActive MonitoringPortal. DenotesPhysicianrole-canset/editdefaultalertlimitsfor anyassignedpatients,viewdataandacknowledgealertsof multipleassignedpatientsorpatientgroups,entermanual events,BPvaluesandperformEWSusingtheActive MonitoringPortal. DenotesSupervisoryClinician(SC)role-viewallpatientsor patientgroupsintheclinicalfacility,acknowledgealertsand performEWSforallpatientsinclinicalfacilityusingthe ActiveMonitoringPortal.SCcanset/editdefaultalarmsfor specificgroupsofpatients,assignpatientsorpatientgroups touserwithClinicianorPhysicianroleandviewdischarged patients. iv UbiqVue TM 2AWirelessPatientMonitoringSystem|UserManual TermDefinition DenotesAdministrator(CFA)role-Multiplefunctions associatedwithoverallsetupandconfigurationofActive MonitoringPortal.Forexample,createsassignroles (SC/Clinician/Physician)fornewusers,resetuserspassword, selectspatientidentificationmethodforthefacility(MRNor PatientID),createslocation/medicalgroups,configuresalert defaultforentireclinicalfacility. DenotesadditionaleditfunctionalityforSC/Clinician/Phys- icianroles. EarlyWarningScoreEarlyWarningScore(EWS)basedontheNationalEarlyWarn- ingSystem(NEWS)isatoolusedtosupporttherecognition andresponsetoadeterioratingpatient.Itisacomposite scoreofsixbedsidevitalparameters:pulserate,bloodpres- sure(BP),oxygensaturation(SpO 2 ),bodytemperature,res- piratoryrate,andlevelofconsciousness. GuestPhysicianExternalorreferralhealthcareprofessionalwhoisnotauser withintheclinicalfacilityandisprovidedwithaccesstoview specificpatientdataintheActiveMonitoringPortal. MonitoringDashboardMulti-Patientmonitoringwindowdisplayscontinuous physiologicalparameters,waveformsandalertstatusof assignedpatientstoauthorizedclinicalpersonnelfornear- realtimeactivemonitoring.Userscanselectmultiplepatient tilevieworsinglepatientzoomview/hybridviewusing availablefiltersettings. Multi-PatientRelay(MPR)Multi-PatientRelaynetworktransmitsdatafrommultiple Biosensorsviahardwaredevices(e.g.wirelessaccesspoints, computer)toUbiqVue™CentralServer. SinglePatientRelay(SPR)Relay(mobile)devicefortransmissionofapatient'sBiosensor datatoUbiqVue™CentralServer. ServiceProviderAdministrator (SPA) Thehighestleveluserthatmanagesadministrationof multipleclinicalfacilitiesandhospitalgroups. UbiqVue™ActiveMonitoring Portal Web-basedapplicationprovidesclinicalstaffremoteaccess, viathein-builtMonitoringDashboard,topatientnearreal- timephysiologicaldata(Biosensorandderived), demographics,EWSscore,trendsandalertstatus. Contents 1Safetyinformation1 1.1Intendeduseandindicationsforuse1 1.2Contraindications1 1.3Warnings2 1…

Text truncated - open the document above for the full version.

Certification Designating a U.S. Agent for Service of Process Date: 04-13-2023 Ref: Section 2.911(d)(7) filing FCC ID: 2AHV9-UB2550 To: Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 USA LifeSignals, Inc. (“the applicant”) as required by section 2.911(d)(7), will also serve as the agent for service of process for the above referenced FCC ID. The applicant acknowledges that they will maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. The applicant further acknowledges their responsibility to inform the FCC whenever the agent information changes. Contact Person: Saravanan Balasubramanian Company Name: LifeSignals, Inc. Company Address: 426 S Hillview Dr., Milpitas, CA 95035. USA. Email: [email protected] Sincerely yours, Contact Person: Saravanan Balasubramanian Company Name: LifeSignals, Inc. Company Address: 426 S Hillview Dr., Milpitas, CA 95035. USA. Email: [email protected]

Attestation Statements Not Covered Entity Applicant & Not Covered Equipment To: Federal Communications Commission Date: 04-13-2023 7435 Oakland Mills Road, Columbia, MD 21046, USA Ref: Information Required by Section 2.911(d)(5)(i) & (ii) FCC ID: 2AHV9-UB2550 LifeSignals, Inc. (“the applicant”) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List, established pursuant to § 1.50002 of reference chapter, as an entity producing “covered” communication equipment. The equipment for which authorization is sought is not “covered” telecommunications equipment and video surveillance equipment produced by entities identified on the Commission’s Covered List that prohibited from receiving an equipment authorization pursuant to section § 2.903 of the FCC rules. Sincerely yours, Applicant Signature Printed Name: Saravanan Balasubramanian Title: VP- Global, Medical Technology & Regulatory Operations Address: 426 S Hillview Dr., Milpitas, CA 95035. USA Tel.: +1 510 770 6412 Ext 4 Email: [email protected]

Attestation Statements Not Covered Equipment To: Federal Communications Commission Date: 04-13-2023 7435 Oakland Mills Road, Columbia, MD 21046, USA Ref: Information Required by Section 2.911(d)(5)(i) filing FCC ID: 2AHV9-UB2550 LifeSignals, Inc. (“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: Saravanan Balasubramanian Title: VP – Global, Medical Technology & Regulatory Operations Address: 426 S Hillview Dr., Milpitas, CA 95035. USA Tel.: +1 510 770 6412 Ext 4 Email: [email protected]

TCB Authority to Act as Agent Number: MS-0045317 Revision: 0 Effective date: Oct 8, 2021 Page 1 of 1 The following is a sample Agency Request letter, which needs to be completed on company letterhead, signed by an authorized Applicant/Agent, and submitted to TÜV Rheinland. Authority to Act as Agent Date:April 25, 2023 TUV Rheinland of North America, Inc. 1279 Quarry Lane., Suite. A Pleasanton, CA 94566 To Whom It May Concern: I appoint Mr. Raghavendra Kulkarni of TUV Rheinland India Ltd. 27/B, 2nd cross, Electronic City, Phase 1 Bangalore – 560 100. INDIA 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 LifeSignals. Inc. 426 S Hillview Dr, Milpitas, CA 95035 USA. 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: ___April 25, 2023________________ Agreement is valid for 12 months from the above date. By: __________________________ Saravanan Balasubramanian (Signature) (Print name) VP-Medical Technology & Regulatory +1.510.770.6412 (Title) Operations (Telephone) On behal f of: ___LifeSignals, Inc._____________ (Company Name)

Date: 25 th April 2023 Federal Communications Commission Authorization and Evaluation division Subject: Confidentiality Request for UB2550 FCC ID: 2AHV9-UB2550 Pursuant to 47 CRF 0.457(d) and 0.459, LifeSignals, Inc. requests that a part of the subject application be held confidential. Type of Confidentiality requested Exhibit Type File name Long-Term Block Diagram DHF09-BLK Long-Term Antenna Design Specification DHF09-ADS Long-Term Schematics DHF09-SCH Long-Term Operational Description 2A Operational Description Short-Term User Manual DHF09-LBL-001 Short-Term Internal Photo 2A Internal Pic Short-Term External Photo 2A External Pic The above materials contain proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to the applicant and provide unjustified benefits to its competitors. Sincerely, Name: Saravanan Balasubramanian Title: Vice President - Medical Systems & Regulatory Affairs Phone: +15107706412

LifeSignals, Inc., 426 S Hillview Drive, Milpitas, CA 95035, USA +1 510.770.6412 [email protected] www.lifesignals.com MODEL DECLARATION LETTER To whomsoever it may concern Sub: Model declaration of UbiqVue TM 2A Wireless Patient Monitoring System. Product Name: UbiqVue TM 2A Wireless Patient Monitoring System Model Number: UX2550 This is to notify that UbiqVue TM 2A Wearable Biosensor (UB2550) is a component of UbiqVue TM 2A Wireless Patient Monitoring System (UX2550) Note: UbiqVue TM 2A Wearable Biosensor (UB2550) is a hardware component of the system that acquires & pre-processes two channels of ECG signals, TTI respiration signals, PPG waveform, ambient temperature, Thermistor data (based on Skin temperature), accelerometer data, SpO2 and pulse rate data and transmits to Single Patient Relay (SPR) or Multi Patient Relay (MPR) device. While UbiqVue TM 2A Wireless Patient Monitoring System (UX2550), receives multiple Biosensor data and further processes to derive Heart Rate, Respiration Rate, Skin temperature, Body temperature, HRV & R-R interval. Sincerely, Saravanan Balasubramanian VP-Global, Medical Technology & Regulatory Operations LifeSignals, Inc. USA.

4 Return Loss and Gain in Passive Mode: {Summary} 2401Mhz 2448Mhz 2495Mhz Return loss -13.3dB -7.9dB -5.4dB Avg Gain -3.6dBi -4.7dBi -5.2dBi Peak Gain 3.6dBi 2.6dBi 2.2dBi {Return Loss} {2401Mhz_Gain} DHF09-ADS Antenna Design SpecificationRev. A Pg. 4 of 6 LifeSignals, Inc. 426 S Hillview Dr, Milpitas, CA 95035, USA {2448Mhz_Gain} {2495Mhz_Gain} 5 Measurement Setup Diagram and Details of Equipment Used: Equipment Manufacturer Model Name Serial number Firmware Version Calibration Due Date Periodicity Used for test Items Network Analyser Agilent E5071C MY46107631 A.10.05 2023.08.29 Yearly Antenna Measurements Horn Antenna Mutronics MU7640V 0509086 - - - Antenna Measurements 3m Fully anechoic Chamber Airlink 3D Anechoic Chamber - - - - Antenna Measurements DHF09-ADS Antenna Design SpecificationRev. A Pg. 5 of 6 LifeSignals, Inc. 426 S Hillview Dr, Milpitas, CA 95035, USA

Produkte Products www.tuv.com EUT External Photos Reference Test Report No: IN23ISA3 001 ULR-TC5688233000000040F Seite 1 von 1 Page 1 of 1 EUT External Photos EUT Front view ****End of EUT External Photos****

Company: LifeSignals, Inc. Condential Property of LifeSignals, Inc. Title: SAP Part Number: Grade: Label Material: Pre Printing: Label Size: 2A Biosensor L0 Label 21.5 x 49 mm 1000001947A ROHS, Medical 21.5 x 49 x 0.1 mm Note: Label Artwork Specification Pre Printing Spec:- (Label outline shall not be printed)Post Printing Spec:- (Label outline shall not be printed) Printer : Offset Printing Ink Manufacturer : Tau Ink Part Number : 1690240-47, Black, Cyan, Magenta, Yellow, White, Green, Orange, Violet Color : Multi Color RGB Do not scale / modify content / change font / modify color / change position / change print material / change print process UX2550_IN UX2550_US 000000 00549F Color Table A0A0A0 32AAE0 0BBEF Manufacturer : Hanel Material : PET Film 25 μm Yellow Release Paper 130g Paper Part Number : PET Film 25μm(±2 μm) - KST1028 Adhesive Part Number : Acrylic Co-polymer, 800 g.f/25mm More Condential Property of LifeSignals, Inc. Post Prin ting: Printer : Zebra ZT410 (600 DPI) Ribbon : ARMOR AXR7+ BLACK Color : Black Pairing ID: XXXXX Five digit alpha numeric random pairing ID assigned by the software Current Revision # Current Revision to be Used: Condential Property of LifeSignals, Inc. Current Revision # is mentioned in the post -print of each label next to the PN #. Model # UX2550_IN LBL1 UX2550_US LBL1 Details of Revision Date of Revision Revision Done by Drawing Revision Details: Condential Property of LifeSignals, Inc. Drawing Revision DWGREV1 New release of UB2550 Biosensor label with ‘single biosensor label’ Die-cut. 17 Nov 2022PM DWGREV2 UbiqVue by LifeSignals Logo updated. LS Inc., name added as distributor. 22 Nov 2022PM DWGREV3 Label Material and Pre-print ink specs updated. 16 Feb 2023PM Characters shown in RED color are to be replaced during printing at the assembly line Characters shown in RED and PURPLE colors are to be post-printed in BLACK DHF09-LBL-002 Device Labels - UB2550 Issued by: Engg Effective Date: 17-02-2023 Rev. D Pg. 1 of 7 Approved: 17-02-2023 16:08 - John Layton - VP MarketingApproved: 16-02-2023 16:05 - Saravanan BApproved: 16-02-2023 09:24 - Krithika Balu - Quality Assurance Label Artwork Specification Pre Printing Spec:- (Label outline shall not be printed) Post Printing Spec:- Use for UX2550_INUse for UX2550_US Company: LifeSignals, Inc. Condential Property of LifeSignals, Inc. Title: SAP Part Number: Grade: Label Material: Pre Printing: Label Size: Biosensor Box L1 Label PP Film 100x80mm 1000001513B ROHS, Medical Manufacturer : HY Material : White, Matt, PolyPropylene Paper Part Number : HY80, 0.08mm Adhesive Part Number : W270, Acrylic, 0.02mm 100 x 80 x 0.1 mm, Corner Radius 2.0 mm Printer : Offset Printing Ink Manufacturer : KSI Ink Part Number : BEST HV Black, Cyan, Magenta, Yellow Anti fadding enhancer : BEST UV Reducer Color : Multi Color RGB Do not scale / modify content / change font / modify color / change position / change print material / change print process Note: 000000 00549F Color Table ED2124 0BBEF Die Cut spec is same as 1000001533C DHF09-LBL-002 Device Labels - UB2550Rev. D Pg. 2 of 7 Expiry date: Manufacturing date: YYYY-MM-DD Replace with Year, Month, Date ZZZZ-MM-DD Replace with Year, Month, Date (13 Months from the Manufacturing Date) Condential Property of LifeSignals, Inc. Data Matrix Format:ECC 200, 32x32 Pixels, 10.837 x 10.837 mm Print size, 75 DPI Data Matrix Content: Serial Number: Post Printing: +B353UB25501/$$+7BIV0ASLLNNNNNXXXXX/16DYYYYMMDD/14DZZZZMMDD Printer : Zebra ZT410 (600 DPI) Ribbon : ARMOR AXR7+ BLACK Color : Black + GUDID Starting Character B353 LIC of LifeSignals, Inc. UB2550 Part number of the product 1 GUDID Packaging Level /$$+7 GUDID Structure Sub Header for Serial Number BIV Build Information 0A Product Revision Number S Manufacturing Site ID LL Assembly Line Number within the site NNNNN Alpha Numeric Continuous running serial number XXXXX Five Digit Unique Pairing ID /16D GUDID Structure Sub Header for Manufacturing date YYYYMMDD Manufacturing Date Code /14D GUDID Structure Sub Header for Expiration date ZZZZMMDD Expiration Date Code Manufacturing Site ID: S List of Site IDs are defined below 0 Dreamtech, Cheonan, Korea 1 Dreamtech, Bac Ninh, Vietnam Assembly Line Number: Unique Serial Number: LL Two digit Assembly Line number, assigned by the manufacturing site NNNNN Five digit alpha numeric continuous running serial number assigned by the software Pairing ID: XXXXX Five digit alpha numeric random pairing ID assigned by the software Characters shown in RED color are to be replaced during printing at the assembly line Build Information: BIV List of Build Information defined below 000 Mass Production 100 Pilot Build 2?V Proto / Engineering Sample Build (? to be replaced with Proto Sub Revision) (V to be replaced with custom char from Purchase Order) 5 Series Part Number: EEEE Replace with the full 5 series part number 7 Series Part Number: CCCC Replace with the full 7 series part number Characters shown in RED and PURPLE colors are to be post-printed in BLACK Current Revision # Current Revision to be Used: Condential Property of LifeSignals, Inc. Current Revision # is mentioned in the post -print of each label next to the PN #. Model # UX2550_IN LBL1 UX2550_US LBL1 Details of Revision Date of Revision Revision Done by Drawing Revision Details: Condential Property of LifeSignals, Inc. Drawing Revision DWGREV1 Initial release. “Refer to instruction manual”, symbol M002 of ISO 7010 added to the pre-print specication. Typo xed in post-print of LS India address. Phone number of LS Inc. removed from Manufacturer Address. 28 Oct 2022PM DWGREV2 UbiqVue by LifeSignals logo updated, address edited to remove ‘Phone’ and ‘Email’ descriptions, and ‘2A Wearable Biosensor’ updated. 22 Nov 2022PM DWGREV3 Expiry date is updated from 1 year to 13 months from date of manufacturing. 16 Dec 2022PM DWGREV4 16 Feb 2023PM DHF09-LBL-002 Device Labels - UB2550Rev. D Pg. 3 of 7 Label Artwork Specification Pre Printin…

Text truncated - open the document above for the full version.

Produkte Products www.tuv.com EUT Internal Photos Reference Test Report No: IN23ISA3 001 ULR-TC5688233000000040F Seite 1 von 2 Page 1 of 2 EUT Internal Photos EUT Internal front Image EUT Internal Rear Image Produkte Products www.tuv.com EUT Internal Photos Reference Test Report No: IN23ISA3 001 ULR-TC5688233000000040F Seite 2 von 2 Page 2 of 2 EUT Internal Module Image RF module shield open ****End of EUT Internal Photos****

Prüfbericht – Produkte Test Report - Products Prüfbericht-Nr.: Test report no.: IN23ISA3 001 ULR-TC5688233000000040F Auftrags-Nr.: Order no.: 146662795 190 Seite 1 von 3 Page 1 of 3 Kunden-Referenz-Nr.: Client reference no.: 2283344 Auftragsdatum: Order date: 2022.02.16 Auftraggeber: Client: LifeSignals, Inc. 426 S Hillview Dr, Milpitas, CA 95035, USA Prüfgegenstand: Test item: UbiqVue 2A Wearable Biosensor using UbiqVue 2A Wireless Patient Monitoring System Bezeichnung.: Identification .: UB2550/UX2550 Auftrags-Inhalt: Order content: Maximum Permissible Expsoure Prüfgrundlage: Test specification: FCC 1.1310 Wareneingangsdatum: Date of sample receipt: 2022.05.16 Prüfmuster-Nr & Serien-Nr.: Test sample no & serial no.: A003068621-001 A003068621-002 2021061001 Prüfzeitraum: Testing period: 2022.05.20 - 2022.06.15 Ort der Prüfung: Place of testing: Wireless laboratory, Bangalore Prüflaboratorium: Testing laboratory: TÜV Rheinland (India) Pvt.Ltd., 27/B, 2nd Cross, Electronic City Phase1 Bangalore -560 100, India FCC Test site registration number: 496599 ISED Test site registration number: 3466E-1 Prüfergebnis*: Test result*: Pass geprüft von: tested by: genehmigt von: authorized by: Datum: Date: 2022.06.16 Ausstellatum: Issue date: 2023.05.08 Stellung / Position: Yogesh V Engineer Stellung / Position: Madhu K N Senior Engineer Sonstiges / Other: FCC ID: 2AHV9-UB2550 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 (India) Pvt. Ltd, Plot No.27/B, 2nd Cross, Electronic city, Industrial Area, Phase I, Hosur Road Bangalore-560 100, India Mail: [email protected] ∙ Web: www.ind.tuv.com Produkte Products www.tuv.com Prüfbericht - Nr.: Test Report No.: Reference Test Report No: IN23ISA3 001 ULR-TC5688233000000040F Seite 2 von 3 Page 2 of 3 RF Exposure Report Following FCC KDB 447498 D01 General SAR test exclusion guidelines The corresponding SAR exclusion threshold condition, listed below: 1) The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation Distances ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/ (min. test separation distance, mm)] · [√f (GHz)] ≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g. Extremity SAR, where  f(GHz) is the RF channel transmit frequency in GHz  Power and distance are rounded to the nearest mW and mm before calculation.  The result is rounded to one decimal place for comparison The test exclusions are applicable only when the minimum test separation distance is ≤ 50 mm and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separation distance is < 5 mm, a distance of 5 mm according to 5) in section 4.1 is applied to determine SAR test exclusion(447498 D01 General RF Exposure Guidance v06) 2) At 100 MHz to 6 GHz and for test separation distances > 50 mm, the SAR test exclusion threshold Is determined according to the following  [Power allowed at numeric threshold for 50 mm in step 1) + (test separation distance - 50 mm)·( f(MHz)/150)] mW, at 100 MHz to 1500 MHz  [Power allowed at numeric threshold for 50 mm in step 1) + (test separation distance - 50 mm)·10] mW at > 1500 MHz and ≤ 6 GHz 3) At frequencies below 100 MHz, the following may be considered for SAR test exclusion,  The power threshold at the corresponding test separation distance at 100 MHz in step 2) is multiplied by [1 + log(100/f(MHz))] for test separation distances > 50 mm and < 200 mm  The power threshold determined by the equation in a) for 50 mm and 100 MHz is multiplied by ½ for test separation distances ≤ 50 mm  SAR measurement procedures are not established below 100 MHz When SAR test exclusion cannot be applied, a KDB inquiry is required to determine SAR evaluation requirements for any test results to be acceptable. Produkte Products www.tuv.com Prüfbericht - Nr.: Test Report No.: Reference Test Report No: IN23ISA3 001 ULR-TC5688233000000040F Seite 3 von 3 Page 3 of 3 SAR Test Exclusion Thresholds Protocol: Wi-Fi 2.4GHz Exclusion calculation considering measured maximum power excluding antenna gain Frequency (GHz) Max.Power (dBm) Tune- up value Max.Power Including Tune-up Tolarence (dBm) Max.Power Including Tune-up Tolarence (mW) Minimum test separation distance (mm) SAR Test Exclusion Calculation Values 1-g Extremity SAR Test exclusion Threshold 2.412 1.32 1 2.32 1.7060 5 0.529930172 3 Protocol: Bluetooth low energy (BLE) Exclusion calculation considering measured maximum power excluding antenna gain Frequency (GHz) Max.Power (dBm) Tune- up value Max.Power Including Tune-up Tolarence (dBm) Max.Power Including Tune-up Tolarence (mW) Minimum test separation distance (mm) SAR Test Exclusion Calculation Values 1-g Extremity SAR Test exclusion Threshold 2.402 7.08 1 8.08 6.4268 5 1.992124594 3 From above table calculation the EUT is exempted from routine SAR evaluation Note: 1. SAR exclusion threshold is calculated using condition1 formulas. 2. Transmitting power level is taken from the RF test report IN23ISA3 001 / ULR-TC5688233000000040F ****END OF TEST REPORT*****

Prüfbericht – Produkte Test Report - Products Prüfbericht-Nr.: Test report no.: IN23ISA3 001 ULR-TC5688233000000040F Auftrags-Nr.: Order no.: 146662795 190 Seite 1 von 112 Page 1 of 112 Kunden-Referenz-Nr.: Client reference no.: 2283344 Auftragsdatum: Order date: 2022.02.16 Auftraggeber: Client: LifeSignals, Inc. 426 S Hillview Dr, Milpitas, CA 95035, USA Prüfgegenstand: Test item: UbiqVue 2A Wearable Biosensor using UbiqVue 2A Wireless Patient Monitoring System Bezeichnung.: Identification .: UB2550/UX2550 Auftrags-Inhalt: Order content: Testing and issue of Test Report and Grant Certificate Prüfgrundlage: Test specification: FCC Part 15 Subpart C 15.247, 15.205 &15.209 Wareneingangsdatum: Date of sample receipt: 2022.05.16 Prüfmuster-Nr & Serien-Nr.: Test sample no & serial no.: A003068621-001 A003068621-002 2021061001 Prüfzeitraum: Testing period: 2022.05.20 - 2022.06.15 Ort der Prüfung: Place of testing: Wireless laboratory, Bangalore Prüflaboratorium: Testing laboratory: TÜV Rheinland (India) Pvt.Ltd., 27/B, 2nd Cross, Electronic City Phase1 Bangalore -560 100, India FCC Test site registration number: 496599 ISED Test site registration number: 3466E-1 Prüfergebnis*: Test result*: Pass geprüft von: tested by: genehmigt von: authorized by: Datum: Date: 2022.06.16 Ausstellatum: Issue date: 2023.05.08 Stellung / Position: Yogesh V Engineer Stellung / Position: Madhu K N Senior Engineer Sonstiges / Other: FCC ID: 2AHV9-UB2550 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 (India) Pvt. Ltd, Plot No.27/B, 2nd Cross, Electronic city, Industrial Area, Phase I, Hosur Road Bangalore-560 100, India Mail: [email protected] ∙ Web: www.ind.tuv.com Produkte Products www.tuv.com Prüfbericht - Nr.: Test Report No.: IN23ISA3 001 ULR-TC5688233000000040F Seite 2 von 112 Page 2 of 112 1 Alle eingesetzten Prüfmittel waren zum angegebenen Prüfzeitraum gemäß eines festgelegten Kalibrierungsprogramms unseres Prüfhauses kalibriert. Sie entsprechen den in den Prüfprogrammen hinterlegten Anforderungen. Die Rückverfolgbarkeit der eingesetzten Prüfmittel ist durch die Einhaltung der Regelungen unseres Managementsystems gegeben. Detaillierte Informationen bezüglich Prüfkonditionen, Prüfequipment und Messunsicherheiten sind im Prüflabor vorhanden und können auf Wunsch bereitgestellt werden. The equipment used during the specified testing period was calibrated according to our test laboratory calibration program. The equipment fulfils the requirements included in the relevant standards. The traceability of the …

Text truncated - open the document above for the full version.