2BUQV-HS-OT10XVideo otoscope

VIDEOOTOSCOPE VIDEOOTOSCOPE Pleasereadthismanualbeforeusethedevicetoensureproperaction duringuseofthesemedicalgradeinstruments.Onlytrainedpractitionersof thesedevicescanusethisproduct.Afterreading,pleasekeepthismanualin asafeplaceincaseyouneedtoconsultit.Withstableperformanceandplug andplay,thisproductisthebestinstrumentfordiagnosis,teachinginENT. SAFETYINFORMATION Basicsafetymeasuresshouldalwaysbefollowedincludingthewarningsand cautionslistedinthisinstructionmanual. Warnings&Cautions: ●Pleasedon’tusethedeviceexposedtoflammablegas. ●Protectalldevicepartsfromwater,moisture,impact,dropping,direct sunlight,heatandfire,freezing,wind,dust,fumes,oils,perfumes,leaking batteries/corrosivesubstances,childrenandanimals. ●Pleasedon’ttouchthecameralensdirectly,ortouchitwithasharpobject. ●Thisdevicehasnosparelightbulbtoreplace. ●Donotusecorrosiveorpolishingsolutiontocleantheinstrument. ●Pleasedonotsharewithhumansandanimals,andplacetheinstrument outofreachofchildrenandanimals. ●Pleasedon’tdisassembleorrepairthedeviceorcomponents.Thewarranty willbeinvalidifthishasbeenattempted.Routinemaintenanceperthis manualisaccepted. ●Youcanrefertothismanualforroutinemaintenance。 ●Storetheinstrumentsinboxinadryroomatnormalroomtemperature. GENERALFEATURES ●Lightweightandcompact,easy-to-operateformfactor; ●Professionalopticallens,clearimagewithlittledistortion; ●Professionaluppercomputeroperationsoftware; ●1.28-inchdisplayandbrightnessadjustment; ●Keyswitchcantakepicturesandadjustthebrightnessofthelightsource; ●2000mAhbatterywithlongbatterylife; ●HighlyvisibleLEDcoolwhitelightsource; ●Earspeculumscrew-intypeforeasyreplacement ●Automaticwhitebalance; ●Type-cportcompatibility. USAGECAUTION ●Thetemperatureoftheproductwillriseslightlywhenusingit(upto38°C),it hasnoeffectonthehumanbody,pleasefeelfreetouseit; ●Whencleaningthelens,itisrecommendedtouseanalcoholswabto wipeitcarefullyandgently; ●Observethesurroundingareabeforeandduringuse,anddonotusethe productinanenvironmentwherepeoplearerunningorwherethereare obviousvibrations; ●Forchildren,itisrecommendedtousetheproductabove1yearold,and minorsareprohibitedfromusingtheproductalonetoavoidinadvertently causinginjury; ●Prohibittheuseofthemainbodyofthemetalrodoutsidethepartofthe useofliquid,soastoavoiddamagetothecircuit; ●Theproducthasabuilt-incarpbattery,ifnotusedfrequently,pleasecharge itonceeverytwomonths. Manufacturer ElectricshockprotectionClassIIequipment Symbolforthemarkingofelectricalandelectronicsdevices accordingto2002/96/EC.Thedevice,accessoriesandthe packaginghavetobedisposedofwastecorrectlyattheendof theusage.pleasefollowLocalOrdinancesorRegulationsfor disposal. TypeBAppliedPart Attention,consultrelativedocuments TROUBLESHOOTING PARAMETERS Trouble Vision PossibleReasonSolution Blankscreen Normaldisplayprotection; Equipmentfailure. Pressandholdthebutton; Contactmaintenance. Vaguepicture, Discoloration, Slowspeed Dirtylenses; USBdatacablecordfailure; Wipethelenswithan alcoholswabordipitin purewater; ReplacetheUSBcable; Picture distortion USBdatacablelinefailure; Internalcameramalfunction. ReplacetheUSBcable; Contactforrepair. LensLEDis dimordoesnot lightup Improperselectionof brightnesslevel; Insufficientbatterypower; DamagedLED. Pressthebrightness switchtoadjustthe appropriatebrightness; Useitafterfully charged; Contactforrepair. Applicationis crash/quit unexpectedly Thecompatibilitybetweenthe devicesoftwareandthe displayterminalsystemis abnormal; Upgradethecomputer operatingsystem; Noresponseto bootorCannot recognized Thebatteryisexhausted; Internalcameramalfunction. Fullychargedandused; Contactforrepairs. Item Parameters NameVideoOtoscope Display1.28’’roundTFTcolordisplay BacklightLED10leveladjustablebacklightLED ImageSensor0.3MegapixelHDLens Depthoffield15~25mm Fieldofview100°(Sensordiagonalfieldofview) Imageresolution720×480p DataFormatJPGE,BMP FramerateMax30fps WhiteBalanceAuto TVDistortion＜25% Min-illumination1.0lux Lightsources LEDillumination IlluminanceofsourceMax.500lux(30mmdistance) InterfaceModeType-C PowerInput5.0VdcfromUSBport Workingcurrent200mA(includeLEDillumination) OperatingsystemWindows Language (Application) English,Chinese Operatingambient Temperature-10°C~40°C Humidity30%~80% Airpressure700hPa~1060hPa Storage&Transport Temperature-20°C~70°C Humidity10%~90%(Withoutcondensation) Airpressure500hPa~1060hPa DEVICEAPPLICATION VideoOtoscopeareusedforthedirectexaminationoftheauditorycanal andtympanicmembrane.Anyuseotherthanthatdescribedhereisnotin accordanceoftheintendeduseoftheproduct,wearenotliableforany resultingdamages.Thehandlesuppliedwiththedeviceistheonlypower supplythatmustbeusedwiththedevice.Onlyatrainedpractitionerinthese skillsisallowedtousethesedevices. PACKAGELIST ●VideoOtoscope1pc ●Type-CUSBcable1pc ●EarSpeculumtips,4mm,5mmtotal8pcsinall ●Instructionmanual1pc MobileAppUsageNotes ● Forthesecurityofyourdeviceandpersonaldata,pleaseensureto downloadtheofficialmobileapplicationexclusivelyfromourcompany's website. ● Wi-FiConnection: 1.First,turnonthedevice.Enableyourmobiledevice'sWi-Fiandlooking for‘HA-E01-xxxxxx’toestablishaconnection. Yourdevicemaydisplayaprompt(variesbyoperatingsystem);select ‘KeepConnected’. 2.AgreenindicatorlightsuponceconnectedwiththeWi-iFisuccessfully. MAINTENANCE ●Donotuseethanolorotherorganicsolventstocleanthelens; ●Wipethelenswithalensbrushorsoftcloth; ●Cleanthesurfaceofthedeviceatleastonceaweekwitha75%alcohol solution; ●Theearcupsintheaccessoriescanbesterilizedbyautoclavingat134°C for10minutes; ●Donotsterilizetheinstrumentinanautoclave; ●Ifliquidenters,turnoffthepowerimmediatelyandsendittotheservice centerforrepair,donotuseahairdryer; ●Prohibittheuseofcorrosiveorpolishingcleaners,donotimmersethe instrumentinwaterorothercleaningsolutions; ●Long-termnon-use,pleasekeepthelensdustprooforputitbackinthe box. SAFETY&ELECTRICALCLASSIFICATION Thefollowingsafetyinspectionsshouldbecarriedoutatleastonceevery 12monthsbyqualifiedpersonnelwithspecializedtrainingandpractical experienceandmakethefollowingchecks. ●Checkequipmentinstrume…

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Rev 1/26/2023 ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 02-04-2026 Ref: Attestation Statements Part 2.911(d)(5)(i) Filing FCC ID: 2BUQV-HS-OT10X [ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD.] 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. [ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD.] certifies that the equipment for which authorization is sought does not include cybersecurity or anti-virus software produced or provided by Kaspersky Lab, Inc. or any of its successors and assignees, including equipment with integrated Kaspersky Lab, Inc. (or any of its successors and assignees) cybersecurity or anti-virus software pursuant to DA-24- 886 and KDB 986446 D01 Covered Equipment Guidance section B(2a). Device is inherently compliant based on hardware limitations or software controls. or A Software Bill of Materials (SBOM) is provided to the TCB for review, and The end-user or third parties cannot install additional software on this device. Sincerely, (Applicant signature) (Applicant printed name) Jinshan Wang Rev 1/26/2023 ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA Date: 02-04-2026 Ref: Attestation Statements Part 2.911(d)(5)(ii) Filing FCC ID: 2BUQV-HS-OT10X [ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD.] ce8rtifies 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, (Applicant signature) (Applicant printed name) Jinshan Wang

ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. U.S. Agent Letter of Attestation To: Federal Communications Commission 7435 Oakland Mills Road, Columbia, MD 21046, USA Date: February 4, 2026 Ref: Attestation Statement – Part 2.911(d)(7) filing FCC ID: 2BUQV-HS-OT10X ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. (“the applicant”) certifies that, as of the date of the filing of the application, CLF Import and Export Limited (“the agent”) is our designated U.S. agent for service of process for the above reference FCC ID. The applicant accepts to maintain an agent for service of process in the United States for no less than one year after either the grantee has permanently terminated all marketing and importation of the applicable equipment within the U.S., or the conclusion of any Commission-related administrative or judicial proceeding involving the equipment, whichever is later. The applicant further acknowledges it is our responsibility to inform the FCC whenever the agent information changes. CLF Import and Export Limited ("the agent) understand it is the agent's obligation to accept service of process in the United States for matters related to the applicable equipment, and at the physical U.S. address and email address. Designated U.S. Agent Company Name: CLF Import and Export Limited FRN: 0033489683 Address: 1312 17th Street #692, Denver, CO 80202, United States Signature: Contact Person: David Chen Tel: +1 949 254 2565 Email: [email protected] Applicant Company Name: ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. FRN: 0037965001 Address: Floor 2 & Floor3, Building 8 of Art & Crafts Park, Beiao Village, Sanjiang Street, Yongjia Country, Wenzhou City, Zhejiang Province, 325100, P.R. China Signature: Contact Person: Jinshan Wang Tel: +86 15040018389 Email: [email protected]

ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. Date: February 4, 2026 Product Model Number: HS-OT10X FCC ID: 2BUQV-HS-OT10X To whom it may concern, Re: Product Certification Representative Authorization Letter We authorize QAI Laboratories Ltd. 3980 North Fraser Way, Burnaby B.C. Canada V5J 5K5 to act on our behalf on all matters concerning the above named equipment. This shall include the following:  Testing  Approval applications and procedures We declare that QAI Laboratories Ltd. is allowed to forward all information related to the approval project to the applied certification body and to the notification entities and to discuss any issues concerning the approval application. Any and all acts carried out by QAI Laboratories Ltd. on our behalf shall have the same effect as acts of our own. Signature： By: Jinshan Wang Title: Sales Manager Tel.: +86 15040018389 Email: [email protected] On behalf of: ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD.

ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. Office of Engineering Technology Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 USA Date: February 4, 2026 Subject; Request for Confidentiality FCC ID: 2BUQV-HS-OT10X To Whom It May Concern, Pursuant to the provisions of the Commission’s rules Title 47 Sections §0.457 and §0.459, we are requesting the Commission to withhold the following attachment(s) as confidential documents from public disclosure indefinitely. These documents contain detailed system and equipment descriptions and are considered as proprietary information in operation of the equipment. The public disclosure of these documents might be harmful to our company and would give competitors an unfair advantage in the market. Schematic Diagram Block Diagram Parts List Operational Description Tune-up Procedure Software Security Requirements for UNII devices It is our understanding that all measurement test reports, FCC ID label format and correspondence during the certification review process cannot be granted as confidential documents and this information will be available for public review once the grant of equipment authorization is issued. Sincerely, Signature： By: Jinshan Wang Title: Sales Manager

Page 1 of 3 1. General Inf ormation 1.1 Antenna Information Manufacturer: FOWATA SHENZHEN CO.,LTD Address of Manufacturer: 3 Floor 6Building 228 industrial Zone Henggang Street Longgang District , Shenzhen，China Product Name: 2.4GHz Antenna Model Name: HS-OT10X Frequency Range: 2400MHz - 2500MHz Type of Antenna: FPCB Antenna Antenna Gain: 0dBi (Max.) Impedance: 50 ohm Antenna View: Length * Width (68mm * 9mm) Page 2 of 3 2. Antenna Specification inf ormation 2.1 Gain Frequency Peak Gain (dBi) Polarity 2400MHz 0 Horizontal 2400MHz -0.62 Vertical 2450MHz -1.21 Horizontal 2450MHz -1.58 Vertical 2500MHz -1.28 Horizontal 2500MHz -1.57 Vertical Page 3 of 3 2.2 Radiation Pattern View

Report No: SSP25100009-1E FCC ID: 2BUQV-HS-OT10X Annex of Test Report Page 1 of 15 Annex A. EUT External Photos Model: HS-OT10X EUT View 1 EUT View 2 Report No: SSP25100009-1E FCC ID: 2BUQV-HS-OT10X Annex of Test Report Page 2 of 15 EUT View 3 EUT View 4 Report No: SSP25100009-1E FCC ID: 2BUQV-HS-OT10X Annex of Test Report Page 3 of 15 EUT View 5 EUT View 6 Report No: SSP25100009-1E FCC ID: 2BUQV-HS-OT10X Annex of Test Report Page 4 of 15 EUT View 7

Report No: SSP25100009-1E FCC ID: 2BUQV-HS-OT10X Annex of Test Report Page 15 of 15 Annex D. Label and Inf ormation FCC Label Sample Label Size: 3cm*1.5cm FCC Label Specifications Text is Black in color and is justified. Labels are printed in indelible ink on permanent adhesive backing or silk-screened onto the EUT or shall be affixed at a conspicuous location on the EUT. Where the EUT is constructed in two or more sections connected by wires and marketed together, the above statement is required to be affixed only to the main control unit. When the EUT is so small or for such use that it is not practicable to place the statement on it, the above information shall be placed in a prominent location in the instruction manual or pamphlet supplied to the user or, alternatively, shall be placed on the container in which the device is marketed. FCC Label Location

Report No: SSP25100009-1E FCC ID: 2BUQV-HS-OT10X Annex of Test Report Page 5 of 15 Annex B. EUT Internal Photos EUT Internal View 1 EUT Internal View 2 Report No: SSP25100009-1E FCC ID: 2BUQV-HS-OT10X Annex of Test Report Page 6 of 15 EUT Internal View 3 EUT Internal View 4 Report No: SSP25100009-1E FCC ID: 2BUQV-HS-OT10X Annex of Test Report Page 7 of 15 EUT Internal View 5 EUT Internal View 6 ANT location Report No: SSP25100009-1E FCC ID: 2BUQV-HS-OT10X Annex of Test Report Page 8 of 15 EUT Internal View 7 EUT Internal View 8 Report No: SSP25100009-1E FCC ID: 2BUQV-HS-OT10X Annex of Test Report Page 9 of 15 EUT Internal View 9 EUT Internal View 10 Report No: SSP25100009-1E FCC ID: 2BUQV-HS-OT10X Annex of Test Report Page 10 of 15 EUT Internal View 11 EUT Internal View 12 Report No: SSP25100009-1E FCC ID: 2BUQV-HS-OT10X Annex of Test Report Page 11 of 15 EUT Internal View 13 EUT Internal View 14 FPCB ANT Report No: SSP25100009-1E FCC ID: 2BUQV-HS-OT10X Annex of Test Report Page 12 of 15 EUT Internal View 15

FCC ID: 2BUQV-HS-OT10X RF Exposure Evaluation According to KDB 447498 D01 General RF Exposure Guidance v06 and part 2.1093，Unless specifically required by the published RF exposure KDB procedures, standalone 1-g head or body and 10-g extremity SAR evaluation for general population exposure conditions, by measurement or numerical simulation, is not required when the corresponding SAR Test Exclusion Threshold condition(s), listed below, is (are) satisfied. For 100 MHz to 6 GHz and test separation distances ≤ 50 mm, the 1-g and 10-g SAR test exclusion thresholds are determined by the following: [(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 Here, The device has been evaluated to meet general RF exposure requirement. The device can be used in portable exposure condition without restriction. For BR+EDR Max Conducted Power(dBm) Tune-up Power(dBm) Max Tune-up Power(dBm) Max Power(mW) Frequency(MHz) Min. distance(mm) Calc. thresholds limit 8.66 8(±1) 9 7.94 2412 5 2.4663 3.0 So a SAR test is not required

Report No: SSP25100009-1E FCC Test Report Page 1 of 48 FCC TEST REPORT FCC ID: 2BUQV-HS-OT10X Report No. : SSP25100009-1E Applicant : ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. Product Name : Video otoscope Model Name : HS-OT10X Test Standard : FCC Part 15.247 Date of Issue : 2026-02-02 Shenzhen CCUT Quality Technology Co., Ltd. 1F, Building 35, Changxing Technology Industrial Park, Yutang Street, Guangming District, Shenzhen, Guangdong, China; (Tel.:+86-755-23406590 website: www.ccuttest.com) This test report is limited to the above client company and the product model only. It may not be duplicated without prior permitted by Shenzhen CCUT Quality Technology Co., Ltd. Report No: SSP25100009-1E FCC Test Report Page 2 of 48 Test Report Basic Information Applicant..................................: ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. Address of Applicant...............: Floor 2 & Floor3, Building 8 of Art & Crafts Park, Beiao Village, Sanjiang Street, Yongjia Country, Wenzhou City, Zhejiang Province, 325100, P.R. China Manufacturer..........................: ZHEJIANG HONSUN MEDICAL TECHNOLOGY CO., LTD. Address of Manufacturer........: Floor 2 & Floor3, Building 8 of Art & Crafts Park, Beiao Village, Sanjiang Street, Yongjia Country, Wenzhou City, Zhejiang Province, 325100, P.R. China Product Name.........................: Video otoscope Brand Name.............................: - Main Model..............................: HS-OT10X Series Models..........................: - Test Standard..........................: FCC Part 15 Subpart C KDB 558074 D01 15.247 Meas Guidance v05r02 ANSI C63.4-2014 ANSI C63.10-2020 Date of Test .............................: 2025-10-21 to 2026-01-28 Test Result...............................: PASS Tested By ................................: (Tate Chen) Reviewed By............................: (Lorzix Luo) Authorized Signatory............: (Lahm Peng) Note : This test report is limited to the above client company and the product model only. It may not be duplicated without prior permitted by Shenzhen CCUT Quality Technology Co., Ltd.. All test data presented in this test report is only applicable to presented test sample. Report No: SSP25100009-1E FCC Test Report Page 3 of 48 CONTENTS 1. General Information ....................................................................................................................................................5 1.1 Product Information .............................................................................................................................................5 1.2 Test Setup Information..........................................................................................................................................6 1.3 Compliance Standards ...........................................................................................................................................7 1.4 Test Facilities ........................................................................................................................................................7 1.5 List of Measurement Instruments ..........................................................................................................................8 1.6 Measurement Uncertainty .....................................................................................................................................9 2. Summary of Test Results ........................................................................................................................................... 10 3. Antenna Requirement ............................................................................................................................................... 11 3.1 Standard and Limit.............................................................................................................................................. 11 3.2 Test Result .......................................................................................................................................................... 11 4. Conducted Emissions ................................................................................................................................................ 12 4.1 Standard and Limit.............................................................................................................................................. 12 4.2 Test Procedure.................................................................................................................................................... 12 4.3 Test Data and Results .......................................................................................................................................... 13 5. Radiated Emissions ................................................................................................................................................... 16 5.1 Standard and Limit.............................................................................................................................................. 16 5.2 Test Procedure.................................................................................................................................................... 16 5.3 Test Data and Results .......................................................................................................................................... 18 6. Band-edge Emissions(Radiated) ............................................................................................................................... 22 6.1 Standard and Limit.............................................................................................................................................. 22 6.2 Test Procedure.................................................................................................................................................... 22 6.3 Test Data and Results .......…

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Report No: SSP25100009-1E FCC ID: 2BUQV-HS-OT10X Annex of Test Report Page 13 of 15 Annex C. Test Photos Radiated Emission Test View 1 Radiated Emission Test View 2 Report No: SSP25100009-1E FCC ID: 2BUQV-HS-OT10X Annex of Test Report Page 14 of 15 Conducted Emission Test View 1