2BACE-S7000Digital Intraoral Scanner System

ManualInformation PartNo.: Version:V1.0 Copyright©FussenTechnologyCo.,Ltd.-2022 ThismanualisapplicabletoFussenDigitalIntraoralScannerSystem(S7000,S7000 Premium). Statement Thismanualisreferencematerialfortheoperation,maintenance,andrepairof theproduct.Theusershalloperatetheproductinstrictaccordancewiththe manual.Fussentakesnolegalliabilityforanyfailureoraccidentcauseddueto failuretocomplywiththismanual.Copyrightinanypartofthismanualisowned byFussen.Withoutourpriorwrittenapproval,anyoneshallnotcopy,reprintor translateitintoanyotherlanguage. Thismanualcontainsproprietaryinformationprotectedundercopyrightlaws, includingbutnotlimitedtotechnicalsecrets,patentinformation,andothertrade secrets.Usersshallbeboundtokeepconfidentialitythereofandshallnotdisclose anypartofthismanualtoathirdparty. Users'accesstothismanualshallnotconstituteourlicensefortheintellectual propertyrightsintheproduct.Therightstomodify,updateandinterpretthis manualareownedbyFussen. Manufacturer'sLiability Fussenwillbeliableforsafety,reliability,andperformanceoftheproductonlyon theconditionthat:assembly,operation,expansion,regulation,improvement,and repairandmaintenanceoftheproductareperformedbypersonsapprovedby Fussen;theelectricalenvironmentintheroomwheretheproductisinstalled meetsrelatednationalstandards,andtheinstrumentisoperatedunderthe instructionsherein.Fussenwill,onyourrequest,provideapaidcircuitdiagram andotherinformationtoassistyourtechnicalstaffinrepairingpartsofthe instrumentwhichareclassifiedbyFussenasmaintainabletousers. FOREWORD ThismanualmainlydescribesthefunctionsandoperationsoftheDigitalIntraoral ScannerSystem. TargetReaders Thismanualisintendedforclinicstaffandotherauthorizedusers. LegendandDesignation Anylegendprovidedinthismanualisusedonlyforexamplinganddescription. Terminology Warning Indicatesoperationorcircumstancewhichmaycausepersonalinjuryor death. Caution Indicatesoperationorcircumstancewhichmaycauseequipmentdamage ordataerrororprocessfailure. Note Indicatesanyimportantinformationwhichyoushouldunderstand. 1 Contents Chapter1SafetyGuide......................................................................................3 1.1IntendedPurpose.........................................................................3 1.2Contraindications..........................................................................3 1.3Construction.................................................................................3 1.4ModelDifference..........................................................................3 1.5OperatingConditions....................................................................4 1.6WarningandNote.........................................................................5 1.6.1SafetyWarning..................................................................5 1.6.2Caution..............................................................................7 1.6.3Note...................................................................................8 1.7SymbolDescription.......................................................................8 1.8FCCStatementofCompliance.................................................10 Chapter2ProductOverview............................................................................11 2.1ProductOverview.......................................................................11 Chapter3InstallationandConnection..............................................................13 3.1InstallationoftheSoftware........................................................13 Installsoftwareonthecomputer.Fordetails,pleaserefertotherelated softwareinstallationguide....................................................................13 3.2InstallationoftheDevice............................................................13 3.3Computer....................................................................................14 Chapter4OperationGuideoftheDevice.........................................................15 4.1InstallingandHeatingaScanTip................................................15 4.2Scan.............................................................................................16 4.2.1UnilateralScan.................................................................17 4.2.2BilateralScan...................................................................18 Chapter5OperationGuideoftheSoftware.....................................................21 5.1Overview.....................................................................................21 5.1.1SystemFunctions.............................................................21 5.1.2OperationCondition........................................................21 5.2BasicExaminationOperations....................................................22 2 5.2.1LoggingintotheSystem..................................................22 5.3SoftwareOperation....................................................................23 5.3.1Openthesoftware(DentalX_TM)...错误！未定义书签。 5.3.2AddingNewScan.............................错误！未定义书签。 5.3.3Scan.................................................错误！未定义书签。 5.3.4ManagementOptions......................错误！未定义书签。 5.3.5Features...........................................错误！未定义书签。 Chapter6Cleaning........................................................................................23 6.1CleantheDevice.........................................................................50 6.2ChangeanddisinfectingScanTips..............................................51 6.2.1DisinfectantMethodsofScanTip....................................51 6.3Maintenance...............................................................................52 6.3.1MaintenanceoftheDevice.............................................52 6.3.2ComputerDataProtection..............................................52 Chapter7Accessories......................................................................................53 Chapter8TroubleShooting...............................…

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FRN：0033432238

Statement This productDigitalIntraoralScannerSystem(S7000)is not a coveredproduct and has no associationwith the manufacturerof the coveredproduct. This productis authorizedSHAREINFO INC.(Address:3557158th St Flushing,NY 11358,USA)tobe the UnitedStates agent. FussenTechnologyCo.,Ltd. 2023-2-24 Annex: US Agent Aggrement

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Page: 1 of 16 TEST REPORT For FCC Part15B Report No. .......................................: CHTEW22110102 Report verification: Project No. ..................................: SHT2112043606EW FCC ID ............................................. : 2BACE-S7000 Applicant’s name ........................... : Fussen Technology Co.,Ltd. Address ............................................. : 3F,Minlida Bld #B, Honghualing Industrial Zone 4 ,Nanshan ,518055 Shenzhen, Guangdong, CHINA Product Name ................................ : Digital Intraoral Scanner System Trade Mark ....................................... : - Model No. ......................................... : S7000 Listed Model(s) ................................. : S7000 Premium Standard ......................................... : 47 CFR FCC Part 15 Subpart B Date of receipt of test sample...........: Oct.10, 2022 Date of testing..............................: Oct.10, 2022-Nov.16, 2022 Date of issue.................................: Nov.17, 2022 Result .................. ........................: Pass Compiled by ( Position+Printed name+Signature): File administrator Fanghui Zhu Supervised by (Position+Printed name+Signature): Project Engineer Weiyang.Xiang Approved by ( position+printed name+signature) .. : RF Manager Hans Hu Testing Laboratory Name ............. : Shenzhen Huatongwei International Inspection Co., Ltd. Address ............................................. : 1/F, Bldg 3, Hongfa Hi-tech Industrial Park, Genyu Road, Tianliao, Gongming, Shenzhen, China Shenzhen Huatongwei International Inspection Co., Ltd. All rights reserved. This publication may be reproduced in whole or in part for non-commercial purposes as long as the Shenzhen Huatongwei International Inspection Co., Ltd. is acknowledged as copyright owner and source of the material. Shenzhen Huatongwei International Inspection Co., Ltd. takes no responsibility for and will not assume liability for damages resulting from the reader's interpretation of the reproduced material due to its placement and context. The test report merely corresponds to the test sample. Report No.: CHTEW22110102 Page: 2 of 16 Date of issue: 2022-11-17 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V04 (2022-01) Contents 1. TEST STANDARDS AND REPORT VERSION ........................................... 3 1.1. Test Standards 3 1.2. Report version information 3 2. TEST DESCRIPTION .................................................................... 4 3. SUMMARY ............................................................................... 5 3.1. Client Information 5 3.2. Product Description 5 3.3. Testing Laboratory Information 5 4. TEST CONFIGURATION ................................................................. 6 4.1. Descriptions of test mode 6 4.2. Configuration of Tested System 6 4.3. Support unit used in test configuration and system 7 4.4. Environmental conditions 7 4.5. Statement of the measurement uncertainty 7 4.6. Equipments Used during the Test 8 5. TEST CONDITIONS AND RESULTS ..................................................... 9 5.1. Conducted Emissions 9 5.2. Radiated Emissions 11 6. TEST SETUP PHOTOS ................................................................ 15 7. EXTERNAL AND INTERNAL PHOTOS ................................................ 16 Report No.: CHTEW22110102 Page: 3 of 16 Date of issue: 2022-11-17 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V04 (2022-01) 1. TEST STANDARDS AND REPORT VERSION 1.1. Test Standards The tests were performed according to following standards: 47 CFR FCC Part 15 Subpart B - Unintentional Radiators ANSI C63.4: 2014 – American National Standard for Methods of Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40GHz 1.2. Report version information Revision No. Date of issue Description N/A 2022-11-17 Original Report No.: CHTEW22110102 Page: 4 of 16 Date of issue: 2022-11-17 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V04 (2022-01) 2. TEST DESCRIPTION Section Test Item Section in CFR 47 Result #1 Test Engineer 5.1 Conducted Emissions 15.107(a) PASS Junman Wang 5.2 Radiated Emissions 15.109(a) PASS Pan Xie Note: #1: The test result does not include measurement uncertainty value Report No.: CHTEW22110102 Page: 5 of 16 Date of issue: 2022-11-17 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V04 (2022-01) 3. SUMMARY 3.1. Client Information Applicant: Fussen Technology Co.,Ltd. Address: 3F,Minlida Bld #B, Honghualing Industrial Zone 4 ,Nanshan ,518055 Shenzhen, Guangdong, CHINA Manufacturer: Fussen Technology Co.,Ltd. Address: 3F, Building #B, Minlida Industrial Building, Zone 4, Honghualing Industrial Zone, 1189 Liuxian Avenue, Pingshan Community, Taoyuan Street, Nanshan District, Shenzhen,China 3.2. Product Description Main unit information: Product Name: Digital Intraoral Scanner System Trade Mark: - Model No.: S7000 Listed Model(s): S7000 Premium Power supply: DC 3.6V from battery Hardware version: V1.4 Software version: V1.0.0 Accessory unit information: Adapter information: Model: LXCP61-012600 Input: 100-240Va.c., 50/60Hz, 1.5A Output: 12.0Vd.c., 6.0A 3.3. Testing Laboratory Information Laboratory Name Shenzhen Huatongwei International Inspection Co., Ltd. Laboratory Location 1/F, Bldg 3, Hongfa Hi-tech Industrial Park, Genyu Road, Tianliao, Gongming, Shenzhen, China Connect information: Tel: 86-755-26715499 E-mail: [email protected] http://www.szhtw.com.cn Qualifications Type Accreditation Number FCC 762235 Report No.: CHTEW22110102 Page: 6 of 16 Date of issue: 2022-11-17 Shenzhen Huatongwei International Inspection Co., Ltd. Report Template Version: V04 (2022-01) 4. TEST CONFIGURATION 4.1. Descriptions of test mode Test mode Description Working mode Enable the prototype scanning function and enter the working state Charging mode(with …

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TEST SETUP PHOTOS Conducted Emissions (AC Mains) Radiated Emissions