2ASFG-CS3800CS 3800 Wireless, Trophy 3800 Wireless

CS 3800 Safety, Regulatory, and Technical Specifications User Guide Notice The Safety, Regulatory and Technical Specifications User Guide includes information on the safety instructions, regulatory information, and the technical specifications of the devices. We recommend that you thoroughly familiarize yourself with this guide to make the most effective use of your system. © Carestream Dental LLC, 2021. The information in this document is subject to change. Neither Carestream Dental LLC nor any of its subsidiaries shall be liable for errors contained herein or for incidental damages in conjunction with the furnishing, performance, or use of this material. No part of this publication may be reproduced without the permission of Carestream Dental, LLC. This document is originally written in English. All trademarks and registered trademarks are the property of their respective holders. The CS 3800 is intended for professional use only. U.S. Federal law restricts this device to sale by or on the order of a dentist. If any serious incident occurs in relation to the device, the user must report it to Carestream Dental and to the competent authority of its Member State in the European Union. Manual Name: CS 3800 Safety, Regulatory, and Technical Specifications User Guide Part Number: TA3977 Revision Number: 01 Print Date: 2021-05 The CS 3800 complies with Medical Device Regulation (EU) 2017/745. CS 3800 Safety, Regulatory, and Technical Specifications User Guide (TA3977)_Ed01iii Contents Chapter 1 Safety Information Indications for Use . . . . . . . . 1 Clinical Benefits and Performance Characteristics . . . . . . . . . . 1 Conventions in This Guide . . . . . 2 Warnings and Safety Instructions . . . . . . . . . . . . 3 Cleaning, Disinfecting, Sterilizing . . . . . . . . . . . . . 7 Cleaning and Disinfecting the Scanner. . . . . . . . . . . 7 Cleaning the Scanner . . . . 7 Disinfecting the Scanner. . . 8 Cleaning and Sterilizing the Scanner Tips . . . . . . . . 9 Manually Cleaning the Scanner Tips . . . . . .10 Cleaning the Scanner Tips in an Automatic Washer or Disinfector . . . . . . . .10 Sterilizing the Scanner Tips . . . . . . . . . . . . .11 Precautions Before Use . . . . . .12 Cleaning, Disinfecting, and Sterilizing. . . . . . . . . . . .12 Visually Inspecting the Scanner for Damage . . . . . . . . . . .12 Visually Inspecting the Scanner Tips . . . . . . . . . .12 Marking and Labeling Symbols . .13 Label Locations . . . . . . . . . .14 CS 3800 Labels . . . . . . . .14 Chapter 2 Regulatory Information General Regulatory Information . .17 WiFi . . . . . . . . . . . . . .20 Guidance and Manufacturer’s Declarations . . . . . . . . . . .21 Compliance with International Regulations . . . . . . . . . . . .24 iv Chapter 3 Technical Specifications Factory . . . . . . . . . . . . . .25 Manufacturer . . . . . . . . . . .25 Model . . . . . . . . . . . . . . .25 CS 3800 Technical Specifications . . . . . . . . . . .25 Length of Cables Supplied with the Unit . . . . . . . . . . . .27 CS 3800 Environmental Requirements . . . . . . . . . . .27 Computer System Requirements . . . . . . . . . . .28 Chapter 4 Contact Information Manufacturer’s Address . . . . . .29 Authorized Representatives . . . .29 CS 3800 Safety, Regulatory, and Technical Specifications User Guide (TA3977)_Ed011 1 Safety Information Indications for Use The CS 3800 is a digital optical scanning device used to record the topographic characteristics of teeth or dental impressions in three dimensions. The resulting topographic impressions are intended for use in the computer-aided design and manufacturing of dental restorative prosthetic devices, dental implant prosthetic devices, and orthodontic models. Clinical Benefits and Performance Characteristics Carestream Dental's intraoral scanners benefit a dental practice by enabling practitioners to acquire digital impressions with the quality and accuracy required for digital CAD/CAM dental applications. The actual performance of the device is dependent on the user's training and operating execution. The user is solely responsible for the accuracy, completeness, and adequacy of the acquired data. 2Chapter 1 Safety Information Conventions in This Guide The following special messages emphasize information or indicate potential risks to personnel or equipment. WARNING: Warns you to avoid injury to yourself or others by following the safety instructions precisely. Caution: Alerts you to a condition that might cause serious damage. Important: Alerts you to a condition that might cause problems. Note: Emphasizes important information. Tip: Provides extra information and hints. CS 3800 Safety, Regulatory, and Technical Specifications User Guide (TA3977)_Ed013 Warnings and Safety Instructions WARNINGS CS 3800: You MUST read and understand this safety information before using the scanner. This scanner sh all only be used inside hospitals and ot her profes sional healthcare facilities and MUST NOT be used near high frequency surgical equipment and the RF shielded room of an ME Syst em for magnetic resonance imaging, where the intensit y of elec tromagnetic disturbance is high. Before using the scanner, check the outer surfaces of the unit and any accessories to ensure there are no rough surfaces, sharp edges, or protrus ions which may cause a safety hazard. You are responsible for the operation and maintenance of the sc anner. You MUST have training to use the scanner. DO NOT place objects within the field of operation of the unit. When the unit is not in use, ensure that the scanner is turned OFF. DO NOT use the scanner in conjunction with ox ygen-rich enviro nments. This unit is not intended for use with fl ammable ane sthetics or flammable agents. DO NOT pull or twist th e cable. DO NOT drop the scanner or the accessories. DANGER OF ELECTRIC SHOCK This is an electrical unit. Do NOT expose it to water spray. Such action can cause an electric shock or a malfunction of the unit. IMPORTANT: All k…

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Summary view of the product View of handpiece (powered by the battery) View of handpiece (powered by the battery) View of handpiece (powered by the battery) View of handpiece (powered by the battery) View of handpiece (powered by the battery) View of battery charging station View of battery charging station View of battery charging station View of charging station View of charging station View of the battery View of the battery View of the tips View of the tips View of the interconnection cable View of the TP-Link Wi-Fi USB adapter View of handpiece powered by charging station via the interconnection cable View of approved AC/DC adapter

25 6 1.50 8 FCC ID: 2ASFG-CS3800IC ID: 24914-CS3800 CS 3800 Laser Label 87654321 1 2345678 A B C D E F F E D C B A DATUM PLANE PRIORITY A, B, C UNLESS SPECIFIED UNIT : mmMETER UNSPECIFIED TOL. ANGLE 1 TRACE FILE : DESIGN SW: CONTRACT NO: DESIGN AUDITING AUDITING APPROVE DATE DATE DATE MATERIAL NAMENAME BUY LEV SIZESIZEPART NUMBERPART NUMBERREV SCALE: 1: 1 PROJECT: SHEET 1 OF 1SHEET 1 OF 1 AREA REV DATEDESCRIPTIONDESCRIPTION SIGNATURE 0 0.5 0.0 0.13 0.00 NA TA2970 CARESTREAM DENTAL LLC HATA GAO 2020-03-27 A2020-03-27 INITIAL RELEASE HATA GAO C CS 3800 DATA PLATE-HANDPIECE, CS 3800 8 ) SEE PACKAGING GROUP FOR ARTWORK. ENVIRONMENTAL SPECIFICATIONS: SUPPLIER MUST PROVIDE IPC-1752A DECLARATION THAT ALL COMPONENT MATERIALS ARE CERTIFIED RoHS-RESTRICTED MATERIALS COMPLIANT. NOTES: 1) MATERIAL: 5 MIL 8B35 + 3M 467 2) PARTS SHALL BE SUPPLIED DIE-CUT TO SHAPE WITH PEEL-OFF LINER. 3) COLORS: BACKGROUND TO BE SILER LINING (PANTONE 428), TEXT AND SYMBOLS TO BE ECLIPSE EXCEPT WHERE INDICATED. 4) SHALL MEET THE DURABILITY REQUIREMENTS OF UL 60601-1. 5) 6) PLACE WRITE-ON OVERLAMINATE OVER ENTIRE SURFACE. SERIAL NUMBER AND MANUFACTURE DATA: THE SERIAL NUMBER SHOULD BE PROVIDED BY CARESTREAM. MANUFACTURE DATE FORMAT: YYYY-MM-DD 7) SN Intraoral Scanner Model : CS 3800 Wireless MD 2020-10-27B UPDATE MODEL HATA GAO 35 14 4xR0.50 Barcode Specification: 1)Bar code format: GS1 DataMatrix ECC 200 2)Height of bar code: 12 mm 3)Printing density: 300 DPI Example （01）60192155943065 （21）EDLA0011 (01) 6019215594 306 5 (21)EDLA0011 2020-12-31CCOMBINE UDI CODE HATA GAO SN Intraoral Scanner Model : Trophy 3800 Wireless MD Carestream Dental LLC 3625 Cumberland Boulevard, Suite 700 Atlanta, GA USA 30339 FCC ID: 2ASFG-CS3800 IC I D: 24914-CS3800 Product label will be adhered on the side enclosure of the scanner handpiece. FCC ID “2ASFG-CS3800” and IC ID “24914-CS3800” will be also engraved on this side enclosure. The statement according to FCC part 15 §15.19(a)(3) has been added in CS 3800 Safety & Regulatory Guide, page 26. Carestream Dental LLC 3625 Cumberland Boulevard, Suite 700 Atlanta, GA USA 30339 FCC ID: 2ASFG-CS3800 IC I D: 24914-CS3800 For Trophy 3800 Wireless: Product label will be adhered on the side enclosure of the scanner handpiece. FCC ID “2ASFG-CS3800” and IC ID “24914-CS3800” will be also engraved on this side enclosure. The statement according to FCC part 15 §15.19(a)(3) has been added in CS 3800 Safety & Regulatory Guide, page 26.

Internal view of handpiece Internal view of handpiece (with heat-sink being removed) View of wifi module with antenna View of wifi module View of wifi chip without shielding View of wifi chip back side View of wifi module with antenna View of wifi module Internal view of PCB Internal view of PCB Internal view of PCB Internal view of PCB Internal view of PCB Internal view of PCB Internal view of PCB Internal view of PCB

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EUT Appearance Report No.: R2009A0650 TA Technology (Shanghai) Co., Ltd. Page 1 of 2 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. EUT Appearance EUT Appearance Report No.: R2009A0650 TA Technology (Shanghai) Co., Ltd. Page 2 of 2 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. a: EUT Picture 1: Constituents of EUT

Report No.: 200902830SHA-001 Appendix A U-NII-1 Band TEST REPORT Page 1 of 1 Appendix E: Test results 1. UNII Band-1 Unwanted Emissions 1.1 Test Data 802.11ac80 5210MHz

Carestream Dental, LLC RF TEST REPORT Report Type: FCC Part 15.407 & ISED RSS-247 RF report Model: CS 3800 Wireless, Trophy 3800 Wireless REPORT NUMBER: 200902830SHA-001 ISSUE DATE: April 29, 2021 DOCUMENT CONTROL NUMBER: TTRF15.407_V1 © 2018 Intertek Intertek Testing Services Shanghai Building No.86, 1198 Qinzhou Road (North) Caohejing Development Zone Shanghai 200233, China Telephone: 86 21 6127 8200 www.intertek.com TEST REPORT This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to permit copying or distribution of this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. TTRF15.407_V1 © 2018 Intertek Page 2 of 34 Report no.: 200902830SHA-001 Applicant: Carestream Dental, LLC 3625 Cumberland Boulevard, Suite 700, Atlanta, GA USA 30339 Manufacturer: Carestream Dental, LLC 3625 Cumberland Boulevard, Suite 700, Atlanta, GA USA 30339 Product Name: Intraoral Scanner Type/Model/PMN/HVIN: CS 3800 Wireless, Trophy 3800 Wireless FCC ID: 2ASFG-CS3800 IC: 24914-CS3800 SUMMARY: The equipment complies with the requirements according to the following standard(s) or Specification: 47CFR Part 15 (2019): Radio Frequency Devices (Subpart C) ANSI C63.10 (2013): American National Standard of Procedures for Compliance Testing of Unlicensed Wireless Devices RSS-247 Issue 2 (February 2017): Digital Transmission Systems (DTSs), Frequency Hopping Systems (FHSs) and Licence-Exempt Local Area Network (LE-LAN) Devices RSS-Gen Issue 5 (March 2019) Amendment 1: General Requirements for Compliance of Radio Apparatus PREPARED BY: REVIEWED BY: Project Engineer Wade Zhang Reviewer Daniel Zhao Report No.: 200902830SHA-001 TEST REPORT TTRF15.407_V1 © 2018 Intertek Page 3 of 34 Content REVISION HISTORY................................................................................................................................................ 5 MEASUREMENT RESULT SUMMARY ..................................................................................................................... 6 1 GENERAL INFORMATION ............................................................................................................................. 7 1.1 DESCRIPTION OF EQUIPMENT UNDER TEST (EUT) ..................................................................................................... 7 1.2 TECHNICAL SPECIFICATION .................................................................................................................................... 7 1.3 ANTENNA INFORMATION....................................................................................................................................... 8 1.4 DESCRIPTION OF TEST FACILITY .............................................................................................................................. 8 2 TEST SPECIFICATIONS ................................................................................................................................... 9 2.1 STANDARDS OR SPECIFICATION ............................................................................................................................... 9 2.2 MODE OF OPERATION DURING THE TEST ................................................................................................................... 9 2.3 TEST SOFTWARE LIST .......................................................................................................................................... 10 2.4 TEST PERIPHERALS LIST ....................................................................................................................................... 10 2.5 TEST ENVIRONMENT CONDITION: .......................................................................................................................... 10 2.6 INSTRUMENT LIST .............................................................................................................................................. 11 2.7 MEASUREMENT UNCERTAINTY ............................................................................................................................. 12 3 26 DB BANDWIDTH & 99% OCCUPIED BANDWIDTH .................................................................................. 13 3.1 LIMIT .............................................................................................................................................................. 13 3.2 MEASUREMENT PROCEDURE ............................................................................................................................... 13 3.3 TEST CONFIGURATION ........................................................................................................................................ 14 3.4 THE RESULTS OF 26 DB BANDWIDTH & 99% OCCUPIED BANDWIDTH ......................................................................... 14 4 MAXIMUM CONDUCTED OUTPUT POWER AND E.I.R.P. ............................................................................. 15 4.1 LIMIT .............................................................................................................................................................. 15 4.2 MEASUREMENT PROCEDURE ..............................................................................................…

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SAR Test Report Report No.: R2009A0650 TA Technology (Shanghai) Co., Ltd. TA-MB-04-003S Page 1 of 3 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. SAR Test Setup Picture 1: Back Side, the distance from handset to the bottom of the Phantom is 0mm Picture 2: Front Side, the distance from handset to the bottom of the Phantom is 0mm 0mm 0mm SAR Test Report Report No.: R2009A0650 TA Technology (Shanghai) Co., Ltd. TA-MB-04-003S Page 2 of 3 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Picture 3: Left Side, the distance from handset to the bottom of the Phantom is 0mm Picture 4: Right Side, the distance from handset to the bottom of the Phantom is 0mm 0mm 0mm SAR Test Report Report No.: R2009A0650 TA Technology (Shanghai) Co., Ltd. TA-MB-04-003S Page 3 of 3 This report shall not be reproduced except in full, without the written approval of TA Technology (Shanghai) Co., Ltd. Picture 5: Bottom Edge, the distance from handset to the bottom of the Phantom is 0mm 0mm

Page 1 of 3 Test Setup Page 2 of 3 1. Radiated Emission 30MHz to 1GHz Above 1GHz Page 3 of 3 2. Conducted Emission 3. Conducted RF test