2ASFG-SONOCHARTDental ultrasonic probe

Sonochart Safety, Regulatory and Technical Specification User Guide ‐ 2 ‐ 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. The information contained in this guide may be subject to modification without notice, justification or notification to the persons concerned. No part of this guide may be reproduced without the express permission of Carestream Dental LLC. This document is originally written in English. The Sonochart product and its accessory are intended for medical professional use only. U.S. Federal law restricts this device to sale by or on the order of a dental healthcare professional. Manual Name: Sonochart Safety, Regulatory, and Technical Specifications User Guide Part Number: SMA87 Revision Number: Gate 2 Print Date: 2023‐03 SMA87_Sonochart_S&R_Ed 2_EN Contents Safety Information ................................................................................ ‐ 4 ‐ Indications for Use ............................................................................................................... ‐ 4 ‐ Clinical benefits and performance characteristics ................................................................. ‐ 4 ‐ Conventions in this Guide .................................................................................................... ‐ 4 ‐ Warning and Safety Instructions .......................................................................................... ‐ 5 ‐ Disposal ............................................................................................................................... ‐ 7 ‐ Precautions Before Use ........................................................................................................ ‐ 8 ‐ Hygiene and Disinfection ..................................................................................................... ‐ 8 ‐ Cleaning and disinfecting the probe head ................................................................ ‐ 8 ‐ Probe head swap ................................................................................................................. ‐ 9 ‐ Maintenance ....................................................................................................................... ‐ 9 ‐ Accessories and consumables ............................................................................................... ‐ 9 ‐ Marking and Labeling Symbols for Sonochart product .......................................................... ‐ 9 ‐ Label Locations .................................................................................................................. ‐ 11 ‐ Regulatory Information ....................................................................... ‐ 13 ‐ General Regulatory Requirements ...................................................................................... ‐ 13 ‐ Compliance with International Regulations ........................................................................ ‐ 19 ‐ Technical Specifications ...................................................................... ‐ 20 ‐ Model: Sonochart .............................................................................................................. ‐ 20 ‐ Main Components Technical Specifications ........................................................................ ‐ 20 ‐ Minimum terminal System Requirements .......................................................................... ‐ 21 ‐ Environmental connectivity requirements .......................................................................... ‐ 22 ‐ Imaging Performance Information ...................................................................................... ‐ 24 ‐ Acoustic output information .............................................................................................. ‐ 25 ‐ Ultrasound Safety ................................................................................................. ‐ 25 ‐ Ultrasonic Operating mode ................................................................................... ‐ 25 ‐ Symbols used ....................................................................................................... ‐ 25 ‐ Sonochart Acoustic Outputs (B‐mode) .................................................................. ‐ 26 ‐ Controlling the Image Quality ............................................................................................ ‐ 27 ‐ Handpiece Environmental Requirements ............................................................................ ‐ 27 ‐ Hydrogel Accessory Environmental Requirements .............................................................. ‐ 28 ‐ Contact Information ............................................................................ ‐ 29 ‐ Manufacturer’s Address ..................................................................................................... ‐ 29 ‐ Factory .............................................................................................................................. ‐ 29 ‐ Authorized Representatives ............................................................................................... ‐ 29 ‐ Authorized Representative in the European Community ....................................... ‐ 29 ‐ UK Responsible Person ......................................................................................... ‐ 29 ‐ Authorized Representative in Brazil ...................................................................... ‐ 29 ‐ List of Importers for European Union according to MDR 2017/745 ...................................... ‐ 29 ‐ List of Importers in Switzerland .......................................................................................... ‐ 30 ‐ ‐ 4 ‐ Safety Informa…

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SonoChart User & Installation Guide Notice The User & Installation Guide for SonoChart includes information on the installation of the handpiece as well as its usage. We recommend that you thoroughly familiarize yourself with this guide to make the most effective use of your system. The SonoChart handpiece is an ultrasonic system intended for use by healthcare professionals to evaluate soft tissues (small oral cavity organs) using clinical applications as diagnostic support of adult patients. The resulting imaging capabilities of the product could be used for dental professional to assess the periodontium context of a patient. © Carestrea m Dental LLC, 2023. 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. The SonoChart product is intended for professional use only. U.S. Federal law restricts this handpiece to sale by or on the order of a dentist. If any serious incident occurs in relation to the handpiece, the user must report it to Carestream Dental and to the competent a uthority of its Member State in the European Union. Manual Name: SonoChart User & Installation Guide. Document Code: SMA86 Revision Number: 01 Print Date: 2023-07 In this guide, all trademarks and registered trademarks are the property of their respective holders. The brand names and logos reproduced in this guide are copyright. The SonoChart product complies with Medical Device Regulation (EU) 2017/745 a nd the UK Medical Device Regulation 2002 (UK MDR 2002). iPhone® and iPad® are trademarks of Apple Inc. registered in the U.S. and other countries. Important: We recommend that you consult the “Safety, Regulatory and the Technical Specification User Guide” before using the SonoChart product. SonoChart User & Installation Guide (SMA86)_Ed011 Contents Chapter 1 Conventions in this Guide Conventions in this Guide. . . . . . . . . . . . . . . . . . . . . . 3 Chapter 2 SonoChart Product Packaging Opening the box . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Chapter 3 Overview Main Components . . . . . . . . . . . . . . . . . . . . . . . . . . 7 Functional Components . . . . . . . . . . . . . . . . . . . . . . . 8 Consumables . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 Intraoral Ultrasound Gel and Hydrogel . . . . . . . . . . . . 10 Chapter 4 Mobile Application Interface Minimum Mobile Terminal System Requirements . . . . . . . . . 11 SonoChart Mobile Application Homepage . . . . . . . . . . . . . 12 Scanning Modes . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Periodontal Chart . . . . . . . . . . . . . . . . . . . . . . . . . . 13 Chapter 5 Setting Up the Mobile Application Installing the Application . . . . . . . . . . . . . . . . . . . . . . 15 Application Signing Up / Signing In . . . . . . . . . . . . . . . . 16 Signing Up . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 Signing In. . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Setting Up the Wireless Communications . . . . . . . . . . 19 Uninstalling/Deleting the Application . . . . . . . . . . . . . . . . 21 Chapter 6 Configuring the Handpiece Handpiece Configuration . . . . . . . . . . . . . . . . . . . . . . 23 Managing User Profile. . . . . . . . . . . . . . . . . . . . . . . . 30 Creating a User Profile. . . . . . . . . . . . . . . . . . . . . 30 Editing / Deleting an existing User Profile. . . . . . . . . . . 34 Chapter 7 Managing the Working/Appointm ent List Appointment List . . . . . . . . . . . . . . . . . . . . . . . . . . 37 Patient Selection . . . . . . . . . . . . . . . . . . . . . . . . . . 38 Chapter 8 Setting Up the Handpiece Using the Intraoral Ultrasound Gel . . . . . . . . . . . . . . . . . 41 Using the Hydrogel . . . . . . . . . . . . . . . . . . . . . . . . . 42 2 Chapter 9 Acquiring Periodontal Measurements Preparing for Acquisition . . . . . . . . . . . . . . . . . . . . . . 43 Full Scan Mode . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 Acquiring a Full Scan Mode Periodontal Measurement . . . 44 Selecting the Full Scan Mode . . . . . . . . . . . . . . . . 44 Modifying the Full Scan Mode Settings . . . . . . . . . . . 45 Adding Periodontal Additional Information . . . . . . . . . . 46 Full Scan Acquisition . . . . . . . . . . . . . . . . . . . . . 51 Full Scan Charting . . . . . . . . . . . . . . . . . . . . . . 55 Charting Display . . . . . . . . . . . . . . . . . . . . . 55 Chart Editing . . . . . . . . . . . . . . . . . . . . . . . 57 Video mode . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 63 Acquiring a Video Mode Periodontal Measurement . . . . . 63 Acquiring a Video . . . . . . . . . . . . . . . . . . . . . . . 63 Periodontal Measurement Tool . . . . . . . . . . . . . . . . 65 Saving a Frame Context in the Mobile Application Gallery . 68 Exporting results outside the mobile application. . . . . . . 71 Autonomous mode . . . . . . . . . . . . . . . . . . . . . . . . . 72 Acquiring a Autonomous Mode Periodontal Measurement . 72 Acquiring periodontal data . . . . . . . . . . . . . . . . . . 72 Autonomous mode with remote display . . . . . . . . . 74 Chapter 10 Maintenance Replacing the Handpiece Head . . . . . . . . . . . . . . . . . . 77 Controlling the Image Quality . . . . . . . . . . . . . . . . . . . 80 Chapter 11 Troubleshooting Error List . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 82 Mobile Application . . . . . . . . . . . . . . . . . . . . . . 83 Safety recommendations . . . . . . . . . . . . . . . . . . . 86 General recommendations . . . . . . . . . . . . . . . . . . 88 Chapter 12 Contact Information Manufacturer’s Address …

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"" Carestream • Carestream Dental, Inc. 3625 Cumber l and Blvd SE Atlanta GA 30339 Federal Communication Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA JuIy 02, 2024 Attestation Statement according to 2.9ll(d)(7) FCC ID: 2ASFG-SONOCHART TO WHOM IT MAY CONCERN: We, Carestream Dental designate Kenneth J Marshall to act as U.S. agent for service of process. Kenneth J Marshall hereby acknow l edges the obligation of the U.S. agent for service of process. Further Cares tream Denta l , Inc. accepts to maintain an agent for no less than one year after the grantee has terminated all marketing and importat i on or the conclus i on of any Commission- related proceeding involving the equipment. Sincerely Kenneth J Marshall FRN 0028170819 FCC ID 2ASFG-SONOCHART 3625 Cumberland Blvd SE Radiation Safety Officer Phone 678-521-5925 Kenneth. ma [email protected] Kenneth J Marshall FRN 0028170819 FCC ID 2ASFG·SONOCHART 3625 Cumberland Blvd SE Radiation Safety Officer Phone 678-521-5925 Kenneth.marsh al l@csden ta I.com

Carestream Dental ‐ Unrestricted Internal Use Carestream Dental LLC 3625 Cumberland Blvd Suite 700 Atlanta GA 30339, United States Federal Communication Commission Authoriz ation and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 USA 01/08/2024 Attestation Statement according to 2.911(d)(5)(i) and 2.911(d)(5)(ii) FCC ID: 2ASFG‐SONOCHART TO WHOM IT MAY CONCERN: Hereby we certify 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. Further we certify that, as of the date of the filing of the application, Carestream Dental is not identified on the Covered List as an entity producing “covered” equipment. Sincerely, _______________ (signature & company stamp) Company Name: Carestream Dental LLC Company Number: 24914 Contact Name: Bilel Lazrag Address: 3625 Cumberland Blvd Suite 700, Atlanta, GA 30339, United States. Telephone No: +33 1 73 08 86 35 Email: [email protected]

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CJ984 : Ublox module without shielding: CJ994: CJ982 : CJ988 : CJ987 : CJ986 : CJ1005 : CJ985 : CJ998 :

Page 1 of 50 Annex D Appendix to Test Report No.: 1-6253-23-01-03_TR1-R02 Testing Laboratory cetecom advanced GmbH Untertuerkheimer Strasse 6 – 10 66117 Saarbruecken/Germany Phone: + 49 681 5 98 - 0 Fax: + 49 681 5 98 - 9075 Internet: https://www.cetecomadvanced.com e-mail: [email protected] Accredited Test Laboratory: The testing laboratory (area of testing) is accredited according to DIN EN ISO/IEC 17025 (2018-03) by the Deutsche Akkreditierungsstelle GmbH (DAkkS) The accreditation is valid for the scope of testing procedures as stated in the accreditation certificate starting with the registration number: D-PL-12047-01-00. Appendix with Calibration data, Phantom certificate and system check information 2012-01-16 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 2 of 50 1 Table of contents 1 Table of contents ....................................................................................................................................... 2 2 Calibration report “Probe EX3DV4” – SN: 7852 ..................................................................................... 3 3 Calibration report “2450 MHz System validation dipole” .................................................................... 14 4 Calibration report “5GHz System check dipole”.................................................................................. 23 5 Calibration certificate of Data Acquisition Unit (DAE4ip) – SN: 1842 ................................................ 40 6 Certificate of “SAM Twin Phantom V4.0, V5.0, V8.0’’ .......................................................................... 41 7 Certificate of “ELI Phantom V8.0’’ ......................................................................................................... 43 8 Application Note System Performance Check ..................................................................................... 44 8.1 Purpose of system performance check ..................................................................................... 44 8.2 System Performance check procedure ...................................................................................... 44 8.3 Uncertainty Budget ...................................................................................................................... 45 8.4 Power set-up for validation ......................................................................................................... 49 8.5 Laboratory reflection ................................................................................................................... 50 8.6 Additional system checks ........................................................................................................... 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 3 of 50 2 Calibration report “Probe EX3DV4” – SN: 7852 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 4 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 5 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 6 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 7 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 8 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 9 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 10 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 11 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 12 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 13 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 14 of 50 3 Calibration report “2450 MHz System validation dipole” Appendix no.: 1-6253-23-01-03_TR1-R02 Page 15 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 16 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 17 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 18 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 19 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 20 of 50 Antenna Parameters with Head TSL From cal. data Measured 2023-06-06 Impedance; transformed to feed point 52.8 Ω + 3.7 jΩ 52.4 Ω + 1.1 jΩ Return Loss -26.9 dB -31.7 dB Appendix no.: 1-6253-23-01-03_TR1-R02 Page 21 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 22 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 23 of 50 4 Calibration report “5GHz System check dipole” Appendix no.: 1-6253-23-01-03_TR1-R02 Page 24 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 25 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 26 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 27 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 28 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 29 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 30 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 31 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 32 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 33 of 50 Antenna Parameters with Head TSL at 5200 MHz From cal. data Measured 2022-05-09 Impedance; transformed to feed point 52.4Ω - 9.7jΩ 51.5Ω + 1.0jΩ Return Loss -20.3dB -35.2dB Antenna Parameters with Head TSL at 5500 MHz From cal. data Measured 2022-05-09 Impedance; transformed to feed point 52.4Ω - 4.1jΩ 51.6Ω – 5.3jΩ Return Loss -26.6dB -25.3dB Antenna Parameters with Head TSL at 5800 MHz From cal. data Measured 2022-05-09 Impedance; transformed to feed point 56.9Ω - 0.2jΩ 58.4Ω – 2.2jΩ Return Loss -23.8dB -21.9dB Appendix no.: 1-6253-23-01-03_TR1-R02 Page 34 of 50 Antenna Parameters with Head TSL at 5200 MHz From cal. data Measured 2023-07-10 Impedance; transformed to feed point 52.4Ω - 9.7jΩ 48.8Ω - 4.9jΩ Return Loss -20.3dB -25.8dB Antenna Parameters with Head TSL at 5500 MHz From cal. data Measured 2023-07-10 Impedance; transformed to feed point 52.4Ω - 4.1jΩ 56.0Ω – 6.0jΩ Return Loss -26.6dB -21.9dB Antenna Parameters with Head TSL at 5800 MHz From cal. data Measured 2023-07-10 Impedance; transformed to feed point 56.9Ω - 0.2jΩ 56.5Ω + 3.5jΩ Return Loss -23.8dB -23.2dB Impedance Measurement Plot for Head TSL Appendix no.: 1-6253-23-01-03_TR1-R02 Page 35 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 36 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 37 of 50 Appendix no.: 1-6253-23-01-03_TR1-R02 Page 38 of 50 Antenna Paramete…

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Page 1 of 6 Annex C Photo documentation Appendix to Test Report No.: 1-6253-23-01-03_TR1-R02 Testing Laboratory cetecom advanced GmbH Untertuerkheimer Strasse 6 – 10 66117 Saarbruecken/Germany Phone: + 49 681 5 98 - 0 Fax: + 49 681 5 98 - 9075 Internet: https://www.cetecomadvanced.com e-mail: [email protected] Accredited Test Laboratory: The testing laboratory (area of testing) is accredited according to DIN EN ISO/IEC 17025 (2018-03) by the Deutsche Akkreditierungsstelle GmbH (DAkkS) The accreditation is valid for the scope of testing procedures as stated in the accreditation certificate starting with the registration number: D-PL-12047-01-00. Appendix no.: 1-6253-23-01-03_TR1-R02 Page 2 of 6 Photo 1: Measurement System DASY Photo 2: DUT - front side view Appendix no.: 1-6253-23-01-03_TR1-R02 Page 3 of 6 Photo 3: DUT - front view without battery Photo 4: DUT - back view (label) Appendix no.: 1-6253-23-01-03_TR1-R02 Page 4 of 6 Photo 5: Battery Photo 6: SAR test position - front side with 0 mm distance Appendix no.: 1-6253-23-01-03_TR1-R02 Page 5 of 6 Photo 7: SAR test position - back side with 0 mm distance Photo 8: SAR test position - right side with 0 mm distance Appendix no.: 1-6253-23-01-03_TR1-R02 Page 6 of 6 Photo 9: SAR test position – left side with 0 mm distance

MAYA-W1 series - Data sheet UBX-21006380 - R04 Functional description Page 6 of 44 C1-Public 1.2 Product features Radio features Description Wi-Fi Standards Wi-Fi 4 IEEE 802.11a/b/g/n Wi-Fi frequency bands 2.4 GHz, channel 1-13 5 GHz, channel 36-165 Bluetooth Bluetooth 5.2 specification support Bluetooth Low Energy and Bluetooth BR/EDR Antennas MAYA-W160: 2 U. FL connectors MAYA-W161: 2 antenna pins MAYA-W166-00B: 1 embedded PCB antenna MAYA-W166-01B: 1 antenna pin Software features Security WPA3, WPA2, WPA2 and WPA mixed mode RF calibration and MAC addresses Available in on-board OTP memory Wi-Fi operational modes Station, Access-Point, Wi-Fi direct, or combination of these Driver support Free drivers for Linux and Android RTOS (with certain types of NXP MCUs) Interfaces Wi-Fi SDIO 3.0 (4-bit, up to 100 MHz clock) Bluetooth 4-wire high-speed UART, HCI transport layer PCM/I2S for audio Other GPIOs Package Dimensions 10.4 x 14.3 x 1.8 mm Mounting Soldering, 86 pins (LGA) Environmental data, quality & reliability Operating temperature -40 °C to +85 °C MSL-level 4 RoHS and REACH compliance Yes Electrical data RF power supply 3.0–3.6 VDC, 1.8 VDC I / O power supply 3.3 VDC or 1.8 VDC Certifications and approvals Type approvals Completed: Europe (RED), US (FCC), Canada (ISED) Planned: Korea, Japan Other country certification: On request Bluetooth qualification v5.2 (Bluetooth BR/EDR and Bluetooth low energy) Support Products EVK-MAYA-W161 Evaluation kit for MAYA-W160 or MAYA-W161 EVK-MAYA-W166 Evaluation kit for MAYA-W166-00B Product variants MAYA-W160-00B Professional grade module with two separate U.FL connectors for Wi-Fi and Bluetooth MAYA-W161-00B Professional grade module with two separate antenna pins for Wi-Fi and Bluetooth MAYA-W166-00B Professional grade module with embedded PCB antenna for Wi-Fi and Bluetooth MAYA-W166-01B Professional grade module with single antenna pin for Wi-Fi and Bluetooth Table 1: MAYA-W1 series product features MAYA-W1 series - Data sheet UBX-21006380 - R04Functional descriptionPage 7 of 44 C1-Public 1.3 Block diagram Four versions of MAYA-W1 are available: MAYA-W161 with two antenna RF pins, MAYA-W160 with two U.FL connectors, MAYA-W166-00B with a single internal antenna, and MAYA-W166-01B with a single antenna pin. Figure 1: Block diagram of MAYA-166 Figure 2: Block diagram of MAYA-161 or MAYA-160 MAYA-W1 series - Data sheet UBX-21006380 - R04 Functional description Page 8 of 44 C1-Public 1.4 Product description MAYA-W1 series comprises ultra-compact Wi-Fi front-end modules with an SDIO host interface and module outline of only 14.3 x 10.4 mm. The module supports Wi-Fi IEEE 802.11a/b/g/n and Bluetooth 5.2 and is developed for reliable, high-demanding, industrial devices and applications. Based on the NXP IW416 chipset, MAYA-W1 includes an integrated MAC/Baseband processor and RF front-end components. The MAYA-W1 series offers three different antenna solutions: x MAYA-W160 has two U.FL connectors for connecting external antennas. It includes an integrated discrete filter in the 2.4 GHz band (optional LTE filter for improved coexistence with LTE bands 7, 38, 40 and 41) and 5 GHz band. x MAYA-W161 has two antenna pins for connecting external antennas. It includes a discrete filter in the 2.4 GHz band (with optional LTE filter for improved coexistence with LTE bands 7, 38, 40 and 41) and 5 GHz band. x MAYA-W166-00B includes an internal niche antenna and integrated discrete filter in the 2.4 GHz band (with optional LTE filter for improved coexistence with LTE bands 7, 38, 40 and 41) and 5 GHz band. x MAYA-W166-01B has a single antenna pin for connecting an external antenna. It includes an integrated discrete filter in the 2.4 GHz band (optional LTE filter for improved coexistence with LTE bands 7, 38, 40 and 41) and 5 GHz band. 1.5 Supported features x Integrated highly effective antenna, antenna pin, or U. FL connectors x Extended operating temperature range of -40 °C to +85 °C x Selectable 1.8 V or 3.3 V IO levels x Simultaneous Wi-Fi and Bluetooth operation with dual antenna configuration x Shared 2.4 GHz Wi-Fi and Bluetooth operation with single antenna or antenna pin (MAYA-W166) x Wi-Fi/Bluetooth coexistence support 1.5.1 Wi-Fi features x Supports Wi-Fi 4, IEEE 802.11 a/b/g/n x Dual-band 2.4 GHz and 5 GHz x Single stream 802.11n with 20 and 40 MHz channel width x Data rate up to 150 Mbps (MCS7) x 802.11n short and long guard interval x Dynamic frequency selection (radar detection) x Power saving features x SDIO 3.0 device interface x Security: WPA3, WPA2, WPA2 and WPA mixed mode x Wi-Fi Standards IEEE 802.11d/e/h/i/k/r/u/v/w x Supports simultaneous station, access point and P2P modes x Supports up to eight stations in AP mode MAYA-W1 series - Data sheet UBX-21006380 - R04 Interfaces Page 14 of 44 C1-Public Symbol Parameter Condition Min Typ Max Unit T OHLD Output hold C L >15 pF (1 card) DDR 50 1.5 – – ns DAT[3:0] Input (referenced to clock rising and falling edges) T IS2x Input setup time C CARD < 10 pF (1 card) DDR 50 3 – – ns T IH2x Input hold time C CARD < 10 pF (1 card) DDR 50 0.8 – – ns DAT[3:0] Output (referenced to clock rising and falling edges) T ODLY2x (max) Output delay time during data transfer mode C L < 25 pF (1 card) DDR 50 – – 7.0 ns T ODLY2x (min) Output hold time C L > 15 pF (1 card) DDR 50 1.5 – – ns Table 8: SDIO timing data – DDR50 mode (50MHz) 2.2.5 SDIO internal pull-up and pull-down specifications Parameter Condition Min Typ Max Unit Internal nominal pull-up/pull-down resistance 60 90 120 k: Table 9: SDIO internal pull-up and pull-down specifications 2.3 Antenna interfaces The MAYA-W1 series supports either an internal antenna (MAYA-166-00B) or external antennas connected through an antenna pin or U. FL connectors (MAYA-W161, MAYA-160 or MAYA-W166-01B). To prevent mutual interference with LTE bands, MAYA-W1 includes an optionally integrated, high- performance 2.4 GHz SAW LTE band pass filter. 2.3.1 Internal antenna MAYA-W166-00B h…

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TEST REPORT Test report no.: 1-6253_23-01-05_TR1-R02 Testing laboratory Applicant cetecom advanced GmbH Untertuerkheimer Strasse 6 – 10 66117 Saarbruecken / Germany Phone: + 49 681 5 98 - 0 Fax: + 49 681 5 98 - 9075 Internet: https://cetecomadvanced.com e-mail: [email protected] Accredited Testing Laboratory: The testing laboratory (area of testing) is accredited according to DIN EN ISO/IEC 17025 (2018-03) by the Deutsche Akkreditierungsstelle GmbH (DAkkS). The accreditation is valid for the scope of testing procedures as stated in the accreditation certificate with the registration number: D-PL-12047-01-00. ISED Testing Laboratory Recognized Listing Number: DE0001 FCC designation number: DE0002 Trophy / Carestream Dental 4 RUE F.PELLOUTIER CROISSY-BEAUBOURG 77435 MARNE LA VALLEE / FRANCE Phone: +33 1 73 08 86 35 Contact: Bilel Lazrag e-mail: [email protected] Manufacturer Trophy / Carestream Dental 4 RUE F.PELLOUTIER CROISSY-BEAUBOURG 77435 MARNE LA VALLEE / FRANCE Test standard/s FCC - Title 47 CFR Part 15 FCC - Title 47 of the Code of Federal Regulations; Chapter I; Part 15 - Radio frequency devices RSS - 247 Issue 3 Digital Transmission Systems (DTSs), Frequency Hopping Systems (FHSs) and Licence - Exempt Local Area Network (LE-LAN) Devices For further applied test standards please refer to section 3 of this test report. Test Item Kind of test item: Ultrasonic device Model name: Sonochart FCC ID: 2ASFG-SONOCHART ISED certification number: 24914-SONOCHART Frequency: 5150 MHz to 5350 MHz & 5470 MHz to 5850 MHz Technology tested: WLAN Antenna: Integrated antenna Power supply: 3.7 V DC by Li-ion battery Temperature range: 10°C to +30°C This test report is electronically signed and valid without handwritten signature. For verification of the electronic signatures, the public keys can be requested at the testing laboratory. Test report authorized: Test performed: Michael Dorongovski René Oelmann Lab Manager Lab Manager Radio Labs Radio Labs Test report no.: 1-6253_23-01-05_TR1-R02 © cetecom advanced GmbH Page 2 of 31 1 Table of contents 1 Table of contents .................................................................................................................................... 2 2 General information ................................................................................................................................ 3 2.1 Notes and disclaimer ................................................................…

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