2AX53DCDS1WIOS-DS2

0000679 Rev.13 - Instructions for Use (Wireless intra oral sensor WIOS-S2; Intraoral Sensor Holders) - CONFIDENTIAL ©2022 Athlos Oy All rights reserved. Operator’s Manual Contents 0000679 | 18 Jan 2022DC-Air™ Operator’s Manual2 | 39 0000679 | 18 Jan 2022DC-Air™ Operator’s Manual2 | 39 Information in this manual applies to DC-Air™ Intraoral Sensor System (DC-Air™ Intraoral Sensor model WIOS-S2 and DC-Air™ Docking Station model WIOS-DS2). This manual and the product described herein are protected by copyright laws and international copyright treaties, as well as other intellectual property laws and treaties. This manual contains original instructions by Athlos Oy. Athlos Oy reserves the right at any time to revise this manual and the product described herein and assumes no obligation to notify any person or entity of such revisions. Language: The original language of this manual is English. Contents 0000679 | 18 Jan 2022DC-Air™ Operator’s Manual3 | 39 CONTENTS 1INTRODUCTION....................................................................................................................................................5 1.1About the DC-Air™................................................................................................................................................5 1.2Intended Use........................................................................................................................................................5 1.2.1Additional Information on Use of DC-Air™.......................................................................................................5 1.3Contraindications..................................................................................................................................................5 1.3.1Warnings, Cautions and Notes.........................................................................................................................6 1.4Essential Performance..........................................................................................................................................6 1.5Safety Precautions................................................................................................................................................6 1.6About This Manual................................................................................................................................................6 1.6.1Printed Copy of the Manual.............................................................................................................................7 1.6.2Conventions Used in This Manual....................................................................................................................7 2PRODUCT OVERVIEW...........................................................................................................................................8 2.1Product Description..............................................................................................................................................8 2.2DC-Air™ Intraoral Sensor System..........................................................................................................................8 2.2.1DC-Air™ Sensor.................................................................................................................................................9 2.2.2DC-Air™ Docking Station................................................................................................................................10 2.2.3DC-Air™ USB-C Connection Cables.................................................................................................................11 2.3Hardware and Software Requirements..............................................................................................................11 2.3.1PC (Windows).................................................................................................................................................11 2.3.2Display............................................................................................................................................................11 2.4Conformance to Standards.................................................................................................................................11 2.5Safety Considerations.........................................................................................................................................12 2.5.1Mains Isolation...............................................................................................................................................12 2.5.2X-Ray Protection.............................................................................................................................................12 2.5.3Prevention of Cross-Contamination...............................................................................................................12 2.5.4Disposal Protocols..........................................................................................................................................12 2.5.5Sensor Inspection...........................................................................................................................................12 2.5.6Termination of Operation..............................................................................................................................12 2.6Protection Against Cybersecurity Threats..........................................................................................................13 2.7Operating Modes................................................................................................................................................13 2.8Battery Low or System Failure............................................................................................................................14 2.8.1Battery Low.................…

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APPLICANT LETTER HEAD LETTER OF AGENCY Date Element Materials Technology 100 Frobisher Business Park Malvern Worcestershire WR14 1BX UK To Whom It May Concern: 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, 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 for your attention to this matter. Yours faithfully company Signature Full Name DocuSign Envelope ID: 36AC4AD2-DB15-4BEA-A106-9324E2089B36 Athlos Oy CEO 10/27/2020 Konstantinos Spartiotis Ph.D.

Date: 2020/11/27 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: Request for confidentiality FCC ID: 2AX53DCDS1 To whom it may concern, We hereby respectfully request that under the provision of 47 CFR 0.459 and 0.457(d) the documents listed below and attached with this application for certification be provided with confidential status. More specifically:  Schematics  Printed Circuit Boards  Hardware Description / Operational Description  Block Diagram  Bill of Materials be treated as Long Term Confidential. The above information is not publicly available. Any exhibit / information for which we have requested confidentiality, but which may not be accorded such treatment by the FCC, should be returned to us. The documents listed above contain trade secrets that are treated as confidential by us. Substantial competitive harm to us could result should they be made available to the public. Sincerely, Name: Job Title: Signature: DocuSign Envelope ID: F04A8DA5-F169-479B-9219-4C33B0191CAC 1/8/2021 Konstantinos Spartiotis Ph.D. CEO

X-ray imaging technology Athlos Oy Business ID Klovinpellontie 1-3, Tower 2 2752258-9 02180 Espoo VAT FI27522589 Finland www.athlos.fi [email protected] To: Element Materials Technology Unit E, South Orbital Trading Park Hedon Road Hull Hu9 1NJ Subject: Request for Short-term confidentiality FCC ID: 2AX53DCDS1 Reference number: TRA-047057-2 Dear FCC TCB, Short-Term Confidentiality (STC) Pursuant to Public Notice DA 04-1705 of the Commission’s policy, in order to comply with the marketing regulations in 47 CFR §2.803 and the importation rules in 47 CFR §2.1204, applicant hereby requests Short-Term Confidential treatment of the following materials (note 1): ■ Internal Photos  User’s Manual  Test Set-up Photos  External Photos Justification: (see rules for short term confidentiality) Planned Release Date STC: 30 th May 2021 (notes 2, 3, 4, 5) Date: Name and signature of applicant: Notes: 1) A document or type of document can only have ONE type of confidentiality!. 2) Short-Term confidentiality is in principle for 45 days from date of grant; it can be extended max 3 times (total time 180 days max.). 3) FCC must be informed when marketing begins earlier. 4) Release takes place automatically thus extension must be requested in time. Element does not remind you of this. 5) Request for extension or for release must be received by Element at least 7 days before date of actual marketing or before expiration of the STC period. DocuSign Envelope ID: BBCEF925-ADBD-4715-A4E1-5F8A90C0019A CEO Konstantinos Spartiotis Ph.D. 1/18/2021

X-ray imaging technology Athlos Oy Business ID Klovinpellontie 1-3, Tower 2 2752258-9 02180 Espoo VAT FI27522589 Finland www.athlos.fi [email protected] Athlos Oy 19/1/2022 To: Element Materials Technology. 100 Frobisher Business Park Malvern Worcestershire WR14 1BX UK RE: Use of SMA Connector FCC ID: 2AX53DCDS1 To Whom It May Concern: Please be advised that in accordance with the Bill Of Materials (“Bill of Materials- ATS_0004_Iss1.1.pdf “) we submitted (7 th January 2021) to Element Materials Technology during the FCC certification filing, we do not use a reverse polarity SMA connector on this product as we meet the following criteria as set out in FCC KDB353028 D01 1) To qualify for professional installation, the applicant must explain why the hardware is not readily available to average consumer. The medical device DC-Air™ is only imported in the USA through the Initial Importer. The authorized Initial Importer of the Athlos DC-Air™ is Freedom Technologies Group LLC (“FTG”), dully registered with the FDA for the importation and distribution in the USA of the DC-Air™ medical device. Therefore, the only avenue for the DC-Air™ medical device in the USA market is through the Athlos authorized Initial Importer. The device is not available to the average consumer. DocuSign Envelope ID: 30E33AAC-0C68-4F12-98BF-6138C695D8F9 X-ray imaging technology Athlos Oy Business ID Klovinpellontie 1-3, Tower 2 2752258-9 02180 Espoo VAT FI27522589 Finland www.athlos.fi [email protected] 2) Marketing—Device cannot be sold via retail to the general public or by mail order; it must be sold to authorized dealers or installers only. Only FTG imports and sells DC-Air™ in the USA. FTG sells only to qualified dental professionals licensed to use x-rays. The installation is done remotely with FTG’s professional installer installing the software and activating the system. FTG also sells through FTG’s authorized distributors who sell to qualified dental professionals licensed to use x-rays. The installation is done remotely with FTG’s authorized dealer’s professional installer(s) installing the software and activating the system or by FTG’s professional installer. 3) Filing must show that intended use is not for consumers and general public; rather device is generally for industrial/commercial use. See attached FDA formal document “ Indications for Use”: “DC-Air™, Athlos-1, Athlos-Air are intended to be used for a radiographic examination by a dental professional to assist in the diagnosing of diseases of the teeth, jaw, and oral structures.” See Athlos Instructions For Use. 4) Explain what is unique, sophisticated, complex, or specialized about the equipment that REQUIRES it to be installed by a professional installer? This is a unique medical device which requires a specialized TWAIN bridge protocol between the dental professional’s practise management system and the DC-Air™ medical device. Each and every DC-Air™ TWAIN bridge protocol is activated for use by FTG’s professional installer or by FTG’s authorized dealer’s professional installer(s). Secondly the DC-Air™ will not work without the calibration file which is controlled by Athlos and resides in the cloud. There are therefore two levels of protection against unauthorized installation by a non-professional and unauthorized use. Thank you for your attention to this matter. DocuSign Envelope ID: 30E33AAC-0C68-4F12-98BF-6138C695D8F9 X-ray imaging technology Athlos Oy Business ID Klovinpellontie 1-3, Tower 2 2752258-9 02180 Espoo VAT FI27522589 Finland www.athlos.fi [email protected] Yours faithfully Company Signature Full Name DocuSign Envelope ID: 30E33AAC-0C68-4F12-98BF-6138C695D8F9 1/19/2022 Konstantinos Spartiotis Ph.D. Athlos Oy CEO

0000718 Rev.4 - Type Label (Wireless intra oral sensor WIOS-S2) Artwork - Docking Station - CONFIDENTIAL Page 1 of 5 Document number0000718 Rev. 4 Document nameType Label Artwork - Docking Station Product(s)Wireless intra oral sensor WIOS-S2 Author(s)Linda Kellberg Created7.1.2021 14.07 Last Modified By(M-Files Server), 7.1.2021 14.07 ****STRICTLY CONFIDENTIAL**** Type Label Artwork – Docking Station Version History:Author:Date:Description: 1.0Linda Kellberg24.11.2020First version. 2.0Linda Kellberg4.12.2020Labeling specification 0000666 updated. No changes to current label artwork are required. 3.0Linda Kellberg16.12.2020Labeling specification 0000666 updated. No changes to current label artwork are required. 4.0Linda Kellberg7.1.2021Illustration of the label location added. No changes to label content. Page 2 of 5 Document number: 0000718 Rev.4 - Type Label (Wireless intra oral sensor WIOS-S2) Artwork - Docking Station Athlos OyKlovinpellontie 1-3, FIN-02180 Espoo, Finlandwww.athlos.fi TABLE OF CONTENTS 1INTRODUCTION.........................................................................................................................................3 1.1Purpose and Scope............................................................................................................................3 1.2References.........................................................................................................................................3 1.3Terms and Abbreviations...................................................................................................................3 2LABEL ARTWORK........................................................................................................................................4 3LABEL LOCATION.......................................................................................................................................5 Page 3 of 5 Document number: 0000718 Rev.4 - Type Label (Wireless intra oral sensor WIOS-S2) Artwork - Docking Station Athlos OyKlovinpellontie 1-3, FIN-02180 Espoo, Finlandwww.athlos.fi 1INTRODUCTION 1.1Purpose and Scope Purpose of this document is to describe the type label artwork of the Docking Station (DS) model WIOS-DS2 which forms a part of the Wireless IntraOral Sensor System (WIOSS) by Athlos Oy. Requirements related to the label are defined in document 0000666 [1] in sections 4.1, 4.2, and 4.4. NOTE: Label artwork is for example purposes only. The size and positioning of symbols and text in the actual printed label may vary. 1.2References #ID:Definition:Revision: 10000666Requirement Specifications (Wireless intra oral sensor WIOS- S2) Labeling Specification Rev. 3 1.3Terms and Abbreviations Term, Abbreviation:Definition: WIOSSWireless IntraOral Sensor System DSDocking Station Page 4 of 5 Document number: 0000718 Rev.4 - Type Label (Wireless intra oral sensor WIOS-S2) Artwork - Docking Station Athlos OyKlovinpellontie 1-3, FIN-02180 Espoo, Finlandwww.athlos.fi 2LABEL ARTWORK Material:Brady Material Type: Polyester, Brady Material No.: B-423 Size:50.8 x 25.4 mm2 1 1 Serial number and UDI described on the label are samples only describing the length (number of characters) of the number with respect to the size of the label and positioning of the data. They do not apply to any actual product. Page 5 of 5 Document number: 0000718 Rev.4 - Type Label (Wireless intra oral sensor WIOS-S2) Artwork - Docking Station Athlos OyKlovinpellontie 1-3, FIN-02180 Espoo, Finlandwww.athlos.fi 3LABEL LOCATION BOTTOM VIEW: Signatures: Document Reviewed: I have reviewed the contents of this document Name:Vasileios Grammatikakis ATHLOS\vasileios.grammatika Title: Vasileios Grammatikakis 2021-01-07 10:30:59 (UTC+00:00) Electronically Signed inTimestamp Document Approved: I approve this document to be immediately released for use Name:Konstantinos Spartiotis ATHLOS\konstantinos.spartio Title:CEO Konstantinos Spartiotis 2021-01-07 12:07:49 (UTC+00:00) Electronically Signed inTimestamp

0000720 Rev.2 - Package Label (Wireless intra oral sensor WIOS-S2) Artwork - Docking Station - CONFIDENTIAL Page 1 of 4 Document number0000720 Rev. 2 Document namePackage Label Artwork - Docking Station Product(s)Wireless intra oral sensor WIOS-S2 Author(s)Linda Kellberg Created4.12.2020 17.52 Last Modified By(M-Files Server), 4.12.2020 17.52 ****STRICTLY CONFIDENTIAL**** Package Label Artwork – Docking Station Version History:Author:Date:Description: 1.0Linda Kellberg24.11.2020First version. 2.0Linda Kellberg4.12.2020Labeling specification 0000666 updated. Label artwork updated accordingly. Page 2 of 4 Document number: 0000720 Rev.2 - Package Label (Wireless intra oral sensor WIOS-S2) Artwork - Docking Station Athlos OyKlovinpellontie 1-3, FIN-02180 Espoo, Finlandwww.athlos.fi TABLE OF CONTENTS 1INTRODUCTION.........................................................................................................................................3 1.1Purpose and Scope............................................................................................................................3 1.2References.........................................................................................................................................3 1.3Terms and Abbreviations...................................................................................................................3 2LABEL ARTWORK........................................................................................................................................4 2.1Package Label....................................................................................................................................4 2.2FCC Warning Label.............................................................................................................................4 Page 3 of 4 Document number: 0000720 Rev.2 - Package Label (Wireless intra oral sensor WIOS-S2) Artwork - Docking Station Athlos OyKlovinpellontie 1-3, FIN-02180 Espoo, Finlandwww.athlos.fi 1INTRODUCTION 1.1Purpose and Scope Purpose of this document is to describe the package label artwork of the Docking Station (DS) model WIOS- DS2 which forms a part of the Wireless IntraOral Sensor System (WIOSS) by Athlos Oy. Requirements related to the label are defined in document 0000666 [1] in sections 3.1, 3.2, and 4.5. NOTE: Label artwork is for example purposes only. The size and positioning of symbols and text in the actual printed label may vary. 1.2References #ID:Definition:Revision: 10000666Requirement Specifications (Wireless intra oral sensor WIOS- S2) Labeling Specification Rev. 2 1.3Terms and Abbreviations Term, Abbreviation:Definition: WIOSSWireless IntraOral Sensor System IOSIntraOral Sensor Page 4 of 4 Document number: 0000720 Rev.2 - Package Label (Wireless intra oral sensor WIOS-S2) Artwork - Docking Station Athlos OyKlovinpellontie 1-3, FIN-02180 Espoo, Finlandwww.athlos.fi 2LABEL ARTWORK 2.1Package Label Material:Brady Material Type: Polyester, Brady Material No.: B-423 (example) Size:76.2 x 50.8 mm 2 (example) 1 2.2FCC Warning Label Material:Brady Material Type: Polyester, Brady Material No.: B-423 (example) Size:50.8 x 25.4 mm 2 (example) 1 Serial number and UDI described on the label are samples only describing the length (number of characters) of the number with respect to the size of the label and positioning of the data. They do not apply to any actual product. Signatures: Document Reviewed: I have reviewed the contents of this document Name:Vasileios Grammatikakis ATHLOS\vasileios.grammatika Title: Vasileios Grammatikakis 2020-12-04 13:23:45 (UTC+00:00) Electronically Signed inTimestamp Document Approved: I approve this document to be immediately released for use Name:Konstantinos Spartiotis ATHLOS\konstantinos.spartio Title:CEO Konstantinos Spartiotis 2020-12-04 15:52:32 (UTC+00:00) Electronically Signed inTimestamp

33.1 50 63.3 67.2 100 26.5 52 SCALE 1/2 LABEL LOCATION

MPE Calculation Prediction of MPE limit at a given distance For purposes of these requirements mobile devices are defined by the FCC as transmitters designed to be used in other than fixed locations and to generally be used in such a way that a separation distance of at least 20 centimeters is normally maintained between radiating structures and the body of the user or nearby persons. These devices are normally evaluated for exposure potential with relation to the MPE limits. As the 20 cm separation specified under FCC rules may not be achievable under normal operation of the EUT, an RF exposure calculation is needed to show the minimum distance required to be less than the power density limit, as required under FCC rules. Equation from IEEE C95.1 Where: S = power density R = distance to the centre of radiation of the antenna EIRP = EUT Maximum power Frequency (MHz) Maximum Conducted Power (dBm) Antenna Gain (dBi) EIRP (mW) Power density limit (S) (mW/cm 2 ) Distance (R) cm required to be less than the power density limit 2402 6.38 3.00 8.7 1.0 0.8 2440 5.96 3.00 7.9 1.0 0.8 2480 5.92 3.00 7.8 1.0 0.8 ππ 4 arranged-re 4 2 S EIRP R R EIRP S==

General SAR test reduction & exclusion guidance KDB 447498 Section 4.3 General SAR test reduction and exclusion guidance For Standalone SAR exclusion consideration, when SAR Exclusion Threshold requirement in KDB 447498 is satisfied, standalone SAR evaluation for general population exposure conditions by measurement or numerical simulation is not required. The SAR Test Exclusion Threshold for frequencies in the range 100 MHz to 6 GHz, and for test separation distance of ≤ 50 mm, is determined as follows. SAR Exclusion Threshold (SARET) = (NT x TSD A ) / √ f GHz Where, NT = Numeric Threshold (3.0 for 1-g SAR and 7.5 for 10-g SAR) TSD A = Minimum Test separation distance or 50 mm (whichever is lower) f GHz = Transmit frequency in GHz Frequency (MHz) Maximum Conducted Power (mW) SAR Exclusion Threshold at 5 mm (mW) SAR Evaluation 2402 4.35 9.68 Not Required 2440 3.94 9.60 Not Required 2480 3.91 9.53 Not Required Therefore standalone SAR evaluation for general population exposure conditions by measurement or numerical simulation is not required.

RF915 7.1 Report on the Radio Testing For Athlos on Intra-Oral Sensor Docking Station / DC-Air (also known as Athlos-1 and Athlos-Air) Report no. TRA-047057-45-01B 20 January 2021 RF915 7.1 REPORT ON THE RADIO TESTING OF A Athlos Intra-Oral Sensor Docking Station / DC-Air (also known as Athlos-1 and Athlos-Air) WITH RESPECT TO SPECIFICATION FCC 47CFR 15.247 TEST DATE: 2020-11-17 to 2020-11-23 Tested by: Atif Tosif & David Garvey Written by: Atif Tosif Radio Test Engineer Approved by: John Charters Lab Manager Date: 20 January 2021 Disclaimers: [1] THIS DOCUMENT MAY BE REPRODUCED ONLY IN ITS ENTIRETY AND WITHOUT CHANGE [2] THE RESULTS CONTAINED IN THIS DOCUMENT RELATE ONLY TO THE ITEM(S) TESTED Report Number: TRA-047057-45-01B Issue: B Report Number: TRA-047057-45-01B RF915 7.1 Page 3 of 70 1 Revision Record Issue Number Issue Date Revision History A 10 December 2020 Original B 20 January 2021 Sections 7.4 and 12.6 updated Report Number: TRA-047057-45-01B RF915 7.1 Page 4 of 70 2 Summary TEST REPORT NUMBER: TRA-047057-45-01B WORKS ORDER NUMBER: TRA-047057-02 PURPOSE OF TEST: Certification TEST SPECIFICATION: 47CFR15.247 EQUIPMENT UNDER TEST (EUT): Intra-Oral Sensor Docking Station / DC-Air (also known as Athlos-1 and Athlos-Air) FCC IDENTIFIER: 2AX53DCDS1 MANUFACTURER/AGENT: Athlos ADDRESS: Klovinpellontie 1-3 Tower 2 Espoo 02180 Finland CLIENT CONTACT: Vasileios Grammatikakis  +358-40-1362566  [email protected] ORDER NUMBER: 140 TEST DATE: 2020-11-17 to 2020-11-23 TESTED BY: Atif Tosif & David Garvey Element Report Number: TRA-047057-45-01B RF915 7.1 Page 5 of 70 2.1 Test Summary Test Method and Description Requirement Clause 47CFR15 Applicable to this equipment Result Radiated spurious emissions (restricted bands of operation and cabinet radiation) 15.247 (d) Pass AC power line conducted emissions 15.207 Pass Occupied bandwidth 15.247 (a) (2) Pass Peak conducted carrier power 15.247 (b) (3) Pass Out of band emissions 15.247 (d) Pass Power spectral density 15.247 (e) Pass Notes: The results contained in this report relate only to the items tested, in the condition at time of test, and were obtained in the period between the date of initial receipt of samples and the date of issue of the report. The apparatus was set up and exercised using the configurations, modes of operation and arrangements defined in this report only. Any modifications made are identified in Section 8 of this report. Particular operating modes, apparatus monitoring methods and performance criteria required by the standards tested to have been performed except where identified in Section 5.2 of this test report (Deviations from Test Standards). Report Number: TRA-047057-45-01B RF915 7.1 Page 6 of 70 3 Contents 1 Revision Record ................................................................................................................................ 3 2 Summary ........................................................................................................................................... 4 2.1 Test Summary ........................................................................................................................... 5 3 Contents ............................................................................................................................................ 6 4 Introduction ....................................................................................................................................... 8 5 Test Specifications ............................................................................................................................ 9 5.1 Normative References .............................................................................................................. 9 5.2 Deviations from Test Standards ................................................................................................ 9 6 Glossary of Terms ........................................................................................................................... 10 7 Equipment under Test ..................................................................................................................... 11 7.1 EUT Identification .................................................................................................................... 11 7.2 System Equipment .................................................................................................................. 11 7.3 EUT Mode of Operation .......................................................................................................... 11 7.4 EUT Radio Parameters ........................................................................................................... 11 7.5 EUT Description ...................................................................................................................... 11 8 Modifications ................................................................................................................................... 12 9 EUT Test Setup............................................................................................................................... 13 9.1 Photographs ............................................................................................................................ 13 9.2 Measurement software ............................................................................................................ 14 10 General Technical Parameters.................................................................................................... 15 10.1 Normal Conditions ................................................................................................................... 15 10.2 Varying Test Conditions .......................................................................................................... 15 11 Duty Cycle .....................................................................................…

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