2AX53DC015WIOS-S2

0000679 Rev.2 - Instructions for Use (Wireless intra oral sensor WIOS-S2) - CONFIDENTIAL ©2020 Athlos Oy All rights reserved. ™ OPERATOR’S MANUAL 0000679 | 18.12.2020DC-Air™ Operator’s Manual2 | 30 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 | 18.12.2020DC-Air™ Operator’s Manual3 | 30 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.........................................................................................................................5 1.4Essential Performance..........................................................................................................................................6 1.5Safety Precautions................................................................................................................................................6 1.6About This Manual................................................................................................................................................6 1.6.1Printed Copy of the Manual.............................................................................................................................6 1.6.2Conventions Used in This Manual....................................................................................................................6 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.................................................................................................................10 2.3Hardware and Software Requirements..............................................................................................................11 2.3.1PC (Windows).................................................................................................................................................11 2.4Conformance to Standards.................................................................................................................................11 2.5Safety Considerations.........................................................................................................................................11 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 2.6Operating Modes................................................................................................................................................13 2.7Battery Low or System Failure............................................................................................................................13 2.7.1Battery Low....................................................................................................................................................13 2.7.2System Failure................................................................................................................................................14 3SET-UP INSTRUCTIONS............................................................................................…

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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: 2020/01/11 Federal Communications Commission Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, Maryland 21046 Re: Request for confidentiality FCC ID: 2AX53DC015 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: E173C49A-2390-4A60-876C-07A62211EBB3 1/11/2021 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: 2AX53DC015 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: 68EA7901-B93B-41C4-9981-3A7418D8739A 1/18/2021 Konstantinos Spartiotis Ph.D. CEO

0000719 Rev.2 - Package Label (Wireless intra oral sensor WIOS-S2) Artwork - IntraOral Sensor - CONFIDENTIAL Page 1 of 4 Document number0000719 Rev. 2 Document namePackage Label Artwork - IntraOral Sensor Product(s)Wireless intra oral sensor WIOS-S2 Author(s)Linda Kellberg Created4.12.2020 17.51 Last Modified By(M-Files Server), 4.12.2020 17.51 ****STRICTLY CONFIDENTIAL**** Package Label Artwork – IntraOral Sensor Version History:Author:Date:Description: 1.0Linda Kellberg24.11.2020First version. 2.0Linda Kellberg4.12.2020Labeling specification 0000666 updated. Label artwork updated accordingly: Information specific to type label added to package label. Type label replaced with package label. Page 2 of 4 Document number: 0000719 Rev.2 - Package Label (Wireless intra oral sensor WIOS-S2) Artwork - IntraOral Sensor 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: 0000719 Rev.2 - Package Label (Wireless intra oral sensor WIOS-S2) Artwork - IntraOral Sensor 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 IntraOral Sensor (IOS) model WIOS-S2 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 3.5. NOTE1: Package label is designed to replace the type label due to size limitations. NOTE2: 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: 0000719 Rev.2 - Package Label (Wireless intra oral sensor WIOS-S2) Artwork - IntraOral Sensor 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 Size:50.8 x 25.4 mm 2 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 13:19:21 (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 15:51:02 (UTC+00:00) Electronically Signed inTimestamp

0000717 Rev.1 - Type Label (Wireless intra oral sensor WIOS-S2) Artwork - IntraOral Sensor - CONFIDENTIAL Page 1 of 4 Document number0000717 Rev. 1 Document nameType Label Artwork - IntraOral Sensor Product(s)Wireless intra oral sensor WIOS-S2 Author(s)Linda Kellberg Created26.11.2020 11.33 Last Modified By(M-Files Server), 26.11.2020 11.33 ****STRICTLY CONFIDENTIAL**** Type Label Artwork – IntraOral Sensor Version History:Author:Date:Description: 1.0Linda Kellberg24.11.2020First version. Page 2 of 4 Document number: 0000717 Rev.1 - Type Label (Wireless intra oral sensor WIOS-S2) Artwork - IntraOral Sensor 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 Page 3 of 4 Document number: 0000717 Rev.1 - Type Label (Wireless intra oral sensor WIOS-S2) Artwork - IntraOral Sensor 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 IntraOral Sensor (IOS) model WIOS-S2 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 3.4. 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. 1 1.3Terms and Abbreviations Term, Abbreviation:Definition: WIOSSWireless IntraOral Sensor System IOSIntraOral Sensor Page 4 of 4 Document number: 0000717 Rev.1 - Type Label (Wireless intra oral sensor WIOS-S2) Artwork - IntraOral Sensor 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. Signatures: Document Reviewed: I have reviewed the contents of this document Name:Vasileios Grammatikakis ATHLOS\vasileios.grammatika Title: Vasileios Grammatikakis 2020-11-26 08:34:03 (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 2020-11-26 09:33:46 (UTC+00:00) Electronically Signed inTimestamp

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 6.31 -1.80 2.82 1.00 0.47 2440 6.30 -1.80 2.82 1.00 0.47 2480 5.97 -1.80 2.61 1.00 0.46 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 4.28 9.68 Not Required 2440 4.27 9.60 Not Required 2480 3.95 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 Wireless Intra-Oral Sensor / DC-Air (also known as Athlos-1 and Athlos-Air) Report no. TRA-047057-45-00B 20 January 2021 RF915 7.1 REPORT ON THE RADIO TESTING OF A Athlos Wireless Intra-Oral Sensor / DC-Air (also known as Athlos-1 and Athlos-Air) WITH RESPECT TO SPECIFICATION FCC 47CFR 15.247 TEST DATE: 2020-11-02 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-047057-45-00B Issue: A Report Number: TRA-047057-45-00B 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 Antenna gain in section 7.4 updated Report Number: TRA-047057-45-00B RF915 7.1 Page 4 of 70 2 Summary TEST REPORT NUMBER: TRA-047057-45-00B WORKS ORDER NUMBER: TRA-047057-02 PURPOSE OF TEST: Certification TEST SPECIFICATION: 47CFR15.247 EQUIPMENT UNDER TEST (EUT): Wireless Intra-Oral Sensor / DC-Air (also known as Athlos-1 and Athlos-Air) FCC IDENTIFIER: 2AX53DC015 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: 2020-11-02 to 2020-11-23 TESTED BY: Atif Tosif & David Garvey Element Report Number: TRA-047057-45-00B 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-047057-45-00B 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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