2ATXZ-AKEM31SWBioXam Capsule

BioXam System User Manual AnX Robotica Corporation BioXam System User Manual AnX Robotica Corporation XXXXX Version X Version Date: XXXXX2023 Page 2 of 101 Copyright Statement: The ownership of the User Manual belongs to AnX Robotica Corporation, and it should not be distributed or reproduced by any means or in any form without prior written permission by AnX Robotica Corporation The User Manual is protected by copyright, and all rights are reserved. AnX Robotica Corporation reserves the right to change the User Manual and the products as described herein. Equipment specifications are subject to change without prior notification. Any information contained in the User Manual is not to be considered a proposal, guarantee, commitment, or contractual conditions. Warranty AnX Robotica Corporation assures that all parts in the BioXam System are well-designed, manufactured, packed and tested for prevention of defects, and assumes no responsibility for any accident, loss, damage or cost increase directly or indirectly resulting from use of the platform. AnX Robotica Corporation will repair or replace parts within the warranty period, while customer is responsible for all other items including normal wear and tear or anything that is out of the control of AnX Robotica Corporation, including but not limited to operation, storage, cleaning, misuse, abuse, patient treatment or diagnosis. This warranty replaces any other warranties which may have been implied in verbal or documented form. Modifications by User or Third Party Any and all modifications to the product which are not expressly in writing approved AnX Robotica Corporation will void this warranty in its entirety. AnX Robotica Corp. 6010 W Spring Creek Pkwy, Plano, TX 75024 USA Toll-free: +1 855.777.0020 www.anxrobotics.com CAUTION:US Federal law restricts this device to sale by or on the order of a physician. BioXam System User Manual AnX Robotica Corporation XXXXX Version X Version Date: XXXXX2023 Page 3 of 101 Table of Contents Chapter 1: Introduction.......................................................................................................................................... 7 1.1 Important Information......................................................................................................................................... 7 1.2 About BioXam System ......................................................................................................................................... 7 1.2.1 NaviCam ® Xpress ™ Controller（MC-US-1002） ........................................................................................... 8 1.2.2 Data Recorder (MC-US-1006) ....................................................................................................................... 9 1.2.3 BioXam Capsule/Tether (Catalog Number) ................................................................................................. 10 1.2.3.1. BioXam Capsule with ph Sensor (Catalog Number) ............................................................................................. 10 1.2.3.2. BioXam Tether (Catalog Number)......................................................................................................................... 11 1.2.4 NaviCam ® Locator (Catalog Number) .......................................................................................................... 11 1.2.5 BioXam Pump (Catalog Number) ................................................................................................................ 11 1.3 Summary of Clinical Studies .............................................................................................................................. 12 Chapter 2: Indications, Contraindications and Warnings ...................................................................................... 13 2.1 Indications ......................................................................................................................................................... 13 2.2 Contraindications ............................................................................................................................................... 13 2.3 Adverse Events .................................................................................................................................................. 13 2.4 Warnings ............................................................................................................................................................ 14 2.5 Emergency Stop Procedure ............................................................................................................................... 16 2.6 Disposal of the BioXam System ......................................................................................................................... 16 2.7 Wiring of Console .............................................................................................................................................. 16 2.8 Control Panel of Console ................................................................................................................................... 17 Chapter 3: Operating the NaviCam Xpress Controller ........................................................................................... 18 3.1 Operation Steps ................................................................................................................................................. 18 3.2 Basic Operation ................................................................................................................................................. 19 3.2.1 Power On/Off ............................................................................................................................................. 19 3.2.2 Power On ................................................................................................................................…

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Date: 12/12/2023 Federal Communications Commissions Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 RE: CFR 47 §2.911 (d)(7) Agent Designation Attestation FCC ID: 2ATXZ-AKEM31SW Grantee FRN: 0034460493 To whom it may concern: AnX Robotica Corp. (“the applicant”) as required by section §2.911(d)(7), will also serve as the agent for service of process for the above referenced FCC ID. The applicant acknowledges that they will maintain an agent for no less than one year after the grantee has terminated all marketing and importation or the conclusion of any Commission-related proceeding involving the equipment. The applicant further acknowledges their responsibility under CFR 47 §2.929(c) to inform the FCC whenever the agent information changes. Tim Thomas AnX Robotica Corp. FCC FRN: 0034460493 6010 W. Spring Creek Pkwy, Plano, TX 75024, USA [email protected] Sincerely yours, Tim Thomas AnX Robotica Corp. 6010 W. Spring Creek Pkwy, Plano, TX 75024, USA

CFR 47 §2.911 (d)(5) Attestation Date: 12-12-2023 FCC ID: 2ATXZ-AKEM31SW Grantee FRN: 0034460493 To: Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 USA 1. AnX Robotica Corp. (“the applicant”) certifies 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. 2. AnX Robotica Corp. (“the applicant”) certifies that, as of the date of the filing of the application, the applicant is not identified on the Covered List as an entity producing “covered” equipment and is not an affiliate or subsidiary of an entity identified on the Covered List. Sincerely yours, Name: Tim Thomas Job Title: VP Regulatory/Quality/Clinical Company Name: AnX Robotica Corp.

AnX Robotica Corp. Date: 2023/12/12 Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 To whom it may concern: I, the undersigned, hereby authorize UL Verification Services Inc. to act on our behalf in all manners relating to application for equipment authorization, including signing of all documents relating to these matters. Any and all acts carried out by UL Verification Services Inc. on our behalf shall have the same effect as acts of our own. I, the undersigned, hereby certify that we are not subject to a denial of federal benefits, that includes FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, 21 U.S.C. 853(a). In authorizing UL Verification Services Inc. as our representative, we still recognize that we are responsible to: a) comply with the relevant provisions of the certification program; b) make all necessary arrangements for the conduct of the evaluation, including provision for examining documentation and access to all areas, records (including internal audit reports) and personnel for the purposes of evaluation (e.g. testing, inspection, assessment, surveillance, reassessment) and resolution of complaints; c) make claims regarding certification only in respect of the scope for which certification has been granted; d) do not use our product certification in such a manner as to bring the Certification Division into disrepute and not make any statement regarding our product certification which the Certification Division may consider misleading or unauthorized; e) upon suspension or cancellation of certification, discontinue use of all advertising matter that contains any reference thereto and return any certification documents as required by the Certification Division; f) use certification only to indicate the products are certified as being in conformity with specified standards; g) endeavor to ensure that no certificate or report nor any part thereof is used in a misleading manner; h) ensure that any reference to our product certification in communication media such as documents, brochures or advertising, complies with the requirements of the Certification Division; i) keep a record of all complaints made known to us relating to the product’s compliance with requirements of the relevant standard and to make these records available to the when requested; j) take appropriate action with respect to such complaints and any deficiencies found in products or services that affect compliance with the requirements for certification; k) document the actions taken. This authorization is valid until further written notice from the applicant. Sincerely Yours, Signed by: Company Name: AnX Robotica Corp. Contact Name: Tim Thomas Title of Person：VP Regulatory/Quality/Clinical Address: 6010 W. Spring Creek Pkwy, Plano, TX 75024, USA

AnX Robotica Corp. Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 Subject: Request for Confidentiality FCC ID: 2ATXZ-AKEM31SW To Whom It May Concern: Pursuant to the provisions of Sections 0.457 and 0.459 of the Commission’s rules (47 CFR §§ 0.457, 0.459), we are requesting the Commission to withhold the following attachments as confidential document from public disclosure indefinitely. Schematic Diagram Block Diagram Theory of Operation Above mentioned document contains detailed system and equipment description are considered as proprietary information in operation of the equipment. The public disclosure of above documents might be harmful to our company and would give competitor an unfair advantage in the market. It is our understanding that all measurement test reports, FCC ID label format and correspondent during certification review process cannot be granted as confidential documents and those information will be available for public review once the grant of equipment authorization is issued. Best Regards Company Name: AnX Robotica Corp. Contact Name: Tim Thomas Title of Person：VP Regulatory/Quality/Clinical Address: 6010 W. Spring Creek Pkwy, Plano, TX 75024, USA Date:1212/2023

Appendix I External Photographs Page 2 of 6 UL-CCIC COMPANY LIMITED This report shall not be reproduced except in full, without the written approval of UL-CCIC COMPANY LIMITED. All View of EUT External Photograph-1 Page 3 of 6 UL-CCIC COMPANY LIMITED This report shall not be reproduced except in full, without the written approval of UL-CCIC COMPANY LIMITED. External Photograph-2 External Photograph-3 Label location Page 4 of 6 UL-CCIC COMPANY LIMITED This report shall not be reproduced except in full, without the written approval of UL-CCIC COMPANY LIMITED. External Photograph-4 External Photograph-5 Page 5 of 6 UL-CCIC COMPANY LIMITED This report shall not be reproduced except in full, without the written approval of UL-CCIC COMPANY LIMITED. External Photograph-6 External Photograph-7 Page 6 of 6 UL-CCIC COMPANY LIMITED This report shall not be reproduced except in full, without the written approval of UL-CCIC COMPANY LIMITED. External Photograph-8 External Photograph-9

Note: 1. This would be a plastic label with a permanent adhesive. 2. Capsule is too small to be printed the FCC ID, so the FCC ID is printed on the package and user manual. Label Location

Appendix II Internal Photographs Page 2 of 3 UL-CCIC COMPANY LIMITED This report shall not be reproduced except in full, without the written approval of UL-CCIC COMPANY LIMITED. Open View of EUT Internal View of EUT-1 Page 3 of 3 UL-CCIC COMPANY LIMITED This report shall not be reproduced except in full, without the written approval of UL-CCIC COMPANY LIMITED. Internal View of EUT-2 RF Module & Antenna Location

FCC ID: 2ATXZ-AKEM31SW According to KDB 447498 D01 General RF Exposure Guidance v06, section 4.3.1 At 100 MHz to 6 GHz and for test separation distances ≤ 50mm, the SAR test exclusion threshold i s determined according to the following [(max. power of channel, including tune-up tolerance, ㎽) / (min. test separation distance, ㎜)] x [√f(㎓)] ≤ 3.0 1.SAR test exclusion threshold Frequency: 2480MHz (min. separation distances = 5 mm) SAR test exclusion thresholds (5 mm) = 3 x 5 / (√ 2.480 ) = 9.525 ㎽ Max. Tune-up Tolerance (mW) SAR Test Exclusion Thresholds (5mm) (mW) 4.47 9.525 Calculation value: 5.0 (mW) / 5 (mm) x √ 2.48 = 1.57 So, Calculation value ≤ 3.0 Remark: -For 2.48GHz RF Max. conducted power is 4.47 (mW) close to 5.0 (mW), so 5.0 (mW) was calculated. -When the minimum test separation distance is < 5 mm, a distance of 5 mm is applied to determine SAR test exclusion. 2. Conclusion: No SAR is required.

Report No.: 4790785577-OTA-1 Page 1 of 12 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. Antenna Gain Test Report Project No.: 4790785577 Client Name： AnX Robotica Corp Client Address: 6010 W. Spring Creek Pkwy, Plano, TX 75024, USA Test Lab Name: UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch Test Lab Address: Building 10, Innovation Technology Park, No. 1, Li Bin Road, Song Shan Lake Hi-Tech Development Zone Dongguan, 523808, People’s Republic of China Product Name： Product Model： BioXam Capsule AKEM-31SW Manufacture： AnX Robotica Corp Antenna Type： FPC Antenna Antenna Size: / Project Engineer： Test Engineer： James Qin Burt Hu Test Standards： ANSI/IEEE std 149-2021 Test Date： 2023.12.26 Issued Date： 2023.12.26 Report No.: 4790785577-OTA-1 Page 2 of 12 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. Revision History Rev. Issue Date Revisions Revised By V0 2023.12.26 Initial Issue \ Report No.: 4790785577-OTA-1 Page 3 of 12 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. Table of Contents 1 Test Equipment Information ............................................................................................................. 4 2 Setup block diagram ......................................................................................................................... 5 3 Test Temperature and Humidity ...................................................................................................... 6 4 Test Step Flow ................................................................................................................................... 7 5 Test Result ......................................................................................................................................... 8 6 Photo ................................................................................................................................................ 12 Report No.: 4790785577-OTA-1 Page 4 of 12 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. 1 Test Equipment Information Equipment Manufacturer Mode No. Serial No. Cal date Cal Due Test Chamber ETS-Lindgren 8500 / / / Test Software ETS-Lindgren EMQuest V1.12 1496 / / Network Analyzer Keysight E5071C MY46524531 2023.10.12 2024.10.11 EXA Singal Analyzer Keysight N9010A MY55150514 2023.10.12 2024.10.11 Report No.: 4790785577-OTA-1 Page 5 of 12 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. 2 Setup block diagram Note： 1) This test report is prepared by testing in a dark room that is completely silenced and shielded from external signals. Report No.: 4790785577-OTA-1 Page 6 of 12 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. 3 Test Temperature and Humidity Temperature: 21.2°C Humidity: 53.3% Report No.: 4790785577-OTA-1 Page 7 of 12 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. 4 Test Step Flow 1) Maintain the test ambient temperature of 23±2 C, the instrument is powered on and preheated for more than 30 minutes; 2) Turn on the darkroom power supply, connect the test cable, and set up the sample according to the standard; 3) Outline sets the test content objectives and conducts calibration tests; 4) Run the software, when the test is completed, export the corresponding test diagram and test data, and save to the corresponding directory. Report No.: 4790785577-OTA-1 Page 8 of 12 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. 5 Test Result Frequency (MHz) Efficiency (%) Gain (dBi) 2400 43.37 2.39 2410 43.04 2.39 2420 43.66 2.44 2430 44.71 2.63 2440 44.21 2.57 2450 43.74 2.46 2460 42.55 2.26 2470 41.17 2.14 2480 39.55 2.00 2490 36.75 1.65 2500 34.74 1.39 Report No.: 4790785577-OTA-1 Page 9 of 12 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. Polarization Pattern Photos Theta Polarization(Theta Angle=90°) Report No.: 4790785577-OTA-1 Page 10 of 12 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. Phi Polarization(Theta Angle=90°) Total 3D Plot(Fre.2430MHz) Report No.: 4790785577-OTA-1 Page 11 of 12 UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch This report shall not be reproduced except in full, without the written approval of UL Verification Services (Guangzhou) Co., Ltd, Song Shan Lake Branch. Report No.: 4790785577-OTA-1 Page 12 of 12 UL Verification Services (Guangzhou) Co., Lt…

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Form-ULID-008536-9 V3.0 The results reported herein have been performed in accordance with the laboratory’s terms of accreditation. This report shall not be reproduced except in full without the written approval of the Laboratory. The results in this report apply to the test sample(s) mentioned above at the time of the testing period only and are not to be used to indicate applicability to other similar products. CFR 47 FCC PART 15 SUBPART C TEST REPORT For BioXam Capsule MODEL NUMBER: AKEM-31SW FCC ID: 2ATXZ-AKEM31SW PROJECT NUMBER: 4790785577 REPORT NUMBER: 4790785577-1 ISSUE DATE: Jan. 22, 2024 Prepared for AnX Robotica Corp. Prepared by UL-CCIC COMPANY LIMITED No. 2, Chengwan Road, Suzhou Industrial Park, Suzhou 215122, China Tel: +86 769 22038881 Fax: +86 769 33244054 Website: www.ul.com Report No.: 4790785577-1 Page 2 of 63 Form-ULID-008536-9 V3.0 UL-CCIC COMPANY LIMITED This report shall not be reproduced except in full, without the written approval of UL-CCIC COMPANY LIMITED. Revision History Rev. Issue Date Revisions Revised By V0 01/22/2024 Initial Issue Report No.: 4790785577-1 Page 3 of 63 Form-ULID-008536-9 V3.0 UL-CCIC COMPANY LIMITED This report shall not be reproduced except in full, without the written approval of UL-CCIC COMPANY LIMITED. Summary of Test Results Clause Test Items FCC Rules Test Results 1 6dB Bandwidth FCC Part 15.247 (a) (2) Pass 2 Conducted Output Power FCC Part 15.247 (b) (3) Pass 3 Power Spectral Density FCC Part 15.247 (e) Pass 4 Conducted Bandedge and Spurious Emission FCC Part 15.247 (d) Pass 5 Radiated Bandedge and Spurious Emission FCC Part 15.247 (d) FCC Part 15.209 FCC Part 15.205 Pass 6 Conducted Emission Test for AC Power Port FCC Part 15.207 N/A (See Note 1) 7 Antenna Requirement FCC Part 15.203 Pass Note: The EUT is powered by battery. Report No.: 4790785577-1 Page 4 of 63 Form-ULID-008536-9 V3.0 UL-CCIC COMPANY LIMITED This report shall not be reproduced except in full, without the written approval of UL-CCIC COMPANY LIMITED. TABLE OF CONTENTS 1.ATTESTATION OF TEST RESULTS ................................................................................. 5 2.TEST METHODOLOGY ..................................................................................................... 6 3.FACILITIES AND ACCREDITATION ................................................................................. 6 4.CALIBRATION AND UNCERTAINTY ................................................................................ 7 4.1. MEASURING INSTRUMENT CALIBRATION ............................................................... 7 4.2. MEASUREMENT UNCERTAINTY................................................................................ 7 5.EQUIPMENT UNDER TEST ............................................................................................... 8 5.1. DESCRIPTION OF EUT ............................................................................................... 8 5.2. MAXIMUM OUTPUT POWER ...................................................................................... 9 5.3. CHANNEL LIST ............................................................................................................ 9 5.4. TEST CHANNEL CONFIGURATION ...........................................................................10 5.5. THE WORSE CASE CONFIGURATIONS ...................................................................10 5.6. DESCRIPTION OF AVAILABLE ANTENNAS ..............................................................10 5.7. THE WORSE CASE CONFIGURATIONS ...................................................................10 5.8. DESCRIPTION OF TEST SETUP ...............................................................................11 6.MEASURING INSTRUMENT AND SOFTWARE USED ....................................................12 7.MEASUREMENT METHODS ............................................................................................13 8.ANTENNA PORT TEST RESULTS ...................................................................................14 8.1. ON TIME AND DUTY CYCLE ......................................................................................14 8.2. 6 dB DTS BANDWIDTH ..............................................................................................16 8.3. CONDUCTED OUTPUT POWER .....................................................................19 8.4. POWER SPECTRAL DENSITY ...................................................................................20 8.5. CONDUCTED BANDEDGE AND SPURIOUS EMISSIONS ........................................23 9.RADIATED TEST RESULTS .............................................................................................32 9.1. LIMITS AND PROCEDURE .........................................................................................32 9.2. RESTRICTED BANDEDGE .........................................................................................38 9.3. SPURIOUS EMISSIONS (1~18GHz) ...........................................................................43 10.ANTENNA REQUIREMENTS .........................................................................................63 Report No.: 4790785577-1 Page 5 of 63 Form-ULID-008536-9 V3.0 UL-CCIC COMPANY LIMITED This report shall not be reproduced except in full, without the written approval of UL-CCIC COMPANY LIMITED. 1. ATTESTATION OF TEST RESULTS Applicant Information Company Name: AnX Robotica Corp. Address: 6010 W. Spring Creek Pkwy, Plano, TX 75024, USA Manufacturer Information Company Name: AnX Robotica Corp. Address: 6010 W. Spring Creek Pkwy, Plano, TX 75024, USA Factory Information Company Name: ANKON MEDICAL TECHNOLOGIES (SHANGHAI) CO., LTD. Address: 1/F, No. 2218, Jinsui Road, China (Shanghai) Pilot Free Trade Zone, Pudong New District, Shanghai, China EUT Description EUT Name: BioXam Capsule Model: AKEM-31SW Sample Number: 6172314 Sample Received Date: Jun. 13, 2023 Date of Tested: Jun. 13, 2023~ Jan. 22, 2024 APPLIC…

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Appendix III Setup Photographs RADIATED RF MEASUREMENT SETUP (9kHz ~ 30MHz) RADIATED RF MEASUREMENT SETUP (30MHz ~ 1GHz) RADIATED RF MEASUREMENT SETUP (ABOVE 1GHz- X axis) RADIATED RF MEASUREMENT SETUP (ABOVE 1GHz- Y axis) RADIATED RF MEASUREMENT SETUP (ABOVE 1GHz- Z axis)