2ATXZMO7010MotiliCap Capsule

1 / 64 NaviCam MotiliCap GI Monitoring System User Manual AnX Robotica Corporation Revision v1 2 / 64 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 condition. Warranty AnX Robotica Corporation assures that all parts in the NaviCam MotiliCap GI Monitoring System are well- designed, manufactured, packed, and tested for the prevention of defects and assumes no responsibility for any accident, loss, damage, or cost increase directly or indirectly resulting from the use of the platform. AnX Robotica Corporation will repair or replace parts within the warranty period. At the same time, the 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 a verbal or documented form. Modifications by User or Third Party Any modification to the product that are not expressly approved in writing by 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. 3 / 64 Chapter 1 Introduction 1.1 Important Information A thorough understanding of the technical principles, clinical applications and risks associated with the NaviCam MotiliCap GI Monitoring System is necessary before using this product. Read this entire manual before using the system for the first time. The product may only be used by healthcare professionals and patients who have received specialized training. CAUTION Failure to follow this instruction may result in damage to the equipment or pollution to environment WARNING Failure to follow instructions could result in injury or even death to operator, patient, or other personnel. To avoid the risk of electric shock, this equipment must only be connected to a power supply that is properly grounded. This device should be kept away from strong magnetic fields. NOTE If an event or information security issue is identified, immediately report it to AnX Robotica Customer Service. 1.2 About NaviCam MotiliCap GI Monitoring System The MotiliCap capsule measures whole gut and regional gut (stomach, small bowel, and colon) transit times. Measurements of gastrointestinal tract transit times are used for evaluating motility disorders. Gastric transit time (gastric emptying time, GET) is indicated for the evaluation of patients with suspected gastroparesis. Delayed gastric emptying is implicated in such disorders as idiopathic and diabetic gastroparesis and functional non-ulcer dyspepsia. 4 / 64 Colonic transit time (CTT) is indicated for the evaluation of colonic transit in patients with chronic constipation and used to aid in differentiating slow and normal transit constipation. Combined small and large bowel transit time (SLBTT) is used as a surrogate measure of colonic transit in patients with chronic constipation when colonic transit time alone cannot be determined. The system measures pH, pressure and temperature throughout the entire GI tract. Pressure contraction data from the antrum and duodenum can be used to calculate motility indices. The NaviCam MotiliCap GI Monitoring System is comprised from the following components: • MotiliCap Capsule (Catalog Number:TBD, Model: AJMC-1) • Data Recorder (Catalog Number: TBD, Model: AJDR) • PC Software(Motiliscan) • Cell phone APP(MotiliCap) • MotiliCap Bar A description of each component is provided below. 1.2.1 MotiliCap Capsule (AJMC-1 ) The capsule consists of a pressure sensor, a pH sensor, and a temperature sensor (Figure 1-1), which separately measure the pressure, pH, and temperature in the GI tract to determine transit times of the stomach, small bowel, and colon. The transit times calculated by capsule motility procedures can substitute for other test methods such as gastric emptying scintigraphy, whole-gut scintigraphy, and radiopaque markers.The capsule is for single use and is valid for 24 months. Figure 1-1 Capsule 1.2.2 Data Recorder (AJDR ) The data recorder records biomedical data transmitted by the capsule. The patient can wear it either cross-body or around the neck using a lanyard. The data recorder weighs approximately 225 grams (0.5 lbs), as shown in Figure 1-2. The data recorder has a service life of 5 years. 5 / 64 Figure 1-2 Data Recorder 1.2.2.1 Components of the Data Recorder The data recorder primarily consists of four components: the lanyard hole, status indicator light, power button, and charging indicator light (Figure 1-2). Table 1-1 Data Record Components Component Description A - Lanyard hole Secures the lanyard B – Status indicator light Indicates battery level and capsule pairing status C - Power button Press and hold to power on the data recorder D - Charging indicator light A dual-color LED indicating the charging status 1.2.2.2Indicator Lights of the Data Recorder The data recorder features two types of indicator lights: the status indicator light and the charging indicator light (see Table 1-2). Table 1-2 State and Interpretation for the Data Recorder Indicator Lights LED-B status indicator light State Interpretation Fully on or partially on Indicates the battery level of the data recorder Fully off The data re…

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Date: 11/23/2024 Federal Communications Commissions Authorization and Evaluation Division 7435 Oakland Mills Road Columbia, MD 21046 RE: CFR 47 §2.911 (d)(5) Attestation FCC ID: 2ATXZMO7010 Grantee FRN: 0034460493 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, the device does not have cybersecurity and / or anti-virus software produced or provided by Kaspersky Lab, Inc. or any of its successors and assignees, identified on the Covered List installed on the device, nor will it be installed by the applicant anytime after certification. 3. 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.

Date: 11/23/2024 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: 2ATXZMO7010 Grantee FRN: 0034460493 To whom it may concern: Applicant (grantee) 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. Contact Person: Tim Thomas Company Name: AnX Robotica Corp. FCC FRN: 0028636884 Company US Address: 6010 W Spring Creek Parkway, Plano, TX 75024 USA Email: [email protected] Sincerely yours, Contact Person: Tim Thomas Contact Person Title: VP, Regulatory/Quality/Clinical Company Name: AnX Robotica Corp. Company Address: 6010 W Spring Creek Parkway, Plano, TX 75024 USA

Date: November 23, 2024 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 Parkway, Plano, TX 75024 USA

Federal Communications Commission 7435 Oakland Mills Road Columbia MD 21046 Subject: Request for Confidentiality FCC ID: 2ATXZMO7010 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 that 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 Parkway, Plano, TX 75024 USA Date: November 23, 2024

DATE: November 23, 2024 Equipment Autorisation Division Federal Communications Commission 7435 Oakland Mills Road Columbia, MD 21046 Request for Short-Term Confidentiality Company name: AnX Robotica Corp. FCC ID: 2ATXZMO7010 FCC Part 15 Certification Pursuant to Sections 0.457 and 0.459 of the commission rules, and in accordance with the FCC Public notice dated June 15, 2004 (DA 04-1705), we hereby request short-term confidentiality for the following items prior to marketing the device.: (1) Test Setup Photos (2) External Photos (3) Internal Photos (4) User Manual The applicant requests the exhibits selected above as short term confidential be withheld from public view for a period of 180 days from the date of the Grant of Equipment Authorization and prior to marketing. This is to avoid premature release of sensitive information prior to marketing or release of the product to the public. Sincerely, Company Name: AnX Robotica Corp. Contact Name: Tim Thomas Title of Person: VP, Regulatory/Quality/Clinical Address: 6010 W Spring Creek Parkway, Plano, TX 75024 USA

Appendix I External 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. External View of EUT-1 External View of EUT-2 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. External View of EUT-3 External View of EUT-4

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. The label is attached to the bottom of the plastic shell of the capsule The label is affixed to the dialysis paper containing the capsules

Appendix II Internal Photographs Page 2 of 7 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 7 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 Internal View of EUT-3 Page 4 of 7 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-4 Internal View of EUT-5 Page 5 of 7 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-6 Internal View of EUT-7 Page 6 of 7 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-8 Internal View of EUT-9 Page 7 of 7 UL-CCIC COMPANY LIMITED This report shall not be reproduced except in full, without the written approval of UL-CCIC COMPANY LIMITED. Antenna and RF Module Location

Antenna photo: Antenna type: PCB antenna Antenna Gain: 0 dBi

Antenna photo:

FCC ID: 2ATXZMO7010 According to KDB 447498 D01 General RF Exposure Guidance v06, section 4.2.4 When the aggregate of the maximum power available at the antenna port and radiating structures of an implanted transmitter, under all operating circumstances, is ≤ 1.0 mW, SAR test exclusion may be applied. 1. SAR test exclusion threshold - Based on field strength 60.72 dBuV/m at 3m transmit power(eirp) of the device was calculated as 0.0004 mW using free space formula. - Maximum power 0.0004 mW is less than 1 mW. 2. Conclusion: No SAR is required.

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 MotiliCap Capsule MODEL NUMBER: CP-US-7010 PROJECT NUMBER: 4791435852 REPORT NUMBER: 4791435852-1 FCC ID: 2ATXZMO7010 ISSUE DATE: JAN. 21, 2025 Prepared for AnX Robotica Corp. Prepared by UL-CCIC COMPANY LIMITED No. 2, Chengwan Road, Suzhou Industrial Park, Suzhou 215122, China Tel: +86 512-6808 6400 Fax: +86 512-6808 4099 Website: www.ul.com Report No.: 4791435852-1 Page 2 of 38 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 01/21/2025 Initial Issue Report No.: 4791435852-1 Page 3 of 38 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 Transmitter Timeout CFR 47 FCC §15.231 (a) (1) Pass 2 20 dB Bandwidth and 99 % Occupied Bandwidth CFR 47 FCC §15.231 (c) Pass 3 Radiated Emission CFR 47 FCC §15.231 (b)(e) CFR 47 FCC §15.205 and §15.209 Pass 4 Conducted Emission Test for AC Power Port CFR 47 FCC §15.207 N/A (See Note 1) 5 Antenna Requirement CFR 47 FCC §15.203 Pass Note 1: The product was powered by battery, so this test item is no need to test. Note 2: The measurement result for the sample received is < Pass > according to < ANSI C63.10-2013, FCC CFR 47 Part 2, FCC CFR 47 Part 15C > when < Simple Acceptance > decision rule is applied. Report No.: 4791435852-1 Page 4 of 38 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 FIELD STRENGTH ..................................................................................... 8 5.3. TEST CHANNEL CONFIGURATION ............................................................................ 8 5.4. DESCRIPTION OF AVAILABLE ANTENNAS ............................................................... 9 5.5. TEST ENVIRONMENT ................................................................................................. 9 5.6. DESCRIPTION OF TEST SETUP ...............................................................................10 5.7. MEASURING INSTRUMENT AND SOFTWARE USED ..............................................11 6. ANTENNA PORT TEST RESULTS ...................................................................................12 6.1. ON TIME AND DUTY CYCLE ......................................................................................12 6.2. TANSMITTER TIMEOUT .............................................................................................15 6.3. 20dB BANDWIDTH .....................................................................................................19 7. RADIATED TEST RESULTS .............................................................................................22 7.1. FIELD STRENGTH OF INTENTIONAL EMISSIONS ...................................................29 7.2. SPURIOUS EMISSIONS (1~6GHz) .............................................................................31 7.3. SPURIOUS EMISSIONS (0.03~1 GHz) .......................................................................33 7.4. SPURIOUS EMISSIONS BELOW 30M .......................................................................35 8. ANTENNA REQUIREMENTS ............................................................................................38 Report No.: 4791435852-1 Page 5 of 38 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: Floor 1, No. 435 Chuanqiao Road, Pilot Free Trade Zone, Pudong New Area, Shanghai 201206, China EUT Description Product Name: MotiliCap Capsule Model Name: CP-US-7010 Series Model Name: / Model Difference: / Sample Number: 7616345 Data of Receipt Sample: Sep. 18, 2024 Test Date: Sep. 18, 2024~ Jan. 21, 2025 APPLICABLE STANDARDS STANDARD TEST RESULTS CFR 47 FCC PART 15 SUBPART C PASS Prepared By: Reviewed By: Tom Tang Emily Wang Authorized By: Kevin Shen Report No.: 4791435852-1 Page 6 of 38 UL-CCIC COMPANY LIMITED This report shall not be reproduced except in full, without the written approval of UL-CCIC COMPANY LIMITED. 2. TEST METHODOLOGY The tests documented in thi…

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Antenna information： Frequency (MHz) Antenna Type Antenna Gain (dBi) 433.92 PCB antenna 0 Antenna photo: Please refer to antenna photo text.

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