2A37F-ECH3000Powered Surgical Stapler

cs Stapler ECHELON™ 3000 da ECHELON™ 3000-stapler de ECHELON™ 3000 Stapler el Συρραπτικό ECHELON™ 3000 es Grapadora ECHELON™ 3000 fi ECHELON™ 3000 -nitoja fr Agrafeuse ECHELON™ 3000 hu ECHELON™ 3000 kapcsozóműszer it Suturatrice ECHELON™ 3000 nl ECHELON™ 3000 Stapler pl Zszywacz ECHELON™ 3000 pt Agrafador ECHELON™ 3000 sv ECHELON™ 3000 stapler tr ECHELON™ 3000 Stapler zh ECHELON™ 3000 吻合器 bg, et, hr, id, lt, lv, mk, no, ro, ru, sk, sl, sr, vi: www.e-ifu.com Please read all information carefully. Failure to properly follow the instructions may lead to serious surgical consequences, such as bleeding, leakage or disruption. Important: This package insert is designed to provide instructions for use of the ECHELON™ 3000 45mm and 60mm Staplers. It is not a reference to surgical techniques. Echelon 3000 Stapler en ECHELON™ 3000 Stapler Radio Frequency Communication Information This device contains radio frequency communication hardware. The intended use of the radio frequency communication hardware is to perform service operations on the device. Federal Communication Commission (FCC) Statements This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. This equipment has been tested and found to comply with the limits for a Class A digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference when the equipment is operated in a commercial environment. This equipment generates, uses, and can radiate radio frequency energy and, if not installed and used in accordance with the instruction manual, may cause harmful interference to radio communications. Operation of this equipment in a residential area is likely to cause harmful interference in which case the user will be required to correct the interference at his own expense. Industry Canada Statement This device contains licence-exempt transmitter(s)/receiver(s) that comply with Innovation, Science and Economic Development Canada’s licence-exempt RSS(s). Operation is subject to the following two conditions: (1) This device may not cause interference. (2) This device must accept any interference, including interference that may cause undesired operation of the device. L’émetteur/récepteur exempt de licence contenu dans le présent appareil est conforme aux CNR d’Innovation, Sciences et Développement économique Canada applicables aux appareils radio exempts de licence. L’exploitation est autorisée aux deux conditions suivantes: 1)L’appareil ne doit pas produire de brouillage; 2)L’appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d’en compromettre le fonctionnement. 22 13 21 17 19 12 16 15 1 4 5 6 7108 2 3 9 14 2423 18 20 11 1 2a 3 2b 4 5 6 7 A BC

1(2) 03/17/2022 Attention: Application Examiner RE: Request for Confidentiality Applicant: Ethicon Endo-Surgery LLC. FCC ID: 2A37F-ECH3000 To Whom It May Concern: Permanent Confidentiality Request is hereby submitted by Ethicon Endo Surgery LLC to withhold permanently from public review certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 47 CFR 0.457(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept permanently confidential: • Schematics • Detailed Block Diagrams • Detailed Operational/Functional Description Short-term Confidentiality Request is hereby submitted by Ethicon Endo Surgery LLC to withhold from public review for a period of 45 days from the date of the Grant of Equipment Authorization and prior to marketing, certain portions of the application for equipment certification for the referenced FCC identifiers. This request for confidentiality is made pursuant to 47 CFR 0.457(d) and 0.459 of the FCC Rules. In particular, the following sections of the application are to be kept confidential for a period of 90 days from the date of Authorization: • Test setup photos • External photos (NOTE: External photos can only be held for short-term confidentiality) • Internal photos • User manual Rationale for request for confidentiality: Ethicon Endo Surgery LLC has invested considerable time and materials in research and development to produce the referenced product. Disclosure of the permanently confidential portions of this application to competitors would not only give them significant competitive advantages in developing similar products, but would also disclose successful implementation of unpublished, leading edge technology developed by us. Disclosure of the short-term confidential portions of this application during the period of importation and/or distribution would reveal key aspects of proprietary technology to competitors and diminish the value of our investment in research and development. The fee for confidentiality has been submitted along with the fee for certification. If you have questions or need further information, please contact the undersigned. Sincerely, 2(2) Jeromy Raczak Assistant Design Engineer Ethicon Endo Surgery LLC

03/17/2022 Federal Communications Commission 445 12 th Street SW Washington, DC 20554 Subject: Limited Agency Agreement Ethicon Endo Surgery LLC. FCC ID: 2A37F-ECH3000 To Whom It May Concern: We, Ethicon Endo Surgery LLC., hereby authorized Intertek Testing Services to act as our Agent for the purpose of preparing application for FCC ID number 2A37F-ECH3000 under all applicable parts of the FCC rules and regulations. The effective date of this limited agency agreement is 03/17/2022. The Limited Agency Agreement expires on 03/17/2023, unless sooner terminated or extended by written notice to Intertek Testing Services and the Federal Communications Commission. This is to advise that we are in full compliance with the Anti-Drug Abuse Act. The applicant is not subject to a denial of federal benefits pursuant to Section 5301 of the Anti-Drug Act of 1988, 21 U.S.C. 862, and no party to the application is subject to a denial of federal benefits pursuant to that section. If you have any questions or comments, please do not hesitate to contact me. Sincerely, Jeromy Raczak Assistant Design Engineer

External Pictures Figure 1: Echelon 3000 Side 1 Figure 2: Echelon 3000 Shaft Close Up Figure 3: Echelon 3000 Jaw Close Up Figure 4: Echelon 3000 Side 1 Shroud Close Up Figure 5: Echelon 3000 Side 2 Figure 6: Echelon 3000 Jaw Side 2 Close Up Figure 7: Echelon 3000 Side 2 Shroud Close Up Figure 8: Echelon 3000 External Features

Internal Pictures Figure 1: Proximal Nozzle Removed Figure 2: Proximal Nozzle Removed Top Figure 3: Side 1 Shroud Removed Figure 4: Side 1 Shroud Removed Close Up Figure 5: Side 2 Shroud Removed Figure 6: Side 2 Shroud Removed Close Up Figure 7: Shroud Removed PCBA Showing PCBA Figure 8: Shroud Removed, PCBA Removed Figure 9: Bottom of PCBA Removed From Device Figure 10: PCBA Battery Bulkhead and Contacts Close Up Figure 11: PCBA Removed From Device Assembly Figure 12: PCBA Front Conformal Coating Removed Figure 13: PCBA Back Conformal Coating Removed

Intertek 731 Enterprise Drive Lexington, KY 40510 Tel 859 226 1000 Fax 859 226 1040 www.intertek.com Ethicon Endo-Surgery Inc SAR EXCLUSION REPORT SCOPE OF WORK SAR EXCLUSION CALCULATION ON THE ECHELON REPORT NUMBER 104871091LEX-001b ISSUE DATE 5/20/2022 PAGES 9 DOCUMENT CONTROL NUMBER Non-Specific EMC Report Shell Rev. December 2017 © 2017 INTERTEK This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to copy or distribute this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. Intertek Testing Services NA, Inc. SAR EXCLUSION TEST REPORT Report Number: 104871091LEX-001b Project Number: G104871091 Report Issue Date: 5/20/2022 Product Name: Echelon Standards: FCC Part 1.1310 Limits for Maximum Permissible Exposure (MPE) RSS-102 Issue 5 Tested by: Client: Intertek Testing Services NA, Inc. 731 Enterprise Drive Lexington, KY 40510 USA Ethicon Endo-Surgery Inc 4545 Creek Rd. Cincinnati, OH 45242 USA Report prepared by Report reviewed by Brian Lackey, Team Leader James Sudduth, Senior Staff Engineer Evaluation For: Ethicon Endo-Surgery Inc Product: Echelon, Model SAR Exclusion Report Date: 5/20/2022 Non-Specific EMC Report Shell Rev. December 2017 Page 3 of 9 Report Number: 104871091LEX-001b Table of Contents 1 Introduction and Conclusion ........................................................................................................................... 4 2 Test Summary ................................................................................................................................................ 4 3 Client Information .......................................................................................................................................... 5 4 Description of Equipment under Test and Variant Models .............................................................................. 6 5 FCC SAR Exclusion Criteria .............................................................................................................................. 7 6 RSS-102 SAR Exclusion Criteria ....................................................................................................................... 8 7 Revision History ............................................................................................................................................. 9 Evaluation For: Ethicon Endo-Surgery Inc Product: Echelon, Model SAR Exclusion Report Date: 5/20/2022 Non-Specific EMC Report Shell Rev. December 2017 Page 4 of 9 Report Number: 104871091LEX-001b 1 Introduction and Conclusion SAR exclusion calculations were performed on the product constructed as described in section 4. Information provided by the client including maximum output power, antenna gain(s), and minimum separation distance(s) was used to determine if the product under evaluation was exempt from SAR. Any change in these stated values may invalidate these results. No additions, deviations, or exclusions have been made from the standard(s) unless specifically noted. Based on the results of our investigation, we have concluded the product under evaluation is exempt from SAR requirements for each of the standard(s) indicated. The results obtained in this test report pertain only to the item(s) evaluated. Intertek does not make any claims of compliance for samples or variants which were not evaluated. 2 Test Summary Section Test Full Name Result 5 FCC SAR Exclusion Calculation Exempt from SAR 6 RSS-102 SAR Exclusion Calculation Exempt from SAR Evaluation For: Ethicon Endo-Surgery Inc Product: Echelon, Model SAR Exclusion Report Date: 5/20/2022 Non-Specific EMC Report Shell Rev. December 2017 Page 5 of 9 Report Number: 104871091LEX-001b 3 Client Information This product was tested at the request of the following: Client Information Client Name: Ethicon Endo-Surgery Inc Address: 4545 Creek Rd. Cincinnati, OH 45242 USA Contact: Matt Cowperthwait Telephone: (513) 337-1120 Email: [email protected] Manufacturer Information Manufacturer Name: Ethicon Endo-Surgery Inc Manufacturer Address: 4545 Creek Rd. Cincinnati, OH 45242 USA Evaluation For: Ethicon Endo-Surgery Inc Product: Echelon, Model SAR Exclusion Report Date: 5/20/2022 Non-Specific EMC Report Shell Rev. December 2017 Page 6 of 9 Report Number: 104871091LEX-001b 4 Description of Equipment under Test and Variant Models Equipment Under Test Product Name Echelon TM Model Name ECH300060L Serial Number U95V3Z Receive Date 1/17/2022 Test Start Date 1/24/2022 Test End Date 2/24/2022 Device Received Condition Good Test Sample Type Production Rated Voltage 12VDC Frequency Band(s) 2400-2483.5MHz Modulation Type(s) GFSK Test Channel(s) 2402MHz, 2440MHz, 2480MHz Maximum Antenna Gain (dBi) 0.5dBi (Antenna AMCA31-2R450G-S1F-T3) Description of Equipment Under Test (provided by client) The Ethicon Echelon TM 3000 60mm Staplers - designed to deliver reliable performance across a wide range of tissue types and thicknesses on a one-handed, easy to use platform. 4.1 Variant Models: There were no variant models covered by this evaluation. Evaluation For: Ethicon Endo-Surgery Inc Product: Echelon, Model SAR Exclusion Report Date: 5/20/2022 Non-Specific EMC Report Shell Rev. December 2017 Page 7 of 9 Report Number: 104871091LEX-001…

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Intertek 731 Enterprise Drive Lexington, KY 40510 Tel 859 226 1000 Fax 859 226 1040 www.intertek.com Ethicon Endo-Surgery Inc TEST REPORT SCOPE OF WORK EMC TESTING – ECHELON REPORT NUMBER 104871091LEX-001.2 ISSUE DATE REVISION DATE 3/4/2022 10/3/2022 PAGES 36 DOCUMENT CONTROL NUMBER Non-Specific EMC Report Shell Rev. December 2017 © 2017 INTERTEK This report is for the exclusive use of Intertek's Client and is provided pursuant to the agreement between Intertek and its Client. Intertek's responsibility and liability are limited to the terms and conditions of the agreement. Intertek assumes no liability to any party, other than to the Client in accordance with the agreement, for any loss, expense or damage occasioned by the use of this report. Only the Client is authorized to copy or distribute this report and then only in its entirety. Any use of the Intertek name or one of its marks for the sale or advertisement of the tested material, product or service must first be approved in writing by Intertek. The observations and test results in this report are relevant only to the sample tested. This report by itself does not imply that the material, product, or service is or has ever been under an Intertek certification program. Intertek Testing Services NA, Inc. EMC TEST REPORT (FULL COMPLIANCE) Report Number: 104871091LEX-001.2 Project Number: G104871091 Report Issue Date: 3/4/2022 Report Revised Date: 10/3/2022 Model(s) Tested: ECH300060L Standards: Title 47 CFR Part 15.247 RSS-247 Issue 2 RSS-Gen Issue 5 Tested by: Client: Intertek Testing Services NA, Inc. 731 Enterprise Dr. Lexington, KY 40510 USA Ethicon Endo-Surgery Inc 4545 Creek Rd. Cincinnati, OH 45242 USA Report prepared by Report reviewed by Brian Lackey, Team Leader James Sudduth, Senior Staff Engineer Evaluation For: Ethicon Endo-Surgery Inc Product: Echelon TM 3000 EMC Test Report Date: 10/3/2022 Non-Specific EMC Report Shell Rev. December 2017 Page 3 of 36 Report Number: 104871091LEX-001.2 Table of Contents 1 Introduction and Conclusion ..................................................................................................................... 4 2 Test Summary .......................................................................................................................................... 4 3 Client Information .................................................................................................................................... 5 4 Description of Equipment under Test and Variant Models .......................................................................... 6 5 System Setup and Method ........................................................................................................................ 7 6 Receiver Spurious Emissions ..................................................................................................................... 8 7 Transmitter Spurious Emissions .............................................................................................................. 13 8 Output Power ........................................................................................................................................ 21 9 Occupied Bandwidth .............................................................................................................................. 23 10 Power Spectral Density ....................................................................................................................... 28 11 Conducted Spurious Emissions ............................................................................................................ 31 12 Antenna Requirement ........................................................................................................................ 35 13 Revision History ................................................................................................................................. 36 Evaluation For: Ethicon Endo-Surgery Inc Product: Echelon TM 3000 EMC Test Report Date: 10/3/2022 Non-Specific EMC Report Shell Rev. December 2017 Page 4 of 36 Report Number: 104871091LEX-001.2 1 Introduction and Conclusion The tests indicated in section 2.0 were performed on the product constructed as described in section 4.0. The remaining test sections are the verbatim text from the actual data sheets used during the investigation. These test sections include the test name, the specified test Method, a list of the actual Test Equipment Used, documentation Photos, Results and raw Data. No additions, deviations, or exclusions have been made from the standard(s) unless specifically noted. Based on the results of our investigation, we have concluded the product tested complies with the requirements of the standard(s) indicated. The results obtained in this test report pertain only to the item(s) tested. Intertek does not make any claims of compliance for samples or variants which were not tested. 2 Test Summary Section Test full name Result 6 Receiver Spurious Emissions (ANSI C63.4: 2014) Pass 7 Transmitter Spurious Emissions (FCC Part 15.247(d), RSS-247 Issue 2 § 5.5) Pass 8 Output Power (FCC Part 15.247(b)(3), RSS-247 Issue 2 § 5.4(d)) Pass 9 Occupied Bandwidth (FCC Part 15.247, RSS-247 Issue 2 § 5.2(a)) Pass 10 Power Spectral Density (FCC Part 15.247(e), RSS-247 Issue 2 § 5.2(b)) Pass 11 Conducted Spurious Emissions (FCC Part 15.247(d), RSS-247 Issue 2 § 5.5) Pass 12 Antenna Requirement (FCC Part 15.203, RSS-Gen Issue 5 § 6.8) Pass General Notes: The lowest internal operating frequency was 24MHz. Evaluation For: Ethicon Endo-Surgery Inc Product: Echelon TM 3000 EMC Test Report Date: 10/3/2022 Non-Specific EMC Report Shell Rev. December 2017 Page 5 of 36 Report Number: 104871091LEX-001.2 3 Client Information This product was tested at the request of the following: Client Information Client Name: Ethicon Endo-Surgery Inc Address: 4545 Creek Rd. Cincinnati, OH 45242 USA Contact: Matt Cowperthwait Email: [email protected]…

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Figure 1 Unintentional and radiated spurious emissions, 30MHz – 1GHz Figure 2 Unintentional emissions, 1GHz – 18GHz Figure 3 Radiated spurious emissions, 1GHz – 18GHz Figure 4 Radiated spurious emissions, 18GHz – 40GHz