2AYUW-RHC1EG1 Wireless Hand Control System

Page 1 of 17 ANSPACH™ EG1 TM WIRELESS HAND CONTROL SYSTEM General Information Device Description The eG1 Wireless Hand Control System consists of the non-sterile reusable Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) and the disposable Wireless Hand Control, EG1A (WIRELESS-HC) which is provided in a sterile package configuration. The Wireless Hand Control, EG1A communicates wirelessly through the Receiver for Wireless Hand Control, EG1A to allow the user to regulate the speed of the eG1 High Speed System. Intended Use The eG1 High Speed System is intended for cutting and shaping bone including the cranium and spine. Indications for Use The eG1 High Speed System is indicated for cutting and shaping bone including the cranium and spine. Contraindications The eG1 High Speed System does not have any known product specific contraindications. Potential Adverse Events As with all major surgical procedures, risks, side effects and adverse events can occur. The following potential adverse events can occur: • Infection • Adverse Tissue Reaction • Injury to Patient • Injury to User Intended User This device is intended to be used by qualified health care professionals e.g. surgeons, physicians, operating room staff, and individuals involved in preparation of the device. Patient Target Group The eG1 Wireless Hand Control System is for use with patients undergoing surgery where the cutting and shaping of bone, including bones of the cranium and spine, is desired. Catalog number & Compatibility Catalog Number Consoles Handpiece SC3001 SC3002 EG1A RECEIVER-HC ● ● WIRELESS-HC ● Page 2 of 17 Note: DePuy Synthes has not tested compatibility with devices provided by other manufacturers and assumes no liability in such instances. Cleaning and Sterilization Receiver for Wireless Hand Control, EG1A (RECEIVER-HC) Receivers are non-sterile capital equipment and shall always be maintained outside the Operating Room Sterile Field. Warning: Do not immerse or sterilize the receiver. 1. Disconnect receiver from console. 2. Clean receiver by wiping with non-abrasive cloth and neutral pH detergent and deionized, distilled, or purified water after each case. 3. Dry thoroughly with non-abrasive cloth. Wireless Hand Control, EG1A (WIRELESS-HC) Warning: Do not reprocess the Hand Control. Hand Controls are disposable and SINGLE USE ONLY. Reprocessing hand controls may result in loss of function causing delay in surgery. The Hand Control is provided sterile. Remove product from the package using established operating room procedures for sterile transfer. Store sterile devices in their original protective packaging, and do not remove them from the packaging until immediately before use. Prior to use, check the product expiration date and verify the integrity of the sterile packaging. Do not use if the package is damaged. Explanation of Symbols Used General Symbols Direction of motion Reference or Catalogue Number (Ref. 5.1.6 ISO 15223-1) Consult Instructions for Use (Ref. 5.4.3 ISO 15223-1) Materials Caution: United States Federal law restricts this device to sale by or on the order of a physician or other licensed health-care provider (21 CFR 801.109) Date of Manufacture Manufacturer (Ref. 5.1.1 and 5.1.3 ISO15223-1) Product is ETL listed to the requirements of US and Canada Keep dry (Ref. 5.3.4 ISO 15223-1) Locked Do not use if package is damaged. (Ref. 5.2.8 ISO 15223-1) Unlocked Page 3 of 17 Non-ionizing electromagnetic radiation. (IEC 60417-5140) Transmitter Interference may occur in the vicinity of equipment marked with this symbol. CAUTION (Ref. 5.4.4 ISO 15223-1) Non-Sterile Ref. 5.2.7 ISO 15223-1 Made in Single sterile barrier system with protective packaging inside (Ref. 5.2.13 ISO 15223-1) Packaging Unit - Indicates the number of pieces in the package (ISO 7000- 2794) Sterilized using ethylene oxide (Ref. 5.2.3 ISO 15223-1) Unique Device Identifier Use-by Date (Ref. 5.1.4 ISO 15223- 1) Lot or Batch Number (Ref. 5.1.5 ISO 15223-1) Temperature Limit ((Ref. 5.3.7 ISO 15223-1) Humidity Limitation (Ref. 5.3.8 ISO 15223-1) Ingress protection rating according IEC 60529 Do not re-use (Ref. 5.4.2 ISO 15223-1) FCC Symbol Follow instructions for use (ISO 7010- M002) Warnings • Surgeon is responsible for learning proper techniques in use of equipment; improper use may cause serious injury to user or patient or damage to system. • Instrument operator and all operating room personnel must wear eye protection. • Do not use if product package has been damaged or opened. • Do not use if the product sterilization barrier or its packaging is compromised. • Visually inspect device/components for damage before using; do not use if damage or wear is evident (unrecognizable markings, missing or removed part numbers, corrosion, etc.). • MR Unsafe—Not for use in Magnetic Resonance Imaging (MRI) environments. • Do not use excessive force. • Wireless Hand Control, EG1A is disposable and intended for single patient use only. • Do not re-sterilize or reuse Wireless Hand Control, EG1A: reuse and/or re-sterilization • Do not modify. Modifications could result in loss of electrical safety. • Faulty devices must not be used. Refer to the section “Disposal of Waste”. • Do not operate in an explosive flammable environment. • Wireless Hand Control, EG1A is only compatible with eG1 Handpiece and Console (SC3001, SC3002). Using other than indicated high speed system may lead to injury. • Receiver for Wireless Hand Control, EG1A and console must be maintained outside sterile field. • Keep Wireless Hand Control, EG1A safety cover in locked position when not in use • Medical Electrical Equipment needs special precautions regarding Electromagnetic Compatibility (EMC) and needs to be installed and put into service according to the EMC information provided in this accompanying documentation. • The emissions characteristics of this equipment make it suitable for use in industrial areas and Page 4 of 17 of the hand control could result in reduced per…

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1(1) 02/02/2022 Attention: Application Examiner RE: Request for Confidentiality Applicant: DepuySynthes Power Tools FCC ID: 2AYUW-WHC1 To Whom It May Concern: Short-term Confidentiality Request is hereby submitted by DepuySynthes Power Tools to withhold from public review for a period of 180 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 180 days from the date of Authorization: • User manual • Internal photos Permanent Confidentiality Request is hereby submitted by DepuySynthes Power Tools 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 Operational/Functional Description • Block Diagram Rationale for request for confidentiality: DePuy Synthes Power Tools 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. 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,

01/06/2022 Federal Communications Commission 445 12 th Street SW Washington, DC 20554 Subject: Limited Agency Agreement DepuySynthes Power Tools FCC ID: 2AYUW-RHC1 To Whom It May Concern: We, DepuySynthes Power Tools, hereby authorized Intertek Testing Services to act as our Agent for the purpose of preparing application for FCC ID number 2AYUW-RHC1 under all applicable parts of the FCC rules and regulations. The effective date of this limited agency agreement is 01/06/2022. The Limited Agency Agreement expires on 01/06/2023, 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,

RECEIVER-HC, EXTERNAL PHOTOS - ALL SIDES:

1 of 1 Receiver for Wireless Hand Control, EG1A - RECEIVER-HC FCC-ID: 2AYUW-RHC1 FCC ID laser marked location on product – shown with reference dimensions below

INTERNAL PHOTOS, RECEIVER-HC: Molex header J3 connects to the Connector cable RF section: Antenna chip AE1 and Balun B1 Component Placement

DePuy Synthes Products, Inc. TEST REPORT SCOPE OF WORK Emissions testing on the Transceiver (Console Receiver), Model EG1A, for Wireless Hand Control REPORT NUMBER 104697163BOX-018a ISSUE DATE [REVISED DATE] November 17, 2021 Original Issue DOCUMENT CONTROL NUMBER Non-Specific Radio Report Shell Rev. December 2017 © 2017 INTERTEK Non-Specific Radio Report Shell Rev. December 2017 Page 2 of 56 DePuy Synthes Products Inc. – Transceiver (Console Receiver), Model: EG1A EMISSIONS TEST REPORT (FULL COMPLIANCE) Report Number: 104697163BOX-018a Project Number: G104697163 Report Issue Date: November 17, 2021 Model(s) Tested: Transceiver (Console Receiver), Model EG1A Model(s) Partially Tested: None Model(s) Not Tested but declared equivalent by the client: None Standards: CFR47 FCC Part 15.247 Subpart C: 10/2021, CFR47 FCC Part 15 Subpart B: 10/2021, RSS-247 Issue 2 February 2017, ISED ICES-003 Issue 7 October 15, 2020, RSS-Gen Issue 5 April 2018 +Amendment 1 March 2019, RSS-102 Issue 5 March 2015 (Permissive Change) Tested by: Client: Intertek Testing Services NA, Inc. 70 Codman Hill Road Boxborough, MA 01719 USA DePuy Synthes Products Inc. 4500 Riverside Drive Palm Beach Gardens, FL 33410 USA Report prepared by Report reviewed by Kouma Sinn / EMC Engineering Supervisor Vathana Ven / EMC Engineering Supervisor 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 permit copying or distribution of 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 Report Number: 104697163BOX-018a Issued: 11/17/2021 Non-Specific Radio Report Shell Rev. December 2017 Page 3 of 56 DePuy Synthes Products Inc. – Transceiver (Console Receiver), Model: EG1A Table of Contents 1 Introduction and Conclusion ........................................................................................... 4 2 Test Summary ...................................................................................................................... 4 3 Client Intrformation ............................................................................................................. 5 4 Description of Equipment Under Test and Variant Models ..................................... 5 5 System Setup and Method ................................................................................................ 6 6 Maximum Peak Output Power and Human RF exposure ......................................... 8 7 6 dB Bandwidth and Occupied Bandwidth ................................................................ 12 8 Maximum Power Spectral Density ................................................................................ 18 9 Band Edge Compliance ................................................................................................... 22 10 Transmitter spurious emissions ................................................................................ 29 11 Digital Device and Receiver Radiated Spurious Emissions ............................... 44 12 AC Mains Conducted Emissions ............................................................................... 51 13 Revision History ............................................................................................................. 56 Intertek Report Number: 104697163BOX-018a Issued: 11/17/2021 Non-Specific Radio Report Shell Rev. December 2017 Page 4 of 56 DePuy Synthes Products Inc. – Transceiver (Console Receiver), Model: EG1A 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 3 Client Information -- 4 Description of Equipment Under Test and Variant Models -- 5 System Setup and Method -- 6 Maximum Peak Output Power and Human RF exposure CFR47 FCC Part 15 Subpart C:10/2021, Section 15.247 (b)(3) RSS-247 Issue 2 February 2017, RSS-102 Issue 5 March 2015 Pass 7 6 dB Bandwidth and Occupied Bandwidth CFR47 FCC Part 15 Subpart C: 10/2021, Section 15.247 (a)(2) RSS-247 Issue 2 February 2017 Pass 8 Maximum Power Spectral Density CFR47 FCC Part 15 Subpart C: 10/2021, Section 15.247 (e) RSS-247 Issue 2 February 2017 Pass 9 Band Edge Compliance CFR47 FCC Part 15 Subpart C: 10/2021, Section 15.247 (d) RSS-247 Issue 2: 02/2017) Pass 10 Transmitter spurious emissions CFR47 FCC Part 15 Subpart C: 10/2021, Section 15.247 (d) RSS-247 Issue 2 February 2017 Pass 11 Digital Device and Receiver Radiated Spurious Emissions (CFR47 FCC Part 15 Subpart B 15.109: 10/2021, ISED ICES-003 Issue 7 October 15, 2020 Pass 12 AC Mains Conducted Emissions FCC …

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Intertek Report Number: 104697163BOX-018a Issued: 11/17/2021 Non-Specific Radio Report Shell Rev. December 2017 Page 10 of 40 DePuy Synthes Products Inc. – Transceiver (Console Receiver), Model: EG1A 6.4 Setup Photographs: Intertek Report Number: 104697163BOX-018a Issued: 11/17/2021 Non-Specific Radio Report Shell Rev. December 2017 Page 16 of 40 DePuy Synthes Products Inc. – Transceiver (Console Receiver), Model: EG1A 7.4 Setup Photographs: Radiated Emissions Test Setup, 30-1000 MHz Radiated Emissions Test Setup, 1-13 GHz Intertek Report Number: 104697163BOX-018a Issued: 11/17/2021 Non-Specific Radio Report Shell Rev. December 2017 Page 17 of 40 DePuy Synthes Products Inc. – Transceiver (Console Receiver), Model: EG1A Radiated Emissions Test Setup, 13-18 GHz Intertek Report Number: 104697163BOX-018a Issued: 11/17/2021 Non-Specific Radio Report Shell Rev. December 2017 Page 18 of 40 DePuy Synthes Products Inc. – Transceiver (Console Receiver), Model: EG1A Radiated Emissions Test Setup, 18-25 GHz Intertek Report Number: 104697163BOX-018a Issued: 11/17/2021 Non-Specific Radio Report Shell Rev. December 2017 Page 31 of 40 DePuy Synthes Products Inc. – Transceiver (Console Receiver), Model: EG1A 8.4 Setup Photographs: Radiated Emissions Test Setup, 30-1000 MHz Radiated Emissions Test Setup, 1-13 GHz Intertek Report Number: 104697163BOX-018a Issued: 11/17/2021 Non-Specific Radio Report Shell Rev. December 2017 Page 37 of 40 DePuy Synthes Products Inc. – Transceiver (Console Receiver), Model: EG1A 9.4 Setup Photographs: