PX2-GMCHG116000

Charging System For Eterna™ Spinal Cord Stimulation System Model 16000 User's Guide CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician. WARNING: This product can expose you to chemicals including ethylene oxide, which is known to the State of California to cause cancer and birth defects or other reproductive harm. For more information, go to www.P65Warnings.ca.gov. ™ Indicates a trademark of the Abbott group of companies. ‡ Indicates a third-party trademark, which is property of its respective owner. Bluetooth and Bluetooth logo are registered trademarks of Bluetooth SIG, Inc. Pat. ht t p: // www. abbot t. com/ pat ents © 2022 Abbott. All Rights Reserved. i Contents A bo ut Thi s G ui de ..............................................................................1 Prescription and Safety Information .......................................................1 Intended Use ...............................................................................1 Indication for Use .........................................................................1 Contraindications ..........................................................................1 Additional Prescription Information ...................................................1 MRI Safety Information ..................................................................1 Warnings.....................................................................................2 Precautions .................................................................................3 Adverse Effec ts.............................................................................4 Product Description ...........................................................................4 Charger Indicators .............................................................................7 Using Your Charge r............................................................................8 Pairing the Charger with the Patient Controller ....................................8 When to Charge Your Generator .......................................................9 Charging Your Charger ................................................................. 10 Setting Up the Charging Apparel .................................................... 12 Charging Your Generator .............................................................. 17 Caring for and Maintaining Your Charger and Charging Apparel ............ 18 Traveling with Your Charging System............................................... 19 Troubleshooting .............................................................................. 20 Troubleshooting Charging Issues .................................................... 20 Service and Ordering Information........................................................ 23 Technical Support....................................................................... 23 Ordering Information ................................................................... 24 Appendix A: Regulatory Statements..................................................... 25 Disposal Guidelines for Battery-Powered Devices ............................... 25 Statement of FCC Compliance ....................................................... 25 Statement of Compliance With Interference-Causing Equipment Standard (Canada).................................................................... 26 Product Classification Statement (CISPR 11, Class B)......................... 26 I de ntification Information for Product Registration .............................. 26 Wireless Technology Information .................................................... 26 Quality of Service for Wireless Technology ........................................ 27 Wireless Security Measures ........................................................... 28 Troubleshooting for Wireless and Coexistence Issues .......................... 28 Appendix B: Product Specifications..................................................... 29 Appendix C: Technical Specifications .................................................. 30 Appendix D: Electromag net ic Com pa t i bi l ity Guidelines ............................ 31 ii Appendix E: Symbols and Definitions ................................................... 37 1 About This Guide This gu ide explains how to use the charging syst em (Model 16000 and charging system accessories). Follow the infor mation in this guide to correctly use your charging system. If you have any questions about your system, contact Technic al Support. Prescription and Safety Information Read this section to gather important prescription and safety info rma tion. Intended Use The charging system is intended to be used to charge the Eterna™ implanta ble pulse generator (IPG), also r eferred to as a generator. Indication for Use The Eterna™ Spinal Cord St imula tion (SCS) System is indicated a s an aid in the management of chronic, intrac table pain of the trunk and/or limbs, including unilate ral or bilateral pain associat ed with the following: failed back surgery syndrome and intractable low back and leg pain. Contraindications The Eterna™ SCS System is contraindicated for patients who are unable to operate the system. Additionally, the system is contraindicated for patients who have failed to receive effective pain re lief duri ng trial stimulation. Additional Prescription Information Refer to the user’s guide for your patient co ntroller for instructions for use a nd other important information, including indication for use, contra indications, warnings, precautions, adver se effects, and the personal identification card related to your neurostimulation system. MRI Safety Information Do not bring your charger into the scanner magnet room. It can be affected by the magnetic resonance imaging (MRI) magnet, may present a projectile ha zar d, and is considered MR Unsafe. 2 Warnings The fol lo wing warnings apply to this charging system: Device ins…

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Abbott Laboratories Neuromodulation 6901 Preston Rd. Plano, TX 75024 800-727-7846 10 January 2023 Element Materials Technology 6775 NE Evergreen Pkwy #400 Hillsboro, OR 97124 FCC ID: PX2-GMCHG1 To whom it may concern, We, Abbott Laboratories (Neuromodulation Division 6901 Preston Road, Plano, TX 75024), are submitting an equipment authorization for an Original certification for the following model which is part of a neurostimulation therapy system. Details of the model name variations, system compatibility and system functionality can be found within the operational description and mandardual (IFU). This system has been approved by the FDA under P010032 S186 and the implantable portion of the system, which is a spinal cord stimulation device that is the world’s smallest implantable, rechargeable spinal cord stimulator currently available for the treatment of chronic pain, has been approved under FCC ID PX2- GMIPG1 Charger Model 16000 Rule part 15.247 is applicable since it uses Bluetooth Low Energy technology as described in KDB 558074 Section 8. The product operates at 0dBm or less when factoring in low duty cycle operation. The Charger is an external device that operates near the torso by recharging an implanted IPG. Rule part 18 is applicable to the charger as well since it produces wireless power energy in the range of 266 kHz-320kHz and follows the characteristics of KDB 680106 Section 5. Power levels are 1.3 Watts or less. Manasi Khare Director, Regulatory Affairs

Abbott Laboratories Neuromodulation 6901 Preston Rd. Plano, TX 75024 800-727-7846 Date: 18-JAN 2023 Subject: Confidentiality Request for FCC ID: PX2- GMCHG1 Pursuant to FCC 47 CRF 0.457(d) and 0.459 and IC RSP-100, Section 10, the applicant requests that a part of the subject FCC/IC application be held confidential. Type of Confidentiality Requested Exhibit ☐ Short Term ☒ Permanent All Block Diagrams ☐ Short Term ☒ Permanent Bill of Materials ☒ Short Term ☐ Permanent External Photos ☒ Short Term ☐ Permanent Test Setup Photos ☐ Short Term ☒ Permanent Internal Photos ☐ Short Term ☒ Permanent Operation Description/Theory of Operation ☐ Short Term ☒ Permanent All Schematics ☒ Short Term ☐ Permanent User’s Manuals ☐ Short Term ☒ Permanent Assembly Drawings Abbott Neuromodulation has spent substantial effort in developing this product that showcase significant features and improvements from current products. Having the subject information easily available to "competition" would negate the advantage they have achieved by developing this product. Not protecting the details of the design will result in financial hardship. The applicant also requests permanent confidentially for internal photos as allowed by KDB 726920 Section II.3. The circuitry is not accessible to the user and will be permanently housed in a hermetically sealed enclosure created by an ultrasonic weld that is equivalent or better than epoxy. Permanent Confidentiality: The applicant requests the exhibits listed above as permanently confidential be permanently withheld from public review due to materials that contain trade secrets and proprietary information not customarily released to the public. Short-Term Confidentiality: The applicant also requests that the exhibits listed 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. Applicant is also aware that they are responsible to notify Element in the event information regarding the product or the product is made available to the public. Element will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. Sincerely, By: __________________________ _Manasi Khare____________________ Director, Regulatory Affairs (Print name)

Eterna Charger Abbott Medical 6901 Preston Road Plano TX 75024 USA REF Label_PN 16000 FCC ID: PX2-GMCHG1 IP22 TM ZFIN_PN Page 15 of 142 Report No. 104606891BOX-001 IEC 60601-1 Clause Requirement + Test Result - Remark Verdict TRF No. IEC60601_1S CLASS II ME EQUIPMENT, externally powered Pass INTERNALLY POWERED ME EQUIPMENT Pass EQUIPMENT with means of connection to a SUPPLY MAIN S complied with CLASS I or CLASS II ME EQUIPMENT requirements when so connected, and when not co nnected to SUPPLY MAINS with INTERNALLY POWERED ME EQUIPMENT requirements Pass TYPE B APPLIED PART TYPE BF APPLIED PART N/A TYPE BF APPLIED PART Pass TYPE CF APPLIED PART N/A DEFIBRILLATION-PROOF APPLIED PARTS N/A 6.3 ENCLOSURES classified according to degree of protection against ingress of wate r and particulate matter as per IEC 60529........................................ : Rated IP22 Pass 6.4 ME EQUIPMENT or its parts intended to be sterilized classif ied according to method(s) of sterilization in instructions for use ................................................. : Not intended to be sterilized N/A 6.5 ME EQUIPMENT and ME SYSTEMS intended for use in an OXYGEN RICH ENVIRONMENT classified for such use and complied with 11.2.2 Not intended for use in an OXYGEN RICH ENVIRONMENT N/A 6.6 CONTINUOUS or Non-CONTINUOUS OPERATION ........ : CONTINUOUS OPERATION Pass 7 ME EQUIPMENT IDENTIFICATION, MARKING, AND DOCUMENTS 7.1.2 Legibility of Markings Test for Markings specified in Clause 7.2-7.6 ......................................................... : See Appended Table 7.1.2 Pass 7.1.3 Required markings can be removed only with a TOOL or by appreciable force, are durable and remain CLEARLY LEGIBLE during EXPECTED SERVICE LIFE of ME EQUIPMENT in NORMAL USE See appended Tables 7.1.3 and 8.10 Pass 7.2 Marking on the outside of ME EQUIPMENT or ME EQUIPMENT parts Pass 7.2.1 At least markings in 7.2.2, 7.2.5, 7.2.6, 7.2.10, and 7.2.1 3 were applied when size of EQUIPMENT, its pa rt, an ACCESSORY, or ENCLOSURE did not permit application of all required markings .................... : See attached copy of Marking Plate Pass Remaining markings fully recorded in ACCOMPANYING DOCUMENTS.................................. : Equipment marked N/A Markings applied to individual packaging when impractical to apply to ME EQUIPMENT Equipment marked N/A Single use item marked ......................................... : Adhesive patch marked single use Pass 7.2.2 ME EQUIPMENT marked with: Pass – the name or trademark and contact information of the MANUFACTURER Pass – a MODEL OR TYPE REFERENCE See attached copy of Marking Plate Pass – a serial number or lot or batch identifier; and Etched on the device and also included on the package markings Pass – the date of manufacture or use by date N/A Detachable components of the ME EQUIPMENT not marked; misidentification does not presen t an unacceptable risk, or USB Cable considered. Misi dentification does not present an unacceptable RISK. Pass

Eterna Charger Abbott Medical 6901 Preston Road Plano TX 75024 USA REF Label_PN 16000 FCC ID: PX2-GMCHG1 IP22 TM ZFIN_PN

Abbott Laboratories Neuromodulation 6901 Preston Rd. Plano, TX 75024 800-727-7846 Antenna Info (Charger) Bluetooth P/N 2450AT43A100 SMD Chip antenna manufactured by Johanson Technology, Inc 2.0 dBi The antenna meets FCC 15.203 requirements by being an integra antenna soldered into the system. All components are enclosed within a sealed/welded enclosure with no user removeable parts. Coil info (Charger) Wireless Power Transfer (WPT) Custom 40 Turn coil manufactured by Abbott supplier The coil is soldered into the system. All components are enclosed within a sealed/welded enclosure with no user removeable parts. Abbott Laboratories Neuromodulation 6901 Preston Rd. Plano, TX 75024 800-727-7846

2.45 GHz SMD Chip AntennaP/N 2450AT43A100 Detail Specification: Page 1 of 6 Part NumberInput Power Frequency RangeImpedance Peak GainOperating Temperature Average GainReel Quanity Return Loss Part Number Explanation BulkSuffix = S T & RSuffix = E 100% Tin Suffix = None Tin / LeadPlease Consult Factory Mechanical Dimensions ±± ±± ++ ±± Mounting Considerations - Vertical Mounting Johanson Technology, Inc. reserves the right to make design changes without notice. All sales are subject to Johanson Technology, Inc. terms and conditions. www.johansontechnology.com 4001 Calle Tecate • Camarillo, CA 93012 • TEL 805.389.1166 FAX 805.389.1821 Ver 1.12012 Johanson Technology, Inc. All Rights Reserved High Frequency Ceramic Solutions 2450AT43A100 1/11/2013 2W max. 50 Ω2400 - 2500 Mhz General Specifications - Vertical Mounting T No. Function 1 Signal Feed Terminal NC (To be used as Anchoring to PCB)0.20 0.1/-0.2 2 7.00L 0.008 P/N Suffix Terminal Configuration -40 to +85°C 1,000 eg. 2450AT43A100S eg. 2450AT43A100E eg. 2450AT43A100 (E or S) 2.0 dBi typ. (XZ-V) 0.5 dBi typ. (XZ-V) 9.5 dB min. Packing Style Termination style 0.50 0.276 W a mm 0.008 1.20 2.00 In 0.079 0.047 0.020 0.20 0.300.012 .004/-.008 1 2 L W a T * GND Plane GND Plane 2.0 5.5 8.0 1.0 0 Note: Matching components may be needed when designing into a PCB so, make sure to leave a shunt-series- shunt or "pi" network available space/footprint when laying out. More info: http://johansontechnology.com/tuning Mount these devices with brown mark facing up. Units: mm * Line width should be designed to provide 50 Ω impedance matching characteristics. 2.45 GHz SMD Chip AntennaP/N 2450AT43A100 Detail Specification: Page 2 of 6 Test Board of Vertical Mounting style, p/n: 2450AT43A100-EB1SMA * This 50ohm trace to the antenna can be shorten (considerably) to suit your PCB space constraints Johanson Technology, Inc. reserves the right to make design changes without notice. All sales are subject to Johanson Technology, Inc. terms and conditions. www.johansontechnology.com 4001 Calle Tecate • Camarillo, CA 93012 • TEL 805.389.1166 FAX 805.389.1821 Ver 1.12012 Johanson Technology, Inc. All Rights Reserved High Frequency Ceramic Solutions 1/11/2013 Typical Electrical Characteristics (T=25°C) ) ) ) 40mm Return Loss Antenna No Ground Ground 20mm 19mm 40mm 9.5m 50Ω Feed Line 0Ω 2.45 GHz SMD Chip AntennaP/N 2450AT43A100 Detail Specification: Page 3 or 6 Johanson Technology, Inc. reserves the right to make design changes without notice. All sales are subject to Johanson Technology, Inc. terms and conditions. www.johansontechnology.com 4001 Calle Tecate • Camarillo, CA 93012 • TEL 805.389.1166 FAX 805.389.1821 Ver 1.12012 Johanson Technology, Inc. All Rights Reserved High Frequency Ceramic Solutions 1/11/2013 Typical Electrical Characteristics (T=25°C) Typical Radiation Patterns on Test Board of Vertical Mounting p/n: 2450AT43A100-EB1SMA ) XY-V/XY-H 180° 270° 0° 90° X Z Y XY-cut scanning direction XY cut @2.45GHz Vertical Horizontal XZ-V/XZ-H YZ-V/YZ-H 180° 270° 0° 90° X Z Y XZ-cut scanning direction 180° 270° 0° 90° X Z Y YZ-cut scanning direction XZ cut @2.45GHz Vertical Horizontal YZ cut @2.45GHz Vertical Horizontal 2.45 GHz SMD Chip AntennaP/N 2450AT43A100 Detail Specification: Page 4 of 6 Part NumberInput Power Frequency RangeImpedance Peak GainOperating Temperature Average GainReel Quanity Return Loss Mounting Considerations - Horizontal Mounting Johanson Technology, Inc. reserves the right to make design changes without notice. All sales are subject to Johanson Technology, Inc. terms and conditions. www.johansontechnology.com 4001 Calle Tecate • Camarillo, CA 93012 • TEL 805.389.1166 FAX 805.389.1821 Ver 1.12012 Johanson Technology, Inc. All Rights Reserved 2400 - 2500 Mhz50 Ω High Frequency Ceramic Solutions 1/11/2013 General Specifications - Horizontal Mounting 2450AT43A1002W max. 2.0 dBi typ. (XZ-V)-40 to +85°C 1.0 dBi typ. (XZ-V)1,000 9.5 dB min. Note: Matching components might be needed when design into a PCB so, make sure to leave a shunt-series- shunt or "pi" network available space/footprint when laying out. More info: http://johansontechnology.com/tuning Mount these devices with brown mark facing up. Units: mm * Line width should be designed to provide 50 Ω impedance matching characteristics. 5.5 8.0 1.0 2.0 0 Ohm GND * GND 6.8 2.45 GHz SMD Chip AntennaP/N 2450AT43A100 Detail Specification: Page 5 of 6 Test Board of Horizontal Mounting style, p/n: 2450AT43A100-EB2SMA * This 50ohm trace to the antenna can be shorten (considerably) to suit your PCB space constraints Johanson Technology, Inc. reserves the right to make design changes without notice. All sales are subject to Johanson Technology, Inc. terms and conditions. www.johansontechnology.com 4001 Calle Tecate • Camarillo, CA 93012 • TEL 805.389.1166 FAX 805.389.1821 Ver 1.12012 Johanson Technology, Inc. All Rights Reserved High Frequency Ceramic Solutions 1/11/2013 Typical Electrical Characteristics (T=25°C) ) Return Loss 9.5mm Ground 20mm 40mm No Ground 50Ω Feed Trace (CPWG) 40mm 5mm 9mm Matching Circuit 2.5mm 2.45 GHz SMD Chip AntennaP/N 2450AT43A100 Detail Specification: Page 6 or 6 Johanson Technology, Inc. reserves the right to make design changes without notice. All sales are subject to Johanson Technology, Inc. terms and conditions. www.johansontechnology.com 4001 Calle Tecate • Camarillo, CA 93012 • TEL 805.389.1166 FAX 805.389.1821 Ver 1.12012 Johanson Technology, Inc. All Rights Reserved High Frequency Ceramic Solutions 1/11/2013 Typical Electrical Characteristics (T=25°C) Typical Radiation Patterns on Test Board of Vertical Mounting p/n: 2450AT43A100-EB2SMA ) XY-V/XY-H 180° 270° 0° 90° X Z Y XY-cut scanning direction XY cut @2.45GHz Vertical Horizontal XZ-V/XZ-H YZ-V/YZ-H 180° 270° 0° 90° X Z Y XZ-cut scanning direction 180° 270° 0° 90° X Z Y YZ-cut scanning direction XZ cut @2.45GHz Vertical Horizontal YZ cut @2.45GHz Vertical Horizontal

Abbott Laboratories Neuromodulation 6901 Preston Rd. Plano, TX 75024 800-727-7846 Antenna Info (Charger) P/N 2450AT43A100 SMD Chip antenna manufactured by Johanson Technology, Inc 2.0 dBi The antenna meets FCC 15.203 requirements by being an integra antenna soldered into the system. All components are enclosed within a sealed/welded enclosure with no user removeable parts.

Abbott Laboratories Neuromodulation 6901 Preston Rd. Plano, TX 75024 800-727-7846 FCC SAR and RF Exposure Evaluation Report For Abbott Laboratories Neuromodulation 6901 Preston Rd. Plano, TX 75024 Report Number: 90976808 Appendix D Date: 24 JAN 2023 Prepared by: Luke Snow, Senior Design/Product Development Engineer Jeremiah Darden, Senior Development Quality Engineer MODEL: 16000 CHARGER PRODUCT TYPE: PORTABLE WIRELESS POWER TRANSFER DEVICE Abbott Laboratories Neuromodulation 6901 Preston Rd. Plano, TX 75024 800-727-7846 Summary of Evaluation ............................................................................................................................. 3 Objective ............................................................................................................................................... 3 Computational Summary Results .......................................................................................................... 6 SAR RF Exposure Evaluation...................................................................................................................... 7 Overview ............................................................................................................................................... 7 Compliance with FCC 2.1093 ................................................................................................................ 7 Limits ..................................................................................................................................................... 7 Assessment ........................................................................................................................................... 8 Measurement Uncertainty .................................................................................................................. 17 Code Verification and Validation ........................................................................................................ 34 Evaluation Process and Results ........................................................................................................... 36 END OF DOCUMENT ................................................................................................................................ 44 Definitions RSS Root Sum Square W Watts A/m Amps per meter dB decibel dBm decibel-milliwatts cm centimeters Mm millimeters In inches kHz kilohertz Hz Hertz RMS Root Mean Squared V/m Volts per meter W/kg Watts per kilogram WPT Wireless Power Transfer IPG Implantable Pulse Generator FEM Finite Element Method Abbott Laboratories Neuromodulation 6901 Preston Rd. Plano, TX 75024 800-727-7846 Summary of Evaluation Standards Specification Method Notes FCC 2.1093:2022 FCC Inquiry SPR-002 Issue 2 Per 2.1093 Radiofrequency radiation exposure evaluation: portable devices. (d)The SAR limits specified in § 1.1310(a) through (c) of this chapter shall be used for evaluation of portable devices transmitting in the frequency range from 100 kHz to 6 GHz. Overall Results Method Clause Description Applied Result Comments 1.1307 (b) (1) (i) (B) SAR Evaluation for human RF exposure pursuant to § 1.1310 using Computational Analysis. KDB 865664 D02 RF Exposure Reporting v01r02 Yes Pass Method from FCC Inquiry for ICES SPR-002 Numerical Computational SAR for Head/Torso. FCC 1.1310 (c) limit applied. Executive Summary Computational analysis using finite element method was used to simulate the specific absorption rate over one gram of tissue with passing results. The computational process from the listed methods includes identifying the exposure conditions of the device under test, building the model within the code validated simulation software and then validating the model with actual measurements using an H-field loop probe. Once the measurement uncertainty was established, the computational simulation was performed, and the results were compared to the limits specified within this document. All applicable results passed. Objective Show SAR compliance for Wireless Power Transfer device operating below 4MHz. Abbott Laboratories Neuromodulation 6901 Preston Rd. Plano, TX 75024 800-727-7846 EUT Use-C ases and key RF exposure conditions SUMMARY: The following RF Exposure conditions are used for the assessment documented in this report Intended Use Portable Location on Body Torso How is the Device Used < 20cm, on the body Radio Under Evaluation WPT (266kHz-320kHz) Body Worn Accessories The charging apparel (model 16750 or 16760) are intended to secure the Gemini Charger (model 16000) at the pulse generator implant location. The accessories are made of spandex and fabric and do not include any RF shielding. Environment General Population/Uncontrolled Exposure Product Description and Intended Use The portable charger is a wireless power transfer device (WPT) that employs charging frequencies between 266 kHz and 320 kHz. When initially powered on, the charger sweeps across the frequencies from 320 kHz down to 266 kHz, with the peak output power achieved at approximately 280 kHz. The frequency continues sweeping until the charger is aligned over the IPG and begins actively charging. Once actively charging, the frequency is fixed at a constant narrowband wavelength. If an IPG is not aligned within a couple minutes, the charger will shut off and any WPT signals are discontinued. Typical IPG charging time ranges from 30min to typical overnight period of 7 hours. Rated power delivered to inductive coil: 1.3 Watts Power accuracy: +/- 0.5 dB Frequency of operation: 266 kHz – 320 kHz Duty cycle: 100% duty cycle Largest Product Dimension: 3.9 inches Charger Intended Use Charger: The charging system is intended to be used to charge the Gemini rechargeable implantable pulse generator (IPG), also referred to as a generator. The charging apparel ( model 16750 or 16760) are intended to secure the Gemini Charger (model 16000) at the pulse generator implant location. 1 Abbott La…

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Abbott Laboratories Neuromodulation 6901 Preston Rd. Plano, TX 75024 800-727-7846 06 January 2023 Element Materials Technology 6775 NE Evergreen Pkwy #400 Hillsboro, OR 97124 FCC ID: PX2-GMCHG1 Charger Model 16000 To whom it may concern, We, Abbott Laboratories (Neuromodulation Division 6901 Preston Road, Plano, TX 75024), are providing this RF Exposure Assessment letter to show compliance to the FCC 1.1310 rule part. This summary uses data from Element Report “ABBO0075.1” and Abbott Report “90976808” to satisfy FCC 47 CFR 1.1307(b)(3)(ii)(B) for multiple RF sources operating in the same time-averaging period. EUT Use-Cases and key RF exposure conditions SUMMARY: The following RF Exposure conditions are used for the assessment documented in this report Intended Use Portable Location on Body Torso How is the Device Used < 20cm, on the body Radios WPT (266kHz-320kHz) Bluetooth Low Energy (2402 – 2483.5 MHz) Body Worn Accessories The charging apparel (model 16750 or 16760) are intended to secure the Gemini Charger (model 16000) at the pulse generator implant location. The accessories are made of spandex and fabric and do not include any RF shielding. Environment General Population/Uncontrolled Exposure Abbott Laboratories Neuromodulation 6901 Preston Rd. Plano, TX 75024 800-727-7846 Overview With respect to the limits on human exposure to RF emissions provided in 47 CFR 1.1310, if the equipment can be shown to qualify for an exemption pursuant to 47 CFR 1.1307(b)(3)(ii)(B) for multiple RF sources, additional evaluation is not required. Compliance with FCC 1.1310 Abbott Laboratories Neuromodulation 6901 Preston Rd. Plano, TX 75024 800-727-7846 Abbott Laboratories Neuromodulation 6901 Preston Rd. Plano, TX 75024 800-727-7846 Assessment Computational SAR per FCC 2.1093 and FCC KDB Inquiry values were used in these calculations. Radio Transmit Frequency (kHz) Duty Cycle Worse Case Separation Computational SAR Exposure (W/kg) Limit (W/kg) Ratio WPT: 266-320kHz 280 100% 0.32 0.11 1.6 0.07 Max Ratio 0.07 The rated values were used in these calculations. The rated power was provided by Abbott in the RF Exposure documentation. Duty Cycle is limited by design. See operational description for Low Duty Cycle Analysis included with submission. Radio Transmit Frequency (MHz) Conducted Output Power (dBm) Power Tolerance (dB) Duty Cycle Antenna Assembly Gain Minimum Separation Distance (cm) Calculated Radiated Exposure Power (mW) ERP Calculated Conducted Exposure Power (mW) Limit (mW) Ratio BTLE: 2402 – 2483.5 2402 0 4 14.1 2 0.32 0.3 0.4 2.8 0.13 Max Ratio 0.13 Sum of Maximum Ratios Limit Compliant 0.20 1 Yes Jeremiah Darden Senior Development Quality Engineer

This report must not be used to claim product certification, approval, or endorsement by A2LA or any agency of the U.S. Government. This Report shall not be reproduced, except in full without written approval of the laboratory. EAR-Controlled Data - This document contains technical data whose export and reexport/retransfer is subject to control by the U.S. Department of Commerce under the Export Administration Act and the Export Administration Regulations. The Department of Commerce’s prior written approval may be required for the export or re- export/retransfer of such technical data to any foreign person, foreign entity or foreign organization whether in the United States or abroad. Abbott Laboratories Gemini System (Charger) Bluetooth Low Energy (DTS) Radio FCC 15:247:2021 Report: ABBO0075.7 Rev. 1, Issue Date: December 21, 2021 CERTIFICATE OF TEST 2018-09-14 Product compliance is the responsibility of the client; therefore, the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this cer…

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