2BBB4-9620SPRINT Patient Remote

PATIENT INSTRUCTIONS FOR USE © 2022 SPR Therapeutics, Inc. All rights reserved. Instructions for SPRINT® PNS Systems SPRINT ® PNS System – Patient Instructions for Use L0242 [A] 2 © 2022 SPR Therapeutics, Inc. All rights reserved. 2022-11-15 The SPRINT® PNS System is manufactured by: SPR Therapeutics, Inc. 22901 Millcreek Blvd Cleveland, OH, 44122 USA 844-378-9108 SprintPNS.com Information on patents can be found at: sprtherapeutics.com/patents SPR Therapeutics, SPRINT®, MicroLead™ and OnePass Introducer™, endura®, extensa®, extensa XT™ and Bimodal™ are trademarks of SPR Therapeutics, Inc., registered in the U.S. and other countries. The BLUETOOTH® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. SPRINT ® PNS System – Patient Instructions for Use L0242 [A] 3 TABLE OF CONTENTS Glossary ...................................................................................................................4 1 Introduction .........................................................................................................5 1.1) About this Manual ....................................................................................................5 1.2) Peripheral Nerve Stimulation (PNS) Treatment ......................................................5 1.3) Your SPRINT® PNS System ......................................................................................6 2 Important Safeguards ..........................................................................................8 2.1) Purpose of the Device (Indications for Use) ...........................................................8 2.2) When the Device Should not be Used (Contraindications) ....................................8 2.3) Warnings, Precautions, & Risks ...............................................................................9 Quick Reference Sections 3 Using Your SPRINT® PNS System ......................................................................16 3.1) Start and Stop Stimulation.....................................................................................16 3.2) Using Your Pulse Generator ....................................................................................17 3.3) Operating Your Hand-Held Remote .......................................................................18 3.4) Home Screens: ON and OFF for Each System ......................................................19 3.5) Adjusting Stimulation ............................................................................................22 4 Connecting & Disconnecting the System ...........................................................25 4.1) Connecting the System ..........................................................................................25 4.2) Disconnecting the System .....................................................................................29 5 Cleaning & Care .................................................................................................31 5.1) Caring for the MicroLead Exit Site(s) .....................................................................31 5.2) Changing the Waterproof Bandage(s) and Mounting Cradle(s) ..........................32 5.3) System Cleaning ....................................................................................................35 5.4) Disposal ..................................................................................................................35 6 Battery & Charging Your System ........................................................................36 6.1) Checking the Rechargeable Battery Level ............................................................37 6.2) Charging the Battery ..............................................................................................38 6.3) Removing / Changing the Battery .........................................................................39 7 Timed/Session Treatment vs Continuous Treatment ..........................................40 7.1) Your Treatment Type ..............................................................................................40 7.2) Session Countdown Timer.....................................................................................41 7.3) Bimodal™ Systems Only .........................................................................................42 APPENDIX A Frequently Asked Questions ..............................................................43 APPENDIX B Troubleshooting ................................................................................44 APPENDIX C Specifications ....................................................................................50 APPENDIX D Symbols and Messages .....................................................................54 APPENDIX E Contacting Customer Service ............................................................58 APPENDIX F MRI Safety Information ......................................................................59 APPENDIX G TSA information ................................................................................62 SPRINT ® PNS System – Patient Instructions for Use L0242 [A] 4 GLOSSARY Bimodal – Stimulation configuration applicable to a Dual-Lead device when each Lead is providing different treatment modalities. This configuration is determined by your provider. Caution – Information on how to prevent damage to or failure of your device. Configuration – How your provider set up your System. Configurations include Single-Lead, Dual-Lead, Bimodal, and stimulation settings. Contraindication – When you should not use the SPRINT® PNS System. Diathermy – A medical treatment applied to the outside of the body that delivers heat into the body. Indication – The purpose of the SPRINT® PNS System. Intensity – The strength of your stimulation. Magnetic Resonance Imaging (MRI) – A medical test that lets doctors see inside your body. Note () – An important reminder for the use of your S…

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CLINICIAN INSTRUCTIONS FOR USE © 2022 SPR Therapeutics, Inc. All rights reserved. Additional information is found in the following materials: Patient Instructions for Use This manual is intended for physicians prescribing the use of the SPRINT® PNS Systems. SPRINT ® PNS System – Clinician Instructions for Use L0241[A] 2 © 2022 SPR Therapeutics, Inc. All rights reserved. 2022-11-16 The SPRINT® PNS System is manufactured by: SPR Therapeutics, Inc. 22901 Millcreek Blvd Cleveland, OH, 44122 USA 844-378-9108 SprintPNS.com Information on patents can be found at: sprtherapeutics.com/patents SPR Therapeutics, SPRINT®, MicroLead™ and OnePass Introducer™, endura®, extensa®, extensa XT™ and Bimodal™ are trademarks of SPR Therapeutics, Inc., registered in the U.S. and other countries. The BLUETOOTH® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. SPRINT ® PNS System – Clinician Instructions for Use L0241[A] 3 TABLE OF CONTENTS Glossary ...................................................................................................................5 1 Introduction .........................................................................................................6 1.1) Indications for Use ...................................................................................................6 1.2) Contraindications .....................................................................................................6 1.3) Warnings ..................................................................................................................7 1.4) Precautions ............................................................................................................10 1.5) MRI Safety Information ..........................................................................................12 2 System Overview ...............................................................................................15 2.1) System Components ..............................................................................................16 2.2) Programming Tools Overview ...............................................................................18 2.3) Device Types ..........................................................................................................20 3 Procedure Preparation .......................................................................................21 3.1) Procedural Precautions .........................................................................................21 3.2) Gather Components ..............................................................................................22 3.3) Assemble Additional Supplies and Set up a Sterile Procedure Tray ....................22 3.4) Patient Take Home Kit ............................................................................................22 3.5) Prepare the MicroLead Exit Site(s) ........................................................................23 4 MicroLead Placement & System Set-up ..............................................................25 4.1) Identifying Lead Placement Target using the OnePass Introducer™ System. .....25 4.2) Testing Stimulation ................................................................................................26 4.3) Confirming Location & Placing the MicroLead(s) .................................................30 4.4) Establishing Therapy Settings ...............................................................................36 5 Patient Counseling.............................................................................................38 5.1) System Use at Home ..............................................................................................38 5.2) MicroLead Exit Site Care and Bandaging Instructions .........................................39 5.3) Air Travel .................................................................................................................39 6 End of Treatment ...............................................................................................40 6.1) MicroLead(s) Withdrawal .......................................................................................40 6.2) System Disposal .....................................................................................................40 APPENDIX A Troubleshooting ................................................................................41 A.1) Lead Connect Errors ..............................................................................................41 A.2) Wireless Errors .......................................................................................................44 A.3) Internal Errors .........................................................................................................45 A.4) System Power Up ...................................................................................................45 A.5) Adhesive and Skin Irritation ...................................................................................46 A.6) Additional Troubleshooting Steps .........................................................................47 APPENDIX B Technical Description And Specifications .................................................49 APPENDIX C Symbols & Messages .........................................................................54 APPENDIX D Microlead Placement In Proximity To Peripheral Nerves ....................58 APPENDIX E Return Product Procedure .................................................................61 SPRINT ® PNS System – Clinician Instructions for Use L0241[A] 4 GLOSSARY Amplitude – the level of current flowing during the stimulus pulse. The Amplitude is measured in milliamperes (mA). See Figure G.1. Figure G.1: Stimulus waveform; Two stimulus pulses are shown (not to scale) Charge – The total magnitude of electrical charge delivered by the rectangular stimulus pulse. The per pulse cha…

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Atten tion: Application Examiner Re: Certification designating a U.S. agent for service of process pursuant to 47 CFR part §2.911(d)(7) of the FCC rules To w hom it may concern, This letter is to certify that SPR Therapeutics, Inc (“Applicant”) accepts responsibilities to act as its own agent pursuant to 47 CFR part §2.911(d)(7) of the FCC rules for service of process. I consent to the obligation to accept service of process on behalf of the Applicant for all certification applications to the FCC. I HEREB Y CERTIFY THAT I am authorized to make the representations above on behalf of the Applicant. I further acknowledge the requirement to maintain an agent extends for no less than one year after the termination of all marketing and importation or the conclusion of and commission- related proceeding involving the equipment and agree to immediately notify the FCC and Intertek if there is any change in the status identified above. Appli cant Company Name Contact Name Address Telephone No Email Applicant FRN : SPR Therapeutics, Inc. : Matt Wunzin | Principal Engineer : 22901 Millcreek Blvd. STE 500, Cleveland, OH, 44122 : 216-378-9108 : [email protected] : 0027161215 Signa ture: ____________________________________ Date: ____________________________________ 06/08/2023

For m: RFT-AMER-TCB-OP-19n Revision: 1 Page 1 of 1 Date: 1/ 25/2023 Matt Wunzin Principal Engineer SPR Therapeutics May 16, 2023 Attention: Application Examiner Re: Covered List, located at https://www.fcc.gov/supplychain/coveredlist and 47 CFR parts §2.903 and §2.911(d)(5)(ii) of the FCC rules Applicant: SPR Therapeutics FCC ID: 2BBB4-9620 REF: 9620 SPRINT PNS Patient Remote To whom it may concern, SPR Therapeutics (“Applicant”) certifies that the equipment for which authorization is sought is not “covered” equipment prohibited from receiving an equipment authorization pursuant to 47 CFR part § 2.903 of the FCC rules and does not originate directly or indirectly from any company named on the covered list located in the link above or any subsidiary or affiliate thereof. Applicant further cert ifies 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 a subsidiary or affiliate of any such entity pursuant to 47 CFR part §1.50002 and required by 47 CFR part § 2.911(d)(5)(ii) of the FCC rules. I HEREBY CERTIFY THAT I am authorized to make the representations above on behalf of the Applicant and agree to immediately notify Intertek if there is any change in the status identified above.

SPRINT Handheld Remote REF 9620 BLE Y1 16MHz Crystal Oscillator NOTES: Timing for the BLE Radio is derived from a 16MHz crystal oscillator (Y1 ) that is factory calibrated to 16MHz +/-20Hz (1.25ppm). Y2 is a low power/ low frequency oscillator that controls the unit while in the low power/ sleep state. This crystal is not connected to or used for the BLE radio RF circuitry. Production units are 100% calibrated to this requirement, and if the crystal can’t be calibrated to this specification, the unit is rejected. See 80025-SCH-0000 for connection details and RF output circuit. Qualcomm BLE Radio IC CSR1011 Chip Antenna AH316M245001-T CR2032 Coin Cell Battery 3V SHARP LCD Module 144x168 User Buttons and Slide Switch Y2 32.768KHz Crystal Oscillator

May 16, 2023 Attention: Application Examiner RE: Request for Confidentiality Applicant: SPR Therapeutics FCC ID: 2BBB4-9620 To Whom It May Concern: Permanent Confidentiality Request is hereby submitted by SPR Therapeutics 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 Rationale for request for confidentiality: SPR Therapeutics 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. If you have questions or need further information, please contact the undersigned. Sincerely, Matt Wunzin Principal Engineer SPR Therapeutics

External Photos: Model: Patient Remote, REF 9620 Front View LCD and Branding Side View Slide Switch (Lock/ Unlock) Back View Product Label with FCC ID Number Front ISO View Top Pushbutton Switches (3) NOTE: FCC ID Number is changing to 2BBB4-9620

06/09/2023 Attention: Application Examiner RE: FCC ID Label for Remote – e-label Applicant: SPR Therapeutics The following is an image of the e-label that will be implemented on the patient Remote (REF 9620) to satisfy the requirement for displaying the FCC ID on the product. This gets displayed every time the Remote is unlocked for use (splash screen).

Internal Photos: Model: Patient Remote, REF 9620 Patient Remote Internal view showing Front Cover with PCBA and buttons, Back Cover, & Battery Door. Antenna Location Remote shown face down Antenna Location (Red Dot)

Peripheral Nerve Stimulator – Patient Remote (9620) Bluetooth Low Energy enabled handheld patient remote controller paired to the External Pulse Generator. The remote utilizes an LCD display to provide a user interface to the patient, three pushbutton switches and a slide switch allows them to control their stimulus session to the External Pulse Generator (Ref 9610). The remote is powered using a single replaceable 3V coin cell battery. The remote utilizes a Qualcomm CSR1011 Bluetooth Low Energy radio integrated circuit loaded with the Bluetooth 4.1 software stack.

Intertek 731 Enterprise Drive Lexington, KY 40510 Tel 859 226 1000 Fax 859 226 1040 www.intertek.com SPR Therapeutics, Inc. SAR EXEMPTION REPORT SCOPE OF WORK SAR EXEMPTION CALCULATION ON THE SPRINT PNS (PATIENT REMOTE REF: 9620) REPORT NUMBER 105410623LEX-009.2 ISSUE DATE REVISED DATE 5/25/2023 6/22/2023 PAGES 11 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 EXEMPTION TEST REPORT Report Number: 105410623LEX-009.2 Project Number: G105410623 Report Issue Date: 5/25/2023 Report Revised Date: 6/22/2023 Product Name: SPRINT PNS (Patient Remote Ref: 9620) Model 9620 Standards: FCC Part 2.1093 RSS-102 Issue 5 Tested by: Client: Intertek Testing Services NA, Inc. 731 Enterprise Drive Lexington, KY 40510 USA SPR Therapeutics, Inc. 22901 Millcreek Blvd Ste 500 Cleveland,OH 44122-5724 USA Report prepared by Report reviewed by David Perry, EMC Engineer Brian Lackey, Team Leader Evaluation For: SPR Therapeutics, Inc. Product: SPRINT PNS (Patient Remote Ref: 9620), Model 9620 SAR Exemption Report Date: 6/22/2023 Non-Specific EMC Report Shell Rev. December 2017 Page 3 of 11 Report Number: 105410623LEX-009.2 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 4.1 Variant Models: ...................................................................................................................................... 6 4.2 Antenna Separation ................................................................................................................................ 7 4.3 Maximum Output Power ........................................................................................................................ 8 5 FCC SAR Exemption Criteria ............................................................................................................................ 9 6 ISED SAR Exemption Criteria ........................................................................................................................ 10 7 Revision History ........................................................................................................................................... 11 Evaluation For: SPR Therapeutics, Inc. Product: SPRINT PNS (Patient Remote Ref: 9620), Model 9620 SAR Exemption Report Date: 6/22/2023 Non-Specific EMC Report Shell Rev. December 2017 Page 4 of 11 Report Number: 105410623LEX-009.2 1 Introduction and Conclusion SAR exemption 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 Requirement Result 5 FCC SAR Exemption Criteria (FCC Title 47 CFR Part 1.1307, 2.1093) Exempt from SAR 6 ISED SAR Exemption Criteria (RSS-102 Issue 5) Exempt from SAR Evaluation For: SPR Therapeutics, Inc. Product: SPRINT PNS (Patient Remote Ref: 9620), Model 9620 SAR Exemption Report Date: 6/22/2023 Non-Specific EMC Report Shell Rev. December 2017 Page 5 of 11 Report Number: 105410623LEX-009.2 3 Client Information This product was tested at the request of the following: Client Information Client Name: SPR Therapeutics, Inc. Address: 22901 Millcreek Blvd Ste 500 Cleveland,OH 44122-5724 USA Contact: Jeff Waterman Telephone: (216) 455-7447 Email: [email protected] om Manufacturer Information Manufacturer Name: SPR Therapeutics, Inc. Manufacturer Address: 22901 Millcreek Blvd Ste 500 Cleveland,OH 44122-5724 USA Evaluation For: SPR Therapeutics, Inc. Product: SPRINT PNS (Patient Remote Ref: 9620), Model 9620 SAR Exemption Report Date: 6/22/2023 Non-Specific EMC Report Shell Rev. December 2017 Page 6 of 11 Report Number: 105410623LEX-009.2 4 Description of Equipment under Test and Variant Models Equipment Under Test Product Name SPRINT PNS (Patient Remote Ref: 9620) Model Number 9620 FCC Identifier 2BBB4-9620 Type of Transmission Bluetooth L…

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Spec Sheet http://www.ty-top.com The data i s reference only. Electrical c haracteristics vary depending on environment or measurement condition. TAIYO YUDEN reserves t he right t o make change to the data at any t ime without notice. Before making final s election, please check product specification. Chip Antennas(Multilayer) AH316M245001-T Features Item Summary MonoPole, 3.2x1.6x0.5mm, for Bluetooth/W-LAN/ZigBee Lifecycle Stage New PN available Standard packaging quantity (minimum) Taping Embossed 3000pcs Products characteristics table SystemBluetooth/W-LAN/ZigBee Frequency Band Width2400 to 2500 MHz Center Frequency2450 MHz Gain1 (Peak Gain)(typ)+1.6 dBi Gain2 (Ave. Gain at OMNI plane)-0.1 dBi Efficiency (typ)-1.4 dB (72 %) VSWR (typ)3 TypeMonoPole Operating Temp. Range-40 to +85 °C RoHS Compliance (10 subst.)Yes REACH Compliance (223 subst.)Yes Halogen FreeYes SolderingReflow External Dimensions Dimension L3.2 ±0.15 mm Dimension W1.6 ±0.15 mm Dimension T0.5 ±0.1 mm Dimension E0.5 ±0.2 mm Dimension bMin 1.0 mm 2022.06.09 Powered by TCPDF (www.tcpdf.org) 1 / 1 ■ Notice for TA I YO YUDEN Products Please read this notice before using the TA I YO YUDEN products. ■ Please conduct validation and verification of our products in actual condition of mounting and operating environment before using our products. ■ The product listed in this spec sheet is intended for use in general electronic equipment (e.g., AV equipment, OA equipment, home electric appliances, office equipment, information and communication equipment including, without limitation, mobile phone, and PC). Please be sure to contact TA I YO YUDEN for further information before using the products for any equipment which may directly cause loss of human life or bodily injury (e.g., transportation equipment including, without limitation, automotive powertrain control system, train control system, and ship control system, traffic signal equipment, disaster prevention equipment, medical equipment classified as Class I, II or III by IMDRF, highly public information network equipment including, without limitation, telephone exchange, and base station). Please do not incorporate our products into any equipment requiring high levels of safety and/or reliability (e.g., aerospace equipment, aviation equipment, medical equipment classified as Class IV by IMDRF, nuclear control equipment, undersea equipment, military equipment). When our products are used even for high safety and/or reliability‐required devices or circuits of general electronic equipment, it is strongly recommended to perform a thorough safety evaluation prior to use of our products and to install a protection circuit as necessary. Please note that unless you obtain prior written consent of TA I YO YUDEN, TA I YO YUDEN shall not be in any way responsible for any damages incurred by you or third parties arising from use of the product listed in this spec sheet for any equipment requiring inquiry to TA I YO YUDEN or prohibited for use by TA I YO YUDEN as described above. ■ Information contained in this spec sheet is intended to convey examples of typical performances and/or applications of our products and is not intended to make any warranty with respect to the intellectual property rights or any other related rights of TA I YO YUDEN or any third parties nor grant any license under such rights. ■ Please note that the scope of warranty for our products is limited to the delivered our products themselves and TA I YO YUDEN shall not be in any way responsible for any damages resulting from a fault or defect in our products. Notwithstanding the foregoing, if there is a written agreement (e.g., supply and purchase agreement, quality assurance agreement) signed by TA I YO YUDEN and your company, TA I YO YUDEN will warrant our products in accordance with such agreement. ■ The contents of this spec sheet are applicable to our products which are purchased from our sales offices or authorized distributors (hereinafter “TAIYO YUDEN’s official sales channel”). Please note that the contents of this spec sheet are not applicable to our products purchased from any seller other than TA I YO YUDEN’s official sales channel. ■ Caution for Export The product listed in this spec sheet may require specific procedures for export according to “U.S. Export Administration Regulations”, “Foreign Exchange and Foreign Trade Control Law” of Japan, and other applicable regulations. Should you have any questions on this matter, please contact our sales staff. ! REMINDERS REMINDERS Safety Design When using our products for high safety and/or reliability-required equipment or circuits, please fully perform safety and/or reliability evaluation. In addition, please install ( i ) systems equipped with a protection circuit and a protection device and/or ( ii ) systems equipped with a redundant circuit or other system to prevent an unsafe status in the event of a single fault for a failsafe design to ensure safety. Intellectual Property Rights Information contained in this catalog is intended to convey examples of typical performances and/or applications of our products and is not intended to make any warranty with respect to the intellectual property rights or any other related rights of TAIYO YUDEN or any third parties nor grant any license under such rights. Limited Warranty Please note that the scope of warranty for our products is limited to the delivered our products themselves conforming to the product specications specied in the individual product specication sheets, and TAIYO YUDEN shall not be in any way responsible for any damages resulting from a failure or defect in our products. Notwithstanding the foregoing, if there is a written agreement ( e.g., supply and purchase agreement, quality assurance agreement ) signed by TAIYO YUDEN and your company, TAIYO YUDEN will warrant our products in accordance with such agreement, provided, however, that our products shall be used for general-purpose and standar…

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Intertek 731 Enterprise Drive Lexington, KY 40510 Tel 859 226 1000 Fax 859 226 1040 www.int…

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