2ABU843004300

Material Specification Title: IFU, Algovita SCS, Trial Stimulator Manual for Clinicians Document Number and Revision 0300-000026-06 Page 1 of 2 Prepared By: Amy Kosbau Approved By: QIG Group The information contained in this document is the sole property of QIG Group. Any reproduction in part or whole without the written permission of QIG Group is prohibited. Do not print the material specification notes pages when printing the literature piece. Do not count the material specification notes pages in the literature piece page count. 1.0 PURPOSE To define all parameters necessary to assure conformance to appropriate specifications. 2.0 SCOPE This specification describes the configuration and content for the IFU, Algovita SCS, Trial Stimulator Manual for Clinicians 3.0 RESPONSIBILITY It is the responsibility of the product development engineer, manufacturing engineer or labeling engineer to maintain this document in accordance with Algostim requirements. 4.0 MATERIAL CHARACTERISTICS 4.1 Content: The content of the instructions for use document shall be defined in the files and PDF provided by Algostim. 4.2 Material: The paper shall be: 4.2.1 Front/Back Cover: 80# uncoated cover 4.2.2 Inner Pages: 40# white smooth opaque text stock. 4.3 Color: 4.3.1 4-color 4.4 Physical Size: 4.4.1 All dimensions are in inches unless otherwise noted. 4.4.2 7.25 ± .20 length x 6.50 ± .20 width 4.5 Type of Binding: Perfect Bound 4.6 Other: 4.6.1 Literature Piece Page Count (including covers, excluding specification notes pages) 34 4.7 Language Translation Requirements & Configuration: 4.7.1 English (en) 5.0 STORAGE CONDITION Store in dry location. Material Specification Title: IFU, Algovita SCS, Trial Stimulator Manual for Clinicians Document Number and Revision 0300-000026-06 Page 2 of 2 QIG Group The information contained in this document is the sole property of QIG Group. Any reproduction in part or whole without the written permission of QIG Group is prohibited. 6.0 QUALITY CHARACTERISTICS 6.1 Clarity of Text : The text shall be easily readable and free of smears and smudges. Graphics content, layout and text shall be consistent with that in the document (pdf) provided by the customer. 6.2 Workmanship: The booklet shall be uniformly cut along its edges and free of significant rough edges or paper slivers. 6.3 Color: Color shall be uniform throughout each lot. 6.4 Lot Quality: Any lot of material, which does not meet the requirements of this specification, is subject to return. Greatbatch Medical reserves the right to return entire lots of material which fail to meet the requirements of this specification. 7.0 PACKAGING/LABELING 7.1 Each package provided by the supplier shall be labeled with: Greatbatch part number, revision level of this specification document, quantity, supplier name, and date of manufacturing. 7.2 A Certificate of Conformance is required with each shipment to include quantity, material characteristics, Greatbatch part number, revision, PO, lot and date of manufacturing. NOTE: Graphics Content and Layout to be shown and per Algostim file. Algovita™ Spinal Cord Stimulation System Trial Stimulator Model 4300 External Pulse Generator (EPG) 2014 ONLY Trial Stimulator Manual for Clinicians Refer to the Information for Prescribers Manual for indications, contraindications, warnings, pre- cautions, adverse events, clinical study results, and related information. Algovita™ is a trademark of QIG Group, LLC FCC Information (US Only) The following is communications regulation information about the Algovita Trial Stimulator and Pocket Programmer. Trial Stimulator FCC ID: 2ABU84300 Pocket Programmer FCC ID: 2ABU84100 These devices comply with part 15 of the FCC Rules. Operation is subject to the following two con- ditions: (1) These devices may not cause harmful interference, and (2) These devices must accept any interference received including interference that may cause undesired operation. Important: Changes and modifications to the products not authorized by Algostim, LLC could void the FCC certification and negate your authority to operate these products. Algovita Spinal Cord Stimulation System Trial Stimulator Manual 1 Contents Explanation of Symbols Used on Packaging and Trial Stimulator 3 Introduction 5 Package Contents 5 Important Safety Information 6 Contraindications 6 Warnings 6 Precautions 7 Adverse Events 8 EPG Description 10 Turning the EPG On or Off 11 Quick Stimulation Off 12 Using the EPG During Intraoperative Test Stimulation 13 Connecting the Trial Cable to the EPG 13 Disconnecting the Trial Cable from the EPG 14 Stimulation Trial 15 Preparing the EPG for a Stimulation Trial 15 After the Stimulation Trial 15 Changing the EPG Batteries 16 Checking the Battery Charge Status 16 Changing the Batteries 17 EPG Care and Storage 18 General EPG Cleaning 18 Cleaning the EPG After Use 18 Cleaning the EPG Battery Contacts 18 EPG Service and Replacement 19 Disposal 19 Troubleshooting 20 Algostim Customer Service 21 Specifications 22 Electromagnetic Compatibility Declaration 24 Wireless Information 28 Algovita Spinal Cord Stimulation System Trial Stimulator Manual 3 Explanation of Symbols Used on Packaging and Trial Stimulator SymbolExplanation 2014 Conformité Européenne (European Conformity). This symbol means that the device fully complies with European Directive AIMD 90/385/EEC and R&TTE Directive 1999/5/EC ONLY Caution: Federal Law (USA) restricts this device to sale on or by the order of a physician This device complies with Part 15 of the Federal Communication Commission rules Authorized representative in Europe Caution Consult instructions for use Serial number Manufacturer Date of manufacture Catalogue number Model Temperature limit Humidity limitation 4 Trial Stimulator Manual Explanation of Symbols Used on Packaging and Trial Stimulator SymbolExplanation Fragile, handle with care Keep dry Atmospheric pressure limitation Keep away from sunlight Do not use if package is damaged Non-ioniz…

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WTD 13.4.9 FCC Compliance Opinion QIGG0010 Information about the Applicant Grantee (Company Name) Algostim, LLC FCC Contact Person Bernard Bosley Address 10675 Naples Street Northeast City, State, Zip Blaine, MN 55449 Job Number QIGG0010 - 4300 Model 4300 FCC ID 2ABU84300 Agent Approval Type Original Equipment Class TNT – Licensed Non-Broadcast Transmitter Worn on Body Rule Part 95I Overview This application is for the original approval of Algostim, LLC's model 4300 Trial Stimulator in the Medical Device Radiocommunication Service. The model 4300 is used to treat chronic pain. The device communicates with two external programmers: Model4100 Pocket Programmer and Model 4500 Clinician Programmer. The Model 4300 Trial Stimulator communicates with the programmers in the 402 - 405 MHz MedRadio band under FCC rule part 95I. The device receives a wake up signal in the 2.4 GHz band but does not initiate telemetry sessions or transmit in the 2.4 GHz band. Confidentiality requested for allowed files. Request is properly addressed and referenced. Short term confidentiality requested. Radiated Power on Grant Per 95.639(f)(1) the maximum permissible EIRP is 25 uW. Per 95.627(g)(3), compliance may be determined with a field strength measurement. The FCC conversion formula that equates the 25 uW EIRP limits to the 18.2 mV/m limit at 3 meters uses the Friis transmission equation modified with a 6 dB contribution due to ground plane reflection. Applying that equation: EIRP = ((V/m/2*3)^2/30, the maximum reported field strength of the fundamental emission is 64.4 dBuV/m at 3 meters, which equals 0.00000021W (EIRP). The field strength of the fundamental measurements are found in Intertek Test Report 101277992MIN-001A page 9 of 25. Recommendation All items have been resolved and completed to my satisfaction; therefore I recommend this application for approval. Signature Dave Tolman, TCB Committee 7/8/2014

FCC Home | Search | RSS | Updates | E-Filing | Initiatives | Consumers | Find People Office of Engineering and Technology Subject: Response to Inquiry to FCC (Tracking Number 632736) (TCB) From: <[email protected]> Date: 6/18/2014 12:07 PM To: <[email protected]> Link to Federal Communications Commission Home Office of Engineering and Technology Inquiry on 06/17/2014 : Inquiry: An applicant, Algostim, has requested long term confidential treatment of their internal photos for four of their devices. I've attached their request for confidentiality letters. They are seeking authorization under FCC Part 95 for all four devices. Based upon the justification they've provided in the attached letters, we are seeking the Commission's permission to upload the internal photos as long-term confidential exhibits. We understand this would be a waiver to the policy stated in FCC KDB 726920 D02 v02, Item c. FCC response on 06/18/2014 The confidentiality requests provided are acceptable. Attachment Details: Request for Confidentiality letter Request for Confidentiality letter Request for Confidentiality letter Request for Confidentiality letter Do not reply to this message. Please select the Reply to an Inquiry Response link from the OET Inquiry System to add any additional information pertaining to this inquiry. Response to Inquiry to FCC (Tracking Number 632736) (TCB) 1 of 16/27/2014 9:17 AM

EPG External Photos Front Back Top Side

29 May 2014 Dear Sir or Madam: We, QiG Group ( a wholly owned subsidiary of Greatbatch, Inc.), located at 1771 East 30 th Street, Cleveland, Ohio 44114, are providing the following Antenna Information for the Algovita Spinal Cord Stimulation (SCS) External Pulse Generator (EPG), Model 4300, RF telemetry communications feature in accordance with the TCB technical requirements: The Algovita Spinal Cord Stimulation (SCS) External Pulse Generator (EPG), Model 4300, utilizes a single PCB Copper Trace Antenna (loop magnetic dipole) for both the 402-405 MHz Medradio RF link and the 2450 MHz wake-up RF link. The etched PCB copper trace antenna is an integral part of the PCB and connected directly to the intentional radiator. The approximate gain of the etched PCB copper trace antenna at 402-405 MHz and 2450 MHz are – 18 dBi, and -5 dBi, respectively. Access to the antenna connections of the intentional radiators are prohibited by the enclosure. Section 47 CFR 15.203 of the FCC rules state the use of permanently attached antennas is considered sufficient to comply with the requirements of this section. PCB within EPG enclosure showing Integral Copper Trace Antenna (Top Side) 402-405 MHz Transceiver RFIC 24 MHz Crystal LC Matching SAW Band Pass Filter Antenna Terminals Antenna Loop Area

RF Exposure Evaluation FCC ID: 2ABU84300 The device is excluded from SAR evaluation and therefore deemed compliant with FCC RF exposure requirements as described below: FCC KDB 447498 D01 v05r02 Section 4.3.1 “The 1-g and 10-g SAR test exclusion thresholds for 100 MHz to 6 GHz at test separation distances ≤ 50 mm are determined by: [(max. power of channel, including tune-up tolerance, mW)/(min. test separation distance, mm)] · [√f(GHz)] ≤ 3.0 for 1-g SAR and ≤ 7.5 for 10-g extremity SAR, where  f(GHz) is the RF channel transmit frequency in GHz  Power and distance are rounded to the nearest mW and mm before calculation  The result is rounded to one decimal place for comparison  3.0 and 7.5 are referred to as the numeric thresholds in the step 2 below The test exclusions are applicable only when the minimum test separation distance is ≤ 50 mm and for transmission frequencies between 100 MHz and 6 GHz. When the minimum test separation distance is < 5 mm, a distance of 5 mm according to 5) in section 4.1 is applied to determine SAR test exclusion.” The device has a maximum conducted output power of 0.0234 mW at 403.65 MHz. The EUT has a maximum EIRP of 0.00021 mW. The closest spacing of the antenna to the user’s extremity is less than 5mm per the description above as the product can be body-worn while transmitting. The table below shows the results of the calculation. The value of 0.003 is well below the exclusion threshold of 3.0, therefore the unit is excluded from SAR evaluation and deemed compliant with FCC RF exposure requirements. Output Power Test Separation Transmit Frequency Exclusion Threshold Specification (mW) (mm) (GHz) 0.0234 5 0.40365 0.003 <=3.0

Test Report Title: Model 4300 External Pulse Generator Conducted Transmit Power Output Report Document Number and Revision: EERE 0628 Revision 1.2 Page 1 of 5 Prepared By: Dave Petsko Approved By: QIG Group The information contained in this document is the sole property of the QIG Group. Any reproduction in part or whole without the written permission of the QIG Group is prohibited. 1. Purpose FCC Rules §2.1046 requires the conducted measurement of transmitter power output be included in the EMC test report documents submitted to the FCC for product certification. This document describes the RF Test Method and Conducted Transmit Power Output Test Results for External Pulse Generator (EPG), Model 4300. 2. References  47 CFR § 2.1046(a)  1310-000060-03 EPG Schematic  1330-000053-03 EPG PCB Assembly Drawings / AP-0001-01-7 ASBY PCB Torpedo EPG 003-b 3. RF Test Method The 402-405 MHz conducted transmit power output of the External Pulse Generator, Model 4300 may be measured directly by attaching a Murata MM8130-2600 coaxial connector with switch to the 50 Ohms I/O point of the PCB (EPG, Model 4300, Assembly Drawing 1330-000053) as shown in Figure 1. Figure 1- Schematic Diagram of Antenna Matching Circuit, External Pulse Generator, Model 4300 The connector body (ground terminal) was soldered to the PCB ground flood area adjacent to capacitor C24. Capacitors C24 was turned CCW (90 0 ) such that C24 was disconnected from the. The open end of capacitor C24 was then soldered to the connector center conductor (hot terminal). (See the schematic location marked X). Finally, to impedance match FLT1 output to the 50 ohms (connector), inductor L22 was changed from 150nH to 36nH (Coilcraft part number 0402CS-36NXJL) and auto-tuned to peak signal strength using a Zarlink base station / PC running the QiG xCT application software revision 2.10. RF Connector 50 ohms X Test Report Title: Model 4300 External Pulse Generator Conducted Transmit Power Output Report Document Number and Revision: EERE 0628 Revision 1.2 Page 2 of 5 QIG Group The information contained in this document is the sole property of the QIG Group. Any reproduction in part or whole without the written permission of the QIG Group is prohibited. Note: Attachment of the coaxial connector to the PCB assembly should be done by a trained electronics technician to allow for proper soldering and prevention of undue stress on the PCB solder connection (I.e. PCB pad area damage may easily occur). The PCB is then connected to a spectrum analyzer via coax cable for measurement of transmitter conducted power output. 4. Equipment Used Table 1 – List of Test Equipment Equipment Mfg. Model Cal ID Cal Due Spectrum Analyzer Rohde Schwartz FSL6 10055 8 NOV 2014 Coax Cable* Johnson/Emerson 415-0033-012 NA NA 5. Sample Information A single sample was used for the Conducted Transmit Power Output Test as described in Table 2 below. Table 2 – Sample Used EPG Sample 1 PCB Serial Number 0083 PCB Version 3.0 SW Version R1.00.0005 5.1. Sample Traceability The PCB certificate of compliance is attached in Appendix A - PCB Certificate of Compliance. 5.2. Sample Retention Sample is retained at QIG’s Cleveland facility. 6. Transmitter Power Output Test Results The 402-405 MHz transmitter measured conducted power output data was recorded for low, medium, and high RF channels selected. The test results are shown in Figure 2 and recorded in Table 3. Test limits are not applicable per FCC §2.1046 requirements. Test Report Title: Model 4300 External Pulse Generator Conducted Transmit Power Output Report Document Number and Revision: EERE 0628 Revision 1.2 Page 3 of 5 QIG Group The information contained in this document is the sole property of the QIG Group. Any reproduction in part or whole without the written permission of the QIG Group is prohibited. Figure 2 - Conducted Transmitter Power, External Pulse Generator, Model 4300 Table 3 – External Pulse Generator, Model 4300, Conducted Transmit Power Output Transmit Power Setting 52 Channel 0 Channel 5 Channel 9 Frequency (MHz) 402.15 403.65 404.85 Power Output (dBm) -16.46 -16.30 -16.51 * Coax Cable Insertion Loss – 0.3 dB 7. Revision History Revision Level Revision Description ECN No# Effective Date 1.1 Initial release 2333 06/09/14 1.2 Removed internal device photo. 2365 07/02/14 Test Report Title: Model 4300 External Pulse Generator Conducted Transmit Power Output Report Document Number and Revision: EERE 0628 Revision 1.2 Page 4 of 5 QIG Group The information contained in this document is the sole property of the QIG Group. Any reproduction in part or whole without the written permission of the QIG Group is prohibited. 8. Appendix A - PCB Certificate of Compliance Test Report Title: Model 4300 External Pulse Generator Conducted Transmit Power Output Report Document Number and Revision: EERE 0628 Revision 1.2 Page 5 of 5 QIG Group The information contained in this document is the sole property of the QIG Group. Any reproduction in part or whole without the written permission of the QIG Group is prohibited.

TEST REPORT Report Number: 101277992MIN-001A Project Number: G101277992 Testing performed on the Model 4300, Trial Stimulator FCC ID: Industry Canada ID: to 47 CFR Part 95 Subpart I: 2013 RSS- 243, Issue 3, November 2010 47 CFR, Part 15:2013, §15.109, Class B Minnetronix Test Performed by: Test Authorized by: Intertek Testing Services NA, Inc. 7250 Hudson Blvd., Suite 100 Oakdale, MN 55128 USA Minnetronix 1635 Energy Park Drive St. Paul, MN 55108 USA Prepared by: Date: October 10, 2013 Uri Spector Reviewed by: Date: October 10, 2013 Simon Khazon 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. EMC Report No: 101277992MIN-001A FCC ID: IC ID: Page 2 of 25 TABLE OF CONTENTS 1.0 GENERAL DESCRIPTION.......................................................................................................... 3 1.1 Product Description; Test Facility ....................................................................................... 4 1.3 Environmental conditions.................................................................................................... 5 1.4 Measurement uncertainty ................................................................................................... 6 1.5 Field Strength Calculation................................................................................................... 6 2.0 TEST SUMMARY.......................................................................................................................... 7 3.0 TEST CONDITIONS AND RESULTS........................................................................................ 8 3.1 Effective Radiated Power at Fundamental ......................................................................... 8 3.2 Bandwidth of Emissions.................................................................................................... 10 3.3 Radiated Spurious Emissions........................................................................................... 12 3.4 Frequency Error ................................................................................................................ 19 3.5 MedRadio Operation ......................................................................................................... 20 3.6 Receiver/digital device radiated emissions....................................................................... 21 4.0 TEST EQUIPMENT .......................................................................................................... 25 EMC Report No: 101277992MIN-001A FCC ID: IC ID: Page 3 of 25 1.0 GENERAL DESCRIPTION Model: 4300 Type of EUT: Trial Stimulator, MedRadio Serial Number: DBR 1427 FCC ID: Industry Canada ID: Related Submittal(s) Grants: N/A Company: Minnetronix Customer: Sue Sibilski Address: 1635 Energy Park Drive St. Paul, MN 55108 Phone: (651) 917-4060 Fax: (651) 917-4066 e-mail: [email protected] Test Standards: 47 CFR, Part 95 Subpart I: 2013 RSS–243, Issue 3, November 2010 RSS-Gen, Issue 2, 2007 47 CFR, Part 15:2013, §15.109, Class B Other Type of radio: Stand -alone Module Hybrid Date Sample Submitted: August 16, 2013 Test Work Started: August 19, 2013 Test Work Completed: October 10, 2013 Test Sample Conditions: Damaged Poor (Usable) Good EMC Report No: 101277992MIN-001A FCC ID: IC ID: Page 4 of 25 1.1 Product Description; Test Facility Product Description: Trial Stimulator Operating Frequency 402-405MHz Power Level Setting 5 Modulation: FSK Emission Designator: 247K8F1D Antenna(s) Info: -20dBi PCB loop antenna (trace) Antenna Installation: User Professional Factory Transmitter power configuration: Internal battery External power source 120VAC 230VAC 400VAC 3VDC AA Alkaline Batteries Other: 50Hz 60Hz Special Test Arrangement: None Test Facility Accreditation: A2LA (Certificate No. 1427.01) Test Methodology: Measurements performed according to the procedures in ANSI C63.10- 2009 / TIA 603-C EMC Report No: 101277992MIN-001A FCC ID: IC ID: Page 5 of 25 1.2 EUT Configuration The equipment under test was operated during the measurement under the following conditions: - Standby - Continuous - Continuous un-modulated - Continuous modulated - Test program (customer specific) - Below Operating modes of the EUT: No. Description 1 The EUT was powered from a fresh batteries and was activated from laptop using xCT program to transmit continuously modulated carrier except frequency error testing were a CW signal was transmitted. Channel 5 (403.65MHz) was utilized for testing. Cables: No. Type Length Designation Note 1 Ground Path Lead 2m Not shielded 2 Stimulation Cable 2m Not shielded Support equipment/Services: No. Item Description 1 Dell Laptop Laptop computer with xCT software General notes: None 1.3 Environmental conditions During the measurement the environmental conditions were within the listed ranges: Normal Temperature: 15-35 ° C Humidity: 30-60 % Atmospheric pressure: 86-106 kPa Extreme Temperature: +25 to +45 ° C Temperature: -20 to +55 ° C DC power: + 10% Battery: As declared by the manufacturer EMC Report No: 101277992MIN-001A FCC ID: IC ID: Page 6 of 25 1.4 Measurement uncertainty The expanded uncertaint…

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