2ABU842004200

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 - 4200 Model 4200 FCC ID 2ABU84200 Agent Approval Type Original Equipment Class DXX – Part 15 Low Power Communications Device TNT – Licensed Non-Broadcast Transmitter Worn on Body Rule Part 15.249, 95I Overview This application is for the original approval of Algostim, LLC's model 4200 programmer charger in the Medical Device Radiocommunication Service. The model 4200 is a patient device used for commanding and querying and charging Algostim pulse generators models 2408 IPG and 2412 IPG. The device communicates with the programmers in the 402 - 405 MHz MedRadio band under FCC rule part 95I. The device transmits a wake up signal in the 2.4 GHz band under rule part 15.249. 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 80.3 dBuV/m at 3 meters, which equals 0.00000807W (EIRP). The field strength of the fundamental measurements are found in Intertek Test Report 101277992MIN-001D page 9 of 37. 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

PPC External Photos Front Back Top Side Side

3 March 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) Patient Programmer Charger, Model 4200, RF telemetry communications feature in accordance with the TCB technical requirements: The Algovita Spinal Cord Stimulation (SCS) Patient Programmer Charger, Model 4200, uses a surface mountable dielectric chip antenna for the 402-405 MHz Medradio RF link and a surface mountable ceramic chip antenna for 2450 MHz Wake-up RF link. Both of the surface mountable chip antennas are an integral part of the PCB Assembly (PCBA) and connected directly to the intentional radiators. The approximate gain of the 402-405 MHz loop antenna and the 2450 MHz loop antenna are – 10 dBi, and -2 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. Patient Programmer Charger (PPC) Unit showing rough locations of the Medradio (402-405 MHz) and Wake-up (2450 MHz) surface mount chip antenna's (see internal PCB photos). Front Side Rear Side 402-405MHz 2450MHz 2450MHz 402-405MHz

RF Exposure Evaluation FCC ID: 2ABU84200 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 0.118 mW at 402.15 MHz. The EUT has a maximum EIRP of 0.00807 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 hand held while transmitting. The table below shows the results of the calculation. The value of 0.015 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) 0.118 5 0.402 0.015 <=3.0

TEST REPORT Report Number: 101277992MIN-005D Project Number: G101277992 Testing performed on the Model 4200, Programmer Charger to ETSI EN 301 839-1 v1.3.1 (2009-10) ETSI EN 301 839-2 v1.3.1 (2009-10) ETSI EN 301 489-27 v1.1.1 (2004-06) 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: November 19, 2013 Uri Spector Reviewed by: Date: November 19, 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-005D Page 2 of 61 TABLE OF CONTENTS 1.0 GENERAL DESCRIPTION.......................................................................................................... 3 2.0 TEST SUMMARY.......................................................................................................................... 4 2.1 Statement of the measurement uncertainty........................................................................ 5 3.0 EQUIPMENT UNDER TEST....................................................................................................... 6 3.1 Power configuration ............................................................................................................ 6 3.2 Antenna configuration ......................................................................................................... 6 3.3 EUT Configuration .............................................................................................................. 7 3.4 Environmental conditions.................................................................................................... 7 4.0 TEST CONDITIONS AND RESULTS........................................................................................ 8 4.1 Effective Radiated Power at Fundamental ......................................................................... 8 4.2 Bandwidth of Emissions.................................................................................................... 12 4.3 Radiated Spurious Emissions........................................................................................... 14 4.4 Frequency Error ................................................................................................................ 20 4.5 MICS Operation ................................................................................................................ 21 4.6 Receiver spurious emissions ............................................................................................ 32 4.6.1 Enclosure radiated spurious emissions........................................................................... 32 4.7 Radiated Emissions of ancillary equipment enclosure..................................................... 37 4.8 Conducted Emissions at AC port, DC port, and Telecommunication port ....................... 41 4.9 Harmonic Current Emissions ............................................................................................ 45 4.10 Voltage Fluctuations and Flicker....................................................................................... 48 4.11 Radiated, Radio-frequency, Electromagnetic Field .......................................................... 50 4.12 Electrostatic Discharge ..................................................................................................... 52 4.13 Electrical Fast Transients / Burst ...................................................................................... 54 4.14 RF common mode (Conducted Disturbances) ................................................................. 56 4.15 Voltage Dips and Voltage Interruptions ............................................................................ 58 4.16 Surges Immunity ............................................................................................................... 59 5.0 TEST EQUIPMENT..................................................................................................................... 61 EMC Report No: 101277992MIN-005D Page 3 of 61 1.0 GENERAL DESCRIPTION Model: 4200 Type of EUT: Programmer Charger, MICS Radio Serial Number: DBR 1471 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: EN 301 839-1 v1.3.1 (2009-10) EN 301 839-2 v1.3.1 (2009-10) EN 300 330-2 V1.3.1 (2006-04) EN 300 440-2 V1.3.1 (2009-03) EN 301 489-1 V1.8.1 (2008-04) EN 301 489-3 V1.4.1 (2002-08) EN 301 489-27 V1.1.1 (2006-04) Operating Frequency Range(s): Range: from 402-405 MHz Power Level Setting: 8 Modulation: FHSS Digital Other Type of radio: Stand -alone Module Hybrid Date Sample Submitted: August 16, 2013 Test Work Started: August 19, 2013 Test Work Completed: November 19, 2013 Test Sample Conditions: Damaged Poor (Usable) Good EMC Report No: 101277992MIN-005D Page 4 of 61 2.0 TEST SUMMARY Referring to the performance criteria and the operating mode during the tests specified in this report, the equipment does not comply wi…

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TEST REPORT Report Number: 101277992MIN-001D Project Number: G101277992 Testing performed on the Model 4200, Programmer Charger 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 and §15.107, 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: November 19, 2013 Uri Spector Reviewed by: Date: November 19, 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-001D FCC ID: IC ID: Page 2 of 37 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 Frequency Error ........................................................................................................................ 19 3.5 MedRadio Operation ......................................................................................................... 20 3.6 Receiver/digital device radiated emissions....................................................................... 30 3.7 Digital device conducted emissions.................................................................................. 34 4.0 TEST EQUIPMENT .......................................................................................................... 37 EMC Report No: 101277992MIN-001D FCC ID: IC ID: Page 3 of 37 1.0 GENERAL DESCRIPTION Model: 4200 Type of EUT: Programmer Charger, MedRadio Serial Number: DBR 1471 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 and §15.107, 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: November 15, 2013 Test Sample Conditions: Damaged Poor (Usable) Good EMC Report No: 101277992MIN-001D FCC ID: IC ID: Page 4 of 37 1.1 Product Description; Test Facility Product Description: Programmer Charger Operating Frequency 402-405MHz Power Level Setting 8 Modulation: FSK Emission Designator: 252KF1D Antenna(s) Info: -9.1dBi chip antenna Antenna Installation: User Professional Factory Transmitter power configuration: Internal battery External power source 100-240VAC 400VAC DC Other: 50-60Hz Special Test Arrangement: As a hand-held device the EUT was rotated through three orthogonal axes to determine and tested with the maximum emissions 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-001D FCC ID: IC ID: Page 5 of 37 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 120VAC and was activated 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 Not shielded USB Power cable 2m Power Cable 2 Model 4230 not shielded cable 1m Charging Paddle Support equipment/Services: No. Item Description 1 Avid Board Implant Emulation board used during MedRadio Communication Sessions testing. 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 % Atmosp…

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Test Report Title: Model 4200 Patient Programmer Charger Conducted Transmit Power Output Report Document Number and Revision: EERE 0627 Revision 1.2 Page 1 of 3 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 Patient Programmer Charger (PPC), Model 4200. 2. References  47 CFR § 2.1046(a)  DS-0000-79-7 Torpedo Patient Programmer / Charger Schematic 001-a  AP-0000-99-9 ASBY PCB Torpedo Patient Programmer / Charger 001-a 3. RF Test Method The 402-405 MHz conducted transmit power output of the Patient Programmer Charger, Model 4200 may be measured directly from the Murata MM8130-2600 RF Connector with Switch using a test coaxial cable and spectrum analyzer. 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 PPC Sample 1 PCB Serial Number 0013 PPC DBR # Dbr1358, log1049 PPC Serial Number [EXID] 0x034569 SW Version Custom EMC Test Software \ PWM, Antenna, MICS test apps, Torpedo\Software\PPC\Tools 5.1. Sample Traceability Traceability records are defined for the sample including workflow/traveler, which includes reference to BOM revision, manufacturing procedures with revision number and component lot or serial numbers. A description of the methods and processes used to assemble/process the materials are recorded in the Minnetronix Development Build Record (DBR) so that the method and processes can be repeated if necessary. The DBR incorporates: Test Report Title: Model 4200 Patient Programmer Charger Conducted Transmit Power Output Report Document Number and Revision: EERE 0627 Revision 1. Page 2 of 3 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.  DA-0001-89-8 ASBY Assembly Procedure for Torpedo PPC Patient Programmer  Revision information for BOMs  Supplements for updates (e.g. software changes, any rework, etc.) 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 1 and recorded in Table 3. Test limits are not applicable per FCC §2.1046 requirements. Figure 1 - Conducted Transmitter Power, Patient Programmer Charger, Model 4200 Test Report Title: Model 4200 Patient Programmer Charger Conducted Transmit Power Output Report Document Number and Revision: EERE 0627 Revision 1. Page 3 of 3 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. Table 3 – Patient Programmer Charger, Model 4200, 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) -9.28 -9.28 -9.34 * 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 Report Number: 101277992MIN-011D Project Number: G101277992 Testing performed on the Model 4200, Programmer Charger FCC ID: Industry Canada ID: to 47 CFR Part 15.249:2013 RSS- 210, Issue 8, 2010 RSS-Gen, Issue 3, 2010 47 CFR, Part 15:2013, §15.107 and §15.109, Class B / ICES-003, Issue 5:2012 For 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 30, 2013 Uri Spector Reviewed by: Date: October 30, 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-011D FCC ID: IC ID: Page 2 of 34 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 Field strength of fundamental ............................................................................................. 8 3.2 Field strength of harmonics and spurious emissions ....................................................... 10 3.2.1 Average correction factor calculation ................................................................................... 18 3.3 Bandwidth of Emissions.................................................................................................... 21 3.4 Transmitter power line conducted emissions ................................................................... 24 3.5 Receiver/digital device radiated emissions....................................................................... 27 3.6 Digital device conducted emissions.................................................................................. 31 4.0 TEST EQUIPMENT..................................................................................................................... 34 EMC Report No: 101277992MIN-011D FCC ID: IC ID: Page 3 of 34 1.0 GENERAL DESCRIPTION Model: 4200 Type of EUT: Programmer Charger, Wakeup Radio Serial Number: DBR 1471 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 15:2013, §15.249 RSS–210, Issue 8, 2010 RSS-Gen, Issue 3, 2010 47 CFR, Part 15:2013, §15.107 and §15.109, Class B ICES-003, Issue 5:2012 Other Type of radio: Stand -alone Module Hybrid Date Sample Submitted: August 16, 2013 Test Work Started: August 19, 2013 Test Work Completed: September 26, 2013 Test Sample Conditions: Damaged Poor (Usable) Good EMC Report No: 101277992MIN-011D FCC ID: IC ID: Page 4 of 34 1.1 Product Description; Test Facility Product Description: Programmer Charger Operating Frequency 2.45GHz Power Level Setting 6 Modulation: OOK Emission Designator: 3MX1D Antenna(s) Info: -2dBi Chip antenna Antenna Installation: User Professional Factory Transmitter Power Configuration: Internal battery External power source 100-240VAC 400VAC DC Other: 50-60Hz Special Test Arrangement: As a hand-held device the EUT was rotated through three orthogonal axes to determine and tested with the maximum emissions Test Facility Accreditation: A2LA (Certificate No. 1427.01) Test Methodology: Measurements performed according to the procedures in ANSI C63.10- 2009 EMC Report No: 101277992MIN-011D FCC ID: IC ID: Page 5 of 34 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 120VAC and was activated to transmit continuously at 2.45GHz. Cables: No. Type Length Designation Note 1 Not shielded USB Power cable 2m Power Cable 2 Model 4230 not shielded cable 1m Charging Paddle Support equipment/Services: No. Item Description 1 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 EMC Report No: 101277992MIN-011D FCC ID: IC ID: Page 6 of 34 1.4 Measurement uncertainty The expanded uncertainty (k = 2) for radiated emissions from 30 to 1000 MHz has been dete…

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