Y8LMN20700-03Wireless transmitter

Copyright © 2012 Spinal Modulation, Inc. All rights reserved. Unauthorized duplication or use is prohibited. AXIUM, SPINAL MODULATION and the Man in Circle Design are trademarks and/or registered trademarks of Spinal Modulation, Inc. Clinical Programmer Model MN20700-03 User Manual Authorization to affix the CE mark granted in 2011 Table of Contents EXPLANATION OF SYMBOLS ON PRODUCT OR PACKAGE LABELING ...........................................1 INTRODUCTION .....................................................................................................................................2 Indications for Use ..............................................................................................................................2 Description ..........................................................................................................................................2 Warnings .............................................................................................................................................2 Precautions .........................................................................................................................................3 CLINICAL PROGRAMMER SYSTEM OVERVIEW .................................................................................4 Clinical Programmer Features ............................................................................................................4 Magnet ................................................................................................................................................5 Charging the Clinical Programmer Battery .........................................................................................5 Programmer Power Up .......................................................................................................................5 MAIN MENU ............................................................................................................................................6 Demo ..................................................................................................................................................6 Programmer Setup .............................................................................................................................6 Change the Date and Time ....................................................................................................................................7 Switch to FCE Programmer ...................................................................................................................................7 Set Password .........................................................................................................................................................7 Establishing Communication with the NS Device ...............................................................................7 Back to Main Menu .............................................................................................................................8 NAVIGATION AND SCREEN ELEMENTS ..............................................................................................8 Neurostimulator Dashboard ................................................................................................................8 Programmer Status Bar ......................................................................................................................9 Workspace Navigation ........................................................................................................................9 Temporary and Permanent Programming ........................................................................................10 More on Editing Text Fields ..............................................................................................................10 USING THE WORKSPACES.................................................................................................................10 Profile Workspace.............................................................................................................................10 Patient Information Tab [Profile>Patient] ..............................................................................................................11 Clinic Information Tab [Profile>Clinic] ...................................................................................................................12 Stimulator Information Tab [Profile>NS] ...............................................................................................................12 Leads Information Tab [Profile>Leads] .................................................................................................................13 System Information Tab [Profile>System] ............................................................................................................13 Stim Workspace................................................................................................................................14 Stim Tabs [Stim>Target Name] .............................................................................................................................14 Impedance Tabs [Stim>Impedance] .....................................................................................................................17 Map Workspace ................................................................................................................................17 Group Workspace .............................................................................................................................17 Lead Tabs [Group>Group Name] .........................................................................................................................17 Periodic Stimulation 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Label Location (back of unit) Clinical Programmer Programmer voor de clinicus Programmiergerät Programmateur clinique Programador clínico Programmatore clinico Klinisk programmerare Clinical Programmer Kliininen ohjelmoija/Klinisk programmeringsenhet MN20700-03 Spinal Modulation, Inc. Menlo Park, CA, US FCC ID Y8L-MN20700-03 SN - Use Only with Spinal Modulation Programmer Charger (MN23400) / Uitsluitend gebruiken met oplaadapparaat voor Spinal Modulation programmer (MN23400) / Nur mit dem Ladegerät für das Programmier-/Bediengerät von Spinal Modulation verwenden (MN23400) / À utiliser uniquement avec le chargeur du programmateur de Spinal Modulation (MN23400) / Para uso exclusivamente con el cargador del programador de Spinal Modulation (MN23400) / Da utilizzare solamente con il caricatore del programmatore Spinal Modulation (MN23400) / Använd enbart med Spinal Modulation programmerar-laddare (MN23400) / Må kun anvendes sammen med Spinal Modulation Programmer-oplader (MN23400) / Käytä vain Spinal Modulation-ohjelmoijan laturin (MN23400) kanssa/ Bruk bare sammen med programmeringsenhetsladeren fra Spinal Modulation (MN23400) I P 20 REF LP0590 Rev 1 MediTech Strategic Consultants B.V. 6291 EN Vaals, NL EC REP AB1234 YYYY-MM

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Nemko Test Report: 10228454RUS1 Applicant: Spinal Modulation, Inc. 1135 O’Brien Drive Menlo Park, CA 94025 USA Equipment Under Test: MN20700-03 (E.U.T.) FCC ID#: Y8LMN20700-03 In Accordance With: FCC Part 95, Subpart E Personal Radio Devices. Tested By: Nemko USA Inc. 802 N. Kealy Lewisville, Texas 75057-3136 TESTED BY: DATE: 07-Mar-13 David Light, Wireless Engineer APPROVED BY: DATE: 22-Mar-13 Michael Cantwell, Reviewer Total Number of Pages: 18 Nemko USA, Inc. CFR 47, PART 95, Subpart E Personal Radio Devices EQUIPMENT: MN20700-03 PROJECT NO.:10228454RUS1 Page 2 of 18 Table Of Contents SECTION 1. SUMMARY OF TEST RESULTS 3 SECTION 2. GENERAL EQUIPMENT SPECIFICATION 5 SECTION 3. MAXIMUM RF TRANSMIT POWER 7 SECTION 4. OCCUPIED BANDWIDTH 9 SECTION 5. FREQUENCY STABILITY 12 SECTION 6. UNWANTED RADIATION 13 SECTION 7. TEST EQUIPMENT LIST 16 ANNEX A TEST DIAGRAMS 17 Nemko USA, Inc. CFR 47, PART 95, Subpart E Personal Radio Devices EQUIPMENT: MN20700-03 PROJECT NO.:10228454RUS1 Page 3 of 18 Section 1. Summary Of Test Results Manufacturer: Spinal Modulations, Inc. Model No.: MN20700-03 Serial No.: CP1013 General: All measurements are traceable to national standards. These tests were conducted on a sample of the equipment for the purpose of demonstrating compliance with FCC Part 95.627. All tests were conducted using measurement procedure ANSI C63.4-2003. Radiated Emissions were made on an open area test site. New Submission Production Unit Class II Permissive Change Pre-Production Unit THIS TEST REPORT RELATES ONLY TO THE ITEM(S) TESTED. THE FOLLOWING DEVIATIONS FROM, ADDITIONS TO, OR EXCLUSIONS FROM THE TEST SPECIFICATIONS HAVE BEEN MADE. See “ Summary of Test Data”. Nemko USA, Inc. authorizes the above named company to reproduce this report provided it is reproduced in its entirety, for use by the company’s employees only. This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the Federal Government. Nemko USA, Inc. is a NVLAP accredited laboratory. Any use which a third party makes of this report, or any reliance on or decisions to be made based on it, are the responsibility of such third parties. Nemko USA, Inc. accepts no responsibility for damages, if any, suffered by any third party as a result of decisions made or actions based on this report. This report applies only to the items tested. Nemko USA, Inc. CFR 47, PART 95, Subpart E Personal Radio Devices EQUIPMENT: MN20700-03 PROJECT NO.:10228454RUS1 Page 4 of 18 Summary Of Test Data Test/Requirement Description Pass / Fail Applicable Rule Parts Maximum RF Transmitting Power Pass 2.1046, 95.135, 95.639(f)(1) Modulation Characteristics Pass 2.1047, 95.631(g), 95.637 Occupied Bandwidth Pass 2.1049, 95.627(d) Unwanted Radiation Pass 2.1053, 95.635(d) Frequency Stability Pass 2.1055, 95.627(d) Test Result: The product as presented for testing complied with test requirements as shown above. Michael Cantwell Nemko USA, Inc. CFR 47, PART 95, Subpart E Personal Radio Devices EQUIPMENT: MN20700-03 PROJECT NO.:10228454RUS1 Page 5 of 18 Section 2. General Equipment Specification Frequency Range: 402 to 405 MHz Operating Frequency(ies) of Sample: 402.15 to 404.85 MHz Number of Channels: 10 User Frequency Adjustment: None Integral Antenna Yes No Nemko USA, Inc. CFR 47, PART 95, Subpart E Personal Radio Devices EQUIPMENT: MN20700-03 PROJECT NO.:10228454RUS1 Page 6 of 18 Description of EUT The EUT is a wireless transmitter used to program medical implants. System Diagram Nemko USA, Inc. CFR 47, PART 95, Subpart E Personal Radio Devices EQUIPMENT: MN20700-03 PROJECT NO.:10228454RUS1 Page 7 of 18 Section 3. Maximum RF Transmit Power NAME OF TEST: Maximum RF Transmit Power PARA. NO.: 95.639 TESTED BY: David Light DATE: 05 March 2013 Minimum Standard: §95.639(f)(1). For transmitters operating in the 401-406 MHz band that are not excepted under § 95.627(b) from the frequency monitoring requirements of § 95.627(a), the maximum radiated power in any 300 kHz bandwidth by MedRadio transmitters operating at 402- 405 MHz, or in any 100 kHz bandwidth by MedRadio transmitters operating at 401-402 MHz or 405-406 MHz shall not exceed 25 microwatts EIRP. For transmitters that are excepted under § 95.627(b) from the frequency monitoring requirements of § 95.627(a), the power radiated by any station operating in 402-405 MHz shall not exceed 100 nanowatts EIRP confined to a maximum total emission bandwidth of 300 kHz centered at 403.65 MHz, the power radiated by any station operating in 401-401.85 MHz or 405- 406 MHz shall not exceed 250 nanowatts EIRP in any 100 kHz bandwidth and the power radiated by any station operating in 401.85-402 MHz shall not exceed 25 microwatts in the 150 kHz bandwidth. Test Results: Complies . . Measurement Data: See attached table. Method of Measurement: The antenna substitution method is used to determine the equivalent radiated power at spurious frequencies. The spurious emissions are measured at a distance of 3 meters. The EUT is then replaced with a reference substitution antenna with a known gain referenced to an isotropic radiator. This antenna is fed with a signal at the spurious frequency. The level of the signal is adjusted to repeat the previously measured level. The resulting eirp is the signal level fed to the reference antenna corrected for gain referenced to an isotropic radiator. Nemko USA, Inc. CFR 47, PART 95, Subpart E Personal Radio Devices EQUIPMENT: MN20700-03 PROJECT NO.:10228454RUS1 Page 8 of 18 Test Data – Maximum RF Transmit Power Frequency Meter SubstitutionPre‐Amp SubstitutionEIRPLimitMargin PolarityComments ReadingLevelGain Antenna Gain (MHz)(dBm)(dBm)(dB)(dBi)(dBm)(dBm)(dB) Power setting = 0x0F 402.15‐57.6‐28.502.2‐26.3‐16.0‐10.30V 402.15‐45.7‐18.802.2‐16.6‐16.0‐0.60H 404.85‐56.9‐27.802.2‐25.6‐16.0‐9.60V 404.85‐46.0‐19.102.2‐16.9‐16.0‐0.90H Note s: Nemko USA, Inc. CFR 47, PART 95, Subpart E Personal Radio Devices EQUIPMENT: MN20700-03 PROJECT NO.:102…

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