OSU3132Insulin Delivery System Transceiver

This device complies with part 15 of the FCC Rules. Operation is subject to the following two conditions : (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Operation of this device is authorized by the FCC under the FCC ID : OSU2007 (Implantable Pump) and OSU3132 (PPC). Any changes or modifications to the system not expressly approved by MiniMed could void the user’s authority to operate the system.

12744 San Fernando Road, Sylmar, CA 91342, Telephone (818) 362-8084, FAX (818) 364-2647, e-mail: [email protected] Medical Research Group, Inc. November 24, 1999 Federal Communications Commission Re : Confidentiality Gentlemen : We are applying for certification of an implantable medical device system. There are trade secrets and patent sensitive information, for which patent applications have not yet been applied and for which patent publications have not been made, in some of the documents supplied. We request that you treat these materials as confidential. The following documents supplied should be treated as confidential: Schematics Block Diagrams Circuit Descriptions Respectfully, Ron Lebel President, Medical Research Group

Nemko EESI, Inc. 11696 Sorrento Valley Road, Suite. F, San Diego, CA 92121 Phone (858) 793-9911 Fax (858) 259-7170 DATEDOCUMENT NAMESUBMITTAL #FCC IDPAGE 11/01/99 Medical Research Group Personal Pump Communicator (PPC) FCC “C” Certification Application – Exterior Photographs 99-207OSU3132RU1 of 3 Photograph 1. Implantable Insulin Delivery System Nemko EESI, Inc. 11696 Sorrento Valley Road, Suite. F, San Diego, CA 92121 Phone (858) 793-9911 Fax (858) 259-7170 DATEDOCUMENT NAMESUBMITTAL #FCC IDPAGE 11/01/99 Medical Research Group Personal Pump Communicator (PPC) FCC “C” Certification Application – Exterior Photographs 99-207OSU3132RU2 of 3 Photograph 2. Top View of Personal Pump Communicator (PPC) Nemko EESI, Inc. 11696 Sorrento Valley Road, Suite. F, San Diego, CA 92121 Phone (858) 793-9911 Fax (858) 259-7170 DATEDOCUMENT NAMESUBMITTAL #FCC IDPAGE 11/01/99 Medical Research Group Personal Pump Communicator (PPC) FCC “C” Certification Application – Exterior Photographs 99-207OSU3132RU3 of 3 Photograph 3. Bottom View of Personal Pump Communicator (PPC)

6021007-006 11/99 USA: Sylmar, Ca. 818-362-5958 Europe: MiniMed S.A., Paris, France (33) 1-46-43-16-16 REF MMT-3132 MiniMed Implantable Pump System 0459 FCC ID: OSU3132

6021007-006 11/99 USA: Sylmar, Ca. 818-362-5958 Europe: MiniMed S.A., Paris, France (33) 1-46-43-16-16 REF MMT-3132 MiniMed Implantable Pump System 0459 FCC ID: OSU3132 Sample FCC Label Diagram Medical Research Group FCC ID: OSU3132

Nemko EESI, Inc. 11696 Sorrento Valley Road, Suite. F, San Diego, CA 92121 Phone (858) 793-9911 Fax (858) 259-7170 DATEDOCUMENT NAMESUBMITTAL #FCC IDPAGE 11/01/99 Medical Research Group Personal Pump Communicator (PPC) FCC “C” Certification Application – Interior Photographs 99-207OSU3132RU1 of 5 Photograph 1. Personal Pump Communicator (PPC) Opened Nemko EESI, Inc. 11696 Sorrento Valley Road, Suite. F, San Diego, CA 92121 Phone (858) 793-9911 Fax (858) 259-7170 DATEDOCUMENT NAMESUBMITTAL #FCC IDPAGE 11/01/99 Medical Research Group Personal Pump Communicator (PPC) FCC “C” Certification Application – Interior Photographs 99-207OSU3132RU2 of 5 Photograph 2. Bottom View of PPC Circuit Board Assembly (Removed From Case) Nemko EESI, Inc. 11696 Sorrento Valley Road, Suite. F, San Diego, CA 92121 Phone (858) 793-9911 Fax (858) 259-7170 DATEDOCUMENT NAMESUBMITTAL #FCC IDPAGE 11/01/99 Medical Research Group Personal Pump Communicator (PPC) FCC “C” Certification Application – Interior Photographs 99-207OSU3132RU3 of 5 Photograph 3. Top View of PPC Circuit Board Assembly (Showing LCD Display) Nemko EESI, Inc. 11696 Sorrento Valley Road, Suite. F, San Diego, CA 92121 Phone (858) 793-9911 Fax (858) 259-7170 DATEDOCUMENT NAMESUBMITTAL #FCC IDPAGE 11/01/99 Medical Research Group Personal Pump Communicator (PPC) FCC “C” Certification Application – Interior Photographs 99-207OSU3132RU4 of 5 Photograph 4. PPC Circuit Board Assembly (LCD Display Opened) Nemko EESI, Inc. 11696 Sorrento Valley Road, Suite. F, San Diego, CA 92121 Phone (858) 793-9911 Fax (858) 259-7170 DATEDOCUMENT NAMESUBMITTAL #FCC IDPAGE 11/01/99 Medical Research Group Personal Pump Communicator (PPC) FCC “C” Certification Application – Interior Photographs 99-207OSU3132RU5 of 5 Photograph 5. PPC Circuit Board Assembly Opened (Interior Side of PCBs)

Nemko EESI, Inc. 11696 Sorrento Valley Road, Suite. F, San Diego, CA 92121 Phone (858) 793-9911 Fax (858) 259-7170 DATEDOCUMENT NAMESUBMITTAL #FCC IDPAGE 11/01/99 Medical Research Group MMT-313x FCC ‘ C’ Ce rt ificatio n Re po rt 99-207OSU313213 of 24 Nemko EESI, Inc. FCC, Part 15C, 15.209 Radiated Emissions Data Sheet (10m Open Area Test Site) Client: Medical Research Group Conducted by:_____________________ EUT: Tranceivers Date of Test: 10-01-99 Model #: MMT-2007 & MMT-313X Test Distance, Amp. gain: 10 m, 59 dB Frequency (MHz) Spectrum Analyzer Reading at 10m (dB μ μμ μ V) Antenna Position (vertical or horizontal) f O Antenna Factor (dB) Amp. Gain (dB) 30m Distance Factor (dB) Total Interference Level at 10m (dB μ μμ μ V/m) Emission Spec. Limit at 10m (dB μ μμ μ V/m) Difference Margin (dB) 0.262-3.1vf 0 42.4 -49.0 -10.0-19.719.2-38.9 Note: No additional harmonics (f 2 -f 10 ) of the fundamental frequency or spurious emissions were observed within 10dB of the limit.

FCC ID: OSU3132 Nemko EESI, Inc. FCC, Part 15C, 15.209 Radiated Emissions Data Sheet (10m Open Area Test Site) Client:Medical Research Group Conducted by: M. Krumweide EUT:TranceiversDate of Test:10-01-99 Model #:MMT-2007 & MMT-313XTest Distance, Amp. gain:10 m, 59 dB Frequency (MHz) Spectrum Analyzer Reading at 10m (dBμμV) Antenna Position (vertical or horizontal) f O Antenna Factor (dB) Amp. Gain (dB) Total Interference Level at 10m (dBμμV/m) Emission Spec. Limit at 10m (dBμμV/m) Difference Margin (dB) 0.262-3.1v f 0 42.4-49.0 -9.778.2-87.9 Notes: 1. No additional harmonics (f 2 -f 10 ) of the fundamental frequency or spurious emissions were observed within 10dB of the limit. 2. The 300m Emission Limit of 19.2dBuV/m has been adjusted to 10m using 40log of the ratio of the distances (close field approximation method) Test Conditions: Standard radiated emissions test set up on FCC registered open field site. The highest emissions for all antenna heights, polarities, and table orientations are the only emissions recorded.

FCC ID: OSU3132 Nemko EESI, Inc. FCC, Part 15C, 15.209 Radiated Emissions Data Sheet (10m Open Area Test Site) Client:Medical Research Group Conducted by: M. Krumweide EUT:TranceiversDate of Test:10-01-99 Model #:MMT-2007 & MMT-313XTest Distance, Amp. gain:10 m, 59 dB Frequency (MHz) Spectrum Analyzer Reading at 10m (dBμμV) Antenna Position (vertical or horizontal) f O Antenna Factor (dB) Amp. Gain (dB) Total Interference Level at 10m (dBμμV/m) Emission Spec. Limit at 10m (dBμμV/m) Difference Margin (dB) 0.262-3.1v f 0 42.4-49.0 -9.778.2-87.9 Notes: 1. No additional harmonics (f 2 -f 10 ) of the fundamental frequency or spurious emissions were observed within 10dB of the limit. 2. The 300m Emission Limit of 19.2dBuV/m has been adjusted to 10m using 40log of the ratio of the distances (close field approximation method) Test Conditions: Standard radiated emissions test set up on FCC registered open field site. The highest emissions for all antenna heights, polarities, and table orientations are the only emissions recorded.

FCC, PART 15, SUBPART C CERTIFICATION APPLICATION For The Personal Pump Communicator (Transceiver) Model: MMT-313x FCC ID: OSU3132 (PENDING) PREPARED FOR: Medical Research Group 12744 San Fernando Road Sylmar, CA 91342 PREPARED ON NOVEMBER 1, 1999 DOCUMENT NUMBER 99-207 This report has been prepared in accordance with all applicable requirements of ANSI C63.4-1992 Nemko EESI, Inc. 11696 Sorrento Valley Road, Suite. F, San Diego, CA 92121 Phone (858) 793-9911 Fax (858) 259-7170 DATEDOCUMENT NAMESUBMITTAL #FCC IDPAGE 11/01/99 Medical Research Group MMT-313x FCC ‘C’ Certification Report 99-207OSU3132ii of 25 DOCUMENT HISTORY REVISIONDATECOMMENTS -11/01/99Initial Release J. L. Griffin NOTE: Nemko EESI, Inc. hereby makes the following statements so as to conform to Chapter 10 (Test Reports) Requirements of ANSI C63.4 (1992) “Methods and Measurement of Radio-Noise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz”: • The unit described in this report was received at Nemko EESI, Inc.'s facilities on September 22, 1999. Testing was performed on the units described in this report September 22 - October 1, 1999. • The Test Results reported herein apply only to the Units actually tested, and to substantially identical Units. • This test report must not be used by the client to claim product endorsement by NVLAP or any agency of the U.S. Government. This document is the property of Nemko EESI, Inc., and shall not be reproduced, except in full, without prior written approval of Nemko EESI, Inc.. However, all ownership rights are hereby returned unconditionally to Medical Research Group, and approval is hereby granted to Medical Research Group and its employees and agents to reproduce all or part of this report for any legitimate business purpose without further reference to Nemko EESI, Inc.. Nemko EESI, Inc. 11696 Sorrento Valley Road, Suite. F, San Diego, CA 92121 Phone (858) 793-9911 Fax (858) 259-7170 DATEDOCUMENT NAMESUBMITTAL #FCC IDPAGE 11/01/99 Medical Research Group MMT-313x FCC ‘C’ Certification Report 99-207OSU3132iii of 25 TABLE OF CONTENTS DOCUMENT HISTORY.......................................................................................................................................ii CERTIFICATION.................................................................................................................................................iv 1.ADMINISTRATIVE DATA AND TEST SUMMARY..................................................................................1 1.1Administrative Data...................................................................................................................................1 2.SYSTEM DESCRIPTION AND CONFIGURATION...................................................................................2 2.1Description of EUT's System.....................................................................................................................2 2.2System Components and Power Cables....................................................................................................5 2.3System Components and Power Cables....................................................................................................5 3.DESIGN MODIFICATIONS FOR COMPLIANCE......................................................................................6 4.DESCRIPTION OF TEST SITE AND EQUIPMENT...................................................................................6 4.1Description of Open Area Test Site...........................................................................................................6 4.2Test Equipment.........................................................................................................................................6 5.DESCRIPTION OF TESTING METHODS...................................................................................................7 5.1Introduction..............................................................................................................................................7 5.2Configuration and Methods of Measurements for Radiated Emissions.........................................................9 5.3Radiated Emission Field Strength.............................................................................................................12 6.TEST RESULTS..............................................................................................................................................13 6.1Radiated Emissions Test Data.................................................................................................................13 6.2Spurious Radiated Emissions Test Data...................................................................................................14 TEST SETUP DRAWINGS AND PHOTOGRAPHS Figure 1. General Test Setup Drawing of EUT and Associated System.................................................................8 Figure 2. Frequency ID of Radiated Emissions Test Setup Drawing....................................................................10 Figure 3. Radiated Emissions Test Setup Drawing..............................................................................................11 Figure 4. Radiated Emissions Test Configuration Photograph..............................................................................16 APPENDICES Conducted & Radiated Emissions Measurement Uncertainties ..........................................................................A-1 Nemko EESI, Inc.’s Test Equipment & Facilities Calibration Program...............................................................B-1 Nemko EESI, Inc. 11696 Sorrento Valley Road, Suite. F, San Diego, CA 92121 Phone (858) 793-9911 Fax (858) 259-7170 DATEDOCUMENT NAMESUBMITTAL #FCC IDPAGE 11/01/99 Medical Research Group MMT-313x FCC ‘C’ Certification Report 99-207OSU3132iv of 25 Nemko EESI, Inc. 11696 Sorrento Valley Road, Suite. F, San Dieg…

Text truncated - open the document above for the full version.

Nemko EESI, Inc. 11696 Sorrento Valley Road, Suite. F, San Diego, CA 92121 Phone (858) 793-9911 Fax (858) 259-7170 DATEDOCUMENT NAMEFCC IDPAGE 11/01/99 Medical Research Group MMT-313x Test Setup Photograph OSU31321 Radiated Emissions Test Configuration Photograph Loop Antenna MIP (under glass) and EUT: PPC