OSU2007Implantable Insulin Delivery System TX

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 MiniMed Implantable Pump (MIP) FCC “C” Certification Application – Exterior Photographs 99-208OSU20071 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 MiniMed Implantable Pump (MIP) FCC “C” Certification Application – Exterior Photographs 99-208OSU20072 of 3 Photograph 2. Top View of MiniMed Implantable Pump (MIP) 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 MiniMed Implantable Pump (MIP) FCC “C” Certification Application – Exterior Photographs 99-208OSU20073 of 3 Photograph 3. Bottom View of MiniMed Implantable Pump (MIP)

REF MMT-2007

REF MMT-2007 CAUTION: This pump features a “non A” style catheter connection. It must be attached to models MMT-4021-4028 side port catheter ONLY. Sample FCC Label

FCC ID: OSU2007 FCC ID Label Diagram Showing FCC Label Placement

FCC, PART 15, SUBPART C C ERTIFICATION APPLICATION For The MiniMed Implant Unit (Transceiver) Model: MMT-2007 FCC ID: OSU2007 (P ENDING) PREPARED FOR: Medical Research Group 12744 San Fernando Road Sylmar, CA 91342 PREPARED ON NOVEMBER 1, 1999 DOCUMENT NUMBER 99-208 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 11/01/99Medical Research Group MIP FCC ‘C’ Certification Report99-208OSU2007ii of 24 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 11/01/99Medical Research Group MIP FCC ‘C’ Certification Report99-208OSU2007iii of 24 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 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 11/01/99Medical Research Group MIP FCC ‘C’ Certification Report99-208OSU2007iv of 24 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 11/01/99Medical Research Group MIP FCC ‘C’ Certification Report99-208OSU20071 of 24 1. ADMINISTRATIVE DATA AND TEST SUMMARY 1.1 Administrative Data CLIENT:Medical Research…

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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-2007 Test Setup Photograph OSU20071 Radiated Emissions Test Configuration Photograph Loop Antenna EUT: MIP (under glass) and PPC