OH27703Glucose Sensor Transmitter (GST1)

1 The Medtronic MiniMed MiniLink™ transmitter (MiniLink) is a component of continuous glucose sensing systems and sensor-enabled pump systems. The MiniLink powers the glucose sensor, collects glucose data, and wirelessly sends the data to a monitor. The monitor is part of a Medtronic MiniMed continuous glucose sensing system or Medtronic MiniMed sensor-enabled pump system. Package contents Indications for use The MiniLink is indicated for use as a component of select Medtronic continuous glucose sensing systems and sensor-enabled pump systems. Contraindications None known. •MiniLink transmitter•MiniLink tester •MiniLink charger•Occlusive dressing (10 pack) •AAA alkaline battery 0LQL/LQNFKDUJHU 0LQL/LQNWHVWHU 0LQL/LQNWUDQVPLWWHU 2 Warnings Do not use the MiniLink to send glucose readings to the monitor while onboard an aircraft. Disconnect the MiniLink from the sensor while travelling on an aircraft or if interference with other transmitting devices occurs. The sensor should be removed if redness, bleeding, pain, tenderness, irritation, or inflammation develops at insertion site, or if user experiences unexplained fever. Occlusive dressing should be removed if irritation or reaction to the tape develops. The sensor may create special needs regarding your medical conditions or medications. Discuss with your doctor before using the sensor. Wait 5 minutes after sensor insertion to see if bleeding occurs at the insertion site: •The MiniLink should not be attached to the sensor until after the bleeding has stopped. •If bleeding persists, apply steady pressure using a sterile gauze or clean cloth at the insertion site until bleeding stops. After bleeding stops, attach the MiniLink to the sensor. •If bleeding persists after 3 minutes, remove the sensor and discard. Insert a new sensor in a different location. Contact the Medtronic Diabetes 24 Hour HelpLine if you experience any adverse reactions associated with the MiniLink or sensor. Note: The MiniLink is designed to withstand common electromagnetic interference, including airport security systems. Precautions Establish a rotation schedule for choosing new sensor sites. Avoid sites that are constrained by clothing, have scar tissue, or are subject to rigorous movement during exercise. 3 Telecommunications notice This device complies with the United States Federal Communications Commission and international standards for electromagnetic compatibility. For the specific regulations and test results in your area, please contact the Medtronic 24 Hour HelpLine listed on the International Contact Card. 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 undesirable operation. Changes or modifications not expressly approved by the party responsible for compliance could void the user's authority to operate the equipment. The MiniLink does not interfere with any radio frequency signals transmitted from outside sources.These FCC standards are designed to provide reasonable protection against excessive radio frequency interference and prevent undesirable operation of the device from unwanted electromagnetic interference. This device receives and radiates radio frequency energy and, if installed and used in accordance with the instruction, may experience interference in its communications. In such an event, you are encouraged to try to correct the interference by one or more of the following measures: •Reorient or relocate the MiniLink and/or receiving pump or monitor •Increase the distance between the MiniLink and the device that is emitting interference •Turn off or move other RF devices, such as the following: cell phones, cordless phones, and wireless networks. This interference will not cause any incorrect data to be sent and will not cause any harm to your pump, monitor, or MiniLink. 4 MiniLink charger The MiniLink transmitter contains a non-replaceable, rechargable battery so you can recharge your MiniLink as needed. Before using your MiniLink for the first time, you should charge the battery fully. To maintain a short re-charging period, charge the MiniLink after each sensor use. While the MiniLink will work more than 14 days without recharging, an empty battery can take up to 2 hours to recharge. Installing a new charger battery 1Unscrew charger battery cap. 2Insert an AAA battery with flat (-) end first and screw on charger cap. 3If battery is installed incorrectly or is bad, the charger will not work when the MiniLink is attached. Repeat steps above using a new battery. 5 Note: A new AAA battery in the charger may charge the MiniLink over 40 times before it needs to be replaced. Charging the MiniLink 1Insert the MiniLink into the charger. Line up the MiniLink connector (flat side down) with the charger and push the two components together fully. Note: The charger contains green and red LEDs (lights). 2When the MiniLink is first connected, the charger’s green LED will blink rapidly for 1-2 seconds as charger powers on. 3As the MiniLink charges, the charger’s green LED will flash occassionally. 4When charging is complete, the charger’s green LED will turn on for 15 to 20 seconds and then turn off. Once the LED is off, disconnect the MiniLink from $JUHHQ/('VKRZV FKDUJHULVZRUNLQJ $UHG/('DSSHDUVLI  FKDUJHUEDWWHU\QHHGV UHSODFHPHQW25  WKHUHLV DSUREOHP ZLWKWKH 0LQL/LQN EDWWHU\ DERXW VHF DERXW VHF 6 the charger. A green LED inside the MiniLink will blink for about 5 seconds and then turn off. This confirms that the MiniLink is ready to use. Note: If the green LED inside the MiniLink does not blink, re-connect the MiniLink to the charger for at least one minute. After one minute, remove the MiniLink from the charger and watch for the MiniLink to flash green. Connect to the sensor. Caution: If the MiniLink LED is sti…

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GST1 ( MMT7703) : External : Top GST1 ( MMT7703) : External : Side GST1 ( MMT7703) : External : Top GST1 ( MMT7703) : External : Bottom

GST1 ( MMT7703) : External : Top GST1 ( MMT7703) : External : Bottom

GST1 ( MMT7703) internal PCB : Top GST1 ( MMT7703) internal PCB : bottom

Report No. SC600996-08 Page 1 of 10 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 MEASUREMENT AND TECHNICAL REPORT MEDTRONIC MINIMED 18000 Devonshire Street Northridge, CA 91325 DATE: 06 March 2006 This Report Concerns: Original Grant: X Class II Change: Equipment Type: Glucose Sensor Transmitter GST1, Model MMT-7703 Deferred grant requested per 47 CFR 0.457(d)(1)(ii)? Yes: Defer until: No: X Company Name agrees to notify the Commission by: N/A of the intended date of announcement of the product so that the grant can be issued on that date. Transition Rules Request per 15.37? Yes: No: X* (*) FCC Part 15, Paragraph(s) 15.209(a) and 15.249(a) Report Prepared by: TÜV AMERICA, INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 Fax: 858 546 0364 Report No. SC600996-08 Page 2 of 10 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 TABLE OF CONTENTS Pages 1.0 GENERAL INFORMATION 3 1.1 Product Description 3 1.2 Related Submittal Grant 3 1.3 Tested System Details 3 1.4 Test Methodology 4 1.5 Test Facility 4 2.0 SYSTEM TEST CONFIGURATION 5 2.1 Justification 5 2.2 EUT Exercise Software 5 2.3 Special Accessories 5 2.4 Equipment Modifications 5 2.5 Configuration of Test System 5 3.0 RADIATED SPURIOUS EMISSIONS/FIELD STRENGTH EQUIPMENT/DATA 6 4.0 ATTESTATION STATEMENT 10 Report No. SC600996-08 Page 3 of 10 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 1.0 GENERAL INFORMATION 1.1 Product Description General Equipment Description: EUT Description: Glucose Sensor Transmitter EUT Name: Glucose Sensor Transmitter GST1 Model No.: MMT-7703 Configurations and modes to be tested: 2Hz Special Transmitter Mode Power Requirements: Voltage: 3.7V Nominal EUT Power Cable: N/A EUT Operating Modes to be Tested : 2Hz EMI Test Software – special software used to facilitate FCC and EMI testing. EUT System Components - Description Model # Serial # FCC ID # Glucose Sensor Transmitter MMT-7703 Support Equipment Description Model # Serial # FCC ID # GST Test Plug Sensor Simulator MMT-7706 Oscillator Frequencies Frequency Derived Frequency Component # / Location Description of Use 27MHz 32.768KHz -- Y1 U3 Transmitter Reference Oscillator Real Time Clock IC 8MHz -- U5 Micro-controller Oscillator Power Supply Manufacturer Model # Serial # Type Ricoh R1180D301C N/A Switched-mode: Linear:X 1.2 Related Submittal Grant None 1.3 Tested System Details The FCC ID’s for all equipment, plus descriptions of all cables used in the tested system are: None Report No. SC600996-08 Page 4 of 10 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 1.4 Test Methodology Purpose of Test: To demonstrate compliance with the following tests. Test Summary Summary of Results Test Description Paragraph Number Low Channel Mid Channel High Channel Pass/Fail Radiated Emissions (30 to 1000 MHz) 15.209(a) -- No Emissions Found -- Pass Radiated Spurious Emissions/Field Strength – Restricted Bands (1GHz to 25GHz) 15.249/ 15.209(a) -- -9.0 @ 7332.8 MHz -- Pass Testing was performed according to the procedures in FCC/ANSI C63.4 and CSA 108.8-M1983. 1.5 Test Facility The open area test site and conducted measurement data were tested by: TÜV AMERICA, INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 678 1400 Fax: 858 546 0364 The Test Site Data and performance comply with ANSI C63.4 and are registered with the FCC, 7435 Oakland Mills Road, Columbia Maryland 21046. All Measurement Data is acquired according to the content of FCC Measurement Procedure and ANSI C63.4, unless supplemented with additional requirements as noted in the test report. Report No. SC600996-08 Page 5 of 10 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 2.0 SYSTEM TEST CONFIGURATION 2.1 Justification The EUT was initially tested for FCC emissions in the following configuration: See Test Setup Photos Exhibit 2.2 EUT Exercise Software None 2.3 Special Accessories None 2.4 Equipment Modifications None 2.5 Configuration of Test System See Test Setup Photos Exhibit Report No. SC600996-08 Page 6 of 10 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 3.0 RADIATED SPURIOUS EMISSIONS EQUIPMENT/DATA Test Conditions: RADIATED SPURIOUS EMISSIONS: FCC Part 15.209(a) and 15.249 The following measurements were performed at the San Diego Testing Facility: † - Test not applicable „ - Roof (Small Open Area Test Site) Test Equipment Used: Model No. Prop. No. Description Manufacturer Serial No. Date Cal’ed E4446A 6823 Spectrum Analyzer Agilent US44300486 04/05 E4440A 6814 Spectrum Analyzer Agilent MY4251044102/06 3146 6641 Log Periodic Antenna EMCO 106X 06/05 3115 6669 Double Ridge Antenna EMCO 9412-4364 08/05 Remarks: One year calibration cycle for all test equipment and sites. Report No. SC600996-08 Page 7 of 10 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Report No. SC600996-08 Page 8 of 10 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Report No. SC600996-08 Page 9 of 10 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 1400 FAX 858 546 0364 Report No. SC600996-08 4.0 ATTESTATION STATEMENT GENERAL REMARKS: SUMMARY: All tests were performed per CFR 47, Part(s) 15.209(a) and 15.249 „ - Performed The Equipment Under Test „ - Fulfills the requirements of CFR 47, Part(s) 15.209(a) and 15.249 Testing Start Date: 21 February 2006 Testing End Date: 22 February 2006 - TÜV AMERICA, INC. - Reviewing Engineer: Test Engineer: David Gray William Dey (EMC Engineer In Charge) (EMC Technician) Page 10 of 10 Rev.No 1.0 TÜV AMERICA INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 678 …

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