OH2712Paradigm 712

Paradigm ® 512 and 712 Infusion Pumps Models MMT-512 MMT-712 User Guide © 2003, Medtronic MiniMed. All rights reserved.BD Logic™ is a trademark of Becton, Dickinson and CompanyBolus Wizard™ is a trademark of Medtronic MiniMed.Dual Wave™ is a trademark of Medtronic MiniMed.Easy Bolus™ is a trademark of Medtronic MiniMed.Energizer ® is a trademark of Eveready Battery Company. Glucagon Emergency Kit ® is a trademark of Eli Lilly and Company. Paradigm ® is a trademark of Medtronic MiniMed. Paradigm Link™ is a trademark of Medtronic MiniMed.Quick-serter ® is a trademark of Medtronic MiniMed. Quick-set ® is a trademark of Medtronic MiniMed. Silhouette ® is a trademark of Medtronic MiniMed. Sof-set ® is a trademark of Medtronic MiniMed. Square Wave™ is a trademark of Medtronic MiniMed.U.S., international, and foreign patent applications are pending. 6024914-012 9/03 Your pump arrives from the factor y in training mode so you can program your settings and practice without inserting a reservoir. The first rewind cancels training mode and installation of a reservoir will be required. Do not rewind your pump until you are ready to use it with insulin. If you press “Rewind” by mistake, refer to step 3, page 39, in the section, “Rewinding you pump” for detailed instructions. PLEASE READ THIS ENTIRE USER GUIDE BEFORE YOU TRY TO OPERATE YOUR PUMP. Table of contents i Table of contents Glossary ........................................... xiiiYour personal information ........................ xvii Basal rate ......................................................................................................... xviiInsulin type .................................................................................................... xviiiCarb ratios (meal bolus info) ................................................................... xviiiBG targets ..................................................................................................... xviiiInsulin sensitivity ........................................................................................ xviii Introduction ..................................... xix Purpose ............................................................................................................. xixHow to use this guide ................................................................................... xx Chapter 1 Before you begin... ................... 1 Availability ........................................................................................................... 1Assistance ........................................................................................................... 1Emergency kit .................................................................................................... 1Disposables ........................................................................................................ 2Accessories ........................................................................................................ 2How to wear your pump ................................................................................ 2Practice, practice, practice... ....................................................................... 3 If you press rewind by mi stake .............................. ..........................................3 Chapter 2 The basics... ......................... 5 Your pump .......................................................................................................... 5 ii Table of contents Install battery .................................................................................................... 6Pump buttons .................................................................................................... 8The pump screen ..............................................................................................9 Is my pump on? ........... ....................................................... ................................... 9 Scroll bar .......................................... .............................................. .......................... 9 Screen backlight .................. .............................................. ................................... 9 Beep/vibrate ......................................................................................................9HOME screen ....................................................................................................10Operating modes ............................................................................................10Menus ................................................................................................................... 11STATUS screen ............................................................................................... 12Alert conditions ............................................................................................... 13 What to do.... ......................... .............................................. ..................................13 Low reservoir alert ......... .................. .................. .................. .................. .............. 13 Low battery alert ............ .................. .................. .................. .................. .............. 13 Alerts for special features ........................................................................... 14If you remove your pump... .......................................................................... 14 Pump settings ...................... .............................................. ..................................14 Insulin ....................................... .............................................. .................................. 14 Chapter 3 Basic programming ...................15 Setting the time and date ............................................................................ 15BG reminder ...............................................................…

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RF uController with 10.00 MHz Oscillator RF Transceiver including 916.50 MHz Oscillator H8 uController with 4.91 MHz Oscillator PARADIGM 7 12 BLOCK DIAGRAM ASIC with 32.768 KHz Osc illator Motor uController with 4.00 MHz Oscillator INTERFACE BOARD RF BOARD MOTHER BOARD LCD Driver EL Driver LCD EL BACKLIGHT LCD BOARD + 5.0 V ENCODER POWER SUPPLY 3.3 VDC

Paradigm Insulin Pump Model MMT-712: Operating Description The MMT-712 is an external insulin pump w/ a Bolus Estimator designed to deliver 0 to 35 Units/hour in basal rates and up to 25.0 Units per meal bolus for either U50, or U100 insulin. It is desired that the 712 deliver basal in single pulses of 1/2 micro-liter each, thus we would have deliveries of u100 and U50 as 0.05 units, user can choose increment of programming (up to 0.1) within this resolution but even if coarser programming is selected, deliveries will still be single pulses. Font size shall remain the same as in 511. An additional screen shall be added to allow user to choose increment of programming type. A new drive motor with reservoir (3ml or up to 25% larger pump volumetrically) and proprietary connector shall be utilized. The keypad shall be similar to the 511 except it may be increased in size to be proportional to the case. The pump shall offer the user a choice of either an audible or a vibrating alarm, and an optional accessory (RF remote transmitter) that can program certain basic functions while allowing the pump to be concealed from view. The pump shall provide a warning indicative of a low or empty reservoir situation as well as a low battery indicator which shall include battery depletion levels - normal, low battery and off no power (depleted battery). The MMT-712 shall utilize a Dot Matrix LCD screen with dedicated Icons that offers multi- language capability as well as a more detailed alarm / error message capability (same as the 511). Programming options shall include up to three customized basal profiles / personal delivery patterns, multiple bolus options and several safety programming options. Selected patterns shall remain in place until user edits / selects to alternate pattern. The MMT-712 insulin pump shall have the capability to store up to approx. 90 days worth of data and download either complete, or selected memory, via RF communication to a future RF download source. A battery backed RAM memory shall be utilized to contain pump, pump configuration, personal delivery patterns, and additional programming parameters. The pump serial number shall be stored in non-volatile memory. The MMT-712 shall utilize the same remote transmitter housing as currently used for the 511product (the transmitter case shall snap together and maintain water resistance). This device shall be able to Suspend, Re-start and program a normal bolus without requiring access to the keypad on the pump. The telemetry range shall be up to 24” with no requirement for orientation. The battery shall remain the same as the MMT-503. Frequencies shall be the same as the 511, (domestic 916.5 Mhz).This device must comply with FCC regulations.

TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC304401-03 Page 1 of 12 Rev.No 1.0 MEASUREMENT AND TECHNICAL REPORT MEDTRONIC MINIMED 18000 Devonshire Street Northridge, CA 91325 DATE: 15 October 2003 This Report Concerns: Original Grant: X Class II Change: Equipment Type: Paradigm 712 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) 15.207(a); 15.209(a ); 15.249(c); RSS 210, 6.1.1(c) Report Prepared by: TÜV AMERICA, INC 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone: 858 546 3999 Fax: 858 546 0364 TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC304401-03 Page 2 of 12 Rev.No 1.0 TABLE OF CONTENTS Pages 1.0 GENERAL INFORMATION 3 1.1 Product Description 3 1.2 Related Submittal Grant 5 1.3 Tested System Details 5 1.4 Test Methodology 5 1.5 Test Facility 5 2.0 SYSTEM TEST CONFIGURATION 6 2.1 Justification 6 2.2 EUT Exercise Software 6 2.3 Special Accessories 6 2.4 Equipment Modifications 6 2.5 Configuration of Test System 6 3,0 CONDUCTED EMISSIONS (15.207(a)) 7 3.1 Equipment / Data 7 4.0 RADIATED EMISSIONS (15.209(a); 15.249(c)) 8 4.1 Equipment 8 4.2 Data 9 5.0 BANDWIDTH (RSS 210, 6.1.1(c)) 10 5.1 Equipment 10 5.2 Data 11 6.0 ATTESTATION STATEMENT 12 TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC304401-03 Page 3 of 12 Rev.No 1.0 1.0 GENERAL INFORMATION EUT Description: Battery operated, pager sized, insulin infusion pump EUT Name: Paradigm Model No.: 712 Serial No.: Product Options: Color options Configurations to be tested: Transmitting RF EUT Specifications and Requirements Length: 3.5” Width: 0.75” Height: 2” Weight: 100grams Power Requirements Voltage: 1.6vdc (If battery powered, make sure battery life is sufficient to complete testing.) # of Phases: N/A Current (Amps/phase(max)): 11mA Current (Amps/phase(nominal)): 500ua Typical Installation and/or Operating Environment Home EUT Power Cable: N/A EUT Interface Ports and Cables: N/A EUT Software. Revision Level: 1.2A Description: Application software EUT Operating Modes to be Tested 1. Delivery mode 2. Alarm State 3. Transmit/ Receive RF TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC304401-03 Page 4 of 12 Rev.No 1.0 EUT System Components: N/A Support Equipment: N/A Oscillator Frequencies Frequency Derived Frequency Component # / Location Description of Use 32.768kHz ASIC (Interface PCB) 4MHz Motor uController 10MHz RF uController 4.91MHz H8 uController 916.5MHz RF Transceiver Power Supply: N/A Power Line Filters: N/A Critical EMI Components: N/A EMC Critical Detail: N/A TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC304401-03 Page 5 of 12 Rev.No 1.0 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 1.4 Test Methodology Purpose of Test: To demonstrate compliance with the following tests. TEST FCC CFR 47# PASS/FAIL Conducted Emissions Radiated Emissions Bandwidth 15.207(a); RSS 210, Paragraph 6.6 15.209(a); 15.249(c); RSS 210 6.2.2(m2) RSS 210, Paragraph 6.1.1(c) N/A -EUT battery operated Pass Pass Tests were 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: 858 546 3999 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. TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC304401-03 Page 6 of 12 Rev.No 1.0 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. TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC304401-03 Page 7 of 12 Rev.No 1.0 3.0 CONDUCTED EMISSIONS (15.207(a); RSS 210, Paragraph 6.6) 3.1 EQUIPMENT 3.2 DATA NOT APPLICABLEEUT IS BATTERY OPERATED. TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC304401-03 Page 8 of 12 Rev.No 1.0 4.0 RADIATED EMISSIONS (FCC Part 15.209(a); 15.249(c)); RSS 210 6.2.2(m2) 4.1 EQUIPMENT The RADIATED EMISSIONS measurements were performed at the San Diego Testing Facility: o - Test not applicable n - Roof (Small Open Area Test Site) (Date of listing July 27, 2001. Site Verification Valid for 3 years from listing.) Testing was performed at a test distance of: n - 3 meters Test Equipment Used: Model No. Prop. No. Description Manufacturer Serial No. Cal Due Date 3146 244 Antenna, Log Periodic Dipole EMCO 1063 07/04 E4440A 6414 Spectrum Analyzer Hewlett Packard MY42510441 08/04 3115 251 Horn Antenna Electro Mechanics Co 2595 12/03 AMF-5D-010180-35-10P 719 PreAmp TUV PS . -- NCR* Remarks: One year calibration cycle for all test equipment and sites. (*) No Calibration Required. TÜV AMERICA, INC. 10040 Mesa Rim Road San Diego, CA 92121-2912 Phone 858 546 3999 FAX 858 546 0364 Report No. SC304401-03 Page 9 of 12 Rev.No 1.0 TÜ…

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