OH2500RU

Confidential - DRAFT - Not to be copied or distributedD9195757-011 3/99 Welcome to the MiniMed User’s Guide for the model 500 Remote Programmer for the model 508 insulin pump! The Model 500 Remote Programmer is an accessory item for the model 508 insulin pump that allows you to program a bolus or suspend and restart your pump remotely! The Remote Programmer contains a transmitter that sends signals to a receiver in your 508 pump. This is designed to add more freedom and flexibility to your daily activities! This user’s guide is designed with visual and printed information to help you learn to use your programmer, however, working with your health professional will speed your familiarity of this tool. Confidential - DRAFT - Not to be copied or distributedD9195757-011 3/99 NEED TO KNOWUSING THE ‘REMOTE’ PROGRAMMER: The Remote Programmer is a very simple and easy to use device.
Three buttons control all the programming: • ‘S’: Suspends or restarts your pump • ‘B’: Allows you to set an audio bolus • ‘A’: activates your programming choices.
The remote programmer runs on a single A23 battery. The programmer will go into ‘sleep mode’ when it is not being used to help preserve battery life. About the LED
When the remote is in “sleep mode”, green LED will be off.
When the remote is awake, the LED will glow and flash very fast.
When the battery is low, the LED will blink in a series of 3 quick flashes until the battery is replaced. Purpose: Allows the user, by way of ‘radio frequency’, to suspend, re-start and program a normal bolus of insulin without using the buttons on the 508 insulin pump. Process: 1. From the TIME OF DAY screen press SEL until you see Set Up II then press ACT. Continue to press SEL until you reach ‘Set RF Device’ screen then press ACT. 2. The word OFF will blink. Press the UP arrow until the word ON appears and press ACT. 3. The word ID will be displayed on the screen. Use the arrows to record the first six digits on the remote programmer as the ID number. Press ACT after each number to confirm and move to the next digit. By pressing ACT after the last number is entered to confirm. Your pump and remote programmer are now linked. Bolus Button Suspend/Restart Button ACT Button LED Confidential - DRAFT - Not to be copied or distributedD9195757-011 3/99
You can have a maximum of three active remote programmers. You may program them following the same steps. 4. You have the ability to add the ID numbers for up to three remote programmers. To add, delete or review remote ID numbers, select this option at step four above. The pump screen will return to the TIME OF DAY screen. Confidential - DRAFT - Not to be copied or distributedD9195757-011 3/99
The remote programmer will work at a distance up to 18 inches.
The Audio Bolus feature must be ON to set a bolus using the remote programmer. Using the Remote Programmer to Deliver a Bolus: Purpose: Allows you to deliver an audio bolus using the remote programmer. Process: 1. Press the A button on the RF Programmer for five seconds to ‘wake-up’ the pump. When a link has occurred the pump will beep and/or vibrate for two seconds. You will now be able to program a Normal bolus. 2. Press the B button as many times as you need to choose the bolus amount. For example, five units would be five presses of the B button. Each press will result in a signal of a beep, vibration or both. 3. Press A to confirm the amount and the again to activate the bolus. If you make a mistake or decide not to use the Remote, simply let the pump time out. Using the RF Programmer to Suspend/Restart the Pump: 1. Press and hold the A button on the Remote Programmer for five seconds to ‘wake-up’ the pump. When a link has occurred the pump will beep and/or vibrate for two seconds. 2. To Suspend: Press the ‘S’ button once then press the ‘A’ button. You will hear three audible beeps, vibrations or both confirming that the pump is in the ‘suspend mode. 3. To Restart: Press the ‘S’ button and then press ‘A’. The pump will beep and or vibrate once and then resume normal operations. Confidential - DRAFT - Not to be copied or distributedD9195757-011 3/99 Device Care and Maintenance INSTALLATION OF THE BATTERY 1. Place the Remote face down on a secure, flat surface. 2. Using a standard Phillips screwdriver, unscrew the rear panel. Remove the used battery and discard properly. 3. Insert new battery cell according to diagram on Remote case. 4. Replace rear panel and screw to connect Remote components. Your remote should start as soon as the battery are inserted. If this does not happen: A. Check to see if the battery is inserted properly B. If yes and it still does not turn on, try a new battery. C. If the remote is still not on, call the 24 hour Clinical services Help Line for assistance: 1- 800-826-2099 If Your Remote is Dropped: 1. Check that the remote panels (front and rear) are still attached. 2. Press the A button to check operation. If Your Remote Becomes Submerged in Water: 1. Pat the outside of the case until dry. 2. Following the procedure above to change the battery, unscrew the rear panel and dry out the two sections. 3. Do not use HOT AIR to dry your remote as this may damage internal electronics. 4. If you need assistance, call the MiniMed Clinical Services Department at 1-800-826-2099. Exposure to Extreme Temperatures: 1. Avoid exposure of your MiniMed remote to temperatures above 113 °F (45°C) or below 33°F (0.5°C) 2. Do not steam sterilize or autoclave your MiniMed remote. Cleaning your Remote: 1. Use a damp (not wet) cloth and mild soap to clean the outside of your MiniMed remote. 2. Never use organic solvents, such as lighter fluid, nail polish remover or paint thinner to clean your remote. Each time you change your battery, clean the compartment to remove any debris or lint that may have accumulated in this area. X-Rays, MRIs and CT Scans: 1. If you are going to have an X-ray, CT scan, MRI or any other type of radiation therapy, TAKE YOUR PUMP AN…

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Welcome to the MiniMed User’s Guide for the model 500 Remote Programmer for the model 508 insulin pump! The Model 500 Remote Programmer is an accessory item for the model 508 insulin pump that allows you to program a bolus or suspend and restart your pump remotely! The Remote Programmer contains a transmitter that sends signals to a receiver in your 508 pump. This is designed to add more freedom and flexibility to your daily activities! This user’s guide is designed with visual and printed information to help you learn to use your programmer. However, working with your health professional will speed your familiarity of this tool. NEED TO KNOWUSING THE ‘REMOTE’ PROGRAMMER: The Remote Programmer is a very simple and easy to use device. ! Three buttons control all the programming: • ‘STOP’: Suspends or restarts your pump • ‘BOL’: Allows you to set an audio bolus • ‘ACT’: activates your programming choices. ! The remote programmer runs on a single A23 battery. The programmer will go into ‘sleep mode’ when it is not being used to help preserve battery life. About the LED ! When the remote programmer is in “sleep mode”, green LED will be off. ! When the remote programmer is awake, the LED will glow and flash very fast. ! When the battery is low, the LED will blink in a series of 3 quick flashes until the battery is replaced. Purpose: Allows the user, by way of ‘radio frequency’, to suspend, restart and program a normal audio bolus of insulin without using the buttons on the 508 insulin pump. Process: To use the Remote Programmer, you must turn this feature ON on your 508 pump. 1. From the TIME OF DAY screen press SEL until you see Set Up II then press ACT. Continue to press SEL until you reach ‘Set RF Device’ screen then press ACT. 2. The word OFF will blink. Press the UP arrow until the word ON appears and press ACT. 3. The word ID will be displayed on the screen. Use the arrows to record the first six digits on the remote programmer as the ID number. Press ACT after each number to confirm and move to the next digit. Press ACT after the last number is entered to confirm. Your pump and remote programmer are now linked. Bolus Button Suspend/Restart Button ACT Button LED ! You can have a maximum of three active remote programmers. You may program them following the same steps. 4. You have the ability to add the ID numbers for up to three remote programmers. To add, delete or review remote programmer ID numbers, select this option at step three above. The pump screen will return to the TIME OF DAY screen. ! The remote programmer will work at a distance up to 18 inches. ! The Audio Bolus feature must be ON to set a bolus using the remote programmer. Using the Remote Programmer to Deliver a Bolus: Purpose: Allows you to deliver an audio bolus using the remote programmer. Process: 1. Press the ACT button on the remote programmer for five seconds to ‘wake-up’ the pump. When a link has occurred the pump will beep and/or vibrate for two seconds. You will now be able to program a normal, audio bolus. 2. Press the BOL button as many times as you need to choose the bolus amount. For example, five units would be five presses of the BOL button. Each press will result in a signal of a beep, vibration or both. 3. Press ACT to confirm the amount and then again to activate the bolus. If you make a mistake or decide not to use the remote programmer, simply let the pump time out. Using the Remote Programmer to Suspend/Restart the Pump: 1. Press and hold the ACT button on the remote programmer for five seconds to ‘wake-up’ the pump. When a link has occurred the pump will beep and/or vibrate for two seconds. 2. To Suspend: Press the STOP button once then press the ACT button. You will hear three audible beeps, vibrations or both confirming that the pump is in the ‘suspend mode. 3. To Restart: Press the STOP button and then press ACT. The pump will beep and or vibrate once and then resume normal operations. Device Care and Maintenance INSTALLATION OF THE BATTERY 1. Place the remote programmer face down on a secure, flat surface. 2. Using a standard Phillips screwdriver, unscrew the rear panel. Remove the used battery and discard properly. 3. Insert new battery according to diagram on remote programmer case. 4. Replace rear panel and screw to connect remote programmer components. Your remote programmer should start as soon as the battery is inserted. If this does not happen: A. Check to see if the battery is inserted properly. B. If the battery is inserted properly and it still does not turn on, try a new battery. C. If the remote programmer still does not turn on, call the MiniMed 24-hour Clinical Services Help Line for assistance at 1-800-826-2099. If Your Remote Programmer is Dropped: 1. Check that the remote programmer panels (front and rear) are still attached. 2. Press the ACT button to check operation. If Your Remote Programmer Becomes Submerged in Water: 1. Pat the outside of the case until dry. 2. Following the battery installation procedure above, unscrew the rear panel and dry out the two sections. 3. Do not use HOT AIR to dry your remote programmer as this may damage internal electronics. 4. If you need assistance, call the MiniMed 24-hour Clinical Services Help Line at 1-800-826-2099. Exposure to Extreme Temperatures: 1. Avoid exposure of your MiniMed remote programmer to temperatures above 113 °F (45 ° C) or below 33°F (0.5 ° C) 2. Do not steam sterilize or autoclave your MiniMed remote programmer. Cleaning your Remote Programmer: 1. Use a damp (not wet) cloth and mild soap to clean the outside of your MiniMed remote programmer. 2. Never use organic solvents, such as lighter fluid, nail polish remover or paint thinner to clean your remote programmer. Each time you change your battery, clean the compartment to remove any debris or lint that may have accumulated in this area. X-Rays, MRIs and CT Scans: 1. If you are going to have an X-ray, CT scan, MRI or any other type of radiation therapy, TAKE YOUR PUM…

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1X 2X DMP6024555-001, REV 2 3/99 12744 San Fernando Road Sylmar, CA 91342 (818)362-5958 12744 San Fernando Road Sylmar, CA 91342 (818)362-5958 ® ® REF MMT-500RU REF MMT-500RU Energizer A23 ® Energizer A23 ® 12 volts - + 12 volts - + FCC ID: XXX500RU D6024555-001 3/99 FCC ID: XXX500RU D6024555-001 3/99 1.161" 0.138" 0.312" 0.047" 1.060" 1.154" 0.648" 0.577" Ø0.274” Hole to provide clearance for mounting screw Clear window through which the underlying serial number label can be seen.

THE FOLLOWING IS THE LABEL MATERIAL FOR THE LABEL: The label material will be Autotex 2V6. This is a .006 thick polyester label with a velvet finish. 3M 467 Adhesive with paper backing applied to the rear of the label. This is a .002 thick acrylic adhesive. We do not have actual samples of the Remote Label, although we do have samples of the label material since we use the same material and adhesive on another product. Please let me know if this information is sufficient. Thanks Jay Yonemoto Manager, Electronics, R&D, External Products

1X 2X DMP6024555-001, REV - 4/99 ® ® REF MMT-500RU REF MMT-500RU 12 volts - + 12 volts - + D6024555-001 4/99 D6024555-001 4/99 FCC ID: OH2500RU FCC ID: OH2500RU EnergizerA23 or equivalent ® EnergizerA23 or equivalent ® 12744 San Fernando Road Sylmar, CA 91342 (818)362-5958 12744 San Fernando Road Sylmar, CA 91342 (818)362-5958 12345 - 67890 1.161" 0.312" 1.154" 0.648" 0.577" Ø0.274” Hole to provide clearance for mounting screw Clear window through which the underlying serial number and bar code label can be seen. 0.138" 0.047" 0.932"

Page 1 of 21 Report No: FC99-016 CERTIFICATION TEST REPORT FOR THE MODEL 500 REMOTE PROGRAMER, MMT-500RU FCC PART 15 SUBPART C COMPLIANCE DATE OF ISSUE: MARCH 22, 1999 PREPARED FOR: MiniMed Inc. 12744 San Fernando Road Sylmar, CA 91342 P.O. No: 15703 W.O. No: 71069 PREPARED BY: Joyce Walker CKC Laboratories, Inc. 5473A Clouds Rest Mariposa, CA 95338 Date of test: March 10, 1999 Report No: FC99-016 DOCUMENTATION CONTROL: _____________________________ Tracy Phillips Documentation Control Supervisor CKC Laboratories, Inc. APPROVED BY: _____________________________ Dennis Ward Director of Laboratories CKC Laboratories, Inc. This report contains a total of 21 pages and may be reproduced in full only. Partial reproduction may only be done with the written consent of CKC Laboratories, Inc. Page 2 of 21 Report No: FC99-016 TABLE OF CONTENTS Administrative Information.............................................................................................3 Summary Of Results........................................................................................................4 Equipment Under Test (EUT) Description......................................................................4 Measurement Uncertainty................................................................................................4 EUT Operating Frequency...............................................................................................4 Peripheral Devices...........................................................................................................4 Report Of Measurements.................................................................................................5 Table 1: Six Highest Fundamental Emission Levels...........................................5 Table 2: Six Highest Spurious Emission Levels..................................................6 Table A : List Of Test Equipment....................................................................................7 EUT Setup........................................................................................................................8 Test Instrumentation And Analyzer Settings...................................................................8 Table B : Analyzer Bandwidth Settings Per Frequency Range...........................8 Spectrum Analyzer Detector Functions...............................................................9 Peak..........................................................................................................9 Quasi-Peak...............................................................................................9 Average....................................................................................................9 Test Methods....................................................................................................................10 Radiated Emissions Testing.................................................................................10 Occupied Bandwidth............................................................................................10 Sample Calculations.........................................................................................................11 Appendix A : Information About The Equipment Under Test........................................12 I/O Ports...............................................................................................................13 Crystal Oscillators................................................................................................13 Printed Circuit Boards..........................................................................................13 Required EUT Changes To Comply....................................................................13 Photograph Showing Radiated Emissions...........................................................14 Photograph Showing Radiated Emissions...........................................................15 Appendix B : Measurement Data Sheets.........................................................................16 Occupied Bandwidth Plot....................................................................................17 Occupied Bandwidth Plot....................................................................................18 Page 3 of 21 Report No: FC99-016 CKC Laboratories, Inc. has Certificates of Accreditation from the following agencies: DATech (Germany); A2LA (USA); FCC (USA); VCCI (Japan); BSMI (Taiwan); HOKLAS (Hong Kong). CKC Laboratories, Inc. has Letters of Acceptance through an MRA for the following agencies: ACA/NATA (Australia); SABS (South Africa); SWEDAC (Sweden); TUV Rheinland-Germany; TUV Rheinland- Korea; TUV Rheinland-Russia; Radio Communication Agency (RA); NEMKO (Norway). ADMINISTRATIVE INFORMATION DATE OF TEST: March 10, 1999 PURPOSE OF TEST: To demonstrate the compliance of the Model 500 Remote Programer, MMT- 500RU, with the requirements for FCC Part 15 Subpart C devices. MANUFACTURER: MiniMed Inc. 12744 San Fernando Road Sylmar, CA 91342 REPRESENTATIVE: Jay Yonemoto TEST LOCATION: CKC Laboratories, Inc. 5473A Clouds Rest Mariposa, CA 95338 TEST PERSONNEL: Skip Doyle TEST METHOD: ANSI C63.4 1992 FREQUENCY RANGE TESTED: 30 MHz - 1000 MHz EQUIPMENT UNDER TEST:Model 500 Remote Programer Manuf: MiniMed Inc. Model: MMT-500RU Serial: Sample 2 FCC ID: (pending) Page 4 of 21 Report No: FC99-016 SUMMARY OF RESULTS The MiniMed Inc. Model 500 Remote Programer, MMT-500RU, was tested in accordance with ANSI C63.4 1992 for compliance with FCC Part 15 Subpart C devices. As received, the above equipment was found to be fully compliant with the limits of FCC Part 15 Subpart C. The results in this report apply only to the items tested, as identified herein. EQUIPMENT UNDER TEST (EUT) DESCRIPTION Hand held battery operated RF remote controller. MEASUREMENT UNCERTAINTY Associated with data in this report is a ±4dB measurement uncertainty. EUT OPERATING FREQUENCY The EU…

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