Paradigm™ Infusion Pump Model MMT-511 User Guide
© 2005, Medtronic MiniMed. All rights reserved. This product is covered by U.S. Patent Nos. 6,551,276 and 6,554,798. Other U.S. and/or foreign patents may be pending. Bolus Wizard® is a registered trademark of Medtronic MiniMed. Dual Wave™ is a trademark of Medtronic MiniMed. Easy Bolus™ is a trademark of Medtronic MiniMed. Square Wave™ is a trademark of Medtronic MiniMed. BD Logic™ is a trademark of Becton, Dickinson and Company Energizer® is a registered trademark of Eveready Battery Company.
Important Safety Information Regarding Your Paradigm Insulin Infusion Pump (includes all models) Avoid Immersing Your Pump In Water Although it is unlikely that water damage will occur if your pump is splashed or briefly dunked, you should avoid immersing your Paradigm infusion pump in water. To swim or participate in other water activities, always disconnect from your Paradigm pump and reconnect after water play.
Table of Contents •••••• Chapter 1 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 For your records . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Assistance . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Availability . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Emergency kit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .3 Pump and user guide conventions . . . . . . . . . . . . . . . . 4 Your pump . .
Blood glucose targets . . . . . . . . . . . . . . . . . . . . . . . . 16 Chapter 2 Getting Started . . . . . . . . . . . . . . . . . . . . . . . . 17 Reservoir and infusion sets . . . . . . . . . . . . . . . . . . . . . 17 Preparing your pump for use . . . . . . . . . . . . . . . . . . . 18 Setting the time and date . . . . . . . . . . . . . . . . . . . . . 18 Installing the reservoir . . . . . . . . . . . . . . . . . . . . . . . 21 Removing the reservoir . . . . . . . . . . . . . . . . . . . . . . .
Easy bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Setting up easy bolus . . . . . . . . . . . . . . . . . . . . . . . . Delivering an easy bolus . . . . . . . . . . . . . . . . . . . . . . Bolus history. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52 53 55 56 Basal menu . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . What are start and stop times? . . . . . . . . . . . . . . . . . Delivering a basal . . . . . . . . . . . . . . . . . .
Chapter 7 Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 Setting the alert type. . . . . . . . . . . . . . . . . . . . . . . . . . 82 Using Auto-off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84 Stop auto off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 85 Reviewing the alarms . . . . . . . . . . . . . . . . . . . . . . . . . 85 Daily totals . . . . . . . . . .
Chapter 9 Troubleshooting & Care . . . . . . . . . . . . . . . . . 113 Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . My pump has a no delivery alarm . . . . . . . . . . . . . What happens if I leave the battery out too long? . What is a check settings alarm? . . . . . . . . . . . . . . . I submerged my pump in water . . . . . . . . . . . . . . . My screen appears distorted . . . . . . . . . . . . . . . . . . Pump maintenance . . . . . . . . . . . . . . . . . . . . . . . . . .
Adverse reactions. . . . . . . . . . . . . . . . . . . . . . . . . . . . 130 Hyperglycemia and diabetic ketoacidosis (DKA) . . 130 Hypoglycemia . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131 Site infection/abscesses . . . . . . . . . . . . . . . . . . . . . . 131 Notice. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132 Insulin pump and remote control . . . . . . . . . . . . . 132 Chapter 11 Alarms and Alerts . . . . . . . . . . . . . . . . . . . . . 135 Alarms . .
Chapter 12 Pump Specifications . . . . . . . . . . . . . . . . . . . . 143 Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Alarms and error messages . . . . . . . . . . . . . . . . . . Backlight . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Insulin delivery . . . . . . . . . . . . . . . . . . . . . . . . . . . . Block . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Delivery accuracy . . . . . . . . . . . . . . . . . . . . . . . . . .
viii
Chapter 1 Introduction •••••• Whether you are beginning pump therapy for the first time, or upgrading from a previous model, we are pleased that you have chosen Medtronic MiniMed as your partner to help you gain better control of your diabetes. We believe that the combination of state-of-the-art technology and the simple, menu-driven programming of the Paradigm pump will provide many benefits.
Assistance Medtronic MiniMed provides a 24-hour help line for assistance in the United States. The help line is staffed with technicians who are trained in the set-up and operation of the Paradigm pump and are able to answer pump-related questions. When calling the help-line, please have your pump and serial number available. The help-line telephone number is also on the back of your pump. 24-hour Product Help-line if calling from inside the United States 800.646.
Emergency kit Keep an emergency kit with you at all times to make sure that you always have necessary supplies.
Pump and user guide conventions The following terms and icons are used to describe the pump in this User Guide. “Press” means to push and release the button. “Hold” means to push and maintain pressure on the button. Flashing words or numbers on the screen indicate information that can be changed in the pump. Information that cannot be changed appears on the screen in characters that do not flash. “Select” means to use the arrow buttons to access a pump feature.
Your pump Take a look at your pump. display screen battery compartment tubing connector buttons reservoir compartment The pump is smart. It remembers your settings and stores a record of its actions. Turn your pump on its side. Look at the reservoir compartment window. This window lets you see the reservoir. You can also find the approximate remaining reservoir volume by looking at the STATUS screen. reservoir window The reservoir compartment only accepts the Paradigm reservoirs.
Installing the battery the first time The Paradigm pump uses a AAA alkaline battery. As a safety measure, Medtronic MiniMed has designed the pump to only accept a NEW battery. The pump is very particular, if you insert a used battery, an alarm will be triggered. If your batteries have been in a cold place, (i.e., your car in the winter), allow the battery to warm to room temperature (up to 30 minutes) before inserting into the pump.
3. Numbers will appear on the pump screen as the pump turns on. Then the following screen will appear. MiniMed 4. If this does not happen: a. Check to see if the battery is inserted properly. If the battery has been installed backwards, discard the battery and install a NEW battery. b. If the battery is inserted properly and your pump still does not turn ON, try a new battery (repeat steps 1 through 4). c. If the pump is still not ON, call the 24-hour Product Helpline. 5.
Home screen The HOME screen serves as the starting point to access the programming screens by pressing ACT, or to access the STATUS screen by pressing ESC. The word MiniMed is always ON when the pump is running. When “MiniMed” does not appear, the pump is not running. MiniMed Area below the line is blank. Modes of operation There are three modes of pump operation: Normal, Special and Attention. Normal In the Normal mode, the word MiniMed appears without circles.
The following features or alarms turn on the open circles: ■ Dual/square wave bolus delivery ■ Basal patterns A or B ■ Temporary basal delivery ■ Block ■ Low reservoir ■ Low battery Attention Solid circles appear when insulin MiniMed delivery has stopped. This will hapThese circles indicate pen if operator interaction is Attention mode. required, an alarm warning is received, or when the pump is suspended. Alarm text; such as, Empty Reservoir will appear on the screen if activated.
The screens that will display solid circles are: Suspend Empty Reservoir Rewind Insulin Type Prime ■ ■ ■ ■ ■ ■ ■ ■ ■ Alarms Errors No Reservoir Check Settings Pump buttons Five buttons are used to program and access the pump features. UP and DOWN buttons EXPRESS BOLUS button ■ The UP ESC button and DOWN ACT button buttons have several functions. ✒ They allow you to scroll through the menus for entry choices.
■ From the HOME screen, the special functions: and buttons have ✒ The button lets you set an Easy Bolus. ✒ The button lets you turn the backlight On or Off. ■ The ESC button is used to move backwards in the menu structure. Use this button to back out of an unintentional menu selection. ■ The ESC button is used to view the STATUS screen from the HOME screen. ■ Press the ACT button to select or activate menu items.
Main menu When you press ACT from the HOME screen, the Main menu will appear. MiniMed MiniMed MAIN MENU ACT Bolus Suspend ACT BOLUS MENU Set Bolus Bolus History Max Bolus Dual/Square Bolus Easy Bolus MiniMed SUSPEND Press ACT to Stop Pump ACT BASAL MENU Set/Edit Temp Basal Set/Edit Basal Basal Review Max Basal Rate Patterns Prime ACT PRIME MENU Rewind Manual Prime* Fixed Prime Prime History Utilities * Manual Prime is only displayed as part of the rewind process.
Five lines of text is always viewable on your pump screen. The top line will always display the word “MiniMed.” The lines that follow identify the name of the menu and the choices/information available in that menu. If there are more choices available in a menu than permitted by the five-line screen size, a scroll bar will appear on the right side of the display. You will MiniMed Basal Prime Utilities MAIN MENU scroll bar need to use the and buttons to move through the menu choices.
Basal menu Use the Basal menu to program a continuous amount of insulin 24 hours-a-day. Your basal rate is the amount of insulin required to maintain your target glucose values when you are not eating. Your healthcare professional will calculate this rate for you. Prime menu Use the Prime menu to fill the infusion set with insulin before use. Utilities menu The utilities menu allows you to customize your pump.
Initial pump settings This is the information you need on the day that you begin using your pump with insulin. If your pump start is to take place in your healthcare professional’s office, you will be given the settings that day. If your pump start is going to take place in another location, make sure to contact your healthcare professional to determine your basal rate and bolus amounts.
Basal rate information Basal Rate Number Start Time Units per Hour #1 #2 #3 #4 Most people will only have one basal rate when starting pump therapy. Meal boluses Carbohydrate Ratio: 1.0 unit of insulin for ______ grams of carbohydrate Correction bolus 1.
Chapter 2 Getting Started •••••• This chapter will guide you through the set-up procedures to get your pump ready to use. Make sure you have read Chapter 1, Introduction and are familiar with all the pump features. Do not continue with this section unless you have watched your video and completed your pump start training.
Refer to the Instructions for Use included with the Paradigm reservoir and infusion sets you have chosen for detailed information. Preparing your pump for use This section guides you through the procedures that you need to complete to prepare your pump for use. You will need the following items: ■ Paradigm Pump ■ Insulin ■ Paradigm Infusion Set ■ Paradigm Reservoir These procedures are sequential. Perform the following procedures in order. Setting the time and date 1.
3. Press the and button to select your preferred time format. Press ACT. MiniMed TIME/DATE SETUP 12 Hour Setup 24 Hour Setup If you have selected the 12 Hour Setup, when pressing the and buttons the AM/PM will change. Make sure that the desired time indicator is displayed. 4. Press ACT to program the time and date. MiniMed TIME/DATE SET 12:00 PM 1JAN2001 Press ACT to change 5. Press the and buttons to set the hour. Press ACT.
6. The minutes will flash. Press the and buttons to set the minutes. Press ACT. MiniMed SET MINUTE 10:12 PM 7. The year will flash. Press the and buttons to set the current year. Press ACT. MiniMed SET YEAR 2001 8. The month will flash. Press the and buttons to set the month. Press ACT. MiniMed SET MONTH 11 9. The day will flash. Use the and day. Press ACT.
10. The time and date will be shown. MiniMed TIME SET AT 10:12 PM 18NOV2001 11. Press the ACT button to return to the UTILITIES menu. Installing the reservoir If using the pump for the first time, remove the shipping cap from the reservoir compartment before installing the reservoir. To install a reservoir into your pump or replace an empty reservoir you will access the PRIME menu to rewind the pump.
Removing the reservoir 1. Remove the infusion set from your body or disconnect the tubing from the infusion site. 2. Using a counter-clockwise motion, unscrew the tubing connector from the pump with a 1/2 turn. 3. Pull the reservoir and the connector away from the pump. 4. Dispose of your used reservoir and infusion set in a safe manner. Rewinding the pump WARNING: Always disconnect the infusion set from your body before inserting or removing the reservoir from the pump. 1. From the HOME screen, press ACT.
WARNING: Never rewind the pump while it is connected to your body or contains a reservoir. Never insert the reservoir into pump while it is connected to your body. 3. Press ACT and the REWIND screen will appear. MiniMed REWIND Disconnect from Body Press ACT to Rewind 4. Press ACT to rewind. 5. The pump will now rewind. MiniMed REWINDING Wait for Notification 6. Once finished, the pump will beep three times and the screen will change to the INSULIN TYPE screen.
7. Use the and buttons to select your reservoir type/insu- lin concentration. Press ACT. 8. Use the button to select Yes and press ACT to verify insulin type. To change the insulin type, select No and press ACT, or press ESC to return to the INSULIN TYPE screen. MiniMed VERIFY INSULIN TYPE No Yes U100u 9. If the MANUAL PRIME screen appears go to step 14 on the next page. WARNING: Do not change your Insulin Type without consulting with your medical doctor.
10. Press ESC to return to the INSULIN TYPE screen to change your Insulin Type if you have selected the wrong insulin type. 11. Press ACT to continue. MiniMed Consult your physician before changing insulin therapy. 12. Press ESC to return to the INSULIN TYPE screen or if you have consulted with your physician press ACT to verify the insulin change. MiniMed VERIFY INSULIN CHANGE No u Yes U100 13. Select Yes to verify the insulin change. Press ACT. Select No if you do not wish to change your insulin type.
16. Fill the reservoir with your insulin. Refer to the Instructions for Use provided with the reservoir. WARNING: Your pump will not accurately deliver insulin if air bubbles are present in the reservoir or infusion set. Take care to remove air bubbles when filling your reservoir and priming your infusion set. 17. Attach the tubing connector to the top of the filled reservoir as described in the instructions that came with the reservoir. 18.
WARNING: Improper placement of the reservoir may result in inaccurate delivery of insulin. Check to make sure the tubing connector is locked onto the reservoir and the pump case correctly, before connecting to the infusion set quick release. If you have already connected the infusion set quick release, disconnect BEFORE correcting the reservoir placement.
Manual Prime 1. Make sure that the infusion set is disconnected from your pump to your body. MiniMed MANUAL PRIME Disconnect from Body Insert/Lock Reservoir Hold ACT to Prime 2. Hold ACT to Prime. The pump will prepare to prime and will beep six times. If you let go of the ACT button, either hold down ACT again to continue or press ESC to repeat the entire “Rewind” procedure. MiniMed PREPARING TO PRIME Hold ACT 3. Continue to hold the ACT button until you hear a second set of six beeps.
4. After the second set of six beeps, the number of units used will count up on the screen and begin filling the tubing with insulin. The pump will beep every two seconds. MiniMed PRIMING - HOLD ACT U ESC if done 0.0 5. Hold the ACT button until insulin droplets form at the infusion set tip. MiniMed PRIMING - HOLD ACT ESC if done U 10.6 6. When droplets form at the tip of the infusion set and you do not have any bubbles in your infusion set, release the ACT button and press ESC.
Priming with fixed prime Fixed priming provides a pre-determined volume for priming the infusion set soft cannula after the introducer needle is removed. Fixed prime is used after the infusion set has been inserted into your body and the quick release connected to the pump. A Fixed Prime is also used if you have disconnected your quick release and you need to reprime the infusion set. Refer to your Instructions for Use, for the type of infusion set you are using, for approximate priming volumes.
Manual Prime will ONLY appear in the Prime menu after you have performed “Rewind” when changing your reservoir. The Manual Prime feature will not reappear once Fixed Prime, or the Prime Menu has been exited. 3. The prime amount will flash. Use the and buttons to set the prime. Press ACT. If a Fixed Prime has been performed previously, the following screen will automatically default to the last entered prime amount. MiniMed FIXED PRIME 0.5 U 4.
If you need to stop a Fixed Prime, select Suspend, and then Resume. Reviewing the prime history Review the prime history to see the primes you have delivered. The prime amounts are not counted into your daily total quantity of insulin. 1. From the HOME screen, press ACT. Press the select Prime. Press ACT. MiniMed Basal Prime Utilities 2. Press the MAIN MENU to select Prime History. Press ACT.
3. Use the and buttons to review the primes. The “F” at the end of the line indicates a fixed prime. An “M” indicates a manual prime. MiniMed PRIME HISTORY .5F 21FEB 08:09P 21FEB 08:07P 22.1M 21FEB 06:51A .5F F (fixed prime) M (manual prime) 4. Press ESC button to exit. How to wear the pump A holster is provided with your pump. The holster is designed to fit on your belt or waistband, where you can access it easily. Using the holster helps protect your pump from impact and scratches.
34 Chapter 2
Chapter 3 Status •••••• Checking pump status The different operations of the Paradigm pump can be easily reviewed by accessing the STATUS screen. 1. From the HOME screen, press ESC to show the STATUS screen. Use the and button to scroll and view all of the information. The STATUS screen to the right is a sample of what you will see on the screen. The “XX” indicate the software version number. MiniMed STATUS 9:28A U100u Temp Basal 0.1U/H Duration 0:30 Time left 0:05 Last Bolus N 9.
The following list is information that appears on the STATUS screen. All this information will not appear all the time or at the same time. ■ Time and date (always present) ■ Insulin type (always present) ■ Status of pump (examples: Rewind, Suspended, Low Reservoir) ■ Bolus delivered by type: Square (S), and Dual (D) ■ Basal pattern: A or B ■ Special basal messages, such as, temporary basal with total units, duration, and time left.
Chapter 4 Bolus Menu •••••• During a bolus delivery most pump features are disabled until after the bolus has been delivered. Suspend and the STATUS screen are always available. The Paradigm pump can be programmed to deliver different types of boluses: ■ Normal Bolus - Delivers a bolus to cover current needs. ■ Square Wave Bolus - Delivers a bolus evenly over a period of time, from 30 minutes to 8 hours. ■ Dual Wave Bolus - Delivers a normal bolus followed by a square wave bolus.
MiniMed BOLUS MENU ACT MiniMed SET BOLUS Set Bolus --.- U * MiniMed BOLUS TYPE MENU Normal Bolus Square Wave Bolus Dual Wave Bolus ACT Bolus History MiniMed BOLUS HISTORY Last 11NOV 10 NOV MAX BOLUS SETUP Max Bolus Easy Bolus 12.4N 18.7S 20.5N MiniMed ACT Dual/SquareBolus 12:00P 11:50A 12:00P 0-25 ACT ACT 10.0 U MiniMed DUAL/SQUARE OPTION Off On MiniMed EASY BOLUS OPTION Off On/Set * The SET BOLUS screen is the default Bolus screen.
Delivering a normal bolus 1. From the HOME screen, press ACT. Bolus will be selected. Press ACT. Bolus Suspend Basal MiniMed MAIN MENU 2. The Set Bolus option will be selected. Press ACT. MiniMed BOLUS MENU Set Bolus Bolus History Max Bolus 3. The dashes for the Set Bolus amount will flash. Use the and buttons to set the desired bolus amount. Press ACT. MiniMed SET BOLUS 2.
4. The bolus will be delivered now. A beep or vibration will occur at the start and end of the bolus. As the bolus is delivered, the amount will count up, until the entire bolus has been delivered. MiniMed BOLUS DELIVERY 12:30PM U 0.1 Dual/Square bolus When you turn the Dual/Square Bolus feature ON, new options will appear when you select Set Bolus. 1. From the HOME screen press ACT. Bolus will be selected. Press ACT. MiniMed MAIN MENU Bolus Suspend Basal 2. Select Dual/Square Bolus. Press ACT.
3. Select ON. Press ACT. MiniMed Off On Dual/Square Option 4. Repeat these steps to turn OFF this feature if desired. Square wave bolus The square wave bolus can be used for insulin delivery when you have eaten a long meal, with extended snacking, or if you have delayed digestion of food. By extending the bolus delivery over a period of time, the insulin is more likely to be available to match your individual needs.
Delivering a square wave bolus A square wave bolus delivers a bolus evenly over a period of time, from 30 minutes to 8 hours. During a Square Wave Bolus other programming cannot be accomplished, except for a Normal Bolus and Suspend. 1. From the HOME screen press ACT. Bolus will be selected. Press ACT. MiniMed MAIN MENU Bolus Suspend Basal 2. Set Bolus will be selected. Press ACT. MiniMed BOLUS MENU Set Bolus Bolus History Max Bolus 3. Select Square Wave Bolus. Press ACT.
4. The SET SQUARE BOLUS screen will appear. The bolus amount will flash. Use the and buttons to set the bolus. Press ACT. MiniMed SET SQUARE BOLUS --:-- --.- U 5. The duration will flash in the upper left corner. Use the and buttons to set the length of the delivery. Press ACT. MiniMed SET DURATION 00:30 Square U 0.6 6. The BOLUS DELIVERY screen will show the square bolus units as they are delivered, starting from zero up to the amount programmed. MiniMed Bolus Delivery 5:00PM Square U 0.0 7.
Normal bolus during a square wave bolus Use this feature if you need additional insulin. You can program a normal bolus during the delivery of a square wave bolus. The normal bolus will interrupt the square wave bolus that is being delivered. The square wave delivery will continue once the normal bolus delivery is finished. 1. From the HOME screen, press ACT. Suspend will be selected. Select Bolus. Press ACT. MiniMed MAIN MENU Bolus Suspend Basal 2. Set Bolus will be selected. Press ACT.
4. The bolus amount will flash. Use the and buttons to set the bolus. Press ACT. MiniMed SET BOLUS U 5.0 5. The BOLUS DELIVERY screen will appear and will display the units as they are delivered. MiniMed BOLUS DELIVERY 12:30PM Normal U 0.1 6. Once the Normal Bolus has been delivered, the pump will beep/vibrate once and return to the BOLUS DELIVERY screen. MiniMed BOLUS DELIVERY 1:10PM Square U 0.3 7. After 30 seconds, the pump will return to the HOME screen.
Dual wave bolus A dual wave bolus is a combination of a normal bolus and a square wave bolus. Programming a dual wave bolus will deliver an immediate bolus followed by another bolus delivered evenly over a period of time, from 30 minutes to 8 hours. ➤ What is the advantage of the dual wave bolus? This bolus option is useful for meals that contain both rapidly and slowly absorbed carbohydrates. Example: Fruit and crackers followed by pasta. This option meets both immediate and extended insulin needs.
3. Select Dual Wave Bolus. Press ACT. MiniMed BOLUS TYPE MENU Normal Bolus Square Wave Bolus Dual Wave Bolus 4. The SET DUAL BOLUS screen will appear. The bolus amount will flash. Use the and buttons to set the immediate bolus amount for the Normal bolus. Press ACT. MiniMed SET DUAL BOLUS 5.0 U Dual Now 5. The SET SQUARE BOLUS screen will appear. The bolus amount will flash. Use the and buttons to set the bolus. Press ACT. MiniMed SET SQUARE BOLUS --:-- 4.
6. The duration icon will flash. Use the button to set the length of the delivery, in 30 minute increments. Press ACT. MiniMed SET DURATION 00:30 4.4 U Dual 7. The BOLUS DELIVERY screen will appear, showing you the number of units of insulin as they are delivered. MiniMed BOLUS DELIVERY 1:32PM Dual U 0.1 8. Once the immediate bolus delivery is completed, the screen will automatically show you the progress of the extended square bolus delivery.
Delivering an express bolus The EXPRESS BOLUS menu. button is a short-cut to the Bolus Type When square/dual wave bolus option is off 1. From the HOME screen, press the button. MiniMed SET BOLUS --.- U 2. The dashes for the Set Bolus amount will flash. Use the and buttons to set the bolus. Press ACT. MiniMed SET BOLUS 0.6 U 3. The BOLUS DELIVERY screen will appear, showing you the number of units of insulin as they are delivered. MiniMed BOLUS DELIVERY 12:30PM U 0.
When square/dual wave bolus option is on 1. From the HOME screen, press the button. 2. The Bolus Type menu will appear. MiniMed BOLUS TYPE MENU Normal Bolus Square Wave Bolus Dual Wave Bolus 3. Select the desired bolus type. Press ACT. The screen that appears will be different, depending on the type of bolus you selected. Program your desired settings. Maximum bolus limit (max bolus) A maximum bolus limit sets a safety limit for the amount of insulin that can be delivered in a single bolus.
2. Select Max Bolus. Press ACT. MiniMed BOLUS MENU Set Bolus Bolus History Max Bolus 3. The current maximum bolus will flash. Use the and buttons to set the maximum amount and press ACT. MiniMed MAX BOLUS SETUP 0-25 U 10.
Easy bolus When using vibrate mode, Easy Bolus is limited to 20 steps or maximum bolus, whichever comes first. An Easy Bolus is an optional way to deliver a bolus without looking at your pump. With each press of the button, you increase the bolus amount by a set amount, called a “step.” Prior to delivering an Easy Bolus, you program how many units of insulin will equal each step. The maximum number of steps depends on the Easy Bolus step size and the maximum bolus.
programmed. Each beep is a different tone. This makes it easy for you to count the beeps, which equal the number of steps you have programmed for your easy bolus delivery. You can set the step at a level between 0.1 to 2.0 units. Set the step to a number that is convenient to use and easy to multiply. Your pump is programmed at the factory with the easy bolus feature turned ON, and the step is set at 0.5 units. Setting up easy bolus Turns ON Easy Bolus and sets the step size.
4. On/Set will be selected. Press ACT. MiniMed EASY BOLUS OPTION Off On/Set If you do not wish to set the Easy Bolus Option, use the button and select OFF. Press ACT. If your Easy Bolus is turned off, you will not be able to use your Remote Control to deliver a bolus. 5. The unit value will flash. The default is 0.5 units. Use the and buttons to set the value to be used as the “step” for the Easy Bolus. MiniMed EASY BOLUS ENTRY U 0.5 6. Press ACT. The screen will return to the Bolus menu.
Delivering an easy bolus The feature is used to easily deliver a Normal Bolus. To deliver other types of boluses, use the Main menu or the button. Practice using this feature while looking at the pump. 1. From the HOME screen, press the button. The “step” amount will appear. MiniMed SET EASY BOLUS U 0.5 2. Press the button the number of times needed to deliver your bolus amount. Each time you press the button, the units increase by the “step” amount. For a step size of 0.
Pressing the or ESC button will cancel the programming. 3. Press ACT when the desired bolus amount is reached. The pump will beep or vibrate back the amount you just selected. 4. Count the beeps or vibrations. If this amount is correct, press ACT to start the bolus delivery. The BOLUS DELIVERY screen will appear. MiniMed BOLUS DELIVERY 1:32PM Normal U 0.1 5. The BOLUS DELIVERY screen will display the units being delivered.
1. From the HOME screen, press ACT. Bolus will be selected. Press ACT. MiniMed MAIN MENU Bolus Suspend Basal 2. Select Bolus History. Press ACT. MiniMed BOLUS MENU Set Bolus Bolus History Max Bolus 3. The BOLUS HISTORY screen will appear. Use the and buttons to review your recent bolus deliveries. MiniMed BOLUS HISTORY Last 11NOV 05:30P 01:05P 11NOV 06:30P 5.0N 6.0S 4.
58 Chapter 4
Chapter 5 Basal •••••• Basal rate is the amount of insulin that the body needs to maintain target glucose values without food. The basal rate should account for approximately one half of the body’s total daily insulin requirements. Your pump mimics your pancreas by delivering insulin continuously over 24 hours. You can set your insulin pump to change rates during the day to match your needs. Some people only use one rate, while others find they need more.
Basal menu The menu choices that appear on the BASAL MENU screens will change if a temporary basal rate has been set or if the Patterns Option has been turned ON. MiniMed BASAL MENU Set/Edit Temp Basal MiniMed SET DURATION --:-ACT Temp --.- U - H MiniMed *Select Patterns ACT SELECT PATTERN Standard 48.0U Pattern A 32.0U Pattern B ---.-U MiniMed Set/Edit Basal ACT SET BASAL RATE 1 12:00A 0.0 U - H MiniMed Basal Review 9.8 U 6.2U/H 0.0U/H 0.
What are start and stop times? Start and stop times are the times that one basal rate stops and the next basal rate starts. It is recommended that you record your basal rates on paper. For best results, discuss setting or changing your basal rate(s) with your healthcare professional. Basal Rate 2 Basal Rate 1 start #2 start #1 stop #1 Midnight 7:00 a.m. *12 a.m 00:00 Basal Rate 3 stop #3 stop #2 start #3 3:00 p.m. or 15:00 12:00 p.m.
Delivering a basal It is recommended that you set basal rates with the assistance of your healthcare professional. 1. From the HOME screen, press ACT. Select Basal. Press ACT. MiniMed BASAL MENU Bolus Suspend Basal 2. Select Set/Edit Basal. Press ACT. MiniMed BASAL MENU Set/Edit Temp Basal Set/Edit Basal Basal Review 3. The basal rate will flash indicating that it can be changed. Use the and buttons to set Basal Rate 1. Press ACT. MiniMed Basal Rate 1 SET BASAL RATE 1 12:00A 0.
4. The screen will change to Basal Rate 2. The start time for rate 2 will flash. If you require only one basal rate, press ACT again. MiniMed Basal Rate 2 SET START TIME 2 --:-- --.- U - H 5. The screen will show the current rate and the 24-hour total. After 30 seconds, the screen will return to the HOME screen. MiniMed BASAL RATE Current Rate 0.6U/H Started #1-12:00A 24 Hr. Total 14.4U 6. If you need to program additional basal rates, continue to set the rate and time.
Maximum basal rate (max basal) ■ A maximum basal rate is a safety limit for the amount of basal insulin that is able to be delivered per hour. ■ It’s important to discuss your maximum basal rate with your healthcare professional. Setting max basal rate The Max Basal Rate sets the maximum basal rate (units/hour) that the pump will deliver. This maximum rate will apply to every basal rate that is set, including a temporary basal rate.
2. Select Max Basal Rate. Press ACT. MiniMed BASAL MENU Set/Edit Basal Basal Review Max Basal Rate 3. The maximum basal rate will flash. Use the and buttons to change the rate. Rate range is 0.0 to 35.0 u/h. Press ACT. MiniMed MAX BASAL RATE 2. 0 U - H Temporary basal rate (temp) Provides a temporary change to programmed basal rates to match a change in short-term insulin requirements. Temporary basal rates offer an easy way to meet situations that may affect your insulin needs.
How does it work? ■ While it is active, a temporary basal rate overrides all other basal rate programming. When the temporary basal delivery is completed, your pump will return to the basal rate that is currently programmed. ■ The temporary basal rate is delivered only once. It does not repeat. If you want another temporary basal rate, you must program the temporary basal rate delivery again. Delivering a temporary basal rate 1. From the HOME screen, press ACT. Select Basal. Press ACT.
4. The temporary basal rate will flash. Use the and but- tons to set the desired basal rate. Press ACT. MiniMed SET EDIT TEMP BASAL 03:30 0.6 HU Verifying temporary basal delivery The pump will beep/vibrate three times every hour while delivering temporary basal rate. You can also verify that a temporary basal rate is delivering by checking the STATUS screen. 1. From the HOME screen, press ESC to access the STATUS screen. Use the and buttons to scroll through the information.
Canceling a temporary basal rate Cancels a temporary basal rate and returns to the programmed basal rate delivery. 1. From the HOME screen, press ACT. Select Basal. Press ACT. MiniMed Bolus MAIN MENU Suspend Basal 2. Select Cancel Temp Basal. Press ACT. MiniMed BASAL MENU Set/Edit Temp Basal Cancel Temp Basal Set/Edit Basal 3. You can verify that a temporary basal rate has been stopped by checking the status screen. The words “Temp Basal” will not appear on the status screen.
Personal basal patterns The personal basal patterns feature is optional for pump users. You may want to explore this option after you become familiar with the basic functions of your pump. It is important that you consult your healthcare professional before using this feature.
Turning on personal basal patterns Your pump is programmed at the factory with this feature turned OFF. Discuss what uses and settings are best for you with your healthcare professional. New selections will appear in the basal menu when you turn this feature ON. 1. From the HOME screen, press ACT. Select Basal. Press ACT. MiniMed MAIN MENU Bolus Suspend Basal 2. Select Patterns. Press ACT. MiniMed BASAL MENU Basal Review Max Basal Rate Patterns 3. Select ON. Press ACT. MiniMed PATTERNS OPTION Off On 4.
Delivering personal basal patterns Personal Basal Patterns allow you to set different basal delivery patterns. 1. From the HOME screen, press ACT. Select Basal. Press ACT. MiniMed MAIN MENU Bolus Suspend Basal 2. To set your patterns, select Set/Edit Basal. Press ACT. MiniMed BASAL MENU Set/Edit Temp Basal Select Patterns Set/Edit Basal If you select Set/Edit Basal and edit a Pattern, this Pattern will be the basal in use by the pump.
4. The SET BASAL RATE screen will appear. Set the Basal Rates desired, then press ACT. MiniMed SET BASAL RATE 1 12:00A 0.8 A U _ H 5. The BASAL RATE screen will appear. The screen will show the current rate, the time it started, and the 24-hour total. The pump will return to the HOME screen if no buttons are pressed. MiniMed BASAL RATE A Current Rate 0.8U/H Started #1 - 12:00A 24 Hr. Total 19.2U 6. The HOME screen will show open circles, indicating the pattern has been set.
Selecting a pattern This feature allows delivery of a personal basal pattern. Only patterns that have been programmed can be selected. 1. From the HOME screen, press ACT. Select Basal. Press ACT. MiniMed MAIN MENU Bolus Suspend Basal 2. To view the 24-hour totals of your patterns, choose Select Patterns. Press ACT. MiniMed BASAL MENU Set/Edit Temp Basal Select Patterns Set/Edit Basal 3. Select desired pattern. Press ACT. MiniMed SELECT PATTERN Standard 16.8 U Pattern A Pattern B 19.6 U 28.
Basal review Basal Review provides a review of daily basal insulin deliveries. You should review your basal rates to make sure they match the rates selected by you and your healthcare professional. There are two types of basal rates to review, Standard and Pattern. You will only see pattern if you set a pattern in the SELECT PATTERN screen from the Basal Menu. Standard basal rates 1. From the HOME screen, press ACT. Select Basal. Press ACT. Bolus Suspend Basal MiniMed MAIN MENU 2. Select Basal Review.
4. If you do have Patterns set, you will see the screen below. The current setting will be highlighted. Use the and but- tons to select the basal you want to review. Press ACT. MiniMed BASAL REVIEW Standard 16.8 U Pattern A 19.6 U Pattern B 24.
76 Chapter 5
Chapter 6 Suspend •••••• The Suspend function stops all insulin deliveries (Basal, Bolus, and Fixed Prime) that you have programmed into your pump. While the pump is in Suspend, you will only be able to view the STATUS screen. No other menu choices are available. You must resume your pump in order for the delivery of basal insulin to restart. Bolus and Fixed Prime will not restart. You must reprogram and activate the Bolus and Fixed Prime settings.
Suspending the pump The pump will beep/vibrate in fifteen minute intervals starting at the closest quarter hour mark while in the Suspend mode. Example: You Suspend the pump at 11:20 AM, the pump will beep/vibrate at 11:30 AM, 11:45 AM, 12:00 PM, 12:15 PM, and so on, until the pump is taken out of the Suspend mode. 1. From the HOME screen, press ACT. Select Suspend. Press ACT. To Suspend the pump while a bolus is being delivered, press ACT.
4. After 30 seconds, your pump will return to the HOME screen which now will show solid circles, indicating your pump is in the Attention mode. MiniMed 5. Press ESC to show the STATUS of your suspended pump. MiniMed pump suspended STATUS 11:30A U100u Suspended at 11:20A Last Bolus N 3.8U 7:58A 22 AUG Resuming pump delivery u 1. Press ACT from the HOME screen and the RESUME screen will appear. MiniMed Stopped at 11:20A RESUME ACT-Restart Basal 2. Press ACT again to restart basal insulin delivery.
80 Chapter 6
Chapter 7 Utilities •••••• The Paradigm pump can be programmed from the Utilities Menu to perform different functions for your safety and convenience. ➤ The Utilities features are: ■ Alarm ■ Daily Totals ■ Block ■ Time/Date ■ Language ■ RF Options ■ Clear Pump ■ Selftest Alarms ➤ Why are alarms important? ■ Your pump monitors activities and alerts you if there is any unusual operation behavior, or an action is required by you.
■ You can review your past alarms in the alarm history screen. ■ Alarms result in closed circles on the screen. ■ Pressing any button will result in a display that explains the alarm. Press the button for instructions on responding to the alarm. Setting the alert type Designates whether a “beep” or “vibration” will serve as the alarm type for your pump. This screen also enables you to set the beep volume level. Vibrate mode will be disabled while you are using the Block feature.
2. The Alarm option will be selected. Press ACT. MiniMed UTILITIES MENU Alarm Daily Totals Block 3. History will be selected. Press the button to select Alert Type. Press ACT. MiniMed ALARM MENU History Alert Type Auto Off 4. Select your preferred alarm from the ALERT TYPE menu. Press ACT.
Using Auto-off Provides a safety mechanism that stops insulin delivery after a defined period of time (1 to 24 hours) if no button presses are detected. Your pump is programmed at the factory with this feature turned OFF (0 hours). Discuss with your healthcare professional what uses and settings are best for you. 1. From the HOME screen, press ACT. Press the button to select Utilities. Press ACT. MiniMed Basal Prime Utilities MAIN MENU 2. Alarm will be selected. Press ACT.
insulin, and an alarm will sound after 12 hours if no buttons are pressed. Press ACT. MiniMed AUTO OFF DURATION 12 Hours You can set Auto Off from 0 (off) to 24 hours. Stop auto off To turn off the Auto Off feature after it has been programmed. Repeat steps 1 through 3 and use the and to program 0 (zero) hours. Press ACT and the Auto Off will no longer be On. Reviewing the alarms Allows you to review the past twelve alarms and/or errors that have occurred. 1. From the HOME screen, press ACT.
2. The Alarm option will be selected. Press ACT. MiniMed UTILITIES MENU Alarm Daily Totals Block 3. The History option will be selected. Press ACT. MiniMed ALARM MENU History Alert Type Auto Off 4. Use the and buttons to review your past alarms.
Reviewing the daily totals Allows you to review the total amount of insulin that you have received in each of the past 14 days. The daily totals include all bolus and basal amounts delivered for that day since midnight, but they do not include amounts delivered through the Prime feature. 1. From the HOME screen, press ACT. Press the button to select Utilities. Press ACT. MiniMed Basal Prime Utilities 2. Press the MAIN MENU button to select Daily Totals. Press ACT.
Block The block feature restricts access to the pump programming. This is an important safety feature if the pump users are young children or disabled individuals whose parents, guardians or caretakers are required to maintain complete control of the pump operation. The Suspend and Easy Bolus can be administered by using the remote control. Setting up block Your pump is programmed at the factory with this feature OFF.
2. Press the button to select Block. Press ACT. MiniMed UTILITIES MENU Alarm Daily Totals Block 3. Press the button to select ON. Press ACT. MiniMed Off On BLOCK OPTION When the Block Option is ON, the pump will display open circles.
Setting the time and date 1. From the HOME screen, press ACT. Press the button to select Utilities. Press ACT. MiniMed Basal Prime Utilities 2. Press the MAIN MENU button to select Time/Date. Press ACT. MiniMed UTILITIES MENU Daily Totals Block Time/Date 3. Select your preferred time format. Press ACT. MiniMed TIME/DATE SETUP 12 Hour Setup 24 Hour Setup 4. Press ACT to program the time and date.
5. The hour will flash. Press the and buttons to select the hour. Press ACT to set the hour. MiniMed SET HOUR 10:12 PM When pressing the and buttons the AM/PM icon will change. Make sure that the desired icon is displayed. 6. The minutes will flash. Press the and buttons to select the minutes. Press ACT. MiniMed SET MINUTE 10:12 PM 7. The year will flash. Press the and buttons to select the current year. Press ACT.
8. The month will flash. Press the and buttons to select the month. Press ACT. MiniMed SET MONTH 11 9. The day will flash. Use the and buttons to select the current day. Press ACT. MiniMed SET DAY 18 10. The time and date will be shown.
Language The language shown on the screens on the pump can be changed. Some languages will not be available on all pump models. Setting the language Allows you to select your preferred language for your pump’s screen displays. 1. From the HOME screen press ACT. Press the button to select Utilities. Press ACT. MiniMed MAIN MENU Basal Prime Utilities 2. Press the button to select Language. Press ACT. MiniMed UTILITIES MENU Block Time/Date Language 3. Select the language you prefer. Press ACT.
RF options (remote control) ➤ What are RF Options? RF Options allow you to program your pump by using a remote control(s). CAUTION: The remote control should not be used aboard an aircraft. Operate your pump using the buttons on the front of the pump while the aircraft doors are closed. ➤ What is a Remote Control? The Model 503 Remote Control is an accessory item for your Paradigm insulin pump that allows you to program a bolus, suspend, and restart your pump without pressing any of the pump buttons.
2. Press the button to select RF Options. Press ACT. MiniMed UTILITIES MENU Time/Date Language RF Options 3. Press the button to select ON. Press ACT. MiniMed RF OPTION Off On 4. ADD ID will be selected. Press ACT. MiniMed RF ID MENU Add ID Delete ID Review ID 5. The RF ID will flash. Press the and buttons to set each of the six numbers for the RF ID code. Press ACT after each number is entered.
6. The RF ID is printed on the back of the remote control. Northridge, CA, USA 1X Type A23 - 12 volts + ! IPX4 FCC ID: OH2503 123456-ABCDE RF ID code REF MMT-503US D6024656-312 12/00 Deleting an RF ID Enables you to delete an RF ID code you have set. 1. From the HOME screen, press ACT. Press the button to select Utilities. Press ACT. MiniMed MAIN MENU Basal Prime Utilities 2. Press the button to select RF Options. Press ACT.
3. ON will be selected. Press ACT. MiniMed RF OPTION Off On 4. Press the button to select Delete ID. Press ACT. MiniMed RF ID MENU Add ID Delete ID Review ID 5. Select the RF ID code you want to delete. Press ACT.
Reviewing the RF ID codes Allows you to review the RF ID codes you have already programmed. 1. From the HOME screen, press ACT. Press the button to select Utilities. Press ACT. MiniMed Basal Prime Utilities 2. Press the MAIN MENU button to select RF Options. Press ACT. MiniMed UTILITIES MENU Time/Date Language RF Options 3. Select ON. Press ACT.
4. Press the button to select Review ID. Press ACT. MiniMed RF ID MENU Add ID Delete ID Review ID 5. Review the RF ID codes you have set. MiniMed REVIEW RF ID 1 000042 2 000034 3 ------ Clear pump In rare instances, you may want to clear the pump settings and return to the factory default settings. CAUTION: Do not use this feature unless directed by your healthcare professional or a Medtronic MiniMed representative.
Clearing pump Clears the programming you have set and restores the factory default settings stored in the pump memory, except for language. 1. From the HOME screen, press ACT. Press the button to select Utilities. Press ACT. MiniMed MAIN MENU Basal Prime Utilities 2. Press the button to select Clear Pump. Press ACT. MiniMed UTILITIES MENU Language RF Options Clear Pump 3. Press ACT.
4. The pump will ask you to Confirm that you want to Clear the pump. Select the option you desire. MiniMed No Yes CONFIRM 5. Press ACT. A message will appear indicating that pump settings have been cleared. Follow the instructions on the screen. MiniMed 14:05 RESET Cleared settings Program as required ESC, ACT to clear 6. The pump will count up to seven (7). When it is finished it will display the following screen. MiniMed 7. Press ACT and the following screen will appear.
8. Disconnect pump from your body. Remove reservoir. Press ACT to rewind. 9. The pump will now rewind. MiniMed REWINDING Wait for Notification 10. When the pump has finished rewinding the INSULIN TYPE screen will appear. Use the and buttons to select your reservoir type/insulin concentration. Press ACT. MiniMed INSULIN TYPE User-fill User-fill U100u U50u 11. If you do not press ACT immediately the screen will automatically change to the INSULIN TYPE screen.
12. Select YES and press ACT to verify insulin type. To change the insulin type, select NO and press ACT, or press ESC to return the INSULIN TYPE screen. MiniMed VERIFY INSULIN TYPE No U100u Yes U100 u The factory setting for insulin concentration is U100u. U50u insulin is currently not approved for pump use in the United States. MiniMed MANUAL PRIME Disconnect from Body Insert/LockU100u Reservoir HOLD ACT to Prime 13. Insert the reservoir into the pump as described in Chapter 2, Getting Started.
If the pump detects a condition; such as, low battery, the test will not finish. A message will appear indicating the condition that caused the test to stop. 1. From the HOME screen, press ACT. Press the arrow button to select Utilities. Press ACT. MiniMed Basal Prime Utilities 2. Press the MAIN MENU arrow button to select SELFTEST. Press ACT.
3. Screen Test: The screen should appear as shown below (all black). MiniMed 4. Selftest: The pump will count down from 10. MiniMed SELFTEST 10 5. Tone Test: You should hear beeps. MiniMed TONE TEST 3 6. Vibrate Test: You will feel vibrations.
7. Once the selftest is completed, TEST OK will appear on the screen. MiniMed TEST OK 8. Contact the 24-hour Product Help-line if any of the tests do not occur as listed above.
Chapter 8 Remote Control •••••• CAUTION: The remote control should not be used aboard an aircraft. Operate your pump using the buttons on the front of the pump while the aircraft doors are closed. The Model 503 Remote Control is an optional accessory item for your Paradigm insulin pump.The remote control allows you to program a bolus or suspend and restart your pump without pressing any of the pump buttons. The remote control is not essential for pump users.
Using your remote control Discuss what uses and settings are best for you with your healthcare professional. See Chapter 7, Utilities for details.
Waking up your pump The remote control will operate within 24 inches from your pump. When the remote control is in “sleep mode,” the green light will be off. Your pump seeks a signal from the remote every two to three seconds. Continuing to hold the ACT button, after the pump “wakes up,” may result in the pump returning to sleep mode. 1. Press and hold the ACT button on the remote for approximately 3 seconds, the green light will blink quickly and a beep/vibrate will occur when your pump wakes up. 2.
Deliver an easy bolus 1. With pump in the HOME screen, press and hold ACT to “wake up” the pump. 2. When the pump is awake, it will beep or vibrate. You will now be able to program an Easy Bolus. 3. Press the B button for each bolus step desired. Each press will result in a step beep or vibration. If the beep alert type is selected, the beeps will change in pitch to assist your counting.
3. To resume basal delivery, press and hold ACT to “wake up” the pump. Press the S button, then press ACT. The pump will beep/vibrate once and then will resume basal delivery. Installing a new remote battery The battery in the remote control needs to be changed approximately every six months, depending on how often you use the remote. 1. Unsnap the rear panel by twisting a coin or screwdriver between the key ring. Remove the used battery and discard properly. 2.
2. Make sure the RF ID is correctly entered. 3. Make sure the pump is not in a “Low Batt” condition. 4. Call the 24-hour Product Help-line for assistance. Cleaning your remote control Use a damp cloth and mild soap to clean the outside of your remote control. Do not use bleach or ammonia. 1. Never use organic solvents, such as nail polish remover or paint thinner, to clean your remote control. If the remote control is dropped 1. Make sure that the remote control panels (front and rear) are still attached.
Chapter 9 Troubleshooting & Care •••••• It is recommended that you read your warranty statement included with your pump for information on what is covered during your warranty period. Troubleshooting My pump has a no delivery alarm When a No Delivery alarm occurs, it means the pump is working correctly. Your pump is not broken, but it has detected that something is preventing insulin from being delivered. Do the following steps: 1. Check your blood glucose and take an injection if needed. 2.
5. Continue troubleshooting by disconnecting at the quick-disconnect and set a 10 unit Fixed Prime. 6. Does insulin come out of the needle at the quick-disconnect? If yes, change your entire infusion set per the instructions in Chapter 2, Getting Started. 7. If NO insulin comes out of the needle at the quick-disconnect or you receive another No Delivery alarm call the 24-hour Product Help-line. CAUTION: Make sure you reset your Fixed Prime per your infusion set instructions. 8.
If the pump goes to the REWIND screen after you clear the alarm, you will need to perform a rewind per the instructions in Chapter 2, Getting Started. What is a check settings alarm? A CHECK SETTINGS alarm occurs when one of the following actions occur: ■ pump was reset due to an error and time and date were not reset, ■ battery has been taken out of the pump and time and date were not reset, ■ or the clear settings procedure performed and time and date were not reset.
6. Perform a selftest. My screen appears distorted The screen may appear distorted or have a “rainbow” appearance if you are wearing polarized sunglasses, are in bright sunlight, or in extreme high or low temperatures. If your screen appears distorted: ■ take off your sunglasses ■ move into the shade ■ make sure your pump is not in direct heat (example: next to a heater) or cold (worn on the outside of your clothing on a very cold day) temperatures.
Pump maintenance Battery Certain features on the Paradigm pump use a lot of battery power. ■ Remote control ■ Backlight ■ Vibration alarm setting If you use these features a lot, your battery will need to be replaced more frequently. If your batteries have been in a cold place, (i.e., your car in the winter), allow the battery to warm to room temperature (up to 30 minutes) before inserting into the pump. Installing a new pump battery The Paradigm pump uses a AAA alkaline battery.
out for more than one (1) minute or if it was placed backwards in the pump. 1. Using the edge of a coin, unscrew the battery cap in a counter-clockwise manner. Insert a new AAA Alkaline battery. Check the label on the back of the pump to make sure you are inserting the battery in the correct direction. battery cap battery o-ring 2. Check the battery cap o-ring and remove any debris. Clean o-ring with a lint free cloth. If the o-ring appears to be damaged call the 24-hour Product Help-line. 3.
Cleaning your pump 1. Use only a damp cloth and mild detergent mixed with water to clean the outside of your pump. 2. After wiping down the pump rinse with clean water and dry with a cloth. 3. Never use organic solvents, such as lighter fluid, nail polish remover, or paint thinner to clean your pump. 4. Keep the reservoir compartment and battery compartment dry and away from moisture. 5. Do not use any lubricants with your pump.
Precautions Avoiding extreme temperatures 1. Avoid exposure of your pump and remote control to temperatures above 104°F (40°C) or below 32°F (0°C). 2. Insulin solutions freeze near 32°F (0°C) and degrade at high temperatures. If you are outside in cold weather, wear your pump close to your body and cover it with warm clothing. If you are in a warm environment, take measures to keep your pump and insulin cool. 3. Do not steam sterilize or autoclave your pump or remote control.
5. Perform the Selftest procedure located in the Utilities menu. 6. Call the 24-hour Product Help-line for assistance.
122 Chapter 9
Chapter 10 User Safety •••••• Indications The Paradigm Insulin pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. Contraindications Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood glucose tests per day and to maintain contact with their healthcare professional. Successful operation of the Paradigm pump requires good vision and hearing.
Warnings Diabetic ketoacidosis (DKA) Insulin pump therapy uses only regular (short-acting) insulin; therefore, any interruption in the delivery of insulin may result in hyperglycemia (high blood glucose) and, subsequently, the rapid onset of diabetic ketoacidosis.
Reservoir and infusion sets Standard Luer infusion sets are not compatible with the Medtronic MiniMed Paradigm pump. Medtronic Minimed Paradigm reservoir and Paradigm infusion sets are specifically designed for use with the pump. Do not modify your Paradigm reservoir or Paradigm infusion set. Do not put any other drugs/medications inside your reservoir to use with this pump. Only insulin that has been prescribed by your physician can be used in this pump.
✒ Act quickly to respond to abnormal blood glucose. Notify your healthcare professional of low blood glucose requiring assistance or of high blood glucose, or of an increased frequency in low or high blood glucose. ✒ Develop a plan with your healthcare professionals, in the event that a high or low blood glucose occurs and you are unable to reach them for advice. ✒ Periodically check your overnight blood glucose levels. Discuss any out-of-target readings with your healthcare professional.
Precautions - hypoglycemia To help prevent hypoglycemia (low blood glucose), routinely follow these precautionary steps: 1. Know the symptoms of hypoglycemia and NEVER ignore these symptoms, no matter how mild they are. ■ Sweating ■ Confusion ■ Headache ■ Palpitations ■ Trembling ■ Speech Impairment ■ Hunger ■ Drowsiness ■ Dizziness ■ Blurred Vision 2. Always carry a fast-acting sugar replacement, such as glucose tablets, juice or hard candy, in case of a low blood glucose. 3.
Precautions - hyperglycemia To help prevent hyperglycemia (high blood glucose), routinely follow these precautionary steps: 1. Know the symptoms of hyperglycemia and NEVER ignore these symptoms, no matter how mild they are: ■ Fatigue ■ Hunger ■ Excessive Thirst ■ Blurred Vision ■ Frequent Urination 2. Always carry insulin and syringes, BG test strips and meter, and urine ketone test strips, in case of a high blood glucose. 3. Monitor your blood glucose frequently, at least four times a day. 4.
Precautions - infusion sets and sites Use only Paradigm style reservoirs labeled “for use with MiniMed Paradigm pumps.” Do not use other reservoirs. To help prevent problems with infusion sets or sites, routinely follow these general precautions: 1. Always check for leaks after changing your reservoir and infusion set. 2. Never use insulin that appears cloudy or has expired. This may indicate the insulin is inactive. Do not expose your insulin to extreme temperatures. 3.
Adverse reactions Hyperglycemia and diabetic ketoacidosis (DKA) Pump wearers use only regular short-acting insulin. As a result, they do not have a reserve of long-acting insulin. You must be aware that interruption of insulin delivery (due to infusion set clogs, leaks, loss of insulin potency, or pump malfunction) can result in a rapid rise of blood glucose levels within two to four hours and the development of DKA within four-to-ten hours.
Hypoglycemia Hypoglycemia can be more subtle for pump users than with patients on conventional therapy. It may occur even when the pump is working properly. Besides reviewing your insulin needs, food intake and exercise patterns, you also should discuss your target blood glucose goals with your physician. Never go to bed with a blood glucose value below your target level. Blood glucose tests should be performed before driving a car, because hypoglycemia may have serious consequences.
Notice Insulin pump and remote control These devices comply with the United States Federal Communications Commission and international standards for Electromagnetic Compatibility regarding their use. These devices comply 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.
CAUTION: Any changes or modifications to the devices not expressly approved by Medtronic MiniMed could void your ability to operate the equipment.
134 Chapter 10
Chapter 11 Alarms and Alerts •••••• Your Paradigm pump has a sophisticated network of safety checks and systems. If the safety network detects anything unusual, your pump alerts you to problems that require your immediate attention. The backlight will illuminate the pump screen and the alarm message will be shown. Alarms All alarms will gradually become higher in pitch until turned off. If using the vibrate mode, all alarms and alerts will start as vibrations.
When you see a alarm message on your pump’s screen: 1. Use the button to scroll down to read ALL of the alarm text. There is often text that is not visible until you scroll down using the button. 2. Follow the instructions in the alarm text. 3. Press ESC and then press ACT to clear the alarm. 4. Make sure all your settings (i.e., time and date) are correct. E (Error) After receiving this alarm, note the error number then call the 24-hour Product Help-line for assistance.
Auto off This alarm alerts you to the fact that no buttons have been pressed during the time limit that you set in the AUTO OFF DURATION screen. MiniMed 11:17A AUTO OFF Time limit expired No buttons pushed during time limit ESC,ACT to clear Empty reservoir There is no insulin in the reservoir. Change reservoir immediately. MiniMed 3:36P EMPTY RESERVOIR Delivery stopped Change reservoir ESC,ACT to clear No reservoir The reservoir is not inserted correctly or no reservoir has been inserted.
No delivery Insulin delivery has stopped. This alarm will occur if your pump detects a blockage. MiniMed 11:17A NO DELIVERY Delivery stopped CHANGE ENTIRE SET Check BG If problem persists Call help-line ESC,ACT to clear Motor error Insulin delivery has stopped. This alarm will occur if your pump detects a motor error. MiniMed MOTOR ERROR 12:05A Delivery stopped Rewind Pump ESC,ACT to clear Batt out limit This alarm will occur if the batteries have been out of your pump for more than a minute.
Max delivery This alarm alerts you when you have taken more insulin than expected based on maximum bolus and maximum basal rates. MiniMed 3:25P MAX DELIVERY Exceeded 1 hour max delivery Check BG ESC,ACT to clear Button error This alarm will occur if a button has been continually pressed for more than 3 minutes.
Bolus stopped If this alarm should occur, it is very important to check bolus history to review how much of the bolus was actually delivered. Reprogram a bolus with the amount not delivered, if required. MiniMed 8.35A BOLUS STOPPED Loose battery cap? Pump dropped or bumped? Check bolus history, Reprogram bolus if required ESC,ACT to clear Failed batt test The pump is designed to test each new battery installed in the pump.
Alerts Silence the Alerts by pressing ESC, ACT to clear. Follow the instructions on the screen. Low battery MiniMed After receiving this alert, DO NOT go to sleep without replacing the battery. 10:09A During a Low Battery condition the vibrate alert type, remote control, and the Backlight are not available.
Message in Alarm History After putting a battery into your new pump, a message “RfBad” may appear in your alarm history screen. (The pump does not alarm in this case.) The “RfBad” message will be the first entry dated Jan 1. Please disregard the message in your alarm history. The pump is operating normally. You do not need to call the 24-hour Product Help-line to report this message. At any time, if you want to test your pump's performance, perform a Selftest.
Chapter 12 Pump Specifications •••••• The Pump Specifications section provides detailed information on specifications related to your pump. The safety features of your pump are individually listed and described. Specifications Alarms and error messages ■ The pump has over 50 safety alarms and error messages. ■ Alerts by audible tone or vibration.
Insulin delivery ■ Allows up to 48 individual basal rates to be programmed in a daily pattern. ■ Different basal rates can be programmed every 30 minutes. ■ Rates can be set from 0.0 to 35.0 units /hour in 0.1-unit increments (limited by maximum basal rate setting). ■ The basal delivery capacity is 0.0-35.0 units/hour. Block ■ The block feature restricts access to all programming except suspend, selftest and the delivery of a bolus with the remote control.
Easy bolus ■ Features programming using audible tones (or vibrate pulses) in user-determined increments. Beep mode range: 0 to maximum bolus Vibrate mode range: 0 to 20 steps or maximum bolus, whichever comes first. ■ Step size < maximum bolus. ■ Adjustable step size: 0.1 to 2.0 units per step. ■ Accessible from Remote Control or pump buttons. Infusion pressure ■ Maximum infusion pressure and occlusion pressure is 13.7 PSI.
Occlusion detection The detection of an occlusion will trigger a “no delivery alarm.” Up to 3.0 units of “missed” insulin are required to trigger the occlusion alarm. If the occlusion is released, this insulin will be delivered. The table below demonstrates occlusion detections based on U100 insulin. Three different rates of insulin delivery are shown. Each with a minimum, typical and maximum time to trigger a “no delivery alarm.” Minimum Time Typical Time Maximum Time bolus delivery (1.
Prime function ■ Is used to fill the infusion set tubing prior to use. ■ Primes are not counted in daily totals but are recorded separately in the prime history. ■ Fixed prime: 0.1-25.0 units (limited by maximum bolus). ■ Manual prime: unlimited. Fill rate is 1 to 5 units/second. Program safety checks ■ Over 50 independent safety systems are continuously monitoring all pump operations. ■ Maximum infusion with single fault condition: 0.0074 ml. Pump size ■ The Paradigm pump is 2 x 3 x .
Square wave bolus ■ Delivers 0.1-25.0 units of insulin over a duration of 30 minutes to eight hours (limited by maximum bolus setting). Temporary basal rate ■ Allows the user to temporarily change the current basal rate for a duration of 30 minutes to 24 hours (limited by maximum basal setting). Time and date display ■ Pump users have the choice of 12-hour or 24-hour formats. ■ Pump users set the time/date, including the year, month and day. ■ The date/time is always displayed on the status screen.
Factory default settings The following are the default settings: Menu Default Bolus Menu: Easy Bolus: ON Increment default: 0.5 unit Dual/Square Bolus: OFF Maximum: 10.0 units Basal Menu: Personal Delivery Patterns: OFF Maximum: 2.0 u/h Basal Rate: 0.0 u/h Prime Menu: Insulin: U100u concentration Utilities Menu: Alarms: History: No defaults Alert type: Audio, medium level Auto-off: OFF Time/Date Menu: Time is 12 a.m.
Icon table Do not reuse: Attention: See Instructions for Use Method of sterilization using Ethylene Oxide: STERILE EO Date of Manufacture: (year - month) 2000-06 Batch code: LOT Use by: (year - month) 2000-06 Catalogue Number REF MMT-511 Serial Number: SN Storage Temperature Range: +55C -20C Fragile Product: Type BF: (Protection from Electrical Shock) Pump: Water tight Remote Transmitter: Splash proof IPX7 IPX4 Radio frequency alert L Country 150 Chapter 12
Language of Instructions for Use Recycle Keep dry F Pump Specifications 151
152 Chapter 12
Index •••••• A adverse reactions 130 Alarms 81, 135, 143 auto-off 137 batt out limit 138 button error 139 check settings 139 E alarm 136 history 86 low battery 141 low reservoir 141 max delivery 139 no delivery 138 off no power 136 Alert type beep 82 vibration 82 auto-off 84, 131 B backlight 143 Basal max basal rate 64, 144 rate 61 setting 62 153
start and stop times 61 basal 61 basal menu 14 Batt 138 Battery pump 114, 117, 146 remote control 109, 111 block when available 88 block feature 144 blood glucose 123, 126, 127, 128, 130, 131 blood sugar.see blood glucose Bolus dual/square wave 40 easy bolus 52 express 49 maximum limit 50 normal 39 square wave 41 using remote 110 bolus history 37, 56 bolus menu 13 C check settings 115 child block.
delivery accuracy 144 diabetic ketoacidosis 124, 130 displacement accuracy 144 DKA 124 drive motor 144 dropped 120 dual wave bolus 37, 46, 144 E easy bolus 37, 52, 53, 55, 145 emergency kit 3 express bolus 11, 37, 49 F factory default settings 99, 149 G general precautions 125 glucagon kit 127 H help line 2 home screen 8 hyperglycemia 124, 128, 130 hypoglycemia 124, 127, 131 I indications 123 infusion pressure 145 infusion set 129 infusion site 129 infusion system 17
insulin 129, 130, 145 insulin delivery 144 K ketones 130 L language 93 M maximum bolus limit 37, 50 Modes attention 9 normal 8 special 8 MRI 125 N no delivery 113 normal bolus 39, 44, 144, 145 O occlusion detection 146 P personal delivery patterns 146 power supply 146 precautions 120 Prime 147 fixed 30, 147 history 32 manual 28, 147
priming 21 pump buttons 10 pump status 35 R remote control 94, 107 reservoir 5, 129, 147 rewind 21, 22 RF ID 94 S safety 147 safety checks 147 selftest 103, 105, 121 serial number 1 settings time/date 18 site infection/abscesses 131 skin infections 124 special 8 specifications 143 square wave bolus 37, 41, 42, 44, 144, 148 square/dual wave bolus 50 square/dual wave bolus option 49 status 35 storing the pump 119 suspend 13 suspend function 77 T temperature 120 temporary basal rate 148
time/date 18, 90 U utilities 81 W warnings 124 water 112 watertight 148 X x-rays 125
