INSULIN PUMP User Guide
Paradigm® 515 and 715 Insulin Pumps User Guide
©2008 Medtronic MiniMed, Inc. All rights reserved. This product is covered by U.S. Patent Nos. 6,551,276; 6,554,798; 6,872,200; 6,936,029; 6,979,326; 6,997,920 and 7,025,743. Other U.S. and/or foreign patents may be pending. Bolus Wizard®, Dual Wave®, Guardian®, Guardian RT®, Paradigm®, Paradigm Link®, Quick-serter®, Quick-set®, Sof-set®, and Square Wave® are registered trademarks of Medtronic MiniMed, Inc. CareLink™ Personal and Easy Bolus™ are trademarks of Medtronic MiniMed, Inc.
Important Safety Information Regarding Your Paradigm Insulin Infusion Pump (includes all models) Avoid Immersing Your Pump In Water The pump was tested and met requirements for IPX7 at time of manufacture. For more information about IPX7, see the Glossary on page 165. Be aware that drops and bumps that occur over time will affect the integrity of the pump case and make it more vulnerable to damage from water. Lotions, sunscreens and insect repellent can also damage the pump case.
Contents Chapter 1: Introduction ..................................................................... 1 Assistance ...................................................................................................... Emergency kit ................................................................................................. Consumables .................................................................................................. Accessories ..........................................................
Meal bolus ................................................................................................. Gram counting ......................................................................................... Exchange counting ..................................................................................... BG targets ................................................................................................. Insulin sensitivity ..................................................................
Time display ............................................................................................ Reservoir volume ...................................................................................... Alert and alarm icons ................................................................................. Scroll bar .................................................................................................. Screen backlight .......................................................................
Resume pump delivery ..................................................................................... 54 Chapter 5: Starting on insulin ............................................................ 57 Prepare your pump for use ................................................................................ Filling the reservoir ......................................................................................... Changing your infusion set ............................................................
Review your Bolus Wizard feature settings ............................................................. Meter option ................................................................................................. Meter rules ............................................................................................... Add, delete, review meter IDs ........................................................................ Normal bolus using Bolus Wizard feature ..............................................
Turn on remote control option ....................................................................... Add, delete, review remote control IDs ............................................................ Block feature ............................................................................................... Turning block on ....................................................................................... Lock keypad feature ...........................................................................
My pump buttons are not acting right during a bolus ................................................ My pump will not display my blood glucose reading from my meter .............................. I dropped my pump ........................................................................................ I submerged my pump in water ......................................................................... I cannot get to the User Settings screen ...............................................................
Audio frequency ........................................................................................... Backlight .................................................................................................... Basal ......................................................................................................... BG target .................................................................................................... Bolus delivery .......................................................
Bolus Wizard feature examples .......................................................................... Insulin delivery default settings ......................................................................... Bolus Wizard feature default settings .................................................................. Icon table ................................................................................................... Warranty ..........................................................................
xiv Contents
Introduction Chapter 1 Thank you for choosing Medtronic Diabetes (legally known as Medtronic MiniMed, Inc.) as your partner in helping you gain better control of your diabetes. Whether you are beginning pump therapy for the first time or upgrading from a previous model, we believe that the combination of state-of-the-art technology and the simple, menu-driven programming of the pump will provide many benefits.
Emergency kit Keep an emergency kit with you at all times to make sure that you always have necessary supplies. Inform a family member, co-worker, and/or friend where this emergency kit is kept. Please refer to the User safety section in this chapter for more information on pump safety.
WARNING: For your protection the pump has undergone extensive testing to confirm appropriate operation when used with Paradigm reservoirs and Paradigm compatible infusion sets manufactured or distributed by Medtronic Diabetes.
How to use this guide NOTE: This user guide shows sample screens only. Your pump screens may be slightly different. For step-by-step instructions, refer to the appropriate sections in this guide. Refer to the Glossary for definitions of terms and functions. The terms and symbols used in this guide are in the table below.
User safety Indications Pump Contraindications Chapter 1 The Paradigm 515/715 pump system is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. 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.
Tubing Connector If insulin, or any liquid, gets inside the tubing connector, it can temporarily block the vents that allow the pump to properly prime the infusion set. This may result in the delivery of too little or too much insulin, which can cause hypoglycemia or hyperglycemia. To prevent liquid from getting inside the tubing connector, after you fill the reservoir make sure you hold the insulin vial upright when you remove the reservoir from the transfer guard.
X-rays, MRIs and CT scans If you are going to have an X-ray, CT scan, MRI or other type of exposure to radiation, take off your pump, meter and remote control before entering a room containing any of this equipment. The Paradigm pump is designed to withstand common electromagnetic interference, including airport security systems. Be sure to carry the Airport Card provided, when you are traveling.
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. It does not interfere with any RF signals transmitted from outside sources.
Communication problems can usually be resolved by: • • • ensuring that there is less than 6 feet (1.8 meters) between the pump and the RF glucose meter; turning off or moving away from other RF transmitting devices; or reorienting or relocating the RF glucose meter or pump, or both. • • Chapter 1 Communications problems may also occur due to cellular telephone interference.
10 Introduction
Introduction to pump therapy Theory of insulin pump therapy All people, with or without diabetes, need background insulin for normal functions of the body without food. They also need a dose of insulin on demand - when food is eaten. People without diabetes can trust that their pancreas will produce this insulin for them. People with diabetes need to take insulin in a way that is most like the way a pancreas produces it.
As long as you are ready to learn how to use the pump, the pump can work for you. Understanding pump therapy If you are new to pump therapy, you will need the following data from your healthcare professional. Gather this before going to your pump start appointment. If you are unsure, contact your healthcare professional or pump trainer for guidance. Basal rate Basal insulin is needed to maintain your target glucose values when you are not eating. Your pump allows up to 48 basal rates to be programmed.
Insulin sensitivity Insulin sensitivity is used to decide a correction bolus for a high BG. This is how much your blood glucose will be dropped with 1 unit of insulin. 1 unit of insulin will lower BG __________ mmol/L (mg/dL). Active Insulin Blood glucose and A1C testing When you check your blood glucose with a meter, you measure blood glucose at the moment you perform the test. This number gives you key feedback for making present and day-to-day adjustments in your diabetes management.
Your healthcare professional will rely on the results of your blood glucose tests to make changes in your pump settings. The results of your A1C tests are used to assess your overall blood glucose control. If you are on pump therapy, you must test your BG at least: • • • • • Upon waking up Before each meal At bedtime If you feel nauseous One hour after any BG above 250 mg/dL (13.9 mmol/L) Below are target guidelines from the American Diabetes Association for adults with diabetes.
Correlation between A1C level and blood glucose levels Mean plasma glucose A1C (percent) mg/dL mmol/L 12 345 19.5 American Diabetes Association. Diabetes Care. “Tests of Glycemia in Diabetes.” & “Standards of Medical Care.” Vol. 31, Supplement 1, January 2008. S18. Low blood glucose (hypoglycemia) Not enough food Too much insulin Chapter 2 Low blood glucose can occur while using the pump for the same reasons it can while using daily injections.
Hypoglycemia protocol: the rule of 15 If blood glucose is 70 mg/dL (3.9 mmol/L) or below: • • • • Eat 15 grams of fast acting carbohydrate Check BG again in 15 minutes; if not above 70 mg/dL (3.9 mmol/L), repeat treatment Check BG again in 15 minutes; if still not above 70 mg/dL (3.9 mmol/L), repeat treatment again. Contact your healthcare professional These items have 15 grams of fast acting carbohydrates: • • • • Glucose tablets (three, 5-gram tablets or four, 4-gram tablets) 4 oz.
Hyperglycemia protocol If one blood glucose reading is above 250 mg/dL (13.9 mmol/L): • • Take a correction bolus right away Test BG in one hour If the second blood glucose is above 250 mg/dL (13.9 mmol/L): • • Chapter 2 • • • • Take an insulin injection by syringe (not through the pump). The amount should be the same as if you were taking a correction bolus. Change the entire infusion set system (new reservoir, infusion set, and cannula).
• • • • • • • Troubleshoot the pump. If help is needed, please call our 24 Hour HelpLine for assistance. Drink liquids with no calories every 30 minutes (for example: 8 oz. diet ginger ale, broth, water). Check your blood glucose and ketones in one hour. Continue to take insulin as discussed with your healthcare professional. Call your healthcare professional right away if your blood glucose and ketones are not decreasing, or you cannot drink fluids. Continue to test blood glucose and ketones.
• • Keep exact records of your blood glucose values, ketones, medication, temperature and all other signs. Keep in mind that you need more insulin and fluids when there are urine ketones. This is true even if your blood glucose is within your target range. Sick day supplies You should have the supplies listed below in the house at all times, and carry them with you when you travel: Fluids that have sugar (regular soda, juice, jello) to replace solid food.
Carbohydrate counting With insulin pump therapy, you must take a bolus for the carbohydrates you eat. You need to count the carbohydrates you plan to eat to see how much insulin to take. There are two basic methods to count carbohydrates, and in truth, they are very much alike. Many people use parts of both of the two methods. Carbohydrate gram counting With this method, you add up the exact number of grams of carbohydrate in each meal.
As you start to learn carbohydrate counting, try to assess the carbohydrates in the food you are eating. Then look at the food labels to see how close you are. Reading a food label Use the Serving Size and Total Carbohydrates information on the food label to determine how many total grams of carbohydrate you will be eating. Then, use the insulin to carbohydrate ratio prescribed by your healthcare professional. This allows you to figure out how much insulin to take for the foods you eat.
Fat and blood glucose Although fat does not have carbohydrate, it may affect your blood glucose level. Your blood glucose can be normal 2 hours after a meal with high fat foods. However, 4-6 hours later your blood glucose will increase. That is because the fat slows down the rate the carbohydrates are absorbed in that meal.
Other things that affect blood glucose Fiber may slow down the rise in blood glucose after a meal. Fiber grams are not absorbed. They can be subtracted from the Total Carbohydrate amount for foods or meals with more than 5 grams of fiber. Fiber is an important part of a healthy diet. Suggestions for fiber intake are the same for people with and without diabetes. Sodium (salt) has no effect on blood glucose. Moderate sodium intake is suggested for people with or without diabetes.
The body needs insulin during exercise. Therefore, it is not suggested that you stop the pump unless the exercise is for a short amount of time (1 hour or less). If you need to remove the pump for more than 1 hour, refer to the If you remove your pump section in the The basics chapter. If you do an exercise that on average lowers your blood glucose, you can use the temporary basal rate feature. You can use this feature to lower the amount of insulin delivered and reduce the risk of hypoglycemia.
The basics Your pump CAUTION: Never use sharp objects to press the buttons on your Paradigm pump as this can damage the buttons or compromise the seal of the pump. Some examples of sharp objects that may damage your keypad are fingernail files, pens or pencils, paper clips, knives, scissors, and keys. battery compartment tubing connector screen ESC reservoir window Chapter 3 Take a look at your pump. The reservoir window allows you to view the insulin in the reservoir.
Install battery CAUTION: Do not use a rechargeable or carbon zinc battery in your pump. For best results use a new Energizer AAA alkaline battery, size E92, type LR03. Medtronic Diabetes designed the pump to only accept a NEW battery. As a safety measure, if you install a battery that does not have full power, the WEAK BATTERY or FAILED BATT TEST alarm may sound. If you receive a WEAK BATTERY alarm, respond to the alarm and continue. The pump will still operate normally, but with a decreased battery life.
5 6 7 While the pump turns on, it will show one or more screens until the HOME screen appears. If the HOME screen does not appear, do these steps: a. Check that the battery is inserted correctly. If the battery has been installed backwards, remove the battery and install it HOME screen properly. b. If your pump still does not turn on or you get a FAILED BATT TEST alarm, remove and replace the battery with a new one. c. If the pump is still not on, call our 24 Hour HelpLine.
Pump buttons The buttons on the pump are used to navigate through the menus and screens, and to program the features of the pump. UP button From the HOME screen, this is the EASY BOLUS button EXPRESS BOLUS button ESC button From the HOME screen ACT button DOWN button From the menus and programming screens EASY BOLUS™ buttonShortcut to set and deliver an Easy Bolus. Turns the backlight on/off from the HOME screen. Opens the MAIN MENU. Increases / decreases the value of a flashing item.
From the HOME screen From the menus and programming screens Press simultaneously with to turn on backlight when in the menus or use as a Shift button by pressing it in combination with another button to access certain features. The pump screen The screen shows five lines of text at one time. The first is the operating mode. The second is the current open menu or function. The last three lines show either information or text that you can select for the current function.
Screen icons There are various icons that appear at the top of your pump screen, like the time, battery and reservoir icons mentioned above. The next sections describe what the icons mean. Battery The battery icon tells you how much usable life is left in your battery. There are four segments in the icon. Each segment represents approximately 25 percent of the usable battery life you have left until you reach Low Battery point.
Alert and alarm icons An open circle (alert) or a solid circle (alarm) are displayed in the upper part of your pump screen only when there is an alert or alarm condition on your pump. For alarm and alert information, see the Troubleshooting and alarms chapter. Alert icon Alarm icon Scroll bar If there is more text than the screen can show, a scroll bar appears in the right side of the screen. Press to view any additional text. When you press from the HOME screen, the light on the screen turns on or off.
Normal mode Mode for standard pump operations for normal basal and bolus delivery. No special features are active (i.e., basal patterns, temp basal, etc.). No alarms and no alerts exist. Special mode Indicates a special feature is active or an alert condition(s) exists. Special mode does not restrict any of the pump functions. When the pump is in Special mode, an open circle appears at the top of the screen and it will beep/vibrate periodically to remind you of the condition.
When the pump is in Attention mode, it will beep/vibrate periodically to remind you of the condition. The beep/vibrate frequency varies depending on the condition that put the pump in Attention mode. Refer to the Alarm conditions section in the Troubleshooting and alarms chapter for alarm conditions that will trigger the Attention mode. See the Stopping your pump section in the Basic programming chapter to learn about Suspend mode. Menus The MAIN MENU is the highest level menu.
BASAL MENU Contains the functions to setup and deliver your basal. Refer to the Basal section in the Basic programming chapter for more information. PRIME MENU Contains the functions to change your reservoir and fill the infusion set with insulin. Refer to the Changing your infusion set section in the Starting on insulin chapter for more information. UTILITIES MENU Contains features for your safety and convenience. Refer to the Utilities chapter for more information.
If you remove your pump You may have an occasion when you need or want to remove your pump. If you have to remove and store your pump, it is recommended that you do the following: Keep a record of your current basal rates and use the Save Settings feature (see the Utilities chapter). To preserve battery life, reset the basal rates to 0 (zero), turn off the RF options (meter, remote), and set Auto-off to dashes or zeroes.
36 The basics
Basic programming Setting the time and date Setting the correct time and date in your pump is necessary for accurate basal insulin delivery and allows you to keep an accurate record of your insulin delivery and other pump functions. You can select a 12-hour or 24-hour clock. You must reset the time and date if you receive a CHECK SETTINGS alarm or you clear your settings (Clear Settings function). 1 Go to the TIME/DATE SETUP screen.
4 Change each of the settings as follows: a. Hour Change the hour. Press ACT. For 12-hour setups, press or until the correct A (am) or P (pm) appears. b. Minutes Change the minutes. Press ACT. c. Year Change the year. Press ACT. d. Month Change the month. Press ACT. e. Day Change the day. Press ACT. 5 38 The TIME SET AT screen will show the settings that you programmed. Press ACT and exit the menus. Your time/date settings are complete.
Selecting the language The language shown on the pump screens can be changed. Some languages will not be available on all pumps. Before you can select another language, you need to set the time using the English screens. Refer to the previous section. To change the language for your pump: 1 Go to the LANGUAGE MENU screen. Main > Utilities > Language 2 Select your language, then press ACT. 3 The language setting is now changed. Exit the menus.
Bolus There are three bolus types: Normal, Square Wave®, and Dual Wave®. This section gives instructions for a Normal bolus using the express bolus button and navigating through the menus. (For information about Square Wave and Dual Wave boluses, refer to the Optimizing pump therapy chapter.) The Normal bolus delivers an immediate food or correction bolus. It can be delivered at any time except during another Normal bolus.
Normal meal bolus using the exchange system Normal bolus can be used to cover the carbohydrate in a meal or snack and to correct a blood glucose that is higher than the target that was chosen for you. Fred has been taught that he needs to take 1 unit of insulin for every carbohydrate exchange that he eats (every milk, every starch or every fruit).
Normal meal bolus practice using exchanges: Choose a meal you might eat and fill in the blanks. Food:__________ exchange:____________ __________ exchange:____________ __________ exchange:____________ total exchanges:____________ You will take _______ units of insulin for each exchange. Your total bolus is _______ for this meal. Normal meal bolus using carbohydrate counting Lydia has been taught that she needs to take 1 unit of insulin for every 10 grams of carbohydrate.
Choose a meal you might eat and fill in the blanks. Food:__________ grams of carbohydrate:____________ __________ grams of carbohydrate:____________ __________ grams of carbohydrate:____________ total grams of carbohydrate:____________ Your insulin to carbohydrate ratio: 1 unit of insulin for _______ grams carbohydrate. Divide your total carbohydrates by your insulin to carbohydrate ratio and take _____ units of insulin for your meal. Meal bolus, correction bolus and insulin sensitivity 1.
Practice: Meal bolus You have determined your meal bolus as: _______ units. Your target blood glucose range is: _______ to _______ (average is _______). Your current blood glucose level is: _________. Your correction factor is: 1 unit of insulin will drop your blood glucose _________. You will take ________ unit(s) of insulin to correct your high blood glucose level. Your total bolus (meal bolus plus correction bolus) is _________.
If a bolus was stopped before delivery was complete, the BOLUS HISTORY screen will show only the amount actually delivered. Refer to the Bolus details section for instructions about viewing bolus details. Do the following steps to view the BOLUS HISTORY screen: 1 Go to the BOLUS HISTORY screen and scroll through the bolus deliveries.
Bolus details You can view the details of any of the deliveries in the BOLUS HISTORY screen. The details include: • • • • bolus types: normal, square, and dual programmed bolus amount delivered bolus amount Bolus Wizard feature information (if used) To see the details of any bolus, do these steps: 1 In the BOLUS HISTORY screen, select the bolus that you want to review and press ACT.
Maximum bolus limit The maximum bolus (max bolus) is a safety feature that limits the amount of insulin that can be delivered in a single bolus. The factory setting is 10.0 units. You can specify the limit from 0.0 to 25.0 units. It is important to discuss this feature with your healthcare professional to determine your maximum bolus amount. To set the maximum bolus limit, do these steps: 1 Go to the MAX BOLUS SETUP screen. 2 3 Main > Bolus > Max Bolus Set your maximum bolus limit and press ACT.
1 2 Go to the BG REMINDER SETUP screen. Main > Bolus > BG Reminder Select On and press ACT. The BG Reminder is now enabled. Exit the menus. Now, the next time you program a bolus, your pump will ask you for the amount of time after your bolus before you want to be reminded to check your blood glucose. When the BG Reminder goes off, your pump will beep or vibrate and the message CHECK BG will appear on the screen. Your pump will beep or vibrate periodically until it is cleared (ESC, ACT).
The start and stop times of basal rates for this example are: • • • 9:00 PM Basal Rate 4 start time 3:00 AM Basal Rate 2 start time rat e1 e4 rat rate 2 • 12:00 a.m. (00:00) to 3:00 a.m. (3:00) for basal rate 1 3:00 a.m. (3:00) to 7:00 a.m. (7:00) for basal rate 2 7:00 a.m. (7:00) to 9:00 p.m. (21:00) for basal rate 3 9:00 p.m. (21:00) to 12:00 a.m.
Basal programming and delivery NOTE: You cannot make changes to your basal rate settings while a percent temp basal is active. To set your basal rates: 1 Go to the SET BASAL RATE 1 screen. Main > Basal > Set/Edit Basal 2 The SET BASAL RATE 1 screen flashes the basal rate in U/H. 3 Enter your first basal rate amount and press ACT. The start time for your first basal rate is midnight (00:00 or 12:00A) and cannot be changed. 4 The SET START TIME 2 screen appears. The dashes under the screen name flash.
Current basal delivery The STATUS screen shows your current basal information. current basal Daily basal rate(s) The BASAL REVIEW screen shows your daily basal rates programmed for delivery from midnight to midnight. Compare your daily insulin deliveries to your blood glucose records to help you and your healthcare professional identify your optimal daily basal insulin rate(s). To review your basal rates, do these steps: 2 3 Go to the BASAL MENU screen. Main > Basal Select Basal Review and press ACT.
If you use patterns, the BASAL REVIEW screen appears. The current basal pattern will be highlighted. Select the pattern you want to view. Press ACT. The delivery details for that pattern will appear. (24-hour total) basal insulin basal rate start times basal delivery rates 4 Exit the menus when you are done. Setting the Max basal rate Maximum (max) basal rate is a safety limit for the amount of basal insulin that is able to be delivered per hour.
Example 2: Max Basal Rusty needs large amounts of insulin to control his blood glucose levels. His new pump was delivered from the factory with a Maximum Basal Rate of 2.0 units per hour, but he needs 2.8 units per hour in the early morning. Rusty will reprogram his Maximum Basal to 3.0 units per hour to accommodate his needs. Stopping your pump You can stop your pump with the suspend function.
Resume pump delivery When the pump is suspended, it defaults to the HOME screen with a solid circle. To resume your pump and basal delivery, do these steps: 1 From any screen, press ACT until the RESUME screen appears. Press ACT again. 2 Your pump will beep once, then the HOME screen will appear without the solid circle. NOTE: A bolus or fixed prime that was stopped by suspend will not restart when you resume your pump. You must reprogram and activate it to finish delivery.
Practice: Suspend function 1 2 3 4 5 Make sure you are NOT connected to your pump while practicing. Program your pump to deliver a Normal bolus of 3.0 units. Once the bolus begins, stop the bolus by suspending your pump. Remember, when you stop the bolus delivery with SUSPEND, ALL insulin delivery will stop. Now, RESUME delivery, so that your basal insulin will continue. Check the STATUS screen. How much insulin did the bolus deliver before you Suspended delivery? _______.
56 Basic programming
Starting on insulin The Paradigm pump is intended for use with U100 insulin. Prepare your pump for use Before continuing with the steps in this chapter, we recommend that you watch your pump training CDROM and complete your pump start training. When you are done practicing and ready to use your pump with insulin, you must make sure the time and date are correct on your pump. You must also program your settings as instructed by your healthcare professional.
Filling the reservoir Warning: Do not use the reservoir or infusion set if any liquid gets on the top of the reservoir or inside the tubing connector (as shown in the image). Liquid can temporarily block the vents. This may result in the delivery of too little or too much insulin, which can cause hypoglycemia or hyperglycemia. If any liquid gets on the top of the reservoir or inside the tubing connector, start over with a new reservoir and infusion set.
1 Remove reservoir from package. Make sure plunger rod is fully extended. 2 Swab vial with alcohol (not shown). 3 Making sure you do not push down on the plunger, press the transfer guard onto the vial. plunger rod reservoir transfer guard vial 4 Push down on the plunger to pressurize the vial. Hold down the plunger rod.
5 While still holding the plunger rod, flip the vial over so the vial is on top, slowly pull down on the plunger to fill the reservoir. 6 Gently tap the side of the reservoir to make any air bubbles rise to the top of the reservoir. 9 To avoid getting liquid on the top of the reservoir, flip the vial over so that it is upright. Turn the reservoir counter-clockwise, then pull straight up to remove the reservoir from the transfer guard.
11 Tap the side of the reservoir to remove any air bubbles. 12 To purge air bubbles that have risen to the top of the reservoir, push up on the plunger until you see insulin in the tubing. 13 Without pulling, turn the plunger counter-clockwise to remove it from the reservoir. Changing your infusion set Removing the reservoir Each time you remove and replace a reservoir in your pump, you have to rewind your pump, and fill the infusion set with insulin. Remove the entire infusion set from your body.
Rewinding your pump Before you continue, make sure the infusion set is NOT connected to your body and the reservoir is NOT in the pump. WARNING: Make sure the infusion set is disconnected from your body before you rewind your pump or fill the infusion set tubing. Never insert the reservoir into the pump while the tubing is connected to your body. Doing so could result in an accidental infusion of insulin. 1 2 3 If you removed your reservoir and are replacing it, go to the REWIND screen.
WARNING: Do not insert the reservoir in the pump if you did not rewind. Doing so could result in inaccurate insulin delivery. Never insert the reservoir into the pump while the tubing is connected to your body. Doing so could result in an accidental infusion of insulin. Insert the reservoir into the top of the pump case. 3 Turn the tubing connector approximately 1/2 -turn clockwise until the connector is seated. The tubing connector should be aligned horizontally with the pump case as shown here.
Manual prime Manual prime fills the infusion set tubing with insulin before you attach it to the infusion site. Manual prime is only available after you rewind your pump. WARNING: Make sure that the infusion set is disconnected from your body before you press ACT to prime the pump. Never insert the reservoir into the pump while the tubing is connected to your body. Doing so could result in an accidental infusion of insulin. 1 2 3 4 After you rewind your pump, the PREPARING TO PRIME screen appears.
Inserting the infusion set WARNING: While the infusion set is connected to your body, do not unscrew and retighten the tubing connector on the reservoir. After you complete all of the following, you will be ready to insert the infusion set into your body: • • • • fill your reservoir rewind your pump insert the reservoir into pump and fill the infusion set with insulin Shown here are the best body areas (shaded) for infusion set insertion. Avoid the 2-inch (5.0 cm) area around the navel.
• Visualize an imaginary clock drawn on your abdomen surrounding your belly button. Rotate infusion sites by starting at 12 o’clock and then rotating the site clockwise to 3 o’clock, 6 o’clock, etc. • Imagine a letter M or a letter W on either side of your belly button. Start at the end of one letter and proceed through the letter, rotating to each intersection in turn. Medtronic Diabetes offers a number of different infusion sets for your pump.
Quick-set infusion set (with Quick-serter®) Always refer to the instructions that shipped with your infusion set. 1 4 Wash your hands. 2 Clean the infusion site. Let it air dry.
68 7 8 9 10 11 12 Starting on insulin
13 Fixed prime A fixed prime fills the soft cannula with insulin and is required after the infusion set is inserted into your body and the introducer needle removed. The prime amount depends on your infusion set type, so read your infusion set instructions for the fixed prime amount. A fixed prime is also required before reconnecting the tubing to the infusion set to make sure that all air is removed from the tubing. Go to the PRIME MENU screen. 2 3 4 Main > Prime Select Fixed Prime and press ACT.
Disconnecting Quick-set The Quick-set allows you the freedom to temporarily disconnect from your pump without removing the infusion set from your body. 1 Hold the side grips of the connector part with your fingers. 70 Starting on insulin 2 Twist the connector counterclockwise. 3 Remove the connector from the site.
Reconnecting Quick-set A fixed prime is used before reconnecting the infusion set to your body to ensure that insulin has filled the infusion set. See the instructions in this chapter. Place the connector part (flat-side facing down) on the infusion set until it is fully seated. Do not grip the connector part by the flat side-grips. 1 2 3 Record keeping for diabetes management Chapter 5 Now that you are using the pump, we will be asking you to test your blood glucose regularly.
Test at least 4-6 times a day.
Using the Bolus Wizard feature What is it? Bolus Wizard is a feature that calculates an estimated bolus to support your food intake or to correct high blood glucose. You need the following information: Carbohydrate counting You need to know how which foods contain carbohydrates and how to count these. Your blood glucose reading You need to know your blood glucose (BG) BG readings reading.
Your personal Bolus Wizard feature settings In addition to your blood glucose reading and/or your food entry, the Bolus Wizard feature uses personal settings that you program into the pump. (For instructions see the How to program the Bolus Wizard feature section in the Using the Bolus Wizard feature chapter.
Bolus Wizard feature settings Information Setting BG units: (how you measure your blood glucose) _____ mg/dL or _____ mmol/L Insulin sensitivity: This ratio is used for your correction bolus calculations. BG units reduced / 1 unit of insulin This ratio is the BG units reduced by 1.0 unit of insulin. #1: __________ range: 10 - 400 mg/dL or 0.5 - 22.2 mmol/L #2: __________ NOTE: #3: __________ (additional settings, if needed) Your insulin sensitivity may vary throughout the day.
Bolus Wizard feature settings Information Setting BG target range: If your current blood glucose is above the BG Target Range, the Bolus Wizard feature will calculate a correction dose. If your current blood glucose is below the BG Target Range, the Bolus Wizard feature will calculate a negative correction and subtract it from your food bolus. #1: __________ range: 60 - 250 mg/dL or 3.3 - 13.
How the Bolus Wizard feature works 1 If you want your current blood glucose to be factored in, enter your BG Reading. • automatically from the meter (refer to the Meter option section of this chapter); or • manually by selecting the button. 2 3 If you are going to eat, enter your food amount in grams or exchanges. The Bolus Wizard feature will calculate a bolus for you. An ESTIMATE DETAILS screen will appear with your estimated total bolus amount.
How to program the Bolus Wizard feature You need your personal settings from the Bolus Wizard feature settings table to setup the Bolus Wizard feature. Your Bolus Wizard feature settings are programmed in the EDIT SETTINGS screen. Main > Bolus > Bolus Wizard Setup > Edit Settings Once the settings are programmed, you do not have to program them again unless the values change. After you program one setting, the screen will automatically go to the next required setting.
Setting the Carb/Exch ratios Your pump allows you to set up to eight Carb/Exch ratios because this ratio may vary throughout the day. Your healthcare professional may only have you program one or two carb ratios when you first start using the Bolus Wizard feature. 1 Make sure the EDIT SETTINGS screen is open. Main > Bolus > Bolus Wizard Setup > Edit Settings 2 Select Carb Ratios, then press ACT. 3 The SET CARB RATIO 1 (if you are using grams) or SET EXCH RATIO 1 (if using exchanges) screen appears.
3 4 The BLOOD GLUCOSE UNITS screen displays. Select mmol/L or mg/dL, then press ACT. The EDIT SETTINGS screen shows the BG units you selected. You are now ready to set your insulin sensitivity. Insulin sensitivity Your insulin sensitivity is the amount your blood glucose (BG) level is reduced by one unit of insulin. This value is used to calculate a suggested insulin dose to correct a high BG. Because this sensitivity may vary throughout the day, your pump lets you set up to eight sensitivity settings.
The BG Target setting allows you to set glucose targets. The Bolus Wizard will use these targets to calculate a correction dose. Because your targets may vary throughout the day, your pump allows you to set up to eight BG targets each day. If you want to set just one target value, instead of a range, set both the low and high values to the same number. Glucose Concentration Setting the BG targets mmol/L 22.2 mg/dL 400 13.9 250 5.6 100 3.
7 In the SET START TIME 2 screen enter the time of the day you want this BG target range to become active. 8 Press ACT. The TARGET RANGE 2 screen appears. 9 The low end of your BG target range flashes on the screen. Set the BG target, then press ACT. 10 The high end of your BG target range flashes on the screen. Enter the BG target, then press ACT. 11 The SET START TIME 3 screen appears. The second BG target range is now set. 12 If you do not need to set up any more BG target ranges, press ESC.
Active insulin time The active insulin time setting lets the pump know which active insulin time to use in calculating the amount of active insulin to subtract before estimating a bolus. Your healthcare professional should determine the active insulin time that is best for you. To set the Active insulin time, do the following steps: 1 Make sure the EDIT SETTINGS screen is open. 2 3 4 5 Main > Bolus > Bolus Wizard Setup > Edit Settings Select Active Ins Time, then press ACT.
meter option turned off. Programming your meter ID links your pump to the meter. If you do not link the meter to your pump, you will enter your blood glucose readings manually. Each meter has its own unique ID. You can link up to three meters to your pump. When the pump is idle (at the HOME screen), it will beep or vibrate when it receives a blood glucose reading from the meter. The reading will appear on the pump screen.
Add, delete, review meter IDs The meter programming screens are very similar to those for the remote control. Make sure to select Meters in the DEVICE OPTIONS screen when programming your meter. If you are not sure that your meter ID is entered in your pump, check the REVIEW METER ID screen. You have to turn on the meter option to add, delete, or review the meter ID(s) programmed in your pump. 1 Go to the METER OPTION screen. 2 3 Main > Utilities > Meter Options Select On, then press ACT.
Use the button to deliver a Normal bolus at any time except during another Normal bolus. A Normal bolus will temporarily interrupt a Square Wave or Dual Wave bolus that is delivering. After the Normal bolus is finished, the Square Wave or Dual Wave bolus delivery will resume. NOTE: If you want to use the pump-to-meter link, make sure the meter option is on. Refer to the Meter option section in this chapter for instructions.
7 The BOLUS DELIVERY screen appears. The pump will beep or vibrate at the start and end of the bolus. As the bolus is delivered, the screen shows the bolus type and amount until the total units have been delivered. The screen then returns to the HOME screen. Bolus Wizard feature examples For the scenarios that follow, Michael has his Bolus Wizard feature turned on with the following settings: Carb ratio: 15 grams per unit of insulin Insulin Sensitivity: 40 mg/dL (2.
Example 2: Blood glucose above target (high blood glucose) and no active insulin The next day, Michael wakes up before school. Before eating the same breakfast, he tests his blood glucose with his meter and finds it to be 200 mg/dL (11.1 mmol/L), which is above his target of 120 mg/dL (6.6 mmol/L). His blood glucose reading is automatically sent to his pump. When prompted by the Bolus Wizard feature, he enters his carbohydrate amount of 60 grams in the ENTER FOOD screen.
Example 4: Blood glucose above target (high blood glucose) with active insulin Michael is at school and wants to eat a snack in the late morning. He tests his blood glucose with his meter and finds it to at 200 mg/dL (11.1 mmol/L), which is above his target of 120 mg/dL (6.6 mmol/L). He estimates that his snack contains 60 grams of carbohydrate, so he enters 60 into the pump when prompted by the Bolus Wizard feature. Based on his settings, and as a result of 1.
Example 5: Blood glucose below target (low blood glucose) with active insulin Another day at school, Michael is getting ready to eat lunch. He tests his blood glucose with his meter and finds it at 70 mg/dL (3.9 mmol/L), which is below his Low BG target of 90 mg/dL (5.0 mmol/L). His reading is automatically sent to his pump. When prompted by the Bolus Wizard feature, he enters his carbohydrate amount of 60 grams in the ENTER FOOD screen. Based on his settings, and despite 1.
Optimizing pump therapy Square Wave and Dual Wave bolus Square Wave bolus delivers a bolus evenly over a period of time (30 minutes to 8 hours). This bolus can be used for insulin delivery when you have eaten a long meal with extended snacking. It can also be useful if you have delayed food digestion due to gastroparesis or meals high in fat. A Square Wave bolus can be useful if a Normal bolus drops your blood glucose too rapidly.
See the following graphic for a description of the different bolus types: Entire bolus amount delivered immediately. INSULIN NORMAL BOLUS Bolus amount delivered evenly over specified time period. SQUARE WAVE BOLUS 2 1 Part of the bolus amount delivered immediately and the remainder delivered evenly over time period.
4 For a Square Wave bolus, do these steps: a. Select Square Wave Bolus, then press ACT. The SET SQUARE BOLUS screen appears. b. Enter the desired amount for the Square Wave bolus units, then press ACT. c. Continue to step 5. For a Dual Wave bolus, do these steps: a. Select Dual Wave Bolus, then press ACT. The SET DUAL BOLUS TOTAL screen appears. b. Enter the desired amount for the total dual bolus units. This amount is the total of Normal and Square Wave bolus units. Press ACT. c.
Square Wave bolus practice Your target pre-meal blood glucose range is ______ to _______. Check your pre-meal blood glucose. Are you within your target? _____ If yes, continue. If no, wait to try the following test until your pre-meal blood glucose is within your target range: TEST: Choose a meal that is high in fat (e.g. hot dogs, pizza, cheese enchiladas). Determine your meal bolus amount. Set the Square Wave bolus to deliver the determined amount of insulin over 2-hours.
Dual Wave bolus practice Can you think of any meals where this feature would help you with blood glucose control? Your target pre-meal blood glucose range is ______ to _______ Check your pre-meal blood glucose. Are you within your target? _____ If yes, continue. If no, try this test when your pre-meal blood glucose is within your target range: TEST: Choose a meal that has a combination of both rapidly absorbed and slowly absorbed carbohydrates. Determine your meal bolus amount.
1 Go to the ENTER BG screen. Press 2 3 4 5 6 on your pump, or use the following path: Main > Bolus > Use Bolus Wizard Enter your blood glucose value, then press ACT. The ENTER FOOD screen appears. Enter your food, then press ACT. The ESTIMATE DETAILS screen appears. Scroll down to review the information there. Press ACT to continue to step 5. If you need to make any changes, press ESC to return to the ENTER BG screen. Make changes as necessary.
8 Press ACT to accept and deliver the bolus. The BOLUS DELIVERY screen appears with an open circle indicating that your pump is in Special Mode. The pump beeps/vibrates at the start of the bolus. During bolus delivery, the pump returns to the HOME screen. If you want to see the progress of the delivery, press ESC to see the STATUS screen. The pump beeps/vibrates at the end of the bolus, and the open circle disappears. Easy bolus The EASY BOLUS button allows a quick way to deliver a Normal bolus.
Step value setup You can set the step value from 0.1 to 2.0 units, or to the set maximum bolus limit of less than 2.0 units (factory setting: 0.1). Set the step to a number that is convenient to use and easy to multiply. Total # Steps = 4 Total # Button Presses = 4 4 Example: 2.0 unit Easy bolus with a step amount set at 0.5 units 1 Step = 0.5 units 3 1 Step = 0.5 units 2 1 Step = 0.5 units 1 1 Step = 0.5 units 0 0 0.5 1.0 1.
For example: You need to deliver a 2.0 unit bolus, and your step size is set to 0.5. Each time you press , the units increase by the step amount of 0.5 units. To deliver 2.0 units, you need to press the button 4 times. (4 X 0.5 = 2.0) The screen will show 2.0 units. NOTE: For your safety, you cannot use the to select the Easy Bolus values. Pressing or ESC will cancel the Easy bolus. 4 If this amount is correct, press ACT to start the Easy Bolus delivery.
Your turn: Easy bolus practice The factory default setting for the Easy Bolus feature is 0.1 unit steps. You can change the step level as necessary to a value that is more convenient for you to use and easier to multiply. Give your next bolus by using the Easy Bolus feature on your pump. How many units did you give? _______ Your step level is ________.
1 Go to the PATTERNS OPTION screen. 2 Main > Basal > Patterns Select On, then press ACT. The patterns feature is now on. Exit the menus. Programming a pattern Your pump will keep your pattern settings even when the Patterns option is turned off. However, the patterns feature must be on to program a basal pattern. To program your patterns, do these steps: 1 Go to the EDIT BASAL screen.
Select a pattern Before you select a pattern to be active, make sure the Patterns feature is turned on. After your standard pattern and/or pattern A or B are set, do these steps to select a pattern to be the active one: 1 Go to the SELECT PATTERN screen. 2 3 Main > Basal > Select Patterns Select the desired pattern, then press ACT. The screen will return to the BASAL MENU. Your basal pattern is now active. Exit the menus. NOTE: If pattern A or B is active, the pump is in Special mode.
Example 2: Basal patterns Cynthia has had diabetes for about 12 years and has been on her Paradigm pump for several weeks. Every Monday, Wednesday and Friday, Cynthia goes on a 3 kilometer walk in the morning. To prevent hypoglycemia on these days, she uses the patterns feature. For those days, she simply switches over to Pattern A, which she has programmed with a lower set of basal rates.
Temp basal types Based on your preference, you can select either Percent of Basal or Insulin Rate. Insulin rate (U/H) Insulin rate is a fixed basal in units per hour (U/H). This temp basal type is independent of your current basal. When you select Insulin rate (U/H) for your temp basal type, your pump will deliver the fixed amount you have set for the duration as set. The amount of your temp basal insulin rate can be set up to your maximum basal rate setting.
Percent of basal Unlike insulin rate, the percent of basal is dependent on your current basal rates. Percent temp basal is a percentage of your current basal (0 - 200 percent limited to your maximum basal rate setting). The maximum percent limit is based on the largest basal rate segment with your programmed temp basal rate time. For example: It is 6:00 AM and your current basal rate is 1.50 U/H. You want to set a temp basal rate of 130 percent for seven hours.
Temp Basal Settings Temp basal type: Percent of basal Duration: 4 hours (1:05 p.m. - 5:05 p.m.) Rate: 50% (50% x rate 2 = 1.275) 1.275 rounded down to the next 0.05 increment is 1.25 U/H (50% x rate 3 = 0.975) 0.975 rounded down to the next 0.05 increment is 0.95 U/H 2.55 U/H (rate 2) 1.50 U/H (rate 1) 1.25 0.95 U/H U/H 7:00 a.m. (07:00) 1:05 p.m. (13:05) 1.95 U/H (rate 3) 12:00 a.m. (00:00) temp basal start time 3:00 p.m. (15:00) 5:05 p.m.
Selecting temp basal type Your pump will remember the temp basal type setting. Once the type is set, you do not have to set it again. To select a temp basal type, do these steps: 1 2 3 Go to the SET TEMP BASAL AS screen. Main > Basal > Temp Basal Type The SET TEMP BASAL AS screen appears. Select Insulin Rate (U/H) or Percent of Basal, then press ACT. The screen will return to the BASAL SETUP screen. The temp basal type is now set. Exit the menus.
Verifying temp basal delivery Temporary basal information is available in the STATUS screen only. During a temporary (temp) basal, the pump is in Special mode (an open circle appears). This open circle will remind you that a temp basal is active. Additionally, your pump will beep/vibrate three times every hour during delivery. During delivery, go to the STATUS screen to see the current temp basal information. Temp Basal of 0.
Example 1: Temp Basal for a decreased temporary basal rate Ramon and his friends got together for an unplanned game of soccer. Before using the pump, he was taking shots to manage his diabetes. Ramon experienced frequent low blood glucose reactions sometimes during, and very often after, he played games with his friends. Now that he is using his Paradigm pump, he can use the Temporary Basal Rate feature to help prevent low blood glucose.
Your turn: Think of an activity where you might need to use a Temporary Basal Rate. At what rate is your current basal rate running? ____________ What Temporary Basal Rate would you try using at this time? ___________________ How long will you be active?___________________ What duration will you set for the Temporary Basal Rate?________________ Test your blood glucose before and during activity and several times after as well.
Utilities You can review alarms in the ALARM HISTORY screen. This screen shows up to 36 past alarms and/or errors. You can also review the details for each alarm when you are in the ALARM HISTORY screen. 1 2 3 4 Chapter 8 Alarm review Go to the ALARM HISTORY screen. Main > Utilities > Alarm > Alarm History Scroll through your past alarms. In the ALARM HISTORY screen, select the alarm you want to review and press ACT. The details for that alarm will appear on the screen.
Auto-off The factory setting for this feature is Off. This is a safety feature that stops insulin delivery after a defined time period (from 1 to 24 hours). If the pump detects that no buttons have been pressed for the selected amount of time in Auto-off, insulin delivery will stop and an alarm will sound. You may choose to program this feature into your pump based on the numbers of hours that you usually sleep at night. Discuss what uses and settings are best for you with your healthcare professional.
Chapter 8 a. For Insulin units: In the WARNING UNITS screen enter the number of units you want remaining for the first warning, then press ACT. The pump will alarm first when the specified units remain, then again when half that remaining amount is used. b. For Time: In the WARNING TIME screen enter the amount of remaining time you want the first warning, then press ACT. The pump will alarm first when the specified time remains, then again one hour before empty.
Pump data management The pump data management feature allows you and your healthcare professional to view and manage your basal and bolus insulin delivery, food intake, and BG data with averages. You can view the details of each day individually or you can average the data over a specified number of days (up to 31 days). • • Daily totals — The system automatically tracks certain types of information for you on a day-to-day basis. The daily totals are the totals for a single day.
Press 4 Chapter 8 The BOLUS screen displays. This screen shows: • total bolus insulin delivered for the day • total food bolus insulin delivered for the day and total percentage of food bolus insulin delivered for the day • total Corr (correction) bolus insulin delivered for the day and total percentage of corr bolus insulin delivered for the day • total man (manual) bolus insulin delivered for the day and total percentage of manual boluses delivered for the day Press 5 to view more information.
3 The AVG BG screen displays. This screen shows: • the average of all blood glucose values entered into the pump for the number of previous days you selected • the average high and low blood glucose values for the number of previous days you selected • the average number of blood glucose values entered into the pump per day for the number of previous days you selected Press 4 The AVG INS (average insulin) screen displays.
• • the average total number of food plus correction boluses delivered per day for the number of previous days you selected the average total number of manual boluses delivered per day for the number of previous days you selected To get back to the HOME screen, press four times. Chapter 8 Personal reminders Alarm clock The alarm clock is a feature that allows you to set daily reminders for various events (8 max). The factory setting for this feature is off.
To use the remote control, these pump settings must be programmed: • • • Remote Options = On Remote control ID code entered in pump (code is on back of remote) Easy Bolus = On Turn on remote control option WARNING: If there is a LOW BATTERY condition, the pump will not receive signals from the remote. To ensure the pump communicates with the remote control, make sure the pump does not have a low battery. (Replacing the low battery with a new battery will restore remote control function.
3 4 Reviewing remote IDs a. Select Review ID, then press ACT. b. The programmed IDs will show in the REVIEW REMOTE ID screen. Exit the menus when you are done. Block restricts access to pump programming. The factory setting for this feature is off. Block is an important safety feature if the pump user requires someone else to maintain complete control of pump operation. When block is on, the remote control is used to deliver a bolus and suspend/resume the pump.
Example 2: Block Oscar is an elderly man with diabetes who needs assistance with all of his daily living activities. He needs his caregiver or family member to help him with his pump as well. To be sure that Oscar does not change any pump settings, his family programmed his Paradigm pump with the Block feature turned on. They use the Remote Control to give him his boluses when he needs them. Lock keypad feature Lock keypad prevents accidental pump keypad presses.
Contact our 24 Hour HelpLine if any of the tests do not occur as described here. NOTE: If the pump detects a condition such as low battery, the selftest will not finish. A message will appear to show the condition that caused the test to stop. 1 4 Main > Utilities > Selftest Select Selftest, then press ACT. Periodically, you will hear beeps as different mechanisms in the pump are being tested. As part of the selftest, the pump will do these tests: a. Screen Test: The screen will appear all black. b.
CAUTION: Do not clear your pump settings unless directed by your healthcare professional or a Medtronic Diabetes representative. If you clear your pump settings, it will be necessary to reprogram all your personal pump settings as directed by your healthcare professional. Additionally, you will have to rewind your pump. Saving the settings Do these steps to save your current pump settings: 1 Go to the UTILITIES MENU screen and select User Settings.
Clearing the settings Take the following steps only if you want to clear your pump to factory default settings. WARNING: Do not clear your pump settings while it is connected to your body. 1 Chapter 8 CAUTION: Do not clear your pump settings unless directed by your healthcare professional or a Medtronic Diabetes representative. If you clear your pump settings, it will be necessary to reprogram all your personal pump settings as directed by your healthcare professional.
4 124 The SETTINGS HISTORY screen displays, giving you a list of all the dates and times of your most recent User Setting operations. Scroll down to view the entire history. When you are done looking at the history, press ESC to exit the menu.
Therapy software Medtronic provides software to optimize your pump use. Contact our 24 Hour HelpLine for more information. Your pump provides real-time glucose values so that you can track glucose concentration patterns and possibly identify episodes of low and high blood glucose. It also stores glucose data so that it can be analyzed to track patterns and/or downloaded to CareLink Personal for analysis of historical glucose values.
You can share your reports with your healthcare professional. These reports can help you and your healthcare professional to discover trends and other information. This can lead to improved therapy management for greater control. Logbook The logbook allows you to enter the following self-reported information: • • • • • Carbohydrates consumed Exercise activity Urine ketone results HbA1c results Infusion set changes The data from your logbook is used in the reports you create.
Insulin pump therapy follow-up We hope that you are now comfortable using the pump and your blood glucose values have improved through insulin pump therapy. Diabetes management requires much more than blood glucose control. You need to take care of your complete physical and mental health. This includes seeking treatment for any condition both directly related to and not related to diabetes. The following recommendations apply to general diabetes as well as insulin pump therapy follow-up.
Laboratory tests • • • Test for HbA1c four or more times a year Test for cholesterol, HDL, LDL, triglyceride yearly Test for microalbuminuria yearly Every visit • • • Blood pressure check Foot exam Review goals for blood glucose, meal plan and exercise Annually • • • • • • • • 128 Dilated eye exam by a qualified ophthalmologist Annual flu shot Regular dental visits Nerve function tests EKG test over age 35 Prostate exam for men, breast exam for women Diabetes education review Replace Glucagon Emergenc
Troubleshooting and alarms This Troubleshooting chapter is designed to help you understand the messages that your pump is giving you when you get an alarm or an alert message. The procedures in the beginning of this chapter are to be used when you get specific alarms or cover a likely condition that might happen. A list of alarms is provided at the end of this chapter.
What happens if I leave the pump battery out too long? If you leave the pump battery out too long (more than five minutes) you may receive a BATT OUT LIMIT alarm message when you install the new battery. Do the following steps: 1 2 3 Set your pump clock to the correct time, date, and year. Check to make sure that all your settings, such as basal rate, are set as desired.
What is a CHECK SETTINGS alarm? This alarm occurs after an E alarm or after you clear your pump. It is advising you to make sure that all your settings are correct. A CHECK SETTINGS alarm occurs after any of these actions: • • • All user settings were cleared (set back to their defaults) because there was an E-error alarm, The CLEAR SETTINGS function was performed, Or after you rewind when practicing without a reservoir when your first get your pump.
The pump is asking me to rewind This is normal after any of the following: 1 2 3 Any E-alarms, The Clear Settings function, Or, a NO DELIVERY Alarm (during the Prime sequence). My bolus stopped The Bolus Stopped error can occur if the battery cap is loose or the pump was bumped or dropped during a bolus. It can also happen if the pump receives a static shock. As a safety measure, the pump stops the bolus when this happens.
7 8 Your pump will not show another reading. Make sure the pump is idle and the HOME screen is blank. If your pump still does not receive your blood glucose reading from the meter, use the up/down buttons to manually enter your blood glucose (in the ENTER BG screen). I dropped my pump Take care to protect your pump from being dropped. 1 2 3 4 5 6 Check that all connections are still tightly in place. If you notice that the drive support cap is loose, or sticking out, discontinue use of the pump.
To get to the USER SETTINGS screen: 1 Go to the UTILITIES MENU screen. Main > Utilities 2 Select User Settings. Hold down 3 See the User Settings section of the Utilities chapter for information about the menu options. and press ACT. Alert conditions Your pump has a sophisticated network of safety checks and systems. If it detects an unusual condition that requires your immediate attention, it beeps or vibrates periodically to alert you.
Answer: Your pump monitors activities and will alert you if a Special mode is active. Some alerts are a normal part of pump therapy, such as an active temporary basal. There are alerts that indicate a condition that is outside normal pump activity. For example, your pump notifies you with an alert when you need to replace the reservoir (LOW RESERVOIR) or replace your pump battery (LOW BATTERY).
Check your pump and test your blood sugar. Follow the guidelines prescribed by your healthcare professional to manage your diabetes as needed. NOTE: The STATUS screen shows any alarms and alerts that are active. Question: Why are alarms important? Answer: Your pump monitors activities and notifies you if there is an unusual pump status or your attention is required. When an attention alarm is active, INSULIN DELIVERY IS STOPPED and immediate operator interaction is required.
Alarm conditions Alarms put the pump in Attention mode. A (ALARM) This alarm shows the letter A followed by two numbers. A-alarms cause all insulin delivery to stop. Your pump settings are retained. If this alarm repeats often, call our 24 Hour HelpLine for assistance. AUTO OFF Alerts you that no buttons were pressed during the time limit you set for the AUTO OFF DURATION feature, and so insulin delivery has been stopped.
E (ERROR) After receiving this alarm, note the error number then call our 24 Hour HelpLine for assistance. An error alarm will show the letter E followed by two numbers. E-alarms cause all insulin delivery to stop, the pump resets, and all your settings are cleared. EMPTY RESERVOIR There is no insulin in the reservoir. Change the reservoir immediately. FAILED BATT TEST The pump tests the voltage of each battery installed. This test ensures a battery with low voltage is not used.
MAX DELIVERY This alarm alerts you when you have taken more insulin than expected based on maximum bolus and maximum basal rates. MOTOR ERROR Insulin delivery has stopped. This alarm occurs if your pump detects a motor error. NO DELIVERY Insulin delivery has stopped. This alarm occurs if your pump detects a blockage. NO RESERVOIR The reservoir is not inserted correctly or no reservoir has been inserted. OFF NO POWER RESET Chapter 11 The battery is dead. Replace battery immediately.
140 Troubleshooting and alarms
Pump maintenance It is recommended that you read your warranty statement included with your pump for information about what is covered during your warranty period. Battery The Paradigm pump uses a single 1.5 V AAA alkaline battery, size E92, type LR03. As a safety measure, Medtronic Diabetes has designed the pump to only accept a NEW battery. If you insert a used battery, the FAILED BATT TEST alarm may be triggered. Refer to the Install battery in The basics chapter for instructions.
Storage If you have to remove and store your pump, it is recommended that you store it with the battery in place. Keep a record of your current basal rates. To preserve battery life, reset the basal rates to 0 (zero), turn off the remote and meter options, and set the Auto-off to dashes or zeroes. Cleaning your pump 1 2 3 4 5 6 7 8 9 142 Use only a damp cloth and mild detergent mixed with water to clean the outside of your pump. Rinse the pump with a clean cloth, dampened with clean water.
Pump specifications This section provides detailed information on specifications related to your pump. The safety features of your pump are individually listed and described. Alarms and error messages • • Indicators: audible tone (beep) or vibration (silent) All alarms and errors show messages on the pump's screen and provide instructions on what to do. Unresolved alarms will escalate to siren mode for added safety.
• • Factory maximum setting: 2.0 units/hour 3 patterns maximum, each with 48 rates BG target • Maximum targets: 8 • Range: 60 - 250 mg/dL (3.3 - 13.9 mmol/L) • Warning limits: less than 90 or greater than 140 mg/dL (less than 5.0 or greater than 7.8 mmol/L) Bolus delivery • • • • Fluid delivered/stroke: 0.05 u Fluid delivered/stroke: 0.5 µL Time between/delivery strokes: 2 seconds Delivery rate (per minute): 1.5 u Bolus history Maximum records shown: 24 Bolus units Increments: 0.
Carb ratios Maximum ratio settings Range Warning limits 8 3 - 150 grams/u less than 5 or greater than 50 grams/u 0.1 - 5.0 u/exch less than 0.3 or greater than 3.0 u/exch Carb units • The food entry when using Bolus Wizard feature • grams: 0 - 300 (increments: 1 gram) • exchanges 0.0 - 20 (increments: 0.5 exch) Daily totals Maximum records shown: 31 days of data, maximum display: 999.95 units/day. Daily delivery accuracy: +0/-0.05 units. Default screen The HOME screen.
Delivery accuracy • • Delivery accuracy: +/-5 percent. Displacement (piston) accuracy: +/-2 percent. Delivery Volume Accuracy Curve ( -0.40% ) Overall Error (MMT-515 Model) Qualification Testing (0.
Pump motor The pump motor has a unique, patented design with an integrated safety check system. The system delivers in precise increments. Dual Wave bolus Delivers a Normal bolus followed by a Square Wave bolus (limited by maximum bolus). Easy bolus • • • • • Features programming using audible tones (or vibrate pulses) in user-defined increments. • Beep mode range: 0 to maximum bolus • Vibrate mode range: 0 to 20 steps or maximum bolus, whichever comes first Default step increment: 0.
Low resv (reservoir) warning Values are based on displayed amount, not actual amount. time: 2 - 24-hours, and @ 1:00 hour before empty 08:00 hours (default when time is selected) units: 5 - 50 units, and @ 1/2 amount remaining 20 units (factory default) Meter value • The BG measurement received from the meter. Appears in the ENTER BG screen during bolus programming. Appears on the screen when the pump is idle at the HOME screen. • Expiration: 12 minutes • Range: 20 - 600 mg/dL (1.1 - 33.
Percent temp basal Default value: 100% of basal programming Power supply The pump is powered by a standard 1.5 V AAA alkaline battery, size E92, type LR03 (Energizer brand recommended). Prime function • • • Fixed prime range: 0.1 - 25.0 units (limited by maximum bolus) Manual prime limit: Warning at 30 units, then at each 10 units thereafter. Fill rate: 1 to 5 units/second. Prime history Maximum records shown: 20 manual and fixed Program safety checks Maximum infusion with single fault condition: 0.
Remote control Uses radio signals to allow users to program Normal boluses or to suspend/resume their pumps. Reservoir • • • The user-filled reservoir is made from impact-resistant, insulin-compatible polypropylene. 515 Pump volume: up to 176 units of U100 insulin 715 Pump volume: up to 300 units of U100 insulin Square Wave bolus Delivers bolus insulin over a duration of 30 minutes up to 8 hours (limited by the max bolus setting).
Status screen Item When What Active Insulin if any (Active Ins:) the amount of active insulin, displayed to the next 0.025U Alarm Clock* (appears if scheduled to alarm) Time set is displayed.
Item When What Serial number (always appears) Software version (always appears) Standard basal delivery data (always appears) Status of pump (i.e., Rewind, Suspended, Low Reservoir, Set Time, etc.) Time (always appears) current basal rate (basal 1, basal 2, etc.) *If all of the Reminders and the Alarm Clock are enabled, only the reminder that is nearest to alarming will appear in the STATUS screen.
3 If your current BG is between or equal to your High or Low BG Target, the total bolus estimate is based only on the food estimate. (food estimate) total bolus estimate = 4 food carb ratio If you do not enter a BG, the total bolus estimate is based only on the food estimate. Notes: • • If a Dual Wave bolus is less than the estimate due to the max bolus limit or a user change, the square (sq) portion is reduced first.
• The Bolus Wizard feature may utilize your current BG measurement, carbohydrate consumption, and active insulin to calculate your estimated bolus.
Bolus Wizard feature examples Settings: • • • • Carb ratio: 30 grams/unit BG Target: 90-120 mg/dL (5.0-6.7 mmol/L) Insulin Sensitivity: 40 mg/dL/unit (2.2 mmol/L/unit) Active Insulin Time: 6 Hours #1: No active insulin from previous bolus delivery. User inputs 60 grams of carbs and does not enter BG. (food estimate) 60 g = 2 units 30 g/u bolus estimate = 2 units #2: No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a BG of 200 mg/dL (11.1 mmol/L).
#3: No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a BG of 70 mg/dL (3.9 mmol/L). (food estimate) (correction estimate) 60 g = 2 units 30 g/u + 3.9 mmol/L - 5.0 mmol/L 2.2 mmol/L/u = -0.5 units 70 mg/dL - 90 mg/dL 40 mg/dL/u = -0.5 units = 2 + (-0.5) = 1.5 units bolus estimate #4: No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a BG of 100 mg/dL (5.6 mmol/L).
#5: Previous bolus activity results in a calculation of 1.5 units unabsorbed (active) insulin. User inputs 60 grams of carbs and a BG of 200 mg/dL (11.1 mmol/L). (food estimate) (correction estimate) 60 g = 2 units 30 g/u + bolus estimate 11.1 mmol/L - 6.7 mmol/L - 1.5 units (active insulin) 2.2 mmol/L/u = 0.5 units 200 mg/dL - 120 mg/dL - 1.5 units (active insulin) 40 mg/dL/u = 0.5 units = 2 + 0.5 = 2.5 units #6: Previous bolus activity results in a calculation of 3.
Insulin delivery default settings Menu Bolus Menu: Item Default Setting Bolus Wizard feature: Off Easy bolus: On Easy bolus step: Dual/Square bolus: Maximum bolus: Basal Menu: Off BG reminder: Off 0:00 - 5:00 0:30 Patterns: Off 0.00 - 35.00 u/h 0.05 u Maximum basal rate: 2.0 u/h Basal rate: 0.0 u/h Lock Keypad: U/H 0.05 u max basal rate setting 0.
Menu Item Default Setting (Time/Date) Time format: Increments 12-hour Block: Off Alarm clock: Off Remote option: Off Meter option: Off User Settings: (no defaults) Language: Limits English Chapter 13 Pump specifications 159
Bolus Wizard feature default settings 160 Item Default Setting Limits Increments Warning Limits carb units: grams none none none ins to carb (or exch) ratio: 15 grams/u or 1 unit/exch 3-150 g/u or 0.1-5.0 u/exch 1 g/u or 0.1 u/exch 5 - 50 g/u or 0.3 - 3.0 u/exch (insulin) sensitivity: 2.8 mmol/L or 50 mg/dL 0.5 - 22.2 mmol/L or 10 - 400 mg/dL 0.1 mmol/L or 1 mg/dL 1.1 - 5.6 mmol/L or 20 - 100 mg/dL BG target: 5.6–5.6 mmol/L or 100–100 mg/dL 3.3 - 13.9 mmol/L or 60 - 250 mg/dL 0.
Icon table Attention: See Instructions for Use Date of manufacture (year - month) Batch code Catalogue number Device serial number Storage temperature range Magnetic Resonance (MR) unsafe Fragile product Type BF equipment (Protection from electrical shock) Conforms to IEC60601-1 sub-clause 44.6 and IEC60529 standard For more information about IPX7, see the Glossary on page 165.
Signifies compliance with Industry Canada EMC and Radio communications requirements 162 Pump specifications
Warranty Medtronic Diabetes warrants the Medtronic MiniMed Insulin Pump against defects in materials and workmanship for a period of 4 years from the date of purchase. During the warranty period, Medtronic Diabetes will, at its discretion, either repair or replace (with a new or recertified pump, at Medtronic Diabetes’ discretion) any defective pump or motor, subject to the conditions and exclusions stated herein. In the event that a pump is repaired or replaced, the warranty period will not be extended.
164 Pump specifications
Glossary A A1C (HbA1c) test - A 2-3 month average of blood glucose values expressed in percent. The normal range varies with different labs and is expressed in percent (such as 4 - 6%). Accept - Pressing the ACT button to approve the selection or setting. Active insulin - Bolus insulin that has been delivered to your body, but has not yet been used. Alarm - Audible or vibrating (silent) notice that indicates the pump is in Attention mode and immediate attention is required.
check your blood glucose after a bolus. BG target - Normal blood glucose level BG Units - Blood glucose units used by the pump (mg/dL or mmol/L). Block - Feature that restricts access to all programming except suspend, selftest and the delivery of a bolus with the remote control. Blood glucose (BG) - A form of digested sugar in the bloodstream. Glucose is the major source of energy for living cells, and is carried to each cell through the blood stream. Cells cannot use glucose without the help of insulin.
time for an action or condition. E Easy bolus™ - Method of delivery for a Normal bolus using the . Easy Bolus button Electromagnetic compatibility The condition that exists when systems and devices that use electromagnetic energy operate properly without causing or suffering accidental electromagnetic interference to or from other electromagnetic devices. Electrostatic discharge - The rapid, spontaneous transfer of electrostatic charge induced by a high electrostatic field.
as well as drug stores and pharmacies. H HbA1c - Glycosylated hemoglobin HDL - High-density lipoprotein A complex of lipids and proteins in approximately equal amounts that functions as a transporter of cholesterol in the blood. Hold - Press and continue to press a pump button. Hyperglycemia - A condition in which blood glucose values are elevated above target. Symptoms may include excessive thirst, frequent urination, dry mouth, headache, fatigue, and blurred vision.
communicates with your pump. Log - A record of measurements, alarms or other actions by your pump. Low resv warning Programmable warning that notifies you with an alert when either a specified number of units remain in the reservoir or a specified amount of time remains before the reservoir will be empty. M Manual bolus - Selectable item available in the BOLUS MENU when the Bolus Wizard feature is active. It is one method of programming a bolus without the Bolus Wizard feature.
Protein - One of the three main sources of energy or calories in food. Proteins are made of amino acids, which are called the building blocks of the cells. The cells need proteins to grow and to mend themselves. Protein is found in many foods such as meat, fish, poultry, and eggs. PSI - Pound-force per square inch. Pump S/N - Pump S/N is the serial number of the pump currently in use. R Reservoir - The syringe that holds insulin. Reset - To set again, or change the information (reset your glucose values).
Timeout - If you do not enter information or do something in a specific length of time, your pump automatically stops what it is doing and goes to the HOME screen.
172 Glossary
Index Index A accessories 3 activity guard 3 CareLink USB 3 holster 3 leather case 3 meter 3 pump clip 3 remote control 3 active insulin 82 Active insulin time setting 83 alarm clock 117 Alarm conditions 137 alarm frequency 143 ALARM HISTORY screen 111 Alarm types A (alarm) 137 Auto off 137 Batt out limit 137 Bolus stopped 137 Button error 137 Check settings 131, 137 E (error) 138 Empty reservoir 138 Failed batt test 138 Max delivery 139 Motor error 139 No delivery 129, 139 No reservoir 139 Off No power 1
settings 74, 75, 76 Active insulin time 76 BG target range 76 BG units 75 Carb ratios 74 Carb units 74 Insulin sensitivity 75 specifications 152 your BG reading 73 buttons, pump 25, 28 C Carb units 78 carbohydrate counting 20 CareLink Personal 125 CareLink USB 3 CHECK BG message 48 cleaning the pump 142 Clear settings 123 consumables 2 correction bolus 40, 85, 86 D Daily totals 114 DAILY TOTALS screen Review 113 default settings insulin delivery 158 Dual Wave bolus programming with Bolus Wizard 95 without
P Patterns basal 100 on/off 100 pattern A, B 100 Program a basal pattern 101 Select a basal pattern 102 standard basal pattern 100 Personal reminders 117 personal settings 74 practicing 62 prime manual 64 PRIME MENU 34 pump battery compartment 25 buttons 25, 28 if you remove your 35 screen 25, 29 using in water 133 warranty 163 R Reminder, alarm clock 117 remote control 3 remote control IDs add, delete, review 118 Remote control option turn on 118 removing your pump 35 reservoir filling the 58 inserting i
176 Index
INSULIN PUMP 6025020-016C_b
