INSULIN PUMP AND CONTINUOUS GLUCOSE MONITORING SYSTEM Insulin Pump User Guide
Paradigm® 522 and 722 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®, Sen-serter®, Silhouette®, Sof-set®, and Square Wave® are registered trademarks of Medtronic MiniMed, Inc.
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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 insulin pump in water. To swim or participate in other water activities, always disconnect from your Paradigm pump and reconnect after water play.
ಘ Contents Chapter 1: Introduction ..................................................................... 1 Assistance ...................................................................................................... 1 Emergency kit ................................................................................................. 2 Consumables .................................................................................................. 3 Accessories .................................................
Insulin pump and RF accessories ........................................................................ 9 RF interference from other devices ................................................................... 10 Chapter 2: Introduction to pump therapy ............................................. 13 Theory of insulin pump therapy ........................................................................... 13 Understanding pump therapy ........................................................................
Chapter 3: The basics ...................................................................... 27 Your pump .................................................................................................... 27 Install battery ................................................................................................ 28 Pump buttons ................................................................................................ 29 The pump screen .........................................................
Maximum bolus limit ........................................................................................ 49 BG Reminder ................................................................................................. 50 Basal .......................................................................................................... 50 Start and stop times ..................................................................................... 51 Your basal settings .........................................
LOW BG .................................................................................................... 76 MAX BOLUS EXCEEDED ................................................................................... 77 How to program the Bolus Wizard feature .............................................................. 77 Turning on the Bolus Wizard feature ................................................................. 77 Selecting the Carb units ...........................................................
Chapter 8: Sensor features .............................................................. 113 Entering your sensor settings ............................................................................ 113 Turning on the sensor .................................................................................. 113 Selecting the BG units .................................................................................. 114 High Glucose Alert .....................................................................
Removing the sensor ................................................................................... 137 Storage ...................................................................................................... 137 Using your system in water ............................................................................... 138 Chapter 10: Utilities ..................................................................... 139 Alarm review ....................................................................
Every month ............................................................................................. 155 Every 3 months .......................................................................................... 155 Laboratory tests ......................................................................................... 156 Every visit ................................................................................................ 156 Annually ...........................................................
SENSOR ERROR ........................................................................................ 166 Alarms ....................................................................................................... 167 What to do ............................................................................................... 167 Alarm conditions ........................................................................................... 168 A (ALARM) .........................................................
Alarm history ............................................................................................... 179 Audio frequency ........................................................................................... 179 Backlight .................................................................................................... 179 Basal ......................................................................................................... 180 BG Target .............................................
Bolus Wizard feature specifications .................................................................... 188 Bolus Wizard feature examples .......................................................................... 191 Insulin delivery default settings ......................................................................... 194 Bolus Wizard feature default settings .................................................................. 196 Sensor features default settings ........................................
xviii Contents
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.
Consumables The pumps use disposable reservoirs and infusion sets for insulin delivery. Installation instructions for Paradigm reservoir and Paradigm compatible infusion sets are provided in the Starting on insulin chapter. • 1 Reservoirs — The 522/522K pump is only used with the 176-unit Paradigm reservoir (MMT-326A). The 722/722K pump can be used with either the 300-unit Paradigm reservoir (MMT-332A) or the 176-unit reservoir, depending on your insulin needs.
To order supplies, call 800-646-4633, +1-818-362-5958 (outside U.S.), refer to the contacts list at the beginning of this user guide, or visit our web site at www.medtronicdiabetes.com. How to wear your pump There are different ways to wear your pump. Medtronic Diabetes has optional accessories that can hide, protect, and add to the convenience of wearing a pump. Refer to the accessories catalog or the website (www.medtronicdiabetes.com) for more information.
How to use this guide NOTE: This user guide shows sample screens only. Your pump screens may be slightly different.
User safety Indications: Paradigm 522/722 Pump The Paradigm MMT-522 and MMT-722 pumps are indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. Sensor and transmitter The sensor and transmitter components are indicated for continuous or periodic monitoring of glucose levels in the fluid under the skin, and possible low and high blood glucose episodes in adults (ages 18 and older).
Meter Contraindications 1 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 insulin pump therapy requires sufficient vision or hearing to allow recognition of the pump signals and alarms.
Magnetic fields Do not use pump cases that have a magnetic clasp. Do not expose your insulin pump to MRI equipment or other devices that generate very strong magnetic fields. The magnetic fields in the immediate vicinity of these devices can damage the part of the pump’s motor that regulates insulin delivery, possibly resulting in over-delivery and severe hypoglycemia. Your pump must be removed and kept outside the room during magnetic resonance imaging (MRI) procedures.
Infusion sets and sites Avoid using an infusion set insertion site that will be irritated by clothing and accessories, or by rigorous stretching and exercise. Sensor ಘChapter Prior to exercising, make sure the sensor is firmly attached. Adverse reactions 1 Operation of the sensor feature requires the insertion of a glucose sensor into the skin. Bleeding, swelling, bruising, or infection at the sensor insertion site are possible risks of sensor use.
These standards are designed to provide reasonable protection against excessive radio frequency interference and prevent undesirable operation of the device from unwanted electromagnetic interference. Operation is subject to the following two conditions: ಘ 1 ಘ 2 This device has been tested and found to comply with the regulations governing such devices in your area. For the specific regulation and test results for your area, please contact your local representative.
Communication problems can usually be resolved by: • • • 1 Communications problems may also occur due to cellular telephone interference. Testing conducted with several different cellular telephones indicates that, while a glucose value is being transmitted, using a cell phone within 12 inches (31 cm) of receiving devices, transmitters or RF glucose meters can interfere with reception of the transmitted values.
12 Introduction
Introduction to pump therapy Theory of insulin pump therapy 2 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 __________ mg/dL (mmol/L). Active Insulin Blood glucose and A1C testing 2 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.
Low blood glucose (hypoglycemia) Low blood glucose can occur while using the pump for the same reasons it can while using daily injections: • • • • not enough food too much insulin more exercise than usual drinking alcoholic beverages 2 It is best to use something that you can always carry with you. Choose a food that is all carbohydrate because it will be fast acting. Avoid using high fat foods such as chocolate. They will not work fast enough, and you may also end up over-treating your lows.
These items have 15 grams of fast acting carbohydrates: • • • • Glucose tablets (three, 5-gram tablets or four, 4-gram tablets) 4 oz.
If the second blood glucose is above 250 mg/dL (13.9 mmol/L): • • Treating hyperglycemia from illness or infection through insulin pump therapy will be discussed on the following pages. ಘChapter • • • • 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). Consider changing the insulin vial if you believe that the insulin is no longer stable.
• • Continue to test blood glucose and ketones. Continue to take correction insulin injections as told until your blood glucose reaches your target level. If your blood glucose is less than 200 mg/dL (11.1 mmol/L) and ketones are present, drink liquids with calories. Some examples of caloric fluids are juice and non-diet soda. Also, extra insulin may be needed. Contact your healthcare professional for guidelines for insulin doses when ketones are present.
• • • Sugar free medicine for fever, cough, congestion, nausea and vomiting. Extra blood glucose and ketone strips. Glucagon emergency kit in case of severe hypoglycemia. This can be used if you cannot eat or are unconscious. Caring for your diabetes when you are sick is worthwhile and can be a challenge. If you are too sick to watch your diabetes carefully, ask a friend or family member to help. If there is no one to help you, ask your healthcare professional for help.
Foods with carbohydrates include: • • • • starches and starchy vegetables fruits and fruit juices milk and milk products sugars and foods with sugar Facts on the nutrition labels on packaged food will help you to figure how much carbohydrate is in a certain food. There are a number of paperback books that list the grams of carbohydrates in many foods. These books are very helpful when you are eating foods without labels or are eating out.
Nutrition Facts Serving Size 1 piece (20g) Serving per Container 22 Total Fat 0g Sodium 0g Total Carbohydrates 12g Sugars 11g Fat and blood glucose 2 Although fat does not have carbohydrate, it may affect your blood glucose level. Your blood glucose can be normal two hours after a meal with high fat foods. However, four to six hours later your blood glucose will increase. That is because the fat slows down the rate the carbohydrates are absorbed in that meal.
• meat • fish • poultry • eggs • cheese • peanut butter • tofu • dried beans • dried peas Protein needs are the same for people with and without diabetes, unless kidney disease is present. Most people eat more protein than they need. Protein does not need to be part of every meal. In general, 140-200 grams of protein a day is enough. If you have high cholesterol or are trying to lose weight, eat leaner proteins such as chicken and fish.
Exercise Your body needs insulin and carbohydrate to provide cells with energy during exercise. How much insulin and carbohydrates you need varies with the types of exercise and with how often you exercise. Using an insulin pump during exercise allows you to reduce your basal rate instead of eating extra carbohydrate. Before, you needed to eat extra carbohydrate to make up for the glucose lowering effect exercise often has on blood glucose. It takes trial and error to get the balance right.
26 Introduction to pump therapy
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. tubing connector screen 3 battery compartment ESC reservoir window ಘChapter 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.
ಘ 5 ಘ 6 ಘ 7 Pump buttons 3 The buttons on the pump are used to navigate through the menus and screens, and to program the features of the pump. ಘChapter 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 HOME screen been installed backwards, remove the battery and install it properly. ಘ b.
The following table describes how to use the buttons on your pump from the HOME screen: Button Description EASY BOLUS™ button—Shortcut to set and deliver an Easy Bolus. Turns the backlight on or off. Opens the MAIN MENU. • • Opens the pump STATUS screen if the sensor feature is turned off. Opens the following screens and graphs from the HOME screen if the sensor feature is turned on: • 1 press opens the 3–hour sensor glucose graph. • 2 presses open the 24–hour sensor glucose graph.
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. NOTE: The screen text in the examples used in this guide might not exactly match the text on your pump screen. Please follow your pump screen instructions. If you have any questions, contact your local representative.
Time display 24-Hr The current time of day is displayed across the top of the pump screen in the format you select—12-hour or 24-hour. The AM or PM is only displayed for the 12-hour format. For instructions on setting the time on your pump, see the Setting the time and date section in the Basic programming chapter. 12-Hr Time Display ಘ Reservoir volume The reservoir volume icon tells you how much insulin is in your pump. This icon is also divided into four segments.
Scroll bar If there is more text than the screen can show, a scroll bar appears on the right side of the screen. Press to view any additional text. Screen backlight When you press from the HOME screen, the light on the screen turns on or off. During programming, the backlight can be turned on by pressing the and the together. The light will stay on while you are pressing any of the pump buttons. It will stay on as long as the current screen is active.
Normal mode Mode for standard pump operations for normal basal and bolus delivery. No special features are active (such as basal patterns, temp basal, and others). No alarms and no alerts exist. Special mode ಘ 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 beeps or vibrates periodically to remind you of the condition.
When the pump is in Attention mode, it will beep or vibrate periodically to remind you of the condition. The beep or 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.
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. STATUS screen The STATUS screen shows information about what your pump is doing. Only check your pump status (press ESC) when you are not programming your pump.
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: • • • Store your pump with the battery in place Keep a record of your current basal rates and use the Save Settings feature (see the Saving the settings section in 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.
38 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). ಘ 1 Go to the TIME/DATE SETUP screen.
ಘ 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. ಘ b. Minutes Change the minutes. Press ACT. ಘ c. Year Change the year. Press ACT.
d. Month Change the month. Press ACT. ಘ e. Day Change the day. Press ACT. ಘ ಘ 5 ಘChapter The TIME SET AT screen will show the settings that you programmed. Press ACT and exit the menus. Your time/date settings are complete. ಘ 4 Selecting the language The language shown on the pump screens can be changed. Some languages may 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.
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.
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. ಗ Do the following steps to view the BOLUS HISTORY screen: ಘ 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) ಗ To see the details of any bolus, do these steps: ಘ 1 Without the Bolus Wizard feature 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 Max bolus amount. ಗ To set the Maximum bolus limit, do these steps: ಘ 1 Go to the MAX BOLUS SETUP screen. ಘ 2 ಘ 3 Main > Bolus > Max Bolus Set your maximum bolus limit and press ACT.
BG Reminder After you deliver a bolus you may want to check your blood glucose. The BG Reminder is an optional feature that makes the pump beep or vibrate to remind you to check your blood glucose after a bolus. However, this reminder is not available after an Easy Bolus. Your pump is set at the factory with the BG Reminder feature turned off. When setting a bolus, if the BG Reminder is on, your pump will ask you to set up the BG Reminder Duration.
Start and stop times When you set your basal rate(s) in the BASAL MENU, your pump prompts you to set the start time for each basal delivery. The start time of one basal rate is the stop time of the previous rate. This gives you continuous basal insulin through a 24-hour period. For basal rate 1, the start time is midnight and cannot be changed. See the following sample graph of basal rates.
For best results, setting or changing your basal rate(s) should be discussed with your healthcare professional. Your basal settings You must program your basal settings before you can deliver basal insulin. Keep a written record of your basal settings. It is recommended that you set your basal rates with the assistance of your healthcare professional. If you plan to take off your pump for an extended period of time, i.e. more than a day, set the basal rate to 0.00 U/H.
Current basal delivery current basal The STATUS screen shows your current basal information. 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). ಗ To review your basal rates, do these steps: Go to the BASAL MENU screen.
ಘ 3 If you do not use patterns, the STANDARD screen appears. The delivery details for your standard basal will appear. 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.
If you are setting your Max basal rate after your basal rates have been set, you cannot set a Max basal that is less than any of the programmed basal rates. ಗ To set your Max basal rate, do these steps: ಘ 1 Go to the MAX BASAL RATE screen. The Max basal rate will be flashing. ಘ 2 ಘ 3 Main > Basal > Max Basal Rate Change the rate and press ACT. Your Max basal rate is now set. Exit the menus. Example 1: Max basal Helen has a very low insulin requirement. Her highest basal rate is only 0.4 units per hour.
When suspended, your pump is in Attention mode with a solid circle showing on the pump. When in Suspend, you can only resume your basal or view the STATUS screen. No other functions are available. ಗ To suspend the pump: ಘ 1 ಘ 2 ಘ 3 Select Suspend from the MAIN MENU, and press ACT. Main > Suspend SUSPEND will flash on your screen. Press ACT to stop your pump. The screen will show that the pump is suspended and the time that it stopped.
Example: Suspend function Helen is ready to eat her lunch. She has just programmed her pump to deliver a meal bolus when the phone rings. Helen wants to talk on the phone and not eat her lunch right away. She knows that if she lets the bolus continue and she does not eat her lunch soon, she may be at risk for low blood glucose. Helen suspends delivery of her pump to stop the bolus, but then resumes delivery to restart her basal insulin.
58 Basic programming
Starting on insulin The Paradigm pump is intended for use with U100 insulin. Prepare your pump for use We recommend that you watch the training CD-ROM enclosed with your pump, and complete your pump start training, before continuing with the steps in this chapter. 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: Using cold insulin can cause air bubbles in the reservoir and tubing. If your insulin is stored in the refrigerator, allow it to reach room temperature before filling your reservoir. When filling the reservoir, take care to remove air bubbles. CAUTION: Insulin comes in different vial types, depending on your country. If your vial is different than the one described in the User Guide, consult with your healthcare professional on how to fill your reservoir.
ಘ6 Gently tap the side of the reservoir to make any air bubbles rise to the top of the reservoir. 4 6 5 ಘ7 Slowly push up on the plunger just enough to remove any air bubbles from the reservoir. Slowly pull down on the plunger to fill the reservoir to the number of units desired. ಘ9 With the vial down, hold the transfer guard. Turn the reservoir counter-clockwise, then pull straight up to remove it from the transfer guard. ಘ Place the tubing connector onto the reservoir.
ಘ To purge air bubbles that have risen to the top of the reservoir, push up on the plunger until you see 12 insulin in the tubing. ಘ 13 Without pulling, turn the plunger counter-clockwise to remove it from the reservoir. 11 13 12 Changing your infusion set Removing the reservoir ಗ Each time you remove and replace a reservoir in your pump, you have to rewind your pump, and fill the infusion set with insulin. ಘ 1 Remove the entire infusion set from your body. ಘ If attached, remove the activity guard.
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. ಘ 1 ಘ 2 ಘ 3 If you removed your reservoir and are replacing it, go to the REWIND screen.
ಘ 1 If you are using the pump for the first time, remove the red shipping cap from the reservoir compartment. 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.
Manual prime Manual prime fills the infusion set tubing with insulin before you insert the set into the body. 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. ಘ 1 ಘ 2 ಘ 3 ಘ 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.
Quick-set infusion set (with Quick-serter®) Always refer to the instructions that shipped with your infusion set.
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. ಘ 1 Go to the PRIME MENU screen. ಘ 2 ಘ 3 ಘ 4 Main > Prime Select Fixed Prime and press ACT. In the FIXED PRIME screen, enter the insulin amount for your infusion set type, then 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. ಘ 1 ಘ 2 ಘ 3 Hold the side grips of the connector part with your fingers. Twist the connector counter-clockwise. Remove the connector from the site. 1 2 3 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.
Record keeping for diabetes management Now that you are using the pump, we will be asking you to test your blood glucose regularly. It is important to test often and write down your blood glucose readings, the food you eat, any exercise you perform and any other notes to explain your blood glucose results. You must test at the recommended times and any other time that you feel your blood glucose is high or low.
After you and your healthcare professional are satisfied with your initial pump settings, you may begin to experiment with different food choices, meal times and exercise schedules.
72 Starting on insulin
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 a high blood glucose. To use this feature, you need the following information: Carbohydrate counting You need to know which foods contain carbohydrates and how to count these. Your blood glucose reading You need to know your blood glucose (BG) 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 this chapter.
Bolus Wizard feature settings Information Setting 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: Your insulin sensitivity may vary throughout the day. #3: __________ (additional settings, if needed) Your pump allows you to program up to eight different insulin sensitivities.
Bolus Wizard feature settings Information Active insulin time: The Bolus Wizard feature uses this time to calculate the active insulin in your system (see the About active insulin section in this chapter). Use your healthcare professional's recommendation for the active insulin time that best represents the insulin type you use and your physiological insulin absorption rate.
MAX BOLUS EXCEEDED Bolus Wizard feature will not deliver more than the limit set for your maximum bolus. If the Bolus Wizard feature calculates a bolus amount that is larger than your max bolus limit setting, the message, MAX BOLUS EXCEEDED will appear. If this happens, do these steps: ಘ 1 ಘ 2 ಘ 3 ಘ 4 ಘ 5 In the MAX BOLUS EXCEEDED screen, press ACT to continue your bolus programming. The EST : MAX screen appears with the estimated and maximum bolus amounts. Continue to the next step.
Selecting the Carb units The carb unit setting lets the pump know which way to count your carbohydrates (grams or exchanges). Any time you make changes to the carb units, you must also reprogram the carb ratios. Refer to the Bolus Wizard feature settings table in this chapter for your carb ratio settings. ಘ 1 Make sure the EDIT SETTINGS screen is open. ಘ 2 ಘ 3 ಘ 4 Main > Bolus > Bolus Wizard Setup > Edit Settings Select Carb Units, then press ACT. The CARB UNITS screen appears.
ಘ5 ಘ6 ಘ7 ಘ8 ಘ9 ಘ 10 The SET START TIME 2 screen appears. The dashes under the screen name flash. The first Carb Ratio or Exchange Ratio is now set. If you do not need a second ratio, press ESC and skip to the next section. If you need to set up another ratio, follow steps 6 through 9. In the SET START TIME 2 screen, enter the time of the day you want this ratio to become active. Press ACT. The SET CARB RATIO 2 screen (if using grams) or SET EXCH RATIO 2 screen (if using exchanges) appears.
Insulin sensitivity values are normally between 20 - 100 mg/dL (1.1 - 5.6 mmol/L). If your value is outside this range, a warning message will appear on the screen. ಘ1 ಘ2 ಘ3 ಘ4 ಘ5 ಘ6 ಘ7 ಘ8 ಘ9 ಘ 10 80 Make sure the EDIT SETTINGS screen is open. Main > Bolus > Bolus Wizard Setup > Edit Settings Select Sensitivity, then press ACT. The INS SENSITIVITY 1 screen appears. The default sensitivity value flashes on the screen. Set the value for your first insulin sensitivity setting, then press ACT.
The BG Target setting allows you to set glucose targets. The Bolus Wizard will use these targets to calculate a correction dose. Because the 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.
ಘ7 ಘ8 ಘ9 ಘ 10 ಘ 11 ಘ 12 In the SET START TIME 2 screen enter the time of the day you want this BG Target range to become active. Press ACT. The TARGET RANGE 2 screen appears. The low end of your BG Target range flashes on the screen. Set the BG Target, then press ACT. The high end of your BG Target range flashes on the screen. Enter the BG Target, then press ACT. The SET START TIME 3 screen appears. The second BG Target range is now set. 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. ಗ To set the Active insulin time, do the following steps: ಘ 1 ಘ 2 ಘ 3 ಘ 4 ಘ 5 Make sure the EDIT SETTINGS screen is open. Main > Bolus > Bolus Wizard Setup > Edit Settings Select Active Ins Time, then press ACT.
Meter option Paradigm Link™ and OneTouch® UltraLink™ glucose meters can be programmed to communicate wirelessly to the Paradigm® insulin pump. When the wireless feature is turned on, glucose values transmitted from these meters to the pump are stored in memory and used for glucose sensor calibration. BG readings Your monitor is set at the factory with the meter option turned off. If you have turned your meter option on, you should turn off the wireless feature when using your glucose sensor.
Meter rules ಗ If you want your pump to communicate with the meter, the following conditions must apply: ಘ 1 ಘ 2 ಘ 3 ಘ 4 ಘ 5 The meter option must be turned on and programmed. Refer to the instructions in this section. Your pump must be within 4 feet (1.2 meters) of your meter to receive the blood glucose reading. The pump cannot have a LOW BATTERY alert condition. When programming a bolus, the blood glucose measurement from the meter will appear as the default blood glucose value on the ENTER BG screen.
ಘ 4 a. Select Delete ID, then press ACT. b. Select the meter ID that you want to delete and press ACT. c. The selected ID is now deleted. Reviewing meter IDs a. Select Review ID, then press ACT. b. The programmed IDs will show in the REVIEW METER ID screen. Exit the menus when you are done. Normal bolus using Bolus Wizard feature After the Bolus Wizard feature is turned on and programmed, this feature can calculate an estimate of insulin you need for your correction bolus and/or your food bolus.
ಘ 4 ಘ 5 ಘ 6 Your pump checks if the entered BG is within your target range. Press ACT to accept the Blood glucose value. You can change this blood glucose value, if necessary, then press ACT. Continue to step 4. The ENTER FOOD screen appears. a. If this is a food bolus, enter the food value you will eat, then press ACT. b. If this is a correction bolus, select 0 (zero) as the value, then press ACT. The ESTIMATE DETAILS screen appears. Review the information on this screen.
Example 1: Blood glucose on target (normal blood glucose) and no active insulin Michael awakens in the morning before school and his mother has breakfast waiting for him. Before he begins eating, he tests his blood glucose with his meter and his blood glucose result of 6.6 mmol/L (120 mg/dL) is automatically sent to his pump. He estimates that his meal consists of 60 grams of carbohydrates. When prompted by the Bolus Wizard feature, he enters this amount in the ENTER FOOD screen.
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 3: Blood glucose below target (low blood glucose) and no active insulin On another morning, Michael sits down before eating the same breakfast. He tests his blood glucose with his meter and finds it to be at 70 mg/dL (3.9 mmol/L), which is below his Low BG Target of v (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.
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 to be 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 to be 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.
ಘ 4 For a. b. c. For a. b. c. ಘ 5 ಘ 6 a Square Wave bolus, do these steps: Select Square Wave Bolus, then press ACT. The SET SQUARE BOLUS screen appears. Enter the desired amount for the Square Wave bolus units, then press ACT. Continue to step 5. a Dual Wave bolus, do these steps: Select Dual Wave Bolus, then press ACT. The SET DUAL BOLUS TOTAL screen appears. Enter the desired amount for the total dual bolus units. This amount is the total of Normal and Square Wave bolus units. Press ACT.
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 (hot dogs, pizza, cheese enchiladas). Determine your meal bolus amount. Set the Square Wave bolus to deliver the determined amount of insulin over two hours. (This duration time is an example.
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.
If you want to use the pump-to-meter link, make sure the meter option is on. Refer to the Meter option section in the Using the Bolus Wizard feature chapter for instructions. ಘ 1 Go to the ENTER BG screen. Press ಘ 2 ಘ 3 ಘ 4 ಘ 5 ಘ 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.
ಘ 7 ಘ 8 The SQUARE DURATION screen appears. Enter the amount of time you want the Square Wave bolus to last, then press ACT. If you have BG Reminder turned On, the BG REMINDER DURATION screen displays. It allows you to set the duration before you are reminded to check your blood glucose after a bolus. 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 or vibrates at the start of the 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.
ಘ 3 When your total bolus amount appears on the SET EASY BOLUS screen, press ACT. Listen/feel to count the steps without looking at the screen. 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 four 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.
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 ________.
Turning on the patterns Your pump is set at the factory with the basal patterns feature turned off. After you turn on patterns, you still have to program and select a pattern (A or B), as described in the next sections, before the patterns feature is active. If you turn off the patterns feature, your pump will automatically select your standard basal pattern. ಘ 1 Go to the PATTERNS OPTION screen. ಘ 2 Main > Basal > Patterns Select On, then press ACT. The patterns feature is now on. Exit the menus.
ಘ9 If you do not need to set up any more basal rates, press ESC. If you need to set up more basal rates, repeat steps 5 through 8 above for each rate. ಘ After you press ESC, the BASAL RATE screen appears. The screen will show: 10 • the current basal pattern and basal rate, • time it started, and • the 24-hour basal total. After you make changes to a pattern, the pump will use that pattern as the current basal. Make sure the basal you want is selected in the SELECT PATTERN screen.
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 temp basal amount is rounded down to the next 0.025 or 0.05 U/H increment based on the basal rate. The maximum percent limit is based on the largest basal rate segment with your programmed temp basal rate time. For example: It is 06:00 a.m. and your current basal rate is 1.50 U/H.
NOTE: The pump delivers basal amounts in 0.05 U/H increments. Because of this, your temp basal amount will be rounded down to the next 0.05 U/H increment. ಘ 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.
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: ಘ 1 ಘ 2 ಘ 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 MENU screen. The temp basal type is now set. Exit the menus.
Verifying temp basal delivery Temp Basal of 0.6 units per hour is now active Temp Basal delivery will last 30 minutes 4 minutes remaining before Temp Basal delivery is finished Press down button to scroll Regular programmed basal rate will resume after the Temp Basal delivery is finished 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.
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.
8 The optional sensor and transmitter can provide continuous glucose measurements to help you control your glucose levels better. The sensor measures the glucose levels in the fluid under your skin. The transmitter receives this measurement from the sensor and sends it wirelessly to the pump. To take advantage of your pump sensor features, call 800-646-4633, +1-818-362-5958 (outside U.S.), or visit our web site at www.medtronicdiabetes.com to purchase your sensor and transmitter.
Selecting the BG units You must select the blood glucose units (BG Units) for the system (either mmol/L or mg/dL). All BG measurements will show in the BG unit type you select. If you have turned on your Bolus Wizard feature, BG units will not be available for sensor setup. Please go to the Setting the BG units section of the Using the Bolus Wizard feature chapter for details. ಘ 1 ಘ 2 ಘ 3 ಘ 4 Make sure the EDIT SETTINGS screen is open.
Example ಗ To set up your High Snooze: ಘ 2 ಘ 3 ಘ 4 Make sure the EDIT SETTINGS screen is open. 8 ಘ 1 ಘChapter You set your High Snooze to 15 minutes. You receive an alert at 1:00 pm and immediately clear it. However, the high glucose condition that caused the alert still exists, so you will receive a second alert at 1:15 pm, 15 minutes after you cleared the first alert.
Setting the Low Snooze After you receive and clear a Low Glucose alert, it will repeat until the low glucose condition is resolved. The Low Snooze feature allows you to set how frequently you want the Low Glucose alert to repeat after you clear it the first time. The Low Snooze feature works similar to the High Snooze. See the Setting the High Snooze section in this chapter for an example. ಘ 1 ಘ 2 ಘ 3 ಘ 4 Make sure the EDIT SETTINGS screen is open.
Setting the Cal Reminder The Cal Reminder feature allows you to set a reminder to calibrate your system. For example, if you set your reminder to four hours, then you will receive a METER BG BY alert (Cal Reminder) four hours before the next meter blood glucose (BG) entry is due (eight hours after your last successful sensor calibration). To set up the Cal Reminder: ಘ 1 ಘ 3 ಘ 4 ಘ 5 Main > Sensor > Sensor Setup > Edit Settings Select Cal Reminder, then press ACT. The CAL REMINDER screen shows On.
ಘ 6 ಘ 7 Repeat step 5 until all seven digits of the Transmitter ID have been selected. A message shows that the Transmitter ID has been changed. After about 30 seconds, the EDIT SETTINGS screen appears. It shows the Transmitter ID you entered. You are now ready to set up the Missed Data. Setting up the Missed Data feature The Missed Data feature allows you to determine how quickly you will receive a WEAK SIGNAL alert when there is no communication between the transmitter and the pump.
The transmitter The Medtronic MiniLink Transmitter (MMT-7703) is a device that takes electronic signals generated by the glucose sensor and sends them by radio frequency to the pump. It has a tester (MMT-7706) and a charger (MMT-7705). ಘChapter 8 MiniLink Transmitter MiniLink Tester MiniLink Charger Transmitter charger The transmitter contains a non-replaceable, rechargeable battery that you can recharge as needed with the charger.
Charging the transmitter Before using the transmitter for the first time, you must fully charge the transmitter battery, which may take up to eight hours. It is recommended to recharge the transmitter after each sensor use. If you choose to recharge the transmitter after each sensor use, the charging time will be less than 20 minutes. A fully charged transmitter battery will work more than 14 days without recharging. After 14 days of use, the transmitter will fully recharge in less than two hours.
When charging is complete, the green light on the charger will stay on, without flashing, for 15 to 20 seconds and then turn off. ಘ 5 After the green charger light turns off, disconnect the transmitter from the charger. The green light on the transmitter will flash for approximately five seconds and then turn off. ಘ 6 ಘ 7 If the green light on the transmitter does not flash, reconnect it to the charger for at least one minute.
WARNING: The sensor may create special needs regarding your medical conditions or medications. Please discuss these conditions and medications with your doctor before using the sensor. Bleeding, swelling, irritation and/or infections at the insertion site are possible risks associated with inserting the sensor and may result from improper insertion and maintenance of insertion site. Choose a site with an adequate fatty layer for sensor insertion.
ಘ6 Place your fingers on the back of the white tape and push the carrier down until it clicks into place. 4 5 6 ಘChapter 8 ಘ7 Turn the white button to lock the Sen-serter. Remove the needle guard from the introducer needle. Rest the Sen-serter legs flat on your skin so the Sen-serter is at a 45-degree angle or greater to the insertion site. Bleeding can occur if you insert the sensor at an angle less than 45 degrees.
ಘ Hold the sensor with two fingers on the base, and gently remove the introducer needle. Do NOT rotate 13 the introducer needle when removing. Dispose of the needle in sharps container. 11 ಘ 14 12 13 Wait five minutes after insertion before connecting the transmitter to the sensor to make sure the sensor is ready to communicate. Make sure that the site is not bleeding before connection. If bleeding occurs, apply pressure using a sterile gauze or clean cloth for three minutes. a.
Connecting the transmitter to the sensor ಘ 1 8 ಘ 2 After the sensor is inserted, wait five minutes before connecting the transmitter. Check for bleeding. Make sure that any bleeding has stopped, then connect the transmitter to the sensor. Touch the inserted sensor at back of assembly to prevent movement.
Preparing the sensor for communication You are now ready to use your pump to start communicating with the sensor and start sensor initialization. The pump will start a timer and notify you when the sensor is ready to use. ಗ Use your pump to follow the steps below: ಘ 1 ಘ 2 ಘ 3 ಘ 4 ಘ 5 Go to the SENSOR START MENU. Main > Sensor > Sensor Start Select New Sensor. Press ACT. Connect the transmitter to your sensor now if you have not already done so. If the screen times out, do not disconnect the sensor.
Entering meter BG Sensor calibration will be successful only if the BG entry is in the range of 40-400 mg/dL (or 2.2 to 22 mmol/L). You should calibrate three to four times spread throughout the day for optimal results. Use one of these ways for all the calibrations throughout the sensor's life, including the first calibration after the initialization. a. To enter a meter BG value manually, follow this path: 8 Main > Sensor > Enter Meter BG ಘChapter ಘ 1 b.
128 Sensor features
Using your sensor Status screens ಗ ಘ 1 9 To get to your status screens: ಘChapter Your STATUS screens tell you what is going on in your pump. In the SENSOR STATUS screen you can check the status of sensor information including when your next calibration will be needed, your sensor's age, and the state of your transmitter battery. From the HOME screen, press the ESC button twice. This takes you to your pump status screen. 5:07 PM ಘ ಘ 2 To see the Sensor Status screen, press ESC one more time.
Reading the sensor glucose graphs Your pump shows an updated, real-time glucose measurement. This measurement is generated by data sent from the sensor to the transmitter, and then to the pump every five minutes. The pump converts these measurements to glucose graphs that include the following information: • • • The most recent sensor glucose measurement or the reason that one is not displayed.
Opening and viewing the graphs The following table describes how to use the graphs. Do the following: If you want to: View information in a graph If there is no SG measurement at the time you select, the reason for the missing measurement will be shown on the right side of the graph (for example, LOST SENSOR). • When you open the graphs, the cursor (flashing vertical line) is always on the right edge of the graph and the graph shows the most recent SG measurement.
The graphs All graphs show High and Low Glucose lines, a real-time SG measurement line, a data section, and the cursor (flashing vertical line). When you open any graph, the cursor flashes on the right edge of the graph. The data section shows the most recent SG measurement or the reason why no measurement shows, and the time in the data section matches the time at the top of the screen. Sensor glucose data points. High Glucose Limit Line at 191 mg/dL (10.6 mmol/L) Low Glucose Limit Line at 58 mg/dL (3.
When you move the cursor left to select an earlier SG measurement, the data section of the graph turns black, the word History appears here, and the time in the data section changes to show the time when the SG measurement was taken or the reason why no SG measurement shows for that time. PM 2:20P History LOST SENSOR alert for every one. Therefore, your system’s alarm/alert history may not match the number of times your graphs do not show an SG measurement.
24-hour graph Each part of the graph between the vertical dashed lines represents 12 hours. The shaded area helps you more easily see the sensor glucose measurements for the previous night. In this example, the selected SG measurement was taken at 11:50 A.M. and the measurement at that time was 211.
The arrow direction shows if your SG measurements are rising or falling. The number of arrows (one or two) shows how rapidly your SG is changing. • One up arrow shows that your SG has been rising at a rate of 3:16P 3 Hour 1 to 2 mg/dL (0.05 to 0.11 mmol/L) per minute. 240 ಘ One down arrow shows that your SG has been falling at a rate 131 9 3:11P 3 Hour of 1 to 2 mg/dL (0.05 to 0.11 mmol/L) per minute.
Calibration history The SENSOR UPDATE HISTORY screen lists the successful sensor calibration BG values that were entered into the pump more than 15 minutes ago. ಗ To view your Sensor Update History: ಘ 1 Go to the SENSOR UPDATE HISTORY screen. ಘ 2 Main > Sensor > Sensor Update Hist. The SENSOR UPDATE HISTORY screen appears. It shows up to 28 calibration values. Sensor alarm history The SENSOR ALARM HISTORY screen lists all of the sensor alerts that have occurred, displaying up to 36 alerts.
Disconnecting the transmitter and removing the sensor Disconnecting the sensor from the transmitter If you are not going to replace the sensor, turn the Sensor features Off to avoid getting a LOST SENSOR alert. ಘChapter 9 ಘ 1 ಘ 2 Hold the transmitter as shown, and pinch the flexible side arms of the sensor between your thumb and forefinger. Gently pull the transmitter away from the sensor assembly.
Using your system in water Your pump must not be used in water and needs to be removed if planning water activities. ಗ You should shower, bathe and swim with the transmitter and the sensor by following the guidelines below: ಘ 1 ಘ 2 ಘ 3 ಘ 4 138 Disconnect the infusion set from the pump and remove the pump. The pump is not water-tight. After the transmitter and sensor are connected, they form a water-tight seal to a depth of 8 feet (2.4 meters) for up to 30 minutes.
Utilities Alarm review You can review alarms and their details in the ALARM HISTORY screen. This screen shows up to 36 past alarms, errors, or LOW RESERVOIR and LOW BATTERY alerts. ಘ 1 ಘ 4 10 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. Press ESC to return to the ALARM HISTORY 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 number of hours that you usually sleep at night. Discuss what uses and settings are best for you with your healthcare professional.
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 displays a LOW RESERVOIR alert 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 displays a LOW RESERVOIR alert 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.
ಘ 4 The INSULIN screen displays. This screen shows: • total insulin delivered for the day • total Basal and Bolus insulin delivered for the day • total percentage of each (Basal and Bolus) delivered for the day • total carbohydrates entered into the pump for the day (entered using the Bolus Wizard feature) Press ಘ 5 The BOLUS screen displays.
ಘ 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 ಘ 4 The • • • SEN AVG 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. Personal reminders Alarm clock Go to the ALARM OPTION screen. ಘ 2 ಘ 3 ಘ 4 ಘ 5 ಘ 6 Main > Utilities > Alarm Clock Select On/Set. Press ACT. Select Add Alarm. Press ACT. Enter the hour (flashing). Press ACT.
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.
Block feature 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. Direct pump programming is limited to suspend, block, and selftest. You can, however, still view status-type screens such as STATUS, BOLUS HISTORY, BASAL REVIEW, and DAILY TOTALS.
Lock keypad feature Lock keypad prevents accidental pump keypad presses. You can only press the and the to view the STATUS screen, button to turn on the backlight. The remote control can be used to give a bolus or put the pump into Suspend. A locked keypad is automatically unlocked during the following: • • • Battery insertion Alarms Alerts Locking the keypad ಘ 1 ಘ 2 ಘ 3 Go to the UTILITIES MENU. Select Lock Keypad, then press ACT. Press ACT again to lock the keypad.
ಘ 3 ಘ 4 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. Selftest: The pump will count down from 10. c. Tone Test: You should hear beeps. d. Vibrate Test: You will feel vibrations. After the selftest is finished, TEST COMPLETE screen appears. The screen will return to the UTILITIES MENU, then to the HOME screen.
Saving the settings ಗ Do these steps to save your current pump settings: ಘ 1 Go to the UTILITIES MENU screen and select User Settings. ಘ 2 Main > Utilities > User Settings Hold down and press ACT. ಘ 3 ಘ 4 ಘ 5 The USER SETTINGS screen is displayed with Save Settings highlighted. Press ACT. If this is the first time you have saved pump settings, go to step 5. If you have previously saved pump settings, a message displays, indicating the date of your last pump settings save.
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. 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.
152 Utilities
Therapy software Medtronic provides software to optimize your pump use. Contact your local representative for more information. CareLink™ Personal Software 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 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 • • • • • • • • 156 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 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. NOTE: It is recommended that you read your warranty statement included with your pump for information on what is covered during your warranty period.
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: ಘ 1 ಘ 2 ಘ 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 you first get your pump.
The pump is asking me to rewind This is normal after any of the following: ಘ 1 ಘ 2 ಘ 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.
ಘ 7 ಘ 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. ಘ 1 ಘ 2 ಘ 3 ಘ 4 ಘ 5 ಘ 6 Check that all connections are still tightly in place. Check the LCD, keypad and pump case for cracks or damage.
Alerts 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. The pump goes into Special mode (an open circle displays), and the backlight illuminates.
ಘ 3 ಘ 4 If the condition is due to a low battery, replace the battery. If the condition is due to a low reservoir, monitor the reservoir volume frequently and change the reservoir when appropriate. Make sure you have a new reservoir, infusion set and vial of insulin with you. Pump alert conditions Listed below are alerts that indicate a condition that is outside normal pump activity.
LOST SENSOR Reason: The pump has not received a signal from the transmitter. Do not disconnect the transmitter from the sensor. Action: ಘ 1 ಘ 2 ಘ 3 ಘ 4 Make sure that the sensor is inserted correctly. Check the REVIEW SETTINGS screen to make sure that the transmitter ID entered into the pump matches the ID on your transmitter: Main > Sensor > Sensor Setup > Review Settings Check the transmitter and sensor connection.
BAD TRANSMTR Reason: The transmitter battery is depleted. Action: Recharge your transmitter immediately. See the Charging the transmitter section in the Sensor features chapter. BAD SENSOR Reason: You may receive this alert after you receive two Cal Errors in a row, without the Cal Errors, or when initializing your sensor. Action: If the alert resulted from two Cal Errors in a row, replace the sensor.
METER BG NOW Reason: A meter BG measurement is needed immediately to calibrate your sensor so that you can continue receiving sensor glucose readings. Action: Take and enter a meter blood glucose measurement. Follow the guidelines in the Calibrating the sensor section in the Sensor features chapter. METER BG BY Reason: A meter BG measurement must be entered by the time that is shown to calibrate your sensor. The METER BG BY alert is also known as the CAL REMINDER alert.
Alarms Your pump has a sophisticated network of safety checks and systems. If the safety network detects anything unusual, your pump notifies you of conditions that require your immediate attention. The backlight illuminates the pump screen and the alarm message displays on the screen. It is important that you understand how your pump behaves when you do not clear an alarm or an alert. See the Alerts section if this chapter for an explanation and an example. Check your pump and test your blood sugar.
Alarm conditions Alarms put the pump in Attention mode. A (ALARM) This alarm shows a 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 the 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. BATT OUT LIMIT Occurs if the battery has been out of the pump for more than five minutes.
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. If the battery does not have enough voltage, this alarm will occur. The pump will not function and the battery must be replaced. (Always make sure that you install a NEW battery into the pump.
RESET The Reset alarm triggers when pump settings are cleared because of one of these reasons: • • Pump settings were cleared (Clear Settings function) and settings have not been reprogrammed. A download attempt from the PC is incomplete. (The download function is applicable to the optional software feature. Refer to the software user guide for more information.) WEAK BATTERY The pump tests the voltage of each battery installed. If the battery voltage is less than full strength, this alarm may occur.
ಘ 3 Within 20 seconds, the green light on the transmitter will flash for about 10 seconds when properly connected. The Sensor feature must be turned On on your pump. Go to the RECONNECT OLD SENSOR screen to start your sensor. Main > Sensor > Sensor Start > Reconnect Old Sensor You should see the sensor icon ಘ 4 on the pump screen, which means that the transmitter and the sensor are communicating. Within the next seven to eight minutes, go to the SENSOR STATUS screen to look for the Sensor ISIG value: a.
Troubleshooting sensor features Reconnect old sensor You should only use this feature if you have disconnected the sensor from the transmitter and have to reconnect them (for example, when flying on an aircraft). ಗ To Reconnect old sensor: ಘ 1 Go to the RECONNECT OLD SENSOR screen. ಘ 2 ಘ 3 Main > Sensor > Sensor Start > Reconnect Old Sensor Press ACT in the RECONNECT OLD SENSOR screen. The SENSOR READY 2 HRS screen appears. Press any button to continue.
Understanding your transmitter, tester, and charger The charger has a green light that shows the charging status and a red light that communicates any problems during charging. See the following graphic for the location of these lights: green light red light Question: Why did the flashing green charger light turn off and a longer flashing red charger light turn on during charging? about 2 secs about 2 secs about 2 secs ಘ Answer: The transmitter battery is very low.
pattern for very low transmitter battery, leave the transmitter on the charger for eight hours to recharge. If the red light is still flashing after eight hours, call our 24 Hour HelpLine. It may be time to replace your transmitter. Question: I had my transmitter on the charger for a day. Will this damage my transmitter? Answer: It will not damage the transmitter. You cannot overcharge it.
Maintenance It is recommended that you read your warranty statement included in the Pumps specifications chapter 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.
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 ಘ 1 ಘ 2 ಘ 3 ಘ 4 ಘ 5 ಘ 6 ಘ 7 ಘ 8 ಘ 9 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.
Cleaning the Sen-serter ಘ 1 ಘ 2 ಘ 3 ಘ 4 ಘ 5 ಘ 6 Wash your hands thoroughly. Dampen a clean cloth with mild liquid soap and warm water. Wipe the Sen-serter. Rinse with warm tap water. Using an antibacterial hand sanitizer (readily available at your local drugstore), wipe down the Senserter. Place the Sen-serter on a clean dry cloth and allow to air dry. Store Sen-serter in the released position to maintain optimum product performance and life.
178 Maintenance
15 This section provides detailed information on specifications related to your pump. The safety features of your pump are individually listed and described. ಘChapter Pump specifications 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.
Basal • • • • Rate increments: 0.05 units/hour Delivery: 0.05 - 35 units/hour (maximum units: 35/hour) 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 • • • • Insulin delivered/stroke: 0.05 u Fluid delivered/stroke: 0.
Carb ratios 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 • • 15 The food entry when using Bolus Wizard feature: ಘChapter Maximum ratio settings 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. The delivery accuracy test was done using the Sof-Set® Ultimate infusion set (MMT–315). Delivery Volume Accuracy Curve (-0.37%) Overall Error (MMT-522 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. ಘChapter Dual Wave bolus Delivers a Normal bolus followed by a Square Wave bolus (limited by maximum bolus). 15 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 @ half of the remaining amount 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 The pump is powered by a standard 1.5 V AAA alkaline battery, size E92, type LR03 (Energizer brand recommended). 15 Prime function • • • ಘChapter Power supply 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.
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. 522/522K Pump volume: up to 176 units of U100 insulin 722/722K Pump volume: up to 300 units of U100 insulin Square Wave bolus Delivers bolus insulin over a duration of 30 minutes up to eight hours (limited by the Max bolus setting).
What Basal pattern information (if active) Pattern A or B Battery Status (always appears) Normal, Low, Off BG meter value (most recent BG value received) (appears if BG meter is enabled) XXX mg/dL time and date received BG Reminder* (Only if enabled) Time remaining before BG Reminder is set to go off H:MM h (if less than 1 hour, 0:XXh where XX is minutes remaining) Block (if active) Current date (always appears) Current temp basal information (if active) rate (units per hour), duration, ti
Bolus Wizard feature specifications There are three different formulas the Bolus Wizard feature uses to estimate a bolus, depending on your current BG. The following formulas apply only when the carb units are in grams. ಘ 1 If your current BG is greater than your High BG Target, the Bolus Wizard feature subtracts active insulin from the BG correction estimate, then adds this to the food estimate to get the total bolus estimate.
ಘ 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) food (grams) carb ratio If you do not enter a BG, the total bolus estimate is based only on the food estimate. 15 ಘ 4 ಘChapter total bolus 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. Active Insulin Curves • Active Insulin Curve 100% 90% 8 Hour 80% 7 Hour 6 Hour 5 Hour 70% 4 Hour % Insulin Remaining 3 Hour 2 Hour 60% 50% 40% 30% 20% 10% 0% 0 1 2 3 4 5 6 7 8 9 Time (hours) Graph adapted from Mudaliar and colleagues, Diabetes Care, Volume 22, Number 9, Sept. 1999, page 1501.
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. ಘChapter • • • • 15 (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) 60 g 30 g/u (correction estimate) + = 2 units bolus estimate 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 #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) = 2 units + = 1.5 units (active insulin) = 0.5 units 200 mg/dL - 120 mg/dL 40 mg/dL/u = 1.5 units (active insulin) = 0.5 units 15 11.1 mmol/L - 6.7 mmol/L 2.2 mmol/L/u ಘChapter 60 g 30 g/u (correction estimate) = 2 + 0.5 bolus estimate = 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 12-hour Off Alarm clock: Off Remote option: Off Meter option: Off User Settings: (no defaults) 15 Block: Language: Increments ಘChapter (Time/Date) Time format: Limits English Pump specifications 195
Bolus Wizard feature default settings 196 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 1 - 200 g/u or 0.075 - 15.0 u/exch 1 g/u or 0.1 u/exch1 g/u 5 - 50 g/u or 0.3 - 3.0 u/exch (insulin) sensitivity: 2.8 mmol/L or 50 mg/dL 10 - 400 mg/dL or 0.5 - 22.2 mmol/L 1 mg/dL or 0.1 mmol/L 20 - 100 mg/dL or 1.1 - 5.6 mmol/L BG Target: 5.6–5.6 mmol/L or 100–100 mg/dL 60 - 250 mg/dL or 3.3 - 13.
Sensor features default settings Feature Options Default Setting Limits, Range of Values On Off Off None High Glucose Alert • • On Off Off Low–22.2 mmol/L (Low–400 mg/dL)a Low Glucose Alert • • On Off Off 2.
Guidance and manufacturer's declaration Guidance and Manufacturer's Declaration - Electromagnetic Emissions The Paradigm 522/722/522K/722K pump system (consisting of the MMT-522/722/522K/722K pump and MMT-7703 transmitter) is intended for use in the electromagnetic environment specified below. The customer or the user of the Paradigm 522/722/522K/722K pump system should make sure that it is used in such an environment.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity Immunity Test Not applicable ±8 kV air IEC 61000-4-2 Compliance Level Electromagnetic Environment - Guidance ±30 kV air (<5% relative humidity) The Paradigm 522/722/522K/722K pump system should not be affected by electrostatic discharge that might occur under normal conditions of use.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity The Paradigm 522/722/522K/722K pump system (consisting of the MMT-522/722/522K/722K pump and MMT-7703 transmitter) is intended for use in the electromagnetic environment specified below. The customer or the user of the Paradigm 522/722/522K/722K pump system should make sure that it is used in such an environment.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity The Paradigm 522/522K/722/722K pump system is intended for use in the electromagnetic environment specified below. The customer or user of the Paradigm 522/522K/722/722K pump system should make sure that it is used in such an environment.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity The Paradigm 522/522K/722/722K pump system is intended for use in the electromagnetic environment specified below. The customer or user of the Paradigm 522/522K/722/722K pump system should make sure that it is used in such an environment.
Recommended separation distances between portable and mobile RF communications equipment and the Paradigm 522/722/522K/722K pump system ಘChapter 15 This section provides information on the recommended separation distance between portable and mobile RF communications equipment and the Paradigm 522/722/522K/722K pump. The Paradigm 522/722/522K/722K pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Icon table Do not reuse Attention: See Instructions for Use Manufacturer Date of manufacture (year - month) Batch code Use by (year - month) 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.
Signifies compliance with Industry Canada EMC and Radio communications requirements ಘChapter 15 Pump specifications 205
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.
Sensor accuracy NOTE: You should review the information in this section with your healthcare professional. ಘ ಘAppendix A The Medtronic MiniMed Paradigm 522/522K/722/722K pumps use a glucose sensor to continuously monitor your glucose levels. The 522/522K/722/722K pumps use the same algorithm as the Guardian RT ®. The Guardian RT was evaluated in two clinical studies and the following information in this section describes the findings.
Performance results in adults The performance of the Guardian RT in adults was evaluated in a clinical study. Guardian RT results were compared to plasma glucose values from a reference method, the YSI 2300 STAT Plus™ glucose analyzer (referred to as YSI). Sixteen subjects with Type I diabetes participated in a single-site in-clinic study. Subjects ranged in age from 18 to 65 years old. Each subject wore two Guardian RT systems simultaneously. One Guardian system was calibrated an average of 3.
Accuracy of Guardian RT readings In this study, YSI measurements (taken every half hour) were paired with the corresponding Guardian RT reading (taken every five minutes). Pairing was done by selecting the Guardian RT value closest in time to the YSI test result. Agreement was analyzed by comparing paired glucose measurements. 3941 Mean Absolute Percent Difference (± SD) 19.7 ± 18.
The Clarke Error Grid was used to assess the clinical relevance of the differences between the Guardian RT readings and the comparative YSI measurements. The Clarke Error Grid divides a correlation plot into 5 zones. See following table. Results in zones A and B are considered clinically acceptable, while results in zones C, D, and E are potentially dangerous and, therefore, clinically significant errors. The Clarke Error Grid zones are labeled on the correlation plot.
The plot below is a correlation plot of Guardian RT readings versus readings from the reference method, the YSI 2300 Glucose Analyzer. It is overlaid with the Clarke Error Grid. The total number of paired data points is 3941.
The percent of Guardian RT readings in the previous graph are presented in the following table according to the percentage of points falling within each zone (A-E). Results are further broken down (stratified) according to the range of glucose concentrations. Glucose Range (mg/dl) Number and (%) of Data Points Evaluated 40-80 A+B A 356 (9) 271 (76.1) 214 (60.1) 81-120 769 (20) 768 (99.9) 121-240 2362 (60) >240 Overall B C D E 57 (16.0) 2 (0.6) 80 (22.5) 3 (0.8) 463 (60.2) 305 (39.
Precision of Guardian RT readings This study was also designed to look at the reproducibility of two sensors worn simultaneously at different locations on the body. Precision was estimated by comparing the glucose readings from the two Guardian RT systems. In this study 11,475 paired sensor Guardian RT values were obtained. On average, they were different by 17.2 percent. The following figure is an example of how data was paired in this study. In the graph there are two tracings of Guardian RT values.
Low and High Alerts in adults The ability of the Guardian RT to detect high and low glucose levels was measured in the same clinical study. Since it is important to set the alert levels in a conservative fashion, the Low Glucose Alert should be set at a value slightly higher than the value of blood glucose you want to detect, and the High Glucose Alert should be set at a value slightly lower than the value of blood glucose you want to detect.
Increasing the Low Alert settings will improve the ability to detect low blood glucose events, but it will also increase the frequency of Guardian RT false alerts for blood glucose levels not below the target value. You should consider this trade-off between the improved ability to detect true low blood glucose versus the increased number of false alerts when setting the low alert threshold.
Guardian RT sensor performance and calibration stability as a function of time The Guardian RT sensor may be worn for up to 3 days (72 hours) and must be calibrated at least twice a day. Two sets of data, approximately equal in number, were collected during the clinical trial. One data set was generated when the frequency of calibrations averaged 3.5 per day (Data Set A), and the other averaged 5 times a day (Data Set B). During the study, a total of 38 sensors were evaluated in 16 individuals.
An analysis of the mean percentage of Absolute Relative Error (ARE percentage) and standard deviations, across 12-hour increments of wear periods, appears in the table below. Both data sets are pooled together in this data. Mean ARE (%) Std. Dev. 0-12 hrs 24.84 20.04 12-24 hrs 19.66 16.17 24-36 hrs 16.43 15.62 36-48 hrs 18.23 19.27 48-60 hrs 16.59 14.25 >60 hrs 22.95 23.51 ಘAppendix Hours From Insertion The median sensor life from Data Sets A and B were 57.5 hours and 72.
The percentage of Guardian RT readings within 20 percent and 30 percent of YSI readings was analyzed according to time after sensor insertion and according to the glucose-concentration range (as determined by the YSI analyzer). See the following table.
Effects of calibration frequency The average bias when Guardian RT was calibrated ~ 3.5 times a day was -20.5 ± 41 mg/dl (LL: -22.40 mg/dl and UL: -18.63 mg/dl). In those calibrated ~ 5 times a day, the bias was -10.2 mg/dl ± 36 mg/dl (LL: -11.74 mg/dl and UL: -8.66 mg/dl).
Time-elapsed plots Glucose Conc (mg/dL) The plot graph below is a representative example of continuous sensor tracing vs. reference blood glucose reading, where sensor showed excellent performance. The open circles (o) on the graph represent the meter calibration readings. The closed circles (•) represent the reference blood glucose readings, and the solid line (—) represents the sensor glucose value.
ಘAppendix Glucose Conc (mg/dL) The plot graph below is a representative example of continuous sensor tracing vs. reference blood glucose reading, where sensor showed average (typical) performance. The open circles (o) on the graph represent the meter calibration readings. The closed circles (•) represent the reference blood glucose readings, and the solid line (—) represents the sensor glucose value.
Glucose Conc (mg/dL) The plot graph below is a representative example of continuous sensor tracing vs. reference blood glucose reading, where sensor showed poor performance. The open circles (o) on the graph represent the meter calibration readings. The closed circles (•) represent the reference blood glucose readings, and the solid line (—) represents the sensor glucose value.
Performance results in children and adolescents The performance of the Guardian RT in Children and Adolescents was evaluated in a clinical study. Guardian RT results were compared to capillary blood glucose measured by a LifeScan OneTouch® Ultra® Meter. Sixty subjects with Type I diabetes participated in a three-site out-patient study. Subjects ranged in age from 7 to 17 years old. Each subject wore a Guardian RT system, which records a sensor glucose value every five minutes.
The accuracy of the Guardian RT was also evaluated by calculating the percentage of Guardian RT readings within 20% and within 30% of the blood glucose meter reading (or within 20 mg/dL (1.1 mmol/L) in the low glucose range). Results are shown in the following table. Plasma Glucose Range (mg/dL) Plasma Glucose Range (mmol/L) Overall Number of Paired Readings Percent Within 20% Percent Within 30% 2599 68% 82% 40-80* 2.2-4.4 360 51% ---- > 80-120 > 4.4-6.7 482 60% 77% > 120-240 > 6.7-13.
The following figure is a correlation plot of Guardian RT readings versus readings from the reference method, the blood glucose meter. It is overlaid with the Clarke Error Grid. The total number of paired data points is 2599. ಘAppendix Sensor BG (mg/dL) A (1733, 66.7%) B (665, 25.6%) C (7, 0.3%) D (193, 7.4%) E (1, 0.0%) A Meter BG (mg/dL) The percent of Guardian RT readings in the above graph are presented in the table below according to the percentage of points falling within each zone (A-E).
Stratified Clarke Error Grid Analysis Range of Comparative Glucose Readings (mg/dL) 226 Total Count A+B A B C D E 40-80 360 (13.9%) 201 (55.8%) 141 (39.2%) 60 (16.7%) 1 (0.3%) 157 (43.6%) 1 (0.3%) 81-120 482 (18.5%) 478 (99.2%) 287 (59.5%) 191 (39.6%) 4 (0.8%) 0 (0%) 0 (0%) 121-240 1055 (40.6%) 1053 (99.8%) 782 (74.1%) 271 (25.7%) 2 (0.2%) 0 (0%) 0 (0%) 240-400 702 (27.0%) 666 (94.9%) 523 (74.5%) 143 (20.4%) 0 (0%) 36 (5.1%) 0 (0%) Overall 2599 (100.0%) 2398 (92.
Low and High Alerts in children and adolescents The ability of the Guardian RT to detect high and low glucose levels was measured in the same clinical study. Since it is important to set the alert levels in a conservative fashion, the Low Glucose Alert should be set at a value slightly higher than the value of blood glucose you want to detect, and the High Glucose Alert should be set at a value slightly lower than the value of blood glucose you want to detect.
Increasing the Low Alert settings will improve the ability to detect low blood glucose events, but it will also increase the frequency of Guardian RT false alerts for blood glucose levels not below the target value. You should consider this trade-off between the improved ability to detect true low blood glucose versus the increased number of false alerts when setting the low alert threshold.
Glossary ಘ A 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. Adverse reaction - An unexpected, unpleasant or dangerous reaction to a sensor when it is inserted into the body. An adverse reaction may be sudden or may develop over time. Alarm - Audible or vibrating (silent) notice that indicates the pump is in Attention mode and immediate attention is required.
Basal rate - The pump setting that provides a continuous infusion of insulin to keep the blood glucose stable between meals and during the night. Basal insulin mimics pancreatic insulin delivery—which meets all the body's non-food related insulin needs. BASAL REVIEW screen - shows the basal rates programmed in the pump, with the 24-hour total for each rate. BG - Blood Glucose BG Reminder - Feature that you can set to remind you to check your blood glucose after a bolus.
low, blood glucose level are elevated, and the body uses fat for energy. This process produces ketones which upset the body's acid-base balance leading to a potentially life threatening situation. DKA - Diabetic Ketoacidosis Dual Wave® bolus - Combination of a Normal bolus that is delivered immediately, then followed by a Square Wave bolus. The Square Wave portion is delivered evenly over a period of time. E Easy bolus™ - Method of delivery for a Normal bolus using the .
Glucagon Emergency Kit - An injectable form of glucagon that can be used to treat severe low blood glucose levels (hypoglycemia). A Glucagon Emergency Kit can be obtained in a pharmacy with a prescription. Glucose tablet - A simple sugar in tablet form, that is taken orally to treat low blood glucose (hypoglycemia). Glucose tablets can be purchased from the Medtronic Diabetes online store at www.medtronicdiabetes.com as well as drug stores and pharmacies.
not enough insulin in the blood. kPa (kilopascal) - A unit of measurement for quantifying force. Used to measure atmospheric pressure. Equivalent to 10,000 dynes per square centimeter. L Link - To turn on and setup the meter option that allows the pump to receive BG readings from a meter that communicates with your pump. Log - A record of measurements, alarms or other actions by your pump. Low Glucose - The pump alerts if the sensor indicates that your sensor glucose measurement is at or below this value.
Nutritional content - The breakdown of nutrients found in a particular food. insertion of the Medtronic Diabetes glucose sensor. Sensitive - Easily irritated (sensitive skin), or able to measure very slight differences (a sensitive instrument). Nutrition label - Used to determine the nutritional content of foods, as well as calories, carbohydrates, fats, proteins, vitamin and mineral content. PSI - Pound-force per square inch. O Pump S/N - Pump S/N is the serial number of the pump currently in use.
condition exists that requires attention. Square Wave® bolus - Immediate bolus delivered evenly over a specified time period (30 minutes to 8 hours). Square Wave portion - (Sq) The second part of a Dual Wave bolus. The Square Wave portion delivers evenly over a period of time after the NOW portion delivers. Status - The condition of a part of your system (battery status, alarm/alert status). Temp - Temporary Temp basal - (Tmp basal) Temporary one-time basal insulin with a specified amount and duration.
236 Glossary
Index ಘ Numerics 3-hour graph 133 24-hour graph 134 A Meter BG By 166 Meter BG Now 166 sensor 163 Sensor End 165 Sensor Error 166 Weak Signal 163 areas inserting infusion set 66 inserting sensor 122 Attention mode 34 auto-off 140 ಘIndex accessories 3 activity guard 4 CareLink USB 3 holster 4 leather case 4 meter 3 pump clip 4 remote control 3 sensor 3 transmitter 3 active insulin 82 Active insulin time setting 83 adverse reactions 9 alarm clock 145 Alarm conditions 168 alarm frequency 179 ALARM HISTORY
battery, pump 175, 185 install 28 removing 158 short life 158 beep/vibrate, alert type 33 BG Reminder 42, 50 BG Targets 81 BG units 79 default settings 197 selecting 114 bleeding 7, 9, 124 Block feature 147 Turn on 147 BLOCK OPTION screen 147 blood glucose checking 126 entering incorrect number 165 rapid change 165 blood glucose units default settings 197 bolus basic 42 details 48 history 47 manual 94 maximum limit 49 stop delivery of 55 bolus delivery Bolus Wizard 86 Easy Bolus 99 bolus delivery, methods f
Missed Data 197 sensor 197 sensor features 197 discarding transmitter 176 disconnecting sensor from transmitter 137 tester from transmitter 171 transmitter from sensor 137 disposing introducer needle 124 downloading pump data 3 Dual Wave bolus programming with Bolus Wizard 97 without Bolus Wizard 94 dual/square option on-off 94 E F filling reservoir 60 FIND LOST SENSOR 172 fixed prime 68 food bolus 42, 74, 76, 86, 87 food entry 74, 86 food label 22 frequency alarm 179 alert 179 G graphs 132 differentiati
L Language setting 41 list calibration values 136 sensor alert 136 Lock keypad feature 148 Lost Sensor alert 164 low battery affects meter option 85 affects remote control 146 affects selftest 148 affects your alert type 139 low BG levels Bolus Wizard and 76 LOW BG warning 76 Low Glucose setting alert frequency 116 Low Glucose Alert default settings 197 Low Glucose limit setting 115 Low Glucose Limit setting 166 low reservoir alert 163 Low resv warning feature 140 Low sensor glucose alert 166 Low Snooze def
S Save settings 150 scroll bar 33 Selftest 148, 161 Sen-serter inserting sensor 121, 122, 123 removing from sensor 123 Sen-serter® cleaning 177 sensor alerts 136, 163 history 136 list 136 best sites 122 calibrating 126, 166 caution inserting 122 choosing insertion site 122 connecting with transmitter 125 default settings 197 disconnected 164 disconnecting from transmitter 137 improper insertion 122 information 129 inserting 121, 122, 124 bleeding 124 guidelines 122 procedure 122 ISIG 171 life 165 precautio
skin bleeding 7, 9 bruising 9 infection 7, 9 redness 9 swelling 7, 9 Special mode 34 Square portion of the Dual Wave bolus 98 Square Wave bolus programming with Bolus Wizard 97 without Bolus Wizard 94 starting sensor procedure 126 steps before 121 STATUS screen 36 Step value setup 100 stopping bleeding 124 supplies, ordering 4 Suspend function 35, 55 swelling 7, 9 swimming 138 system initialization 126 T Temp basal Canceling a 110 Deliver a 109 rates 105 Selecting type 109 verify delivery 110 temp basal ty
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