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 Insulin Pump (includes all models) Avoid Immersing Your Pump In Water The pump was tested and met requirements for IPX7 at time of manufacture. For more information about IPX7, see the Glossary on page 229. Be aware that drops and bumps that occur over time will affect the integrity of the pump case and make it more vulnerable to damage from water. Lotions, sunscreens and insect repellent can also damage the pump case.
Contents Chapter 1: Introduction ..................................................................... 1 Assistance ...................................................................................................... 1 Emergency kit ................................................................................................. 2 Consumables .................................................................................................. 3 Accessories ....................................................
Adverse reactions ........................................................................................ Notice ......................................................................................................... Insulin pump and RF accessories ....................................................................... RF interference from other devices ................................................................... 10 10 10 11 Chapter 2: Introduction to pump therapy ...............................
Chapter 3: The basics ...................................................................... 27 Your pump .................................................................................................... Install battery ................................................................................................ Pump buttons ................................................................................................ The pump screen ..................................................................
Maximum bolus limit ........................................................................................ BG Reminder ................................................................................................. Basal .......................................................................................................... Start and stop times ..................................................................................... Your basal settings .....................................................
LOW BG .................................................................................................... MAX BOLUS EXCEEDED ................................................................................... How to program the Bolus Wizard feature .............................................................. Turning on the Bolus Wizard feature ................................................................. Selecting the Carb units .......................................................................
Chapter 8: Sensor features .............................................................. 111 Entering your sensor settings ............................................................................ Turning on the sensor ................................................................................... Selecting the BG units .................................................................................. High Glucose Alert ................................................................................
Removing the sensor .................................................................................... 132 Storage ...................................................................................................... 132 Using your system in water ............................................................................... 133 Chapter 10: Utilities ...................................................................... 135 Alarm review ..................................................................
Every month ............................................................................................. Every 3 months .......................................................................................... Laboratory tests ......................................................................................... Every visit ................................................................................................ Annually ...........................................................................
SENSOR ERROR ........................................................................................ Alarms ....................................................................................................... What to do ............................................................................................... Alarm conditions ........................................................................................... A (ALARM) .........................................................................
Alarm history ............................................................................................... Audio frequency ........................................................................................... Backlight .................................................................................................... Basal ......................................................................................................... BG Target .............................................................
Bolus Wizard feature specifications .................................................................... Bolus Wizard feature examples .......................................................................... Insulin delivery default settings ......................................................................... Bolus Wizard feature default settings .................................................................. Sensor features default settings ........................................................
xviii Contents
Introduction Chapter 1 Thank you for choosing Medtronic Diabetes (legally known as Medtronic MiniMed, Inc.) as your partner in helping you gain better control of your diabetes. Whether you are beginning pump therapy for the first time or upgrading from a previous model, we believe that the combination of state-of-the-art technology and the simple, menu-driven programming of the pump will provide many benefits.
Emergency kit Keep an emergency kit with you at all times to make sure that you always have necessary supplies. Inform a family member, co-worker, and/or friend where this emergency kit is kept. Please refer to the User safety section in this chapter for more information on pump safety.
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. • 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.
Not all devices or accessories are available in all countries where the pump is approved. 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.
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 The Paradigm REAL-Time insulin pump can be programmed to receive fingerstick blood glucose values transmitted from the LifeScan OneTouch® UltraLink™ Meter or the BD Paradigm Link® Meter for use in the Bolus Wizard calculator and for use as calibration values for the glucose sensor. Glucose values from other glucose meters must be manually entered into the pump.
Tubing Connector If insulin, or any liquid, gets inside the tubing connector, it can temporarily block the vents that allow the pump to properly prime the infusion set. This may result in the delivery of too little or too much insulin, which can cause hypoglycemia or hyperglycemia. To prevent liquid from getting inside the tubing connector, after you fill the reservoir make sure you hold the insulin vial upright when you remove the reservoir from the transfer guard.
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.
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 Prior to exercising, make sure the sensor is firmly attached. Adverse reactions 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: 1 Chapter 1 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.
The pump includes a programmable WEAK SIGNAL alert that notifies you when one or more expected transmissions were not received as expected by the pump. (The pump will also issue a LOST SENSOR alert if communication is interrupted for an extended period of time.) Communication problems can usually be resolved by: • • • ensuring that there is less than 6 feet (1.
Introduction to pump therapy Theory of insulin pump therapy All people, with or without diabetes, need background insulin for normal functions of the body without food. They also need a dose of insulin on demand - when food is eaten. People without diabetes can trust that their pancreas will produce this insulin for them. People with diabetes need to take insulin in a way that is most like the way a pancreas produces it.
As long as you are ready to learn how to use the pump, the pump can work for you. Understanding pump therapy If you are new to pump therapy, you will need the following data from your healthcare professional. Gather this before going to your pump start appointment. If you are unsure, contact your healthcare professional or pump trainer for guidance. Basal rate Basal insulin is needed to maintain your target glucose values when you are not eating. Your pump allows up to 48 basal rates to be programmed.
Insulin sensitivity Insulin sensitivity is used to decide a correction bolus for a high BG. This is how much your blood glucose will be dropped with 1 unit of insulin. 1 unit of insulin will lower BG __________ mg/dL (mmol/L). Active Insulin Blood glucose and A1C testing When you check your blood glucose with a meter, you measure blood glucose at the moment you perform the test. This number gives you key feedback for making present and day-to-day adjustments in your diabetes management.
Your healthcare professional will rely on the results of your blood glucose tests to make changes in your pump settings. The results of your A1C tests are used to assess your overall blood glucose control. If you are on pump therapy, you must test your BG at least: • • • • • Upon waking up Before each meal At bedtime If you feel nauseous One hour after any BG above 250 mg/dL (13.9 mmol/L) Below are target guidelines from the American Diabetes Association for adults with diabetes.
Correlation between A1C level and blood glucose levels Mean plasma glucose A1C (percent) mg/dL mmol/L 12 345 19.5 American Diabetes Association. Diabetes Care. “Tests of Glycemia in Diabetes.” & “Standards of Medical Care.” Vol. 31, Supplement 1, January 2008. S18.
Hypoglycemia protocol: the rule of 15 Check with your healthcare professional for guidelines on treating your low BG. The following instructions are commonly used to treat a BG that is 70 mg/dL (3.9 mmol/L) or lower: 1 2 3 4 18 Eat 15 grams of fast acting carbohydrate. Check BG again in 15 minutes; if not above 70 mg/dL (3.9 mmol/L), repeat treatment. Check BG again in 15 minutes; if still not above 70 mg/dL (3.9 mmol/L), repeat treatment again.
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): • • • • • • 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. Check urine for ketones and call your healthcare professional if ketones are present.
• • • Call your healthcare professional right away if your blood glucose and ketones are not decreasing, or you cannot drink fluids. Continue to test blood glucose and ketones. 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.
Sick day supplies You should have the supplies listed below in the house at all times, and carry them with you when you travel: • • • • • • Fluids that have sugar (regular soda, juice, jello) to replace solid food. Sugar-free liquids (diet drinks, bouillon, water) for replacing lost fluids. Thermometer. Sugar free medicine for fever, cough, congestion, nausea and vomiting. Extra blood glucose and ketone strips. Glucagon emergency kit in case of severe hypoglycemia.
Carbohydrate gram counting With this method, you add up the exact number of grams of carbohydrate in each meal. Food labels, food list and meal planning books are great tools for carbohydrate gram counting. Carbohydrate exchange system This method uses food groups called exchange groups. One exchange with carbohydrate has about 15 grams of carbohydrate.
The following food label shows 12 grams of carbohydrates for each 1 piece serving. If your carbohydrate ratio is 1 unit of insulin for every 12 grams of carbohydrate, you would need 1 unit of insulin for each 1 piece serving of this food.
There are bolus type options available on your pump that can be helpful in handling the rare high-fat meal. Before using bolus type options, you should be at ease using basic pump features and consult with your healthcare professional. Protein and blood glucose Protein has little effect on blood glucose when eaten in moderate amounts, and normally does not require any insulin.
Healthy eating habits Insulin pump therapy gives you the choice of when, what and how much to eat without impacting blood glucose control. This gives you the flexibility to sleep-in, postpone or skip meals, and eat snacks—the same as people who do not have diabetes. Be careful to not abuse this freedom and compromise your nutritional health. All people need to make healthy food choices to be mentally and physically healthy. It is not an exact science to figure your meal bolus based on carbohydrate counting.
The basics Your pump CAUTION: Never use sharp objects to press the buttons on your Paradigm pump as this can damage the buttons or compromise the seal of the pump. Some examples of sharp objects that may damage your keypad are fingernail files, pens or pencils, paper clips, knives, scissors, and keys. battery compartment tubing connector screen ESC reservoir window Chapter 3 Take a look at your pump. The reservoir window allows you to view the insulin in the reservoir.
Install battery CAUTION: Do not use a rechargeable or carbon zinc battery in your pump. For best results use a new Energizer AAA alkaline battery, size E92, type LR03. Medtronic Diabetes designed the pump to only accept a new battery. As a safety measure, if you install a battery that does not have full power, the WEAK BATTERY or FAILED BATT TEST alarm may sound. If you receive a WEAK BATTERY alarm, respond to the alarm and continue. The pump will still operate normally, but with a decreased battery life.
5 6 7 While the pump turns on, it will show one or more screens until the HOME screen appears. If the HOME screen does not appear, do these steps: a. Check that the battery is inserted correctly. If the battery has been installed backwards, remove the battery and install it HOME screen properly. b. If your pump still does not turn on or you get a FAILED BATT TEST alarm, remove and replace the battery with a new one. c. If the pump is still not on, call your local help line or representative.
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.
Button Description • Returns to previous screen or exits the menu. • Backs out of unintentional menu selections if the ACT button has not been pressed yet. • Press simultaneously with • Use as a Shift button by pressing it in combination with another button to access certain features. to turn on backlight when in the menus. 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.
Screen icons There are various icons that appear at the top of your pump screen, like the time, battery and reservoir icons mentioned above. The next sections describe what the icons mean. Battery The battery icon tells you how much usable life is left in your battery. There are four segments in the icon. Each segment represents approximately 25 percent of the usable battery life you have left until you reach Low Battery point.
Sensor icons A dark sensor icon means that the sensor is on and the pump is receiving sensor data. A light-colored sensor icon with a dark circle around it means that the sensor is on, but the pump is not receiving sensor data. For information about the sensor, see the Sensor features chapter.
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 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). 1 Go to the TIME/DATE SETUP screen.
c. Year Change the year. Press ACT. d. Month Change the month. Press ACT. e. Day Change the day. Press ACT. 5 The TIME SET AT screen will show the settings that you programmed. Press ACT and exit the menus. Your time/date settings are complete. Selecting the language The language shown on the pump screens can be changed. Some languages 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. Do the following steps to view the BOLUS HISTORY screen: 1 Go to the BOLUS HISTORY screen and scroll through the bolus deliveries.
Bolus details You can view the details of any of the deliveries in the BOLUS HISTORY screen. The details include: • • • • bolus types: normal, square, and dual programmed bolus amount delivered bolus amount Bolus Wizard feature information (if used) To see the details of any bolus, do these steps: 1 In the BOLUS HISTORY screen, select the bolus that you want to review and press ACT.
Maximum bolus limit The Maximum bolus (Max bolus) is a safety feature that limits the amount of insulin that can be delivered in a single bolus. The factory setting is 10.0 units. You can specify the limit from 0.0 to 25.0 units. It is important to discuss this feature with your healthcare professional to determine your Max bolus amount. To set the Maximum bolus limit, do these steps: 1 Go to the MAX BOLUS SETUP screen. 2 3 Main > Bolus > Max Bolus Set your maximum bolus limit and press ACT.
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.
10 When you have finished programming your pump, you can save your settings. Refer to the User settings section in the Utilities chapter for instructions. 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.
(24-hour total) basal insulin basal rate start times basal delivery rates Chapter 4 Basic programming 53
4 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. Exit the menus when you are done. Setting the Max basal rate Maximum basal (Max basal) rate is a safety limit for the amount of basal insulin that is able to be delivered per hour. Your pump is sent from the factory with the Max basal set to 2.0 units per hour.
Stopping your pump Suspend stops all insulin delivery including the current basal and any bolus or prime deliveries that are in progress. While suspended, your pump will not deliver insulin until you resume your pump. When you resume your pump, the basal delivery will continue. The pump will beep or vibrate about every 15 minutes on the hour to remind you that it is not delivering insulin. Example: You suspend your pump at 11:20 a.m. The pump will beep or vibrate at 11:30 a.m., 11:45 a.m.
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.
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: Do not use the reservoir or infusion set if any liquid gets on the top of the reservoir or inside the tubing connector (as shown in the image). Liquid can temporarily block the vents. This may result in the delivery of too little or too much insulin, which can cause hypoglycemia or hyperglycemia. If any liquid gets on the top of the reservoir or inside the tubing connector, start over with a new reservoir and infusion set.
1 plunger rod 3 reservoir transfer guard 4 5 6 vial Push down on the plunger to pressurize the vial. Hold down the plunger rod. While still holding the plunger rod, flip the vial over so the vial is on top, slowly pull down on the plunger to fill the reservoir. Gently tap the side of the reservoir to make any air bubbles rise to the top of the reservoir. Slowly push up on the plunger just enough to remove any air bubbles from the reservoir.
11 Tap the side of the reservoir to remove any air bubbles. 12 To purge air bubbles that have risen to the top of the reservoir, push up on the plunger until you see insulin in the tubing. 13 Without pulling, turn the plunger counter-clockwise to remove it from the reservoir. Changing your infusion set Removing the reservoir Each time you remove and replace a reservoir in your pump, you have to rewind your pump, and fill the infusion set with insulin. 1 2 60 Remove the entire infusion set from your body.
3 Turn the tubing connector half-turn counter clockwise, then pull the reservoir and connector out from the pump. 4 5 Safely dispose of the used reservoir and infusion set item in a sharp's container. You must now rewind your pump as described in the next section.
Rewinding your pump Before you continue, make sure the infusion set is NOT connected to your body and the reservoir is NOT in the pump. WARNING: Make sure the infusion set is disconnected from your body before you rewind your pump or fill the infusion set tubing. Never insert the reservoir into the pump while the tubing is connected to your body. Doing so could result in an accidental infusion of insulin. 1 2 3 If you removed your reservoir and are replacing it, go to the REWIND screen.
WARNING: Do not insert the reservoir in the pump if you did not rewind. Doing so could result in inaccurate insulin delivery. Never insert the reservoir into the pump while the tubing is connected to your body. Doing so could result in an accidental infusion of insulin. 2 Insert the reservoir into the top of the pump case. 3 Turn the tubing connector approximately 1/2 -turn clockwise until the connector is seated. The tubing connector should be aligned horizontally with the pump case as shown here.
Manual prime Manual prime fills the infusion set tubing with insulin before you 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. 1 2 3 4 After you rewind your pump, the PREPARING TO PRIME screen appears.
Inserting the infusion set WARNING: While the infusion set is connected to your body, do not unscrew and retighten the tubing connector on the reservoir. After you complete all of the following, you will be ready to insert the infusion set into your body: • • • • fill your reservoir rewind your pump insert the reservoir into pump and fill the infusion set with insulin Shown here are the best body areas (shaded) for infusion set insertion. Avoid the 2-inch (5.0 cm) area around the navel.
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. 1 Go to the PRIME MENU screen. 2 3 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.
Reconnecting Quick-set A fixed prime is used before reconnecting the infusion set to your body to ensure that insulin has filled the infusion set. See the instructions in this chapter. Place the connector part (flat side facing down) on the infusion site until it is fully seated. Do not grip the connector part by the flat-side grips. 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 very important to look at your blood glucose readings as feedback regarding your diabetes management, not as statements about you or your self-worth. Try not to have an emotional reaction to the numbers and do not judge them too harshly. You will soon learn how to modify the numbers easily and precisely through insulin pump therapy. Test at least four to six times per day. These are the recommended times to test to determine control: • • • • • • • • • Overnight (occasionally, at approximately 2:00 a.
70 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 BG readings Meter Chapter 6 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 Carb units: _____ grams or ____ exchanges Carb ratios: Bolus Wizard feature uses this for your food bolus calculations. #1: __________ If you count carbs: this ratio is the amount of carbohydrate grams covered by one unit of insulin. #3: __________ (additional settings, if needed) range: 3 - 150 grams/unit #4: __________ If you count exchanges: this ratio is the amount of insulin you need to cover one (carb) exchange. #5: __________ range: 0.
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: #3: __________ (additional settings, if needed) Your insulin sensitivity may vary throughout the day. Your pump allows you to program up to eight different insulin sensitivities.
Bolus Wizard feature settings Information Setting #8: __________ 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.
LOW BG If your blood glucose in the ENTER BG screen is below 70 mg/dL (3.9 mmol/L), the Bolus Wizard feature displays a LOW BG warning. Read the instructions, then press ACT or ESC to clear the message. You can then continue programming to deliver your bolus. MAX BOLUS EXCEEDED Bolus Wizard feature will not deliver more than the limit set for your maximum bolus.
Turning on the Bolus Wizard feature 1 Go to the EDIT SETTINGS screen. 2 3 4 Main > Bolus > Bolus Wizard Setup > Edit Settings The EDIT SETTINGS screen appears with Wizard: Off selected. Press ACT. The WIZARD ON/OFF screen appears. Select On, then press ACT. The EDIT SETTINGS screen appears, showing that the wizard is now turned on. You are now ready to select your carb units. Selecting the Carb units The carb unit setting lets the pump know which way to count your carbohydrates (grams or exchanges).
2 Select Carb Ratios, then press ACT. • If you use grams as your carb units: Carb ratio is the number of carb grams that are covered by one (1.0) unit of insulin. • If you use exchanges as your carb units: Carb ratio is the number of insulin units that are needed to cover one (1.0) carb exchange. 3 The SET CARB RATIO 1 (if you are using grams) or SET EXCH RATIO 1 (if using exchanges) screen appears. The default ratio flashes on the screen. 4 Set your first ratio, then press ACT.
Insulin sensitivity Your insulin sensitivity is the amount your blood glucose (BG) level is reduced by one unit of insulin. This value is used to calculate a suggested insulin dose to correct a high BG. Because this sensitivity may vary throughout the day, your pump lets you set up to eight sensitivity settings. Your healthcare professional may only have you program one or two insulin sensitivities when you first start using the Bolus Wizard feature.
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.
7 In the SET START TIME 2 screen enter the time of the day you want this BG Target range to become active. 8 Press ACT. The TARGET RANGE 2 screen appears. 9 The low end of your BG Target range flashes on the screen. Set the BG Target, then press ACT. 10 The high end of your BG Target range flashes on the screen. Enter the BG Target, then press ACT. 11 The SET START TIME 3 screen appears. The second BG Target range is now set. 12 If you do not need to set up any more BG Target ranges, press ESC.
Active insulin time The active insulin time setting lets the pump know which active insulin time to use in calculating the amount of active insulin to subtract before estimating a bolus. Your healthcare professional should determine the active insulin time that is best for you. To set the Active insulin time, do the following steps: 1 Make sure the EDIT SETTINGS screen is open. 2 3 4 5 Main > Bolus > Bolus Wizard Setup > Edit Settings Select Active Ins Time, then press ACT.
Meter option 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. 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 If you want your pump to communicate with the meter, the following conditions must apply: 1 2 3 4 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.
4 Deleting meter IDs 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.
4 5 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 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 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.
90 Using the Bolus Wizard feature
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. DUAL WAVE BOLUS SQUARE WAVE BOLUS 2 1 Part of the bolus amount delivered immediately and the remainder delivered evenly over time period.
4 For a Square Wave bolus, do these steps: a. Select Square Wave Bolus, then press ACT. The SET SQUARE BOLUS screen appears. b. Enter the desired amount for the Square Wave bolus units, then press ACT. c. Continue to step 5. For a Dual Wave bolus, do these steps: a. Select Dual Wave Bolus, then press ACT. The SET DUAL BOLUS TOTAL screen appears. b. Enter the desired amount for the total dual bolus units. This amount is the total of Normal and Square Wave bolus units. Press ACT. c.
Square Wave bolus practice Your target pre-meal blood glucose range is ______ to _______. Check your pre-meal blood glucose. Are you within your target? _____ If yes, continue. If no, wait to try the following test until your pre-meal blood glucose is within your target range: TEST: Choose a meal that is high in fat (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.
1 Go to the ENTER BG screen. Press 2 3 4 5 6 on your pump, or use the following path: Main > Bolus > Use Bolus Wizard Enter your blood glucose value, then press ACT. The ENTER FOOD screen appears. Enter your food, then press ACT. The ESTIMATE DETAILS screen appears. Scroll down to review the information there. Press ACT to continue to step 5. If you need to make any changes, press ESC to return to the ENTER BG screen. Make changes as necessary.
8 Press ACT to accept and deliver the bolus. The BOLUS DELIVERY screen appears with an open circle indicating that your pump is in Special Mode. The pump beeps or vibrates at the start of the bolus. During bolus delivery, the pump returns to the HOME screen. If you want to see the progress of the delivery, press ESC to see the STATUS screen. The pump beeps or vibrates at the end of the bolus, and the open circle disappears. Easy bolus The EASY BOLUS button allows a quick way to deliver a Normal bolus.
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 1.5 2 Total # Units 1 2 The EASY BOLUS ENTRY screen flashes the step value. Change the value, then press ACT. The step value is the increment you will use for your Easy bolus. The screen will return to the BOLUS MENU. Your step amount is now programmed and Easy Bolus is ready to use.
NOTE: For your safety, you cannot use the to select the Easy Bolus values. Pressing or ESC will cancel the Easy bolus. 4 If this amount is correct, press ACT to start the Easy Bolus delivery. The BOLUS DELIVERY screen will show the units being delivered. When the total bolus is finished, the pump will beep or vibrate. If this amount is wrong, press ESC or to start over. The pump will return to the HOME screen. Example 1: Easy bolus Alexander is a busy executive with an accounting firm.
Basal patterns The Basal Patterns feature is optional for pump users. You can set your pump to deliver a standard basal and two additional basal patterns to meet your individual daily, weekly, or monthly needs. Keep a paper copy of your programmed patterns with you at all times in case you need to reprogram your pump. To select and use pattern A or pattern B, the patterns option must be turned on and programmed.
2 3 Select the basal pattern you want to program, then press ACT. The SET BASAL RATE 1 screen appears. The basal rate flashes, indicating that it can be changed. Set your first rate, then press ACT. The start time for your first basal rate is midnight and cannot be changed. 4 The SET START TIME 2 screen appears. The dashes under the screen name flash. The first basal rate is now set. If you want to use the same rate for the whole day, press ESC and skip to step 10.
Example 1: Basal patterns Ken has had his insulin pump for about a month. He tests his blood glucose 4 - 6 times a day and records his results in his logbook. He is happy with his glucose control during the week but on the weekends, he noticed that he has to eat more food to prevent his blood glucose from running too low. Ken has realized that during the week while he is at work, he is very inactive and sits at a desk most of the time.
A temporary basal rate allows an immediate short-term change to your basal insulin for a specified period of time (30 minutes to 24 hours). This rate can be up to your Maximum basal rate setting. It offers an easy way to immediately meet short-term insulin needs for temporary activities or situations. When your blood glucose is temporarily high or low, a temp basal rate allows you to set a temporarily higher or lower basal to accommodate your blood glucose.
Temp Basal Settings Temp basal type: Insulin rate (U/H) Duration: 4 hours (1:05 p.m.-5:05 p.m.) Rate: 1.25 U/H 1.25 U/H temp basal rate 1.50 U/H (rate 1) 7:00 a.m. (7:00) 2.55 U/H (rate 2) 1.25 1.25 U/H U/H 1.95 U/H (rate 3) 12:00 a.m. (00:00) 1:05 p.m. (13:05) 3:00 p.m. (15:00) 5:05 p.m.
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.
Temp Basal Settings Temp basal type: Percent of basal Duration: 4 hours (1:05 p.m. - 5:05 p.m.) Rate: 50% (50% x rate 2 = 1.275) 1.275 rounded down to the next 0.05 increment is 1.25 U/H (50% x rate 3 = 0.975) 0.975 rounded down to the next 0.05 increment is 0.95 U/H 2.55 U/H (rate 2) 1.50 U/H (rate 1) 1.25 0.95 U/H U/H 7:00 a.m. (07:00) 1:05 p.m. (13:05) 1.95 U/H (rate 3) 12:00 a.m. (00:00) temp basal start time 3:00 p.m. (15:00) 5:05 p.m.
Selecting temp basal type Your pump will remember the temp basal type setting. Once the type is set, you do not have to set it again. To select a temp basal type, do these steps: 1 2 3 Go to the SET TEMP BASAL AS screen. Main > Basal > Temp Basal Type The SET TEMP BASAL AS screen appears. Select Insulin Rate (U/H) or Percent of Basal, then press ACT. The screen will return to the BASAL 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.
Sensor features Chapter 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. 1 Make sure the EDIT SETTINGS screen is open. 2 3 4 Main > Sensor > Sensor Setup > Edit Settings Select BG Units, then press ACT.
Setting the High Snooze Example 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. If you immediately clear the alert again, then the alert will repeat at 1:30 pm and continue to repeat every 15 minutes until you resolve the condition that caused the alert.
4 5 Select your Low Glucose limit between 40–390 mg/dL (2.2–21.6 mmol/L). Your Low Glucose limit must be at least 10 mg/dL (0.6 mmol/L) below your High Glucose limit. Press ACT. The EDIT SETTINGS screen shows the Low Glucose value set. You are now ready to set up your Low Snooze. Setting the Low Snooze After you receive and clear a Low Glucose alert, it will repeat until the low glucose condition is resolved.
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). 1 Make sure the EDIT SETTINGS screen is open. 2 3 4 5 Main > Sensor > Sensor Setup > Edit Settings Select Cal Reminder, then press ACT.
7 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). Chapter 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.
2 Connect the transmitter to the charger by lining it up, flat side down, with the charger. Push the two components together fully. Always allow at least one minute before disconnecting the transmitter from the charger or the transmitter may not work properly. If you disconnect the transmitter before one minute, reconnect it to the charger for at least one minute.
Starting the sensor To start the sensor working, you must complete the following steps in order: Insert a battery into the transmitter's charger. Charge the transmitter battery. Set up the sensor features. Insert the sensor and wait five minutes. Connect the transmitter to the sensor. Start the sensor and wait two hours. Enter your first meter BG. Chapter 8 • • • • • • • Inserting the sensor Before inserting the sensor, you must fully charge and set up the transmitter.
Areas to avoid: • • • • • Frequently used injection or pump/sensor sites 2-inch (5.0 cm) area around navel Site where clothing will rub or constrict Scarred or hardened tissue Areas subjected to a lot of movement Clean site with alcohol, making sure site is dry before inserting the sensor. Do not use skin-preparation solutions prior to insertion. However, I.V. Prep may be used after insertion and before applying a sterile dressing. Lift back of tape slightly to apply I.V. Prep.
Chapter 8 11 While holding the sensor in place, gently slide the Sen-serter away from the sensor. Do not twist, bend or lift the Sen-serter while removing it from the sensor. 12 While still holding the sensor in place, remove the white paper from the adhesive pad. Press the adhesive against your skin. 13 Hold the sensor with two fingers on the base, and gently remove the introducer needle. Do NOT rotate the introducer needle when removing. Dispose of the needle in sharps container.
Connecting the transmitter to the sensor Before connecting the transmitter to the sensor, you must have the transmitter fully charged and set up (see Charging the transmitter and Entering the transmitter ID sections in this chapter). You must also have the features set up and the sensor inserted (see the instructions in this chapter and those provided with your sensor). Allow at least one minute after disconnecting the transmitter from the charger before you can connect it to the sensor.
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. Use your pump to follow the steps below: 2 3 4 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. 1 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: Main > Sensor > Enter Meter BG b.
Using your sensor Status screens To get to your status screens: 1 From the HOME screen, press the ESC button twice. This takes you to your pump status screen. 2 To see the Sensor Status screen, press ESC one more time. This screen will only be available if the Sensor feature has been turned On. Chapter 9 Your STATUS screens tell you what is going on in your pump.
The following conditions can prevent a real-time sensor glucose measurement from being taken: • • • • • • • • A Lost Sensor alert. A Sensor Error alert. A new sensor that you just inserted is being initialized. A Cal Error alert. More than 12 hours has passed since the last system calibration. Find Lost Sensor (15 minutes). Weak signal alert. Reconnect old sensor (two hours). Opening and viewing the graphs The following table describes how to use the graphs.
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. Low Glucose Limit Line at 58 mg/dL (3.
PM 2:20P History LOST SENSOR NOTE: There are many reasons your graphs may not show an SG measurement, but your system does not 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. Examples of real-time sensor glucose graphs The following pages show examples of the different graph types. 3-hour graph Each part of the graph between the vertical dashed lines represents one hour.
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 1 to 2 mg/dL (0.05 to 0.11 mmol/L) per minute. 3:16P 3 Hour 240 • One down arrow shows that your SG has been falling at a rate of 1 to 2 mg/dL (0.05 to 0.11 mmol/L) per minute. 3:11P 3 Hour 131 • Two up arrows show that your SG has been rising at a rate of 2.0 mg/dL (0.
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. To view your Sensor Update History: 1 Go to the SENSOR UPDATE HISTORY screen. 2 Main > Sensor > Sensor Update Hist. The SENSOR UPDATE HISTORY screen appears. It shows up to 28 calibration values. 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. 1 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. If you need to connect the transmitter to the tester, wait one minute after disconnecting the transmitter from the sensor.
Using your system in water WARNING: Do not use your pump in water or wear it during water activities. The pump is not watertight and it may become damaged if it is used in water. You should shower, bathe and swim with the transmitter and the sensor by following the guidelines below: 3 4 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.
134 Using your sensor
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. 1 4 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. Select another alarm to review, or exit the menus if you are done.
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.
Press 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 5 to view more information. The BOLUS screen displays.
3 The AVG BG screen displays. This screen shows: • the average of all blood glucose values entered into the pump for the number of previous days you selected • the average high and low blood glucose values for the number of previous days you selected • the average number of blood glucose values entered into the pump per day for the number of previous days you selected Press 4 The SEN AVG screen displays.
• • • the average total number of correction only boluses delivered per day for the number of previous days you selected 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 1 Go to the ALARM OPTION screen.
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 statustype 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 screen, and the to view the STATUS 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 1 2 3 Go to the UTILITIES MENU. Select Lock Keypad, then press ACT. Press ACT again to lock the keypad.
2 3 4 Select Selftest, then press ACT. Periodically, you will hear beeps as different mechanisms in the pump are being tested. As part of the selftest, the pump will do these tests: a. Screen Test: The screen will appear all black. b. 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.
Main > Utilities > User Settings 2 Hold down 3 4 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. Read the instructions on the screen, then press ACT to save your current settings. You can press ESC if you want to cancel the 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.
4 148 The SETTINGS HISTORY screen displays, giving you a list of all the dates and times of your most recent User Setting operations. Scroll down to view the entire history. When you are done looking at the history, press ESC to exit the menu.
Therapy software Medtronic provides software to optimize your pump use. Contact 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 • • • • • • • • 152 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.
7 8 Monitor your blood glucose closely. If you followed these steps and you are still receiving a NO DELIVERY alarm, call your local representative. What happens if I leave the pump battery out too long? If you leave the pump battery out too long (more than five minutes) you may receive a BATT OUT LIMIT alarm message when you install the new battery. Do the following steps: 1 2 3 Set your pump clock to the correct time, date, and year.
• • The amount of insulin the pump is delivering. The usage of some features. The backlight, vibrate, remote control and meter options decrease battery life. 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.
I cannot get out of the priming loop There are several causes of and resolutions to this problem: 1 2 3 Is the reservoir pump full? • If no, place a full reservoir or shipping cap in the pump. • If yes, make sure you are disconnected from the pump. Hold the ACT button until the second set of beeps and the numbers appear on the screen. • If yes, your pump is okay. Go to step 4 in the Manual prime section in the Starting on insulin chapter to finish the manual prime.
My pump will not display my blood glucose reading from my meter 1 2 3 4 5 6 7 8 Make sure you are using the correct meter (a blood glucose meter supported by MWT1 technology). Your pump will communicate with this meter only. Make sure your meter's RF (radio frequency) feature is on and working correctly. Make sure the meter option in your pump is set to On and you have set the meter ID number correctly on the pump. Make sure your pump does not have a low battery alert condition.
I submerged my pump in water Your pump is designed to resist accidental contact with water. Do not submerge in water during bathing, showering, swimming, or other water activities. 1 2 3 4 5 6 Pat the outside of the case until dry. Open the reservoir compartment and check the compartment and reservoir for water. If wet, dry it completely within 10 minutes of exposure to water. Exposure to liquids, including water or insulin can corrode the mechanism.
It is important that you understand how your pump behaves when you do not clear an alarm or an alert: • • Alarm — If you do not clear an alarm, the pump does not display any subsequent alarms or alerts until the first alarm is cleared. After you clear the first alarm, the pump displays any subsequent alarms, followed by any alerts in order of their importance. Alert — If you do not clear an alert, the pump does not display any subsequent alerts until the first alert is cleared.
Pump alert conditions Listed below are alerts that indicate a condition that is outside normal pump activity. LOW RESERVOIR You can program the pump to sound an alert when either a specified number of units remains or a specified amount of time remains before the reservoir will be empty. LOW BATTERY If you get this alert, do not go to sleep without replacing the battery. The backlight, the remote, and meter functions are disabled during a LOW BATTERY condition.
LOST SENSOR Reason: The pump has not received a signal from the transmitter. Do not disconnect the transmitter from the sensor. Action: 1 2 3 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.
BUTTON ERROR Occurs if a button has been continually pressed for more than three minutes. CHECK SETTINGS When this alarm is active, you should check and/or reprogram your pump settings, including the time/ date. E (ERROR) An E-error alarm will show the letter E followed by two numbers. E-alarms cause all insulin delivery to stop, the pump resets, and all your settings are cleared. After receiving this alarm, note the error number then call your local Medtronic Diabetes representative for assistance.
NO DELIVERY Insulin delivery has stopped. This alarm occurs if your pump detects a blockage. NO RESERVOIR The reservoir is not inserted correctly or no reservoir has been inserted. OFF NO POWER The battery is dead. Replace battery immediately. Follow the directions on the screen. Check to make sure that the time is correct on the screen. Reset the time if necessary.
2 3 Push the tester into the transmitter until the flexible side arms of the tester click into the notches on both sides of the transmitter. 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.
2 With the tester arms pinched, gently pull the transmitter away from the tester. To save transmitter battery life, do not leave the tester connected after testing. 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). To Reconnect old sensor: 1 Go to the RECONNECT OLD SENSOR screen.
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 Question: Why did the flashing green charger light turn off and a longer flashing red charger light turn on during charging? red light about 2 secs about 2 secs about 2 secs Answer: The transmitter battery is very low.
Answer: It will not damage the transmitter. You cannot overcharge it. Question: What should I do if the transmitter’s green light did not flash after removing it from the charger? Answer: Reconnect the transmitter to the charger for at least one minute, remove it and watch the transmitter’s green light flash and then turn off.
172 Troubleshooting and alarms
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 1 2 3 4 5 6 7 8 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 1 2 3 4 5 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.
176 Maintenance
Pump specifications Chapter 15 This section provides detailed information on specifications related to your pump. The safety features of your pump are individually listed and described. Alarms and error messages • • Indicators: audible tone (beep) or vibration (silent). All alarms and errors show messages on the pump's screen and provide instructions on what to do. Unresolved alarms will escalate to siren mode for added safety.
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 The food entry when using Bolus Wizard feature: • • Chapter 15 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. Chapter 15 Dual Wave bolus Delivers a Normal bolus followed by a Square Wave bolus (limited by maximum bolus). Easy bolus • • • • • Features programming using audible tones (or vibrate pulses) in user-defined increments. • Beep mode range: 0 to maximum bolus • Vibrate mode range: 0 to 20 steps or maximum bolus, whichever comes first Default step increment: 0.
Low resv (reservoir) warning Values are based on displayed amount, not actual amount. time: 2 - 24-hours, and @ 1:00 hour before empty 08:00 hours (default when time is selected) units: 5 - 50 units, and @ 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 Power supply Prime function • • • Chapter 15 The pump is powered by a standard 1.5 V AAA alkaline battery, size E92, type LR03 (Energizer brand recommended). 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).
Status screen When What Alarm Clock* (appears if scheduled to alarm) Time set is displayed.
Item When What Standard basal delivery data (always appears) current basal rate (basal 1, basal 2, etc.) Status of pump (such as Rewind, Suspended, Low Reservoir, Set Time, and so on) Time (always appears) *If all of the Reminders and the Alarm Clock are enabled, only the reminder that is nearest to alarming will appear in the STATUS screen. Bolus Wizard feature specifications There are three different formulas the Bolus Wizard feature uses to estimate a bolus, depending on your current BG.
(food estimate) total bolus estimate = A B (correction estimate) C-D E + - active insulin 2 Chapter 15 where: A = food (grams) B = carb ratio C = current BG D = High BG Target E = insullin sensitivity If your current BG is less than your Low BG Target, the Bolus Wizard feature adds the BG correction estimate to the food estimate to get the total bolus estimate.
Notes: • • 188 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. Based on the Active Insulin Time setting you choose, the pump keeps track of how much insulin is still active in your body. This prevents the stacking of insulin, and lowers the chances of hypoglycemia.
• 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% Chapter 15 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. (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) + = 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 Chapter 15 60 g 30 g/u (correction estimate) = 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) 60 g 30 g/u (correction estimate) = 2 units + 11.1 mmol/L - 6.7 mmol/L 2.2 mmol/L/u = 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 = 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 Off Easy bolus: On Easy bolus step: Dual/Square bolus: Maximum bolus: Basal Menu: 2u Off 10.0 u 0 - 25 u (per single bolus) 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 Temp basal type: Utilities Menu: 0.
Menu Item Default Setting (Time/Date) Time: 12 a.m.
Bolus Wizard feature default settings 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 Sensor Options Default Setting Limits, Range of Values Off None Off Low–22.2 mmol/L (Low–400 mg/dL)a Off 2.
Guidance and manufacturer's declaration Guidance and Manufacturer's Declaration - Electromagnetic Emissions Emissions Test RF emissions Compliance Group 1 The Paradigm 522/722/522K/722K pump system uses RF energy only for system communication functions. Therefore, its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment.
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 Immunity Test Voltage dips, short interruptions and voltage variations on power supply lines IEC 61000-4-11 IEC 60601 Test Level <5% UT (>95% dip in UT) for 0.
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. IEC 60601 Level Compliance Level Electromagnetic Environment Guidance 150kHz to 80MHz Radiated RF IEC 61000-4-3 10 V/m 10V/m 80MHz to 6.0GHz d = 0.35 P 80 MHz to 800 MHz d = 0.70 P 800 MHz to 6.
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. Immunity Test IEC 60601 Level Compliance Level Electromagnetic Environment Guidance transmitters, an electromagnetic site survey should be considered.
Recommended separation distances between portable and mobile RF communications equipment and the Paradigm 522/722/522K/722K pump system Chapter 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 44.6 and IEC60529 standard For more information about IPX7, see the Glossary on page 229.
Signifies compliance to Australian EMC and Radio communications requirements Signifies compliance with Industry Canada EMC and Radio communications requirements Chapter 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. Appendix 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. Agreement between the matched pair was estimated by evaluating the difference between the Guardian RT reading and the YSI measurement.
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) A+B A B C D E 40-80 356 (9) 271 (76.1) 214 (60.1) 57 (16.0) 2 (0.6) 80 (22.5) 3 (0.8) 81-120 769 (20) 768 (99.9) 463 (60.2) 305 (39.7) 1 (0.1) N/Aa N/A 121-240 2362 (60) 2352 (99.6) 1476 (62.5) 876 (37.
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. The High Glucose Alert Sometimes the Guardian RT will alert when the blood glucose levels are not high.
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 The median sensor life from Data Sets A and B were 57.5 hours and 72.9 hours, respectively.
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. a.
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.
Appendix A 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. Appendix A Sensor BG (mg/dL) A (1733, 66.7%) B (665, 25.6%) C (7, 0.3%) D (193, 7.4%) E (1, 0.0%) 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 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.
settings remain in effect until you change them. Diabetic Ketoacidosis (DKA) - A serious condition that occurs when the insulin levels are 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 Duration - Amount of time it takes to administer a bolus or basal delivery. Also, length of time for an action or condition.
G Gastroparesis - A condition of the digestive system that slows down the emptying of food from the stomach. Glucagon - A hormone that raises the level of glucose in the blood. The alpha cells of the pancreas make glucagon when the body needs to put more sugar into the blood. Glucagon primarily causes sugar stored in the liver to be released into the blood stream. Glucagon Emergency Kit - An injectable form of glucagon that can be used to treat severe low blood glucose levels (hypoglycemia).
what size bolus you should take when eating carbohydrates. Your healthcare professional will determine your insulin to carbohydrate ratio. IPX7 - Protected against water immersion. Immersion for 30 minutes at a depth of up to 1 meter. K Ketone kPa (kilopascal) - A unit of measurement for quantifying force. Used to measure atmospheric pressure. Equivalent to 10,000 dynes per square centimeter.
MWT1 technology - MWT1 is the wireless Radio Frequency (RF) technology that is used to transmit information from the meter to the pump. You can program your pump to automatically receive your BG reading from this meter. N Normal bolus - An immediate delivery of a specified unit amount of insulin. Normal mode - Regular operating mode. No special features are active, no alert or alarm conditions exist. Insulin delivery is normal during this mode. Now portion - The normal portion of a Dual Wave bolus.
Sensor Age - Sensor age is the amount of time, in days and hours, since the sensor was first inserted. Sensor features - Optional continuous glucose monitoring capabilities. Sensor glucose (SG) - Glucose levels in the fluid under your skin measured by the sensor. Set - To enter or establish a value for your pump (set your BG Reminder). S/N# - Serial number. Sodium - Is an essential element for your body. As table salt, it is used freely in foods as a flavor enhancer and a preservative.
236 Glossary
Index Numerics 3-hour graph 128 24-hour graph 129 A Meter BG By 163 Meter BG Now 163 sensor 160 Sensor End 162 Sensor Error 163 Weak Signal 160 areas inserting infusion set 65 inserting sensor 119 Attention mode 34 auto-off 136 B Index 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 81 Active insulin time setting 82 adverse reactions 10 alarm clock 141 Alarm conditions 165 alarm frequency 177 ALARM HISTORY
battery, pump 173, 183 install 28 removing 154 short life 154 beep/vibrate, alert type 33 BG Reminder 41, 49 BG Targets 80 BG units 78 default settings 196 selecting 112 bleeding 8, 10, 121 Block feature 143 Turn on 143 BLOCK OPTION screen 143 blood glucose checking 123 entering incorrect number 162 rapid change 162 blood glucose units default settings 196 bolus basic 41 details 47 history 46 manual 92 maximum limit 48 stop delivery of 55 bolus delivery Bolus Wizard 85 Easy Bolus 97 bolus delivery, methods
Missed Data 196 sensor 196 sensor features 196 discarding transmitter 174 disconnecting sensor from transmitter 132 tester from transmitter 168 transmitter from sensor 132 disposing introducer needle 121 downloading pump data 3 Dual Wave bolus programming with Bolus Wizard 95 without Bolus Wizard 92 dual/square option on-off 92 E F filling reservoir 58 FIND LOST SENSOR 169 fixed prime 67 food bolus 41, 73, 75, 85, 86 food entry 72, 85 food label 23 frequency alarm 177 alert 177 G graphs 127 differentiati
L Language setting 40 list calibration values 131 sensor alert 131 Lock keypad feature 144 Lost Sensor alert 161 low battery affects meter option 84 affects remote control 142 affects selftest 144 affects your alert type 135 low BG levels Bolus Wizard and 76 LOW BG warning 76 Low Glucose setting alert frequency 114 Low Glucose Alert default settings 196 Low Glucose limit setting 113 Low Glucose Limit setting 163 low reservoir alert 160 Low resv warning feature 136 Low sensor glucose alert 163 Low Snooze def
S Save settings 145 scroll bar 33 Selftest 144, 157 Sen-serter inserting sensor 119, 120 removing from sensor 121 Sen-serter® cleaning 175 sensor alerts 131, 160 history 131 list 131 best sites 119 calibrating 123, 163 caution inserting 119 choosing insertion site 119 connecting with transmitter 122 default settings 196 disconnected 161 disconnecting from transmitter 132 improper insertion 119 information 125 inserting 119, 120, 121 bleeding 121 guidelines 120 procedure 120 ISIG 168 life 162 precaution 10
skin bleeding 8, 10 bruising 10 infection 8, 10 redness 10 swelling 8, 10 Special mode 34 Square portion of the Dual Wave bolus 96 Square Wave bolus programming with Bolus Wizard 95 without Bolus Wizard 92 starting sensor procedure 123 steps before 119 STATUS screen 36 Step value setup 97 stopping bleeding 121 supplies, ordering 4 Suspend function 35, 55 swelling 8, 10 swimming 133 system initialization 123 T Temp basal Canceling a 108 Deliver a 107 rates 102 Selecting type 107 verify delivery 108 temp bas
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