Paradigm® Veo™ User Guide
©2008 Medtronic MiniMed, Inc. All rights reserved. Bolus Wizard®, CareLink®, Dual Wave®, Guardian®, MiniLink®, Paradigm®, Quick-serter®, Quick-set®, Silhouette®, Sof-set®, and Square Wave® are registered trademarks of Medtronic MiniMed, Inc. Easy Bolus™, Enlite™ and Veo™ are trademarks of Medtronic MiniMed, Inc. Energizer® is a registered trademark of Eveready Battery Company. Glucagon Emergency Kit® is a registered trademark of Eli Lilly and Company.
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Important Safety Information Regarding Your Paradigm Insulin Pump (includes all models) Avoid Immersing Your Pump In Water Although it is unlikely that water damage will occur if your pump is splashed or briefly dunked, you should avoid immersing your Paradigm insulin pump in water. To swim or participate in other water activities, always disconnect from your Paradigm pump and reconnect after you are out of the water.
Contents Chapter 1: Introduction ..................................................................... 1 Assistance ...................................................................................................... 1 Emergency kit ................................................................................................. 1 Consumables .................................................................................................. 2 Accessories ....................................................
Understanding pump therapy ............................................................................. 12 Basal rate .................................................................................................. 12 Meal bolus ................................................................................................. 12 Gram counting ......................................................................................... 12 Exchange counting ......................................................
Screen icons ............................................................................................... 29 Battery .................................................................................................. 29 Time display ............................................................................................ 30 Reservoir volume ...................................................................................... 30 Alert and alarm icons ....................................................
Review your bolus deliveries .............................................................................. 44 Bolus details ............................................................................................... 45 Maximum bolus limit ........................................................................................ 47 Example 1: Max bolus .................................................................................... 47 Example 2: Max bolus ..............................................
Rewinding your pump .................................................................................... 66 Inserting the reservoir in your pump .................................................................. 67 Filling the tubing ......................................................................................... 68 Inserting the infusion set ................................................................................ 69 Quick-set infusion set (with Quick-serter®) ..............................
Example 2: Blood glucose above target (high blood glucose) and no active insulin ........... 92 Example 3: Blood glucose below target (low blood glucose) and no active insulin ............ 93 Example 4: Blood glucose above target (high blood glucose) with active insulin .............. 94 Example 5: Blood glucose below target (low blood glucose) with active insulin ............... 95 Chapter 7: Optimizing pump therapy ................................................... 97 Square Wave and Dual Wave bolus ...
Chapter 8: Sensor features .............................................................. 119 Entering your sensor settings ............................................................................ 119 Turning on the sensor .................................................................................. 119 Turning on the Glucose Alerts ........................................................................ 120 Setting the Glucose Limits ................................................................
24-hour graph ......................................................................................... 147 How to check for rapid changes in sensor glucose ................................................... 148 The rapid change arrows ............................................................................... 148 How to make glucose alerts silent ...................................................................... 149 Calibration history ..............................................................
User settings ................................................................................................ 167 Saving the settings ...................................................................................... 168 Restoring the settings .................................................................................. 168 Clearing the settings ................................................................................... 169 History ..........................................................
LOW RESERVOIR ......................................................................................... 181 LOW BATTERY ........................................................................................... 181 Sensor alert conditions ................................................................................... 181 WEAK SIGNAL ............................................................................................ 181 ALERT SILENCE .............................................................
NO DELIVERY ............................................................................................. 189 NO RESERVOIR ........................................................................................... 189 OFF NO POWER .......................................................................................... 189 RESET ..................................................................................................... 189 WEAK BATTERY ............................................................
Easy bolus ................................................................................................... 201 Filling the infusion set .................................................................................... 201 Infusion pressure ........................................................................................... 201 Insulin sensitivity .......................................................................................... 201 Low resv (reservoir) warning .........................
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.
CAUTION: If you give yourself insulin by using a syringe, the Bolus Wizard feature will not be able to correctly determine the active insulin in your system. Consult with your healthcare professional on how long you need to wait after a manual injection before you can rely on the active insulin calculation of your Bolus Wizard feature. Consumables The pumps use disposable reservoirs and infusion sets for insulin delivery.
• • Sensor — The sensor (MMT-7002/MMT-7003/MMT-7008) continuously converts tiny amounts of glucose from your fatty layer under the skin into an electronic signal. This signal is sent to the transmitter. CareLink USB Upload Device — The Medtronic Diabetes CareLink USB (MMT-7305) is used to download the Paradigm 554 or 754 pump data to the diabetes management software using a USB port on your computer. To order supplies, contact your local representative.
Conventions Meaning Pump buttons always bold and uppercase; for example, ESC, ACT Screen and menu names always uppercase; for example, MAIN MENU, REWIND screen Menu selections always bold; for example, 24 Hour Setup, On, Off Flashing (blinking) screen item you can change the value for that item with the NOTE and TIP additional helpful information CAUTION warns of a potential hazard which, if not avoided, may result in minor or moderate injury to the equipment WARNING notifies you of a potenti
The continuous glucose values provided by the Paradigm 554/754 pump systems are not intended to be used directly for making therapy adjustments. Rather, they provide an indication that a confirmation fingerstick measurement may be required. All therapy adjustments should be based on measurements obtained using a home glucose monitor and not based on the value displayed by the pump.
Magnetic fields Do not use pump cases that have a magnetic clasp. Do not expose your insulin pump to MRI equipment or other devices that generate very strong magnetic fields. The magnetic fields in the immediate vicinity of these devices can damage the part of the pump’s motor that regulates insulin delivery, possibly resulting in over-delivery and severe hypoglycemia. Your pump must be removed and kept outside the room during magnetic resonance imaging (MRI) procedures.
Infusion sets and sites Avoid using an infusion set insertion site that will be irritated by clothing and accessories, or by rigorous stretching and exercise. Sensor 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. The sensor should be removed if redness, pain, tenderness or swelling develop at the insertion site.
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 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 1.
10 Introduction
Introduction to pump therapy Theory of insulin pump therapy All people, with or without diabetes, need background insulin for normal functions of the body without food. They also need a dose of insulin on demand - when food is eaten. People without diabetes can trust that their pancreas will produce this insulin for them. People with diabetes need to take insulin in a way that is most like the way a pancreas produces it.
As long as you are ready to learn how to use the pump, the pump can work for you. Understanding pump therapy If you are new to pump therapy, you will need the following data from your healthcare professional. Gather this before going to your pump start appointment. If you are unsure, contact your healthcare professional or pump trainer for guidance. Basal rate Basal insulin is needed to maintain your target glucose values when you are not eating. Your pump allows up to 48 basal rates to be programmed.
Active Insulin Active insulin is the bolus insulin that has already been delivered to your body, but has not yet been used. The pump considers your active insulin time setting in determining any active insulin still in your body from prior boluses. This may help prevent hypoglycemia caused by over-correcting for high blood glucose. Blood glucose and A1C testing BG testing Chapter 2 When you check your blood glucose with a meter, you measure blood glucose at the moment you perform the test.
• • • At bedtime If you feel nauseous One hour after any BG above 13.9 mmol/L (250 mg/dL) Below are target guidelines from the American Diabetes Association for adults with diabetes. Consult your healthcare professional to find out what your targets should be. Summary of recommendations for adults with diabetes mellitus Glycemic control A1C <7.0 percent Preprandial plasma glucose (before meals) 5.0–7.2 mmol/L (90–130 mg/dL) Peak postprandial plasma glucose (1–2 hours after meals) <10.
As you know, you cannot always avoid low blood glucose. It is important that you create a routine to follow when your BG is low. If you have a routine, you will have something ready to treat a low BG. This makes it less likely that you will over-treat your low BG, and cause your BG to go up too much. It is best to use something that you can always carry with you. Choose a food that is all carbohydrate because it will be fast acting. Avoid using high fat foods such as chocolate.
High blood glucose (hyperglycemia) High blood glucose can occur while using the pump for the same reasons it can while using daily injections: • • • • too much food not enough insulin loss of insulin strength disruption of insulin delivery from the pump The goal of treating hyperglycemia is to prevent Diabetic Ketoacidosis (DKA) and delay or prevent diabetes problems due to high blood glucose over a lengthy period of time.
Treating hyperglycemia from illness or infection through insulin pump therapy will be discussed on the following pages. Diabetes ketoacidosis (DKA) DKA results from untreated hyperglycemia. DKA is a serious medical problem that needs treatment right away. The insulin pump therapy uses only fast-acting insulin, so DKA can occur rapidly if insulin delivery is disrupted. It is important that you understand these guidelines.
Sick day management Managing diabetes during an illness or infection requires frequent blood glucose and urine ketone testing. Illness and infection put extra stress on the body and often raise blood glucose. The insulin pump allows you to make changes. It lets you quickly and easily respond to blood glucose changes due to illness and infection. Even if you are not able to eat, you need insulin. Depending on blood glucose testing, you may or may not need to adjust your basal insulin to cover your needs.
Nutrition Good nutrition and making healthy choices are important for everyone. Additionally, for those with diabetes, it is more important to know the nutrient content in food, and how the nutrients affect blood glucose. Carbohydrates have the most effect on blood glucose, notably within a few hours of being eaten. Counting carbohydrates allows you to match your insulin dose to the food you are eating. This is your insulin to carbohydrate ratio.
Facts on the nutrition labels on packaged food will help you to figure how much carbohydrate is in a certain food. There are a number of paperback books that list the grams of carbohydrates in many foods. These books are very helpful when you are eating foods without labels or are eating out. Also, if you know the exchange system, you can count carbohydrate exchanges. Your healthcare professional will give you an insulin to carbohydrate ratio at the start. This will be a place to begin.
Fat and blood glucose Although fat does not have carbohydrate, it may affect your blood glucose level. Your blood glucose can be normal two hours after a meal with high fat foods. However, four to six hours later your blood glucose will increase. That is because the fat slows down the rate the carbohydrates are absorbed in that meal.
Other things that affect blood glucose Fiber may slow down the rise in blood glucose after a meal. Fiber grams are not absorbed. They can be subtracted from the Total Carbohydrate amount for foods or meals with more than 5 grams of fiber. Fiber is an important part of a healthy diet. Suggestions for fiber intake are the same for people with and without diabetes. Sodium (salt) has no effect on blood glucose. Moderate sodium intake is suggested for people with or without diabetes.
The body needs insulin during exercise. Therefore, it is not suggested that you stop the pump unless the exercise is for a short amount of time (one hour or less). If you need to remove the pump for more than one hour, refer to the If you remove your pump section in The basics chapter. If you do an exercise that on average lowers your blood glucose, you can use the temporary basal rate feature. You can use this feature to lower the amount of insulin delivered and reduce the risk of hypoglycemia.
24 Introduction to pump therapy
The basics Your pump CAUTION: Never use sharp objects to press the buttons on your Paradigm pump as this can damage the buttons or compromise the seal of the pump. Some examples of sharp objects that may damage your keypad are fingernail files, pens or pencils, paper clips, knives, scissors, and keys. screen 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 HOME screen been installed backwards, remove the battery and install it 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 last sensor graph selected. • 2 presses open the pump STATUS screen.
The pump screen The screen shows five lines of text at one time. The first is the operating mode. The second is the current open menu or function. The last three lines show either information or text that you can select for the current function. NOTE: The screen text in the examples used in this guide might not exactly match the text on your pump screen. Please follow your pump screen instructions. If you have any questions, contact your local representative.
Time display 24-Hr The current time of day is displayed across the top of the pump screen in the format you select—12-hour or 24-hour. The AM or PM is only displayed for the 12hour format. For instructions on setting the time on your pump, see the Setting the time and date section in the Basic programming chapter. 12-Hr Time Display Reservoir volume The reservoir volume icon tells you how much insulin is in your pump. This icon is also divided into four segments.
Scroll bar If there is more text than the screen can show, a scroll bar appears on the right side of the screen. Press to view any additional text. Screen backlight When you press from the HOME screen, the light on the screen turns scroll bar on or off. During programming, the backlight can be turned on by pressing the and the together. The light will stay on while you are pressing any of the pump buttons. It will stay on as long as the current screen is active.
Normal mode Mode for standard pump operations for normal basal and bolus delivery. No special features are active (such as basal patterns, temp basal, and others). No alarms and no alerts exist. Special mode 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, alerts 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.
CAPTURE EVENT Contains the options you use to enter information about different events into the system. Examples of events include: the amount of insulin used for injections, and the carbohydrates consumed during meals or snacks. The Capture Event option appears in the MAIN MENU after this feature has been turned on in the UTILITIES MENU menu. See the Capturing Events section in the Basic programming chapter for more details. BASAL MENU Contains the functions to setup and deliver your basal.
• • • • • • Special features that are turned on Last alarm/alert that was cleared within 24 hours Most recent BG meter reading received within 24 hours Reservoir status Battery status Time and date Refer to the Pump specifications chapter for a complete list of the information that is available in the STATUS screen. If you remove your pump You may have an occasion when you need or want to remove your pump.
36 The basics
Basic programming Setting the time and date Setting the correct time and date in your pump is necessary for accurate basal insulin delivery and allows you to keep an accurate record of your insulin delivery and other pump functions. You can select a 12-hour or 24-hour clock. You must reset the time and date if you receive a CHECK SETTINGS alarm or you clear your settings (Clear Settings function). 1 Go to the TIME/DATE SETUP screen.
4 Change each of the settings as follows: a. Hour Change the hour. Press ACT. For 12-hour setups, press or P (pm) appears. b. Minutes Change the minutes. Press ACT. c. Year Change the year. Press ACT. d. Month Change the month. Press ACT. e. Day Change the day. Press ACT.
5 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. To change the language for your pump: 1 Go to the LANGUAGE MENU screen.
The Normal bolus delivers an immediate food or correction bolus. It can be delivered at any time except during another Normal bolus. During a Normal bolus, most pump features are disabled until after all the bolus has been delivered. The suspend function and the STATUS screen, however, are always available. Setting the Normal bolus Normal bolus can be used to cover the carbohydrate in a meal or snack and/or to correct a blood glucose that is higher than your blood glucose target.
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.
Normal meal bolus practice using carbohydrates 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 you used the Bolus Wizard feature to deliver any of these boluses, the BOLUS HISTORY screen shows the carbohydrate/food (CH) and blood glucose values that the Bolus Wizard feature used to calculate the boluses. (with the Bolus Wizard feature) date carb value BG value time amount/type Chapter 4 N = Normal S = Square Wave DN = Normal part of dual wave bolus DS = Square part of dual wave bolus 2 Refer to the instructions in the Bolus details section to see the details for any of these boluses.
• • delivered bolus amount Bolus Wizard feature information (if used) To see the details of any bolus, do these steps: 1 2 In the BOLUS HISTORY screen, select the bolus that you want to review and press ACT. The details for that bolus will appear on the screen. Scroll through the details. Without the Bolus Wizard feature With the Bolus Wizard feature delivery is active If the Bolus Wizard feature calculated your bolus, more information will appear in the BOLUS DETAIL screen.
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 75.0 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 2 3 Go to the MAX BOLUS SETUP screen. Main > Bolus > Bolus Setup > Max Bolus Set your Max bolus limit and press ACT.
When you set the scroll rate to 0.05, you can use the following increments to program a bolus: • • 0.05 unit increments for a bolus of 9.95 units or less 0.10 unit increments for a bolus of 10 units or more When you set the scroll rate to 0.10, the increments will increase or decrease by 0.10 units during bolus programming regardless of the bolus value. To program your scroll rate: 1 Go to the SET SCROLL RATE screen. 2 3 Main > Bolus > Bolus Setup > Scroll Rate The scroll rate value appears flashing.
When the BG Reminder goes off, your pump will beep or vibrate and CHECK BG will appear on the screen. Your pump will beep or vibrate periodically until it is cleared (ESC, ACT). When you set a BG Reminder after a bolus, the STATUS screen will show the amount of time remaining before the reminder goes off. Here, the STATUS screen indicates that the BG Reminder will go off in 18 minutes. Capturing Events The Capture Event feature electronically saves certain types of information.
Entering BG measurements You can save non-calibrating BG readings in device history. Non-calibration meter BG measurements are those that are taken at times when you will not use them for calibration, such as after eating or when your blood glucose is rising or falling rapidly. You also have the option of using the entered reading for calibration purposes. Do not calibrate if your sensor is not communicating with your device.
• • If you want to use the new BG measurement for calibration, select Save and Calibrate. This option is available when the Auto Calibration feature is Off and your sensor is communicating with the pump. The BG measurements must be between 2 mmol/L (40 mg/dL) and 22.2 mmol/L (400 mg/dL). • If the Bolus Wizard is on and the saved BG is below your BG Target range, the BG Saved screen appears.
Entering carbohydrate information This section shows you how to enter information about the carbohydrates you eat or drink. Before you begin Before you can enter carbohydrate information, you must select the carbohydrate units (Carb Units) for the Capture Event feature. You can set the carbohydrate units to grams or exchanges. To set the carbohydrate units: 1 Go to the CARB UNITS screen. 2 Main > Capture Event > Carb Units Select either Grams or Exchanges, then press ACT. The CAPTURE EVENT menu shows.
Entering Other markers This section shows you how to enter markers other than Enter BG, Insulin Marker, Meal Marker, or Exercise Marker. Examples of Other markers include: when you take medications, when you feel ill, when you are under stress, and so on. The Other marker appears in CareLink Personal reports, and shows at what time you have entered it in the Capture Event feature.
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 (00:00 or 12:00 a.m.) 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, such as more than a day, set the basal rate to 0.000 U/H.
9 The BASAL RATE screen appears. Your basal rate(s) will now deliver as programmed. Exit the menus. NOTE: The pump delivers basal amounts in 0.025 U/H increments for basal rates of less than 1.00 U/H, and in 0.05 U/H increments for basal rates of 1.00 U/H or more. 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 The STATUS screen shows your current basal information.
3 If you do not use patterns, the STANDARD screen appears. The delivery details for your standard basal will appear. (24-hour total) basal insulin basal rate start times basal delivery rates If you use patterns, the BASAL REVIEW screen appears. The current basal pattern will be highlighted. Select the pattern you want to view. Press ACT. The delivery details for that pattern will appear.
If you are setting your Max basal rate after your basal rates have been set, you cannot set a Max basal that is less than any of the programmed basal rates. To set your Max basal rate, do these steps: 1 Go to the MAX BASAL RATE screen. The Max basal rate will be flashing. 2 3 Main > Basal > Basal Setup > Max Basal Rate Change the rate and press ACT. Your Max basal rate is now set. Exit the menus. Example 1: Max basal Helen has a very low insulin requirement. Her highest basal rate is only 0.
When suspended, your pump is in Attention mode with a solid circle showing on the pump. When in Suspend, you can only resume your basal or view the STATUS screen. If the Sensor feature is turned on, you can also view the sensor graphs and the SENSOR STATUS screen. No other functions are available. To suspend the pump: 1 Select Suspend from the MAIN MENU, and press ACT. Main > Suspend 2 SUSPEND will flash on your screen. Press ACT to stop your pump.
NOTE: A bolus or fill cannula that was stopped by suspend will not restart when you resume your pump. You must reprogram and activate it to finish delivery. 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.
Practice: Resume basal delivery after a suspend Make sure you are NOT connected to your pump while practicing. 1 2 Give a 3.0 unit bolus now. While it is delivering, suspend the bolus. Check here if you were able to suspend the bolus. 3 4 Now restart the pump. Check here if you were able to restart the pump.
62 Basic programming
Starting on insulin The Paradigm pump is intended for use with U100 insulin. Prepare your pump for use Before continuing with the steps in this chapter, we recommend that you watch your pump training CD-ROM if available, and complete your pump start training. When you are done practicing and ready to use your pump with insulin, you must make sure the time and date are correct on your pump. You must also program your settings as instructed by your healthcare professional.
Filling the reservoir 1 Remove the reservoir from the package. Make sure the plunger rod is fully extended. 2 Swab the vial with alcohol. 3 Making sure you do not push down on the plunger, press the transfer guard onto the vial. plunger rod 1 3 reservoir transfer guard vial 4 Push down on the plunger to pressurize the vial. 5 While still holding the plunger rod, flip the vial over so the vial is up, slowly pull down on the plunger to fill the reservoir.
10 Place the tubing connector onto the reservoir. Turn the connector clockwise, pressing gently against the reservoir until you feel it slide in. Push in and continue turning until the reservoir and the connector lock with a click. 7 8 9 10 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.
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 Remove the entire infusion set from your body. 2 If attached, remove the activity guard. 3 Turn the tubing connector half-turn counter clockwise, then pull the reservoir and connector out from 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. Main > Reservoir + Set > Reservoir Setup In the REWIND screen, press ACT to start the rewind process.
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. 2 4 5 6 3 tubing connector Attach the activity guard, if desired. If the pump has returned to the HOME screen, press ACT to show the REWIND COMPLETE screen. Press ACT again to go to the FILL TUBING screen. You must now fill the infusion set tubing as described in the next section.
WARNING: If the FILL TUBING screen does not display, do NOT continue. Do NOT insert the infusion set into your body. Please contact your local representative for assistance. Take care to remove air bubbles when filling the infusion set tubing. 4 5 If you use more than 30 units of insulin to fill the infusion set tubing, the MAX FILL REACHED alarm screen will appear. If you get this alarm, do these steps: a. Make sure that you are not connected to the pump. b.
• and fill the infusion set with insulin Shown here are the best body areas (shaded) for infusion set insertion. Avoid the 5.0 cm (2-inch) area around the navel. It is important that you change your infusion set every two to three days. Be sure to rotate the infusion set insertion sites so that they do not become overused. The abdominal area is usually the preferred area to use, because insulin typically works faster there compared to other insertion areas.
Quick-set infusion set (with Quick-serter®) There are different infusion sets that you can use with your pump. As an example, the following procedure shows how to insert the Quick-set infusion set. Always refer to the instructions that shipped with your infusion set.
Filling the cannula Filling the soft cannula with insulin is required after the infusion set is inserted into your body and the introducer needle is pulled out. The insulin amounts required to fill the cannula depend on the type of infusion set you are using. Refer to your infusion set instructions for this information. If you are using an infusion set with a needle, press ESC to skip this step. If you do not complete the Fill Cannula steps, your pump triggers a FINISH LOADING alarm.
Disconnecting Quick-set The Quick-set allows you the freedom to temporarily disconnect from your pump without removing the infusion set from your body. 1 2 3 Hold the side grips of the connector part with your fingers. Twist the connector counter-clockwise. Remove the connector from the site. 1 2 3 Reconnecting Quick-set Place the connector part (flat side facing down) on the infusion site until it is fully seated. Do not squeeze 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 important to test often and write down your blood glucose readings, the food you eat, any exercise you perform and any other notes to explain your blood glucose results. You must test at the recommended times and any other time that you feel your blood glucose is high or low.
After you and your healthcare professional are satisfied with your initial pump settings, you may begin to experiment with different food choices, meal times and exercise schedules.
76 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 You need to know your blood glucose (BG) reading.
• • target blood glucose range active insulin time (hours) Get this information from your healthcare professional, and, for best results, talk to your healthcare professional before making any changes. Keep a record of your settings in the following Bolus Wizard feature settings table: Bolus Wizard feature settings Information Carb units: _____ grams or ____ exchanges Carb ratios: Bolus Wizard feature uses this for your food bolus calculations. Ratio: Start time: 1. __________ 1. midnight 2.
Bolus Wizard feature settings Information Insulin sensitivity: This ratio is used for your correction bolus calculations. This ratio is the BG units reduced by 1.0 unit of insulin. range: 0.5–22.2 mmol/L/u or 10–400 mg/dL/u NOTE: Your insulin sensitivity may vary throughout the day. Your pump allows you to program up to eight different insulin sensitivities. Setting Ratio: Start time: 1. __________ 1. midnight 2. __________ 2. __________ 3. __________ 3. __________ 4. __________ 4. __________ 5.
Bolus Wizard feature settings Information BG Target range: If your current blood glucose is above the BG Target range, the Bolus Wizard feature will calculate a correction dose. If your current blood glucose is below the BG Target range, the Bolus Wizard feature will calculate a negative correction and subtract it from your food bolus. range: 3.3–13.9 mmol/L or 60–250 mg/dL NOTE: Your pump will allow you to program up to eight different BG Target ranges.
Bolus Wizard warnings When using the Bolus Wizard feature, the pump may display a HIGH BG, LOW BG, and MAX BOLUS EXCEEDED warnings. HIGH BG If your blood glucose in the ENTER BG screen is above 13.9 mmol/L (250 mg/dL), the Bolus Wizard feature displays a HIGH BG warning. Read the instructions, then press ACT or ESC to clear the message. You can then continue programming to deliver your bolus. LOW BG If your blood glucose in the ENTER BG screen is below 3.
Once the settings are programmed, you do not have to program them again unless the values change. After you program one setting, the screen will automatically go to the next required setting. After you program all your settings, review them as described in this section to make sure they are set correctly. Instructions for programming the Bolus Wizard feature settings are in the next paragraphs. Program your settings in the order described to make sure you program all the settings.
Setting the Carb/Exch ratios Your pump allows you to set up to eight Carb/Exch ratios because this ratio may vary throughout the day. Your healthcare professional may only have you program one or two carb ratios when you first start using the Bolus Wizard feature. To set the Carb/Exch ratios: 1 Make sure the EDIT SETTINGS screen is open. 2 3 4 5 6 7 Using the Bolus Wizard feature Chapter 6 8 9 10 Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings Select Carb Ratios, then press ACT.
Setting the BG units You can select mmol/L or mg/dL as your Blood Glucose Unit (measurement type). You can also set these units in the Sensor and Capture Event menus. 1 Make sure the EDIT SETTINGS screen is open. 2 3 4 Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings Select BG Units, then press ACT. The BLOOD GLUCOSE UNITS screen displays. Select mmol/L or mg/dL, then press ACT. The EDIT SETTINGS screen shows the BG units you selected. You are now ready to set your insulin sensitivity.
9 Press ACT. The SET START TIME 3 screen appears. The second insulin sensitivity is now set. 10 If you do not need to set up any more insulin sensitivities, press ESC. If you need to set up more insulin sensitivities, repeat steps 6 through 9 above for each insulin sensitivity. You are now ready to set up the BG Target. Setting the BG Targets The BG Target setting allows you to set glucose targets. The Bolus Wizard will use these targets to calculate a correction dose.
Pumps are sent from the factory with default BG Target range of 5.6–5.6 mmol/L (100–100 mg/dL). 1 Make sure the EDIT SETTINGS screen is open. 2 3 4 5 6 7 8 9 10 11 12 Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings Select BG Target, then press ACT. The TARGET RANGE 1 screen appears. The low end of your BG Target range flashes on the screen. Set the BG Target, then press ACT. The high end of your BG Target range flashes on the screen. Enter the BG Target, then press ACT.
Your Paradigm pump is shipped from the factory with an active insulin time setting of six hours, which most closely matches the published scientific data. If your healthcare professional prescribes a different time for you, the active insulin time setting can be adjusted in the Bolus Wizard menu in one-hour increments from two to eight hours. For more details about active insulin, see the Bolus Wizard feature specifications section in the Pump specifications chapter.
Meter option BG readings You can set up your pump to automatically receive your blood glucose reading from the linked meter. This meter may not be Meter available in all countries. Check with your local Medtronic Diabetes representative. Your pump is set at the factory with the meter option turned off. See the Add, delete, review meter IDs section in this chapter to turn the meter option on, and to enter your meter ID. Programming your meter ID links your pump to the meter.
Add, delete, review meter IDs The meter programming screens are very similar to those for the remote control. Make sure to select Meters in the DEVICE OPTIONS screen when programming your meter. You have to turn on the meter option to add, delete, or review the meter ID(s) programmed in your pump. To turn on the meter option: 1 2 3 4 Go to the METER OPTION screen. Main > Utilities > Connect Devices > Meters Select On, then press ACT. The METER ID MENU appears.
Use the button to deliver a Normal bolus at any time except during another Normal bolus. A Normal bolus will temporarily interrupt a Square Wave or Dual Wave bolus that is delivering. After the Normal bolus is finished, the Square Wave or Dual Wave bolus delivery will resume. NOTE: If you want to use the pump-to-meter link, make sure the meter option is on. Refer to the Meter option section for instructions.
Bolus Wizard feature examples For the scenarios that follow, Michael has his Bolus Wizard feature turned on with the following settings: Carb ratio: 15 grams per unit of insulin Insulin Sensitivity: 2.2 mmol/L (40 mg/dL) per unit of insulin BG Target: 5.0–6.
Example 2: Blood glucose above target (high blood glucose) and no active insulin The next day, Michael wakes up before school. Before eating the same breakfast, he tests his blood glucose with his meter and finds it to be 11.1 mmol/L (200 mg/dL), which is above his target of 6.6 mmol/L (120 mg/dL). His blood glucose reading is automatically sent to his pump. When prompted by the Bolus Wizard feature, he enters his carbohydrate amount of 60 grams in the ENTER FOOD screen.
Example 3: Blood glucose below target (low blood glucose) and no active insulin On another morning, Michael sits down before eating the same breakfast. He tests his blood glucose with his meter and finds it at 3.9 mmol/L (70 mg/dL), which is below his Low BG Target of 5.0 mmol/L (90 mg/dL). His reading is automatically sent to his pump. When prompted by the Bolus Wizard feature, he enters his carbohydrate amount of 60 grams in the ENTER FOOD screen.
Example 4: Blood glucose above target (high blood glucose) with active insulin Michael is at school and wants to eat a snack in the late morning. He tests his blood glucose with his meter and finds it to be at 11.1 mmol/L (200 mg/dL), which is above his target of 6.6 mmol/L (120 mg/dL). He estimates that his snack contains 60 grams of carbohydrate, so he enters 60 into the pump when prompted by the Bolus Wizard feature. Based on his settings, and as a result of 1.
Example 5: Blood glucose below target (low blood glucose) with active insulin Another day at school, Michael is getting ready to eat lunch. He tests his blood glucose with his meter and finds it at 3.9 mmol/L (70 mg/dL), which is below his Low BG Target of 5.0 mmol/L (90 mg/dL). 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.
96 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 or 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: INSULIN Entire bolus amount delivered immediately. NORMAL BOLUS Bolus amount delivered evenly over specified time period. SQUARE WAVE BOLUS 1 2 Part of the bolus amount delivered immediately and the remainder delivered evenly over time period.
4 5 For a. b. c. For a. b. a Square Wave bolus, do these steps: Select Square Wave Bolus, then press ACT. The SET SQUARE BOLUS screen appears. Enter the desired amount for the Square Wave bolus units, then press ACT. Continue to step 5. a Dual Wave bolus, do these steps: Select Dual Wave Bolus, then press ACT. The SET DUAL BOLUS TOTAL screen appears. Enter the desired amount for the total dual bolus units. This amount is the total of Normal and Square Wave bolus units. Press ACT. 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.
The Bolus Wizard feature must be turned on and the settings must be programmed (see the How to program the Bolus Wizard feature section in the Using the Bolus Wizard feature chapter). Also, make sure the dual/ square option is turned on (see the Turning on the Dual Wave/Square Wave option section in this chapter). If you want to use the pump-to-meter link, make sure the meter option is on. Refer to the Meter option section for instructions. 1 2 3 4 5 6 102 Go to the ENTER BG screen.
7 The Bolus Wizard feature recommends splitting the food portion of your bolus 50/50 between the Square and Now portions. The entire correction amount is always recommended to the Now portion. In this example the NOW portion consists of half of the food insulin plus the correction amount less the active insulin (1.5U + 2.5U - 1.5U). This gives 2.5U or 62% of total insulin of 4.0U. The Square portion consists of the other half of the food insulin (1.5U), which is 38% of total insulin of 4.0U.
Easy bolus setup 1 Go to the EASY BOLUS OPTION screen. Main > Bolus > Bolus Setup > Easy Bolus Select On/Set, then press ACT. NOTE: If you are using the remote control, the Easy Bolus must be set to on. Step value setup You can set the step value from 0.1 to 2.0 units, or to the set maximum bolus limit of less than 2.0 units (factory setting: 0.1). Set the step to a number that is convenient to use and easy to multiply. Total # Steps = 4 Total # Button Presses = 4 4 Example: 2.
Delivering Easy Bolus Practice using the Easy Bolus feature while looking at the pump screen as you count the beeps. This feature only works from the HOME screen. After you are familiar with Easy Bolus, you can use the audible tones for bolus delivery without having to look at the screen. 1 From the HOME screen, press 2 flashing. Press the number of times needed for your bolus amount. Watch the amount change on the screen . The SET EASY BOLUS screen appears with the single step value with each press.
Example 1: Easy bolus Alexander is a busy executive with an accounting firm. He wears his Paradigm pump on his belt and does not want to take it off to give himself a bolus. Alexander can easily reach down and feel for the Easy Bolus button to give a bolus. He previously programmed his pump to deliver an Easy Bolus in steps of 0.5 unit increments. From the HOME , the pump will sound a different tone so he can keep track of the number screen, with each press of the of button presses.
Missed Bolus Reminder Missed Bolus Reminder feature helps you remember to give yourself a meal bolus. It triggers a MISSED BOLUS alert if you do not deliver a bolus during the time periods that you set. Set these time periods for the meals for which you want to receive a reminder. The pump is set at the factory with the Missed Bolus Reminder feature turned Off. Add, delete, and review bolus reminders You have to turn on the Missed Bolus Reminder option to add, delete and review the programmed reminders.
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.
3 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. If you want to program another basal rate, follow steps 5 through 8.
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.
Temp basal rates Temp basal should be used based on the guidance of your healthcare professional. This feature is useful to manage blood glucose levels during unusual short-term activities or conditions. These conditions could be an illness or physical activity. 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.
If you make changes to your normal basal rate, your U/H temp basal is not affected and will continue to deliver as programmed. Temp Basal Settings Temp basal type: Insulin rate (U/H) Duration: 4 hours (13:05-17:05) Rate: 1.25 U/H 1.25 U/H temp basal rate 1.50 U/H (rate 1) 07:00 (7:00 a.m.) 2.55 U/H (rate 2) 1.25 1.25 U/H U/H 13:05 (1:05 p.m.) 1.95 U/H (rate 3) 00:00 (12:00 a.m.) 15:00 (3:00 p.m.) 17:05 (5:05 p.m.
Your current basal rates: Your Maximum basal rate setting: 2.0 U/H Segment #1: 00:00 1.50 U/H Segment #2: 11:00 1.60 U/H (largest) Segment #3: 16:00 1.30 U/H If your current basal changes (for example, from rate 1 to rate 2), your percent temp basal amount will also change. The pump will deliver the percentage for the duration that you have set.
You cannot make changes to your normal basal rate while a percent temp basal is active. You must either wait until the temp basal is finished or cancel the temp basal in order to reprogram your normal basal rate setting(s). Temp Basal Settings Temp basal type: Percent of basal Duration: 4 hours (13:05-17:05) 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.
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 > Basal Setup > Temp Basal Type The SET TEMP BASAL AS screen appears. Select Insulin Rate (U/H) or Percent of Basal, then press ACT. The screen will return to the BASAL SETUP screen. The temp basal type is now set. Exit the menus.
Verifying temp basal delivery Temporary basal information is available in the STATUS screen only. During a temporary (temp) basal, the pump is in Special mode (an open circle appears). This open circle will remind you that a temp basal is active. Additionally, your pump will beep/vibrate three times on the hour regardless of the starting/ending time for the temp basal. During delivery, go to the STATUS screen to see the current temp basal information. Temp Basal of 0.
Example 1: Temp Basal for a decreased temporary basal rate Ramon and his friends got together for an unplanned game of soccer. Before using the pump, he was taking shots to manage his diabetes. Ramon experienced frequent low blood glucose reactions sometimes during, and very often after, he played games with his friends. Now that he is using his Paradigm pump, he can use the Temporary Basal Rate feature to help prevent low blood glucose.
Your turn: Think of an activity where you might need to use a Temporary Basal Rate. At what rate is your current basal rate running? ____________ What Temporary Basal Rate would you try using at this time? ___________________ How long will you be active?___________________ What duration will you set for the Temporary Basal Rate?________________ Test your blood glucose before and during activity and several times after as well.
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, contact your local representative to purchase your sensor and transmitter.
Turning on the Glucose Alerts The Glucose alerts must be turned on if you want the system to send you an alert when the sensor glucose measurements reach or exceed your Glucose Limits. For a Low sensor glucose alert, the pump plays four consecutive tones, in falling pitch, if an audible beep has been selected as the alert type. For a High sensor glucose alert, the pump plays four consecutive tones, in rising pitch, if an audible beep has been selected as the alert type.
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. Make sure the EDIT SETTINGS screen is open. 2 3 4 Main > Sensor > Edit Settings Select BG Units, then press ACT. The BLOOD GLUCOSE UNITS screen shows mmol/L and mg/dL. Select your BG units. Press ACT. The EDIT SETTINGS screen shows the BG Units type you selected. You are now ready to set up your glucose limits.
Setting the Glucose Limits start time If your healthcare professional recommends that you set more than one pair of Glucose Limits, you must enter a start time for each. For example, you may use one pair of Glucose Limits during the day and another pair at night. The example below shows two pairs of Glucose Limits. The first pair begins at midnight, and the second pair begins at 09:00. 00:00 00:00 09:00 Glucose Limits 1 High Glucose Limit: 13.3 mmol/L (240 mg/dL) Low Glucose Limit: 3.
6 7 8 9 10 Chapter 8 To set a second pair of Glucose Limits, select the time of day you want this pair to become active. Press ACT. The SET GLUCOSE LIMITS 2 screen appears. The default Low Glucose Limit flashes (OFF). Select your Low Glucose Limit. The value must be between 2.2 and 21.6 mmol/L (40 and 390 mg/dL). Press ACT. The default High Glucose Limit flashes (OFF). Select your High Glucose Limit, then press ACT. The value must be between 2.8 and 22.2 mmol/L (50 and 400 mg/dL). 11 Press ACT.
Setting the Low Repeat After you receive and clear a Low Glucose, Fall Rate of Change, or Low Predictive alert, the alert will repeat until the condition that caused the alert is resolved. After you clear a Low Suspend alarm and resume basal delivery, the alarm will repeat if a low glucose condition still exists. The Low Repeat feature allows you to set how frequently you want the above alerts or alarm to repeat after you clear it the first time. The Low Repeat feature works similar to the High Repeat one.
Understanding the Time Sensitivity Settings To use the Predictive alerts, you need to first set your Low or High Glucose Limits, and then your Time Sensitivities. Time Sensitivity means the length of time, in minutes, you want to be notified before you reach your High or Low Glucose Limit.
Setting the Rate of Change Alerts The Rate of Change alerts tell you when your sensor glucose (SG) changes at, or faster than, the per-minute rate pre-selected by you. There are two alerts: • • FALL RATE for SG decreases at or faster than your pre-selected rate. The pump plays two consecutive tones, in falling pitch, if an audible beep has been selected as the alert type. RISE RATE for SG increases at or faster than your pre-selected rate.
Setting the Low Glucose Suspend To set up the Low Glucose Suspend: 1 2 3 4 5 Chapter 8 If the Glucose, Predictive, and Fall Rate of Change alerts are set up, your pump will generate an alert to warn you about low or dropping sensor glucose values. However, if you do not treat or are unaware of your low blood glucose, you can set the Low Glucose Suspend feature to stop insulin delivery.
Setting the Cal Reminder The Cal Reminder feature allows you to set a reminder to calibrate your system. For example, if you set your reminder to four hours, then you will receive a METER BG BY alert (Cal Reminder) four hours before the next meter blood glucose (BG) entry is due (eight hours after your last successful sensor calibration). To set up the Cal Reminder: 1 Make sure the EDIT SETTINGS screen is open. 2 3 4 5 Main > Sensor > Edit Settings Select Cal Reminder, then press ACT.
Write the Transmitter ID of the transmitter you are using here: __________________. Make sure the EDIT SETTINGS screen is open. 2 Main > Sensor > Edit Settings Select Transmtr ID, then press ACT. The SET TRANSMITTER ID screen appears. The screen shows seven dashes for the Transmitter ID, the first of which (on the left) is flashing. 3 Select the first number of the Transmitter ID (the number on the screen must match the first number of the Transmitter ID).
Setting the sensor glucose graph timeout The sensor glucose graph timeout is how long the graphs show on the pump screen until the HOME screen automatically appears. The default timeout is two (2) minutes, and you can set it for 2, 4, or 6 minutes. Using a continuous graph display You can also select NONE to set the sensor graph timeout to display continuously. If you select NONE, the sensor graphs will show until another screen or menu is selected, or an alarm/alert occurs.
Using the Sensor Demo The Sensor Demo shows you a demonstration of a sensor graph. To view the Sensor Demo screen, you must first turn on the Sensor Demo feature. After the Sensor Demo feature is turned on, the first line of the STATUS and SENSOR STATUS screens will show SENSOR DEMO: On. 1 Chapter 8 Turning on the Sensor Demo feature Make sure the EDIT SETTINGS screen is open. Main > Sensor > Edit Settings 2 3 The EDIT SETTINGS screen shows Sensor Demo: Off. Press ACT.
• • • • • • Set up the sensor features. Insert the sensor. If you are using the Enlite Sensor (MMT-7008), wait five minutes. If you are using a different sensor (MMT-7002/MMT-7003), wait 10–15 minutes. Connect the transmitter to the sensor. Start the sensor and wait two hours. Enter your first meter BG. Inserting the Enlite sensor This procedure shows you how to insert the Enlite Sensor (MMT-7008) using the Enlite Serter (MMT-7510).
7 To detach the Serter from the pedestal, place two fingers on the pedestal arms and slowly pull the Serter straight up. Do not detach the pedestal from the Serter in mid-air, as this might damage the sensor. Chapter 8 WARNING: Never point a loaded Serter toward any body part where insertion is not desired. 8 Place the base of the Serter flat against your insertion site. WARNING: The Serter injects sensor upon button release. NOTE: A second button push is required to remove the Serter from the sensor.
9 To insert the sensor, complete the following four steps: A A Press the button in and then release. B B Wait 5 seconds to allow adhesive time to stick to skin. C C Press and hold in the button. D D While holding the Serter button in, lift the Serter away from the skin. 10 If you inserted the sensor into yourself, complete step A. If you are a healthcare professional or caregiver who inserted the sensor into a Patient, complete step B. Patient: A A Gently hold the base of the sensor against skin.
WARNING: If bleeding occurs, apply steady pressure using sterile gauze or clean cloth for up to 3 minutes. 11 Straighten the sensor adhesive tab so that it lies flat against the skin. Chapter 8 12 While holding the sensor in place, gently lift the adhesive tab. Carefully remove the bottom piece of white paper from under the adhesive. Press the adhesive against your skin. 13 Before connecting the device, apply overtape. Do not cover the sensor connectors or adhesive tab with overtape.
Connecting the transmitter to the sensor Before connecting the transmitter to the sensor, you must have the transmitter fully charged and set up (see your transmitter user guide and Entering the transmitter ID section 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). To connect the transmitter to the sensor: 1 Connect the transmitter to the sensor, as shown.
Chapter 8 4 5 [Optional]: Apply occlusive dressing over the transmitter and the sensor. Follow the instructions in the next section to start your sensor. Preparing the sensor for communication Connect your transmitter to your sensor as described in the previous section. When the green light on the transmitter flashes, use your pump to follow the steps below. 1 2 3 4 5 Go to the LINK SENSOR MENU screen. Main > Sensor > Link to Sensor Select New Sensor. Press ACT.
Follow these guidelines for best calibration results: • • • • • Calibrate three to four times spread out throughout the day. Avoid calibrating when your glucose is changing rapidly, such as after eating or exercise. Enter your meter BG reading into the pump immediately after testing your BG. Do not wait to enter it later. Always use clean dry fingers when you check your blood glucose. Only use your fingertips to obtain blood samples for calibration.
• Chapter 8 3 If the Bolus Wizard is on, the saved BG is above your BG Target range, and the calculated correction estimate is more than the preset scroll rate increment, the Cal Saved screen appears. This screen indicates that your saved BG is above your BG Target set in the Bolus Wizard feature, and the pump beeps three times. Go to the ENTER BG screen of the Bolus Wizard feature to enter a correction bolus. See Using the Bolus Wizard feature chapter for more information.
140 Sensor features
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. Using your sensor Chapter 9 Your STATUS screens tell you what is going on in your pump.
Reading the sensor glucose graphs NOTE: If your graphs say DEMO in the upper left corner of your screen, you must turn off the SENSOR DEMO mode to see your actual graphs (see the Using the Sensor Demo section in the Sensor features chapter). Your pump shows an updated, continuous glucose measurement. This measurement is generated by data sent from the sensor to the transmitter, and then to the pump every five minutes.
Opening and viewing the graphs The following table describes how to use the graphs. Do the following: If you want to: From the HOME screen, press ESC. The last graph you viewed (3-, 6-, 12or 24-hour) shows the details for your most recent sensor glucose (SG) measurement. View information in a graph If there is no SG measurement at the time you select, the reason for the missing measurement will be shown on the right side of the graph (for example, LOST SENSOR).
The graphs All graphs show High and Low Glucose Limits lines, a continuous 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. There are three marks on the cursor at 5, 10, and 15 mmol/L (100, 200, and 300 if mg/dL is selected). 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.
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. 14:20 History LOST SENSOR Examples of continuous sensor glucose graphs The following pages show examples of the different graph types. Each part of the graph between the vertical dashed lines represents one hour.
6-hour graph Each part of the graph between the vertical dashed lines represents one hour. In this example, the selected SG measurement was taken at 1:12, and the value at that time was 8.3 mmol/L (150 mg/dL). 1:12 History 8.3 23:00 2:00 6 hours 12-hour graph Each part of the graph between the vertical dashed lines represents one hour. In this example, the reason no measurement is displayed is LOST SENSOR and it occurred at 14:20.
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 and the value at that time was 11.7 mmol/L (211 mg/dL). The shaded area is the 12 hours from 18:00 to 6:00 Chapter 9 11:50 24 Hour 11.
How to check for rapid changes in sensor glucose If your sensor glucose (SG) rises or falls faster than a certain rate, rapid change arrows automatically appear in the graphs next to the SG measurement, as shown in the following section. The rapid change arrows These examples show how the rapid change arrows tell you when your SG rises or falls faster than a certain per-minute rate. The arrow direction shows if your SG measurements are rising or falling.
How to make glucose alerts silent The Alert Silence feature allows you to silence glucose alerts for a preset amount of time. You may use this feature when you are in a business meeting, watching a movie in a theater, and so on. The system records the time and glucose measurement for each alert during this silent period. You can see this alert information in the SENSOR ALERT HISTORY screen. See the Sensor alert history section in this chapter for details.
4 5 6 7 • Alert Silence: Hi/Lo • Alert Silence: All To change the current alert silence settings, select Alert Silence, then press ACT. Select the alert silence option you want, then press ACT. The SET DURATION screen flashes a set of dashes or the length of time that you entered the last time you set an alert to silent. Select your alert silence length between 30 minutes (minimum) and 24 hours (maximum), then press ACT. The pump is in Special mode for the set silenced period.
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. Carefully remove any occlusive dressing from the transmitter and sensor. 2 3 Remove the sensor's adhesive tab from the transmitter. 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.
152 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, BG data, SG data, and AUC 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 32 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.
Item Description The number of times the Bolus Wizard feature delivered a food bolus only. Corr Only The total amount of insulin delivered using the Bolus Wizard feature with BG correction amount only. #Corr Only The number of times the Bolus Wizard feature delivered a BG correction bolus only. Food+Corr The total amount of insulin delivered using the Bolus Wizard feature with food and BG correction amount.
Item Description #Predict Lo The number of Low Predictive Glucose alerts. #Rise Rate The number of Rise Rate alerts. #Fall Rate The number of Fall Rate alerts. Number SGs The number of SG measurements received from the transmitter. Meter blood glucose information The table below lists the different types of meter blood glucose information that the system automatically records.
5 6 7 8 9 To view sensor glucose information for the same day you have selected in step 2, press ACT from the DELIVERY STATS screen. The SENSOR STATS screen appears, showing the sensor glucose information for the day you selected. The day you selected is shown on the title line of the screen. to view more information. See the table in the Sensor glucose information section in this Press chapter for descriptions of the sensor glucose information.
7 8 9 Press to view more information. See the table in the Sensor glucose information section in this chapter for descriptions of the information shown here. To view meter blood glucose measurement information for the same days you selected in step 3, press ACT. The METER STATS screen shows the meter blood glucose information. to view more information. See the table in the Meter blood glucose information section in this Press chapter for descriptions of the information shown here.
In the following example the AUC Limits are defined as 3.9 to 7.8 mmol/L (70 to 140 mg/dL), and are represented by the light shaded area. The actual AUC is the dark shaded area, between the sensor glucose curves and the defined limits. On average, the SG exceeded the AUC high limit by 1.7 mmol/L (30 mg/dL), and the AUC low limit by 0.2 mmol/L (3.9 mg/dL). 22.2 (400) 19.4 15.5 (280) AUC High Average = 1.7 mmol/L (30 mg/dL) 11.6 (210) 7.
5 6 Select your High AUC Limit. The number must be between 2.2 and 22.2 mmol/L (40 and 400 mg/dL). It can be equal to, but not lower than, the AUC Low Limit. Press ACT. The AUC MENU screen shows the AUC Limit you selected. To view AUC data for a single day: 1 2 3 Go to the AUC MENU. Main > Utilities > Daily Totals > Calculate AUC Select the day that you want to view. • To view totals for today, select Today. • To view totals for a previous day, select the date. Press ACT.
Personal reminders Alarm clock The alarm clock is a feature that allows you to set a maximum of eight daily reminders for various events. The factory setting for this feature is off. The alarm clock can be useful to remind you when to check your blood glucose, eat, bolus, etc. When the alarm clock goes off, the ALARM CLOCK screen appears. Press ESC, then ACT to clear the reminder. Go to the ALARM OPTION screen. 2 3 4 5 6 Main > Utilities > Alarm Clock Select On/Set. Press ACT. Select Add Alarm. Press ACT.
To use the remote control, these pump settings must be programmed: • • • Remote Options = On Remote control ID code entered in pump (code is on back of remote) Easy Bolus = On Turn on remote control option WARNING: If there is a LOW BATTERY condition, the pump will not receive signals from the remote. To ensure the pump communicates with the remote control, make sure the pump does not have a low battery. (Replacing the low battery with a new battery will restore remote control function.
Other Devices option The factory setting for this feature is Off. Other devices may be available to be linked to your pump. If available, refer to the appropriate device user guide for programming and operating instructions. NOTE: The use of RF (radio frequency) devices with the pump reduces battery life. Block feature Turning block on NOTE: Chapter 10 Block restricts access to pump programming. The factory setting for this feature is off.
Example 2: Block Oscar is an elderly man with diabetes who needs assistance with all of his daily living activities. He needs his caregiver or family member to help him with his pump as well. To be sure that Oscar does not change any pump settings, his family programmed his Paradigm pump with the Block feature turned on. They use the Remote Control to give him his boluses when he needs them. Lock keypad feature Lock keypad prevents accidental pump keypad presses.
NOTE: If the pump detects a condition such as low battery, the selftest will not finish. A message will appear to show the condition that caused the test to stop. 1 2 3 Main > Utilities > Selftest Select Selftest, then press ACT. Periodically, you will hear beeps as different mechanisms in the pump are being tested. As part of the selftest, the pump will do these tests: a. Screen Test: The screen will appear all black. b. Selftest: The pump will count down from 10. c. Tone Test: You should hear beeps. d.
Saving the settings Do these steps to save your current pump settings: 1 2 3 4 5 Go to the UTILITIES MENU screen and select User Settings. Main > Utilities > User Settings Hold down and press ACT. The USER SETTINGS screen is displayed with Save Settings highlighted. Press ACT. If this is the first time you have saved pump settings, go to step 5. If you have previously saved pump settings, a message displays, indicating the date of your last pump settings save.
Clearing the settings Take the following steps only if you want to clear your pump to factory default settings. WARNING: Do not clear your pump settings while it is connected to your body. CAUTION: Do not clear your pump settings unless directed by your healthcare professional or a Medtronic Diabetes representative. If you clear your pump settings, it will be necessary to reprogram all your personal pump settings as directed by your healthcare professional. Additionally, you will have to rewind your pump.
170 Utilities
Therapy management software Medtronic provides software to optimize your pump use. Contact your local representative for more information. CareLink® Personal Software Your pump provides continuous 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 • • • • • • • • 174 Dilated eye exam by a qualified eye care professional 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 Em
Troubleshooting, alerts 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.
What happens if I leave the pump battery out too long? If you leave the pump battery out too long (more than five minutes) you may receive a BATT OUT LIMIT alarm message when you install the new battery. Do the following steps: 1 2 3 Set your pump clock to the correct time, date, and year. Check to make sure that all your settings, such as basal rate, are set as desired.
What is a CHECK SETTINGS alarm? This alarm occurs after an E alarm or after you clear your pump. It is advising you to make sure that all your settings are correct. A CHECK SETTINGS alarm occurs after any of these actions: • • • All user settings were cleared (set back to their defaults) because there was an E-error alarm, The Clear Settings function was performed, or After you rewind when practicing without a reservoir when you first get your pump.
My pump buttons are not acting right during a bolus If the , or buttons are pressed and held down while a bolus is being delivered, the screen will freeze on that amount. Once the button is released, the units will ramp up to the amount delivered so far. Pressing and holding down the button will not stop the delivery of a bolus.
I submerged my pump in water Your pump is designed to resist accidental contact with water. Do not submerge in water during bathing, 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.
Answer: Your pump monitors activities and will alert you if a Special mode is active. Some alerts are a normal part of pump therapy, such as an active temporary basal. There are alerts that indicate a condition that is outside normal pump activity. For example, your pump notifies you with an alert when you need to replace the reservoir (LOW RESERVOIR) or replace your pump battery (LOW BATTERY).
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.
MISSED BOLUS Reason: You have not delivered a bolus during the time period you specified in the Missed Bolus Reminder feature. Action: Set a meal bolus if needed. 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.
Action: Recharge your transmitter as soon as possible. See your transmitter user guide for charging instructions. CHARGE TRANSMTR Reason: The transmitter battery is depleted. Action: Recharge your transmitter immediately. See your transmitter user guide for charging instructions. CHANGE 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.
Action: Follow the guidelines in the Calibrating the sensor section in the Sensor features chapter to enter a new meter BG for calibration. If you receive a Cal Error on your second calibration, a CHANGE SENSOR alert will occur. Call your local representative if you have questions. 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.
HIGH PREDICTED Reason: The sensor glucose measurements may reach or go above your High Glucose Limit in the length of time you selected for the High Predictive alert. The pump plays three consecutive tones, in rising pitch, if an audible beep has been selected as the alert type. RISE RATE Reason: The sensor glucose measurements are rising at a rate that is equal to or faster than the Set Rise Rate Limit you selected for the alert.
NOTE: The STATUS screen shows any alarms and alerts that are active. Question: Why are alarms important? Answer: Your pump monitors activities and notifies you if there is an unusual pump status or your attention is required. When an alarm is active, INSULIN DELIVERY IS STOPPED and immediate operator interaction is required. If the vibrate mode is on and your pump triggers the LOW SUSPEND alarm, it immediately starts with a siren to get your attention.
Alarm conditions Alarms put the pump in Attention mode. A (ALARM) This alarm shows the letter A followed by two numbers. A-alarms cause all insulin delivery to stop. Your pump settings are retained. If this alarm repeats often, call your local Medtronic Diabetes representative 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.
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. EMPTY RESERVOIR There is no insulin in the reservoir. Change the reservoir immediately.
MAX DELIVERY This alarm alerts you when you have taken more insulin than expected based on Maximum bolus and Maximum basal rates. MOTOR ERROR Insulin delivery has stopped. This alarm occurs if your pump detects a motor error. NO DELIVERY Insulin delivery has stopped. This alarm will occur if your pump detects a blockage or if the reservoir is empty. Refer to the first page of the Troubleshooting chapter for additional information.
LOW SUSPEND When your sensor glucose measurement is below the Low Suspend Limit, the LOW SUSPEND alarm screen appears, and all insulin delivery stops. A siren starts immediately to get your attention or to get help from others if you are unable to respond to the alarm. The pump vibrates and sounds the siren until you or someone else pushes a button on the pump.
To keep your insulin delivery suspended after clearing the alarm: 1 2 3 Press ACT with the Suspend option highlighted in the LOW SUSPEND/CHECK BG screen. The SUSPEND screen appears, and the pump soon returns to the HOME screen. Check your BG and treat as appropriate. After your blood glucose has returned to an acceptable measurement, see the following section to restart delivering your pump's programmed basal.
Testing the transmitter The tester acts like a sensor. If you get sensor-related alerts, use the tester to make sure that the transmitter is working. Connecting the tester 1 Hold the transmitter and the tester as shown. Line up the flat side of the tester with the flat side of the transmitter. 2 Push the tester into the transmitter until the flexible side arms of the tester click into the notches on both sides of the transmitter.
Disconnecting the tester 1 Hold the transmitter body as shown and pinch the side arms of the tester. 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. To Reconnect old sensor: Go to the RECONNECT OLD SENSOR screen.
Find lost sensor If you receive a Lost Sensor alert: 194 1 Relocate the pump closer to the sensor, and go to the LINK SENSOR MENU. 2 3 Main > Sensor > Link to Sensor Select Find Lost Sensor, then press ACT. The SENSOR READY 15 MIN screen appears. Press any button to continue. An alert will sound in 15 minutes when a meter BG is required for calibration.
Maintenance It is recommended that you read your warranty statement included in this user guide for information about what is covered during your warranty period. Battery The Paradigm pump uses a single 1.5 V AAA alkaline battery, size E92, type LR03. As a safety measure, Medtronic Diabetes has designed the pump to only accept a NEW battery. If you insert a used battery, the FAILED BATT TEST alarm may be triggered. Refer to the Install battery section in The basics chapter for instructions.
Storage If you have to remove and store your pump, it is recommended that you store it with the battery in place. Keep a record of your current basal rates. To preserve battery life, reset the basal rates to 0 (zero), turn off the remote and meter options, and set the Auto-off to dashes or zeroes. Cleaning your pump 1 2 3 4 5 6 7 8 9 196 Use only a damp cloth and mild detergent mixed with water to clean the outside of your pump. Rinse the pump with a clean cloth, dampened with clean water.
Pump specifications 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.
Backlight • • LCD (Liquid Crystal Display) type Time-out: 30 seconds Basal • • • • Delivery: 0.025–35 units/hour (maximum units: 35/hour) Factory maximum setting: 2.0 units/hour 3 patterns maximum, each with 48 rates Increments: • 0.025 units for basal amounts in the range of 0.025 to 0.975 units • 0.05 units for basal amounts in the range of 1 to 9.95 units • 0.1 units for basal amounts of 10.0 units or larger BG Target Maximum targets: 8 • • Range: 3.3–13.
Bolus units Increments: Based on selected scroll rate Bolus Wizard feature Chapter 15 See the Bolus Wizard feature specifications section in this chapter for information. Carb ratios Maximum ratio settings 8 Range Warning limits 1–200 grams/u less than 5 or greater than 50 grams/u 0.075– 15.0 u/exch less than 0.3 or greater than 3.0 u/exch Carb units The food entry when using Bolus Wizard feature: • • grams: 0–300 (increments: 1 gram) exchanges: 0.0–20 (increments: 0.
The following is a representative delivery accuracy curve. All infusion sets have +/-5 percent overall delivery accuracy error. Delivery Volume Accuracy Curve (-1.60%) Overall Error (MMT-754 Model) Qualification Pump (0.
Easy bolus • Chapter 15 • • • • • 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 Factory default: off Default step increment: 0.1 unit Step size ≤ maximum bolus. Adjustable step size: 0.1 to 2.0 units per step. Accessible from the remote control or pump buttons.
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: 1.1–33.
Power supply The pump is powered by a standard 1.5 V AAA alkaline battery, size E92, type LR03 (Energizer brand recommended). Chapter 15 Reservoir + Set history Maximum records shown: 20 (fill tubing and fill cannula) Program safety checks Maximum infusion with single fault condition: 0.0 units Pump size The dimensions of the pump are approximately: • • 554 pump: • 5.1 x 8.3 (7.1 at the battery cap) x 2.0 cm • 2.0 x 3.3 (2.8 at the battery cap) x 0.82 inches 754 pump: • 5.1 x 9.4 (8.
Square Wave bolus Delivers bolus insulin over a duration of 30 minutes up to eight hours (limited by the Max bolus setting). Temporary (temp) basal rate Allows you to temporarily change the current basal rate for a duration of 30 minutes up to 24 hours (limited by Maximum basal setting). The temp basal rate can be set to either Percent of basal or Insulin rate. Time and date screen 12-hour or 24-hour formats. Pump users set the time/date, including the year, month and day.
Item When What BG Reminder* (Only if enabled) Time remaining before BG Reminder is set to go off H:MM h (if less than 1 hour, 0:XXh where XX is minutes remaining) Block (if active) Current date (always appears) Current temp basal information (if active) rate (units per hour), duration, time remaining Last alarm/alert (if cleared within 24 hours) (Last:) with the date, time and abbreviation for the most recently cleared alarm/alert Last bolus information (appears if at least one bolus was sta
Item Time When What (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 four different formulas the Bolus Wizard feature uses to estimate a bolus, depending on your current BG. The following formulas apply only when the carb units are in grams. 1 (food estimate) total bolus estimate = A B Chapter 15 If your current BG is greater than your High BG Target, the Bolus Wizard feature subtracts active insulin from the BG correction estimate, then adds this to the food estimate to get the total bolus estimate.
3 If your current BG is between or equal to your High or Low BG Target, the total bolus estimate is based only on the food estimate. (food estimate) total bolus estimate = 4 food (grams) carb ratio If you do not enter a BG, the total bolus estimate is based only on the food estimate. NOTES: • If a Dual Wave bolus is less than the estimate due to the max bolus limit or a user change, the square (sq) portion is reduced first.
• The Bolus Wizard feature may utilize your current BG measurement, carbohydrate consumption, and active insulin to calculate your estimated bolus. Active Insulin Curves • Active Insulin Curve Chapter 15 100% 90% 8 Hour 80% 7 Hour 6 Hour 5 Hour 70% 4 Hour % Insulin Remaining 3 Hour 2 Hour 60% 50% 40% 30% 20% 10% 0% 0 1 2 3 4 5 6 7 8 9 Time (hours) Graph adapted from Mudaliar and colleagues, Diabetes Care, Volume 22, Number 9, Sept. 1999, page 1501.
Bolus Wizard feature examples Settings: • • • • Carb ratio: 30 grams/unit BG Target: 5.0–6.7 mmol/L (90–120 mg/dL) Insulin Sensitivity: 2.2 mmol/L/units (40 mg/dL/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: Bolus estimate: 2 60 g 30 g/u = 2 units 2 units No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a BG of 11.1 mmol/L (200 mg/dL).
3 No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a BG of 3.9 mmol/L (70 mg/dL). Food estimate: = 2 units 3.9 mmol/L - 5.0 mmol/L 2.2 mmol/L/u or 70 mg/dL - 90 mg/dL 40 mg/dL/u Chapter 15 Correction estimate: 60 g 30 g/u = -0.5 units = -0.5 units Bolus estimate = Food estimate + Correction estimate Bolus estimate = 2 units + (-0.5) units = 1.5 units 4 No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a BG of 5.6 mmol/L (100 mg/dL).
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 11.1 mmol/L (200 mg/dL). Food estimate: 60 g 30 g/u = 2 units Active insulin: 1.5 units Correction estimate: 11.1 mmol/L - 6.7 mmol/L 2.2 mmol/L/u or 200 mg/dL - 120 mg/dL 40 mg/dL/u - Active insulin = 0.5 units - Active insulin = 0.5 units Bolus estimate = Food estimate + Correction estimate Bolus estimate = 2 units + 0.5 units = 2.
Insulin delivery default settings Menu Default Setting Bolus Wizard feature: Off Easy bolus: Off Easy bolus step: Scroll Rate: Dual/Square bolus: Maximum bolus: Basal Menu: 2.0 u 0.10 u Increments 0.1 u 0.025 u; 0.05 u; 0.10 u Off 10.0 u 0.0–75.0 u (per single bolus) BG Reminder: Off 0:00–5:00 0:30 Patterns: Off 0.000–35.0 u/h 0.025 u (for 0.025– 0.975 u/h); 0.05 u (for 1.00–9.95 u/h); 0.
Menu Item Default Setting Capture Option: Low reservoir warning: 214 Pump specifications Increments Off (20) insulin units (Time/Date) Time: 12 a.m.
Bolus Wizard feature default settings Item Default Setting Increments Warning Limits — — — carb units: grams ins to carb (or exch) ratio: 15 grams/u or 1 unit/exch 1–200 g/u or 0.075– 15.0 u/exch 0.1 g/u for 0–9.9 g/u; 1 g/u for ratios of 10.0 g/u or more (or 0.001 u/exch for 0.075– 0.099 u/exch; 0.01 u/exch for 0.10–9.99 u/exch; 0.1 u/exch for 10.0– 15.0 u/exch) 5–50 g/u or 0.3– 3.0 u/exch (insulin) sensitivity: 2.8 mmol/L/ u or 50 mg/dL/u 0.5–22.2 mmol/L/u or 10–400 mg/dL/u 0.
Feature Glucose Limits 1 Options • • Glucose Limits 2 through Glucose Limits 8 • • 216 Default Setting Limits, Range of Values Low: 4.4 mmol/L (80 mg/dL) High: 13.3 mmol/L (240 mg/dL) Low: On 4.4 mmol/L (80 mg/dL) Low Glucose Limit range:a 2.2 – 21.6 mmol/L (40 – 390 mg/dL) High: On 13.3 mmol/L (240 mg/dL) High Glucose Limit range:b 2.8 – 22.2 mmol/L (50 – 400 mg/dL) Low: Off, or a valid range from 2.2 to 21.6 mmol/L (40 to 390 mg/dL) High: Off, or a valid range from 2.8 to 22.
Feature Rate of Change Alerts Options • • On Off Default Setting Fall Rate Limit Off On Off Rise Rate Limit range: 0.065–0.275 mmol/L/min (1.1–5.
Feature Options Alert Silence • • • • • AUC Limits Always on a. Off Hi Alerts Lo Alerts Hi and Lo Alerts All Sensor Alerts Default Setting Limits, Range of Values Off If any option other than Off is selected in the ALERT SILENCE screen, the SET DURATION screen displays. The value range is from 00:30 to 24:00. Low Limit 3.9 mmol/L (70 mg/dL) Low Limit range:d 2.2–22.2 mmol/L (40– 400 mg/dL) High Limit 10 mmol/L (180 mg/dL) High Limit range:e 2.2–22.
Guidance and manufacturer's declaration Guidance and Manufacturer's Declaration - Electromagnetic Emissions Emissions Test RF emissions Compliance Group 1 The Paradigm 554/754 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 554/754 pump system (consisting of the MMT-554/754 pump and MMT-7703 transmitter) is intended for use in the electromagnetic environment specified below. The customer or the user of the Paradigm 554/754 pump system should make sure that it is used in such an environment.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity The Paradigm 554/754 pump is intended for use in the electromagnetic environment specified below. The customer or user of the Paradigm 554/754 pump system should make sure that it is used in such an environment.
Guidance and Manufacturer's Declaration - Electromagnetic Immunity The Paradigm 554/754 pump is intended for use in the electromagnetic environment specified below. The customer or user of the Paradigm 554/754 pump system should make sure that it is used in such an environment. Immunity Test Radiated RF IEC 61000-4-3 IEC 60601 Level 10 V/m 80 MHz to 6.0 GHz Compliance Level 10 V/m Electromagnetic Environment Guidance 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 554/754 pump is intended for use in the electromagnetic environment specified below. The customer or user of the Paradigm 554/754 pump system should make sure that it is used in such an environment. NOTE: IEC 60601 Level Compliance Level Electromagnetic Environment Guidance At 80 MHz and 800 MHz, the higher frequency range applies. Chapter 15 Immunity Test NOTE: These guidelines may not apply in all situations.
Recommended separation distances between portable and mobile RF communications equipment and the Paradigm 554/754 pump system This section provides information on the recommended separation distance between portable and mobile RF communications equipment and the Paradigm 554/754 pump. The Paradigm 554/754 pump is intended for use in an electromagnetic environment in which radiated RF disturbances are controlled.
Icon table Follow instructions for use Attention: Read all warnings and precautions in instructions for use. Chapter 15 Manufacturer Date of manufacture (year - month) Batch code Use by (year - month) Catalogue number Device serial number Storage temperature range Magnetic Resonance (MR) unsafe Fragile product Type BF equipment (protection from electrical shock) Conforms to IEC60601-1 sub-clause 44.
Signifies compliance to Australian EMC and Radio communications requirements Signifies compliance with Industry Canada EMC and Radio communications requirements European conformity. This symbol means the device fully complies with MDD93/42/EEC (NB 0459). European conformity. This symbol means the device complies with R&TTE1999/5/EC directives (NB 0976). Applies to 868.35 MHz device (MMT-554WW, MMT-754WW).
Glossary A1C (HbA1c) test - A 2-3 month average of blood glucose values expressed in percent. The normal range varies with different labs and is expressed in percent (such as 4 - 6%). Accept - Pressing the ACT button to approve the selection or setting. Active insulin - Bolus insulin that has been delivered to your body, but has not yet been used. Adverse reaction - An unexpected, unpleasant or dangerous reaction to a sensor when it is inserted into the body.
pump for the delivery of basal insulin: Standard, A, and B. For each pattern, there is an option of setting up to 48 basal rates. 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.
bolus) in the last 24-hours. Maximum records: 32 days Default - A setting or value for your pump that is assigned automatically by your system. Some default settings cannot be changed; other default settings remain in effect until you change them. DKA - Diabetic Ketoacidosis Dual Wave® bolus - Combination of a Normal bolus that is delivered immediately, then followed by a Square Wave bolus. The Square Wave portion is delivered evenly over a period of time.
Generate - create a result (your pump will generate a graph). 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).
Interstitial fluid - The fluid between the cells in the human body. Log - A record of measurements, alarms or other actions by your pump. Introducer needle - This needle allows the insertion of a cannula or a sensor into the subcutaneous tissue. It is removed and discarded after insertion leaving only the cannula or the sensor in the body. Low Glucose - The pump displays an alert if the sensor indicates that your sensor glucose is at or below this value.
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. The now portion delivers immediately and is then followed by the Square portion. Nutrition - The process by which the body draws nutrients from food and uses them to make or mend cells.
Sensitive - Easily irritated (sensitive skin), or able to measure very slight differences (a sensitive instrument). Sensor Age - Sensor age is the amount of time, in days and hours, since the sensor was first inserted. Sensor glucose (SG) - Glucose levels in the fluid under your skin measured by the sensor. Sensor icon - An icon on your pump that tells you whether the Sensor feature is On or Off. Serter - The Serter is an aid for the insertion of a Medtronic Diabetes glucose sensor.
Transmtr Batt - The status of the transmitter battery. Possible values are Good, Low, or Bad. Transmtr ID - The serial number of the transmitter currently in use. Transmtr Ver - The software version of the transmitter currently in use. W Weak Signal - The pump displays an alert if it has not received data from the sensor for an amount of time that you set.
Index Numerics A accessories 2 activity guard 3 CareLink USB 3 holster 3 leather case 3 meter 2 pump clip 3 remote control 2 sensor 3 transmitter 2 active insulin 86 Active insulin time setting 87 adverse reactions 7 alarm clock 163 Alarm conditions 187 alarm frequency 197 ALARM HISTORY screen 153 Alarm types A (alarm) 187 Auto off 187 Batt out limit 187 for alert conditions 181 low reservoir alert 181 High Predicted 185 High XX.X MMOL/L 184 Lost Sensor 182 Low Predicted 184 Low Transmtr 182 Low X.
basal rate daily 56 maximum 57 patterns 108 programming 55 stop delivery of 58 temp 111 bathing 151 battery, pump 195, 203 install 26 removing 176 short life 176 beep/vibrate, alert type 31 BG, entering 50 BG Reminder 40, 48, 90, 99, 103 BG Targets 85 BG units 84 default settings 217 bleeding 5, 7 Block feature 165 turn on 165 BLOCK OPTION screen 165 blood glucose checking 138 entering incorrect number 183 rapid change 183 blood glucose measurements 50, 127 non-calibration meter, examples of 50 blood glucos
continuous sensor glucose levels 144 correction bolus 40, 89, 90 correction estimate 139, 207 D E Easy bolus 103, 104 cancel 105 deliver 105 step value 104 electromagnetic emissions 219 Electromagnetic environment 224 electromagnetic immunity 220 emergency kit 1 emissions 219 ENTER BG screen 50 ENTER FOOD screen 52 entering carbohydrate information 52 exercise information 52 insulin injection information 51 meter BG 137, 138, 139 alert 137 Bolus Wizard 138 frequency 137 Other markers 53 Entering meter BG
setting Predictive glucose alert 124 setting Rate of Change alerts 126 setting the Cal Reminder 128 turning on Glucose Alerts 120 graphs 144 continuous glucose 142 continuous sensor glucose levels 144 differentiating between current and earlier events in 143 opening 143, 144 green light transmitter 192 H high BG levels Bolus Wizard and 81 HIGH BG warning 81 High Glucose Limit default settings 216 setting 120, 184 High Predicted alert 185 High Predictive alert 125 High Repeat default settings 216 setting 12
modes Attention 32 Normal 32 Special 32 MWT1 2 MWT1 technology 77, 139 N O occlusive dressing irritation 5, 7 reaction 5, 7 Other markers 53 P pain 7 Patterns basal 108 on/off 108 pattern A, B 108 Program a basal pattern 108 Select a basal pattern 109 standard basal pattern 108 Personal reminders 163 personal settings 77 practicing 67 Q Quick-serter 71 Quick-set infusion set disconnecting 73 inserting 71 reconnecting 73 R Rate of Change alerts sensitivity and alarm frequency 126 reaction to occlusive d
default settings 215 disconnected 182 disconnecting from transmitter 151 information 141 ISIG 192 life 183 precaution 7 programming 119 reconnecting 193 removing 151 setting up 119 signals 185 too high 185 too low 185 stabilizing 183 starting 131 status screens 141 Transmitter ID 128 using in water 151 SENSOR ALERT HISTORY 150 sensor alerts Alert Silence 181 Cal Error 183, 184 Change Sensor 183 Charge Transmtr 183 Fall Rate 185 High Predicted 185 High XX.
T Temp basal canceling 116 delivering 115 rates 111 selecting type 115 verify delivery 116 temp basal types Insulin rate 111 Percent of basal 112 tenderness 7 terms and symbols 3 test plug.
242 Index
