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.
Warranty Medtronic Diabetes warrants the Medtronic MiniMed Insulin Pump against defects in materials and workmanship for a period of 4 years from the date of purchase. During the warranty period, Medtronic Diabetes will, at its discretion, either repair or replace (with a new or recertified pump, at Medtronic Diabetes’ discretion) any defective pump or motor, subject to the conditions and exclusions stated herein. In the event that a pump is repaired or replaced, the warranty period will not be extended.
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 .................................................................................... 64 Inserting the reservoir in your pump .................................................................. 65 Filling the tubing ......................................................................................... 66 Inserting the infusion set ................................................................................ 67 Quick-set infusion set (with Quick-serter®) ..............................
Example 2: Blood glucose above target (high blood glucose) and no active insulin ........... 90 Example 3: Blood glucose below target (low blood glucose) and no active insulin ............ 91 Example 4: Blood glucose above target (high blood glucose) with active insulin .............. 92 Example 5: Blood glucose below target (low blood glucose) with active insulin ............... 93 Chapter 7: Optimizing pump therapy ................................................... 95 Square Wave and Dual Wave bolus ...
Chapter 8: Sensor features .............................................................. 117 Entering your sensor settings ............................................................................ 117 Turning on the sensor .................................................................................. 117 Turning on the Glucose Alerts ........................................................................ 118 Setting the Glucose Limits ................................................................
Examples of continuous sensor glucose graphs ..................................................... 145 3-hour graph .......................................................................................... 145 6-hour graph .......................................................................................... 146 12-hour graph ......................................................................................... 146 24-hour graph .......................................................................
Lock keypad feature ...................................................................................... 165 Locking the keypad ..................................................................................... 165 Unlocking the keypad .................................................................................. 165 Selftest ...................................................................................................... 165 User settings ......................................................
Alerts ........................................................................................................ 177 Example: ................................................................................................. 178 What to do ............................................................................................... 178 Pump alert conditions ..................................................................................... 179 LOW RESERVOIR ................................................
FINISH LOADING ......................................................................................... 186 MAX FILL REACHED ...................................................................................... 186 MAX DELIVERY ........................................................................................... 187 MOTOR ERROR ........................................................................................... 187 NO DELIVERY ..................................................................
Carb ratios .................................................................................................. 199 Carb units ................................................................................................... 199 Daily totals .................................................................................................. 199 Default screen .............................................................................................. 199 Delivery accuracy ..................................
Glossary ...................................................................................... 227 Index .........................................................................................
xx Contents
Introduction Chapter 1 Thank you for choosing Medtronic Diabetes (legally known as Medtronic MiniMed, Inc.) as your partner in helping you gain better control of your diabetes. Whether you are beginning pump therapy for the first time or upgrading from a previous model, we believe that the combination of state-of-the-art technology and the simple, menu-driven programming of the pump will provide many benefits.
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.
Communication problems can usually be resolved by: • • • ensuring that there is less than 1.8 meters (6 feet) between the receiving device and transmitter, to include RF glucose meters; turning off or moving away from other RF transmitting devices; or reorienting or relocating the transmitter or receiving device, or both. • • Chapter 1 Communications problems may also occur due to cellular telephone interference.
10 Introduction
Introduction to pump therapy Theory of insulin pump therapy All people, with or without diabetes, need background insulin for normal functions of the body without food. They also need a dose of insulin on demand - when food is eaten. People without diabetes can trust that their pancreas will produce this insulin for them. People with diabetes need to take insulin in a way that is most like the way a pancreas produces it.
As long as you are ready to learn how to use the pump, the pump can work for you. Understanding pump therapy If you are new to pump therapy, you will need the following data from your healthcare professional. Gather this before going to your pump start appointment. If you are unsure, contact your healthcare professional or pump trainer for guidance. Basal rate Basal insulin is needed to maintain your target glucose values when you are not eating. Your pump allows up to 48 basal rates to be programmed.
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.
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. Preventing DKA If you have nausea or vomiting, immediately check your blood glucose and ketones. If your blood glucose is above 13.
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.
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 reservoir from package. Make sure plunger rod is fully extended. 2 Swab 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 the most common site for set insertions because absorption is very consistent.
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.
74 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.
Bolus Wizard feature settings Information Setting Insulin sensitivity: This ratio is used for your correction bolus calculations. BG units reduced / 1 unit of insulin This ratio is the BG units reduced by 1.0 unit of insulin. #1: __________ range: 0.5–22.2 mmol/L/u or 10–400 mg/dL/u #2: __________ NOTE: Your insulin sensitivity may vary throughout the day. #3: __________ (additional settings, if needed) Your pump allows you to program up to eight different insulin sensitivities.
Bolus Wizard feature settings Information Setting BG Target range: If your current blood glucose is above the BG Target range, the Bolus Wizard feature will calculate a correction dose. If your current blood glucose is below the BG Target range, the Bolus Wizard feature will calculate a negative correction and subtract it from your food bolus. #1: __________ start time #2: __________ (midnight) range: 3.3–13.
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 in this chapter 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.
94 Using the Bolus Wizard feature
Optimizing pump therapy Square Wave and Dual Wave bolus Square Wave bolus delivers a bolus evenly over a period of time (30 minutes to 8 hours). This bolus can be used for insulin delivery when you have eaten a long meal with extended snacking. It can also be useful if you have delayed food digestion due to gastroparesis or meals high in fat. A Square Wave bolus can be useful if a Normal bolus drops your blood glucose too rapidly.
See the following graphic for a description of the different bolus types: 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.
If you want to use the pump-to-meter link, make sure the meter option is on. Refer to the Meter option section in the Using the Bolus Wizard feature chapter for instructions. 1 2 3 4 5 6 Go to the ENTER BG screen. Press on your pump, or use the following path: Main > Bolus > Use Bolus Wizard Enter your blood glucose value, then press ACT. The ENTER FOOD screen appears. Enter your food, then press ACT. The ESTIMATE DETAILS screen appears. Scroll down to review the information there.
7 The SQUARE DURATION screen appears. Enter the amount of time you want the Square Wave bolus to last, then press ACT. NOTE: If you have BG Reminder turned On, the BG REMINDER DURATION screen displays. It allows you to set the duration before you are reminded to check your blood glucose after a bolus. See the BG Reminder section in the Basic programming chapter for information about this feature. 8 Press ACT to accept and deliver the bolus.
Step value setup You can set the step value from 0.1 to 2.0 units, or to the set maximum bolus limit of less than 2.0 units (factory setting: 0.1). Set the step to a number that is convenient to use and easy to multiply. Total # Steps = 4 Total # Button Presses = 4 4 Example: 2.0 unit Easy bolus with a step amount set at 0.5 units 1 Step = 0.5 units 3 1 Step = 0.5 units 2 1 Step = 0.5 units 1 1 Step = 0.5 units 0 0 0.5 1.0 1.
3 When your total bolus amount appears on the SET EASY BOLUS screen, press ACT. Listen/feel to count the steps without looking at the screen. For example: You need to deliver a 2.0 unit bolus, and your step size is set to 0.5. Each time you press , the units increase by the step amount of 0.5 units. To deliver 2.0 units, you need to press the button four times. (4 X 0.5 = 2.0) The screen will show 2.0 units. NOTE: For your safety, you cannot use the to select the Easy Bolus values.
Your turn: Easy bolus practice The factory default setting for the Easy Bolus feature is 0.1 unit steps. You can change the step level as necessary to a value that is more convenient for you to use and easier to multiply. Give your next bolus by using the Easy Bolus feature on your pump. Your step level is ________.
Add You can set up to four Missed Bolus Reminders. 1 2 3 Select Add Reminder on the MISSED BOLUS REMINDER screen, then press ACT. The Start Time flashes. Times can be entered in 30 minute increments. Set the Start Time, then press ACT. After this time is set, the End Time flashes. Set the End Time, then press ACT. If you enter the same Start Time and End Time, you will get one Missed Bolus Reminder in a 24 hour period.
Turning on the patterns Your pump is set at the factory with the basal patterns feature turned off. After you turn on patterns, you still have to program and select a pattern (A or B), as described in the next sections, before the patterns feature is active. If you turn off the patterns feature, your pump will automatically select your standard basal pattern. 1 Go to the PATTERNS OPTION screen. 2 Main > Basal > Basal Setup > Patterns Select On, then press ACT. The patterns feature is now on.
9 If you do not need to set up any more basal rates, press ESC. If you need to set up more basal rates, repeat steps 5 through 8 above for each rate. 10 After you press ESC, the BASAL RATE screen appears. The screen will show: • the current basal pattern and basal rate, • time it started, and • the 24-hour basal total. After you make changes to a pattern, the pump will use that pattern as the current basal. Make sure the basal you want is selected in the SELECT PATTERN screen.
Example 2: Basal patterns Cynthia has had diabetes for about 12 years and has been on her Paradigm pump for several weeks. Every Monday, Wednesday and Friday, Cynthia goes on a 3 kilometer walk in the morning. To prevent hypoglycemia on these days, she uses the patterns feature. For those days, she simply switches over to Pattern A, which she has programmed with a lower set of basal rates.
Temp basal types Based on your preference, you can select either Percent of Basal or Insulin Rate. Insulin rate (U/H) Insulin rate is a fixed basal in units per hour (U/H). This temp basal type is independent of your current basal. When you select Insulin rate (U/H) for your temp basal type, your pump will deliver the fixed amount you have set for the duration as set. The amount of your temp basal insulin rate can be set up to your Maximum basal rate setting.
Percent of basal Unlike insulin rate, the percent of basal is dependent on your current basal rates. Percent temp basal is a percentage of your current basal (0–200 percent limited to your Maximum basal rate setting). The temp basal amount is rounded down to the next 0.025 or 0.05 U/H increment based on the basal rate. The maximum percent limit is based on the largest basal rate segment with your programmed temp basal rate time. For example: It is 06:00 and your current basal rate is 1.50 U/H.
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 every hour during delivery. During delivery, go to the STATUS screen to see the current temp basal information. Temp Basal of 0.
Example 1: Temp Basal for a decreased temporary basal rate Ramon and his friends got together for an unplanned game of soccer. Before using the pump, he was taking shots to manage his diabetes. Ramon experienced frequent low blood glucose reactions sometimes during, and very often after, he played games with his friends. Now that he is using his Paradigm pump, he can use the Temporary Basal Rate feature to help prevent low blood glucose.
Your turn: Think of an activity where you might need to use a Temporary Basal Rate. At what rate is your current basal rate running? ____________ What Temporary Basal Rate would you try using at this time? ___________________ How long will you be active?___________________ What duration will you set for the Temporary Basal Rate?________________ Test your blood glucose before and during activity and several times after as well.
116 Optimizing pump therapy
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 mg/dL and mmol/L. 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 9:00. 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 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 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, the Low Glucose Suspend feature is set up 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.
NOTE: A new AAA or LR-03 battery contains enough power to recharge the transmitter more than 40 times. If the battery is installed incorrectly or is low, the charger will not work. Repeat the battery installation steps using a new battery. Installing a battery in the gray charger LOT 3 Push the battery cover in and slide it off (as shown in the following illustration). Insert a new Alkaline AAA or LR-03 battery.
Charging the transmitter To charge the transmitter: 1 If a green light on the transmitter is lit or flashing, do not connect it to the charger. The transmitter will not charge with its green light on. Wait until the green light turns off (approximately 30 seconds), and then connect the transmitter to the charger. 2 Connect the transmitter to the charger by lining it up, flat side down, with the charger. Push the two components together fully.
Starting the sensor To start the sensor working, you must complete the following steps in order: • • • • • • • • Insert a battery into the transmitter's charger. Charge the transmitter battery. Set up the sensor features. Insert the sensor. 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.
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 pad. 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 Charging the transmitter and Entering the transmitter ID sections in this chapter). You must also have the features set up and the sensor inserted (see the instructions in this chapter and those provided with your sensor). 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 You are now ready to use your pump to start communicating with the sensor and start sensor initialization. The pump will start a timer and notify you when the sensor is ready to use. Use your pump to follow the steps below: 1 2 3 4 5 Go to the LINK SENSOR MENU screen.
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.
and the pump beeps three times. Go to the ENTER BG screen of the Bolus Wizard feature to enter a correction bolus. See the Using the Bolus Wizard feature chapter for more information. • 2 Chapter 8 If the information is not correct, select Cancel, then press ACT. The SENSOR MENU screen reappears with Calibrate selected. Repeat the procedure and enter the correct information. c.
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 measurement at that time was 8.3 mmol/L. 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. 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 For the Enlite sensor, remove the adhesive tab from the transmitter. Hold the transmitter as shown, and pinch the flexible side arms of the sensor between your thumb and forefinger.
3 4 152 Once out of the water, put the pump back on and reconnect the infusion set. Check your infusion set tape and the sensor tape to make sure that they are not damaged.
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.
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 #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.
8 9 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. Press to view more information. See the table in the Meter blood glucose information section in this chapter for descriptions of the information shown here. AUC calculation The AUC (Area Under the Curve) feature measures how much and how long your sensor glucose measurements are outside the pre-defined AUC Limits.
6 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. AUC High and AUC Low values appear for the selected day. • AUC High is the average of AUC for sensor glucose values above the AUC High Limit for that day.
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. 1 Go to the ALARM OPTION screen. 2 3 4 5 6 Main > Utilities > Alarm Clock Select On/Set. Press ACT. Select Add Alarm.
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.) 1 Go to the REMOTE OPTION screen. 2 3 Main > Utilities > Connect Devices > Remotes Select On, then press ACT. The REMOTE ID MENU screen appears.
NOTE: The use of RF (radio frequency) devices with the pump reduces battery life. Block feature Block restricts access to pump programming. The factory setting for this feature is off. Block is an important safety feature if the pump user requires someone else to maintain complete control of pump operation. When block is on, the remote control is used to deliver a bolus and suspend/resume the pump. Direct pump programming is limited to suspend, block, and selftest.
Lock keypad feature Lock keypad prevents accidental pump keypad presses. You can only press the and the to view the STATUS screen, button to turn on the backlight. The remote control can be used to give a bolus or put the pump into Suspend. A locked keypad is automatically unlocked during the following: • • • Battery insertion Alarms Alerts Locking the keypad Go to the UTILITIES MENU. Select Lock Keypad, then press ACT. Press ACT again to lock the keypad.
3 4 Periodically, you will hear beeps as different mechanisms in the pump are being tested. As part of the selftest, the pump will do these tests: a. Screen Test: The screen will appear all black. b. Selftest: The pump will count down from 10. c. Tone Test: You should hear beeps. d. Vibrate Test: You will feel vibrations. After the selftest is finished, TEST COMPLETE screen appears. The screen will return to the UTILITIES MENU, then to the HOME screen.
Saving the settings 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.
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 • • • • • • • • 172 Dilated eye exam by a qualified ophthalmologist Annual flu shot Regular dental visits Nerve function tests EKG test over age 35 Prostate exam for men, breast exam for women Diabetes education review Replace Glucagon Emergenc
Troubleshooting, 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 the Charging the transmitter section in the Sensor features chapter. CHARGE TRANSMTR Reason: The transmitter battery is depleted. Action: Recharge your transmitter immediately. See the Charging the transmitter section in the Sensor features chapter. 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: 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 attention alarm is active, INSULIN DELIVERY IS STOPPED and immediate operator interaction is required. If the vibrate mode is on, all alarms and alerts start as vibrations and then change to beeps.
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.
NOTE: Two hours after you choose to keep your insulin delivery suspended, the pump automatically resumes delivering insulin at the basal rate (standard, pattern or temporary) that is programmed to be active for that time. The pump returns to the HOME screen as insulin delivery resumes. When you press ACT from the HOME screen, the following message appears: Basal delivery is resumed. Check BG. Press any key to cont.
3 Within 20 seconds, the green light on the transmitter will flash for about 10 seconds when properly connected. The Sensor feature must be turned On on your pump. Go to the RECONNECT OLD SENSOR screen to start your sensor. Main > Sensor > Link to Sensor > Reconnect Old Sensor You should see the sensor icon 4 on the pump screen, which means that the transmitter and the sensor are communicating. Within the next seven to eight minutes, go to the SENSOR STATUS screen to look for the Sensor ISIG value: a.
Troubleshooting sensor features Reconnect old sensor You should only use this feature if you have disconnected the sensor from the transmitter and have to reconnect them. To Reconnect old sensor: 1 Go to the RECONNECT OLD SENSOR screen. 2 3 Main > Sensor > Link to Sensor > Reconnect Old Sensor Press ACT in the RECONNECT OLD SENSOR screen. The SENSOR READY 2 HRS screen appears. Press any button to continue. An alert will sound in two hours when a meter BG is required for calibration.
Answer: The transmitter battery is very low. Leave the transmitter on the charger for eight hours to completely recharge. If the red light is still flashing after eight hours, call your local representative. It may be time to replace your transmitter. Question: Why do I see quick flashing red lights on the charger? Answer: Your charger battery is low. Make sure that the transmitter is not connected to the charger. Replace the charger battery with a new AAA or LR-03 battery.
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 Use only a damp cloth and mild detergent mixed with water to clean the outside of your pump. Rinse the pump with a clean cloth, dampened with clean water.
Cleaning the Serter This procedure describes how to clean the Enlite Serter (MMT-7510). If you are using a different sensor and insertion device, follow the directions in the user guide for the insertion device you are using. 1 2 3 4 Dampen a clean cloth with mild liquid soap and warm water. Wipe the Serter. Rinse the Serter with warm tap water. Wipe the Serter with 70% isopropyl alcohol. Place the Serter on a clean, dry cloth and let air dry.
196 Maintenance
Pump specifications Chapter 15 This section provides detailed information on specifications related to your pump. The safety features of your pump are individually listed and described. Alarms and error messages • • Indicators: audible tone (beep) or vibration (silent). All alarms and errors show messages on the pump's screen and provide instructions on what to do. Unresolved alarms will escalate to siren mode for added safety.
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 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.
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 Wave® bolus - Combination Dual 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.
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). A Glucagon Emergency Kit can be obtained in a pharmacy with a prescription.
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. K kPa (kilopascal) - A unit of measurement for quantifying force. Used to measure atmospheric pressure. Equivalent to 10,000 dynes per square centimeter. L LDL (Low-density lipoprotein) A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood.
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.
Sensor Age - Sensor age is the amount of time, in days and hours, since the sensor was first inserted. Sensor features - Optional continuous glucose monitoring capabilities. Sensor glucose (SG) - Glucose levels in the fluid under your skin measured by the sensor. Set - To enter or establish a value for your pump (set your BG Reminder). Set bolus - Selectable item available in the BOLUS MENU when the Bolus Wizard feature is inactive. One method of programming a bolus without the Bolus Wizard feature.
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 84 Active insulin time setting 85 adverse reactions 7 alarm clock 162 Alarm conditions 185 alarm frequency 197 ALARM HISTORY screen 153 Alarm types A (alarm) 185 Auto off 185 Batt out limit 185 for alert conditions 179 low reservoir alert 179 High Predicted 183 High XX.X MMOL/L 182 Lost Sensor 180 Low Predicted 182 Low Transmtr 180 Low X.
BASAL MENU 34 basal rate daily 56 maximum 57 patterns 105 programming 55 stop delivery of 58 temp 108 bathing 151 battery, charger low 192 battery, pump 193, 203 install 26 removing 174 short life 174 beep/vibrate, alert type 31 BG, entering 50 BG Reminder 40, 48, 88, 97, 101 BG Targets 83 BG units 82 default settings 217 bleeding 5, 7 Block feature 164 turn on 164 BLOCK OPTION screen 164 blood glucose checking 138 entering incorrect number 181 rapid change 181 blood glucose measurements 50, 125 non-calibra
Clear settings 168 connecting transmitter to sensor 136 tester 189 consumables 2 continuous glucose graphs reading 142 continuous graph display 128 continuous sensor glucose levels 144 correction bolus 40, 87, 88 correction estimate 139, 207 discarding transmitter 194 disconnecting sensor from transmitter 151 tester from transmitter 190 transmitter from sensor 151 downloading pump data 3 Dual Wave bolus programming with Bolus Wizard 99 without Bolus Wizard 96 dual/square option on-off 96 E Daily totals 1
glucose monitoring settings entering 118, 119, 120, 122, 124, 126, 160 selecting BG units 119 setting AUC limits 160 setting Glucose Limits 118 setting Glucose Limits, guidelines 120 setting Glucose Limits, setting start time 120 setting Glucose Limits, switching limits off 120 setting Predictive glucose alert 122 setting Rate of Change alerts 124 setting the Cal Reminder 126 turning on Glucose Alerts 118 graphs 144 continuous glucose 142 continuous sensor glucose levels 144 differentiating between current
METER BG NOW alert 125 Meter BG Now alert 182 meter IDs add, delete, review 87 meter option 86 rules 86 METER OPTION screen 87 METER STATS screen 159, 160 MiniLink transmitter 2 Missed Bolus alert 180 Missed Bolus Reminder 104 modes Attention 32 Normal 32 Special 32 MWT1 2 MWT1 technology 75, 138 no delivery 173 Normal bolus with Bolus Wizard 87 without Bolus Wizard 40 Normal mode 32 Now 100 Now portion of the Dual Wave bolus 97, 100 nutrition 19 O occlusive dressing irritation 5, 7 reaction 5, 7 Other ma
sensor alerts 150, 179 history 150 list 150 calibrating 137, 182 connecting with transmitter 136 default settings 215 disconnected 180 disconnecting from transmitter 151 information 141 ISIG 190 life 181 precaution 7 programming 117 reconnecting 191 removing 151 setting up 117 signals 183 too high 183 too low 183 stabilizing 181 starting 132 status screens 141 Transmitter ID 126 using in water 151 warnings 5 SENSOR ALERT HISTORY 150 sensor alerts Alert Silence 179 Cal Error 181, 182 Change Sensor 181 Charge
T Temp basal canceling 113 delivering 112 rates 108 selecting type 112 verify delivery 113 temp basal types Insulin rate 109 Percent of basal 110 tenderness 7 terms and symbols 3 test plug.
242 Index
