INSULIN PUMP User Guide
Paradigm® 515 and 715 Insulin Pumps User Guide
© 2006, Medtronic MiniMed. All rights reserved. This product is covered by U.S. Patent Nos. 6,551,276; 6,554,798; 6,872,200; 6,936,029; 6,979,326; 6,997,920; and 7,025,743. Other U.S. and/or foreign patents may be pending. Paradigm®, Paradigm Link®, Quick-serter®, Quick-set®, Silhouette®, and Sof-set®, CareLink®, Bolus Wizard®, Dual Wave®, and Square Wave® are registered trademarks of Medtronic MiniMed. Easy Bolus™ and ParadigmPAL™ are trademarks of Medtronic MiniMed.
Important Safety Information Regarding Your Paradigm Insulin Infusion Pump (includes all models) Avoid Immersing Your Pump In Water Although it is unlikely that water damage will occur if your pump is splashed or briefly dunked, you should avoid immersing your Paradigm infusion pump in water. To swim or participate in other water activities, always disconnect from your Paradigm pump and reconnect after water play.
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Contents Your personal information ............................................ xv Basal rate ..................................................................................................xv Carb ratios (meal bolus information) ............................................................... xvi Chapter 1 Introduction .................................................1 Availability ................................................................................................. 1 Assistance .............
Screen icons ..........................................................................................15 Battery .............................................................................................15 Time display .......................................................................................16 Reservoir volume .................................................................................16 Alert and alarm icons ............................................................................
Chapter 4 Starting on insulin ........................................ 43 Prepare your pump for use ........................................................................... 43 Filling the reservoir ................................................................................... 44 Changing your infusion set ............................................................................ 46 Removing the reservoir .............................................................................
Review your Bolus Wizard feature settings ....................................................... 70 Meter option ............................................................................................. 70 Meter rules ............................................................................................71 Add, delete, review meter IDs .....................................................................71 Normal bolus using Bolus Wizard feature ....................................................
Chapter 8 Utilities .................................................. 105 Alarm review ...........................................................................................105 Alarm details ....................................................................................... 105 Setting your alert type ...............................................................................105 Auto-off ..................................................................................................
My bolus stopped .................................................................................. 128 My pump buttons are not acting right during a bolus ........................................ 128 My pump won’t display my blood glucose reading from my meter ........................ 128 I dropped my pump ................................................................................ 129 I submerged my pump in water ..................................................................
Chapter 11 Pump specifications ..................................... 139 Alarms and error messages ..........................................................................139 Alarm history ...........................................................................................139 Backlight .................................................................................................139 Basal ......................................................................................................
Bolus Wizard feature examples .................................................................. 148 Default (factory) settings ............................................................................150 Icon table ................................................................................................153 Glossary .............................................................. 155 Index xii Contents ................................................................
Practice lessons and examples Bolus examples Meal bolus Normal meal bolus using the exchange system ..................................................25 Bolus practice .........................................................................................26 Normal meal bolus practice using exchanges ....................................................26 Normal meal bolus using carbohydrate counting ................................................
Bolus Wizard feature examples Example 1: BG on target (normal BG) and no active insulin ...................................75 Example 2: BG above target (high BG) and no active insulin ..................................76 Example 3: Blood glucose below target (low BG) and no active insulin .....................76 Example 4: Blood glucose above target (high BG) with active insulin .......................77 Example 5: Blood glucose below target (low BG) with active insulin ........................
Your personal information You may need the following information from your healthcare professional before going to your pump start appointment. If you are unsure, contact your healthcare professional or pump trainer for instructions. NOTE - This information is not for the Bolus Wizard® feature. Refer to Chapter 5, “Using the Bolus Wizard feature” for information on the Bolus Wizard feature. Basal rate Basal insulin is required to maintain your target glucose values when you are not eating.
Pattern A Basal rate Start time number #1 midnight #2 #3 (additional basal rates) #4 #5 #6 #7 #8 Pattern B Basal rate (units per hour) Basal rate Start time number #1 midnight #2 #3 (additional basal rates) #4 #5 #6 #7 #8 Carb ratios (meal bolus information) Your carb ratios are used to calculate your meal boluses. If you count grams: this ratio is the number of carb grams covered by one (1) unit of insulin.
Chapter: 1 Introduction Thank you for choosing Medtronic MiniMed 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. This User Guide is designed to help you to understand pump therapy and the operation of your pump.
Emergency kit Keep an emergency kit with you at all times to make sure that you always have necessary supplies. Inform a family member, co-worker, and/or friend where this emergency kit is kept. Please refer to “User safety” on page 7 for more information on pump safety.
Disposables The pumps use disposable reservoirs and infusion sets for insulin delivery. Installation instructions for Paradigm reservoir and infusion sets are provided in Chapter 4, “Starting on insulin.” ➠ Reservoirs: The 515 pump is intended for use with a 176-unit Paradigm reservoir (MMT-326). The 715 pump is intended for use with a 300-unit Paradigm reservoir (MMT-332), however it can also use the MMT-326 as well.
Download pump and meter data The Medtronic CareLink™ Therapy Management System for Diabetes Web site is designed to help you take information from all of your diabetes management tools—your insulin pump, blood glucose meters, and logbook—and organize it into easy-to-read charts, graphs, and tables. These reports can help you and your healthcare professional discover trends and other information that can lead to improved therapy management for greater control of your diabetes.
ParadigmPAL With ParadigmPAL™ you can do the following with your pump settings: ➠ See your pump settings on your PC screen. ➠ Backup, or save, pump settings to diskette or the hard drive of your PC. ➠ Quickly change your pump settings in case your healthcare professional needs to make a change to your pump therapy. ➠ Print copies of your pump settings for your records. How to wear your pump There are different ways to wear your pump.
How to use this guide NOTE - This User Guide shows sample screens only. Your pump screens may be slightly different. For step-by-step instructions, refer to the appropriate sections in this guide. See the Glossary for definitions of terms and functions. The terms and symbols used in this guide are in the table below.
User safety Indications The Paradigm 515/715 pump system is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus in persons requiring insulin. Contraindications Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four (4) blood glucose tests per day and to maintain contact with their healthcare professional.
Precautions Although the pump has multiple safety alarms, it cannot notify you if the set is leaking or the insulin has lost its potency. It is essential, therefore, that you test your blood glucose levels at least four times per day. If your blood glucose is out of range, check the pump and the infusion set to ensure that the necessary amount of insulin is being delivered. Avoid extreme temperatures 1 Avoid exposure of your pump and remote control to temperatures above 108°F (42°C) or below 34°F (1°C).
Notice CAUTION: Any changes or modifications to the devices not expressly approved by Medtronic MiniMed could void your ability to operate the equipment. Insulin pump and RF accessories The pump, Paradigm Link meter, and remote control comply with the United States Federal Communications Commission and international standards for electromagnetic compatibility. Do not use the RF meter to send your blood glucose reading to the pump while on an aircraft. Manually enter your blood glucose levels.
10 Chapter: 1
Chapter: 2 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. 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, a new AAA Energizer alkaline battery is recommended. Medtronic MiniMed 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” alarms may sound. If a “weak battery” alarm happens, respond to the alarm and continue. The pump will still operate normally, but with a decreased battery life.
5 While the pump turns on, it will show various screens until the HOME screen appears. 7 Ver X.XX HOME screen NOTE - If you are replacing a battery for a pump that has very recently been in use, the only screen you will see before the HOME screen is the one displaying the version number. If the HOME screen does not appear, do these steps: a. Check that the battery is inserted correctly. If the battery has been installed backwards, remove the battery and install it properly. b.
Pump buttons The buttons on the pump are used to navigate through the menus and screens, and to program the features of the pump. UP button (From the HOME screen, this is the EASY BOLUS button.) EXPRESS BOLUS button DOWN button ESC button From the HOME screen EASY BOLUS button—Shortcut to set and deliver an Easy Bolus. Turns the backlight on/off from the HOME screen. Opens the MAIN MENU. Opens 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, call the Medtronic MiniMed 24 Hour HelpLine.
Time display The current time of day is displayed across the top of the pump screen in the format you select—12-hour or 24-hour. The AM or PM is only displayed for the 12-hour format. For instructions on setting the time on your pump, see “Setting the time and date” on page 23. 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.
Screen backlight When you press from the HOME screen, the light on the screen turns on or off. During programming, the backlight can be turned on by pressing the and the together. The light will stay on while you are pressing any of the pump buttons. It will stay on as long as the current screen is active. To conserve your battery, the backlight will turn off automatically while the pump is vibrating. After the vibration is finished, the light will turn back on.
Special - indicates a special feature is active or an alert condition(s) exists. Special mode does not restrict any of the pump functions. When the pump is in Special mode, an open circle appears at the top of the screen and it will beep/vibrate periodically to remind you of the condition.
Menus The MAIN MENU is the highest level menu. There are submenus, functions, status and programming screens in the lower menu levels. The menus are described in the following paragraphs. TIP - If a screen item is flashing (blinking), during programming, press value. / to change the MAIN MENU - Highest menu level in the menu system. When you press ACT from the HOME screen, the MAIN MENU will appear. BOLUS MENU - Contains the settings and functions for bolus deliveries.
STATUS screen The STATUS screen shows information about what your pump is doing. The information that shows on the STATUS screen depends on the current activities and conditions of your pump. ➠ To open the STATUS screen, press ESC until the STATUS screen appears. ➠ To view more text on STATUS screen, press / to scroll and view all of the information. ➠ To exit the STATUS screen, press ESC until the STATUS screen disappears.
If you remove your pump Pump settings You may have an occasion when you need or want to remove your pump. If you have to remove and store your pump, it is recommended that you 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 RF options (meter, remote), and set Auto-off to dashes or zeroes. NOTE - Your pump keeps a record of the basal and bolus insulin it delivers. Setting your basal to 0.
22 Chapter: 2
Chapter: 3 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.
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. TIME SET AT 8:33 AM 26FEB2004 Bolus There are three bolus types: Normal, Square Wave , and Dual Wave . This section gives instructions for a Normal bolus using the express bolus button and navigating through the menus. (For information about Square Wave and Dual Wave boluses, refer to chapter 6, “Optimizing pump therapy.
2 If the SET BOLUS screen appears: (Dual/Square option is off) Go to Step 3. 3 Enter your bolus amount and press ACT. SET BOLUS 0.0 U If the BOLUS TYPE screen appears: (Dual/Square Wave is on) Select Normal Bolus and press ACT. Go to Step 3. SET BOLUS* 0.0 U / BOLUS TYPE Normal Bolus Square Wave Bolus Dual Wave Bolus SET BOLUS* 2.5 * “SET NORMAL BOLUS” will show if Dual/Square option is on.
Bolus practice: Going through the menus, program a 2.0 unit Normal bolus now. Check here if you were able to program it. Using the express bolus button , program a 2.0 unit Normal bolus now. Check here if you were able to program it. Normal meal bolus practice using exchanges: Choose a meal you might eat and fill in the blanks.
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. Your total bolus (meal bolus plus correction bolus) is _________.
Review your bolus deliveries You can view a list of your bolus deliveries in the BOLUS HISTORY screen. This screen shows a list of the dates, times, units, and types for your last 24 boluses. This feature is helpful for record keeping or to check if you bolused for your last meal. If a bolus was stopped before delivery was complete, the BOLUS HISTORY screen will show only the amount actually delivered. See “Bolus details” on page 30 for instructions about viewing bolus details.
Bolus details You can view the details for any of the deliveries in the BOLUS HISTORY screen. The details include: ➠ bolus types: normal, square, and dual ➠ programmed bolus amount ➠ delivered bolus amount Bolus Wizard feature information (if you are using the feature) To see the details for any bolus, do these (without the Bolus steps: Wizard feature) ➠ 1 In the BOLUS HISTORY screen, select the bolus that you want to review and press ACT. 2 The details for that bolus will appear on the screen.
Maximum bolus limit The maximum bolus (max bolus) is a safety feature that you can use to set a limit on the amount of insulin that can be delivered in a single bolus. The factory setting is 10.0 units. You can reset the limit to anywhere between 0.0 units up to 25.0 units. It is important to discuss this feature with your healthcare professional to determine your maximum bolus limit. To set the maximum bolus limit, do these steps: 1 Go to the MAX BOLUS SETUP screen.
BG reminder When you deliver a bolus you may want to check your blood glucose afterwards. The BG reminder is an optional feature that you can use to have the pump send you a reminder you to check your blood glucose after a bolus. You can set the pump to remind you with an audible ‘beep’ or by vibrating. Your pump is set at the factory with this feature turned off.
Basal Basal insulin is required to maintain your target glucose values when you are not eating. Your healthcare professional will calculate this rate for you. Your basal insulin should account for approximately one half of the body’s total daily insulin requirements. Your pump mimics your pancreas by delivering insulin continuously over 24-hours. You can set your insulin pump to change rates during the day to match your needs. Your needs depend on your lifestyle and insulin requirements.
Your basal settings You must program your basal settings before you can deliver basal insulin. Keep a written record of your basal settings. It is recommended that you set your basal rates with the assistance of your healthcare professional. If you plan to take off your pump for an extended period of time, i.e. more than a day, set the basal rate to 0.00 U/H. This will ensure that the insulin delivery records in your pump are accurate.
If you need to program more than one basal rate for the day, do these steps: a. In the SET START TIME 2 screen, enter the start time for the next rate and press ACT. b. The SET BASAL RATE 2 screen will appear. Enter the rate and press ACT. SET START TIME 2 - -: - - _. _ _ U H ACT SET BASAL RATE 2 7:30A _. _ _ U H ACT start time (flashing) to set / rate (flashing) / c. Repeat steps a and b for each additional basal rate. Each rate will have a different number (i.e.
Basal review Temporary basal information is only available in the STATUS screen. Current basal delivery The STATUS screen shows your current basal information. standard basal is the current basal STATUS U100 Last Bolus N 3.8U 9:07A 11 JAN Basal 1: 0.80 U/H Units Left: 128.0U Battery: Normal Remote: On Tue 11 JAN 2004 S/N #000000 Paradigm 515 Ver X.XX X.X Daily basal rate(s) The BASAL REVIEW screen shows your daily basal rates programmed for delivery from midnight to midnight (12:00A to 12:00A).
2 If you do not use patterns: The delivery details for your standard basal will appear. STANDARD 16.80 U 0.60U/H 1.00U/H 0.80U/H 1) 12:00A 2) 11:30A 3) 12:00P basal rate start times If you use patterns: The screen will show the basal patterns. The current basal pattern will be highlighted. Select the pattern you want to view. Press ACT. (24-hour total) The start time and basal insulin from 12:00A units for each delivery rate in that to 12:00A basal delivery rates pattern will appear.
Max basal rate Maximum basal rate is a safety limit for the amount of basal insulin that is able to be delivered per hour. This maximum rate will apply to every basal rate that is set, including a temporary basal. It is important to discuss what your max (maximum) basal rate should be with your healthcare professional.
Stopping your pump You can stop your pump with the suspend function. Suspend stops all insulin delivery including the current basal and any bolus or prime deliveries that are in progress. While suspended, your pump will not deliver insulin until you Resume your pump. When basal is resumed, the pump is taken out of the Suspend mode. The pump will beep or vibrate about every 15 minutes on the hour to remind you that it is not delivering insulin. Example: You suspend your pump at 11:20AM.
Resume pump delivery When the pump is suspended, it defaults to the HOME screen with a solid circle. Do these steps to resume your pump and basal delivery: 1. From any screen, press ACT until the RESUME screen appears. Press ACT again. 2. Your pump will beep once, then the HOME screen will appear (with no circle). NOTE - A bolus or fixed prime that was stopped by suspend will not restart when you resume your pump. You must reprogram and activate it to finish delivery.
Practice: Suspend function 1 Make sure you are NOT connected to your pump while practicing. Program your pump to deliver a Normal bolus of 3.0 units. Once the bolus begins, stop the bolus by suspending your pump. Remember, when you stop the bolus delivery with “Suspend,” ALL insulin delivery will stop. 2 Now, “Resume” delivery so that you will continue to receive your basal insulin. 3 Check the STATUS screen. 4 How much insulin did the bolus deliver before you Suspended delivery? _______.
42 Chapter: 3
Chapter: 4 Starting on insulin Prepare your pump for use Before continuing with the steps in this chapter, we recommend that you watch your pump training CD-ROM and complete your pump start training. When you are done practicing and ready to use your pump with insulin, you must: 1 Make sure the time and date are correct on your pump, 2 program your settings as instructed by your healthcare professional, 3 install the reservoir, and 4 prime the infusion set.
Filling the reservoir WARNING: When filling the reservoir, take care to remove air bubbles. CAUTION: Insulin comes in different vial types depending on your country. If your vial is different than the one described in this User Guide, consult with your healthcare professional on how to fill your reservoir. 1 Remove reservoir from package. Make sure plunger rod is fully extended. plunger rod 2 Swab vial with alcohol.
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. 6 Gently tap the side of the reservoir to make any air bubbles rise to the top of the reservoir. 9 While holding the transfer guard, turn the reservoir counter-clockwise then pull straight up to remove it from the transfer guard. 7 Slowly push up on the plunger just enough to remove any air bubbles from the reservoir.
11 Tap the side of the reservoir to remove any air bubbles. 12 To purge air bubbles that have risen to the top of the reservoir, push up on the plunger until you see insulin in the tubing. 13 Without pulling, turn the plunger rod counter-clockwise to remove it from the reservoir. Changing your infusion set Removing the reservoir Each time you remove and replace a reservoir in your pump, you have to rewind and prime your pump. Priming requires insulin. 1 Remove the entire infusion set from your body.
Rewinding your pump Before you continue, make sure the pump is NOT connected to your body. WARNING: Make sure the infusion set is disconnected from your body before you rewind or prime the pump. Never insert the reservoir into the pump while the tubing is connected to your body. Doing so could result in an accidental infusion of insulin. 1 If you removed your reservoir and are replacing it, go to the REWIND screen. Main > Prime > Rewind 2 In the REWIND screen, press ACT to start the rewind process.
Inserting the reservoir in your pump If your reservoir is already inserted in your pump, continue to “Manual prime” on page 49. You must do these steps in the order described. Your pump screen will show instructions to help you with these steps. If you are practicing, do NOT insert the reservoir in your pump. CAUTION: You must rewind your pump before installing a new reservoir. As part of the pump’s function, it measures the reservoir volume.
Manual prime Manual prime fills the infusion set tubing with insulin before you attach it to the infusion site. Manual prime is only available after you rewind your pump. WARNING: Make sure the infusion set is disconnected from your body before you press ACT to prime the pump. Never insert the reservoir into the pump while the tubing is connected to your body. Doing so could result in an accidental infusion of insulin. 1 After you rewind your pump, the PREPARING TO PRIME screen will appear.
IS PRIMING COMPLETE? Disconnect from body See user guide for instruction. ESC, ACT to clear If your manual prime uses more than 30U insulin, the pump will ask you, “is priming complete?” If you get this message, do these steps: a. Make sure you are not connected to the pump. b. Read the message on the screen, then press ESC, ACT to clear. a. If your manual prime is complete (you see droplets on the tip of the infusion set needle), press ESC and continue to step 5.
Quick-set infusion set (with Quick-serter®) Always refer to the instructions that shipped with your infusion set. 1 Wash your hands. 2 Clean and dry the infusion site.
10 11 12 13 Disconnecting Quick-set The Quick-set allows you the freedom to temporarily disconnect from your pump without removing the infusion set from your body. Hold the side grips of the connector part with your fingers. 52 Chapter: 4 Twist the connector counterclockwise. Remove the connector from the site.
Reconnecting Quick-set A fixed prime is used before reconnecting the Quick-set to ensure that insulin has filled the infusion set. Refer to the section, “Fixed prime” on the next page for instructions. Place the connector part (flat-side facing down) on the infusion set until it is fully seated. Do not grip the connector part by the flat side-grips.
Fixed prime A fixed prime fills the soft cannula with insulin and is required after the infusion set is inserted into your body and the introducer needle is pulled out. Additionally, a fixed prime is required prior to reconnecting the tubing to the infusion set to ensure that all air is removed from the tubing. NOTE - Prime amounts depend on the type of infusion set you are using. See your infusion set instructions for your fixed prime amount. 1 Go to the PRIME MENU.
Record keeping for diabetes management Now that you are using the pump with insulin, we will be asking you to test your blood glucose regularly. The information from your blood glucose journal is your healthcare professional's only method of making adjustments in your pump settings. 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.
Using your daily journal To use the daily journal that came with your pump, follow these easy steps: 1 Write the day and date in the spaces provided on the top of the page. 2 Find the time of the entry you are making. Test your blood glucose and enter the value in the space labeled “blood glucose.” 3 If you are eating at this time, write the grams of carbohydrates in the space labeled “carbohydrates.
Chapter: 5 Using the Bolus Wizard feature What is it? A feature that calculates an estimated bolus: ➠ to support your food intake AND/OR ➠ to correct high blood glucose Information you need Food entry You need to know how many exchanges or grams of carbohydrates you are going to eat. (You need to know what foods contain carbohydrate and understand carbohydrate counting.) Your blood glucose (BG) reading You need to know your blood glucose levels.
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 “Bolus Wizard feature settings table,” on this page and the next page. Bolus Wizard feature settings Information Carb units: Carb ratios: Bolus Wizard feature uses this for your food bolus calculations. If you count carbs: This ratio is the amount of carbohydrate grams covered by one (1) unit of insulin.
Bolus Wizard feature settings Information BG target range: If your current BG is above the BG Target Range, the Bolus Wizard feature will calculate a correction dose. If your current BG is below the BG Target Range, the Bolus Wizard feature will calculate a negative correction and subtract it from your food bolus. range: (mg/dL) 60 - 250 (mmol/L) 3.3 - 13.9 NOTE - Your pump will allow you to program up to eight (8) different BG target ranges.
How the Bolus Wizard feature works If you are going to eat and you want the Bolus Wizard feature to estimate your food bolus: 1 Enter your blood glucose reading. ➠ automatically from the Paradigm Link meter (refer to “Meter option” on page 70) or ➠ manually by selecting the button. 2 Enter your food amount in carbs or exchanges. 3 The Bolus Wizard feature will calculate an estimated food bolus for you. An ESTIMATE DETAILS screen will appear with your estimated total food bolus amount.
More about the Bolus Wizard feature About high or low blood glucose levels If your blood glucose is less than 60 mg/dL (3.3 mmol/L), or more than 250 mg/dL (13.9 mmol/L), the Bolus Wizard screen will notify you and give you instructions. Read the instructions and press ACT or ESC to clear the message. You can continue programming and deliver your bolus. LOW BG DO NOT BOLUS UNTIL BG IS NORMAL. Treat low BG. Monitor BG. HIGH BG Check for occlusion Check ketones. Consider insulin injection. Monitor BG.
About active insulin Active insulin is the bolus insulin that has already been delivered to your body, but has not yet been used. The Bolus Wizard feature 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. The Bolus Wizard feature automatically tracks active insulin ESTIMATE DETAILS If there is no 4.
Bolus Wizard feature on/off 1 Go to the EDIT SETTINGS screen. Bolus > Bolus Wizard Setup > Edit Settings 3 Select On or Off and press ACT. 2 Select Wizard and press ACT. EDIT SETTINGS Off Wizard Carb Units: ----BG Units: ACT WIZARD ON/OFF Off On ACT 4 The EDIT SETTINGS screen will appear. Press ACT to program your settings.
Carb units The carb unit setting lets the pump know which way to count your carbohydrates (grams or exchanges). See the “Bolus Wizard feature settings” table on page 58 for your carb ratio settings. NOTE - Any time you make changes to the carb units, you must also reprogram the carb ratios. 1 In the EDIT SETTINGS screen, select Carb Units and press ACT. EDIT SETTINGS Wizard: On Carb Carb Units: Units:- - BG Units: --- 2 Select Grams or Exchanges and press ACT.
NOTE - Carb ratio values are normally between 5–50 grams/u or WARNING A carb ratio of XX is valid but outside the usual range of 5-50.* ESC to correct, ACT to continue 0.3–3.0 u/exch. If your ratio value is outside the range, this warning message will appear on the screen. Press ESC to correct or ACT to continue. (* 0.3 - 3.0 for exch) To set just one ratio: a. Press ESC.
BG (blood glucose) units You can select mg/dL or mmol/L as your BG units (unit of measurement type). NOTE - If you make changes to your BG units setting, you must reprogram your insulin sensitivity and BG targets. 7 In the EDIT SETTINGS screen, select BG Units and press ACT. 8 Select mg/dL or mmol/L and press ACT. 9 The screen will return to the EDIT SETTINGS screen to set your insulin sensitivity next.
3 The SET START TIME 2 screen will appear. 4 To set just one insulin sensitivity: To set more than one insulin sensitivity: Press ESC. SET START TIME 2 _: _ mg/dL ___ per unit insulin a. Set the start time for the next insulin sensitivity and press ACT. SET START TIME 2* 7:30A mg/dL ___ per unit insulin (flashing) set, then press ACT (flashing) b. Set the value for the next insulin sensitivity and press ACT. INS SENSITIVITY 2* 7:30A mg/dL 50 per unit insulin c.
NOTE - Pumps are sent from the factory with a BG target range of 90-140 mg/dL (5.0-7.8 mmol/L). If you adjust your BG targets outside of 90-140 mg/dL (5.0-7.8 mmol/L), the pump screen displays a warning that the values are acceptable but outside the normal range. 1 In the EDIT SETTINGS screen, select BG Target and press ACT. 2 Enter the low end of your BG target range and press ACT. Then enter the high end of your BG target range and press ACT.
Active insulin time The active insulin time setting lets the pump know which active insulin time to use in calculating the amount of active insulin to subtract before estimating a bolus. See “About active insulin” on page 62 for more information about this setting. Your healthcare professional should determine the active insulin time that is best for you. To set the time, take the following steps: 1 In the EDIT SETTINGS screen, select Active Ins Time and press ACT.
Review your Bolus Wizard feature settings Check your Bolus Wizard feature settings in the REVIEW SETTINGS screen. If necessary, compare this information with your information in the Bolus Wizard feature settings table. Bolus > Wizard Setup > Review Settings 1 In the REVIEW SETTINGS screen, scroll through the text to view your Bolus Wizard settings. 2 Exit the menus when you are done.
Meter rules If you want your pump to communicate with the Paradigm Link meter, the following conditions must apply: 1 The meter option must be turned on and programmed. See “Meter option” on page 70 for instructions. 2 Your pump must be within 4 feet (1.22 meters) of your Paradigm Link meter to receive blood glucose readings. 3 The pump cannot have a LOW BATTERY alert condition.
2 Add, delete or review your meter ID(s) as desired. Add Delete Review a. Select Add ID and press ACT. a. Select Delete ID and press ACT. a. Select Review ID and press ACT. b. Use the up and down arrow buttons to enter each of the six ID numbers. Press ACT after each entry. b. Select the meter ID that you want to delete and press ACT. b. The programmed IDs will show in the REVIEW METER ID screen. ADD METER ID - - - - - - (flashing) c.
Normal bolus using Bolus Wizard feature After the Bolus Wizard feature is turned on and programmed, this feature can calculate an estimate of insulin you need for your correction bolus and/or your food bolus. You have the option of using the estimate or changing it as necessary. Additionally, your pump can receive your blood glucose readings from the Paradigm Link meter, if they are linked. Use to deliver a normal bolus at any time except during another Normal bolus.
4 In the ENTER FOOD screen, if this is a food bolus: if this is a correction bolus: enter the food value you will select 0 (zero) as the value and eat and press ACT. press ACT. ENTER FOOD 45 ENTER FOOD grams* 0 * or exch (flashing) 5 Review the information in the ESTIMATE DETAILS screen. Press ACT to continue to step 6. If you need to make any changes, press ESC to return to the ENTER BG screen (step 3) and make changes as necessary. grams* * or exch (flashing) ESTIMATE DETAILS Est total: 4.
Bolus Wizard feature examples For the scenarios that follow, Michael has his Bolus Wizard feature turned on with the following settings: ➠ Carb ratio: 15 grams per unit of insulin ➠ Insulin Sensitivity: 40 mg/dL (2.2 mmol/L) per unit of insulin ➠ BG Target: 90-120 mg/dL (5.0 - 6.
Example 2: Blood glucose above target range and no active insulin The next day, Michael wakes up before school. Before eating the same breakfast, he tests his blood glucose with his Paradigm Link meter and finds it to be 200 mg/dL (11.1 mmol/L), which is above his High BG target of 120 mg dL (6.7 mmol/L). His blood glucose reading is automatically sent to his pump. When prompted by the Bolus Wizard feature, he enters his carbohydrate amount of 60 grams in the ENTER FOOD screen.
Example 4: Blood glucose above target range with active insulin Michael is at school and wants to eat a snack in the late morning. He tests his blood glucose with his Paradigm Link meter and finds it to at 200 mg/dL (11.1 mmol/L), which is above his High BG target of 120 mg/dL (6.7 mmol/L). He estimates that his snack contains 60 grams of carbohydrate, so he enters 60 into the pump when prompted by the Bolus Wizard feature. Based on his settings, and as a result of 1.
Example 5: Blood glucose below target range with active insulin Another day at school, Michael is getting ready to eat lunch. He tests his blood glucose with his Paradigm Link meter and finds it at 70 mg/dL (3.9 mmol/L), which is below his Low BG target of 90 mg/dL (5.0 mmol/L). His reading is automatically sent to his pump. When prompted by the Bolus Wizard feature, he enters his carbohydrate amount of 60 grams in the ENTER FOOD screen. Based on his settings, and despite 1.
Chapter: 6 Optimizing pump therapy Square Wave and Dual Wave boluses 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 quickly.
Dual/Square Wave bolus on-off NOTE - It is important that you consult with your healthcare professional before using a Square Wave or Dual Wave bolus. You should be familiar with the basic functions of your pump before exploring these options. To set up a Dual Wave or Square Wave bolus, you must first turn on the Dual/Square bolus option. If the option is off, a Dual Wave or Square Wave bolus cannot be programmed or delivered. 1 Go to the DUAL/SQUARE OPTION screen.
For a Square Wave bolus do these steps: For a Dual Wave bolus do these steps: a. Select Square Wave Bolus. Press ACT. The SET SQUARE BOLUS screen will appear. a. Select Dual Wave Bolus and press ACT. The SET DUAL BOLUS TOTAL screen will appear. b. Enter the desired amount for the Square Wave bolus units and press ACT. b. Enter the desired amount for the total dual bolus units. Press ACT. c. Continue to step 5. SET SQUARE BOLUS 1.2U SET DUAL BOLUS TOTAL 1.
Example 1: Square Wave bolus Use of a Square Wave bolus while eating a meal high in fat Conner loves pizza. When he was using insulin shots, he began to avoid pizza because he always had high blood glucose readings several hours after eating this high fat meal. Now that Conner is using the Paradigm pump, he can use the Square Wave bolus feature to help with this problem.
Your turn: Square Wave bolus practice Your target pre-meal blood glucose range is ______ to _______. Check your pre-meal blood glucose. Are you within your target? _____ If yes, continue. If no, wait to try the following test until your pre-meal blood glucose is within your target range: TEST: Choose a meal that is high in fat (e.g. hot dogs, pizza, cheese enchiladas). Determine your meal bolus amount. Set the Square Wave bolus to deliver the determined amount of insulin over 2-hours*.
Example 2: Dual Wave bolus Set a Dual Wave bolus for correcting elevated blood glucose before a meal Marsha uses the Square Wave bolus for the majority of her meals. She tests her pre-meal blood glucose and finds that it is above her target level. Marsha would like to correct her elevated blood glucose before she eats. The Dual Wave bolus can be used to deliver some insulin now to help correct her blood glucose elevation, and then deliver her Square Wave bolus to cover her meal.
Using the Bolus Wizard feature for a Square Wave or Dual Wave bolus If you are using the Bolus Wizard feature to calculate your Square Wave or Dual Wave bolus amounts, you will be prompted to enter your blood glucose reading and/or the (carb or exchange) units you will eat. The Bolus Wizard feature will use this input to calculate your suggested correction and/or food bolus amount. If you do not want to use the Bolus Wizard feature estimate, you can change it, if desired.
4 For a Square Wave bolus do these steps: For a Dual Wave bolus do these steps: The SET SQUARE BOLUS screen will appear. NOTE - The number of units you program for the Change the amount if desired. Press ACT to SET DUAL BOLUS TOTAL is a total of both the accept. Normal and Square Wave bolus units. SET SQUARE BOLUS Estimate 4.0U ACT a. The SET DUAL BOLUS TOTAL screen will appear. Change the amount if desired. Press ACT to accept. b.
5 The SQUARE DURATION screen will appear. Enter the amount of time you want the Square Wave bolus to last and press ACT. Square Duration Sq: 1.2 u NOTE - If you have the BG Reminder feature turned on, a screen displays ACT allowing you to accept or modify the length of time after this bolus before you are reminded to check your blood glucose. 6 Press ACT to accept and deliver the bolus. The BOLUS DELIVERY screen appears. The pump beeps or vibrates at the start and end of the bolus.
NOTE - If you are using the remote control, the Easy Bolus must be set to on. Step value setup You can set the step value from 0.1 to 2.0 units (factory setting: 0.1). Set the step to a number that is convenient to use and easy to multiply. Example: 2.0 unit Easy bolus with a step amount set at 0.5 units Total # Steps = 4 Total # Button Presses = 4 4 1 Step = 0.5 units 3 1 Step = 0.5 units 2 1 Step = 0.5 units 1 0 1 Step = 0.5 units 0 0.5 1.0 1.
1 From the HOME screen, press . The SET EASY BOLUS screen will appear. The single “step” value will be flashing. SET EASY BOLUS 0.1 U (flashing) 2 Press the number of times needed for your bolus amount. Watch the amount change on the screen with each press. The pump will vibrate or sound a different tone for each press. When your total bolus amount appears on the screen, press ACT. Listen/feel to count the steps without looking at the screen. SET EASY BOLUS x 10 1.
Example 1: Easy bolus Alexander is a busy executive with an accounting firm. He wears his Paradigm pump on his belt and does not want to take it off to give himself a bolus. Alex can easily reach down and feel for the Easy Bolus button to give a bolus. He previously programmed his pump to deliver an Easy Bolus in steps of 0.5 unit increments. From the HOME screen, with each press of the track of the number of button presses. , the pump will sound a different tone so he can keep He wants to give himself 2.
Basal patterns The Basal Patterns feature is optional for pump users. You can set your pump to deliver a standard basal and two additional basal patterns to meet your individual daily, weekly, or monthly needs. Keep a paper copy of your programmed patterns with you at all times in case you need to reprogram your pump. To select and use pattern A or pattern B, the patterns option must be on and programmed.
Program a pattern Your pump will keep your pattern settings even when the Patterns option is turned off. The patterns feature must be on to program a basal pattern. NOTE - Be aware. When 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 PATTERNS screen. Do these steps to program your patterns: 1 Go to the EDIT BASAL screen.
5 After you press ESC, the BASAL RATE screen appears. The screen will show: ➠ the current basal pattern and basal rate, ➠ time ➠ the it started, and indicates Pattern A is the active pattern BASAL RATE A Current Rate 0.80 U/H Started #1 - 12:00A 24 Hr. Total 19.20 24-hour basal total. Select a pattern Before you try to select a pattern to be active, make sure the Patterns feature is on.
Example 1: Basal patterns Ken has had his insulin pump for about a month. He tests his blood glucose 4 - 6 times a day and records his results in his logbook. He is happy with his glucose control during the week but on the weekends, he noticed that he has to eat more food to prevent his blood glucose from running too low. Ken has realized that during the week while he is at work, he is very inactive and sits at a desk most of the time.
Temp (temporary) basal rates Temp basal should be used based on the guidance of your healthcare professional. The temp (temporary) basal rate feature is useful to manage blood glucose levels during unusual short-term activities or conditions. These conditions could be an illness or physical activity. A temporary basal rate allows an immediate short-term change to your basal insulin for a specified period of time (30 minutes to 24-hours). This rate can be up to your maximum basal rate setting.
Temp basal types Based on your preference, you can select either Percent of Basal or Insulin Rate. Insulin rate 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 The temp basal type is dependent on your current basal rates. Percent temp basal is a percentage increase or decrease of your current basal (0 - 200 percent limited to your maximum basal rate setting). The maximum percent limit is based on the largest basal rate segment with your programmed temp basal rate time. For example: It is 6:00AM and your current basal rate is 1.50 U/H. You want to set a temp basal rate of 130 percent for seven (7) hours.
NOTE - The pump delivers basal amounts in 0.05 U/H increments. Because of this, your temp basal amount will be rounded down to the next 0.05 U/H increment. temp basal settings temp basal type: Percent of basal duration: 4 hours (1:05p - 5:05p) rate: 120 percent (%) (120% x rate 2 = 3.06) 3.06 rounded down to the next 0.05 increment is 3.05 U/H 1.50 U/H (rate 1) 7:00a.m. (07:00) temp basal start time 3.05 U/H 2.55 U/H (rate 2) 2.30 U/H 1.95 U/H (rate 3) 3:00 p.m. (15:00) 1:05 p.m. 5:05 p.m.
Selecting temp basal type Your pump will remember the temp basal type setting. Once the type is set, you do not have to set it again. To select a temp basal type, do these steps: 1 Go to the BASAL MENU. BASAL MENU Main > Basal > Temp Basal Type Max Basal Rate Patterns Temp Basal Type Select Temp Basal Type and press ACT. ACT 2 The SET TEMP BASAL AS screen will appear. Select Insulin Rate or Percent of Basal and press ACT.
3 In the SET TEMP BASAL screen, the temporary basal rate will flash. Enter your temp basal rate, then press ACT. OR SET TEMP BASAL U/H 3:00P 0.05 3:00P U H appears if Temp Basal Type is set to “Insulin rate (U/H)” 4 The BASAL MENU will appear. Your temp basal is now set and delivering. Exit the menus.
Canceling a temp basal Use the cancel temp basal function in the BASAL MENU to cancel a temporary basal. This function immediately stops the temp basal and resumes the regular programmed basal delivery. To cancel a temp basal, do these steps: 1 Go to the BASAL MENU. Main > Basal > Cancel Temp Basal 2 Select Cancel Temp Basal and press ACT to accept.
Example 2: Temp Basal for an increased temporary basal rate Gail has had a cold with a cough for a couple of days. Because she is not feeling well, she tests her blood glucose more frequently. She finds that her blood glucose levels are running above target range before meals and she has needed several correction boluses to keep her blood glucose levels within her normal limits. Gail decides to use the Temporary Basal Rate to increase her basal rate during the day today.
Chapter: 7 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 ➠ ➠ ➠ ➠ ➠ ➠ ➠ ➠ ➠ 104 Dilated eye exam by a qualified opthalmologist 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 Emergen
Chapter: 8 Utilities Alarm review You can review alarms in the ALARM HISTORY screen. This screen shows up to 36 past alarms and/or errors. You can also review the details for each alarm when you are in the ALARM HISTORY screen. 1 Go to the ALARM HISTORY screen Main > Utilities > Alarm > Alarm History 2 Scroll through your past alarms. ALARM HISTORY 11OCT 10:35P LoRes 08OCT 04:08P ChkSet 05OCT 11:35A LoBat 3 If you want to review the details for an alarm, continue to “Alarm details” below.
1 Go to the ALERT TYPE screen. Main > Utilities > Alarm > Alert Type 2 Select your alert type and press ACT. That alert type is now active. Exit the menus. ALERT TYPE Beep Long Beep Medium Beep Short Vibrate Auto-off The factory setting for this feature is off (set to 0 hours). This is a safety feature that stops insulin delivery after a defined time period (from 1 to 24-hours).
For “Insulin units”: Enter the number of units you want remaining when the first warning will go off. Press ACT. WARNING UNITS 20 U (flashing) can be 5.0 – 50.0 The pump will alarm first when the specified units remain, then again when half that remaining amount is used. For “Time”: Enter the amount of remaining time you want for the first warning. Press ACT. WARNING TIME 8:00 (flashing) can be 2 –24 Hours The pump will alarm first when the specified time remains, then again one hour before empty.
Review daily insulin totals The DAILY TOTALS screen provides a day-by day history of the total amount of insulin that delivered for the past 31 days. This screen includes all bolus and basal amounts delivered midnight-to midnight for each of the past 31 days. The today line in the DAILY TOTALS screen shows the amount of insulin you delivered so far that day. NOTE - The amount of insulin used to prime your pump is not included in the DAILY TOTALS screen.
Pump data management The pump data management feature allows you and your healthcare professional to view and manage your basal and bolus insulin delivery, blood glucose information, and food intake with averages up to 31 days. You can view the details of each day individually. You can also average the data over a specified time period that you select up to (up to 31 days). This is done in the DAYS TO AVERAGE screen as explained in “Days to average” on page 111.
➠ total man (manual) bolus insulin delivered for the day and total percentage of manual boluses delivered for the day To view more data, press . 5 The NUM BOLUS screen is displayed.
Days to average The DAYS TO AVERAGE screen allows you to choose the number of days to average. This example shows the previous 12 days as the number of days to be averaged 1 Select Daily Average and press ACT. ACT DAYS TO AVERAGE 3 The AVG BG screen is displayed.
the total average percentage of bolus insulin delivered for the previous 12 days ➠ the average total correction bolus insulin delivered per day ➠ the total average percentage of bolus insulin delivered per day for the previous 12 days ➠ the average total manual bolus insulin delivered per day ➠ To view more data, press . 6 The NUM BOLUS screen is displayed.
Main > Utilities > Alarm Clock 2 Select On/Set. Press ACT. 3 Select Add Alarm. Press ACT. ALARM CLOCK ALARM OPTION Off On/Set Add Alarm Delete Alarm Review Alarms 4 Use the or buttons to select the hours (flashing). Press ACT. Use the buttons again to select the minutes (flashing). Press ACT. ADD ALARM (hours flashing) 12:00 (A) ADD ALARM (minutes flashing) 3:00 (A) 5 Repeat step 3 and step 4 to program additional alarm clock times. Exit the menus when you are done.
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. Select On and press ACT.
Add Select Add ID and press ACT. Enter each of the six ID numbers. Press ACT after each. ADD REMOTE ID Delete Select Delete ID and press ACT. Select the remote ID that you want to delete and press ACT. DELETE REMOTE ID 1 111111 2 222222 3 ------ (flashing) ______ After you set the last number of the ID, the screen will return to the REMOTE ID MENU. The selected ID is now deleted. Review Select Review ID and press ACT. The programmed IDs will show in the REVIEW REMOTE ID screen.
Example 1: Block Nicholas is a very active toddler who wears a Paradigm pump. His parents don't want to worry that he will play with the pump and accidentally change his programmed settings. They simply activated the Block feature, and now, except for the Suspend and Self-Test, no other features are active when using the pump buttons. When Nicholas needs a bolus, his parents and caregivers simply program it with the Remote Control.
Lock keypad feature Lock keypad prevents accidental pump keypad presses. The only button you can press is the to view the STATUS screen. The remote control can be used to give a bolus or put the pump into Suspend. To lock keypad 1 Go to the Lock Keypad screen Main > Utilities > Lock Keypad 3 Select Lock Keypad 2 Select Utilities Press ACT. 4 Press ACT to lock keypad. Press ACT.
1 Go to the UTILITIES MENU. Select Selftest and press ACT. MAIN MENU ACT Basal Prime Utilities Main > Utilities > Selftest 2 As part of the selftests, the pump will do these tests: UTILITIES MENU Meter Options Remote Options Selftest NOTE - Periodically, you will hear beeps as different mechanisms in the pump are being tested. a. Screen Test: The screen will appear all black as shown here. b. Selftest: The pump will count down from 10. c. Tone Test: You should hear beeps. d.
User settings The user settings function allows you to save, restore, and clear all pump settings. You can also view a listing of the dates and times of all recent user settings operations you have done. The Save Settings feature lets you keep a set of pump settings that you can restore to your pump if it is cleared or you need to go back to these settings for any reason.
3 If this is the first time you have saved pump settings, go to step 4. If you have previously saved pump settings, a message displays, indicating the date of your last pump settings save. Read the instructions on the screen then press ACT to save your current settings (or press ESC to cancel the save). 4 The SETTINGS SAVED message displays to confirm that your current pump settings have been saved. Exit the menus.
4 The SETTINGS RESTORED message displays to confirm that your current pump settings have been replaced with the pump settings you had saved on the given date. Exit the menus and check your pump settings to verify the restore. SETTINGS RESTORED User settings have been restored. PLEASE CHECK SETTINGS ACT Clear 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.
4 You will see a RESET screen, and then the pump will go through various screens while it restarts. After the pump clears all of your settings, the screen will go to the TIME/DATE SETUP screen 3:32A RESET Settings cleared by user Reprogram settings ESC, ACT to clear 5 Reset the time and date as described in “Setting the time and date” on page 23. 6 After you set the time and date, you must rewind your pump. See “Rewinding your pump” on page 47 for instructions.
Language setting The language shown on the pump screens can be changed. Some languages will not be available on all pumps. To change the language for your pump, do these steps: 1 Go to the UTILITIES screen, select Language and press ACT. Main > Utilities > Language 2 The LANGUAGE MENU screen is displayed. Select your language and press ACT UTILITIES MENU Selftest User Settings Language ACT LANGUAGE MENU English Espanol Francais 3 The language setting is now changed. Exit the menus.
124 Chapter: 8
Chapter: 9 Troubleshooting This chapter is designed to help you understand the messages that your pump is giving you when you get an alarm or an alert message. The procedures in the beginning of this chapter are to be used when you get specific alarms or cover a likely condition that might happen. A list of alarms is provided at the end of this chapter. NOTE - It is recommended that you read your warranty statement included with your pump for information on what is covered during your warranty period.
7 Monitor your blood glucose closely. 8 If you followed these steps and you are still receiving a No Delivery alarm, call the 24 Hour HelpLine. What happens if I leave the battery out too long? If you leave the 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 Set your pump clock to the correct time, date, and year. 2 Check to make sure that all your settings, such as basal rate, are set as desired.
The usage of some features. The backlight, vibrate, remote control and/or meter options decrease battery life. What is a CHECK SETTINGS alarm? This alarm occurs after an E alarm or after you clear your pump. It is advising you to make sure that all your settings are correct.
The pump is asking me to rewind This is normal after any of the following: 1 any E-alarms, 2 the Clear Settings function, 3 or, a “No Delivery” Alarm (during the Prime sequence). My bolus stopped The Bolus Stopped error can occur if the battery cap is loose or the pump was bumped or dropped during a bolus. It can also happen if the pump receives a static shock. As a safety measure, the pump stops the bolus when this happens.
8 If your pump still does not receive your blood glucose reading from the Paradigm Link meter, use the up/down buttons to manually enter your blood glucose (in the ENTER BG screen). I dropped my pump Take care to protect your pump from being dropped. 1 Check that all connections are still tightly in place. 2 Check the LCD, keypad and pump case for cracks or damage. 3 Check infusion set, including the tubing connector and tubing for cracks or damage.
I cannot get to the User Settings menu If you do not hold down the button while pressing ACT when you have User Settings highlighted, you will see the following screen: This feature is not normally accessible. To access, consult your User Guide. 1 Go to the Utilities screen and highlight User Settings. Then, hold down the button and press ACT. 2 See “User settings” on page 119 for information about the menu options. Alert conditions Your pump has a sophisticated network of safety checks and systems.
Low reservoir alert 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. 3:36P LOW RESERVOIR ESC, ACT to clear Low battery alert If you get this alert, DO NOT go to sleep without replacing the battery. The backlight and the remote and Paradigm Link meter functions are disabled during a LOW BATTERY condition.
What to do When an alarm is triggered, the pump goes into Attention mode and an alarm message shows on the screen. The pump then defaults to the HOME screen. Do these steps when you get an alarm: 1 View the alarm. From the HOME screen, press any button to see the alarm message. (any button) 2 Read all of the alarm text. There are instructions on how to fix the alarm condition. (Press to read more text, if available.) ALARM MESSAGE / 3 Clear the alarm.
Alarm conditions Alarms put the pump in “Attention” mode. A (Alarm) This alarm shows an “A” followed by two numbers. A-alarms cause all insulin delivery to stop. Your pump settings are retained. If this alarm repeats often, call the Medtronic MiniMed 24 Hour HelpLine for assistance.
Button error Occurs if a button has been continually pressed for more than 3 minutes. 10:05A BUTTON ERROR Button pressed for more than 3 min ESC, ACT to clear Check settings When this alarm is active, you should check and/or reprogram your pump settings, including the time/date. 8:35A CHECK SETTINGS Delivery stopped Reprogram settings ESC, ACT to clear E (Error) After receiving this alarm, note the error number then call the Medtronic MiniMed 24 Hour HelpLine for assistance.
Is priming complete? If you manually prime your pump with more than 30u insulin, this message appears. Press ESC, ACT to clear the message. If manual prime is complete, press ESC. If the manual prime is not complete, press and hold ACT until manual prime is complete. 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.
Off no power The battery is dead. Replace battery immediately. Follow the directions on the screen. Check to make sure that the time is correct on the screen. Reset the time if necessary.
Chapter: 10 Pump maintenance It is recommended that you read your warranty statement included with your pump for information about what is covered during your warranty period. Battery The Paradigm pump uses a AAA battery. As a safety measure, Medtronic MiniMed has designed the pump to only accept a NEW battery. If you insert a used battery, the “failed batt test” alarm may be triggered. See “Install battery” on page 12 for instructions. The use of cold batteries causes erratic pump behavior.
Cleaning your pump 1 Use only a damp cloth and mild detergent mixed with water to clean the outside of your pump. 2 Rinse the pump with a clean cloth, dampened with clean water. 3 Dry with a clean cloth. 4 Never use organic solvents, such as lighter fluid, nail polish remover, or paint thinner to clean your pump. 5 Keep the reservoir compartment and battery compartment dry and away from moisture. 6 Do not use any lubricants with your pump. 7 Use a 70 percent alcohol wipe to disinfect your pump.
Chapter: 11 Pump specifications This section provides detailed information on specifications related to your pump. The safety features of your pump are individually listed and described. Alarms and error messages ➠ ➠ Indicators: audible tone (beep) or vibration (silent) All alarms and errors show messages on the pump’s screen and provide instructions on what to do. Unresolved alarms will escalate to siren mode for added safety.
BG (blood glucose) target Maximum BG targets range: 8 (mg/dL) (mmol/L) warning limits: 60 – 250 3.3 – 13.9 lower limit: upper limit: less than 90 mg/dL greater than 140 mg/dL Bolus delivery Insulin delivered/stroke Fluid delivered/stroke Time between/delivery strokes Delivery rate (per minute) 0.05u 0.5 µL 2 seconds 1.5u Bolus history Maximum records shown: 24 Bolus units Increments: 0.1 units Bolus Wizard feature (See “Bolus Wizard feature examples” on page 148 for information.
Pump motor The pump motor has a unique, patented design with an integrated safety check system. The system delivers in precise increments. Dual Wave bolus Delivers a normal bolus followed by a Square Wave bolus (limited by maximum bolus). Easy bolus Features programming using audible tones (or vibrate pulses) in user-defined increments. Beep mode range: 0 to maximum bolus; Vibrate mode range: 0 to 20 steps or maximum bolus, whichever comes first. ➠ ➠ ➠ ➠ Default step increment: 0.
Meter value The blood glucose measurement received from Paradigm Link meter. Appears in the ENTER BG screen during bolus programming. Appears on the screen when the pump is idle at the HOME screen. Maximum ID entries expiration: range: 3 12 minutes (mg/dL) (mmol/L) warning limits: 20 – 600 1.1 – 33.3 less than 20 or greater than 100 mg/dL less than 1.1 or greater than 5.6 mmol/L Normal bolus Range 0.1 – 25.0 units of insulin (limited by maximum bolus setting).
Program safety checks Maximum infusion with single fault condition: 0.0 ml. Pump size The dimensions of the pump are approximately: 515 Pump: (inches) (cm) 2.0 x 3.0 (2.8 at the battery cap) x 0.75 inches 5.1 x 7.6 (7.1 at the battery cap) x 2.0 cm 715 Pump: (inches) (cm) 2.0 x 3.7 (3.5 at the battery cap) x 0.75 inches 5.1 x 9.4 (8.9 at the battery cap) x 2.
Status screen ➠ Alarm Clock:* (appears if scheduled to alarm) Time set is displayed.
➠ Standard basal delivery data: (always appears) ➠ Status of pump (i.e., Rewind, Suspended, Low Reservoir, Set Time, etc.) ➠ Time (always appears) current basal rate (basal 1, basal 2, etc.) *If all Reminders and Alarm Clock are enabled, only the reminder nearest to alarming will appear in the STATUS screen.
Bolus Wizard feature specifications There are three different formulas the Bolus Wizard feature uses to estimate a bolus, depending on your current blood glucose: correction estimate food estimate 1 If current blood glucose is greater than your High Target BG = food carb ratio + = food carb ratio + food estimate 3 If current BG is between or = High or Low Target BG = food carb ratio insulin sensitivity current BG - Low BG Target insulin sensitivity correction estimate + 0 Notes: If a Dual Wa
Active Insulin Curve 100% 90% 8 Hour 80% 7 Hour 6 Hour 5 Hour % Insulin Remaining 70% 4 Hour 3 Hour 60% 2 Hour 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 September 1999, page 1501 Active insulin only reduces the correction portion of the estimate, not the food portion.
Bolus Wizard feature examples Settings: ➠ Carb ratio: 30 grams/unit ➠ Insulin Sensitivity: 40 mg/dL/unit ➠ BG Target: 90-120 mg/dL ➠ Active Insulin Time: 6 Hours #1: No active insulin from previous bolus delivery. User inputs 60 grams of carbs and does not enter blood glucose. (food estimate) 60g 30g/u = 2 units estimate = 2 units #2: No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a blood glucose of 200.
#3: No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a blood glucose of 70. (correction) (food estimate) 60g 30g/u = 2 units + 70mg/dL - 90mg/dL 40mg/dL/u = -20mg/dL 40mg/dL = -0.5 unit = 2 + (-0.5) = 1.5 unit estimate = 1.5 unit #4: No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a blood glucose of 100.
#6: Previous bolus activity results in a calculation of 3.5 units unabsorbed (active) insulin. User inputs 60 grams of carbs and a blood glucose of 200. (correction) (food estimate) 60g 30g/u = 2 units + 200mg/dL - 120mg/dL 40mg/dL/u - 3.5 units (active insulin) = 2 - 3.5 = -1.5 units* * This negative number indicates that active insulin is sufficient to cover the correction that is needed. Thus, correction will be 0 units. Active insulin does not reduce the food portion of the estimate.
Menu Item Default Setting Lock Keypad: (Alarm) History: Alert type: Auto-off: Low reservoir warning: Utilities Menu: 5 - 50 u; 2nd: @ 1\2 amount (2:00 - 24:00; 2nd: after 1:00) 20 u (0:30) (no defaults) audio, beep-med Off (20) insulin units 12 a.m.
Menu Item Default Setting Limits Increments none none 3 - 150g/u or 0.1 - 5.0 u/exch 1 g/u or 0.1 u/exch 10 - 400 mg/dL or 0.5 - 22.2 mmol/L 1 mg/dL or 0.1 mmol/L 60 - 250 mg/dL or 3.3- 13.9 mmol/L 1 mg/dL or 0.1 mmol/L 2 - 8 Hours 1 hour Bolus Wizard feature Settings carb units: grams or exchanges ins to carb (or exch) ratio: 15 grams/u or 1 unit/exch (insulin) sensitivity: 50 mg/dL or 2.8 mmol/L BG target: 100- 100 mg/dL or 5.6-5.
Icon table Do not reuse Attention: See Instructions for Use Method of sterilization using ethylene oxide w r Date of manufacture (year - month) Manufacturer Batch code LOT Configuration Use by (year - month) Catalogue number REF Device serial number SN Storage temperature range Fragile product Type BF equipment (Protection from electrical shock) Conforms to IEC60601-1 sub-clause 44.
154 Chapter: 11
Glossary A Accept - Pressing the ACT button to approve the selection or setting. Active insulin - Insulin that has been delivered to your body, but has not yet been used. Alarm - Audible or vibrating (silent) notice that indicates the pump is in Attention mode and immediate attention is required. Alarms are prefixed in the alarm history with the letter A. Alarm clock - The feature you can use like any alarm clock. You can set the pump to send you an alarm at certain times of the day as reminders.
BG (blood glucose) target range - The range of your normal or desirable blood glucose levels. You can set up the pump so that you receive an alarm when your blood glucose level is below or above your target range. BG (blood glucose) units - Blood glucose unit of measure (mg/dL or mmol/L). Block - The feature that restricts access to all programming except suspend, selftest and the delivery of a bolus with the remote control.
Dual Wave™ bolus - Combination of a normal bolus that is delivered immediately, then followed by a Square Wave bolus. The Square Wave portion is delivered evenly over a period of time. Duration - Amount of time it takes to administer a bolus or basal delivery. Also, length of time for an action or condition. E Easy bolus™ - Method of delivery for a Normal bolus using the Easy Bolus button . Exch ratio - (Exchange ratio) Used when counting carbohydrates as exchanges.
L LDL - (Low-density lipoprotein) A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol in the blood. Link - To turn on and setup the meter option that allows the pump to receive blood glucose readings from the Paradigm Link meter. Low resv warning - Programmable warning that notifies you with an alert when either a specified number of units remain in the reservoir or a specified amount of time remains before the reservoir will be empty.
Pattern, standard - Your normal basal that supports your usual day-to-day activity. When the Patterns feature is off, the pump uses your standard (basal) pattern. Press - To push and release a pump button. Prime - To fill (prime) the cannula with insulin. This can be done automatically by the pump (a “Fixed prime”), or manually (a “Manual prime.” See Fixed prime (page 157) or Manual prime (page 158). PSI - Pound-force per square inch. R Resume - Continue basal insulin delivery after the pump is suspended.
160 Glossary
Index Symbols μL 159 Numerics 24 Hour HelpLine 1 A accept 155 accessories, activity guard 5 holster 5 leather case 5 meter 3 pump clip 5 remote control 3 ACT button 14 active insulin time, setting 69 active insulin, definition 155 information about 62 alarm clock feature 155 ALARM HISTORY screen 105, 155 alarm, conditions 133 definition 155 alarms, ’A’ alarm 133 ’auto off’ 133 ’batt out limit’ 133 ’bolus stopped’ 133 ’check settings’ 127, 134 ’E’ (error) 134 ’empty reservoir’ 134 ’failed batt test’ 134 ’
definition 156 selecting 66 BG (blood glucose), definition 155 block feature, definition 156 turning on 115 BLOCK OPTION screen 115 blood glucose (BG) target range, mg/dL 140 mmol/L 140 blood glucose (BG) target warnings, lower limit 140 upper limit 140 blood glucose (BG) targets, maximum number of 140 blood glucose meter data, and Carelink™ 4 downloading 4 bolus 156 basic 24 bolus deliveries, history of 29 viewing details on 30 bolus delivery specifications, amount of fluid delivered per pump stroke 140 am
cleaning your pump 138 clearing factory settings 121 correction bolus 24 correction bolus factor 156 correction bolus, amount of insulin needed 156 corr bolus amount 156 definition 156 formula for calculating 156 procedure (Bolus Wizard feature) 74 D DAILY TOTALS screen, reviewing daily insulin totals 108 daily totals, definition 156 maximum number of records 140 default (factory) pump settings 150 display type (pump) 139 disposable parts 3 DKA (Diabetic Ketoacidosis) 156 Down button 14 downloading, blood
setting 66 warning limits (mg/dL) 141 warning limits (mmol/L) 141 L language setting 123 LDL (Low-density lipoprotein) 158 Link 158 lock keypad feature 117 logbook feature data, downloading 4 including in reports 4 types of 4 low battery alert 131 low battery, affect on alerts 105 affect on remote control 114 affect on Selftest feature 117 affects on meter readings 71 low blood glucose, Bolus Wizard feature notice 61 low reserve alert feature 106 low reserve alert types, insulin units 107 time 107 low rese
P Paradigm Link meter 3, 57 ParadigmPAL, managing your pump settings 5 pump setting reports 5 types of data you can manage 5 Pattern feature 158 pattern, standard 159 patterns, A and B 91 basal 91 programming a basal pattern 92 selecting a basal pattern 93 standard basal pattern 91 turning on/off 91 personal reminders 112 personal settings 57 press 159 Prime menu 19 prime, definition 159 fill rate 142 fixed 54 fixed prime range 142 history 54 manual 49 manual prime limit 142 maximum number of records (fixed
removing the 46 transfer guard 44 tubing connector 11 restores, history of 122 restoring your pump settings 120 Resume feature 159 Rewind feature 159 rewinding your pump 47 S saves, history of 122 saving your pump settings 119 screen, language setting 123 scroll 159 select 159 Selftest 117, 129 Set bolus 159 setting, active insulin time 69 maximum bolus limit 31 Special mode, definition 159 information about 18 Square Wave bolus, definition 159 information about 79 programming without Bolus Wizard feature
INSULIN PUMP 6025066-016C 081406
