Instruction/ maintenance manual of the product 715 Energizer
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Paradigm ® 515 and 715 Infusion Pumps User Guide.
© 2005, Medtronic MiniMed. All rights reserved. This product is covered by U.S. Patent Nos. 6,551,276 and 6,554,798. Other U.S. and/or foreign patents m ay be pending. Pa r a d i g m ® , Quick-serter ® , Quick-set ® , Silhouette ® , and Sof-set ® , are registered trademarks of Medtronic MiniMed.
Important Safety Information Regarding Y our P ar adigm Insulin Infusion Pump (includes all models) Avoid Immersing Y our Pump In W ater Although it is unlikely that water damage will occu r if your pump is splashed or briefly dunked, you should avoid immersing your P ara digm infusion pump in water .
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Contents v Contents Glossary .................... .......................................... x vi i Your personal inform ation .................. ........................ x xi ii Basal rate .............. ................................. ............
vi Contents HOME screen ........... ................. ............................ ............. .............. .......... 15 Screen icons .......... ................................. ................................. .............. 15 Battery .......
Contents vii Chapter 4 Starting on insulin .............. .......................... 4 3 Prepare your pump for use ................. ................................. ......................... 43 Filling the reservoir .................. ..............
viii Contents Review your Bolus Wizard feature settings ............... ................ .............. .......... 73 Meter option ........... ................. ............................ ............. .............. .......... 73 Meter rules ......
Contents ix Chapter 8 Utilitie s .................................................. 1 09 Alarm review ......... ................. .............. ............. ............................ .......... 109 Alarm details ........... ......................
xC o n t e n t s I dropped my pump .......... ................. .............................. .............. ......... 133 I submerged my pump in water ............. ................. ............. .............. ......... 133 I cannot get to the User Settings menu .
Contents xi BG (blood glucose) target .................................................................. .......... 144 Bolus delivery ........ ................. .............. ............. ............................ .......... 144 Bolus history ..
xii Contents.
xiii Practice lessons and examples Bolus examples Meal bolus Normal meal bolus using the exchange system .. ............................ ............. ....... 25 Bolus practice ................ ................. ................................. .....
xiv Bolus Wizard feature examples Example 1: BG on target (normal BG) and no active insulin ........ ................ ........... 78 Example 2: BG above target (high BG) and no active insulin ....... ................ ........... 79 Example 3: Blood glucose below target (low BG) and no active insu lin .
Glossary xvii Glossary A Accept - P ressing the AC T 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.
xviii Glossary BG (blood glucose) target range - The range of your normal or desirable blood glucose levels. Y ou can set up the pump so that you receive an alarm when your blood gl ucose level is below or above your target range. BG (blood glucose) units - Blood glucose unit of measure (mg/dL or mmol/L).
Glossary xix Dual Wave™ bolus - Combination of a normal bolus that is delivered immediately , then followed by a Square W ave bolus. The Square W ave portion is delivere d evenly over a period of time. Duration - Amount of time it takes to administer a bolus or basal delivery .
xx Glossary L LDL - (Low-density lipoprotein) A complex of lipids and proteins, with greater amo unts of lipid than protein, that transports cholesterol in the blood. Link - T o turn on and setup the meter option that allows the pump to receive blood glucose readings from the P aradigm Link meter .
Glossary xxi Pattern, standard - Y our normal basal that supports your usual day-to-day activity . When the P atterns feature is o ff, the pump uses your standard (basal) pattern. Press - T o push and release a pump button. Prime - T o fill (prime) the cannula with insulin.
xxii Glossary.
xxiii Your personal information Y ou may need the followin g information from your healthcare professional before going to your pump start appointment. If you are unsure, contact your healthcare profession al o r p u m p t ra i n e r f o r instructions.
xxiv Carb ratios (meal bolus information) Y our carb ratios are used to calculate your meal boluses. If you count gr ams: this ratio is th e number of ca rb grams covered by one (1) unit of insulin. If you count exchanges: this ratio is the number of insulin units you need to cover one carb exchange.
Introduction 1 Chapter: 1 Introduction Thank you for choosing Medtronic Mi niMed as your partner in helping you gain better control of your diabetes. Whether you are beginning pump therapy for the fir.
2C h a p t e r : 1 Emergency kit Keep an emergency kit with you at all times to make sure that yo u 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 in formation on pump safety.
Introduction 3 Disposables The pumps use disposable reservoirs and infusion se ts for insulin delivery. Installation instructions for Paradigm reservoir and infusio n sets are provided in Chapter 4, “Starting on insulin.” ➠ Reservoirs: The 515 pump is intended for use with a 17 6-unit P aradigm reservoir (MMT-326).
4C h a p t e r : 1 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 eas y-to-read charts, graphs, and tables.
Introduction 5 ParadigmPAL With P aradigmP A L™ you ca n do the following with your pump settings: ➠ See your pump settings on your PC screen. ➠ Backup, or save, pump settings to disk ette or the hard drive of your PC. ➠ Quickly change your pump settin gs in case your healthcare professional nee ds to make a change to your pump therapy .
6C h a p t e r : 1 How to use this guide NOTE - This User Guide shows sample screens only. Your pump screen s may be slight ly different. For step-by-step instructions, refe r to the appropriate sections in this guide. See the Glossary for definitions of terms and functions.
Introduction 7 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 diab etes mellitus in persons requiring insulin.
8C h a p t e r : 1 Precautions Although the pump has multiple safe ty 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 .
Introduction 9 Notice Insulin pump and RF accessories The pump, Paradigm Link meter, and remote co ntrol comply with the United States Federal Communications Commission and international st andards for electromagnetic compatibility. Do not use the RF meter to send your blood gluc ose reading to the pump while on an aircraft.
10 Chapter: 1.
The basics 11 Chapter: 2 The basics Your pump Take a look at your pump. The rese rvoir window allows you to view the insulin in th e reservoir. The reservoir, with the tubing connector attached, is in serted into the reservoir compartment of the pump.
12 Chapter: 2 Install battery Medtronic MiniMed designed the pump to only a ccept 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 basics 13 5 While the pump turns on, it will show vari ous screens until the HOM E screen appears. NOTE - If you are replacing a battery for a pump that has very recently been in use, the only screen you will see before th e HOME screen is the one di splaying the version number.
14 Chapter: 2 Pump buttons The buttons on the pump are used to navigate through the menus and screens, and to program the featur es of the pump. From the HOME screen EASY BOLUS button—Shortcut to set and deliver an Easy Bolus. From the menus and programming screens Increases / decreases the value of a flashing item.
The basics 15 The pump screen The screen shows five lines of te xt at one time. The first is the operating mode. The second is the current open menu or function. The last three lines sh ow either information or text that you can select for the current function.
16 Chapter: 2 Time display The current time of day is displa yed across the top of the pump screen in the format you select—12-ho ur or 24-hour . The AM or PM is only displayed for the 12-ho ur form at. For instructions on setting the time on your pump, see “Setti ng the time and date” on page 23.
The basics 17 Screen backlight When you press from the HOM E screen, the light on the scr een 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.
18 Chapter: 2 Special - indicates a special feature is active or an alert condition(s) exists. Special mode does not rest rict 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.
The basics 19 Menus The MA IN ME NU 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 (bli nking), during programming, press / to change the value.
20 Chapter: 2 STATUS screen The STA T US screen shows information about what yo ur 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.
The basics 21 If you remove your pump Pump settings You may have an occasion when you need or want to remov e 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.
22 Chapter: 2.
Basic programming 23 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 a l l o w s y o u t o k e e p a n a c c u r a t e r ec o r d o f y o u r i n s u lin delivery and other pump functions.
24 Chapter: 3 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. Bolus insulin delivery types This section provide.
Basic programming 25 NOTE - I f y o u h a v e t h e B G R e m i n d e r f e ature turned On, a screen displa y s a l l o w i n g y o u t o a c c e p t o r modify the length of time after this bolus before you are remind ed to ch eck your blood glucose.
26 Chapter: 3 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 , prog ram 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.
Basic programming 27 1. Insulin sensitivity should equal the amount (in mg/dL or mmol/L) that blood glucose will be lowered after taking 1 unit of insulin. T o determine insulin sensitivity , divide 1700 by T otal D aily D ose ( TDD 2 ) of Insuli n. The answer is your “Correction Factor” (1700 R ule).
28 Chapter: 3 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 glu cose _________ .
Basic programming 29 Review your bolus deliveries You can view a list of your bolus deliveries in th e BOLUS HISTORY screen. This screen shows a list of the dates, times, units, and types fo r your last 24 boluses. This featur e is helpful for re cord keeping or to check if you bolused for your last meal.
30 Chapter: 3 Bolus details You can view the details for any of the deliveries in the BOLUS HI STORY screen. The details include: ➠ bolus types: normal, square, and dual ➠ programmed bolus amount .
Basic programming 31 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. Th e factory setting is 10.0 units. You can reset the limit to anywhere between 0.
32 Chapter: 3 BG reminder When you deliver a bolus you may want to check yo ur blood glucose afterwar ds. 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.
Basic programming 33 Basal Basal insulin is required to main tain your target glucose values when you are not eating. Your healthcare professional will calc ulate this rate for you. Your basal insulin should account for approximately one half of the body’s total daily insulin requiremen ts.
34 Chapter: 3 Your basal settings You must program your basal setting s before you can deliver basal insu lin. Keep a written record of your basal settings. It is recommended that you set your basal rates with the assistance of your healthcare professional.
Basic programming 35 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 .
36 Chapter: 3 Basal review Temporary basal information is only available in the STATUS screen. Current basal delivery The STATUS screen shows your current basal information. Daily basal rate(s) The BASAL REVIEW screen shows your daily basal ra tes programmed for delivery from midnight to m i d n i g h t ( 1 2 : 0 0 A t o 1 2 : 0 0 A ) .
Basic programming 37 3 Exit the menus when you are done. 2 If you do not use patterns: The delivery details for your standard basal will appear. If you use patterns: The screen will show the basal patterns. The current basal pattern will be highlighted.
38 Chapter: 3 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 ra te should be with your healthcare professional.
Basic programming 39 Stopping your pump You can stop your pump with the suspend function. Suspend stops al l insulin delivery including the current basal and any bolus or prime deliveries that are in progress. While su spended, your pump will not deliver insulin until you Resume your pump.
40 Chapter: 3 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 sc reen appears. Press AC T again.
Basic programming 41 Practice: Suspend function 1 Make sure you are NOT connected to your pump while pr acticing. Program your pump to deliver a No rmal bolus of 3.0 units. Once the bolus begins, stop the bolus by suspending your pump. Remember , when you stop the bo lus delivery with “Suspend,” ALL insulin delivery will stop.
42 Chapter: 3.
Starting on insulin 43 Chapter: 4 Starting on insulin Prepare your pump for use Before continuing with the step s in this chapter, we recommend th at you watch your pump training CD-ROM and complete your pump start training.
44 Chapter: 4 Filling the reservoir WARNING: Your pump will not accurately de liver insulin if air bubbles are in the reservoir or the infusion set. To pr event this, take care to remove air bubbles when filling your reservoir. 1 Remove reservoir from package.
Starting on insulin 45 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.
46 Chapter: 4 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.
Starting on insulin 47 Rewinding your pump Before you continue, make sure the pu mp is NOT connected to your body. 1 If you removed your reservoir and are re placing it, go to the REWIND screen. Main > Prime > Rewind 2 In the REWIND screen, press AC T to start the rewind process.
48 Chapter: 4 Inserting the reservoir in your pump If your reservoir is already inserted in your pump, continue to “Ma nual prime” on page 49. You must do these steps in the order described. Your pump screen will show in structions to help you with these steps.
Starting on insulin 49 Manual prime Manual prime fills the infusion set tubing with in sulin before you attach it to the infusion site. Manual prime is only available after you rewind your pump. 1 After you rewind your pump, the PREPARING TO PRIME screen will appear.
50 Chapter: 4 5 Press ESC . Your manual prime is complete. 6 You can now insert the infusion set into yo ur body as described in the next section. Insert the infusion set After you complete all of the.
Starting on insulin 51 Quick-set infusion se t (with Quick-serter®) Always refer to the instructions that shipped with your infusion set. 1 Wash your hands.
52 Chapter: 4 7 8 91 0.
Starting on insulin 53 11 12 13.
54 Chapter: 4 Connecting Quick-set Disconnecting Quick-set The Quick-set allows you the freedom to temporarily disconnect from your pu mp without removing the infusion set from your body. If you inserted a new reservoir, you should have already done a manual prime.
Starting on insulin 55 Fixed prime A fixed prime fills the soft cannula wi th insulin and is required after th e infusion set is inserted into your body. Additionally, a fixed prime is required if you disconnect your quic k release and you need to reprime the infusion set or if you change your infusion set without changing the reservoir.
56 Chapter: 4 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 yo ur blood glucose journal is your healthcare professional's only me t ho d of m a ki n g a d ju s tm e n ts i n y o ur p u mp s et t in g s .
Starting on insulin 57 Using your daily journal To use the daily journal that came wi th your pump, follo w 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 yo ur blood glucose and ente r the value in the space labeled “blood glucose.
58 Chapter: 4.
Using the Bolus Wizard feature 59 Chapter: 5 Using the Bolus Wizard feature What is it? A feature that calculates an estimated bolus: Information you need Food entry You need to know how many exchan ges or grams of carbohydrates you are going to eat. (You need to know what foods contain carbohydrate and understand carbohydrate counting.
60 Chapter: 5 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.
Using the Bolus Wizard feature 61 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 Ta rget Range, the Bolus Wizard feature will calculate a negative correction and subtract it from your food bolus.
62 Chapter: 5 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 (r efer to “Meter option” on page 73) or ➠ manually by selecting the button.
Using the Bolus Wizard feature 63 More about the Bolus Wizard feature About high or low blood glucose levels If your blood glucose is less th an 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.
64 Chapter: 5 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.
Using the Bolus Wizard feature 65 For more details about active in sulin, see “Bolus Wizard featur e specifications” on page 150. CAUTION: The Bolus Wizard feature cannot co rrectly determine the active insulin in your system after you ha ve taken a manual inje ction of insulin.
66 Chapter: 5 How to program the Bolus Wizard feature You need your personal settings from the Bolus Wizard feature settings table to setup the Bolus Wizard feature.
Using the Bolus Wizard feature 67 Carb units The carb unit setting lets the pump know whic h way to count your carbohydrates (grams or exchanges). See the “Bolus Wizard feature settings” table on page 60 for your carb ratio settings. NOTE - Any time you make changes to the carb units, you must also reprogram the carb ratios.
68 Chapter: 5 6 The screen will return to the EDIT SETTINGS screen. Set your BG Units as described in the “BG (blood glucose) units” on page 69. NOTE - Carb ratio values are normally between 5–50 grams/u or 0.3–3.0 u/exch. If your ratio va lue is outside the range, this warning message will appear on the screen .
Using the Bolus Wizard feature 69 BG (blood glucose) units You can select mg/dL or mmol/L as your BG units (uni t of measurement type). NOTE - If you make changes to your BG units setting, you must reprogram your insulin sensitivity and BG targets.
70 Chapter: 5 3 The SET START TIME 2 screen will appear. 5 The screen will return to the EDIT SETTINGS sc reen. You can no w program your BG target(s). BG (blood glucose) target range The BG target range setting allows you to set your blood glucose target range.
Using the Bolus Wizard feature 71 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 warn ing that the values are accepta ble but outside the normal range.
72 Chapter: 5 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 estima ting a bolus. See “About active insulin” on page 64 for more information about this setting.
Using the Bolus Wizard feature 73 Review your Bolus Wizard feature settings Check your Bolus Wizard feature settings in the RE VIEW SETTINGS screen. If necessary, compare this information with your information in th e Bolus Wizard feature settings table.
74 Chapter: 5 Meter rules If you want your pump to communi cate with the Paradigm Link mete r, the following conditions must apply: 1 The meter option must be turned on and pr ogrammed. See “Meter option” on page 73 for instructions. 2 Your pump must be within 4 feet (1.
Using the Bolus Wizard feature 75 2 Add, delete or review your meter ID(s) as desired. 3 Exit the menus when your are done. Add Delete Rev iew a. Select Add 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.
76 Chapter: 5 Normal bolus using Bolus Wizard feature After the Bolus Wizard feature is turned on and programmed, this f eature can calculate an estimate of insulin you need for your correct ion bolus and/or your food bolus. You have the option of using the estimate or changing it as necessary.
Using the Bolus Wizard feature 77 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. 6 In the SET BOLUS screen, th e estimated bolus amount shows (flashing).
78 Chapter: 5 Bolus Wizard feature examples For the scenarios that follow, Michael has his Bolus Wi zard 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.
Using the Bolus Wizard feature 79 Example 2: Blood glucose above ta rget range and no active insulin The next day, Michael wakes up before school. Be fore eating the same breakfast, he tests his blood glucose with his Paradigm Link meter and finds it to be 200 mg/dL (11.
80 Chapter: 5 Example 4: Blood glucose above ta rget 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.
Using the Bolus Wizard feature 81 Example 5: Blood glucose below ta rget 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), wh ich is below his Low BG ta rget of 90 mg/dL (5.
82 Chapter: 5.
Optimizing pump therapy 83 Chapter: 6 Optimizing pump therapy Square Wave and Dual Wave boluses Square W ave bolus delivers a bolus evenly over a period of time (30 minut es to 8-hours). This bolus can be used for insulin delivery when you have eaten a long meal with extended snacking.
84 Chapter: 6 Dual/Square Wave bolus on-off NOTE - It is important that you consult with your he althcare professional before using a Square Wave or Dual Wave bolus. You sh ould be familiar with the basic functions of your pump before exploring these options.
Optimizing pump therapy 85 5 The SQUARE DURATION screen will ap pear. Enter the amount of time you want the Square Wave bolus to last and press AC T . NOTE - If you have the BG Reminder feature tur ned on, a screen displays allowing you to accept or modify the length of time after this bolus before you are reminded to check your blood glucose.
86 Chapter: 6 Example 1: Square Wave bolus - Use of a Square Wave bolus whil e 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 eat ing this high fat meal.
Optimizing pump therapy 87 Your turn: Square Wave bolus practice Your target pre-meal blood glucose range is ______ to _______. Check your pre-meal blood glucose.
88 Chapter: 6 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 majori ty of her meals. She tests her pre-meal blood glucose and finds that it is above her target level.
Optimizing pump therapy 89 Using the Bolus Wizard feature for a Square Wave or Dual Wave bolus If you are using the Bolus Wizard feature to calculate your Squa re Wave or Dual Wave bolus amounts, you will be prompted to enter your blood glucose reading an d/or the (carb or exchange) units you will eat.
90 Chapter: 6 5 The SQUARE DURATION screen will appear . Enter the amount of time you want the Square Wave bolus to last and press ACT . NOTE - If you have the BG Reminder feature turned on, a screen displays allowing you to accept or modify the le ngth of time after this bolus before you are reminded to check your blo od glucose.
Optimizing pump therapy 91 6 Press ACT to accept and deliver the bolus. The BOLUS DELIVERY appears. The pump beeps or vibrates at the start an d end of the bolus. Shortly after bolus delivery begins, the screen defaults to the HOME screen. If you want to see the progress of the delivery, press ESC to see the status screen.
92 Chapter: 6 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. 2 In the EAS Y BO LUS E NT RY screen, the “step” value will appear flashing.
Optimizing pump therapy 93 1 From the HOME screen, press . The SET EASY BOLUS screen will appear. The single “step” value will be flashing. 2 Press the number of time s needed for your bolus amount. Watch the amount chan ge on the screen with each press.
94 Chapter: 6 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 ca n easily reach down an d feel for the Easy Bolus button to give a bolus.
Optimizing pump therapy 95 Basal patterns The Basal Patterns feature is optional for pump user s. You can set your pump to deliver a standard basal and two additional basal patter ns to meet your individual daily, weekly, or monthl y needs. Keep a paper copy of your programmed pa tterns with you at all times in case you need to reprogram your pump.
96 Chapter: 6 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 patt ern, the pump will use that pattern as the current basal.
Optimizing pump therapy 97 5 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. Select a pattern Before you try to select a pattern to be active, make sure the Pa tterns feature is on.
98 Chapter: 6 Example 1: Basal patterns Ken has had his insulin pump for about a month. He tests his bloo d glucose 4 - 6 times a day and records his results in his logbook. He is happy wi th his glucose control duri ng the week but on the weekends, he noticed that he has to eat more food to prevent hi s blood glucose from running too low.
Optimizing pump therapy 99 Temp (temporary) basal rates 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 illn ess or unplanned physical activity that is not part of your daily routine.
100 Chapter: 6 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).
Optimizing pump therapy 101 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 curren t basal (0 - 200 per cent limited to your maximum basal rate setting).
102 Chapter: 6 NOTE - The pump delivers basal amounts in 0.05 U/H in crements. Be cause of this, your temp basal amount will be rounde d down to the next 0.05 U/H increment. temp basal start time (120% x rate 3 = 2.34) 2.34 rounded down to the next 0.
Optimizing pump therapy 103 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 BA SAL M EN U. Main > Basal > Temp Basa l Type Select Temp Basal Type and press AC T .
104 Chapter: 6 3 In the SET TEMP BASAL screen, the temporary basal rate will flash. Enter your temp basal rate, then press ACT . 4 The BASAL MENU will appear. Your temp basal is now set and delivering. Exit the menus. Verifying temp basal delivery Temporary basal information is available in the STATUS screen only.
Optimizing pump therapy 105 Canceling a temp basal Use the cancel temp basal function in the BASAL ME NU 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 BAS AL M ENU .
106 Chapter: 6 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.
Insulin pump ther apy follow-up 107 Chapter: 7 Insulin pump therapy follow-up We hope that you are now comforta ble using the pump and your blood glucose values have improved through insulin pump therapy. Diabetes management requires much more than blood glucose control.
108 Chapter: 7 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.
Utilities 109 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.
110 Chapter: 8 1 Go to the ALERT TYPE screen. Main > Utilities > Alarm > Alert Type 2 Select your alert type and press AC T . That alert type is now active. Exit the menus. Auto-off The factory setting for this feature is off (set to 0 hours).
Utilities 111 NOTE - If you use “time” as the low resv warning ty pe and you deli ver large boluses, the actual time remaining could be less than the warning ti me. “Time” low resv warning types are intended to let you know if you will have en ough insulin while you are sleeping.
112 Chapter: 8 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 bolu s and basal amounts delivered midnight-to midnight for each of the past 31 da ys.
Utilities 113 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 info rmation, and food intake with averages up to 31 days. You ca n view the deta ils of each day individually.
114 Chapter: 8 ➠ total man (manual) bolus insulin delivered for th e day and total percentage of manual boluses delivered for the day To view more data, press .
Utilities 115 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 AC T . Main > Utilities > Daily Totals > Daily Average 2 The DAYS TO AVERAGE screen is displayed.
116 Chapter: 8 ➠ the total average percentage of bolus in sulin delivered for the previous 12 days ➠ the average total correction bolus insulin delivered per day ➠ the total average percentage of bolus insuli n delivered per day for the previous 12 days ➠ the average total manual bolu s insulin delivered per day To view more data, press .
Utilities 117 Main > Utilities > Alarm Clock 5 Repeat step 3 and step 4 to program additional alarm clock times. Exit the menus when you are done. Remote control option The factory setting for this feature is off. You may want to explore the remote option after you have become completely familiar with the basic functions of your pump.
118 Chapter: 8 Turn on remote control option 1 Go to the REMOTE OPTION screen. Select On and press ACT . Main > Utilities > Remote Options 2 The REMOTE ID MENU screen wi ll appear. Add, delete or review your remote ID as described in the next section.
Utilities 119 3 Exit the menus when your are done. Block feature The block allows you to prevent (block) people fr om changing pump setting that should not be working with the pump s settings. Th is feature is an important safety feature, especially if the pump user requires someone else to maintain complete control of pump operation.
120 Chapter: 8 Example 1: Block Nicholas is a very active toddler who wears a Para digm pump. His parents don't want to worry that he will play with the pump and accidentally chan ge his programmed settings.
Utilities 121 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 us ed to give a bolus or put the pump into Suspend.
122 Chapter: 8 1 Go to the UTILITIES MENU. Select Selftest and press ACT . Main > Utilities > Selftest 2 As part of the selftests, the pump will do these tests: NOTE - Periodically, you will hear beeps as differen t mechanisms in the pu mp are bei ng tested.
Utilities 123 User settings The user settings function allows you to save, restor e, and clear all pump setti ngs. You can also view a listing of the dates and times of all recent user settings operations you have done.
124 Chapter: 8 3 If this is the first time you have saved pump setting s, 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).
Utilities 125 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. Clear settings Take the following steps only if you want to clear your pump to factory default settings.
126 Chapter: 8 4 You will see a RESET screen, and then the pump will go through various screens while it restarts . After the pump clears a ll of your settings, the screen will go to the TIME/DATE SETUP screen 5 Reset the time and date as described in “Setting the time and date” on page 23.
Utilities 127 Language setting The language shown on the pump screens can be changed. Some la nguages 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 .
128 Chapter: 8.
Troubleshooting 129 Chapter: 9 Troubleshooting This chapter is designed to help you understand th e messages that your pump is giving you when you get an alarm or an alert message. The procedures in the beginn ing of this chap ter are to be used when you get specific alarms or cover a li kely condition that might happen.
130 Chapter: 9 7 Monitor your blood glucose closely. 8 If you followed these steps and you are still receiv ing a No Delivery alarm, call the 24-hour Product Help Line.
Troubleshooting 131 ➠ or after you rewind when practicing without a reservoir when your fi rst get your pump. In this case, i t i s j u s t a r e m i n d e r t o m a k e s u r e a l l y o u r s e ttings are programmed before you begin using the pump with insulin.
132 Chapter: 9 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 rece ives a static shock. As a safety measure, the pump stops the bolus when this happens.
Troubleshooting 133 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 co nnector and tubing for cracks or damage.
134 Chapter: 9 I cannot get to the User Settings menu If you do not ho ld down the butt on while pressing ACT when you have User Settings highlighted, you will see the following screen: 1 Go to the Utilities screen and highlight User Settings. Then, hold down the button and press ACT .
Troubleshooting 135 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. Low battery alert If you get this alert, DO NOT go to sleep without replacing the battery.
136 Chapter: 9 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, pr ess any button to see the alarm message.
Troubleshooting 137 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 Product Help Line for assistance.
138 Chapter: 9 Button error Occurs if a button has been continually pressed for more than 3 minutes. Check settings When this alarm is active, you sh ould check and/or reprogram your pump settings, including the time/date.
Troubleshooting 139 Is priming complete? If you manually prime your pump with more than 30u insulin, this message appears. Press ESC , AC T to clear the message. If manual prime is complete, press ESC . If the manual prime is not complete, press and hold AC T until manual prime is complete.
140 Chapter: 9 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.
Pump maintenance 141 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 .
142 Chapter: 10 Cleaning your pump 1 Use only a damp cloth and mild detergent mixed with wat er to clean the outside of your pump. 2 Rinse the pump with a clean clot h, dampened with clean water. 3 Dry with a clean cloth. 4 Never use organic solvents, such as lighter fluid, na il polish remover, or paint thinner to clean your pump.
Pump specifications 143 Chapter: 11 Pump specifications This section provides detailed in format ion on specifications related to your pump. The s afety features of your pump are individually listed and described.
144 Chapter: 11 BG (blood glucose) target Bolus delivery Bolus history Maximum records shown: 24 Bolus units Increments: 0.1 units Bolus Wizard feature (See “Bolus Wizard feature example s” on page 152 for information.
Pump specifications 145 Pump motor The pump motor has a unique, patented design with an in tegrated 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).
146 Chapter: 11 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. Normal bolus Range 0.1 – 25.0 units of insulin (limited by maximum bolus setting).
Pump specifications 147 Program safety checks Maximum infusion with single fault condition: 0.0 ml. Pump size The dimensions of the pump are: Pump weight Remote control Uses radio signals to allow users to program No rmal boluses or to s uspend/resume their pumps.
148 Chapter: 11 Status screen ➠ Alarm Clock:* (appears if scheduled to alarm) Time set is displayed. ➠ Au to -of f: (appears if enabled) X HR ➠ Basal pattern information: (if active) Pattern A o.
Pump specifications 149 *If all Reminders and Alarm Cloc k are enabled, only the remind er nearest to alarmi ng will appear in the STATUS screen. ➠ Standard basal delivery data: (always appears) current basa l rate (basal 1, basal 2, etc.) ➠ Status of pump (i.
150 Chapter: 11 Bolus Wizard feature specifications There are three different formulas the Bolus Wizard feature uses to estimate a bolus, depending on your current blood glucose: 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.
Pump specifications 151 ➠ Active insulin only reduces the correction po rtion of the estimate, not the food portion. ➠ For a current blood glucose that is above the high target, if the active insulin is more than the correction estimate, the correction portion of the estimate is changed to zero (0).
152 Chapter: 11 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 previ ous bolus delivery. User inputs 60 grams of carbs and does not enter blood glucose.
Pump specifications 153 #3: No active insulin from previous bolu s delivery. User inputs 60 grams of carbs and a blood glucose of 70 . #4: No active insulin from previous bo lus delivery. User inputs 60 grams of carbs and a blood glucose of 100. #5: Previous bolus activity result s in a calculation of 1.
154 Chapter: 11 Default (factory) settings #6: Previous bolus activity resu lts in a calculation of 3.5 uni ts unabsorbed (active) insulin. Us er inputs 60 grams of carbs and a blood glucose of 200. Menu Item Default Setting Limits Increments Warning Limits Bolus Menu: Bolus Wizard feature: Off Easy bolus: On Easy bolus step: 0.
Pump specifications 155 Utilities Menu: Lock Keypad: Off (Alarm) History: (no defaults) Alert type: audio, beep-med Auto-off: Off Low reservoir warning: (20) insulin units 5 - 50 u; 2nd: @ 12 amount (2:00 - 24:00; 2nd: after 1:00) 20 u (0:30 mins) (Time/Date) Time: 12 a.
156 Chapter: 11 Menu Item Default Setting Limits Increments Warning Limits Bolus Wizard feature Settings carb units: grams or exchanges none none none ins to carb (or exch) ratio: 15 grams/u or 1 unit/exch 3 - 150g/u or 0.1 - 5.0 u/exch 1 g/u or 0.1 u/exch 5 - 50 g/u or 0.
Pump specifications 157 Icon table Do not reuse Attention: See Inst ructions for Use Method of sterilizatio n using ethylene oxide Date of manufacture (year - month) Manufacturer Batch code Configurat.
158 Chapter: 11.
Index 159 Index Symbols μL xxi Numerics 24-hour Product Help Line 1 A accept xvii accessories, activity guard 5 holster 5 leather case 5 meter 3 pump clip 5 remote control 3 ACT button 14 active insu.
160 Index BG (blood glucose), definition xvii block feature, definition xviii turning on 119 BLOCK OPTION screen 119 blood glucose (BG) target range, mg/dL 144 mmol/L 144 blood glucose (BG) target war.
Index 161 correction bolus, amount of insulin needed xviii corr bolus amount xviii definition xviii formula for calculating xviii procedure (Bolus Wizard feature) 77 D DAILY TOTALS screen, reviewing d.
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