Paradigm®515 and 715 Infusion PumpsUser Guide
xContentsI dropped my pump ... 133I submerged my pump in water ...
78 Chapter: 5Bolus Wizard feature examplesFor the scenarios that follow, Michael has his Bolus Wizard feature turned on with the following settings:➠
Using the Bolus Wizard feature 79 Example 2: Blood glucose above target range and no active insulinThe next day, Michael wakes up before school. Bef
80 Chapter: 5 Example 4: Blood glucose above target range with active insulinMichael is at school and wants to eat a snack in the late morning. He tes
Using the Bolus Wizard feature 81 Example 5: Blood glucose below target range with active insulinAnother day at school, Michael is getting ready to e
82 Chapter: 5
Optimizing pump therapy 83 Chapter: 6Optimizing pump therapySquare Wave and Dual Wave bolusesSquare Wave bolus delivers a bolus evenly over a period o
84 Chapter: 6Dual/Square Wave bolus on-offNOTE - It is important that you consult with your healthcare professional before using a Square Wave or Dual
Optimizing pump therapy 85 5 The SQUARE DURATION screen will appear. Enter the amount of time you want the Square Wave bolus to last and press ACT. NO
86 Chapter: 6 Example 1: Square Wave bolus - Use of a Square Wave bolus while eating a meal high in fatConner loves pizza. When he was using insulin s
Optimizing pump therapy 87 Your turn: Square Wave bolus practiceYour target pre-meal blood glucose range is ______ to _______.Check your pre-meal b
Contents xiBG (blood glucose) target ...144Bolus delivery ...
88 Chapter: 6 Example 2: Dual Wave bolus - Set a Dual Wave bolus for correcting elevated blood glucose before a mealMarsha uses the Square Wave bolus
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
90 Chapter: 65 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 ha
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 and end of
92 Chapter: 6Step value setupYou 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 u
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
94 Chapter: 6 Example 1: Easy bolusAlexander is a busy executive with an accounting firm. He wears his Paradigm pump on his belt and does not want t
Optimizing pump therapy 95 Basal patternsThe Basal Patterns feature is optional for pump users. You can set your pump to deliver a standard basal and
96 Chapter: 6Program a patternYour pump will keep your pattern settings even when the Patterns option is turned off. The patterns feature must be on t
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, ➠ t
xii Contents
98 Chapter: 6 Example 1: Basal patternsKen has had his insulin pump for about a month. He tests his blood glucose 4 - 6 times a day and records his
Optimizing pump therapy 99 Temp (temporary) basal ratesThe temp (temporary) basal rate feature is useful to manage blood glucose levels during unusual
100 Chapter: 6Temp basal typesBased on your preference, you can select either Percent of Basal or Insulin Rate.Insulin rateInsulin rate is a fixed bas
Optimizing pump therapy 101 Percent of basalThe temp basal type is dependent on your current basal rates. Percent temp basal is a percentage increase
102 Chapter: 6NOTE - 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
Optimizing pump therapy 103 Selecting temp basal typeYour pump will remember the temp basal type setting. Once the type is set, you do not have to set
104 Chapter: 63 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 a
Optimizing pump therapy 105 Canceling a temp basalUse the cancel temp basal function in the BASAL MENU to cancel a temporary basal. This function imme
106 Chapter: 6 Example 2: Temp Basal for an increased temporary basal rateGail has had a cold with a cough for a couple of days. Because she is not f
Insulin pump therapy follow-up 107 Chapter: 7Insulin pump therapy follow-upWe hope that you are now comfortable using the pump and your blood glucose
xiii Practice lessons and examplesBolus examplesMeal bolusNormal meal bolus using the exchange system ...
108 Chapter: 7Laboratory tests➠ Test for HbA1c four or more times a year➠ Test for cholesterol, HDL, LDL, triglyceride yearly➠ Test for microalbuminur
Utilities 109 Chapter: 8UtilitiesAlarm reviewYou can review alarms in the ALARM HISTORY screen. This screen shows up to 36 past alarms and/or errors.
110 Chapter: 81 Go to the ALERT TYPE screen. Main > Utilities > Alarm > Alert Type 2 Select your alert type and press ACT. That alert type is
Utilities 111 NOTE - If you use “time” as the low resv warning type and you deliver large boluses, the actual time remaining could be less than the wa
112 Chapter: 8Review daily insulin totalsThe DAILY TOTALS screen provides a day-by day history of the total amount of insulin that delivered for the p
Utilities 113 Pump data managementThe pump data management feature allows you and your healthcare professional to view and manage your basal and bolus
114 Chapter: 8➠ total man (manual) bolus insulin delivered for the day and total percentage of manual boluses delivered for the dayTo view more data,
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 a
116 Chapter: 8➠ the total average percentage of bolus insulin delivered for the previous 12 days ➠ the average total correction bolus insulin delivere
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 don
xivBolus Wizard feature examplesExample 1: BG on target (normal BG) and no active insulin ...78Example 2: BG above tar
118 Chapter: 8Turn on remote control option1 Go to the REMOTE OPTION screen. Select On and press ACT. Main > Utilities > Remote Options2 The REM
Utilities 119 3 Exit the menus when your are done. Block featureThe block allows you to prevent (block) people from changing pump setting that should
120 Chapter: 8 Example 1: BlockNicholas is a very active toddler who wears a Paradigm pump. His parents don't want to worry that he will play wi
Utilities 121 Lock keypad featureLock keypad prevents accidental pump keypad presses. The only button you can press is the to view the STATUS screen.
122 Chapter: 81 Go to the UTILITIES MENU. Select Selftest and press ACT. Main > Utilities > Selftest2 As part of the selftests, the pump will do
Utilities 123 User settingsThe user settings function allows you to save, restore, and clear all pump settings. You can also view a listing of the dat
124 Chapter: 83 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,
Utilities 125 4 The SETTINGS RESTORED message displays to confirm that your current pump settings have been replaced with the pump settings you had sa
126 Chapter: 84 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 se
Utilities 127 Language settingThe language shown on the pump screens can be changed. Some languages will not be available on all pumps. To change the
Glossary xvii GlossaryAAccept - Pressing the ACT button to approve the selection or setting.Active insulin - Insulin that has been delivered to your b
128 Chapter: 8
Troubleshooting 129 Chapter: 9TroubleshootingThis chapter is designed to help you understand the messages that your pump is giving you when you get an
130 Chapter: 97 Monitor your blood glucose closely.8 If you followed these steps and you are still receiving a No Delivery alarm, call the 24-hour Pro
Troubleshooting 131 ➠ or after you rewind when practicing without a reservoir when your first get your pump. In this case, it is just a reminder to ma
132 Chapter: 9My bolus stoppedThe Bolus Stopped error can occur if the battery cap is loose or the pump was bumped or dropped during a bolus. It can a
Troubleshooting 133 I dropped my pumpTake care to protect your pump from being dropped.1 Check that all connections are still tightly in place.2 Check
134 Chapter: 9I cannot get to the User Settings menuIf you do not hold down the button while pressing ACT when you have User Settings highlighted, yo
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 amou
136 Chapter: 9What to doWhen an alarm is triggered, the pump goes into Attention mode and an alarm message shows on the screen. The pump then defaults
Troubleshooting 137 Alarm conditionsAlarms put the pump in “Attention” mode.A (Alarm)This alarm shows an “A” followed by two numbers. A-alarms cause a
xviii GlossaryBG (blood glucose) target range - The range of your normal or desirable blood glucose levels. You can set up the pump so that you receiv
138 Chapter: 9Button errorOccurs if a button has been continually pressed for more than 3 minutes.Check settingsWhen this alarm is active, you should
Troubleshooting 139 Is priming complete?If you manually prime your pump with more than 30u insulin, this message appears. Press ESC, ACT to clear the
140 Chapter: 9Off no powerThe battery is dead. Replace battery immediately. Follow the directions on the screen. Check to make sure that the time is c
Pump maintenance 141 Chapter: 10Pump maintenanceIt is recommended that you read your warranty statement included with your pump for information about
142 Chapter: 10Cleaning your pump1 Use only a damp cloth and mild detergent mixed with water to clean the outside of your pump. 2 Rinse the pump with
Pump specifications 143 Chapter: 11Pump specificationsThis section provides detailed information on specifications related to your pump. The safety fe
144 Chapter: 11BG (blood glucose) targetBolus deliveryBolus historyMaximum records shown: 24 Bolus unitsIncrements: 0.1 unitsBolus Wizard feature(See
Pump specifications 145 Pump motorThe pump motor has a unique, patented design with an integrated safety check system. The system delivers in precise
146 Chapter: 11Meter valueThe blood glucose measurement received from Paradigm Link meter. Appears in the ENTER BG screen during bolus programming. Ap
Pump specifications 147 Program safety checksMaximum infusion with single fault condition: 0.0 ml.Pump sizeThe dimensions of the pump are:Pump weightR
Glossary xix Dual Wave™ bolus - Combination of a normal bolus that is delivered immediately, then followed by a Square Wave bolus. The Square Wave por
148 Chapter: 11Status screen➠ Alarm Clock:* (appears if scheduled to alarm)Time set is displayed.➠ Auto-off: (appears if enabled) X HR➠ Basal pattern
Pump specifications 149 *If all Reminders and Alarm Clock are enabled, only the reminder nearest to alarming will appear in the STATUS screen. ➠Standa
150 Chapter: 11Bolus Wizard feature specificationsThere are three different formulas the Bolus Wizard feature uses to estimate a bolus, depending on y
Pump specifications 151 ➠ Active insulin only reduces the correction portion of the estimate, not the food portion.➠ For a current blood glucose that
152 Chapter: 11Bolus Wizard feature examplesSettings:➠ Carb ratio: 30 grams/unit ➠ Insulin Sensitivity: 40 mg/dL/unit➠ BG Target: 90-120 mg/dL ➠ Activ
Pump specifications 153 #3: No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a blood glucose of 70. #4: No active ins
154 Chapter: 11Default (factory) settings#6: Previous bolus activity results in a calculation of 3.5 units unabsorbed (active) insulin. User inputs 60
Pump specifications 155 Utilities Menu: Lock Keypad:Off(Alarm) History:(no defaults)Alert type:audio, beep-medAuto-off:OffLow reservoir warning:(20) i
156 Chapter: 11Menu Item Default SettingLimits Increments Warning LimitsBolus Wizard feature Settingscarb units: gramsor exchangesnone none noneins to
Pump specifications 157 Icon tableDo not reuseAttention: See Instructions for UseMethod of sterilization using ethylene oxideDate of manufacture (year
xx GlossaryLLDL - (Low-density lipoprotein) A complex of lipids and proteins, with greater amounts of lipid than protein, that transports cholesterol
158 Chapter: 11
Index 159 IndexSymbolsμL xxiNumerics24-hour Product Help Line 1Aaccept xviiaccessories,activity guard 5holster 5leather case 5meter 3pump clip 5remote
160 Index BG (blood glucose),definition xviiblock feature,definition xviiiturning on 119BLOCK OPTION screen 119blood glucose (BG) target range,mg/dL 1
Index 161 correction bolus,amount of insulin needed xviiicorr bolus amount xviiidefinition xviiiformula for calculating xviiiprocedure (Bolus Wizard f
162 Index Llanguage setting 127LDL (Low-density lipoprotein) xxleft the battery out too long, what to do 130Link xxlock keypad feature 121logbook feat
Index 163 PParadigm Link meter 3, 59ParadigmPAL,managing your pump settings 5pump setting reports 5types of data you can manage 5Pattern feature xxpat
164 Index reservoir,filling 44inserting into your pump 48low reservoir alert 110plunger rod 44removing the 46transfer guard 44tubing connector 11resto
Index 165 UUp button 14user settings 123Utilities menu,described 19factory settings 155Wwater resistance (pump) 133
166 Index
Glossary xxi Pattern, standard - Your normal basal that supports your usual day-to-day activity. When the Patterns feature is off, the pump uses your
© 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
xxii Glossary
xxiii Your personal informationYou may need the following information from your healthcare professional before going to your pump start appointment. I
xxivCarb 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
Introduction 1 Chapter: 1IntroductionThank you for choosing Medtronic MiniMed as your partner in helping you gain better control of your diabetes. Whe
2Chapter: 1Emergency kitKeep an emergency kit with you at all times to make sure that you always have necessary supplies. Inform a family member, co-w
Introduction 3 DisposablesThe pumps use disposable reservoirs and infusion sets for insulin delivery. Installation instructions for Paradigm reservoir
4Chapter: 1Download pump and meter dataThe Medtronic CareLink™ Therapy Management System for Diabetes Web site is designed to help you take informatio
Introduction 5 ParadigmPALWith ParadigmPAL™ you can do the following with your pump settings:➠ See your pump settings on your PC screen.➠ Backup, or s
6Chapter: 1How to use this guideNOTE - This User Guide shows sample screens only. Your pump screens may be slightly different. For step-by-step instru
Introduction 7 User safetyIndicationsThe Paradigm 515/715 pump system is indicated for the continuous delivery of insulin, at set and variable rates,
Important Safety InformationRegarding Your Paradigm Insulin Infusion Pump (includes all models)Avoid Immersing Your Pump In WaterAlthough it is unlike
8Chapter: 1PrecautionsAlthough the pump has multiple safety alarms, it cannot notify you if the set is leaking or the insulin has lost its potency. It
Introduction 9 Notice Insulin pump and RF accessoriesThe pump, Paradigm Link meter, and remote control comply with the United States Federal Communica
10 Chapter: 1
The basics 11 Chapter: 2The basicsYour pumpTake a look at your pump. The reservoir window allows you to view the insulin in the reservoir. The reservo
12 Chapter: 2Install batteryMedtronic MiniMed designed the pump to only accept a NEW battery. As a safety measure, if you install a battery that does
The basics 13 5 While the pump turns on, it will show various screens until the HOME screen appears.NOTE - If you are replacing a battery for a pump t
14 Chapter: 2Pump buttonsThe buttons on the pump are used to navigate through the menus and screens, and to program the features of the pump.From the
The basics 15 The pump screenThe screen shows five lines of text at one time. The first is the operating mode. The second is the current open menu or
16 Chapter: 2Time displayThe 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
The basics 17 Screen backlightWhen you press from the HOME screen, the light on the screen turns on or off. During programming, the backlight can be
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18 Chapter: 2Special - indicates a special feature is active or an alert condition(s) exists. Special mode does not restrict any of the pump functions
The basics 19 MenusThe MAIN MENU is the highest level menu. There are submenus, functions, status and programming screens in the lower menu levels. Th
20 Chapter: 2STATUS screenThe STATUS screen shows information about what your pump is doing. The information that shows on the STATUS screen depends o
The basics 21 If you remove your pumpPump settingsYou may have an occasion when you need or want to remove your pump. If you have to remove and store
22 Chapter: 2
Basic programming 23 Chapter: 3Basic programmingSetting the time and dateSetting the correct time and date in your pump is necessary for accurate basa
24 Chapter: 35 The TIME SET AT screen will show the settings that you programmed. Press ACT and exit the menus. Your time/date settings are complete.B
Basic programming 25 NOTE - If you have the BG Reminder feature turned On, a screen displays allowing you to accept or modify the length of time after
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 expr
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 in
Contents vContentsGlossary ... xviiYour personal information ...
28 Chapter: 3 Practice: Meal bolusYou have determined your meal bolus as: _______ units.Your target blood glucose range is: _______ to _______ (avera
Basic programming 29 Review your bolus deliveriesYou can view a list of your bolus deliveries in the BOLUS HISTORY screen. This screen shows a list of
30 Chapter: 3Bolus detailsYou can view the details for any of the deliveries in the BOLUS HISTORY screen. The details include:➠ bolus types: normal, s
Basic programming 31 Maximum bolus limitThe maximum bolus (max bolus) is a safety feature that you can use to set a limit on the amount of insulin tha
32 Chapter: 3BG reminderWhen you deliver a bolus you may want to check your blood glucose afterwards. The BG reminder is an optional feature that you
Basic programming 33 BasalBasal insulin is required to maintain your target glucose values when you are not eating. Your healthcare professional will
34 Chapter: 3Your basal settingsYou must program your basal settings before you can deliver basal insulin. Keep a written record of your basal setting
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 t
36 Chapter: 3Basal reviewTemporary basal information is only available in the STATUS screen.Current basal deliveryThe STATUS screen shows your current
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
vi ContentsHOME screen ... 15Screen icons ...
38 Chapter: 3Max basal rateMaximum basal rate is a safety limit for the amount of basal insulin that is able to be delivered per hour. This maximum ra
Basic programming 39 Stopping your pumpYou can stop your pump with the suspend function. Suspend stops all insulin delivery including the current basa
40 Chapter: 3Resume pump deliveryWhen the pump is suspended, it defaults to the HOME screen with a solid circle. Do these steps to resume your pump an
Basic programming 41 Practice: Suspend function1 Make sure you are NOT connected to your pump while practicing.Program your pump to deliver a Normal
42 Chapter: 3
Starting on insulin 43 Chapter: 4Starting on insulinPrepare your pump for useBefore continuing with the steps in this chapter, we recommend that you w
44 Chapter: 4Filling the reservoirWARNING: Your pump will not accurately deliver insulin if air bubbles are in the reservoir or the infusion set. To p
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 reserv
46 Chapter: 4Changing your infusion setRemoving the reservoirEach time you remove and replace a reservoir in your pump, you have to rewind and prime y
Starting on insulin 47 Rewinding your pumpBefore you continue, make sure the pump is NOT connected to your body. 1 If you removed your reservoir and a
Contents viiChapter 4 Starting on insulin ... 43Prepare your pump for use ...
48 Chapter: 4Inserting the reservoir in your pumpIf your reservoir is already inserted in your pump, continue to “Manual prime” on page 49. You must d
Starting on insulin 49 Manual primeManual prime fills the infusion set tubing with insulin before you attach it to the infusion site. Manual prime is
50 Chapter: 45 Press ESC. Your manual prime is complete. 6 You can now insert the infusion set into your body as described in the next section.Insert
Starting on insulin 51 Quick-set infusion set (with Quick-serter®)Always refer to the instructions that shipped with your infusion set. 1 Wash your
52 Chapter: 478910
Starting on insulin 53 11 1213
54 Chapter: 4Connecting Quick-setDisconnecting Quick-setThe Quick-set allows you the freedom to temporarily disconnect from your pump without removing
Starting on insulin 55 Fixed primeA fixed prime fills the soft cannula with insulin and is required after the infusion set is inserted into your body.
56 Chapter: 4Record keeping for diabetes managementNow that you are using the pump with insulin, we will be asking you to test your blood glucose regu
Starting on insulin 57 Using your daily journalTo use the daily journal that came with your pump, follow these easy steps:1 Write the day and date in
viii ContentsReview your Bolus Wizard feature settings ... 73Meter option ...
58 Chapter: 4
Using the Bolus Wizard feature 59 Chapter: 5Using the Bolus Wizard featureWhat is it?A feature that calculates an estimated bolus: Information you nee
60 Chapter: 5Get this information from your healthcare professional, and, for best results, talk to your healthcare professional before making any cha
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 correctio
62 Chapter: 5How the Bolus Wizard feature worksIf you are going to eat and you want the Bolus Wizard feature to estimate your food bolus:1 Enter your
Using the Bolus Wizard feature 63 More about the Bolus Wizard featureAbout high or low blood glucose levelsIf your blood glucose is less than 60 mg/dL
64 Chapter: 5About active insulinActive insulin is the bolus insulin that has already been delivered to your body, but has not yet been used. The Bolu
Using the Bolus Wizard feature 65 For more details about active insulin, see “Bolus Wizard feature specifications” on page 150. CAUTION: The Bolus Wi
66 Chapter: 5How to program the Bolus Wizard featureYou need your personal settings from the Bolus Wizard feature settings table to setup the Bolus Wi
Using the Bolus Wizard feature 67 Carb unitsThe carb unit setting lets the pump know which way to count your carbohydrates (grams or exchanges). See t
Contents ixChapter 8 Utilities ...109Alarm review ...
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
Using the Bolus Wizard feature 69 BG (blood glucose) unitsYou can select mg/dL or mmol/L as your BG units (unit of measurement type). NOTE - If you ma
70 Chapter: 53 The SET START TIME 2 screen will appear. 5 The screen will return to the EDIT SETTINGS screen. You can now program your BG target(s).B
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 B
72 Chapter: 5Active insulin timeThe active insulin time setting lets the pump know which active insulin time to use in calculating the amount of activ
Using the Bolus Wizard feature 73 Review your Bolus Wizard feature settingsCheck your Bolus Wizard feature settings in the REVIEW SETTINGS screen. If
74 Chapter: 5Meter rulesIf you want your pump to communicate with the Paradigm Link meter, the following conditions must apply:1 The meter option must
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 Reviewa. Select
76 Chapter: 5Normal bolus using Bolus Wizard featureAfter the Bolus Wizard feature is turned on and programmed, this feature can calculate an estimate
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 ch
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