User GuideINSULIN PUMP
Review your Bolus Wizard feature settings ... 83Meter option ...
Add, delete, review meter IDs The meter programming screens are very similar to those for the remote control. Make sure to selectMeters in the DEVICE
Use the button to deliver a Normal bolus at any time except during another Normal bolus. A Normalbolus will temporarily interrupt a Square Wave or D
7 The BOLUS DELIVERY screen appears. The pump will beep or vibrate at the start and end of the bolus.As the bolus is delivered, the screen shows the b
Example 2: Blood glucose above target (high blood glucose) and no active insulinThe next day, Michael wakes up before school. Before eating the same b
Example 4: Blood glucose above target (high blood glucose) with active insulinMichael is at school and wants to eat a snack in the late morning. He te
Example 5: Blood glucose below target (low blood glucose) with active insulinAnother day at school, Michael is getting ready to eat lunch. He tests hi
Optimizing pump therapySquare Wave and Dual Wave bolusSquare Wave bolus delivers a bolus evenly over a period of time (30 minutes to 8 hours). This bo
See the following graphic for a description of the different bolus types:TIMEINSULIN123DUAL WAVEBOLUSSQUARE WAVEBOLUSNORMALBOLUSNowPortionSquarePortio
4 For a Square Wave bolus, do these steps:a. Select Square Wave Bolus, then press ACT. The SET SQUARE BOLUS screen appears.b. Enter the desired amount
Square Wave bolus practiceYour target pre-meal blood glucose range is ______ to _______.Check your pre-meal blood glucose. Are you within your target?
Turn on remote control option ... 118Add, delete, review remote control IDs ...
Dual Wave bolus practiceCan you think of any meals where this feature would help you with blood glucose control?Your target pre-meal blood glucose ran
1 Go to the ENTER BG screen.Press on your pump, or use the following path:Main > Bolus > Use Bolus Wizard2 Enter your blood glucose value, then
8 Press ACT to accept and deliver the bolus. The BOLUS DELIVERY screen appears with an open circleindicating that your pump is in Special Mode. The pu
Step value setup You can set the step value from 0.1 to 2.0 units, or to the set maximum bolus limit of less than 2.0 units(factory setting: 0.1). Set
For example: You need to deliver a 2.0 unit bolus, and your step size is set to 0.5. Each time you press, the units increase by the step amount of 0.5
Your turn: Easy bolus practiceThe factory default setting for the Easy Bolus feature is 0.1 unit steps. You can change the step level asnecessary to a
1 Go to the PATTERNS OPTION screen.Main > Basal > Patterns2 Select On, then press ACT. The patterns feature is now on. Exit the menus.Programmin
Select a pattern Before you select a pattern to be active, make sure the Patterns feature is turned on. After your standardpattern and/or pattern A or
Example 2: Basal patternsCynthia has had diabetes for about 12 years and has been on her Paradigm pump for several weeks.Every Monday, Wednesday and F
Temp basal typesBased on your preference, you can select either Percent of Basal or Insulin Rate.Insulin rate (U/H) Insulin rate is a fixed basal in u
My pump buttons are not acting right during a bolus ... 132My pump will not display my blood glucose rea
Percent of basalUnlike insulin rate, the percent of basal is dependent on your current basal rates. Percent temp basal is apercentage of your current
1.50 U/H(rate 1)2.55 U/H(rate 2)1.25 U/H1.95 U/H(rate 3)(50% x rate 3 = 0.975)0.975 rounded down to the next 0.05 increment is 0.95 U/H(50% x rate 2 =
Selecting temp basal type Your pump will remember the temp basal type setting. Once the type is set, you do not have to set itagain. To select a temp
Verifying temp basal delivery Temporary basal information isavailable in the STATUS screenonly.During a temporary (temp) basal,the pump is in Special
Example 1: Temp Basal for a decreased temporary basal rateRamon and his friends got together for an unplanned game of soccer. Before using the pump, h
Your turn:Think of an activity where you might need to use a Temporary Basal Rate. At what rate is your current basal rate running? _________
Utilities Alarm reviewYou can review alarms in the ALARM HISTORY screen. This screen shows up to 36 past alarms and/orerrors. You can also review the
Auto-offThe factory setting for this feature is Off. This is a safety feature that stops insulin delivery after adefined time period (from 1 to 24 hou
a. For Insulin units:In the WARNING UNITS screen enter the number of units you want remaining for the first warning,then press ACT.The pump will alarm
Pump data managementThe pump data management feature allows you and your healthcare professional to view and manage yourbasal and bolus insulin delive
Audio frequency ... 143Backlight ...
Press to view more information.4 The BOLUS screen displays. This screen shows:• total bolus insulin delivered for the day• total food bolus insulin
3 The AVG BG screen displays. This screen shows:• the average of all blood glucose values entered into the pump for the number of previous days yousel
• the average total number of food plus correction boluses delivered per day for the number ofprevious days you selected• the average total number of
To use the remote control, these pump settings must be programmed:• Remote Options = On• Remote control ID code entered in pump (code is on back of re
3 Reviewing remote IDsa. Select Review ID, then press ACT.b. The programmed IDs will show in the REVIEW REMOTE ID screen.4Exit the menus when you are
Example 2: BlockOscar is an elderly man with diabetes who needs assistance with all of his daily living activities. Heneeds his caregiver or family me
Contact our 24 Hour HelpLine if any of the tests do not occur as described here.NOTE: If the pump detects a condition such as low battery, the selftes
CAUTION: Do not clear your pump settings unless directed by your healthcare professional or aMedtronic Diabetes representative. If you clear your pump
Clearing the settings Take the following steps only if you want to clear your pump to factory default settings.WARNING: Do not clear your pump setting
4 The SETTINGS HISTORY screen displays, giving you a list of all the dates and times of your most recentUser Setting operations. Scroll down to view t
Bolus Wizard feature examples ... 155Insulin delivery default settings ...
Therapy softwareMedtronic provides software to optimize your pump use. Contact our 24 Hour HelpLine for moreinformation.CareLink Personal™Your pump pr
You can share your reports with your healthcare professional. These reports can help you and yourhealthcare professional to discover trends and other
Insulin pump therapy follow-upWe hope that you are now comfortable using the pump and your blood glucose values have improvedthrough insulin pump ther
Laboratory tests• Test for HbA1c four or more times a year• Test for cholesterol, HDL, LDL, triglyceride yearly• Test for microalbuminuria yearlyEvery
Troubleshooting and alarmsThis Troubleshooting chapter is designed to help you understand the messages that your pump is giving youwhen you get an ala
What happens if I leave the pump battery out too long?If you leave the pump battery out too long (more than five minutes) you may receive a BATT OUT L
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 allyour settings
The pump is asking me to rewindThis is normal after any of the following:1 Any E-alarms,2 The Clear Settings function,3 Or, a NO DELIVERY Alarm (durin
7 Your pump will not show another reading. Make sure the pump is idle and the HOME screen is blank.8 If your pump still does not receive your blood gl
To get to the USER SETTINGS screen:1 Go to the UTILITIES MENU screen.Main > Utilities2Select User Settings. Hold down and press ACT.3 See the User
Contentsxiv
Answer: Your pump monitors activities and will alert you if a Special mode is active. Some alerts are anormal part of pump therapy, such as an active
Check your pump and test your blood sugar. Follow the guidelines prescribed by your healthcareprofessional to manage your diabetes as needed.NOTE: The
Alarm conditionsAlarms put the pump in Attention mode. A (ALARM) This alarm shows the letter A followed by two numbers. A-alarms cause all insulin del
E (ERROR) After receiving this alarm, note the error number then call our 24 Hour HelpLine for assistance. An erroralarm will show the letter E follo
MAX DELIVERY This alarm alerts you when you have taken more insulin than expected based on maximum bolus andmaximum basal rates. MOTOR ERROR Insulin
Troubleshooting and alarms140
Pump maintenanceIt is recommended that you read your warranty statement included with your pump for information aboutwhat is covered during your warra
StorageIf 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 ra
Pump specificationsThis section provides detailed information on specifications related to your pump. The safety features ofyour pump are individually
• Factory maximum setting: 2.0 units/hour• 3 patterns maximum, each with 48 ratesBG target•Maximum targets: 8• Range: 60 - 250 mg/dL (3.3 - 13.9 mmol/
IntroductionThank you for choosing Medtronic Diabetes (legally known as Medtronic MiniMed, Inc.) as your partner inhelping you gain better control of
Carb ratiosMaximum ratio settings Range Warning limits8 3 - 150 grams/u less than 5 or greater than 50 grams/u0.1 - 5.0 u/exch less than 0.3 or greate
Delivery accuracy• Delivery accuracy: +/-5 percent.• Displacement (piston) accuracy: +/-2 percent.Delivery Volume Accuracy Curve ( -0.40% ) Overall Er
Pump motorThe pump motor has a unique, patented design with an integrated safety check system. The systemdelivers in precise increments.Dual Wave bolu
Low resv (reservoir) warningValues are based on displayed amount, not actual amount.time: 2 - 24-hours, and @ 1:00 hour before empty08:00 hours (defau
Percent temp basalDefault value: 100% of basal programmingPower supplyThe pump is powered by a standard 1.5 V AAA alkaline battery, size E92, type LR0
Remote controlUses radio signals to allow users to program Normal boluses or to suspend/resume their pumps.Reservoir• The user-filled reservoir is mad
Status screenItem When WhatActive Insulin if any (Active Ins:) the amount of activeinsulin, displayed to the next0.025UAlarm Clock* (appears if schedu
Item When WhatSerial number (always appears)Software version (always appears)Standard basal delivery data (always appears) current basal rate (basal 1
3 If your current BG is between or equal to your High or Low BG Target, the total bolus estimate isbased only on the food estimate.(food estimate)
• The Bolus Wizard feature may utilize your current BG measurement, carbohydrate consumption, andactive insulin to calculate your estimated bolus.• Ac
Emergency kitKeep an emergency kit with you at all times to make sure that you always have necessary supplies. Informa family member, co-worker, and/o
Bolus Wizard feature examplesSettings:• Carb ratio: 30 grams/unit• BG Target: 90-120 mg/dL (5.0-6.7 mmol/L)• Insulin Sensitivity: 40 mg/dL/unit (2.2 m
#3: No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a BG of 70 mg/dL (3.9mmol/L).(food estimate) 60 g 30 g/u= 2
#5: Previous bolus activity results in a calculation of 1.5 units unabsorbed (active) insulin. User inputs 60grams of carbs and a BG of 200 mg/dL (11.
Insulin delivery default settingsMenu Item DefaultSettingLimits IncrementsBolus Menu: Bolus Wizard feature: OffEasy bolus: OnEasy bolus step: 0.1 u 2
Menu Item DefaultSettingLimits Increments(Time/Date) Timeformat:12-hourBlock: OffAlarm clock: OffRemote option: OffMeter option: OffUser Settings: (no
Bolus Wizard feature default settingsItem DefaultSettingLimits Increments Warning Limitscarb units: grams none none noneins to carb (orexch) ratio:15
Icon table Attention: See Instructions for UseDate of manufacture (year - month)Batch codeCatalogue numberDevice serial numberStorage temperature rang
Signifies compliance with Industry Canada EMC and Radio communicationsrequirementsPump specifications162
WarrantyMedtronic Diabetes warrants the Medtronic MiniMed Insulin Pump against defects in materials andworkmanship for a period of 4 years from the da
Pump specifications164
WARNING: For your protection the pump has undergone extensive testing to confirm appropriateoperation when used with Paradigm reservoirs and Paradigm
Glossary AA1C (HbA1c) test - A 2-3 monthaverage of blood glucosevalues expressed in percent.The normal range varies withdifferent labs and isexpressed
check your blood glucoseafter a bolus.BG target - Normal blood glucoselevelBG Units - Blood glucose unitsused by the pump (mg/dL ormmol/L).Block - Fea
time for an action orcondition.EEasy bolus™ - Method of deliveryfor a Normal bolus using theEasy Bolus button .Electromagnetic compatibility -The cond
as well as drug stores andpharmacies.HHbA1c - GlycosylatedhemoglobinHDL - High-density lipoprotein Acomplex of lipids and proteinsin approximately equ
communicates with yourpump.Log - A record of measurements,alarms or other actions byyour pump.Low resv warning -Programmable warning thatnotifies you
Protein - One of the three mainsources of energy or caloriesin food. Proteins are made ofamino acids, which are calledthe building blocks of thecells.
Timeout - If you do not enterinformation or do somethingin a specific length of time,your pump automaticallystops what it is doing andgoes to the HOME
Glossary172
Index Aaccessories 3activity guard 3CareLink USB 3holster 3leather case 3meter 3pump clip 3remote control 3active insulin 82Active insulin ti
settings 74, 75, 76Active insulin time 76BG target range 76BG units 75Carb ratios 74Carb units 74Insulin sensitivity 75specifications 152your
How to use this guideNOTE: This user guide shows sample screens only. Your pump screens may be slightly different. For step-by-step instructions, refe
Normal Boluswith Bolus Wizard 85without Bolus Wizard 40Normal mode 32Now 96Now portionof the Dual Wave bolus 93, 96nutrition 19PPatternsbasal 1
Index176
6025020-016C_b INSULIN PUMP
Paradigm®515 and 715 Insulin PumpsUser Guide
User safetyIndicationsPumpThe Paradigm 515/715 pump system is indicated for the continuous delivery of insulin, at set and variablerates, for the mana
Tubing ConnectorIf insulin, or any liquid, gets inside the tubing connector, it can temporarily block the vents that allow thepump to properly prime t
X-rays, MRIs and CT scansIf you are going to have an X-ray, CT scan, MRI or other type of exposure to radiation, take off yourpump, meter and remote c
These devices comply with Part 15 of the FCC Rules. Operation is subject to the following two conditions:(1) This device may not cause harmful interfe
Communication problems can usually be resolved by:• ensuring that there is less than 6 feet (1.8 meters) between the pump and the RF glucose meter;• t
Introduction10
Introduction to pump therapyTheory of insulin pump therapyInsulin pumps deliver insulin closer to the way the human pancreas delivers insulin than any
As long as you are ready to learn how to use the pump, the pump can work for you.Understanding pump therapyIf you are new to pump therapy, you will ne
Insulin sensitivityInsulin sensitivity is used to decide a correction bolus for a high BG. This is how much your blood glucosewill be dropped with 1 u
Your healthcare professional will rely on the results of your blood glucose tests to make changes in yourpump settings. The results of your A1C tests
©2008 Medtronic MiniMed, Inc. 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
Correlation between A1C level and blood glucose levelsMean plasma glucoseA1C (percent) mg/dL mmol/L12 345 19.5American Diabetes Association. Diabetes
Hypoglycemia protocol: the rule of 15If blood glucose is 70 mg/dL (3.9 mmol/L) or below:• Eat 15 grams of fast acting carbohydrate• Check BG again in
Hyperglycemia protocolIf one blood glucose reading is above 250 mg/dL (13.9 mmol/L):• Take a correction bolus right away•Test BG in one hourIf the sec
• Troubleshoot the pump. If help is needed, please call our 24 Hour HelpLine for assistance.• Drink liquids with no calories every 30 minutes (for exa
• Keep exact records of your blood glucose values, ketones, medication, temperature and all othersigns.• Keep in mind that you need more insulin and f
Carbohydrate countingWith insulin pump therapy, you must take a bolus for the carbohydrates you eat. You need to count thecarbohydrates you plan to ea
As you start to learn carbohydrate counting, try to assess the carbohydrates in the food you are eating.Then look at the food labels to see how close
Fat and blood glucoseAlthough fat does not have carbohydrate, it may affect your blood glucose level. Your blood glucose canbe normal 2 hours after a
Other things that affect blood glucoseFiber may slow down the rise in blood glucose after a meal. Fiber grams are not absorbed. They can besubtracted
The body needs insulin during exercise. Therefore, it is not suggested that you stop the pump unless theexercise is for a short amount of time (1 hour
Important Safety InformationRegarding Your Paradigm Insulin Infusion Pump(includes all models)Avoid Immersing Your Pump In WaterThe pump was tested an
The basicsYour pumpCAUTION: Never use sharp objects to press the buttons on your Paradigm pump as this can damage thebuttons or compromise the seal of
Install batteryCAUTION: Do not use a rechargeable or carbon zinc battery in your pump. For best results use a newEnergizer AAA alkaline battery, size
5 While the pump turns on, it will show one or more screens untilthe HOME screen appears.If the HOME screen does not appear, do these steps:a. Check t
Pump buttonsThe buttons on the pump are used to navigate through the menus and screens, and to program thefeatures of the pump. EXPRESSBOLUSbuttonESCb
From the HOME screen From the menus and programming screensPress simultaneously with to turn on backlight when in the menusor use as a Shift button b
Screen iconsThere are various icons that appear at the top of your pump screen, like the time, battery and reservoiricons mentioned above. The next se
Alert and alarm iconsAn open circle (alert) or a solid circle (alarm) are displayed in the upper partof your pump screen only when there is an alert o
Normal modeMode for standard pump operations for normal basal and bolus delivery. No special features areactive (i.e., basal patterns, temp basal, etc
When the pump is in Attention mode, it will beep/vibrate periodically to remind you of the condition. Thebeep/vibrate frequency varies depending on th
BASAL MENUContains the functions to setup and deliver your basal. Refer to the Basal section in the Basicprogramming chapter for more information.PRIM
If you remove your pumpYou may have an occasion when you need or want to remove your pump. If you have to remove and storeyour pump, it is recommended
The basics36
Basic programmingSetting the time and dateSetting the correct time and date in your pump is necessary for accurate basal insulin delivery and allowsyo
4 Change each of the settings as follows:a. HourChange the hour. Press ACT.For 12-hour setups, press or until the correct A (am)or P (pm) appears.b
Selecting the languageThe language shown on the pump screens can be changed. Some languages will not be available on allpumps. Before you can select a
BolusThere are three bolus types: Normal, Square Wave®, and Dual Wave®. This section gives instructions for aNormal bolus using the express bolus butt
Normal meal bolus using the exchange systemNormal bolus can be used to cover the carbohydrate in a meal or snack and to correct a blood glucosethat is
Normal meal bolus practice using exchanges: Choose a meal you might eat and fill in the blanks.Food:__________ exchange:______________________ exchang
Choose a meal you might eat and fill in the blanks.Food:__________ grams of carbohydrate:______________________ grams of carbohydrate:________________
Practice: Meal bolusYou have determined your meal bolus as: _______ units.Your target blood glucose range is: _______ to _______ (average is _______).
ContentsChapter 1: Introduction ... 1Assistance ...
If a bolus was stopped before delivery was complete, the BOLUS HISTORY screen will show only theamount actually delivered. Refer to the Bolus details
Bolus detailsYou can view the details of any of the deliveries in the BOLUS HISTORY screen. The details include: • bolus types: normal, square, and du
Maximum bolus limitThe maximum bolus (max bolus) is a safety feature that limits the amount of insulin that can be deliveredin a single bolus. The fac
1 Go to the BG REMINDER SETUP screen.Main > Bolus > BG Reminder2 Select On and press ACT. The BG Reminder is now enabled. Exit the menus.Now, th
The start and stop times of basal rates for thisexample are:• 12:00 a.m. (00:00) to 3:00 a.m. (3:00) for basalrate 1• 3:00 a.m. (3:00) to 7:00 a.m. (7
Basal programming and deliveryNOTE: You cannot make changes to your basal rate settings while a percent temp basal is active. To set your basal rates
Current basal deliveryThe STATUS screen shows your current basal information.current basalDaily basal rate(s)The BASAL REVIEW screen shows your daily
If you use patterns, the BASAL REVIEWscreen appears.The current basal pattern will behighlighted. Select the pattern you wantto view. Press ACT.The de
Example 2: Max BasalRusty needs large amounts of insulin to control his blood glucose levels. His new pump was deliveredfrom the factory with a Maximu
Resume pump deliveryWhen the pump is suspended, it defaults to the HOME screen with a solid circle. To resume your pump and basal delivery, do these s
Meal bolus ... 12Gram counting ...
Practice: Suspend function1 Make sure you are NOT connected to your pump while practicing.Program your pump to deliver a Normal bolus of 3.0 units. On
Basic programming56
Starting on insulinThe Paradigm pump is intended for use with U100 insulin.Prepare your pump for useBefore continuing with the steps in this chapter,
Filling the reservoirWarning: Do not use the reservoir or infusion set if any liquid gets on the top of the reservoir or insidethe tubing connector (a
1 Remove reservoir from package. Make sureplunger rod is fully extended. plungerrodtransferguardreservoir2 Swab vial with alcohol (not shown).3
5 While still holding theplunger rod, flip the vialover so the vial is on top,slowly pull down on theplunger to fill thereservoir. 6 Gently tap
11 Tap the side of thereservoir to remove any airbubbles. 12 To purge air bubbles thathave risen to the top of thereservoir, push up on the plu
Rewinding your pump Before you continue, make sure the infusion set is NOT connected to your body and the reservoir is NOT inthe pump.WARNING: Make su
WARNING: Do not insert the reservoir in the pump if you did not rewind. Doing so could resultin inaccurate insulin delivery.Never insert the reservoir
Manual primeManual prime fills the infusion set tubing with insulin before you attach it to the infusion site. Manualprime is only available after you
Time display ... 30Reservoir volume ...
Inserting the infusion setWARNING: While the infusion set is connected to your body, do not unscrew and retighten the tubingconnector on the reservoir
• Visualize an imaginary clock drawn on your abdomen surrounding your belly button.Rotate infusion sites by starting at 12 o’clock and then rotating t
Quick-set infusion set (with Quick-serter®)Always refer to the instructions that shipped with your infusion set.1 Wash your hands. 2 Clean the infu
7 8 910 11 12Starting on insulin68
13Fixed primeA fixed prime fills the soft cannula with insulin and is required after the infusion set is inserted into yourbody and the introducer nee
Disconnecting Quick-setThe Quick-set allows you the freedom to temporarily disconnect from your pump without removing theinfusion set from your body.1
Reconnecting Quick-setA fixed prime is used before reconnecting the infusion set to your body to ensure that insulin has filled theinfusion set. See t
Test at least 4-6 times a day.These are the recommended times to test to determine control:• Overnight (occasionally, at approximately 2 - 3:00 AM)• P
Using the Bolus Wizard featureWhat is it?Bolus Wizard is a feature that calculates an estimated bolus to support your food intake or to correct highbl
Your personal Bolus Wizard feature settingsIn addition to your blood glucose reading and/or your food entry, the Bolus Wizard feature uses personalset
Resume pump delivery ... 54Chapter 5: Starting on insulin ...
Bolus Wizard feature settingsInformation SettingBG units: (how you measure your blood glucose) _____ mg/dL or _____ mmol/LInsulin sensitivity:This ra
Bolus Wizard feature settingsInformation SettingBG target range:If your current blood glucose is above the BG Target Range, theBolus Wizard feature wi
How the Bolus Wizard feature works1 If you want your current blood glucose to be factored in, enter your BG Reading.• automatically from the meter (re
How to program the Bolus Wizard featureYou need your personal settings from the Bolus Wizard feature settings table to setup the Bolus Wizardfeature.
Setting the Carb/Exch ratiosYour pump allows you to set up to eight Carb/Exch ratios because this ratio may vary throughout the day.Your healthcare pr
3 The BLOOD GLUCOSE UNITS screen displays. Select mmol/L or mg/dL, then press ACT.4 The EDIT SETTINGS screen shows the BG units you selected. You are
Setting the BG targets The BG Target setting allows you to setglucose targets. The Bolus Wizard will usethese targets to calculate a correction dose.B
7 In the SET START TIME 2 screen enter the time of the day you want this BG target range to becomeactive.8 Press ACT. The TARGET RANGE 2 screen appear
Active insulin timeThe active insulin time setting lets the pump know which active insulin time to use in calculating theamount of active insulin to s
meter option turned off. Programming your meter ID links your pump to the meter. If you do not link themeter to your pump, you will enter your blood g
Komentarze do niniejszej Instrukcji