Medtronic Revel Guida Utente

User Guide6025306-019C_aUser Guide

ContentsChapter 1: Introduction ... 1Assistance ...

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

TIMEINSULIN123DUAL WAVEBOLUSSQUARE WAVEBOLUSNORMALBOLUSNowPortionSquarePortionPart of the bolus amount delivered immediately and the remainder deliver

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?

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

The Bolus Wizard feature must be turned on and the settings must be programmed (see the How toprogram the Bolus Wizard feature section in the Using th

amount less the active insulin (1.5U + 2.5U - 1.5U). This gives 2.5U or 62% of total insulin of 4.0U.The Square portion consists of the other half of

Easy bolus setup1 Go to the EASY BOLUS OPTION screen.Main > Bolus > Bolus Setup > Easy BolusSelect On/Set, then press ACT.NOTE: If you are us

Chapter 2: The basics ... 13Your pump ...

Delivering Easy BolusPractice using the Easy Bolus feature while looking at the pump screen as you count the beeps. Thisfeature only works from the HO

Example 1: Easy bolusAlexander is a busy executive with an accounting firm. He wears his Paradigm pump on his belt and doesnot want to take it off to

Missed Bolus ReminderMissed Bolus Reminder feature helps you remember to give yourself a meal bolus. It triggers a MISSEDBOLUS alert if you do not del

Basal patternsThe Basal Patterns feature is optional for pump users. You can set your pump to deliver a standard basaland two additional basal pattern

3 The SET BASAL RATE 1 screen appears. The basal rate flashes, indicating that it can be changed. Setyour first rate, then press ACT.The start time fo

Example 1: Basal patternsKen has had his insulin pump for about a month. He tests his blood glucose 4 - 6 times a day and recordshis results in his lo

Temp basal ratesTemp basal should be used based on the guidance of your healthcare professional. This feature is useful tomanage blood glucose levels

1.50 U/H(rate 1)2.55 U/H(rate 2)1.95 U/H(rate 3)1.25 U/Htemp basal rate7:00 a.m.(7:00)1:05 p.m.(13:05)3:00 p.m.(15:00)5:05 p.m.(17:05)12:00 a.m.(00:00

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 =

Bolus practice: ... 29Normal meal bolus practice using exchan

3 The screen will return to the BASAL SETUP screen. The temp basal type is now set. Exit the menus.If you select Percent of Basal as your temp basal t

Verifying temp basal deliveryTemporary basal information is available in the STATUS screen only.During a temporary (temp) basal, the pump is in Specia

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? ____________What Te

Sensor featuresThe optional sensor and transmitter can provide continuous glucose measurements to help you controlyour glucose levels better. The sens

Turning on the Glucose AlertsThe Glucose alerts must be turned on if you want the system to send you an alert when the sensor glucosemeasurements reac

Selecting the BG unitsYou must select the blood glucose units (BG Units) for the system (either mmol/L or mg/dL). All BGmeasurements will show in the

2 Select Glucose Limits, then press ACT. The SET GLUCOSE LIMITS 1 screen appears. The Low GlucoseLimit flashes 80 mg/dL (4.4 mmol/L).The start time fo

Setting the High RepeatAfter you receive and clear a High Glucose, Rise Rate of Change, or High Predictive alert, the alert willrepeat until the condi

3 Select your Low Repeat time. The time must be between 5 minutes (0:05) and 1 hour (1:00).4 Press ACT. The EDIT SETTINGS screen shows the Low Repeat

Chapter 4: Starting on insulin ... 51Prepare your pump for use ...

6 Select the Time Sensitivity (how many minutes before you reach your High Glucose Limit). To turn offthe High Predictive Alert, reduce the Time Sensi

•Range:mg/dL/minmmol/L/minfrom 1.1 to 5.0from 0.065 to 0.275• Increments:mg/dL/minmmol/L/min0.10.0054 Press ACT. The SET RISE RATE LIMIT screen flashe

4 Select your Cal Reminder time between 5 minutes (0:05) and 6 hours (6:00).5 Press ACT. The EDIT SETTINGS screen shows the Cal Reminder time you sele

Main > Sensor > Edit Settings2 Select Weak Signal, then press ACT. The SET WEAK SIGNAL screen flashes the default time of30 minutes (0:30).3 Sel

3 To change any settings, return to the EDIT SETTINGS menu.Main > Sensor > Edit Settings4 Save your settings after you have set your preferences

The transmitterThe Medtronic MiniLink Transmitter (MMT-7703) is a device that takes electronic signals generated by theglucose sensor and sends them b

3 Connect the transmitter to your sensor now if you have not already done so. If the screen times out,do not disconnect the sensor. Start from step 1

Entering meter BG for calibrationSensor calibration is necessary for optimal glucose sensor performance. Only BG entries in the range of 40–400 mg/dL

See page 38 for more information. To enter BG values through your linked meter:1 Test your BG with a fingerstick.2 The BG value is automatically sent

Sensor features118

Normal bolus using Bolus Wizard feature ... 74Bolus Wizard feature examples ...

Using your sensorStatus screensYour STATUS screens tell you what is going on in your pump. In the SENSOR STATUS screen you can checkthe status of sens

Reading the sensor glucose graphsNOTE: If your graphs say DEMO in the upper left corner of your screen, you must turn off the SENSORDEMO mode to see y

Opening and viewing the graphsThe following table describes how to use the graphs.If you want to: Do the following:Open the graphs From the HOME scree

Indicates that your glucose has risen above 315 mg/dL (17.5 mmol/L).Sensor glucose data points.Each time you bolus, a marker will appear on your graph

Examples of real-time sensor glucose graphsThe following pages show examples of the different graph types.3-hour graphEach part of the graph between t

12-hour graphEach part of the graph between the vertical dashed lines represents one hour. In this example, the reasonno measurement is displayed is L

How to check for rapid changes in sensor glucoseIf your sensor glucose (SG) rises or falls faster than a certain rate, rapid change arrows automatical

How to make glucose alerts silentThe Alert Silence feature allows you to silence glucose alerts for a preset amount of time. You may usethis feature w

3 Depending on your current settings, one of the following Alert Silence options will appear in theSENSOR MENU.• Alert Silence: Off• Alert Silence: Hi

2 The SENSOR ALERT HISTORY screen appears. The most recent alert is highlighted. Select the alert youwant to get more information on, then press ACT.3

Percent of basal ... 97Chapter 7: Sensor features ...

UtilitiesAlarm reviewYou can review alarms and their details in the ALARM HISTORY screen. This screen shows up to 36 pastalarms, errors, or LOW RESERV

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

WARNING: When the pump detects a low reservoir condition during a bolus or Fill Cannuladelivery, the LOW RESERVOIR alert displays after the delivery i

Pump data managementThe pump data management feature allows you and your healthcare professional to view and manage yourbasal and bolus insulin delive

Item Description#Food Only The number of times the Bolus Wizard feature delivered a food bolusonly.Corr Only The total amount of insulin delivered usi

Item Description#Predict Lo The number of Low Predictive Glucose alerts.#Rise Rate The number of Rise Rate alerts.#Fall Rate The number of Fall Rate a

4Press to view more information. See the table in the Insulin delivery information section in thischapter for descriptions of information shown here.

5Press to view more information. See the table in the Insulin delivery information section in thischapter for descriptions of the information shown h

6 Press ACT. The AUC MENU screen shows the AUC Limit you selected. To view AUC data for a single day:1 Go to the AUC MENU.Main > Utilities > Dai

Personal remindersAlarm clockThe alarm clock is a feature that allows you to set a maximum of eight daily reminders for various events.The factory set

24-hour graph ... 124How to check for rapid changes in sensor gl

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

Other Devices optionThe factory setting for this feature is Off.Other devices may be available to be linked to your pump. If available, refer to the a

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 settingsTake the following steps only if you want to clear your pump to factory default settings.WARNING: Do not clear your pump settings

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

Utilities146

Meter optionAbout metersYou can set up your pump to automatically receive your bloodglucose readings from Bayer's CONTOUR® NEXT LINK WirelessMete

4 When programming a bolus, the blood glucose measurement from the meter will appear as the defaultblood glucose value on the ENTER BG screen. The pum

Clearing the settings ... 144History ...

Therapy management softwareMedtronic provides software to optimize your pump use. Contact our 24 Hour HelpLine for moreinformation.CareLink® Personal

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, alerts and alarmsThis chapter is designed to help you understand the messages that your pump is giving you when you getan alarm or an

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

My pump buttons are not acting right during a bolusIf the , or buttons are pressed and held down while a bolus is being delivered, the screen wil

5 Perform the Selftest procedure located in the UTILITIES MENU.6 Call our 24 Hour HelpLine for assistance.I submerged my pump in waterYour pump is des

Question: Why are alerts important?Answer: Your pump monitors activities and will alert you if a Special mode is active. Some alerts are anormal part

What to do ... 158Pump alert conditions ...

Pump alert conditionsListed below are alerts that indicate a condition that is outside normal pump activity. LOW RESERVOIRYou can program the pump to

MISSED BOLUSReason: You have not delivered a bolus during the time period you specified in the Missed Bolus Reminderfeature.Action: Set a meal bolus

LOW TRANSMTRReason: Occurs when the transmitter battery is close to running out of power. This alert will repeat dailyat noon while this condition e

CAL ERRORReason: An error occurred when entering a new meter BG measurement to calibrate the system. Somepossible causes are:• An incorrect blood gl

HIGH XXX MG/DL (XXX = SG measurement)Reason: The sensor glucose number is higher than or equal to your high glucose limit. If you do not set aHigh G

SENSOR ERRORReason: The sensor signals are either too high or too low.Action: You do not need to change the sensor. Clear the alert. If the alert pe

What to doWhen an alarm is triggered, the pump goes into Attention mode and analarm message shows on the screen. The pump then defaults to the HOME sc

BOLUS STOPPEDIf this alarm occurs, it is very important to check bolus history to review how much of the bolus wasactually delivered. If necessary,

MAX FILL REACHEDIf you use more than 30 units of insulin to fill the infusion set tubing, this message appears. Press ESC,ACT to clear the message.

MAX DELIVERYThis alarm alerts you when you have taken more insulin than expected based on Maximum bolus andMaximum basal rates. MOTOR ERRORInsulin

MAX DELIVERY ... 168MOTOR ERROR ...

WEAK BATTERYThe pump tests the voltage of each battery installed. If the battery voltage is less than full strength, thisalarm may occur. The pump w

4 Within the next seven to eight minutes, go to the SENSOR STATUS screen to look for the Sensor ISIGvalue:a. The sensor ISIG value on this screen shou

2 Press ACT in the RECONNECT OLD SENSOR screen.3 The SENSOR READY 2 HRS screen appears. Press any button to continue. An alert will sound in twohours

Troubleshooting, alerts and alarms172

MaintenanceIt is recommended that you read your warranty statement included in this user guide for informationabout what is covered during your warran

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

Cleaning the Sen-serter1 Wash your hands thoroughly.2 Dampen a clean cloth with mild liquid soap and warm water. Wipe the Sen-serter.3 Rinse with warm

Maintenance176

Pump specificationsThis section provides detailed information on specifications related to your pump. The safety features ofyour pump are individually

Backlight• LCD (Liquid Crystal Display) type•Time-out: 30 secondsBasal• Delivery: 0.025–35 units/hour (maximum units: 35/hour)• Factory maximum settin

Paradigm® REAL-Time Revel™ Insulin PumpUser Guide

Delivery accuracy ... 180Pump motor ...

Bolus unitsIncrements: Based on selected scroll rateBolus Wizard featureSee the Bolus Wizard feature specifications section in this chapter for inform

Delivery accuracy• Testing has confirmed that the delivery accuracy for the maximum/minimum bolus/basal amounts arewithin the +/-5 percent of the prog

Dual Wave bolusDelivers a Normal bolus followed by a Square Wave bolus (limited by maximum bolus).Easy bolus• Features programming using audible tones

Low resv (reservoir) warningValues are based on displayed amount, not actual amount.time: 2–24-hours, and @ 1:00 hour beforeempty08:00 hours (default

Power supplyThe pump is powered by a standard 1.5 V AAA alkaline battery, size E92, type LR03 (Energizer brandrecommended).Reservoir + Set historyMaxi

Square Wave bolusDelivers bolus insulin over a duration of 30 minutes up to eight hours (limited by the Max bolus setting).Temporary (temp) basal rate

Quality of serviceCommon consumer electronic devices that transmit in the same frequency band used by the transmittermay prevent the pump from receivi

Item When WhatBG Reminder*(Only if enabled)Time remaining before BG Reminder is set to go off H:MM h (if less than 1 hour, 0:XXh where XX is minutes r

Item When WhatTime (always appears)*If all of the Reminders and the Alarm Clock are enabled, only the reminder that is nearest to alarmingwill appear

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.• Based on

Accuracy of Guardian RT readings ... 209Precision of Guardian RT readings ...

• The Bolus Wizard feature may utilize your current BG measurement, carbohydrate consumption, andactive insulin to calculate your estimated bolus.• Ac

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

4 No active insulin from previous bolus delivery. User inputs 60 grams of carbs and a BG of 100 mg/dL(5.6 mmol/L).Food estimate:Carb grams ÷ Carb rati

Insulin delivery default settingsMenu Item DefaultSettingLimits IncrementsBolus Menu: Bolus Wizard feature: OffEasy bolus: OffEasy bolus step: 0.1 u 2

Menu Item DefaultSettingLimits IncrementsCapture Option: OffLow reservoir warning: (20) insulinunitsif units: 1st @ 5–50 u; 2nd @ halfamountremaining

Bolus Wizard feature default settingsItem DefaultSettingLimits Increments Warning Limitscarb units: grams — — —ins to carb (orexch) ratio:15 grams/uor

Feature Options Default Setting Limits, Range of ValuesGlucose Limits•Maximum of 8 Glucose Limits.• One pair of Glucose Limits (Glucose Limits 1) is a

Feature Options Default Setting Limits, Range of ValuesLow Repeat•On•Off(Set to On when Low Glucose,Low Predictive, or Falling Rateof Change Alert is

Feature Options Default Setting Limits, Range of ValuesSensor glucosegraph timeout• 2 minutes• 4 minutes• 6 minutes•NONEc2 minutes —Alert Silence•Off•

Guidance and manufacturer's declarationGuidance and Manufacturer's Declaration - Electromagnetic EmissionsThe Paradigm 523/723/523K/723K pum

IntroductionThank you for choosing Medtronic Diabetes (legally known as Medtronic MiniMed, Inc.) as your partner inhelping you gain better control of

Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe Paradigm 523/723/523K/723K pump system (consisting of the MMT-523/723/523K/

Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe Paradigm 523/723/523K/723K pump system (consisting of the MMT-523/723/523K/

Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe Paradigm 523/723/523K/723K pump is intended for use in the electromagnetic

Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe Paradigm 523/723/523K/723K pump is intended for use in the electromagnetic

Recommended separation distances between portable and mobile RF communicationsequipment and the Paradigm 523/723/523K/723K pump systemThis section pro

Icon tableFollow instructions for useAttention: Read all warnings and precautions in instructions for use.ManufacturerDate of manufacture (year - mont

Radio communicationPump specifications 205Chapter 15

Pump specifications206

Sensor accuracyNOTE: You should review the information in this section with your healthcare professional. The Medtronic MiniMed Paradigm 523/723/523K/

Performance results in adultsThe performance of the Guardian RT in adults was evaluated in a clinical study. Guardian RT results werecompared to plasm

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

Accuracy of Guardian RT readingsIn this study, YSI measurements (taken every half hour) were paired with the corresponding Guardian RTreading (taken e

The Clarke Error Grid was used to assess the clinical relevance of the differences between the Guardian RTreadings and the comparative YSI measurement

The plot below is a correlation plot of Guardian RT readings versus readings from the reference method,the YSI 2300 Glucose Analyzer. It is overlaid w

The percent of Guardian RT readings in the previous graph are presented in the following table accordingto the percentage of points falling within eac

Precision of Guardian RT readingsThis study was also designed to look at the reproducibility of two sensors worn simultaneously at differentlocations

Low and High alerts in adultsThe ability of the Guardian RT to detect high and low glucose levels was measured in the same clinicalstudy. Since it is

Increasing the Low Alert settings will improve the ability to detect low blood glucose events, but it willalso increase the frequency of Guardian RT f

Guardian RT sensor performance and calibration stability as a functionof timeThe Guardian RT sensor may be worn for up to 3 days (72 hours) and must b

An analysis of the mean percentage of Absolute Relative Error (ARE percentage) and standard deviations,across 12-hour increments of wear periods, appe

The percentage of Guardian RT readings within 20 percent and 30 percent of YSI readings was analyzedaccording to time after sensor insertion and accor

WARNING: For your protection the pump has undergone extensive testing to confirm appropriateoperation when used with Paradigm reservoirs and Paradigm

Effects of calibration frequencyThe average bias when Guardian RT was calibrated ~ 3.5 times a day was -20.5 ± 41 mg/dl (LL: -22.40mg/dl and UL: -18.6

Time-elapsed plotsThe plot graph below is a representative example of continuous sensor tracing vs. reference blood glucosereading, where sensor showe

The plot graph below is a representative example of continuous sensor tracing vs. reference blood glucosereading, where sensor showed average (typical

The plot graph below is a representative example of continuous sensor tracing vs. reference blood glucosereading, where sensor showed poor performance

Performance results in children and adolescentsThe performance of the Guardian RT in Children and Adolescents was evaluated in a clinical study.Guardi

The accuracy of the Guardian RT was also evaluated by calculating the percentage of Guardian RTreadings within 20% and within 30% of the blood glucose

The following figure is a correlation plot of Guardian RT readings versus readings from the referencemethod, the blood glucose meter. It is overlaid w

Stratified Clarke Error Grid AnalysisRange ofComparativeGlucoseReadings(mg/dL)TotalCount A + B A B C D E40-80 360 (13.9%) 201(55.8%)141(39.2%)60 (16.7

Low and High alerts in children and adolescentsThe ability of the Guardian RT to detect high and low glucose levels was measured in the same clinicals

Increasing the Low Alert settings will improve the ability to detect low blood glucose events, but it willalso increase the frequency of Guardian RT f

• Activity guard — If you are active in sports, or you are a child, use the guard to protect the pumpfrom disconnecting.• Leather case — Fine leather

Glossary AA1C (HbA1c) test - A 2-3 monthaverage of blood glucosevalues expressed in percent.The normal range varies withdifferent labs and isexpressed

pump for the delivery of basalinsulin: Standard, A, and B.For each pattern, there is anoption of setting up to 48basal rates.Basal rate - The pump set

DDaily totals - Shows the totalinsulin delivered (basal andbolus) in the last 24-hours.Maximum records: 32 daysDefault - A setting or value foryour pu

HHbA1c - GlycosylatedhemoglobinHDL - High-density lipoprotein Acomplex of lipids and proteinsin approximately equalamounts that functions as atranspor

LLDL (Low-density lipoprotein) -A complex of lipids andproteins, with greateramounts of lipid than protein,that transports cholesterol inthe blood.Lin

weekend, extended periods ofhigher or lower activity, ormenses.Predictive alerts - These alertscan be used so that youreceive alarms before thesensor

Status - The condition of a partof your system (batterystatus, alarm/alert status).Status screen - Displays thecurrent operations of thepump, includin

Glossary236

Index Numerics3-hour graph 1236-hour graph 12312-hour graph 12424-hour graph 124Aaccessories 3activity guard 4CareLink USB 3holster 3leather c

programming 44stop delivery of 47temp 95bathing 128battery, pump 173, 183install 14removing 154short life 154beep/vibrate, alert type 19BG, e

Conventions MeaningGo to the...screen.when a step instructs you to go to a certain screen, the path to thatscreen is shown. For example:Go to the ALAR

DDaily totals 132DAILY TOTALS screenReview 131default settingsAlert Silence 197AUC Limits 197BG Units 196Cal Reminder 196Cal Repeat 196Glucose

setting Rate of Changealerts 109setting the CalReminder 110turning on GlucoseAlerts 104graphs 121continuous glucose 120continuous sensor glucosel

Normal boluswith Bolus Wizard 74without Bolus Wizard 27Normal mode 20Now 86Now portionof the Dual Wave bolus 83, 86Oocclusive dressingirritation

Charge Transmtr 161Fall Rate 163High Predicted 163High XXX MG/DL 163Lost Sensor 160Low Predicted 163Low Transmtr 161Low XX MG/DL 162Meter BG B

starting sensorsteps before 114STATUS screen 22Step value setup 88supplies, ordering 3Suspend function 21, 47swelling 7, 9swimming 128system in

Index244

MeterThe Paradigm pump can be programmed to receive fingerstick blood glucose values transmitted fromBayer's CONTOUR® NEXT LINK Wireless Meter, B

Reservoir and infusion setsStandard Luer sets are not compatible with the Medtronic MiniMed Paradigm pump. Medtronic DiabetesParadigm reservoirs and P

Tubing ConnectorIf insulin, or any liquid, gets inside the tubing connector, it can temporarily block the vents that allow thepump to properly prime t

©2009 Medtronic MiniMed, Inc. All rights reserved.This product is covered by U.S. Patents. Other U.S. and/or foreign patents may be pending. Please vi

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, sensor, transmitte

NoticeCAUTION: Any changes or modifications to the devices not expressly approved by Medtronic Diabetescould void your ability to operate the equipmen

Wireless transmission between the pump and transmitter within the 6 feet (1.8 meters) operatingrange may be interrupted due to the transmitter orienta

Introduction12

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

The following table describes how to use the buttons on your pump from the HOME screen:Button DescriptionEASY BOLUS™ button – Shortcut to set and deli

The pump screenThe screen shows five lines of text at one time. The first is the operating mode. The second is the currentopen menu or function. The l

Time displayThe current time of day is displayed across the top of the pump screen in theformat you select—12-hour or 24-hour. The AM or PM is only di

Contacts: Africa:Medtronic Africa (Pty) Ltd.Tel: +27 (0) 11 677 4800Australia:Medtronic Australasia Pty. Ltd.Tel: 1800 668 670 (product orders)Tel: 18

Scroll barIf there is more text than the screen can show, a scroll bar appears onthe right side of the screen. Press to view any additional text.Scre

Normal modeMode for standard pump operations for normal basal and bolusdelivery. No special features are active (such as basal patterns, tempbasal, an

When the pump is in Attention mode, it will beep or vibrate periodically to remind you of the condition.The beep or vibrate frequency varies depending

CAPTURE EVENTContains the options you use to enter information about different events into the system. Examples ofevents include: the amount of insuli

• The amount of active insulin, if any• Special features that are turned on• Last alarm/alert that was cleared within 24 hours• Most recent BG meter r

The basics24

Basic programmingSetting the time and dateSetting the correct time and date in your pump is necessary for accurate basal insulin delivery and allowsyo

c. YearChange the year. Press ACT.d. MonthChange the month. Press ACT.e. DayChange the day. Press ACT.5The TIME SET AT screen will show the settings t

Selecting the languageThe language shown on the pump screens can be changed. Some languages may not be available on allpumps. Before you can select an

Select Set Bolus and press ACT. Go to step 2.You can also use the EXPRESS BOLUS button to get to step 2. Press from your HOME screen.2 a. If the SE

Macedonia:KemofarmTel: +389 2 260 36 03Fax: +389 2 260 36 49Magyarország:Medtronic Hungária Kft.Tel: +36 1 889 0688Malaysia:Medtronic International Lt

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 exchangesChoose a meal you might eat and fill in the blanks.Food:__________ exchange:______________________ exchange:

Normal meal bolus practice using carbohydratesChoose a meal you might eat and fill in the blanks.Food:__________ grams of carbohydrate:_______________

Practice: Meal bolusYou have determined your meal bolus as: _______ units.Your target blood glucose range is: _______ to _______ (average is _______).

(with the Bolus Wizard feature)datetimeamount/typecarb value BG valueN = NormalS = Square WaveDN = Normal part of dual wave bolus DS = Square part of

• delivered bolus amount• Bolus Wizard feature information (if used) To see the details of any bolus, do these steps:1 In the BOLUS HISTORY screen, se

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

When you set the scroll rate to 0.025, you can use the following increments to program a bolus:• 0.025 unit increments for a bolus of 0.975 units or l

1 Go to the BG REMINDER SETUP screen.Main > Bolus > Bolus Setup > BG Reminder2 Select On and press ACT. The BG Reminder is now enabled. Exit

Turning on the Capture Event featureThe Capture Events option appears in the MAIN MENU after this feature has been turned on in theUTILITIES MENU. To

Česká republika:Medtronic Czechia s.r.o.Tel: +420 233 059 401Non-stop help line:+420 233 059 059

3 Enter your new measurement, then press ACT. The BG measurement must be between 20–600 mg/dL(1.1–33.3 mmol/L). A message asks if you want to save the

2 Enter the amount of insulin you used, then press ACT. A message appears asking you if you want tosave this information. The Yes option is selected.3

5 Make sure the number shown on the screen is correct.• If the information is correct, press ACT. The information you entered is saved to the system a

Viewing Capture Event historyYou can view up to 10 captured events saved into the device. The most recent event will be displayed atthe top of the CAP

12:00 AMBasal Rate 1start time3:00 AMBasal Rate 2start time7:00 AMBasal Rate 3start time9:00 PMBasal Rate 4start time24 hoursrate 3rate 4 rate 1rate 2

Your basal settingsYou must program your basal settings before you can deliver basal insulin. Keep a written record of yourbasal settings.It is recomm

Current basal deliveryThe STATUS screen shows your current basal information.current basalDaily basal rate(s)The BASAL REVIEW screen shows your daily

basal rate start timesbasal delivery rates(24-hour total)basal insulin4 Exit the menus when you are done.Setting the Max basal rateMaximum basal (Max

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

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 programming50

Starting on insulinThe Paradigm pump is intended for use with U100 insulin. The following insulins have been tested byMedtronic MiniMed and found to b

Setting up the reservoirWarning: Do not use the reservoir or infusion set if any liquid gets on the top of the reservoir or insidethe tubing connector

5 While still holding the plunger rod, flip the vial over so the vial is on top, slowly pull down on theplunger to fill the reservoir.6 Gently tap the

11 121314Use your reservoir immediately after you fill it. Do not store it filled.Changing your infusion setRemoving the reservoir Each time you remov

Rewinding your pumpBefore you continue, make sure the infusion set is NOT connected to your body and the reservoir is NOT inthe pump.WARNING: Make sur

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

3 After the reservoir is positioned, you need to fill the infusion set tube with insulin. Press and hold ACTuntil insulin droplets form on the tip of

• insert the reservoir into pump• and fill the infusion set with insulinShown here are the best body areas (shaded) for infusion setinsertion. Avoid t

Important Safety InformationRegarding Your Paradigm Insulin Pump(includes all models)Avoid Immersing Your Pump In WaterThe pump was tested and met req

Quick-set infusion set (with Quick-serter®)There are different infusion sets that you can use with your pump. As an example, the following proceduresh

Filling the cannulaFilling the soft cannula with insulin is required after the infusion set is inserted into your body and theintroducer needle is pul

123Reconnecting Quick-setPlace the connector part (flat side facing down) on the infusion site until it is fully seated. Do not squeezethe connector p

It is very important to look at your blood glucose readings as feedback regarding your diabetesmanagement, not as statements about you or your self-wo

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 ahigh

• target blood glucose range•active insulin time (hours)Get this information from your healthcare professional, and, for best results, talk to your he

Bolus Wizard feature settingsInformation SettingInsulin sensitivity:This ratio is used for your correction bolus calculations.This ratio is the BG uni

Bolus Wizard feature settingsInformation SettingBG Target range:If your current blood glucose is above the BG Target range,the Bolus Wizard feature wi

Bolus Wizard warningsWhen using the Bolus Wizard feature, the pump may display a HIGH BG, LOW BG, and MAX BOLUSEXCEEDED warnings.HIGH BGIf your blood

Once the settings are programmed, you do not have to program them again unless the values change.After you program one setting, the screen will automa

WarrantyMedtronic Diabetes warrants the Medtronic MiniMed Insulin Pump against defects in materials andworkmanship for a period of 4 years from the da

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

Setting the BG unitsYou can select mmol/L or mg/dL as your Blood Glucose Unit (measurement type). You can also set theseunits in the Sensor and Captur

9 Press ACT. The SET START TIME 3 screen appears. The second insulin sensitivity is now set.10 If you do not need to set up any more insulin sensitivi

Main > Bolus > Bolus Setup > Bolus Wizard Setup > Edit Settings2 Select BG Target, then press ACT.3The TARGET RANGE 1 screen appears. The

Your Paradigm pump is shipped from the factory with an active insulin time setting of six hours, whichmost closely matches the published scientific da

Review your Bolus Wizard feature settingsCheck your Bolus Wizard feature settings in the REVIEW SETTINGS screen. If necessary, compare thisinformation

Your pump checks if the entered BG is within your target range. Press ACT to accept the bloodglucose value. You can also change this blood glucose val

Example 1: Blood glucose on target (normal blood glucose) and no active insulinMichael awakens in the morning before school and his mother has breakfa

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 3: Blood glucose below target (low blood glucose) and no active insulinOn another morning, Michael sits down before eating the same breakfast.