Medtronic Paradigm 522 Betriebsanweisung

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Inhaltsverzeichnis

Seite 1 - Insulin Pump User Guide

Insulin Pump User GuideINSULIN PUMP ANDCONTINUOUS GLUCOSE MONITORING SYSTEM

Seite 2 - 522 and 722 Insulin Pumps

Chapter 3: The basics ... 27Your pump ...

Seite 3 - 6025250-013_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

Seite 4

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

Seite 5

Meter optionParadigm Link™ and OneTouch® UltraLink™ glucose meters canbe programmed to communicate wirelessly to the Paradigm®insulin pump. When the w

Seite 6 - Regarding Y

Meter rules If you want your pump to communicate with the meter, the following conditions must apply:1 The meter option must be turned on and program

Seite 7

Deleting meter IDsa. Select Delete ID, then press ACT.b. Select the meter ID that you want to delete and press ACT.c. The selected ID is now deleted.R

Seite 8 - Contents

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

Seite 9 - Contentsviii

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

Seite 10 - Contents ix

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

Seite 11 - Contentsx

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

Seite 12 - Contents xi

Using the Bolus Wizard feature90

Seite 13 - Contentsxii

Maximum bolus limit ... 48BG Reminder ...

Seite 14 - Contents xiii

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

Seite 15 - Contentsxiv

See the following graphic for a description of the different bolus types:TIMEINSULIN123DUAL WAVEBOLUSSQUARE WAVEBOLUSNORMALBOLUSNowPortionSquarePortio

Seite 16 - Contents xv

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

Seite 17 - Contentsxvi

Square Wave bolus practiceYour target pre-meal blood glucose range is ______ to _______.Check your pre-meal blood glucose. Are you within your target?

Seite 18 - Contents xvii

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

Seite 19 - Contentsxviii

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

Seite 20 - Introduction

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

Seite 21 - Emergency kit

Example:2.0 unit Easy bolus with a step amount set at 0.5 unitsTotal # Steps = 4Total # Button Presses = 41 Step = 0.5 units1 Step = 0.5 units1 Step =

Seite 22 - Accessories

NOTE: For your safety, you cannot use the to select the Easy Bolus values. Pressing or ESCwill cancel the Easy bolus. 4 If this amount is correct

Seite 23 - How to wear your pump

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

Seite 24 - How to use this guide

LOW BG ... 76MAX BOLUS EXCEEDED ...

Seite 25 - User safety

2 Select the basal pattern you want to program, then press ACT.3 The SET BASAL RATE 1 screen appears. The basal rate flashes, indicating that it can b

Seite 26 - Warnings

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

Seite 27 - Transmitter

A temporary basal rate allows an immediate short-term change to your basal insulin for a specified periodof time (30 minutes to 24 hours). This rate c

Seite 28 - Precautions

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

Seite 29 - Adverse reactions

Percent of basalUnlike insulin rate, the percent of basal is dependent on your current basal rates. Percent temp basal is apercentage of your current

Seite 30 - Introduction 11

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 =

Seite 31 - Introduction12

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

Seite 32 - Introduction to pump therapy

Verifying temp basal delivery Press down button to scrollTemp Basal of 0.6 units per hour is now activeTemp Basal delivery will last 30 minutes4 minu

Seite 33 - Understanding pump ther

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

Seite 34 - Blood glucose and A1C testing

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

Seite 35

Chapter 8: Sensor features ... 111Entering your sensor settings ...

Seite 36

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

Seite 37

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

Seite 38 - Hyperglycemia protocol

Setting the High SnoozeAfter you receive and clear a High Glucose alert, it will repeat until the high glucose condition is resolved.The High Snooze f

Seite 39 - Diabetes ketoacidosis (DKA)

4 Select your Low Glucose limit between 40–390 mg/dL (2.2–21.6 mmol/L). Your Low Glucose limit mustbe at least 10 mg/dL (0.6 mmol/L) below your High G

Seite 40 - Sick day management

Setting the Cal ReminderThe Cal Reminder feature allows you to set a reminder to calibrate your system. For example, if you setyour reminder to four h

Seite 41 - Nutrition

7 A message shows that the Transmitter ID has been changed. After about 30 seconds, the EDITSETTINGS screen appears. It shows the Transmitter ID you e

Seite 42 - Reading a food label

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

Seite 43 - Fat and blood glucose

2 Connect the transmitter to the charger by lining it up, flat side down, withthe charger. Push the two components together fully. Always allow at lea

Seite 44 - • meat • fish • poultry

Starting the sensorTo start the sensor working, you must complete the following steps in order:• Insert a battery into the transmitter's charger.

Seite 45 - Exercise

Areas to avoid:•Frequently used injection or pump/sensor sites• 2-inch (5.0 cm) area around navel• Site where clothing will rub or constrict• Scarred

Seite 46 - The basics

Removing the sensor ... 132Storage ...

Seite 47 - Install battery

11 While holding the sensor in place, gently slide the Sen-serter away from the sensor. Do not twist, bendor lift the Sen-serter while removing it fro

Seite 48 - Pump buttons

Connecting the transmitter to the sensor Before connecting the transmitter to the sensor, you must have the transmitter fully charged and set up(see C

Seite 49

Preparing the sensor for communicationYou are now ready to use your pump to start communicating with the sensor and start sensor initialization.The pu

Seite 50 - HOME screen

Entering meter BGSensor calibration will be successful only if the BG entry is in the range of 40-400 mg/dL (or 2.2 to 22mmol/L). You should calibrate

Seite 51 - Screen icons

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

Seite 52 - Operating modes

The following conditions can prevent a real-time sensor glucose measurement from being taken:• A Lost Sensor alert.• A Sensor Error alert.• A new sens

Seite 53 - Attention mode

The graphsAll graphs show High and Low Glucose lines, a real-time SG measurement line, a data section, and thecursor (flashing vertical line).When you

Seite 54 - The basics 35

2:20PHistoryLOSTSENSORPMNOTE: There are many reasons your graphs may not show an SG measurement, but your system doesnot alert for every one. Therefor

Seite 55 - STATUS screen

24-hour graphEach part of the graph between the vertical dashed lines represents 12 hours. The shaded area helps youmore easily see the sensor glucose

Seite 56 - If you remove your pump

The arrow direction shows if your SG measurements are rising or falling. The number of arrows (one ortwo) shows how rapidly your SG is changing.•One u

Seite 57 - The basics38

Every month ... 151Every 3 months ...

Seite 58 - Basic programming

Calibration historyThe SENSOR UPDATE HISTORY screen lists the successful sensor calibration BG values that were enteredinto the pump more than 15 minu

Seite 59 - Selecting the language

Disconnecting the transmitter and removing the sensorDisconnecting the sensor from the transmitterIf you are not going to replace the sensor, turn the

Seite 60 - Setting the Normal bolus

Using your system in waterWARNING: Do not use your pump in water or wear it during water activities. The pump is not water-tight and it may become dam

Seite 62 - Basic programming 43

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

Seite 63 - Basic programming44

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

Seite 64 - Review your bolus deliveries

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 displays a

Seite 65

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

Seite 66 - Bolus details

Press to view more information.4 The INSULIN screen displays. This screen shows:•total insulin delivered for the day• total Basal and Bolus insulin

Seite 67 - Maximum bolus limit

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 yousele

Seite 68 - BG Reminder

SENSOR ERROR ... 163Alarms ...

Seite 69 - Start and stop times

• the average total number of correction only boluses delivered per day for the number of previousdays you selected•the average total number of food p

Seite 70 - Basic programming 51

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 rem

Seite 71 - Daily basal rate(s)

Block featureBlock restricts access to pump programming. The factory setting for this feature is off. Block is animportant safety feature if the pump

Seite 72 - Chapter 4

Lock keypad featureLock keypad prevents accidental pump keypad presses. You can only press the to view the STATUSscreen, and the button to turn on t

Seite 73 - Setting the Max basal rate

2 Select Selftest, then press ACT.3 Periodically, you will hear beeps as different mechanisms in the pump are being tested. As part of theselftest, th

Seite 74 - Resume pump delivery

Main > Utilities > User Settings2Hold down and press ACT.3 The USER SETTINGS screen is displayed with Save Settings highlighted. Press ACT.4 I

Seite 75 - Basic programming56

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

Seite 76 - Starting on insulin

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

Seite 77 - Filling the reservoir

Therapy softwareMedtronic provides software to optimize your pump use. Contact your local representative for moreinformation.CareLink™ Personal Softwa

Seite 78 - Starting on insulin 59

You can share your reports with your healthcare professional. These reports can help you and yourhealthcare professional to discover trends and other

Seite 79 - Changing your infusion set

Alarm history ... 177Audio frequency ...

Seite 80 - Starting on insulin 61

Insulin pump therapy follow-upWe hope that you are now comfortable using the pump and your blood glucose values have improvedthrough insulin pump ther

Seite 81 - Rewinding your pump

Laboratory tests•Test for HbA1c four or more times a year• Test for cholesterol, HDL, LDL, triglyceride yearly• Test for microalbuminuria yearlyEvery

Seite 82 - Starting on insulin 63

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

Seite 83 - Manual prime

7 Monitor your blood glucose closely.8 If you followed these steps and you are still receiving a NO DELIVERY alarm, call your localrepresentative.What

Seite 84 - Inserting the infusion set

• The amount of insulin the pump is delivering.•The usage of some features. The backlight, vibrate, remote control and meter options decreasebattery l

Seite 85 - Starting on insulin66

I cannot get out of the priming loopThere are several causes of and resolutions to this problem:1 Is the reservoir pump full?•If no, place a full rese

Seite 86 - Disconnecting Quick-set

My pump will not display my blood glucose reading from my meter1 Make sure you are using the correct meter (a blood glucose meter supported by MWT1 te

Seite 87 - Reconnecting Quick-set

I submerged my pump in waterYour pump is designed to resist accidental contact with water. Do not submerge in water during bathing,showering, swimming

Seite 88 - Starting on insulin 69

It is important that you understand how your pump behaves when you do not clear an alarm or an alert:•Alarm — If you do not clear an alarm, the pump d

Seite 89 - Starting on insulin70

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

Seite 90 - What is it?

Bolus Wizard feature specifications ... 186Bolus Wizard feature examples ...

Seite 91

LOST SENSOR Reason: The pump has not received a signal from the transmitter. Do not disconnect the transmitterfrom the sensor.Action:1 Make sure that

Seite 92 - Bolus Wizard feature settings

BAD TRANSMTRReason: The transmitter battery is depleted. Action: Recharge your transmitter immediately. See the Charging the transmitter section in t

Seite 93

METER BG NOWReason: A meter BG measurement is needed immediately to calibrate your sensor so that you cancontinue receiving sensor glucose readings.A

Seite 94 - Bolus Wizard warnings

AlarmsYour pump has a sophisticated network of safety checks and systems. If the safety network detectsanything unusual, your pump notifies you of con

Seite 95 - MAX BOLUS EXCEEDED

Alarm conditionsAlarms put the pump in Attention mode. A (ALARM) This alarm shows a letter A followed by two numbers. A-alarms cause all insulin deliv

Seite 96 - Setting the Carb/Exch ratios

BUTTON ERROROccurs if a button has been continually pressed for more than three minutes. CHECK SETTINGS When this alarm is active, you should check a

Seite 97 - Setting the BG units

NO DELIVERYInsulin delivery has stopped. This alarm occurs if your pump detects a blockage. NO RESERVOIRThe reservoir is not inserted correctly or no

Seite 98 - Insulin sensitivity

2 Push the tester into the transmitter until the flexible side arms of the tester click into the notches onboth sides of the transmitter.3 Within 20 s

Seite 99 - Target Range

2 With the tester arms pinched, gently pull the transmitter away from the tester. To save transmitterbattery life, do not leave the tester connected a

Seite 100 - About active insulin

Understanding your transmitter, tester, and chargerThe charger has a green light that shows the charging status and a red light that communicates anyp

Seite 102 - Meter option

Answer: It will not damage the transmitter. You cannot overcharge it.Question: What should I do if the transmitter’s green light did not flash after r

Seite 103 - Meter rules

Troubleshooting and alarms172

Seite 104

MaintenanceIt is recommended that you read your warranty statement included in the Pumps specifications chapter forinformation about what is covered d

Seite 105 - Bolus Wizard feature examples

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

Seite 106

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

Seite 107

Maintenance176

Seite 108

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

Seite 109

Basal•Rate increments: 0.05 units/hour• Delivery: 0.05 - 35 units/hour (maximum units: 35/hour)• Factory maximum setting: 2.0 units/hour• 3 patterns m

Seite 110 - Optimizing pump therapy

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

Seite 111

Delivery accuracy•Delivery accuracy: +/-5 percent.• Displacement (piston) accuracy: +/-2 percent.•The delivery accuracy test was done using the Sof-Se

Seite 112 - Optimizing pump therapy 93

Paradigm®522 and 722 Insulin PumpsUser Guide

Seite 113 - Optimizing pump therapy94

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

Seite 114 - Optimizing pump therapy 95

Pump motorThe pump motor has a unique, patented design with an integrated safety check system. The systemdelivers in precise increments.Dual Wave bolu

Seite 115 - Optimizing pump therapy96

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

Seite 116 - Easy bolus

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

Seite 117 - Delivering Easy Bolus

Remote controlUses radio signals to allow users to program Normal boluses or to suspend/resume their pumps.Reservoir•The user-filled reservoir is made

Seite 118 - Optimizing pump therapy 99

Status screenItem When WhatAlarm Clock* (appears if scheduled toalarm)Time set is displayed.Auto-off (appears if enabled) X HRBasal pattern informatio

Seite 119 - Basal patterns

Item When WhatStandard basal delivery data (always appears) current basal rate (basal 1, basal 2,etc.)Status of pump (such as Rewind, Suspended, Low R

Seite 120 - Select a pattern

(food estimate)A Bwhere:+=(correction estimate)total bolus estimateC - D EA = food (grams)B = carb ratioC = current BGD = High BG TargetE =

Seite 121 - Temp basal rates

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

Seite 122 - Temp basal types

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

Seite 123 - Temp Basal Settings

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 mm

Seite 124 - Percent of basal

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

Seite 125

#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 unit

Seite 126 - Delivering a temp basal

#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.

Seite 127 - Canceling a temp basal

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

Seite 128 - Optimizing pump therapy 109

Menu Item DefaultSettingLimits Increments(Time/Date) Time: 12 a.m.(midnight)(Time/Date) Date: 1/1/05(Time/Date) Timeformat:12-hourBlock: OffAlarm cloc

Seite 129 - Optimizing pump therapy110

Bolus Wizard feature default settingsItem DefaultSettingLimits Increments Warning Limitscarb units: grams none none noneins to carb (orexch) ratio:15

Seite 130 - Sensor features

Sensor features default settingsFeature Options Default Setting Limits, Range of ValuesSensor• On•OffOff NoneHigh GlucoseAlert• On• OffOff Low–22.2 mm

Seite 131 - High Glucose Alert

Guidance and manufacturer's declarationGuidance and Manufacturer's Declaration - Electromagnetic Emissions The Paradigm 522/722/522K/722K pu

Seite 132 - Low Glucose Alert

Guidance and Manufacturer's Declaration - Electromagnetic Immunity The Paradigm 522/722/522K/722K pump system (consisting of the MMT-522/722/522K

Seite 133 - Setting the Alarm Snooze

Guidance and Manufacturer's Declaration - Electromagnetic Immunity The Paradigm 522/722/522K/722K pump system (consisting of the MMT-522/722/522K

Seite 134 - Entering the transmitter ID

Guidance and Manufacturer's Declaration - Electromagnetic Immunity The Paradigm 522/722/522K/722K pump system (consisting of the MMT-522/722/522K

Seite 135 - Reviewing your settings

ConsumablesThe pumps use disposable reservoirs and infusion sets for insulin delivery. Installation instructions forParadigm reservoir and Paradigm co

Seite 136 - Transmitter charger

Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe Paradigm 522/522K/722/722K pump system is intended for use in the electroma

Seite 137 - Sensor features118

Guidance and Manufacturer's Declaration - Electromagnetic ImmunityThe Paradigm 522/522K/722/722K pump system is intended for use in the electroma

Seite 138 - Inserting the sensor

Recommended separation distances between portable and mobile RF communicationsequipment and the Paradigm 522/722/522K/722K pump system This section pr

Seite 139 - Sensor features120

Icon table Do not reuseAttention: See Instructions for UseManufacturerDate of manufacture (year - month)Batch codeUse by (year - month)Catalogue numbe

Seite 140 - Sensor features 121

Signifies compliance to Australian EMC and Radio communicationsrequirementsSignifies compliance with Industry Canada EMC and Radio communicationsrequir

Seite 141 - Sensor features122

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

Seite 142 - Calibrating the sensor

Sensor accuracyNOTE: You should review the information in this section with your healthcare professional. The Medtronic MiniMed Paradigm 522/522K/722/

Seite 143 - Entering meter BG

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

Seite 144 - Using your sensor

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

Seite 145

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

Seite 146 - The graphs

Not all devices or accessories are available in all countries where the pump is approved.To order supplies, call 800-646-4633, +1-818-362-5958 (outsid

Seite 147 - 3-hour graph

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

Seite 148 - The rapid change arrows

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

Seite 149 - Using your sensor130

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

Seite 150 - Sensor alarm history

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

Seite 151 - Removing the sensor

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

Seite 152 - Using your system in water

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

Seite 153 - Using your sensor134

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

Seite 154 - Utilities

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

Seite 155 - Auto-off

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

Seite 156 - Review daily insulin totals

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

Seite 157 - Pump data management

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

Seite 158 - Utilities 139

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

Seite 159 - Utilities140

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

Seite 160 - Remote control option

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

Seite 161 - Utilities142

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

Seite 162 - Block feature

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

Seite 163 - Selftest

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

Seite 164 - User settings

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

Seite 165 - Restoring the settings

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

Seite 166 - History

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

Seite 167 - Utilities148

Basal rate - The pump settingthat provides a continuousinfusion of insulin to keep theblood glucose stable betweenmeals and during the night.Basal ins

Seite 168 - Therapy software

User safetyIndications: Paradigm 522/722PumpThe Paradigm MMT-522 and MMT-722 pumps are indicated for the continuous delivery of insulin, at set andvar

Seite 169 - Therapy software150

settings remain in effect untilyou change them.Diabetic Ketoacidosis (DKA) - Aserious condition that occurswhen the insulin levels arelow, blood gluco

Seite 170 - Recommended follow-up

GGastroparesis - A condition ofthe digestive system thatslows down the emptying offood from the stomach.Glucagon - A hormone thatraises the level of g

Seite 171 - Annually

what size bolus you shouldtake when eatingcarbohydrates. Yourhealthcare professional willdetermine your insulin tocarbohydrate ratio.Introducer needle

Seite 172 - Troubleshooting and alarms

MWT1 technology - MWT1 is thewireless Radio Frequency (RF)technology that is used totransmit information from themeter to the pump. You canprogram you

Seite 173 - Troubleshooting and alarms154

Sensor Age - Sensor age is theamount of time, in days andhours, since the sensor wasfirst inserted.Sensor features - Optionalcontinuous glucose monito

Seite 175 - My bolus stopped

Index Numerics3-hour graph 12824-hour graph 129Aaccessories 3activity guard 4CareLink USB 3holster 4leather case 4meter 3pump clip 4remote co

Seite 176 - I dropped my pump

battery, pump 173, 183install 28removing 154short life 154beep/vibrate, alert type 33BG Reminder 41, 49BG Targets 80BG units 78default setting

Seite 177 - I submerged my pump in water

Missed Data 196sensor 196sensor features 196discardingtransmitter 174disconnectingsensor from transmitter 132tester from transmitter 168transmit

Seite 178 - What to do

LLanguage setting 40listcalibration values 131sensor alert 131Lock keypad feature 144Lost Sensor alert 161low batteryaffects meter option 84affe

Seite 179 - WEAK SIGNAL

MeterThe Paradigm REAL-Time insulin pump can be programmed to receive fingerstick blood glucose valuestransmitted from the LifeScan OneTouch® UltraLin

Seite 180 - LOW TRANSMTR

reading the real-time glucosegraphs 125real-time glucose graphsreading 125real-time sensor glucoselevels 127RECONNECT OLD SENSOR 169Reminder, alar

Seite 181 - CAL ERROR

skinbleeding 8, 10bruising 10infection 8, 10redness 10swelling 8, 10Special mode 34Square portionof the Dual Wave bolus 96Square Wave bolus pro

Seite 182 - SENSOR ERROR

6025250-011C 112106

Seite 183 - NOTE: The ST

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

Seite 184 - Alarm conditions

Magnetic fieldsDo not use pump cases that have a magnetic clasp.Do not expose your insulin pump to MRI equipment or other devices that generate very s

Seite 185 - Troubleshooting and alarms166

Infusion sets and sitesAvoid using an infusion set insertion site that will be irritated by clothing and accessories, or by rigorousstretching and exe

Seite 186 - Testing the transmitter

©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

Seite 187 - Disconnecting the tester

These standards are designed to provide reasonable protection against excessive radio frequencyinterference and prevent undesirable operation of the d

Seite 188 - Find lost sensor

The pump includes a programmable WEAK SIGNAL alert that notifies you when one or more expectedtransmissions were not received as expected by the pump.

Seite 189

Introduction to pump therapyTheory of insulin pump therapyInsulin pumps deliver insulin closer to the way the human pancreas delivers insulin than any

Seite 190

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

Seite 191 - Troubleshooting and alarms172

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

Seite 192 - Maintenance

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

Seite 193 - Cleaning the transmitter

Correlation between A1C level and blood glucose levelsMean plasma glucoseA1C (percent) mg/dL mmol/L12 345 19.5American Diabetes Association. Diabetes

Seite 194 - Cleaning the Sen-serter

Hypoglycemia protocol: the rule of 15Check with your healthcare professional for guidelines on treating your low BG. The following instructionsare com

Seite 195 - Maintenance176

These items have 15 grams of fast acting carbohydrates:•Glucose tablets (three, 5-gram tablets or four, 4-gram tablets)• 4 oz. of juice or soda (not d

Seite 196 - Pump specifications

If the second blood glucose is above 250 mg/dL (13.9 mmol/L):•Take an insulin injection by syringe (not through the pump). The amount should be the sa

Seite 197 - Pump specifications178

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

Seite 198 - Default screen

• Call your healthcare professional right away if your blood glucose and ketones are not decreasing, oryou cannot drink fluids.•Continue to test blood

Seite 199 - Delivery accuracy

Sick day suppliesYou should have the supplies listed below in the house at all times, and carry them with you when youtravel:• Fluids that have sugar

Seite 200 - Pump specifications 181

Carbohydrate gram countingWith this method, you add up the exact number of grams of carbohydrate in each meal. Food labels, foodlist and meal planning

Seite 201 - Occlusion detection

The following food label shows 12 grams of carbohydrates for each 1 piece serving. If your carbohydrateratio is 1 unit of insulin for every 12 grams o

Seite 202 - Pump specifications 183

There are bolus type options available on your pump that can be helpful in handling the rare high-fatmeal. Before using bolus type options, you should

Seite 203 - Pump specifications184

Healthy eating habitsInsulin pump therapy gives you the choice of when, what and how much to eat without impacting bloodglucose control. This gives yo

Seite 204 - Status screen

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

Seite 205 - Pump specifications186

Install batteryCAUTION: Do not use a rechargeable or carbon zinc battery in your pump. For best results use a newEnergizer AAA alkaline battery, size

Seite 206

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

Seite 207 - Pump specifications188

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

Seite 208 - Pump specifications 189

Schweiz:Medtronic (Schweiz) AGTel: + 41 (0)31 868 016024-Stunden-Hotline 0800 633 333Fax Allgemein: +41 (0)31 8680199Serbia & Montenegro:Novolab S

Seite 209

Button Description• Returns to previous screen or exits the menu.•Backs out of unintentional menu selections if the ACT button has not been pressed ye

Seite 210 - Chapter 15

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

Seite 211

Sensor iconsA dark sensor icon means that the sensor is on and the pump is receivingsensor data. A light-colored sensor icon with a dark circle around

Seite 212 - Pump specifications 193

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

Seite 213 - Pump specifications194

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

Seite 214 - Pump specifications 195

PRIME MENUContains the functions to change your reservoir and fill the infusion set with insulin. Refer to the Changingyour infusion set section in th

Seite 215

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

Seite 217 - Pump specifications198

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

Seite 218 - Pump specifications 199

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

Seite 219 - Pump specifications200

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

Seite 220 - Pump specifications 201

BolusThere are three bolus types: Normal, Square Wave®, and Dual Wave®. This section gives instructions for aNormal bolus using the express bolus butt

Seite 221 - Pump specifications202

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

Seite 222 - Pump specifications 203

Normal meal bolus practice using exchanges: Choose a meal you might eat and fill in the blanks.Food:__________ exchange:______________________ exchang

Seite 223 - Icon table

Choose a meal you might eat and fill in the blanks.Food:__________ grams of carbohydrate:______________________ grams of carbohydrate:________________

Seite 224

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

Seite 225 - Warranty

If a bolus was stopped before delivery was complete, the BOLUS HISTORY screen will show only the amountactually delivered. Refer to the Bolus details

Seite 226 - Sensor accuracy

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

Seite 227 - Performance results in adults

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

Seite 228 - Sensor accuracy 209

BG ReminderAfter you deliver a bolus you may want to check your blood glucose. The BG Reminder is an optionalfeature that makes the pump beep or vibra

Seite 229 - Appendix A210

Start and stop timesWhen you set your basal rate(s) in the BASAL MENU, your pump prompts you to set the start time for eachbasal delivery. The start t

Seite 231 - Appendix A212

For best results, setting or changing your basal rate(s) should be discussed with your healthcareprofessional.Your basal settingsYou must program your

Seite 232 - Sensor accuracy 213

10 When you have finished programming your pump, you can save your settings. Refer to the Usersettings section in the Utilities chapter for instructio

Seite 233 - Low and High Alerts in adults

basal rate start timesbasal delivery rates(24-hour total)basal insulinBasic programming 53Chapter 4

Seite 234 - The High Glucose Alert

If you use patterns, the BASAL REVIEW screen appears.The current basal pattern will be highlighted. Select the pattern you want to view. Press ACT.The

Seite 235 - Appendix A216

Stopping your pumpSuspend stops all insulin delivery including the current basal and any bolus or prime deliveries that are inprogress. While suspende

Seite 236 - Sensor accuracy 217

Example: Suspend functionHelen is ready to eat her lunch. She has just programmed her pump to deliver a meal bolus when thephone rings. Helen wants to

Seite 237 - Appendix A218

Starting on insulinThe Paradigm pump is intended for use with U100 insulin.Prepare your pump for useWe recommend that you watch the training CD-ROM en

Seite 238 - Sensor accuracy 219

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

Seite 239 - Time-elapsed plots

plungerrodtransferguardreservoirvial314 Push down on the plunger to pressurize the vial. Hold down the plunger rod.5 While still holding the plunger r

Seite 240

11 Tap the side of the reservoir to remove any air bubbles.12 To purge air bubbles that have risen to the top of the reservoir, push up on the plun

Seite 241 - Appendix A222

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

Seite 242 - Sensor accuracy 223

3 Turn the tubing connector half-turn counterclockwise, then pull the reservoir and connectorout from the pump.tubing connectorhalf-turn counter-clock

Seite 243 - Appendix A224

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

Seite 244 - Sensor accuracy 225

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

Seite 245 - Appendix A226

Manual primeManual prime fills the infusion set tubing with insulin before you insert the set into the body. Manual primeis only available after you r

Seite 246 - The Low Glucose Alert

Inserting the infusion setWARNING: While the infusion set is connected to your body, do not unscrew and retighten the tubingconnector on the reservoir

Seite 247

Quick-set infusion set (with Quick-serter®)Always refer to the instructions that shipped with your infusion set.Starting on insulin66

Seite 248 - Glossary

Fixed primeA fixed prime fills the soft cannula with insulin and is required after the infusion set is inserted into yourbody and the introducer needl

Seite 249 - Glossary230

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

Seite 250 - Glossary 231

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

Seite 251 - Glossary232

Starting on insulin70

Seite 252 - Glossary 233

Adverse reactions ... 10Notice ...

Seite 253 - Glossary234

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

Seite 254 - Glossary 235

Your personal Bolus Wizard feature settingsIn addition to your blood glucose reading and/or your food entry, the Bolus Wizard feature uses personalset

Seite 255 - Glossary236

Bolus Wizard feature settingsInformation SettingCarb units: _____ grams or ____ exchangesCarb ratios:Bolus Wizard feature uses this for your food bolu

Seite 256 - Numerics

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

Seite 257 - Index238

Bolus Wizard feature settingsInformation Setting#8: __________Bolus Wizard feature settingsInformation SettingActive insulin time:The Bolus Wizard fea

Seite 258 - Index 239

LOW BGIf your blood glucose in the ENTER BG screen is below 70 mg/dL (3.9 mmol/L), the Bolus Wizard featuredisplays a LOW BG warning. Read the instruc

Seite 259 - Index240

Turning on the Bolus Wizard feature 1 Go to the EDIT SETTINGS screen.Main > Bolus > Bolus Wizard Setup > Edit Settings2 The EDIT SETTINGS scr

Seite 260 - Index 241

2 Select Carb Ratios, then press ACT.• If you use grams as your carb units: Carb ratio is the number of carb grams that are covered byone (1.0) unit o

Seite 261 - Index242

Insulin sensitivity Your insulin sensitivity is the amount your blood glucose (BG) level is reduced by one unit of insulin. Thisvalue is used to calcu

Seite 262 - 6025250-011C 112106

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

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