Energizer MMT-511 Betriebsanweisung

Paradigm™ Infusion PumpModel MMT-511User Guide

vi Adverse reactions. . . . . . . . . . . . . . . . . . . . . . . . . . . . 130Hyperglycemia and diabetic ketoacidosis (DKA) . . 130Hypoglycemia

88 Chapter 7 BlockThe block feature restricts access to the pump programming. This is an important safety feature if the pump users are young children

Utilities 89 2. Press the button to select Block. Press ACT.3. Press the button to select ON. Press ACT.When the Block Option is ON, the pump wi

90 Chapter 7 Setting the time and date1. From the HOME screen, press ACT. Press the button to select Utilities. Press ACT.2. Press the button to

Utilities 91 5. The hour will flash. Press the and buttons to select the hour. Press ACT to set the hour.When pressing the and buttons the AM

92 Chapter 7 8. The month will flash. Press the and buttons to select the month. Press ACT.9. The day will flash. Use the and buttons to selec

Utilities 93 LanguageThe language shown on the screens on the pump can be changed. Some languages will not be available on all pump models. Setting th

94 Chapter 7 RF options (remote control)➤What are RF Options?RF Options allow you to program your pump by using a remote control(s).CAUTION: The remot

Utilities 95 2. Press the button to select RF Options. Press ACT.3. Press the button to select ON. Press ACT.4. ADD ID will be selected. Press

96 Chapter 7 6. The RF ID is printed on the back of the remote control.Deleting an RF IDEnables you to delete an RF ID code you have set.1. From the

Utilities 97 3. ON will be selected. Press ACT.4. Press the button to select Delete ID. Press ACT.5. Select the RF ID code you want to delete. Pre

vii Chapter 12Pump Specifications . . . . . . . . . . . . . . . . . . . . 143Specifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

98 Chapter 7 Reviewing the RF ID codesAllows you to review the RF ID codes you have already programmed.1. From the HOME screen, press ACT. Press the

Utilities 99 4. Press the button to select Review ID. Press ACT.5. Review the RF ID codes you have set.Clear pumpIn rare instances, you may want t

100 Chapter 7 Clearing pumpClears the programming you have set and restores the factory default settings stored in the pump memory, except for langua

Utilities 101 4. The pump will ask you to Confirm that you want to Clear the pump. Select the option you desire.5. Press ACT. A message will appear

102 Chapter 7 8. Disconnect pump from your body. Remove reservoir. Press ACT to rewind.9. The pump will now rewind.10. When the pump has finished re

Utilities 103 12. Select YES and press ACT to verify insulin type. To change the insulin type, select NO and press ACT, or press ESC to return the IN

104 Chapter 7 If the pump detects a condition; such as, low battery, the test will not finish. A message will appear indicating the condition that cau

Utilities 105 3. Screen Test: The screen should appear as shown below (all black).4. Selftest: The pump will count down from 10.5. Tone Test: You s

106 Chapter 7 7. Once the selftest is completed, TEST OK will appear on the screen.8. Contact the 24-hour Product Help-line if any of the tests do n

107 Chapter 8• • • • • • Remote ControlCAUTION: The remote control should not be used aboard an air-craft. Operate your pump using the buttons on

viii

108 Chapter 8 Using your remote controlDiscuss what uses and settings are best for you with your health-care professional. See Chapter 7, Utilities fo

Remote Control 109 Waking up your pumpThe remote control will operate within 24 inches from your pump. When the remote control is in “sleep mode,” the

110 Chapter 8 Deliver an easy bolus1. With pump in the HOME screen, press and hold ACT to “wake up” the pump.2. When the pump is awake, it will beep

Remote Control 111 3. To resume basal delivery, press and hold ACT to “wake up” the pump. Press the S button, then press ACT. The pump will beep/vibr

112 Chapter 8 2. Make sure the RF ID is correctly entered.3. Make sure the pump is not in a “Low Batt” condition. 4. Call the 24-hour Product Help-

113 Chapter 9• • • • • • Troubleshooting & CareIt is recommended that you read your warranty statement included with your pump for information

114 Chapter 9 5. Continue troubleshooting by disconnecting at the quick-disconnect and set a 10 unit Fixed Prime. 6. Does insulin come out of the n

Troubleshooting & Care 115 If the pump goes to the REWIND screen after you clear the alarm, you will need to perform a rewind per the instructions

116 Chapter 9 6. Perform a selftest.My screen appears distortedThe screen may appear distorted or have a “rainbow” appearance if you are wearing pola

Troubleshooting & Care 117 Pump maintenanceBatteryCertain features on the Paradigm pump use a lot of battery power. Remote control Backlight Vibr

1 Chapter 1• • • • • • IntroductionWhether you are beginning pump therapy for the first time, or upgrading from a previous model, we are pleased t

118 Chapter 9 out for more than one (1) minute or if it was placed back-wards in the pump.1. Using the edge of a coin, unscrew the battery cap in a c

Troubleshooting & Care 119 Cleaning your pump1. Use only a damp cloth and mild detergent mixed with water to clean the outside of your pump. 2.

120 Chapter 9 PrecautionsAvoiding extreme temperatures1. Avoid exposure of your pump and remote control to temperatures above 104°F (40°C) or below

Troubleshooting & Care 121 5. Perform the Selftest procedure located in the Utilities menu. 6. Call the 24-hour Product Help-line for assistance

122 Chapter 9

123 Chapter 10• • • • • • User Safety IndicationsThe Paradigm Insulin pump is indicated for the continuous delivery of insulin, at set and variab

124 Chapter 10 WarningsDiabetic ketoacidosis (DKA)Insulin pump therapy uses only regular (short-acting) insulin; therefore, any interruption in the de

User Safety 125 Reservoir and infusion setsStandard Luer infusion sets are not compatible with the Medtronic MiniMed Paradigm pump. Medtronic Minimed

126 Chapter 10 ✒Act quickly to respond to abnormal blood glucose. Notify your healthcare professional of low blood glucose requiring assistance or of

User Safety 127 Precautions - hypoglycemiaTo help prevent hypoglycemia (low blood glucose), routinely follow these precautionary steps:1. Know the s

2 Chapter 1 AssistanceMedtronic MiniMed provides a 24-hour help line for assistance in the United States. The help line is staffed with technicians wh

128 Chapter 10 Precautions - hyperglycemiaTo help prevent hyperglycemia (high blood glucose), routinely fol-low these precautionary steps:1. Know the

User Safety 129 Precautions - infusion sets and sitesUse only Paradigm style reservoirs labeled “for use with MiniMed Paradigm pumps.” Do not use oth

130 Chapter 10 Adverse reactionsHyperglycemia and diabetic ketoacidosis (DKA)Pump wearers use only regular short-acting insulin. As a result, they do

User Safety 131 HypoglycemiaHypoglycemia can be more subtle for pump users than with patients on conventional therapy. It may occur even when the pump

132 Chapter 10 NoticeInsulin pump and remote controlThese devices comply with the United States Federal Communica-tions Commission and international s

User Safety 133 CAUTION: Any changes or modifications to the devices not expressly approved by Medtronic MiniMed could void your ability to operate th

134 Chapter 10

135 Chapter 11• • • • • • Alarms and AlertsYour Paradigm pump has a sophisticated network of safety checks and systems.If the safety network detec

136 Chapter 11 When you see a alarm message on your pump’s screen:1. Use the button to scroll down to read ALL of the alarm text. There is often tex

Alarms and Alerts 137 Auto off This alarm alerts you to the fact that no buttons have been pressed during the time limit that you set in the AUTO OFF

Introduction 3 Emergency kitKeep an emergency kit with you at all times to make sure that you always have necessary supplies. This kit should include:

138 Chapter 11 No delivery Insulin delivery has stopped. This alarm will occur if your pump detects a blockage. Motor errorInsulin delivery has stoppe

Alarms and Alerts 139 Max delivery This alarm alerts you when you have taken more insulin than expected based on maximum bolus and maximum basal rates

140 Chapter 11 Bolus stoppedIf this alarm should occur, it is very important to check bolus history to review how much of the bolus was actually deliv

Alarms and Alerts 141 AlertsSilence the Alerts by pressing ESC, ACT to clear. Follow the instructions on the screen. Low battery After receiving this

142 Chapter 11 Message in Alarm HistoryAfter putting a battery into your new pump, a message “RfBad” may appear in your alarm history screen. (The pum

143 Chapter 12• • • • • • Pump Specifications The Pump Specifications section provides detailed information on specifications related to your pump

144 Chapter 12 Insulin delivery Allows up to 48 individual basal rates to be programmed in a daily pattern. Different basal rates can be programmed ev

Pump Specifications 145 Easy bolus Features programming using audible tones (or vibrate pulses) in user-determined increments. Beep mode range: 0 to

146 Chapter 12 Occlusion detectionThe detection of an occlusion will trigger a “no delivery alarm.” Up to 3.0 units of “missed” insulin are required t

Pump Specifications 147 Prime function Is used to fill the infusion set tubing prior to use. Primes are not counted in daily totals but are recorded s

4 Chapter 1 Pump and user guide conventionsThe following terms and icons are used to describe the pump in this User Guide. “Press” means to push and r

148 Chapter 12 Square wave bolus Delivers 0.1-25.0 units of insulin over a duration of 30 minutes to eight hours (limited by maximum bolus setting).Te

Pump Specifications 149 Factory default settingsThe following are the default settings:Menu DefaultBolus Menu: Easy Bolus: ON Increment default: 0.5 u

150 Chapter 12 Icon tableDo not reuse:Attention: See Instructions for UseMethod of sterilization using Ethylene Oxide:Date of Manufacture: (year - mo

Pump Specifications 151 Language of Instructions for UseRecycleKeep dryF

152 Chapter 12

153 • • • • • • IndexAadverse reactions 130Alarms 81, 135, 143auto-off 137batt out limit 138button error 139check settings 139E alarm 136history 86

start and stop times 61basal 61basal menu 14Batt 138Batterypump 114, 117, 146remote control 109, 111blockwhen available 88block feature 144blood glu

delivery accuracy 144diabetic ketoacidosis 124, 130displacement accuracy 144DKA 124drive motor 144dropped 120dual wave bolus 37, 46, 144Eeasy bolus 3

insulin 129, 130, 145insulin delivery 144Kketones 130Llanguage 93Mmaximum bolus limit 37, 50Modesattention 9normal 8special 8MRI 125Nno delivery 113

priming 21pump buttons 10pump status 35Rremote control 94, 107reservoir 5, 129, 147rewind 21, 22RF ID 94Ssafety 147safety checks 147selftest 103, 105

Introduction 5 Your pumpTake a look at your pump. The pump is smart. It remembers your settings and stores a record of its actions.Turn your pump on i

time/date 18, 90Uutilities 81Wwarnings 124water 112watertight 148Xx-rays 125

6 Chapter 1 Installing the battery the first timeThe Paradigm pump uses a AAA alkaline battery. As a safety mea-sure, Medtronic MiniMed has designed t

Introduction 7 3. Numbers will appear on the pump screen as the pump turns on. Then the following screen will appear. 4. If this does not happen: a.

© 2005, Medtronic MiniMed. All rights reserved.This product is covered by U.S. Patent Nos. 6,551,276 and 6,554,798. Other U.S. and/or foreign paten

8 Chapter 1 Home screenThe HOME screen serves as the start-ing point to access the programming screens by pressing ACT, or to access the STATUS screen

Introduction 9 The following features or alarms turn on the open circles: Dual/square wave bolus delivery Basal patterns A or B Temporary basal delive

10 Chapter 1 The screens that will display solid circles are:Pump buttonsFive buttons are used to program and access the pump features. The UP and DO

Introduction 11 From the HOME screen, the and buttons have special functions:✒ The button lets you set an Easy Bolus.✒ The button lets you tu

12 Chapter 1 Main menuWhen you press ACT from the HOME screen, the Main menu will appear. MiniMedMAIN MENUBolusSuspendBasalPrimeUtilitiesMiniMedBOLUS

Introduction 13 Five lines of text is always viewable on your pump screen. The top line will always display the word “MiniMed.” The lines that follow

14 Chapter 1 Basal menuUse the Basal menu to program a continuous amount of insulin 24 hours-a-day. Your basal rate is the amount of insulin required

Introduction 15 Initial pump settingsThis is the information you need on the day that you begin using your pump with insulin. If your pump start is to

16 Chapter 1 Basal rate informationMost people will only have one basal rate when starting pump therapy. Meal bolusesCorrection bolusBlood glucose ta

17 Chapter 2• • • • • • Getting StartedThis chapter will guide you through the set-up procedures to get your pump ready to use. Make sure you have

Important Safety Information Regarding Your Paradigm Insulin Infusion Pump (includes all models)Avoid Immersing Your Pump In WaterAlthough it is unlik

18 Chapter 2 Refer to the Instructions for Use included with the Paradigm reser-voir and infusion sets you have chosen for detailed information.Prepar

Getting Started 19 3. Press the and button to select your preferred time format. Press ACT.If you have selected the 12 Hour Setup, when pressing

20 Chapter 2 6. The minutes will flash. Press the and buttons to set the minutes. Press ACT.7. The year will flash. Press the and buttons to

Getting Started 21 10. The time and date will be shown.11. Press the ACT button to return to the UTILITIES menu.Installing the reservoirIf using the p

22 Chapter 2 Removing the reservoir1. Remove the infusion set from your body or disconnect the tubing from the infusion site.2. Using a counter-clo

Getting Started 23 WARNING: Never rewind the pump while it is connected to your body or contains a reservoir. Never insert the reservoir into pump whi

24 Chapter 2 7. Use the and buttons to select your reservoir type/insu-lin concentration. Press ACT.8. Use the button to select Yes and press

Getting Started 25 10. Press ESC to return to the INSULIN TYPE screen to change your Insulin Type if you have selected the wrong insulin type. 11. Pre

26 Chapter 2 16. Fill the reservoir with your insulin. Refer to the Instructions for Use provided with the reservoir.WARNING: Your pump will not accu

Getting Started 27 WARNING: Improper placement of the reservoir may result in inac-curate delivery of insulin. Check to make sure the tubing connector

28 Chapter 2 Manual Prime1. Make sure that the infusion set is disconnected from your pump to your body.2. Hold ACT to Prime. The pump will prepare

Getting Started 29 4. After the second set of six beeps, the number of units used will count up on the screen and begin filling the tubing with insu-

30 Chapter 2 Priming with fixed primeFixed priming provides a pre-determined volume for priming the infusion set soft cannula after the introducer nee

Getting Started 31 Manual Prime will ONLY appear in the Prime menu after you have performed “Rewind” when changing your reservoir. The Manual Prime fe

32 Chapter 2 If you need to stop a Fixed Prime, select Suspend, and then Resume. Reviewing the prime historyReview the prime history to see the primes

Getting Started 33 3. Use the and buttons to review the primes. The “F” at the end of the line indicates a fixed prime. An “M” indicates a manual

34 Chapter 2

35 Chapter 3• • • • • • Status Checking pump statusThe different operations of the Paradigm pump can be easily reviewed by accessing the STATUS sc

36 Chapter 3 The following list is information that appears on the STATUS screen. All this information will not appear all the time or at the same tim

37 Chapter 4• • • • • • Bolus MenuDuring a bolus delivery most pump features are disabled until after the bolus has been delivered. Suspend and th

i • • • • • • Table of ContentsChapter 1Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . 1For your records . . . . . . . . .

38 Chapter 4 * The SET BOLUS screen is the default Bolus screen. If Dual/Square is ON the BOLUS TYPE MENU screen will appear.MiniMedBOLUS MENUBolus H

Bolus Menu 39 Delivering a normal bolus1. From the HOME screen, press ACT. Bolus will be selected. Press ACT. 2. The Set Bolus option will be select

40 Chapter 4 4. The bolus will be delivered now. A beep or vibration will occur at the start and end of the bolus. As the bolus is delivered, the amo

Bolus Menu 41 3. Select ON. Press ACT. 4. Repeat these steps to turn OFF this feature if desired.Square wave bolusThe square wave bolus can be used f

42 Chapter 4 Delivering a square wave bolusA square wave bolus delivers a bolus evenly over a period of time, from 30 minutes to 8 hours.During a Squa

Bolus Menu 43 4. The SET SQUARE BOLUS screen will appear. The bolus amount will flash. Use the and buttons to set the bolus. Press ACT.5. The du

44 Chapter 4 Normal bolus during a square wave bolusUse this feature if you need additional insulin. You can program a normal bolus during the deliver

Bolus Menu 45 4. The bolus amount will flash. Use the and buttons to set the bolus. Press ACT. 5. The BOLUS DELIVERY screen will appear and will

46 Chapter 4 Dual wave bolusA dual wave bolus is a combination of a normal bolus and a square wave bolus. Programming a dual wave bolus will deliver a

Bolus Menu 47 3. Select Dual Wave Bolus. Press ACT.4. The SET DUAL BOLUS screen will appear. The bolus amount will flash. Use the and buttons to s

ii Blood glucose targets . . . . . . . . . . . . . . . . . . . . . . . . 16Chapter 2Getting Started . . . . . . . . . . . . . . . . . . . . . . .

48 Chapter 4 6. The duration icon will flash. Use the button to set the length of the delivery, in 30 minute increments. Press ACT.7. The BOLUS DEL

Bolus Menu 49 Delivering an express bolusThe EXPRESS BOLUS button is a short-cut to the Bolus Type menu.When square/dual wave bolus option is off1.

50 Chapter 4 When square/dual wave bolus option is on1. From the HOME screen, press the button. 2. The Bolus Type menu will appear.3. Select the

Bolus Menu 51 2. Select Max Bolus. Press ACT.3. The current maximum bolus will flash. Use the and buttons to set the maximum amount and press ACT.

52 Chapter 4 Easy bolusWhen using vibrate mode, Easy Bolus is limited to 20 steps or maximum bolus, whichever comes first. An Easy Bolus is an optiona

Bolus Menu 53 programmed. Each beep is a different tone. This makes it easy for you to count the beeps, which equal the number of steps you have progr

54 Chapter 4 4. On/Set will be selected. Press ACT. If you do not wish to set the Easy Bolus Option, use the button and select OFF. Press ACT. If y

Bolus Menu 55 Delivering an easy bolusThe feature is used to easily deliver a Normal Bolus. To deliver other types of boluses, use the Main menu or th

56 Chapter 4 Pressing the or ESC button will cancel the programming. 3. Press ACT when the desired bolus amount is reached. The pump will beep or v

Bolus Menu 57 1. From the HOME screen, press ACT. Bolus will be selected. Press ACT. 2. Select Bolus History. Press ACT.3. The BOLUS HISTORY screen

iii Easy bolus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52Setting up easy bolus . . . . . . . . . . . . . . . . . . .

58 Chapter 4

59 Chapter 5• • • • • • Basal Basal rate is the amount of insulin that the body needs to main-tain target glucose values without food.The basal ra

60 Chapter 5 Basal menuThe menu choices that appear on the BASAL MENU screens will change if a temporary basal rate has been set or if the Patterns Op

Basal 61 What are start and stop times?Start and stop times are the times that one basal rate stops and the next basal rate starts. It is recommended

62 Chapter 5 Delivering a basalIt is recommended that you set basal rates with the assistance of your healthcare professional.1. From the HOME screen

Basal 63 4. The screen will change to Basal Rate 2. The start time for rate 2 will flash. If you require only one basal rate, press ACT again.5. The

64 Chapter 5 Maximum basal rate (max basal) A maximum basal rate is a safety limit for the amount of basal insulin that is able to be delivered per ho

Basal 65 2. Select Max Basal Rate. Press ACT.3. The maximum basal rate will flash. Use the and buttons to change the rate. Rate range is 0.0 to 3

66 Chapter 5 How does it work? While it is active, a temporary basal rate overrides all other basal rate programming. When the temporary basal deliver

Basal 67 4. The temporary basal rate will flash. Use the and but-tons to set the desired basal rate. Press ACT.Verifying temporary basal delivery

iv Chapter 7Utilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . .

68 Chapter 5 Canceling a temporary basal rateCancels a temporary basal rate and returns to the programmed basal rate delivery.1. From the HOME screen

Basal 69 Personal basal patternsThe personal basal patterns feature is optional for pump users. You may want to explore this option after you become f

70 Chapter 5 Turning on personal basal patternsYour pump is programmed at the factory with this feature turned OFF. Discuss what uses and settings are

Basal 71 Delivering personal basal patternsPersonal Basal Patterns allow you to set different basal delivery patterns. 1. From the HOME screen, pres

72 Chapter 5 4. The SET BASAL RATE screen will appear. Set the Basal Rates desired, then press ACT. 5. The BASAL RATE screen will appear. The screen

Basal 73 Selecting a patternThis feature allows delivery of a personal basal pattern. Only pat-terns that have been programmed can be selected.1. Fro

74 Chapter 5 Basal reviewBasal Review provides a review of daily basal insulin deliveries. You should review your basal rates to make sure they match

Basal 75 4. If you do have Patterns set, you will see the screen below. The current setting will be highlighted. Use the and but-tons to select t

76 Chapter 5

77 Chapter 6• • • • • • SuspendThe Suspend function stops all insulin deliveries (Basal, Bolus, and Fixed Prime) that you have programmed into you

v Chapter 9Troubleshooting & Care . . . . . . . . . . . . . . . . . 113Troubleshooting . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

78 Chapter 6 Suspending the pumpThe pump will beep/vibrate in fifteen minute intervals starting at the closest quarter hour mark while in the Suspend

Suspend 79 4. After 30 seconds, your pump will return to the HOME screen which now will show solid circles, indicating your pump is in the Attention

80 Chapter 6

81 Chapter 7• • • • • • UtilitiesThe Paradigm pump can be programmed from the Utilities Menu to perform different functions for your safety and co

82 Chapter 7 You can review your past alarms in the alarm history screen. Alarms result in closed circles on the screen. Pressing any button will re

Utilities 83 2. The Alarm option will be selected. Press ACT.3. History will be selected. Press the button to select Alert Type. Press ACT.4. Sel

84 Chapter 7 Using Auto-offProvides a safety mechanism that stops insulin delivery after a defined period of time (1 to 24 hours) if no button presses

Utilities 85 insulin, and an alarm will sound after 12 hours if no buttons are pressed. Press ACT.You can set Auto Off from 0 (off) to 24 hours.Stop a

86 Chapter 7 2. The Alarm option will be selected. Press ACT.3. The History option will be selected. Press ACT.4. Use the and buttons to review

Utilities 87 Reviewing the daily totalsAllows you to review the total amount of insulin that you have received in each of the past 14 days. The daily