Paradigm Real Time x22K for Pediatrics User Guide

© 2007, Medtronic MiniMed. 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; 6,997,920 and 7,025,743. Other U.S. and/or foreign patents may be pending. Bolus Wizard®, Dual Wave®, Paradigm®, Quick-serter®, Quick-set®, Silhouette®, Sof-set®, and Square Wave® are registered trademarks of Medtronic MiniMed. Easy Bolus™ is a trademark of Medtronic MiniMed. Energizer® is a registered trademark of Eveready Battery Company. Glucagon Emergency Kit® is a registered trademark of Eli Lilly and Company.

6025265-011 031207

REF MMT-522K MMT-722K

Important Safety Information Regarding Your Paradigm Insulin Infusion Pump (includes all models) Avoid Immersing Your Pump In Water Although it is unlikely that water damage will occur if your pump is splashed or briefly dunked, you should avoid immersing your Paradigm infusion pump in water. To swim or participate in other water activities, always disconnect from your Paradigm pump and reconnect after water play. If you inadvertently submerge your pump in water, dry the pump quickly using a soft, clean towel and verify that it is working properly by selecting “self test” from the pump’s UTILITIES MENU. If you believe that water has entered your pump or you observe any other possible pump malfunction, please check your blood glucose, treat high blood glucose (if necessary) with an injection and contact our 24 Hour HelpLine at 1-800-MINIMED (1-800-646-4633) for further assistance. Symptoms of high blood glucose include fatigue, excessive thirst and nausea. You should always contact your healthcare professional if you experience excessively high or low blood glucose levels, or if you have any questions about your care.

Electrostatic Discharge Although your Paradigm pump is designed to be unaffected by typical levels of electrostatic discharge (ESD), very high levels of ESD can result in a reset of the pump’s software with an associated pump error alarm. In most cases, exposure to high levels of ESD will trigger the pump’s A-13 alarm although, under certain circumstances, high level ESD exposure can cause A-44, Bolus Stopped or Max Delivery alarms. High levels of ESD are more likely in situations where the relative humidity is very low, such as inside a heated building during the winter in areas where it is cold outside. If your pump experiences an A-13 or other error alarm, press the “ESC” and “ACT” buttons to clear the alarm. If you are unable to clear the alarm by pressing “ESC” and “ACT,” you may need to remove and replace the pump’s battery to clear the alarm. After clearing the alarm, you should always verify that your pump is set to the correct date and time and that all other settings (basal rate, max basal and bolus limits, etc.) are programmed to the desired values, since the software reset could erase your previously programmed settings. Please see the Alarms and Alerts section of this User Guide for more details regarding what to do if your pump displays an error alarm or other alert message. Please contact our 24-Hour Line at 1-800-MINIMED (1-800-646-4633) to report any error alarms or other problems that occur with your pump.

Contents Your personal information ... xi Basal rate ... xi Carb ratios (meal bolus information) ... xii

Chapter 1 Introduction ...1 Availability ... 1 Assistance ... 1 Emergency kit ... 2 Disposables ... 3 Accessories ... 3 How to wear your pump ... 4 How to use this guide ... 5 User safety ... 6 Indications ... 6 Contraindications ... 6 Warnings ... 7 Reservoir and infusion sets ... 7 X-rays, MRIs and CT scans ... 7 Adverse reactions ... 7 Precautions ... 7 Avoid extreme temperatures ... 8 Infusion sets and sites ... 8 Notice ... 8 Insulin pump and RF accessories ... 8

Chapter 2 The basics ... 11 Your pump ... 11 Install battery ... 12 Pump buttons ... 14 The pump screen ... 15 HOME screen ... 15 Screen icons ...15 Contents

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Battery ...15 Time display ...16 Reservoir volume ...16 Alert and alarm icons ...16 Sensor icons ...16 Scroll bar ...17 Screen backlight ...17 Beep/vibrate ... 17 Operating modes ... 18 Menus ... 19 STATUS screen ... 21 If you remove your pump ... 22 Pump settings ...22 Insulin ...22

Chapter 3 Basic programming ... 23 Setting the time and date ... 23 Bolus ... 24 Normal bolus ...24 From the menu ...24 Using the EXPRESS BOLUS button ...24 Review your bolus deliveries ... 29 Bolus details ...30 Maximum bolus limit ... 31 BG reminder ...32 Basal ... 33 Start and stop times ...33 Your basal settings ...34 Basal programming and delivery ...34 Basal review ...36 Current basal delivery ...36 Daily basal rate(s) ...36 Max basal rate ... 38 Stopping your pump ... 39 Resume pump delivery ... 41

Chapter 4 Starting on insulin ... 43 Prepare your pump for use ... 43 ii

Contents

Filling the reservoir ... 44 Changing your infusion set ... 46 Removing the reservoir ...46 Rewinding your pump ...47 Inserting the reservoir in your pump ...48 Manual prime ...49 Insert the infusion set ...50 Quick-set infusion set (with Quick-serter®) ...51 Disconnecting Quick-set ...52 Reconnecting Quick-set ...53 Fixed prime ...54 Prime history ... 54 Record keeping for diabetes management ... 55 Determining your pump settings ... 55 Using your daily journal ... 56

Chapter 5 Using the Bolus Wizard feature ... 57 What is it? ... 57 Information you need ... 57 Food entry ...57 Your blood glucose reading ...57 Your personal Bolus Wizard feature settings ...57 How the Bolus Wizard feature works ... 60 More about the Bolus Wizard feature ...61 About high or low BG levels ...61 About maximum delivery ...61 About active insulin ...62 How to program the Bolus Wizard feature ... 63 Bolus Wizard feature On/Off ...63 Carb units ...64 Carb/Exch ratios ...64 BG units ...66 Insulin sensitivity ...66 BG targets ...67 Active insulin time ...69 Review your Bolus Wizard feature settings ... 70 Meter option ... 70 Contents

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Meter rules ...71 Add, delete, review meter IDs ...71 Normal bolus using Bolus Wizard feature ... 73 Bolus Wizard feature examples ... 75

Chapter 6 Optimizing pump therapy ... 79 Square Wave and Dual Wave bolus ... 79 Dual Wave/Square Wave bolus On/Off ...80 Square Wave or Dual Wave bolus without Bolus Wizard feature ...80 Using the Bolus Wizard feature for a Square Wave or Dual Wave bolus ...84 Easy bolus ... 86 Easy bolus setup ...86 Step value setup ...87 Deliver Easy Bolus ...87 Basal patterns ... 90 Patterns on/off ...90 Program a pattern ...91 Select a pattern ...92 Temp basal rates ... 94 How does temp basal work? ...94 Temp basal types ...95 Insulin rate ...95 Percent of basal ...96 Selecting temp basal type ...98 Deliver a temp basal ...98 Verifying temp basal delivery ...99 Canceling a temp basal ... 100

Chapter 7 Insulin pump therapy follow-up ... 103 Recommended follow-up ...103 Everyday ... 103 Every month ... 103 Every 3 months ... 103 Laboratory tests ... 104 Every visit ... 104 Annually ... 104

iv

Contents

Chapter 8 Utilities ... 105 Alarm review ...105 Alarm details ... 105 Setting your alert type ...105 Auto-off ...106 Low resv alert (Low reservoir warning) ...106 Review daily insulin totals ...108 Pump data management ... 109 Days to average ... 111 Personal reminders ...113 Alarm clock ... 113 Remote control option ...113 Turn on remote control option ... 114 Add, delete, review remote control IDs ... 114 Block feature ...115 Turn Block on ... 115 Lock keypad feature ...117 To lock keypad ... 117 To unlock keypad ... 117 Selftest ...118 User settings ...119 Save settings ... 119 Restore settings ... 120 Clear settings ... 121 History ... 122 Language setting ...122

Chapter 9 Troubleshooting ... 123 My pump has a no delivery alarm... ... 123 What happens if I leave the battery out too long? ... 124 Why doesn’t my pump battery last very long? ... 124 What is a CHECK SETTINGS alarm? ... 125 My screen appears distorted ... 125 I cannot get out of the priming loop ... 125 The pump is asking me to rewind ... 126 My bolus stopped ... 126 My pump buttons are not acting right during a bolus ... 126 Contents

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My pump won’t display my BG reading from my meter ... 126 I dropped my pump ... 127 I submerged my pump in water ... 127 I cannot get to the User Settings menu ... 127 Alert conditions ...128 What to do ... 128 Low reservoir alert ... 128 Low Battery alert ... 129 Alarms ...129 What to do ... 130 Alarm conditions ...131 A (Alarm) ... 131 Auto off ... 131 Batt out limit ... 131 Bolus stopped ... 131 Button error ... 131 Check settings ... 132 E (Error) ... 132 Empty reservoir ... 132 Failed batt test ... 132 Is priming complete? ... 132 Max delivery ... 133 Motor error ... 133 No delivery ... 133 No reservoir ... 133 Off no power ... 133 Reset ... 134 Weak Battery ... 134

Chapter 10 Pump maintenance ... 135 Battery ...135 Storage ...135 Cleaning your pump ...136

Chapter 11 Pump specifications ... 137 Alarms and error messages ...137 Alarm history ...137 Backlight ...137 vi

Contents

Basal ...137 BG target ...137 Bolus delivery ...137 Bolus history ...137 Bolus Wizard feature ...138 Carb ratios ...138 Carb units ...138 Daily totals ...138 Default screen ...138 Pump motor ...138 Dual Wave bolus ...138 Easy bolus ...139 Infusion pressure ...139 Insulin sensitivity ...139 Low resv (reservoir) warning ...139 Meter value ...139 Normal bolus ...139 Occlusion detection ...140 Percent temp basal ...140 Power supply ...140 Prime function ...140 Prime history ...140 Program safety checks ...140 Pump size ...141 Pump weight ...141 Remote control ...141 Reservoir ...141 Square Wave bolus ...141 Temporary (temp) basal rate ...141 Time and date screen ...141 Status screen ...142 Bolus Wizard feature specifications ...143 Bolus Wizard feature examples ... 145 Default settings ...147 Guidance and manufacturer’s declaration ...149 Icon table ...154

Glossary ... 155 Contents

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Index

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Contents

... 161

Practice lessons and examples Bolus examples Meal bolus Normal meal bolus using the exchange system ...25 Bolus practice ...26 Normal meal bolus practice using exchanges ...26 Normal meal bolus using carbohydrate counting ...26

Correction bolus Meal bolus, correction bolus and insulin sensitivity ...27 Practice: Meal bolus ...28

Max bolus Example 1: Max bolus ...31 Example 2: Max bolus ...31

Basal examples Basal programming Practice: Basal programming ...35

Max basal Example 1: Max Basal ...38 Example 2: Max Basal ...38

Suspend/Resume examples Example: Suspend function ...40 Practice: Suspend function ...40 Practice: Resume basal delivery after a suspend ...41

Bolus Wizard feature examples ix

Example 1: BG on target (normal BG) and no active insulin ...75 Example 2: BG above target (high BG) and no active insulin ...76 Example 3: Blood glucose below target (low BG) and no active insulin ...76 Example 4: Blood glucose above target (high BG) with active insulin ...77 Example 5: Blood glucose below target (low BG) with active insulin ...78

Square Wave bolus examples Your turn: Square Wave bolus practice ...82 Your turn: Dual Wave bolus practice ...83

Easy bolus examples Example #1: Easy bolus ...89 Your turn: Easy bolus practice ...89

Basal patterns examples Example 1: Basal patterns ...93 Example 2: Basal patterns ...93 Your turn ...93

Temp Basal examples Example 1: Temp Basal for a decreased temporary basal rate ... 100 Example 2: Temp Basal for an increased temporary basal rate ... 101 Your turn ... 101

Block examples Example 1: Block ... 116 Example 2: Block ... 116

x

Your personal information You may need the following information from your healthcare professional before going to your pump start appointment. If you are unsure, contact your healthcare professional or pump trainer for instructions.

NOTE - This information is not for the Bolus Wizard® feature. Refer to chapter 5 for Bolus Wizard feature settings.

Basal rate Basal insulin is required to maintain your target glucose values when you are not eating. Your pump can be programmed with up to three (3) basal patterns (standard, pattern A, pattern B) to accommodate your varying insulin needs on different days (example: weekday versus weekend day). Each pattern can have up to 48 basal rates. When you first start pump therapy, your healthcare professional may only have you program one or two basal rates. Get your basal rate settings from your healthcare professional.

Standard Basal rate number

Start time

Basal rate (units per hour)

#1 midnight #2 #3 Additional basal rates #4 #5 #6 #7 #8

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Pattern B

Pattern A Basal rate Start time number #1 midnight #2 #3 (additional basal rates) #4 #5 #6 #7 #8

Basal rate (units per hour)

Carb ratios (meal bolus information) Your carb ratios are used to calculate your meal boluses. If you count grams: this ratio is the number of carb grams covered by one (1) unit of insulin. If you count exchanges: this ratio is the number of insulin units you need to cover one carb exchange.

xii

Basal rate Start time number #1 midnight #2 #3 (additional basal rates) #4 #5 #6 #7 #8

When breakfast lunch dinner snacks

Start time

Basal rate (units per hour)

(grams/u or u/exch)

Chapter 1

Introduction Thank you for choosing Medtronic MiniMed as your partner in helping you gain better control of your diabetes. Whether you are beginning pump therapy for the first time or upgrading from a previous model, we believe that the combination of state-of-the-art technology and the simple, menu-driven programming of the pump will provide many benefits. This user guide is designed to help you to understand pump therapy and the operation of your pump. We strongly recommend that you work closely with your healthcare professional for a safe and complete pump start. Your pump is indicated for the continuous delivery of insulin, at set and variable rates, for the management of diabetes mellitus for persons requiring insulin. Based on your settings, the pump delivers your custom basal automatically and continuously 24-hours a day. It also provides bolus deliveries to support your immediate insulin needs for food intake and/or high blood glucose. The Bolus Wizard feature can calculate your bolus amount for you based on your personal settings.

Availability The pump and accompanying products are available from Medtronic MiniMed and authorized distributors.

Assistance Medtronic MiniMed provides a 24 Hour HelpLine for assistance. The HelpLine is staffed with technicians who are trained in the set-up and operation of the pump and are able to answer pump-related questions. When calling the HelpLine or your local Medtronic MiniMed office, please have your pump and serial number available. The phone number for the 24 Hour HelpLine is also on the back of your pump.

Department

Telephone number

24 Hour HelpLine (calls within the United States)

800.646.4633 (800.M i n i M e d )

24 Hour HelpLine (calls outside the United States)

818.576.5555

Web site

www.minimed.com

Introduction

1

Emergency kit Keep an emergency kit with you at all times to make sure that you always have necessary supplies. Inform a family member, co-worker, and/or friend where this emergency kit is kept. Please refer to the “User safety” section in this chapter for more information on pump safety. Your emergency kit should include these items: ➠ Fast-acting glucose tablets

➠ Paradigm® Wallet Card

➠ Blood glucose monitoring supplies

➠ Dressing and adhesive

➠ Urine ketone monitoring supplies

➠ Glucagon Emergency Kit®

➠ Extra Paradigm infusion set and Paradigm

➠ Extra AAA alkaline batteries (Energizer® brand

reservoir

is recommended)

➠ Insulin syringe and fast-acting insulin (with

dosage instructions from your healthcare professional)

CAUTION:

2

Chapter 1

If you give yourself insulin by using a syringe, the Bolus Wizard feature will not be able to correctly determine the active insulin in your system.You must generally wait at least 8 hours after an injection before relying on your Bolus Wizard feature to calculate your active insulin. But, the length of time you need to wait depends on your active insulin setting in the Bolus Wizard feature. See “About active insulin” on page 62 for more information.

Disposables The pumps use disposable reservoirs and infusion sets for insulin delivery. Installation instructions for Paradigm reservoir and infusion sets are provided in chapter 4, “Starting on insulin.” ➠

Reservoirs: The 522K pump is intended for use with a 176-unit Paradigm reservoir (MMT-326). The 722K pump is intended for use with a 300-unit Paradigm reservoir (MMT-332), however it can also use the MMT-326 as well.

➠

Infusion sets: Medtronic MiniMed provides a variety of Paradigm infusion sets to fit your needs. Contact your healthcare professional who will assist you to choose an infusion set that fits your needs.

WARNING:

For your protection the pump has undergone extensive testing to confirm appropriate operation when used with Paradigm reservoirs and Paradigm infusion sets manufactured or distributed by Medtronic MiniMed. We recommend using Medtronic MiniMed infusion sets and reservoirs as we cannot guarantee appropriate operation if the pump is used with reservoirs or infusion sets offered by third-parties and therefore we are not responsible for any injury or malfunctioning of the pump that may occur in association with such use.

Accessories ➠ ➠

➠

Meter: You can program your pump to automatically receive your BG reading from a linked meter which may have been included with your pump. Remote control: The optional Paradigm remote control can be used with the pump to deliver normal boluses and suspend/resume the pump from a distant location. (This User Guide provides programming instructions for the remote control. Refer to the remote control User Guide for operating instructions.) Transmitter: The transmitter (MMT-7703) is a small device that connects to the sensor. It comes with a blue tester and a charger. When connected to a sensor that is inserted in the body, the transmitter automatically initializes the sensor and begins to periodically transmit glucose data to the pump using a radio signal.

Introduction

3

➠ ➠

Sensor: The sensor continuously converts tiny amounts of glucose from your fatty layer under the skin into an electronic signal. ComLink: The Medtronic MiniMed ComLink is used to download the Paradigm 522K or 722K pump data to the diabetes management software using a serial communications interface cable installed on your computer. To order supplies, call 800-646-4633 (1-800-MiniMed) 818-362-5958 (outside U.S.) www.minimed.com

How to wear your pump There are different ways to wear your pump. Medtronic MiniMed has optional accessories that can hide, protect, and add to the convenience of wearing a pump. Refer to the accessories catalog or the website (www.minimed.com) for more information. ➠ ➠ ➠ ➠

4

Holster: to wear the pump on your belt. Pump clip: to wear the pump underneath your clothing. Activity guard: If you are active in sports, or you are a child, use the guard to protect the pump from disconnecting. Leather case: Fine leather lined with nylon. Styling complements business and formal wear. Velcro flap provides easy access to pump for programming. Wear it vertically with the built-in belt clip.

Chapter 1

How to use this guide NOTE - This user guide shows sample screens only. Your pump screens may be slightly different. For step-by-step instructions, refer to the appropriate sections in this guide. Refer to the Glossary for definitions of terms and functions. The terms and symbols used in this guide are in the table below. Term / symbol

Meaning

“Press”

to push and release the button

“Hold”

to push and keep pressure on the button

“Select”

to press

“Exit the menus”

press ESC until the HOME screen appears

Pump Buttons

always bold and uppercase; for example, ESC, ACT

/

to highlight a screen item you want to select

Screen and menu names always uppercase; for example, MAIN MENU, REWIND screen Menu selections

always bold; for example, 12-Hour Setup, On, Off

Flashing (blinking) screen item

you can change the value for that item with the

NOTE and TIP

additional helpful information

CAUTION

warns of a potential hazard which, if not avoided, may result in minor or moderate injury to the equipment

WARNING

notifies you of a potential hazard which, if not avoided, could result in death or serious injury. It may also describe potential serious adverse reactions and safety hazards

/

buttons

when a step instructs you to “Go to” a screen, the path to that screen is shown. For example: Go to the ALARM MENU. “Go to the...screen.”

Main > Utilities > Alarm

1. From the MAIN MENU, select Utilities and press ACT. 2. In the UTILITIES MENU, select Alarm and press ACT. 3. The ALARM MENU appears.

Introduction

5