MiniMed model 530 Users Guide July 2003

This device is protected under one or more of the following U.S. Patents: [US]4,562,751 [US]5,050,764 [US]5,376,070 [US]4,678,408 [US]5,080,653 [US]5,399,823 [US]4,685,903 [US]5,097,122 Other U.S. and/or foreign patents may be pending.

D9195742-013 7/03

Table of Contents Introduction to the model 508 insulin pump Let’s Get Started!

-------------------- 1

-----------------------------2

In Preparation for Your Pump Start - - - - - - - - - - - - - - - - 2

Becoming Familiar With Your Pump

----------------5

Buttons - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 6 Liquid Crystal Display (LCD) - - - - - - - - - - - - - - - - - - - - - 6 Turn Your Pump Over

-------------------------7

Main Programming Screens - - - - - - - - - - - - - - - - - - - - - - 8 Setup I - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 8 Setup II - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 9

508 Quick Start Guide - - - - - - - - - - - - - - - - - - - - - - 11 Verifying & Setting the Time and Date: - - - - - - - - - - - - 12 Setting Your Basal Rate - - - - - - - - - - - - - - - - - - - - - - - - 14 Reviewing Your Profiles - - - - - - - - - - - - - - - - - - - - - - - - 16 The Reservoir and Infusion Set - - - - - - - - - - - - - - - - - - 17 Changing the Reservoir and Infusion Set - - - - - - - - - - - 18 Reservoir Placement - - - - - - - - - - - - - - - - - - - - - - - - - 18 To Remove the Reservoir Converter

- - - - - - - - - - - - - - 20

To Reinstall the Reservoir Converter - - - - - - - - - - - - - - 21 Sof-set and Reservoir Change

- - - - - - - - - - - - - - - - - - 22

Reservoir Change Using Silhouette and Quick-set - - - - - 24 Installing the Reservoir and Infusion Set

- - - - - - - - - - 26

Removing the Reservoir and Infusion Set - - - - - - - - - - - 28

Priming the Pump - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 29 Bolus - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 31 Setting A Normal Bolus - - - - - - - - - - - - - - - - - - - - - - - 31

Stopping and Restarting Your Pump

- - - - - - - - - - - - - - 32

To Stop or Put Your Pump in ‘Suspend’ - - - - - - - - - - - - 32 To Restart Your Pump

- - - - - - - - - - - - - - - - - - - - - - - - 33

Prime History and Use - - - - - - - - - - - - - - - - - - - - - - - - - 34 Reservoir Volume and Low Volume Alert - - - - - - - - - - - 35 Initial Pump Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - 37

Basal Rates: why and how - - - - - - - - - - - - - - - - - 41 Q & A - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 41 Setting the Maximum Basal Rate - - - - - - - - - - - - - - - - - - 44 Setting Your Basal Rate - - - - - - - - - - - - - - - - - - - - - - - - 45 Personal Delivery Patterns - - - - - - - - - - - - - - - - - - - - - - 47 To Turn Personal Delivery Patterns ON - - - - - - - - - - - - - 47 To Set Personal Delivery Patterns - - - - - - - - - - - - - - - - 47

Setting a Temporary Basal Rate - - - - - - - - - - - - - - - - - - 49 Verifying Delivery - - - - - - - - - - - - - - - - - - - - - - - - - - - 50

Stopping or Resetting a Temporary Basal Rate - - - - - - 51 Verifying the Change - - - - - - - - - - - - - - - - - - - - - - - - - 52

Insulin Boluses: why and how

- - - - - - - - - - - - - 53

Q & A - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 53 Setting the Maximum Bolus Limit - - - - - - - - - - - - - - - - - 55 Reviewing Bolus History - - - - - - - - - - - - - - - - - - - - - - - - 56 Variable Bolus - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 57 Setting A Normal Bolus - - - - - - - - - - - - - - - - - - - - - - - - 58 Square Wave Bolus Option - - - - - - - - - - - - - - - - - - - - - - 59 Dual Wave Bolus Option - - - - - - - - - - - - - - - - - - - - - - - - 60 Audio Bolus - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 62

To Turn Audio Bolus Feature On - - - - - - - - - - - - - - - - - 62 To Set an Audio Bolus - - - - - - - - - - - - - - - - - - - - - - - - 63

Daily Totals and History - - - - - - - - - - - - - - - - - - - - - - - - 64

Clocks and Alarms

- - - - - - - - - - - - - - - - - - - - - - - - - 65

Changing the Time Display - - - - - - - - - - - - - - - - - - - - - - 65 Setting the Beep Volume - - - - - - - - - - - - - - - - - - - - - - - 66 Reviewing Your Alarms - - - - - - - - - - - - - - - - - - - - - - - - - 67 Setting the Automatic Off - - - - - - - - - - - - - - - - - - - - - - 68 Alarm Type - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 69

Other Useful Features

- - - - - - - - - - - - - - - - - - - - - - 71

Using The Remote Control - - - - - - - - - - - - - - - - - - - - - - 71 Using the Remote Control to Deliver a Bolus - - - - - - - - 74 Using the Remote Control to Suspend/Restart the Pump - - - - - - - - - - - - - - - - - - - 75

Child Block Activation - - - - - - - - - - - - - - - - - - - - - - - - - 76 Setting Your Insulin Concentration - - - - - - - - - - - - - - - - 77

Pump Function Evaluation Options

- - - - - - - 79

Self Test - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 79 Lead Screw Rotation Test - - - - - - - - - - - - - - - - - - - - - - - 81

Pump Care and Maintenance Batteries

- - - - - - - - - - - - - - 83

- - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 83

Low Battery & Vibration

- - - - - - - - - - - - - - - - - - - - - 83

To Remove the Battery Carrier - - - - - - - - - - - - - - - - - - 84 To Install New Batteries - - - - - - - - - - - - - - - - - - - - - - - 85

Installation of the Spring Belt Clip - - - - - - - - - - - - - - - - 86 Pump Care - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 87 If Your Pump is Dropped - - - - - - - - - - - - - - - - - - - - - - 87 If Your Pump Becomes Submerged in Water - - - - - - - - - 88 Exposure to Extreme Temperatures - - - - - - - - - - - - - - - 89 Cleaning Your Pump

- - - - - - - - - - - - - - - - - - - - - - - - - 90

X-Rays, MRI’S and CT Scans

- - - - - - - - - - - - - - - - - - - - 90

Remote Control Care and Maintenance - - - - - - - - - - - - 91 Installation of the Battery

- - - - - - - - - - - - - - - - - - - - - 91

If Your Remote Control is Dropped - - - - - - - - - - - - - - - 91 If Your Remote Control Becomes Submerged in Water - - - - - - - - - - - - - - - - - - 92 Exposure to Extreme Temperatures - - - - - - - - - - - - - - - 92 Cleaning Your Remote Control

- - - - - - - - - - - - - - - - - - 92

FCC Notice for the Remote Control - - - - - - - - - - - - - - - 93

Pump User Safety Information

- - - - - - - - - - - - - 95

Caution - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 95 Indications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 95 Contraindications - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 95 Warnings - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 96 Precautions - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 97 General - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 97 Infusion Sets and Sites Hypoglycemia

- - - - - - - - - - - - - - - - - - - - - - - 99

- - - - - - - - - - - - - - - - - - - - - - - - - - - - 100

Hyperglycemia and Diabetic Ketoacidosis (DKA) - - - - 101

Adverse Reactions - - - - - - - - - - - - - - - - - - - - - - - - - - - 102 Hyperglycemia and Diabetic Ketoacidosis (DKA) - - - - 102 Hypoglycemia

- - - - - - - - - - - - - - - - - - - - - - - - - - - - 103

Site Infection/Abscesses

- - - - - - - - - - - - - - - - - - - - - 103

Troubleshooting: Alarms and Screen Messages - - - - - - - - - - - - - - 105 Error Messages - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 105 Error Restart Procedure - - - - - - - - - - - - - - - - - - - - - - 105

Alarm Messages - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 106 Alarm Restart Procedure - - - - - - - - - - - - - - - - - - - - - 106

Troubleshooting & Diabetes Management Issues - - - - - - - - - - - - - - - - - - - - - - - - 109 Blood Glucose Monitoring - - - - - - - - - - - - - - - - - - - - - 109 Low Blood Glucose - Hypoglycemia - - - - - - - - - - - - - 111 Problems & Solutions - - - - - - - - - - - - - - - - - - - - - - - 111 Prevention and Treatment Tips - - - - - - - - - - - - - - - - - 112

Hyperglycemia and Diabetic Ketoacidosis – DKA High Blood Glucose Problems & Solutions

- - - 113

- - - - - - - - 113

Sick Day Management - - - - - - - - - - - - - - - - - - - - - - - - 116 Infusion Sets and Infusion Sites - - - - - - - - - - - - - - - - - 118 Skin Site Selection

- - - - - - - - - - - - - - - - - - - - - - - - - 118

Problems & Solutions - - - - - - - - - - - - - - - - - - - - - - - 119

Daily Living, Lifestyle Activities - - - - - - - - - - - - - - - - - - 120 Temporary Removal Guidelines - - - - - - - - - - - - - - - - - 121 Physical Activity - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 122

Pump Overview - - - - - - - - - - - - - - - - - - - - - - - - - - - - 125 Pump Specifications - - - - - - - - - - - - - - - - - - - - - - - - - - 125 Memory - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 127 Safety Features - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 128 Factory Settings - - - - - - - - - - - - - - - - - - - - - - - - - - - - 130 Icon Table - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 131

Glossary - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 133 Index - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - 139 Check Point Answers - - - - - - - - - - - - - - - - - - - - - - - 145

Welcome

1

Introduction to the model 508 insulin pump Whether you are beginning pump therapy for the first time, or upgrading from a previous model, we are pleased that you have chosen Medtronic MiniMed as your partner to help you gain better control of your diabetes. We believe that the combination of state-of-theart technology with simple, menu-driven programming will provide many benefits. There are three main sections to this user’s guide: • A ‘Quick Start’ guide is available beginning on page 11. It has been designed to get you up and pumping! • Following the ‘Quick Start’ guide, you will find more detailed information on specific programming features and more advanced options. • A detailed troubleshooting guide and glossary are also included. NEED TO KNOW facts, and Checkpoints Throughout, you will find included in the margins and at the end of many sections. These are cues for you to check your understanding. answers can be found in the Checkpoint answers section.

This user’s guide is designed to help you learn to use your pump, however, working with your health care professional will speed your familiarity with the pump and pump therapy.

2

Welcome

Let’s Get Started! IN PREPARATION FOR YOUR PUMP START The Medtronic MiniMed 508 has been designed to be very simple to learn and most pump wearers find the time spent learning how to operate their pump enjoyable! However, valuable time will be lost to both you and your health care team if you have not become familiar with your pump prior to your pump start. Pump Start "Homework" Along with your pump, remote control (where applicable) and supplies, you have received: • This user’s guide with ‘Quick Start’ guide • Programming and Alarm Cards With your pump in hand, watch the video and review the user’s guide and ‘Quick Start’ guide. After doing this you should come to the pump start comfortable with the following basic functions: • Using the SEL button to move through the pump screens • Using the ACT button to choose a pump feature • Changing the Time and Date on the pump • Delivering a Bolus • Stopping the pump by placing the pump in Suspend and then restarting the pump • Setting three (3) Basal Rates and changing them • Setting a Temporary Basal Rate and then canceling it • Filling a Medtronic MiniMed reservoir syringe, attaching an infusion set to the syringe and priming the tubing (use tap water or a bottle of saline - no need to waste insulin!) • Inserting the syringe into your pump and delivering a Prime to take up "slack" in the system

Welcome

3

Please bring the following items with you to your pump start: • One (1) Medtronic MiniMed pump, remote control and all the supplies that came in your pump box • Two or three (2-3) extra Medtronic MiniMed reservoir syringes and infusion sets (Sof-set®, Silhouette™, etc.) • Three or Four (3-4) tape patches (IV3000*, Polyskin, etc.) • Insulin • Any questions that you have from your "homework" Coming prepared will help make your pump start a comfortable learning experience. Do not hesitate to call your Medtronic MiniMed representative or your health care professional if you have any questions during your preparation for your pump start.

NEED TO KNOW

ALWAYS TREAT YOUR DIABETES FIRST!!! As you start pump therapy REMEMBER: Your pump uses only fast acting, Regular insulin. This means you do not have longer-acting insulin in your body. Without insulin your blood glucose will rise and you could experience diabetic ketoacidosis (DKA), which could result in hospitalization. If your insulin delivery is interrupted for any reason, you must be prepared to replace the missed insulin injection immediately. The quickest way to do so is to TAKE AN INJECTION OF REGULAR INSULIN.

* IV3000 is a trademark of Smith & Nephew

4

Welcome

Keep an emergency kit with you at all times. This kit should include: •Fast-acting glucose tablets • Blood glucose monitoring supplies, urine ketone monitoring supplies • Regular insulin & insulin syringe with directions from your health care professional regarding how much insulin to take • An extra infusion set and Medtronic MiniMed reservoir • Dressing and adhesive • Extra batteries (MMT-104) • 508 programming and alarm cards Let another family member or friend know where this is kept.

Please refer to the Pump User Safety Information section on page 95 for more information on pump therapy including troubleshooting and diabetes management issues.

Welcome

5

Becoming Familiar With Your Pump Take a look at your pump.

The pump is small, lightweight and has a large, backlit liquid crystal display (LCD). The pump is also smart - storing approximately 90 days worth of data in memory. With the ComStation, you will be able to connect your pump to a computer to ‘download’ this stored information.

NEED TO KNOW ‘Press’ means to push and release the button being used. Blinking words or numbers, seen in an ‘outline fashion’, indicate information that can be changed.

BLINKING Information that cannot be changed is printed on the screen in whole, black characters.

NORMAL

6

Welcome

BUTTONS Four buttons let you program all of the pump’s features and options. 1.

The SEL (Select) button will scroll through the screens. You will have about seven seconds to view each screen. If you wish to view the screen for longer periods, continue to hold the SEL button after each press.

2.

The ACT (Activate) button will activate programming changes you wish to make. You will always hear a single beep after you have successfully activated a change.

3.

The UP and DOWN arrows will change the number to the value of your choice. UP scrolls the number higher and DOWN scrolls the number lower. • The UP arrow lets you set an audio bolus. • The DOWN arrow lets you turn the backlight on or off.

LIQUID CRYSTAL DISPLAY (LCD) The pump has a unique LCD which combines both text and icons to notify you of all operations, alerts and alarms. Take a moment to become familiar with all the parts of the LCD. The LCD also has a backlight to help you see the pump in low light conditions.

8 8:8 8

8.8.Z

AM PM A PROG TEMP BOLUS B BASAL SETUP S PROF: HIST:

Alarm Type

U H

TOTAL

...

RF Device

A B

Personal Delivery Patterns

S

Future Applications Low Battery Indicator Reservoir Volume

Welcome

7

TURN YOUR PUMP OVER • Look at the reservoir compartment window. This window lets you see how much insulin remains in the syringe. • Apply pressure to the top of the case and pull open the reservoir compartment door. • Find the mechanical driver arms and lead screw, reservoir converter and the Luer neck lever.

You will put insulin into a special syringe called a reservoir. The Luer neck lever holds the reservoir in position. The driver arms will be fit over the squared-off end of the reservoir plunger. The driver arms are connected to the driver block which moves insulin through the reservoir and tubing and into your body.

#1 1. Find: a.

What button must be pressed to activate a change? ______

The battery compartment located on the lower left side of the pump case. b. The toll-free Medtronic MiniMed Clinical Services Help Line number. ______________________

8

Welcome

MAIN PROGRAMMING SCREENS

03:02 PM AM

12:00 PM

AM

BOLUS

8 8:8 8 PM PROG

AM

BASAL PROF:

2. Bolus

8.0.0

1

U H

NOW

4. Basal Rate

..PRIME

HIST:

7. Prime & Low Reservoir Volume

++:++

++.+

TEMP BASAL

+.5.+

PROG

1 .N .LAST

HIST:

1. Time of Day

8.6.0

U

SUSPEND

3. Suspend

06.0

U H

TOTAL

T O D A Y.

... 5. Temporary Basal Rate

SETUP8I

U

6. Daily Totals

SETUP8II

8. Set Up I

9. Set Up II

++:Hr PM PROG

++:Hr PM PROG

SETUP I

83:06 PM

AM

8.8.Z

SET.TIME

1. Set Time and Date

++:Hr PM PROG

AM

8.0.0

AUT0--0FF 2. Automatic Off

8.2.0

SELFTEST 4. Self Test

AM

AM

2.

B EE P8VO L

3. Beep Volume

SETUP

SETUP8II 5. Set Up II

EXIT8888

6. Set Up I Exit

Welcome

9

SETUP II

12:00 PM

AM

BOLUS HIST:

0FF

U

12:00 PM BOLUS

VARIABLE

1. Variable Bolus

1.0.0

AM

HIST:

U

MAXIMUM8

2. Maximum Bolus

Off .ALARM9

HIST:

8 8:8 8 PM PROG

AM

BASAL PROF:

RF.DEV. 5. Radio Frequency Device

4. Alarm Review

O.FFn TYPE..

8. Alarm Type

12:Hr PM PROG

12:HU PM PROG

8.0.0

DISPLAY 10. Time Display

SETUP

EXIT8888

13. Set Up II Exit

BASAL PROF:

AM

3 2.0

U H

MAXIMUM8

3. Maximum Basal Rate

12:00 PM

O.FF

AM

BOLUS HIST:

U

AUDIO8M

6. Audio Bolus AM

7. Basal Patterns AM

AM

8 8:8 8 PM PROG

U H

PATTERNS

8 8:8 8 PM PROG

BASAL PROF:

O.FFn U H

BLOCK8

9. Child block

1.0.0

INSULIN

11. Insulin Concentration

SETUP8I 12. Set up I

Quick Start

11

508 Quick Start Guide The following guidelines are basic instructions to get you started using your pump. Please refer to the detailed instructions in this user’s guide regarding additional options including various bolus and basal rates.

12

Quick Start

Verifying & Setting the Time and Date Why: Sets the time and date for your specific area. Where: SET UP I on the SET TIME screen. How: 1.

From the TIME OF DAY screen, press SEL to SET UP I then press ACT. You will see the SET AM TIME screen. Press ACT, “PROG 83:06 PM HOURS” will appear.

8.8.Z

2.

3.

4.

5.

6.

SET.TIME

Use the arrows to select the hour, then press ACT. The screen will say “PROG MINUTES”.

83 3:06 PM

Use the arrows to select the minutes and press ACT. The screen will say “PROG YEAR”.

84:0 06 PROG

Use the arrows to select the year and press ACT. The screen will say “PROG MONTH”. Use the arrows to select the month and press ACT. The screen will say “PROG DAY”. Use the arrows to select the day and press ACT.

AM

PROG

8.8.Z HOURS

AM PM

8.8.Z

MINUTES PM 84:07 PROG

AM

0.9 9 YEAR

PM 84:07 PROG

AM

0.1 2 MONTH

84:07 PROG

AM PM

0.0 4 DAY

Quick Start

7.

The time and date that you just set will be displayed.

84:07 PM

AM

8.8.Z

04DEC99

NEED TO KNOW The 508 does not have an On/Off button. As soon as you install batteries, the pump will be On and the current time will be shown on the window display.

WHY IS THE TIME AND DATE NECESSARY? ✗

The time shown on your clock is used to time the insulin delivery of your basal rate(s) and to monitor other pump operations.

✗

The date is used to sort the long term data stored in the pump’s memory.

✗

This stored information can be downloaded to a computer for you or your health care professional to use in assisting you in your glucose control goals.

13

14

Quick Start

Setting Your Basal Rate Why: Provides a continuous amount of insulin 24 hours a day. Where: Main Menu on the BASAL RATE screen. How: 1.

2.

From the TIME OF DAY screen, press SEL until you see the BASAL RATE screen, then press ACT. The first basal rate always starts at midnight - this time cannot be changed. Use the arrows to select your basal rate. Press ACT.

8 8:8 8 PM

AM

PROG

BASAL PROF:

4.

To add another basal rate, use the arrows to select your start time. The start time for the second basal rate is the end time for the first basal rate. Press ACT. Use the arrows to select a basal rate. Press ACT.

12:00 PM

AM

8.0 0.4

6:00 PM PROG

AM

8.+.+

6:00 PM

8.0.8

BASAL PROF:

6.

Follow this process to set additional rates as necessary. When all rates have been set, press ACT. The total amount of insulin delivered as a basal rate for the day will appear on the screen.

BASAL

U H

2 AM

BASAL PROF:

U H

1

PROG

5.

NOW

PROG

BASAL PROF:

3.

1

8.0.0

U H

U H

2

1.16.8

U

TOTAL

24.HOURS