MiniMed 640G System Getting Started Guide Sept 2014

Table Of Contents

Introduction I MiniMed Care

Introducing the MiniMed 640G System MiniMed Care...3 Welcome...4 The Delivery of Insulin...7

Register today

Menu Map...8

Getting Started with the MiniMed 640G Insulin Pump Section 1: Pump Basics... 10 Section 2: Home Screen... 12 Section 3: Basal Patterns... 14 Section 4: Giving Boluses... 18

At Medtronic we are not just committed to developing new and innovative products to help improve the lives of people with diabetes. We also provide you with ongoing support and customer service to help you make the most of your pump therapy and continuous glucose monitoring.

Section 5: Contour® Next LINK 2.4 Meter... 22 Section 6: Infusion Set & Reservoir (changing the Quick-set Infusion Set)... 25 Section 7: Alerts and Alarms... 32 Section 8: Suspend Delivery... 34

Getting Started with Continuous Glucose Monitoring Section 9: Introduction to Continuous Glucose Monitoring... 35

By registering for MiniMed Care, you can benefit from the following: Updates about our latest research and breakthrough technologies

Section 10: Sensor Glucose (SG) and Blood Glucose (BG)... 36 Section11: Trends... 37 Section 12: Personalised Alerts... 38 Section 13: Reading the Sensor Display... 48 Section 14: Connecting your Pump and Transmitter... 50 Section 15: Inserting and Starting the Sensor... 52

Regular tips and tricks for easier diabetes management Access to free interactive learning modules and tailored content for pump users

Section 16: Calibrating... 58 Section 17: Other Sensor Alerts... 62

Appendix

Register for MiniMed Care today at

Charging and storing your transmitter... 63

www.medtronic-diabetes.co.uk/minimedcare/registration

CareLink™ Personal Therapy Management Software... 64 X-Rays and Traveling By Air... 65 SmartGuard™ Suspend by Sensor Features... 66 2

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Introduction I Welcome

Introduction I Welcome

Getting Started with the MiniMed™ 640G System MiniMed™ 640G System Benefit from the unique MiniMed connection for secure insulin delivery, with an infusion set for every lifestyle.

With our most responsive sensor system yet, you can continuously monitor your glucose levels with superior comfort* and accuracy**.

Welcome! We are glad that you have chosen insulin pump therapy and are excited for you to begin using your MiniMed™ 640G. The MiniMed™ 640G system features innovative technology to more closely mimic the way a healthy pancreas delivers basal insulin to the body and help you achieve better glucose control. The MiniMed 640G system has been designed to provide you with: Advanced protection from dangerous high and lows Personalised convenience to help you manage daily diabetes tasks The MiniMed 640G insulin pump also has a new, improved design for consistent ease of use. Whether you are just starting pump therapy or upgrading from a previous pump model, this guide provides you step-by-step instructions on the basic operation and programming of your MiniMed 640G system, including Continuous Glucose Monitoring.

Did You Know? A complete explanation of the technical and operational aspects of your pump can be found in the MiniMed 640G System User Guide.

During your in-person training, your trainer will build on this information and help ensure you are confident to begin using your MiniMed 640G. With the accurate1 Contour® Next LINK 2.4 by Bayer, you can wirelessly send blood glucose results to your MiniMed 640G and deliver an insulin bolus discreetly.

Upload your pump to CareLink™ to conveniently track your glucose control and remotely share this information with your healthcare professional. www.medtronicdiabetes.com/carelink

*The size of the new generation Enlite sensor has been reduced by 80%. **When combined with the MiniMed 640G system and Guardian 2 Link transmitter. Enlite Sensor Performance addendum to user guide. 1. Section 8 clinical study. Data on file. Bayer Healthcare, LLC.

Intelligent for Better Control

We hope you enjoy learning about your new insulin pump.

Did You Know? An interactive online version of this training is available at www.XXXXXXX.com

Information contained herein does not replace the recommendations of your healthcare professional. Please refer to the User Guide and your HCP for more information. When using an insulin pump, check your blood glucose minimum 4 times a day.

IMPORTANT: Do NOT attach the insulin pump to your body or attempt to use insulin in your pump as you use this guide to practice and learn. Attaching and using must only be done when you receive formal training with your healthcare professional or a certified product trainer.

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5

Introduction I The Delivery of insulin 1

The Delivery of Insulin

3

5

2 4

Infusion Set*

let’s get started!

1

Tubing: carries insulin from the pump to you

2

Reservoir Connector: end of the tubing that attaches the reservoir which holds the insulin

3

Insertion Site Section: other end of the tubing that attaches to you

4

Cannula: tiny flexible tube placed into your body** by the insertion needle included in the insertion site section

5

Adhesive: holds the infusion set in place

6

Reservoir Compartment: part of the pump where the reservoir fits

6

You should replace both the infusion set and the reservoir every 2 to 3 days.

*Quick-set® infusion set shown in illustration. 6

Reservoir

**Some infusion sets do not use a cannula but have a small needle that remains inserted in the body.

Pump 7

Introduction I Menu Map

Introduction I Menu Map

Menu Map

Navigation Press

from any screen to open the Menu.

Press

and

Press

on the desired menu item to open.

to scroll through the menu items.

The scroll bar appears on menus to indicate when additional text is available.

Suspend Delivery Audio Options History Reservoir & Tubing

Press

Press

to scroll down to view additional items.

Press

to scroll back up. to return to the Home screen.

to go to previous screen. Hold

Insulin Settings Sensor Settings Event Markers

Press

Reminders Utilities

Home Screen

History Summary Daily History Alarm History Sensor Glucose Review*

Suspend Delivery

ISIG History*

Audio Options

8

Audio Audio & Vibrate Vibrate Volume

Reservoir & Tubing

Sensor Settings

Reminders

Sensor Sensor Connections* Alert Silence* High Settings* Low Settings* Calibrate Sensor* Auto Calibration*

Personal Bolus BG Check Missed Meal Bolus Low Reservoir Set Change Calibration*

Insulin Settings

Utilities

Bolus Wizard Setup Basal Pattern Setup Preset Temp Setup Preset Bolus Setup Dual/Square Wave Bolus Increment Max Basal/Bolus Easy Bolus Auto Suspend Bolus Speed

Airplane Mode Display Options Time & Date Remote Bolus Block Self Test Carb Unit Manage Settings Sensor Demo Device Options Language

New Reservoir

Event Markers BG Injections Food Exercise Other

Fill Cannula *Only available when Sensor feature is on.

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Insulin Pump I Pump Basics

Insulin Pump I Pump Basics

Section 1: Pump Basics

Inserting the Battery Your insulin pump is powered by a AA battery. A lithium, alkaline, or rechargeable AA battery can be used. The battery you place into your pump should always be new or fully charged.

Before inserting the battery or pressing any buttons, let’s take a closer look at your pump.

The Front of Your Pump Up, • • •

Down,

Left, and

To insert the battery and get started, you will need:

Right

Press to scroll up or down through a menu or list Press to move to desired area on the screen

Back Up

Press to change the value in an area

•

The belt clip found with the accessories

•

The AA battery found with the accessories

Right Select

Back Press to return to a previous screen Notification Light

• Press and hold to return to the starting screen, called the Home screen

Down

Menu

Select • Press to select or confirm a value or menu option that is highlighted •

The battery cap found with the pump

Menu

Left

•

•

Press when directions say ‘select ’

•

Press to get to the Menu

•

Press and hold to put pump into sleep mode

Step 1. Place the battery into the battery compartment with the negative (flat) end going in first.

Step 2. Place the battery cap onto the pump. Use the edge of the belt clip to turn the cap to the right (clockwise) and tighten until the slot is horizontal to the pump. See image below.

Notification Light • Flashes when an Alert or an Alarm is occurring Note: Do not undertighten or try to overtighten the battery cap. It should be aligned horizontally with the pump case as shown here.

The Bottom and Back of Your Pump Pump Serial and Model Number

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Medtronic Diabetes HelpLine Telephone Number

You may need to provide this information if you call for assistance.

Once the battery is inserted, the pump will power on and the Startup Wizard will begin. You will need to follow it step-by-step to set up your language, time format, time and date. 11

Insulin Pump I Home Screen

Insulin Pump I Home Screen

Section 2: Home Screen

Status Bar

The Home Screen will be your starting place to access all features in the pump. Status bar: provides a quick look at the pump’s status

Current time

Bolus: gives you access to the bolus delivery screen and other bolus insulin options

Active insulin: displays any insulin still active from a previous bolus

BG reading: displays a BG taken in the last 12 minutes

The Status Bar displays the following icons so you can quickly view important information. Battery icon: Shows the level of charge your battery has. As the battery charge decreases, the icon will become less full and change to yellow and then red.

 Reservoir icon: Shows the approximate amount of insulin left in your reservoir. As insulin is used, the icon will become less full and change to yellow and then red. Audio icon: Shows the audio mode you are using:

Basal: gives you access to basal insulin options

audio

, vibrate

or audio and vibrate

.

Backlight When you are not pressing buttons on your pump, you will notice that the Backlight will soon turn off. The pump is still on; it is just saving battery life. You can simply press any button to make the screen reappear.

Unlocking the Pump After the Backlight has been off for a few minutes, the pump goes into Sleep mode and the pump is locked. When you begin using your pump again, you will see a screen like the one shown here when you leave the Home screen. You will need to press the arrow key that is highlighted to unlock the pump. This confirms you are reading the screen and the button presses are not accidental.

Status Screens There will be times when you need additional status information such as the number of insulin units left in your reservoir, the last BG entered or your current basal rate. To access the Status Screens, press

to

highlight the Status Bar and press

.

Remember: You can go back to the previous screen by pressing

.

If the wrong key is pressed, you will see the screen here. Select OK to return to the Home screen and try again.

You can press and hold if you wish to put the pump into Sleep mode and keep it locked when you are not using it. Doing this can also help save battery life. 12

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Insulin Pump I Basal Patterns

Insulin Pump I Basal Patterns

Section 3: Basal Patterns

Setting Multiple Basal Rates

Basal insulin is delivered throughout the day and night to cover insulin needs between meals and during the night. The pump supplies basal insulin by delivering small amounts of short-acting insulin throughout each hour, every hour of the day and night. This allows for insulin to be increased and decreased to adjust for your body’s needs.

1. From the Home screen, select Basal > Insulin Settings > Basal Pattern Setup.

2. Select Basal 1 > Options > Edit.

3. Press on the time segment. The End time will be flashing.

to change End time to 03:00 4. Press and press .

Basal insulin amounts must be programmed into your pump. This is done by setting a basal pattern. A basal pattern consists of one or more basal rates being delivered over the course of 24 hours.

Basal Patterns Set up - Multiple Basal Rates It is likely when you start on pump therapy, that you will need more than one basal rate throughout the day and night to meet your body’s insulin needs. For example, a Basal Pattern may look like this:

1.000

03:00 – 08:00

U/hr

00:00 – 03:00

0.500

0.700 U/hr

00:00

0.800 U/hr

08:00-15:00

0.650 U/hr

06:00

12:00 24 Hours

15:00-19:00

0.550 U/hr

19:00-24:00

0.600 U/hr

18:00

5. Press

to 0.700 U/hr and press

.

24:00

In this example, the basal pattern includes 5 different basal rates over 24 hours.

Note: The basal rates shown are for illustration purposes only – your basal settings will be different.

14

You can see you are automatically asked to enter the end time of the second basal rate. This basal rate will need to end at 8:00 and will need to be changed to 0.800 U/hr. 15

Insulin Pump I Basal Patterns

6. Change End time to 08:00 and basal rate to 0.800 U/hr using and press . You can now enter the next end time.

Insulin Pump I Basal Patterns

7. Repeat steps 3 to 6 to enter the 3 next time segments and basal rates. For the last time segment, you will need to enter 24:00 as the end time to complete the full 24 hours.

Set Temp Basal Rate 1. From the Home screen, select Basal > Temp Basal.

2. Press to set duration and press .

3. Select Next.

4. Select Percent.

9. Verify that Basal 1 is entered correctly. Press to view all basal rates.

8. Select Done.

10. If NO changes need to be made: Select Save. This basal pattern delivers 15.85 U over 24 hours.

Note: If you choose to use Rate, select Type, and you can then enter the U/hr desired.

11. If changes need to be made: Press . Press and press . Repeat steps 7 to 9.

5. Press or to enter the percent of current basal rate desired .

12. Select Save.

Temporary (Temp) Basal Rate This feature lets you immediately increase or decrease your basal insulin for the period of time (duration) that you set. It is the easiest way to immediately adapt your basal rate according to your daily life and is often used for exercise and sick days. A Temp Basal can be set in either Percent (delivers a percent of the current basal rate) or by Rate (delivers the amount that you enter). 16

6. Select Begin.

Note: The Home screen reads Basal (T) since

Cancel Temp Basal Rate If you ever set a Temp Basal and decide you do not need it, it can be canceled. 1. From the Home screen, select Basal (T).

you have a Temp Basal active. Select Basal (T) to review the details of the active Temp Basal. When the Temp Basal is complete, the basal will automatically return to the regularly programmed basal rate.

2. Select Cancel Temp Basal. Note: Basal rate has now returned to the currently programmed rate. 17

Insulin Pump I Giving Boluses

Insulin Pump I Giving Boluses

Section 4: Giving Boluses A bolus is given to cover food that contains carbohydrate and/or to correct glucose levels that are above your target range.

3. Follow the instructions to program the following settings: Carb Ratio, Insulin Sensitivity Factor (Sensitivity), BG Target and Active Insulin Time. Each setting will include a short description: you need to select Next and enter the requested data.

Bolus Wizard Calculating how much bolus insulin to give can be challenging. When using the Bolus Wizard, all you will need to do is enter your current BG reading along with the amount of carbs you are about to eat. Once you do this, the Bolus Wizard uses the individual settings provided by your health care professional to estimate your bolus amount. Because these settings are specific to you, you can use it to calculate the precise amount of bolus insulin you need for your food and BG. This can help you better control your glucose levels. Note: Before using the Bolus Wizard, you need to program your individual settings with the help of your health care professional.

Carb Ratio

Insulin Sensitivity Factor

BG Target

Active Insulin Time

4. Select Save. The Bolus Wizard setup is now complete.

Using the Bolus Wizard Here you can see the Bolus Wizard calculation screen and a short description of the steps below: If you have tested your glucose using your compatible Bayer meter, the BG and correction dose will already be showing.

Turning the Bolus Wizard On and Setup 1. From the Menu, select Insulin Settings > Bolus Wizard Setup > Bolus Wizard.

2. Press to continue reading text and select Next.

You will first test and enter your current BG.

You will then enter grams of carbohydrates to be eaten.

The pump displays estimated amount of insulin to be delivered.

Note: The boluses shown are for illustration purposes only – your settings and bolus results will be different.

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Insulin Pump I Giving Boluses

Insulin Pump I Giving Boluses

Giving a Manual Bolus

Stopping a Bolus

When giving a manual bolus, you simply enter the amount of bolus insulin that you think you need for the carbohydrates you are eating, or to lower your BG if it is high.

To stop a bolus while it is delivering: 1. From the Home screen, select Stop Bolus. 2. Press

1.  From the Home screen, select Bolus.

2. Press

to 1.0 u and press

and select Yes.

.

3. Select Done. 3. Select Deliver Bolus.

4.  Confirmation that Bolus has started will appear.

The Home screen will show the amount as it is being delivered.

Once the bolus has finished delivering, the pump will return to the normal Home screen.

Notice that Stop Bolus also now appears.

Notice there is Active Insulin now displayed. Active insulin is insulin from boluses that are still working to lower your blood glucose level and/or to cover your carbohydrate intake that is still not absorbed. Each time you give a bolus, it is added to the active insulin amount. As time passes, the amount will decrease. You will learn more about active insulin during your training.

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The Bolus Stopped screen will show you how much of the bolus insulin was delivered before it was actually stopped.

Checking Last Bolus

Checking Bolus History

There may be times when you need to see the time or amount of the last bolus that was given. You can see the last bolus delivered in the Quick Status screen. From the Home screen, select the Status Bar > Quick Status (see page 13).

You may also want to review the last several boluses that were delivered. You can see the last several boluses delivered in Daily History. Press Menu button > History > Daily History.

The (N) behind the Last bolus amount means the bolus was delivered as a normal bolus. There are additional ways to give a bolus which you will learn about later.

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Insulin Pump I C ontour ® N ext LINK 2.4 Meter

Insulin Pump I C ontour ® N ext LINK 2.4 Meter

Section 5: C ontour ® N ext LINK 2.4 Meter

Connecting your Pump and Meter

The Contour Next LINK 2.4 meter from Bayer is the only blood glucose meter able to communicate wirelessly with your MiniMed 640G insulin pump. With the Contour Next LINK 2.4 meter, you can: •

Wirelessly send glucose readings to your pump Deliver a bolus remotely

•

Upload your pump data to CareLink™ Personal

Connect to a MiniMed Pump?

Review the parts of your meter here:

5.2

USB Connector

CONNECT TO PUMP

Manual Connect Auto Connect

10:24 l 11.10

mmol L

Before Meal

Display Screen

Bolus Reminder Notes

Protective USB Cap

Selection/Scrolling Buttons

2. Press OK. CONNECT TO PUMP Select "Connect Device" on your Pump.

OK Skip

3. Press Auto Connect.

Menu and Power Button

Test Strip Port and Port Light

1. Press OK when asked Connect to a MiniMed Pump? CONNECT TO PUMP

•

*

You will connect your pump and meter at your in-person training. For more information on using your meter, see the User Guide found in the meter box.

4. Press

OK Go Back

on your pump.

Put the meter down and pick up your pump.

5. Select Utilities.

6. Select Device Options.

7. Select Connect Device.

8.  Select Auto Connect.

9. Press

10. Select Continue.

Contour Next LINK 2.4 Meter

Charging your meter Your meter has a permanent rechargeable battery. It is important that the meter be charged prior to your in-person training. To charge your meter: 1. Plug the USB connector into a computer.** The computer must be ON and not in sleep, hibernate or power save mode.

.

2. The meter will briefly display Do Not Test-charging and the test strip port light will flash. You cannot do a blood glucose test while the battery is charging. 3. When charging is complete, the test strip port light will turn off. You can then unplug your meter.

Place the meter and pump next to each other.

* The Contour Next Link 2.4 meter only works with Contour® Next glucose testing strips. ** If you would prefer not to charge your meter using your computer, you can purchase a compatible outlet charger by calling Bayer Customer Service.

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Insulin Pump I C ontour ® N ext LINK 2.4 Meter

11. Select Search on your pump.

Insulin Pump I Infusion set and Reservoir

Section 6: Infusion Set and Reservoir

12. Select Search on your meter. The search may take up to 2 minutes. CONNECT TO PUMP

Select “Search” on Your Pump and meter.

The following is a step-by-step guide to changing the Quick-set® Infusion set.

Search Cancel

START HERE: 13. Check to see that the Device SN (serial number) on the pump screen matches the Device SN on the meter.

1.

14. If they match, select Confirm on the pump.

2.

3.

Select Reservoir & Tubing.

Select New Reservoir.

CONNECT TO PUMP

Use Pump to confirm Device SN: BGJ133333F

15. C  heck to see that the SN on the back of the pump matches the SN now on the meter screen.

16. Select Next on the meter.

Wash your hands. Press .

4.

5.

Remove the infusion set you have been using by loosening the adhesive and pulling away from body.

Remove the used reservoir from the pump.

PUMP CONNECTED

MiniMed Pump connected: AA1234567B

Next Delete

Uploading your pump to CareLink™ Personal CareLink Personal software is a web-based program that is provided free of charge. This software allows you to upload the data from your pump and glucose meter and review it on easy-to-read reports. This enables you to conveniently track your glucose control and remotely share this information with your healthcare professional. To upload information from your pump to CareLink Personal, you will use the Contour Next LINK 2.4 meter as the communication device from the pump to your computer, through the USB connector of the meter.

6.

Select Rewind.

To set up your CareLink Personal account, go to www.medtronicdiabetes.com/carelink 24

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Continued on next page

Insulin Pump I Infusion set and Reservoir

FILL RESERVOIR & CONNECT TO THE INFUSION SET TUBING Follow the next steps to fill reservoir with insulin and connect to the infusion set tubing.

3.

Insulin Pump I Infusion set and Reservoir

1.

2.

CONNECT RESERVOIR TO INFUSION SET

1

1

Plunger

Remove Removefrom frompackage. package. Make sure insulin vial is at room temperature to reduce the risk of air bubbles.

4.

Transfer guard

Plunger

5.

Wipe vial with alcohol. Place vial on table. Firmly press the blue transfer guard onto vial.

Push and hold plunger down.

6.

7.

Remove infusion set from package. Remove the paper that holds the tubing together.

Insulin vial

Plunger

2.

Connector

You will place the reservoir connector onto the end of the infusion set to the filled reservoir.

Pull plunger down to the amount that you plan to fill with insulin.

Insulin vial

1.

Gently push connector onto reservoir. Turn clockwise until locked. You will hear a click. IMPORTANT: Do not touch the top of the reservoir before connecting it to the infusion set. Please make sure that the connector and the top of the reservoir are dry.

3.

4.

If you see air bubbles, tap reservoir to move them to top. Push plunger just a bit to move them into tubing.

Twist plunger counterclockwise to loosen and remove.

Plunger

With your thumb still on the plunger, flip over so vial is on top. Release thumb and pull plunger down to fill with insulin.

8.

Reservoir

Transfer guard

Tap the reservoir to move air bubbles to top of reservoir. Push plunger up to move air into vial.

If needed, pull plunger back down to amount of insulin needed for 2-3 days.

To avoid getting insulin on top of the reservoir, turn vial over so it is upright. Hold transfer guard and turn reservoir counter-clockwise and remove from transfer guard.

IMPORTANT: If insulin or any other liquid gets inside the tubing connector, it can temporarily block the vents that allow the pump to properly fill the infusion set. This may result in the delivery of too little or too much insulin, which could cause hypoglycemia or hyperglycemia.

THE BACKLIGHT MAY HAVE TURNED OFF Press any button to turn the screen back on

Select Load Reservoir and unlock the pump if necessary.

26

Select Next.

27

Continued on next page

Insulin Pump I Infusion set and Reservoir

Insulin Pump I Infusion set and Reservoir

1.

PLACE RESERVOIR INTO PUMP

1.

Blue hub

INSERT INFUSION SET

Now place the filled reservoir into the reservoir compartment of the pump.

Next, follow the steps to insert the infusion set into your body.

Tubing slot

Place reservoir into pump.

2.

3.

Place blue hub into quick-serter, placing the handle in the tubing slot.

2.

3.

Needle guard

Be careful not to push or hold blue button.

Select Next.

Turn clockwise, until you feel reservoir lock into place.

LOAD RESERVOIR AND FILL TUBING

Adhesive

1.

Holding the serter with one hand, gently press infusion set to secure. Be careful not to push all the way into serter. Do not hold or press on the blue button.

2.

4.

Follow these steps to load the reservoir and fill the tubing.

Select Load and keep holding

.

Drops at end of tubing

5.

6.

Choose an insertion site from the shaded areas shown here. Wipe with alcohol or antiseptic.

Turn to loosen needle guard and pull.

Needle guard

When you see this screen, select Next.

4.

3.

Blue button

Holding needle guard, pull off the paper that covers the adhesive.

Pull blue button down until you hear it click. After you see drops, press and select Next.

Select Fill and keep holding until you see drops at the end of tubing, then let go. 28

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Continued on next page

Insulin Pump I Infusion set and Reservoir

7.

8.

Insulin Pump I Infusion set and Reservoir

9.

Blue button

FILL CANNULA

1.

2.

Select Fill.

Select Fill amount and enter: - 0.300 if using 6mm cannula - 0.500 if using 9mm cannula Then press .

You will now fill the cannula, the little tube under your skin, with insulin.

White Buttons

Hold serter against cleaned site.

Press the two white buttons at the same time.

Press the blue button to unlock.

10.

11.

12.

Blue handle

Note: Your pump will remember the Fill amount that you used last. Always verify that the Fill amount is correct. • If it is correct, press and press .

Pull serter away from body. Press adhesive against skin.

Hold infusion set. Pull blue handle straight out to remove needle.

3.

to Fill Now

. Change to • If it is incorrect, press correct amount and. Press .

Fold blue handle until locked.

Fill Now.

Select Fill Now.

4. Note: Alternative infusion sets offered are Mio™, Silhouette®and Sure-T®. Most of the steps described in this section will be different for each infusion set. Please refer to the instructions for insertion included in the infusion set box.

Note: Select Stop Filling if you need to stop, for example, if you notice the Total amount is incorrect. This should rarely happen if you have verified the Fill amount on the previous screen.

The Home screen displays the insulin as it fills the cannula.

Your infusion set change is now complete!

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31

Insulin Pump I Alerts and Alarms

Insulin Pump I Alerts and Alarms

Section 7: Alerts and Alarms

To address and clear the alert or alarm:

Alerts

1. Read the text on the screen to understand the alert or alarm and the steps that should be taken

An alert makes you aware of a situation that may need your attention. When an alert occurs, you should check to see what your pump is telling you. Examples of alerts include Low reservoir or Low battery.

2. Press 3. Press

. on the desired option.

Example of alarm:

Alarm When an alarm occurs, something has been detected that is preventing insulin from being delivered. You are not getting insulin. It is important that you address an alarm right away. Examples of alarms are Insulin flow blocked and Replace battery now.

Press

When an alert or alarm occurs:

Notification Light

ALERT

ALARM

•  Alert: the audio/vibration pattern repeats every 5 minutes or every 15 minutes (depending on the alert) until the alert is cleared.

The red light on the pump will blink once followed by a pause. This sequence continues until the alert is cleared.

The red light on the pump will blink twice followed by a pause. This sequence continues until the alarm is cleared.

•  Alarm: the audio/vibration pattern repeats every minute for 10 minutes if the alarm is not cleared. After 10 minutes, the alarm begins to siren.

The flashing pattern is shown here:

The flashing pattern is shown here:

Audio

Depending on your Audio Option settings, the pump emits a repeated alert tone, a continuous three-pulse vibration, or both.

Display

The pump will display a notification with a yellow icon and instructions on what to do.

The pump will display a notification with a red icon and instructions on what to do.

IMPORTANT: It is important that you are able to address an Insulin flow blocked alarm. This alarm means that insulin is not able to get through the tubing or cannula. If this alarm occurs, check your blood glucose and check to see if your infusion set has become dislodged or if your tubing is kinked. • I f you don’t detect an issue and are unable to change your reservoir and infusion set right away, you might choose to select Resume Basal. If an Insulin flow blocked alarm occurs again, follow the steps on the screen. Select Rewind and change your reservoir and infusion set. • I f you detect an issue or if your reservoir has run out of insulin, follow the steps on the screen. Select Rewind to change your reservoir and infusion set. You can call the Product helpline if you have questions about your pump, alerts or alarms.

Notification light

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33

Insulin Pump I Suspend Delivery

CGM I Introduction to Continuous Glucose Monitoring

Section 8: Suspend Delivery

Section 9: Introduction to Continuous Glucose Monitoring

Remember your pump is delivering basal insulin throughout every hour of the day. Although you should never stop this insulin delivery for more than an hour or so, there will be times when you will want to manually suspend, or stop delivery, and disconnect from your pump.

Continuous glucose monitoring (CGM) gives you a more complete picture of your glucose control:

This is done using the Suspend Delivery feature. Using Suspend Delivery stops all insulin delivery. The most common reasons to manually suspend delivery might include bathing and water activities. Infusion sets are designed so you can easily disconnect from your pump and leave it in a safe place. When the pump is manually suspended, all insulin delivery stops. All insulin delivery will remain stopped until you resume delivery. When the delivery is resumed, basal insulin will begin to deliver again. The pump will not deliver any of the basal insulin you missed while the pump was suspended. If you manually suspend delivery while a bolus is delivering, the bolus delivery will stop. When you resume delivery, the remainder of the bolus will not be delivered. To place the pump in Manual Suspend: from the Menu, select Suspend Delivery > and select Yes. Press

• Using a sensor allows you to receive up to 288 sensor glucose readings every 24 hours, filling the gaps between your BG tests. •  Graphs and trend arrows show the speed and direction your glucose levels are moving. • CGM alerts notify you of high and low glucose values.  iniMed 640G also includes SmartGuardTM, Medtronic’s exclusive closed loop M technology. SmartGuard mimics some functions of a healthy pancreas, to provide you with advanced protection from hypoglycemia1: SmartGuard can: •  PREDICT when you are approaching low glucose levels 30 minutes in advance • Automatically STOP insulin delivery before you go hypoglycemic • And automatically RESUME it when your glucose levels recover*. Your Continuous Glucose Monitoring (CGM) system includes 3 key items: 1

Glucose sensor

The Enlite™ sensor measures glucose levels in the body.

2

Transmitter**

T he Guardian™ 2 Link transmitter connects to the glucose sensor and sends glucose readings to your insulin pump.

3

Insulin pump

The MiniMed™ 640G insulin pump displays glucose readings.

Other items include: Enlite serter, Enlite overtape, Guardian 2 Link charger and watertight tester. Always use the components that were sent with your MiniMed 640G System.

Notice that the Home screen has changed. 2

To resume Basal Insulin Delivery, select Resume from the Home screen.

3 1

Drawings throughout this document are only generic representations of the system components.

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1. Bergenstal RM, Klonoff DC, Garg SK. et al. Threshold-Based Insulin-Pump Interruption for Reduction of Hypoglycemia. N Engl J Med. 2013; 369(3):224-232. * See Appendix pages 66-67 for further details on how SmartGuard works. ** The transmitter must be within 1.8 meters of the insulin pump in order to communicate sensor readings. The MiniMed 640G insulin pump will not communicate with MiniLink transmitters.

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CGM I Sensor Glucose (SG) and Blood Glucose (BG)

CGM I Trends

Section10: Sensor Glucose (SG) and Blood Glucose (BG)

Section 11: Trends

Your BG meter measures glucose levels in your blood. The glucose sensor measures glucose in the fluid surrounding the cells of your tissue called interstitial fluid.

Sensor glucose trends give insight into the direction and the speed that your glucose is changing. The sensor graph and trend arrows are used to show your trend information.

Transmitter

IMPORTANT: When using CGM, focus less on each individual glucose number and more on the direction and speed that your glucose is changing.

Skin Glucose Sensor Interstitial Fluid Cell

Example of Sensor information on the Home Screen

Glucose Blood Vessel

Glucose travels between these two areas (blood and interstitial fluid). Most of the time, it travels to your blood first, and then to your interstitial fluid. Because of how glucose moves, your BG meter readings (BG) and sensor glucose readings (SG) will be close, but will rarely match exactly. This difference is normal and should be expected. When glucose levels are rising or falling quickly, you should expect to see an even larger difference between your BG meter readings and the sensor glucose readings. Examples of times when this larger difference may occur include: •

After meals or taking a bolus of insulin

•

During exercise

•

When arrows appear on your pump screen as explained in the next section

IMPORTANT: Sensor glucose is not the same as blood glucose. Your SG and BG readings will be close to one another, but will rarely match exactly. Sensor glucose values should not be used to make diabetes treatment decisions. Always confirm your glucose value with a BG meter first.

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Trend Arrows Sensor Glucose Graph

Sensor Glucose Reading

By looking at the sensor information above, you can see that your current glucose reading is 5.6 mmol/L. When you look at the graph, you can see that you are trending downward. Furthermore, you see arrows above the number. These arrows indicate the rate that your glucose values are moving up or down: or - SG has been rising or falling by about 1-2 mmol/L over the last 20 minutes or

- SG has been rising or falling by about 2-3 mmol/L over the last 20 minutes

or

- SG has been rising or falling by about 3 mmol/L over the last 20 minutes

Note: You may be likely to notice your glucose trending up or down after eating, giving a bolus, or when exercising.

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CGM I Personalised Alerts

CGM I Personalised Alerts

Section 12: Personalised Alerts

Low Settings

Your CGM alert and suspend settings are most beneficial if they are personalised for your needs. Your healthcare professional will work with you to determine your initial settings and help with adjustments that need to be made, as you learn more from the information that CGM provides.

The Low Settings include alerts, as well as the SmartGuard™ suspend by sensor features. You can choose to be alerted if your sensor glucose: • is approaching your low limit (Alert before low) • has reached your low limit (Alert on low)

The graph below shows an example of the different settings that can be personalised for both High and Low sensor glucose readings. Personalised Alerts

The SmartGuard suspend by sensor features can automatically suspend insulin if your sensor glucose: • is approaching your low limit (Suspend before low) • has reached your low limit (Suspend on low)

(

This will keep you from getting additional insulin that would continue to lower your sensor glucose level.

13.9

Alert on High Alert before High Rise Rate (

4.0

High Snooze)

Sensor Glucose Readings

Low Snooze)

Suspend before Low Alert before Low Suspend on Low Alert on Low

CGM Alert Setting

22.2 mmol/L High Limit

Alert on High Alert Before High Rise Alert

Turning Sensor Feature On Before setting any of these sensor alerts, you must first turn the sensor feature on. To turn the sensor feature on, go to the Menu > Sensor Settings and select Sensor.

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(

High Snooze) Snooze

( Suspend before Low Alert before Low Suspend on Low Alert on Low A

Low Snooze) Sensor Glucose Readings

2.2 mmol/L

Your low (Lo) limit can be set from 2.8 to 5.0 mmol/L. This is the value on which the other low settings described below are based. You can set up to eight low limits for different periods of the day or night.

Alert

Reason

Alert before low

If Suspend before low is on, you will be alerted when insulin is suspended. If Suspend before low is off, you will be alerted when the sensor predicts you will reach your low limit in 30 minutes.

Alert on low

Sensor glucose value is equal to or lower than your low limit.

Steps to take Do not treat your glucose based on SG. Confirm it using your BG meter. Treat if necessary based on instructions from your healthcare professional and continue to monitor.

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