MiniMed™ 640G System - Medtronic Diabetes UK

MiniMed™ 640G System - Medtronic Diabetes UK
Getting Started with the
MiniMed 640G System
™
Intelligent for Better Control
Table Of Contents
Introducing the MiniMed 640G System
MiniMed Care............................................................................................................................................................3
Welcome .....................................................................................................................................................................4
The Delivery of Insulin ...........................................................................................................................................7
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
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
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
Section 16: Calibrating ..................................................................................................................................... 58
Section 17: Other Sensor Alerts .................................................................................................................... 62
Appendix
Charging and storing your transmitter ........................................................................................................ 63
CareLink™ Personal Therapy Management Software.............................................................................. 64
X-Rays and Traveling By Air ............................................................................................................................... 65
SmartGuard™ Suspend by Sensor Features ................................................................................................ 66
2
Introduction I MiniMed Care
Register today
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.
By registering for MiniMed Care, you can benefit from the following:
Updates about our latest research and breakthrough
technologies
Regular tips and tricks for easier diabetes management
Access to free interactive learning modules and tailored
content for pump users
Register for MiniMed Care today at
www.medtronic-diabetes.co.uk/minimedcare/registration
3
Introduction I Welcome
MiniMed™ 640G System
Benefit from the unique MiniMed
connection for secure insulin delivery,
with an infusion set for every lifestyle.
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.
With our most responsive sensor
system yet, you can continuously
monitor your glucose levels with
superior comfort* and accuracy**.
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.
1. Bailey T, et al. Accuracy and user performance evaluation of the Contour® Next Link 2.4 blood glucose monitoring system. Clin Chim Acta. 2015; 448:139-45.
Intelligent for Better Control
4
Introduction I Welcome
Getting Started with the MiniMed™ 640G System
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.
We hope you enjoy learning about your new insulin pump.
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.
5
let’s get
started!
6
This document does not replace the Instructions for
Use. For a listing of indications, contraindications,
precautions, warnings, and potential adverse events,
please refer to the Instructions for Use.
Introduction I The Delivery of insulin
1
The Delivery of Insulin
3
5
2
4
Infusion Set*
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
Reservoir
6
You should replace both the infusion set and the
reservoir every 2 to 3 days.
*Quick-set® infusion set shown in illustration.
**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
Menu Map
Suspend Delivery
Audio Options
History
Reservoir & Tubing
Insulin Settings
Sensor Settings
Event Markers
Press
Reminders
Utilities
Home Screen
History
Summary
Daily History
Alarm History
Sensor Glucose Review*
Suspend Delivery
ISIG History*
8
Audio Options
Reservoir & Tubing
Audio
Audio & Vibrate
Vibrate
Volume
New Reservoir
Fill Cannula
Introduction I
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.
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
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
*Only available when Sensor feature is on.
Event Markers
BG
Injections
Food
Exercise
Other
9
Insulin Pump I
Pump Basics
Section 1: Pump Basics
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
Right
•
Press to scroll up or down through
a menu or list
•
Press to move to desired area
on the screen
•
Press to change the value in an area
Back
Up
Back
Left
•
Press to return to a previous screen
•
Press and hold to return to the starting
screen, called the Home screen
Notification
Light
•
Right
Select
Down
Menu
Select
•
Menu
Press to select or confirm a value
or menu option that is highlighted
•
Press to get to the Menu
•
Press and hold to put pump into sleep mode
Press when directions say ‘select ’
Notification Light
•
Flashes when an Alert or an Alarm is occurring
The Bottom and Back of Your Pump
Pump Serial
and Model Number
10
Medtronic Diabetes
HelpLine Telephone
Number
You may need
to provide this
information if you
call for assistance.
Insulin Pump I
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.
To insert the battery and get started, you will need:
•
The battery cap found with the pump
•
The belt clip found with the accessories
•
The AA battery found with the accessories
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.
Note: Do not undertighten or try to overtighten
the battery cap. It should be aligned horizontally
with the pump case as shown here.
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
Section 2: Home Screen
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
Basal: gives you access
to basal insulin options
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.
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
Insulin Pump I
Home Screen
Status Bar
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:
audio
Note:
, vibrate
or audio and vibrate
.
If you are using a 1.8mL insulin reservoir, the range of
reservoir icons will start with the second green icon.
Not displayed with a
1.8mL reservoir
If starting with a full 1.8mL reservoir and using the
minimum amount of insulin recommended to fill the
shortest tubing (45 cm) and a steel cannula, the pump will
display the second green (not full) reservoir icon after
the reservoir and infusion set change is complete.
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
.
13
Insulin Pump I
Basal Patterns
Section 3: Basal Patterns
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.
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
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
24:00
Insulin Pump I
Basal Patterns
Setting Multiple Basal Rates
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
.
5. Press
to 0.700 U/hr and press
.
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.
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.
8. Select Done.
9. Verify that Basal 1 is entered correctly.
Press
to view all basal rates.
10. If NO changes need to be made:
Select Save.
11. If changes need to be made:
Press
.
This basal
pattern
delivers
15.85 U over
24 hours.
Press
and press .
Repeat steps 7 to 9.
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
Insulin Pump I
Basal Patterns
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.
Note: If you choose to
use Rate, select Type,
and you can then
enter the U/hr desired.
5. Press
or
to enter the
percent of current basal
rate desired .
6. Select Begin.
Note: The Home screen reads Basal (T) since
Cancel Temp Basal Rate
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
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).
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
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.
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.
Turning the Bolus Wizard On and Setup
1. From the Menu, select Insulin
Settings > Bolus Wizard Setup >
Bolus Wizard.
18
2. Press
to continue reading text and
select Next.
Insulin Pump I Giving Boluses
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.
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.
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.
19
Insulin Pump I Giving Boluses
Giving a Manual 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.
1. From the Home screen,
select Bolus.
2. Press
3. Select Deliver Bolus.
4. Confirmation that Bolus has
started will appear.
The Home
screen will
show the
amount
as it is being
delivered.
to 1.0 u and press
.
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.
20
Insulin Pump I Giving Boluses
Stopping a Bolus
To stop a bolus while it is delivering:
1. From the Home screen, select Stop Bolus. 2. Press
and select Yes.
3. Select Done.
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.
21
Insulin Pump I C ontour ® n ext LINK 2.4 Meter
Section 5: C ontour ® n ext LINK 2.4 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
Review the parts of your meter here:
Menu and Power Button
5.2
10:24 l 11.10
Test Strip Port*
and Port Light
mmol
L
Before Meal
Display Screen
USB Connector
Bolus
Reminder
Notes
Protective USB Cap
Selection/Scrolling Buttons
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.
* 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.
22
Insulin Pump I C ontour ® n ext LINK 2.4 Meter
Connecting your Pump and Meter
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.
1. Press OK when asked
Connect to a MiniMed Pump?
CONNECT TO PUMP
Connect to a
MiniMed Pump?
2. Press OK.
CONNECT TO PUMP
Select "Connect
Device" on your Pump.
OK
Skip
3. Press Auto Connect.
CONNECT TO PUMP
Manual Connect
Auto Connect
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.
.
Place the meter and pump next to each other.
23
Insulin Pump I C ontour ® n ext LINK 2.4 Meter
11. Select Search on your pump.
12. Select Search on your meter.
The search may take up to 2 minutes.
CONNECT TO PUMP
Select “Search” on
Your Pump and meter.
13. Check to see that the Device
SN (serial number) on the
pump screen matches the
Device SN on the meter.
Search
Cancel
14. If they match, select Confirm
on the pump.
CONNECT TO PUMP
Use Pump to confirm
Device SN:
BGJ133333F
15. Check 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.
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.
To set up your CareLink Personal account, go to www.medtronicdiabetes.com/carelink
24
Insulin Pump I Infusion set and Reservoir
Section 6: Infusion Set and Reservoir
The following is a step-by-step guide to changing the Quick-set® Infusion set.
START HERE:
1.
Wash your hands.
Press .
2.
3.
Select Reservoir &
Tubing.
Select New Reservoir.
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.
6.
Select Rewind.
25
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.
1.
Plunger
rod
Reservoir
Plunger
Transfer
guard
Remove from package. Make sure
insulin vial is at room temperature
to reduce the risk of air bubbles.
4.
Transfer guard
2.
Plunger
5.
Pull plunger down to the
amount that you plan to fill
with insulin.
Insulin vial
Plunger
Insulin
vial
Wipe vial with alcohol.
Place vial on table.
Firmly press the blue
transfer guard onto vial.
Push and hold plunger
down.
6.
With your thumb still on the plunger,
flip over so vial is on top. Release
thumb and pull plunger down to
fill with insulin.
7.
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.
26
Insulin Pump I Infusion set and Reservoir
CONNECT
RESERVOIR TO
INFUSION SET
1.
2.
Connector
You will place the
reservoir connector
onto the end of the
infusion set to the
filled reservoir.
Remove infusion set from package.
Remove the paper that holds the
tubing together.
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
THE BACKLIGHT MAY
HAVE TURNED OFF
Press any button to turn
the screen back on
Select Load Reservoir
and unlock the pump if
necessary.
Select Next.
27
Continued on next page
Insulin Pump I Infusion set and Reservoir
1.
PLACE RESERVOIR
INTO PUMP
Now place the
filled reservoir
into the reservoir
compartment of
the pump.
Place reservoir into pump.
2.
3.
Turn clockwise, until you feel
reservoir lock into place.
Select Next.
LOAD RESERVOIR
AND FILL TUBING
1.
2.
Follow these
steps to load the
reservoir and fill
the tubing.
Select Load and keep holding
When you see this screen,
select Next.
4.
3.
Drops at end
of tubing
Select Fill and keep holding
until you
see drops at the end of tubing, then let go.
28
.
After you see drops,
press
and select
Next.
Insulin Pump I Infusion set and Reservoir
1.
Blue hub
INSERT
INFUSION SET
Next, follow the
steps to insert the
infusion set into
your body.
Tubing slot
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.
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.
4.
Blue button
Pull blue button down
until you hear it click.
Adhesive
Holding needle guard,
pull off the paper that
covers the adhesive.
5.
Choose an insertion site from the
shaded areas shown here. Wipe
with alcohol or antiseptic.
6.
Needle guard
Turn to loosen
needle guard
and pull.
29
Continued on next page
Insulin Pump I Infusion set and Reservoir
7.
8.
9.
Hold serter against
cleaned site.
Press the two white
buttons at the same time.
Press the blue button
to unlock.
10.
11.
12.
Blue button
White
Buttons
Blue handle
1
2
Pull serter away from body.
Press adhesive against skin.
Hold infusion set. Pull
blue handle straight
out to remove needle.
Fold blue handle
until locked.
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.
30
Insulin Pump I Infusion set and Reservoir
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.
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
.
3.
to Fill Now
. Change to
• If it is incorrect, press
correct amount and. Press
.
Fill Now.
Select Fill Now.
4.
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!
31
Insulin Pump I Alerts and Alarms
Section 7: Alerts and Alarms
Alerts
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.
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.
When an alert or alarm occurs:
Notification
Light
ALERT
ALARM
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.
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.
Notification light
32
The pump will display a notification
with a red icon and instructions on
what to do.
Insulin Pump I Alerts and Alarms
To address and clear the alert or alarm:
1. Read the text on the screen to understand the alert or alarm and the steps that
should be taken
2. Press
3. Press
.
on the desired option.
Example of alarm:
Press
• Alert: the audio/vibration pattern repeats every 5 minutes or every 15
minutes (depending on the alert) until the alert 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.
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.
• If 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.
• If 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.
33
Insulin Pump I Suspend Delivery
Section 8: Suspend Delivery
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.
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
Notice that the Home screen has changed.
To resume Basal Insulin Delivery, select Resume
from the Home screen.
34
CGM I Introduction to Continuous Glucose Monitoring
Section 9: Introduction to Continuous Glucose Monitoring
Continuous glucose monitoring (CGM) gives you a more complete picture of your
glucose control:
• 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.
MiniMed 640G also includes SmartGuardTM, Medtronic’s exclusive closed loop
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**
The 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.
2
3
1
Drawings throughout this document are only generic representations of the system components.
1. Conget I., Choudhary P., Olsen B., et al. Prevention of hypoglycemia by the predictive low glucose management feature in a user
evaluation study. Diabetologia. 2015, 58 (Suppl 1), p 416.
* 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.
35
CGM I Sensor Glucose (SG) and Blood Glucose (BG)
Section10: Sensor Glucose (SG) and Blood Glucose (BG)
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.
Transmitter
Skin
Glucose Sensor
Interstitial Fluid
Cell
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.
36
CGM I Trends
Section 11: Trends
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.
IMPORTANT: When using CGM, focus less on each individual glucose number
and more on the direction and speed that your glucose is changing.
Example of Sensor information on the Home Screen
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
or
- SG has been rising or falling by about 2-3 mmol/L over the last 20 minutes
- 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.
37
CGM I Personalised Alerts
Section 12: Personalised Alerts
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 graph below shows an example of the different settings that can be personalised
for both High and Low sensor glucose readings.
Personalised Alerts
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
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.
38
High Limit
CGM I Personalised Alerts
Low Settings
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 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.
22.2 mmol/L
Alert on High
Alert Before High
Rise Alert
(
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.
39
CGM I Personalised Alerts
Note: If either Suspend on low or Suspend before low is turned on, Alert on low will
automatically be set to on so you know that your glucose is at or below your low limit.
SmartGuard
Suspend features
Suspend
before low
Suspend
on low
Impact on insulin
delivery if suspend
feature is turned on
Insulin delivery is
temporarily stopped
if sensor glucose
value is approaching
your low limit.
Information displayed by the pump
You will receive this alert
message and need to
check your BG. Insulin
delivery will remain
suspended after the
alert is cleared.
After the alert or alarm
message is cleared and
insulin delivery has
stopped, the Home screen
will display:
• Suspended before low
or Suspended on low at
the bottom of the screen
If the alert is not cleared
in 10 minutes, the pump
will begin to siren.
• a shaded area to
You will receive this alarm
message and need to
check your BG. Insulin
will remain suspended
after the alarm is cleared.
• a flashing SmartGuard
represent the time
when insulin has been
suspended
suspend by sensor icon.
Insulin delivery is
temporarily stopped
if sensor glucose
value has reached
or fallen below your
low limit.
If the alarm is not
cleared after 10 minutes,
the pump will begin to
siren and an emergency
message will appear on
the pump screen.
Notes:
• Only one suspend feature can be used during each time segment; you cannot
turn both Suspend before low and Suspend on low on.
• Insulin delivery will not be suspended if you are more than 3.9 mmol/L above
your low limit.
40
CGM I Personalised Alerts
Resuming Basal Insulin
Automatic Basal Resume
In addition to suspending insulin delivery, the pump can also automatically resume
delivery of basal insulin. If insulin has been suspended by either Suspend before low
or Suspend on low, insulin delivery will automatically be resumed:
• if SG values are above the low limit and are trending upward. If you have the
Resume basal alert on, you will be alerted when this occurs.
• after a maximum suspend time of 2 hours. You will always be alerted (even if
the Resume basal alert is off ) when this occurs. It is important that you check
your BG and ensure your glucose is at a safe level.
Manual Basal Resume
You can choose to resume basal insulin delivery yourself at any time. You simply need
to select Suspended before/on low on the Home screen and follow the instructions
on the screen.
Setting up your Low Settings:
In this example, we will set up multiple time segments with different alert and
suspend settings.
on the time segment.
1. From the Menu, go to Sensor
Settings > Low Settings and select
Low Settings to turn On.
2. Press
to set Lo limit
3. Press or
and press .
4. Press to continue onto the
next screen.
41
CGM I Personalised Alerts
5. Select each feature you wish to turn on.
In this example, Suspend before low
has been turned on. Notice that Alert
on low is automatically turned on.
6. Once settings are selected,
select Next.
on the time segment. Repeat steps 3 to 7 to enter the next time segment
7. Press
and select the features you want to turn on for this segment. In this example,
Alert before low, Suspend on low, and Resume basal alert have been turned on.
8. Select Done.
42
9. Verify that settings are correct
and select Save.
CGM I Personalised Alerts
10. If snooze time needs to be changed,
press to Snooze and press .
The low snooze time can be set
from 5 minutes to 1 hour.
11. Press or
and press
to the correct time
.
Your Low Settings setup
is now complete.
Time that you want to wait
to be reminded that an alert
condition still exists.
Remember: Sensor glucose values must be confirmed with a BG meter reading
before diabetes treatment decisions can be made.
High Settings
The High Settings allow you to be alerted if your sensor glucose:
•
is rising rapidly (Rise Alert)
•
is approaching your high limit (Alert before high)
•
has reached your high limit (Alert on high)
Personalized Alerts
22.2 mmol/L
High Limit
Alert
A
ert on High
(
Low Snooz
Alert Before High
Sensor Glucose
Readings
Suspend before Low
Alert before Low
Rise Alert
(
High Snooze)
Suspend on Low
Alert on Low
2.2 mmol/L
CGM Alert Setting
43
CGM I Personalised Alerts
Your high (Hi) limit can be set from 5.6 to 22.2 mmol/L. This is the value on which
other high settings described below are based.
Remember: Your high limit is not the same as your glucose target. Your healthcare
professional will help you determine the best setting so that you are alerted when
needed while preventing unnecessary or inconvenient alerts.
Reason
Alert
Alert before
high
Sensor glucose reading is expected to reach the
high glucose limit in the length of time that you set
for the Time before high*.
Alert on high
Sensor glucose value is equal to or higher to the
high limit you set.
Sensor glucose reading is increasing at a rate that is
equal to or faster than the Rate Limit that you set.
The Rise Alert can be set to alert if glucose is rising
as follows:
Rise Alert
•
•
•
•
- SG is rising at a rate of 0.056 mmol/L
per minute or more
- SG is rising at a rate of 0.111 mmol/L
per minute or more
- SG is rising at a rate of 0.167 mmol/L
per minute or more
Custom - SG is rising at the rate that you set.
This can be set from 0.050 to 0.275
mmol/L per minute
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.
*Time before high determines how many minutes before reaching the high limit that you will
receive an Alert before high. This can be set from 5 to 30 minutes.
Remember: You can set up to 8 different time segments throughout the day and
night. Each time segment can have different high limits and high alerts that work
best for you during that time of day or night.
44
CGM I Personalised Alerts
Setting up your High Settings:
1. From the Menu, go to Sensor
Settings > High Settings and
select High Settings to turn On.
If you are changing settings that
are already entered, press
to Setup and press .
3. Press or
to set Hi limit and
press . In this example, the limit
is set to 13.8 mmol/L.
2. Press on the time segment. If you
are setting multiple time segments
with different high limits and alerts,
press
to set the first End time and
press . In this example, only one
time segment is set.
to continue onto the
4. Press
next screen and select each
alert you wish to turn on.
45
CGM I Personalised Alerts
5. Once settings are selected, select Next.
In this example, the Alert on high has
been turned on.
6. Select Done.
7. Verify that settings are correct and
select Save.
8. If snooze time needs to be changed,
press to Snooze and press .
The high snooze time can be set from
5 min to 3 hours.
9. Press or to the correct time
and press .
Your High Settings setup is now complete.
Changing High and Low Settings
To make changes to your existing High or Low settings, go to Sensor Settings
> High Settings or Low Settings > Setup and select Edit.
46
CGM I Personalised Alerts
Alert Silence
If a sensor alert occurs when Alert Silence is on, a Sensor alert occurred message is
displayed and the notification light flashes, but there is no beep or vibration during
the set period of time.
To set Alert Silence: from the Menu, go to Sensor Settings > Alert Silence.
You can select which alerts you would like to silence and set the time you want
these alerts to be silent for.
Alerts will automatically return to audio and/or vibrate at the end of the duration
that you set.
Note: If an alert is received during Alert Silence, go to the Menu > History and
select Alarm History to see the alerts that occurred.
47
CGM I Sensor Display
Section 13: Reading the Sensor Display
Once the sensor has started giving you sensor glucose readings, the Home screen will
display them similar to what you see here.
Additional Sensor Icons
Trend Arrows
High Alert Limit
Most recent Sensor
Glucose (SG) Reading
3-hour Sensor Glucose Graph
SmartGuard Suspend by
Sensor Icon
Low Alert Limit
Bolus Marker
The Sensor Glucose reading is updated every 5 minutes.
Status Bar
In addition to the pump icons, you will see additional sensor icons on the Status Bar
when using CGM.
Connection icon: shows radio frequency (RF)
communication between the pump and sensor.
Calibration icon: represents the time left until next
calibration is due. The icon empties as time decreases.
Down arrow means calibration is needed.
Sensor Life icon: represents the number of days before
sensor needs to be changed.
Additional icons: appear when the sensor is in warm up,
pump and transmitter are out of range, system cannot
be calibrated, or calibration or sensor age are unknown.
48
CGM I Sensor Display
SmartGuard Suspend by Sensor Icon
During any time segment when either Suspend before low or Suspend on low is set
to on, you will see the Suspend by sensor icon on the Home screen :
Suspend before low or Suspend on low is on and ready. If either suspend
becomes active, the icon will flash while insulin delivery is stopped.
Suspend before low or Suspend on low is on but is unavailable. This can be
due to a recent suspend or when no SG values are available.
Sensor Status
You can go to the Sensor status menu to see, for example, when your next calibration
is due, time left on your sensor, and battery life remaining on your transmitter.
From the Home screen, select the Status Bar and select Sensor.
You will also see additional sensor status information in
Notifications, Quick Status, and Settings Review screens.
Sensor Graph
A graph that shows the last 3 hours of sensor glucose
readings will always display on the Home screen. Your high
and low glucose limits entered in your sensor settings will
be shown in red.
You can also view 6-hour, 12-hour and 24-hour glucose
trend graphs by selecting the sensor graph. Blue squares
at the bottom of the graph represent a bolus.
A gold shaded area represents time when insulin was
suspended by sensor.
49
CGM I Connecting your Pump and Transmitter
Section 14: Connecting your Pump and Transmitter
Before using the sensor for the first time, you will need to wirelessly connect the
pump and transmitter so that they can communicate with each other. This allows
the sensor information to be displayed on the pump screen.
To wirelessly connect your pump and transmitter:
1. Attach your transmitter to the charger
and make sure it is fully charged.
charger
transmitter
3. Select Auto Connect > Press
> Select Continue.
Steps for Manual Connect can be found
in the MiniMed 640G User Guide.
50
and select Utilities > Device
2. Press
Options > Connect Device.
Only one transmitter can be connected
to the pump at one time. When you need
to connect a new transmitter, you must
first select Manage Devices, select the
transmitter number and select Delete.
4. Make sure the transmitter is on the
charger before proceeding. Now
start the search processes on
both devices.
CGM I Connecting your Pump and Transmitter
4b. Immediately select Search on the
pump. The search can take up to 2
minutes.
!
4a. Remove transmitter from charger.
If green light on transmitter does not
flash, reconnect to charger until
fully charged.
5. Once device is found, confirm that
the serial number (SN) shown on
the pump is the serial number on
the back of your transmitter and
select Confirm. If you receive the No
devices found message, place the
transmitter back onto the charger.
Then remove the transmitter from
the charger and immediately select
Retry on the pump.
6. Connection is now complete. The
transmitter serial number will be
displayed on the pump screen.
Note: These steps only need to be done
as a first time set-up. You will not have to
repeat with each new sensor you start.
Note: If you stop using CGM for a period of time and need to store your
transmitter, please make sure to leave it connected to the charger during
the storage period. This will help ensure you get the most life out of your
transmitter battery.
51
CGM I Inserting and Starting the Sensor
Section 15: Inserting and Starting the Sensor***
Before you insert your sensor, gather all of your supplies:
Enlite™ System Components*
Thumb print
A
B
C
A
D
Bump on button
One-press Serter
Enlite Sensor & Pedestal
A – Pedestal
B – Needle Housing
C – Sensor
D – Clear Liner
Sensor Overtape
Guardian 2 Link
A – Pre-cut Hole
*For more details on the Enlite system components, consult the User Guides
One-press serter is required in order to insert the sensor properly
Enlite sensor is individually packaged and comes attached to a plastic pedestal
which is necessary for proper loading into the serter
Sensor overtape is required to keep the sensor securely in place
Guardian™ 2 Link transmitter is connected after the sensor is inserted and covered
with the overtape
***Please refer to the One-press serter user Guide and your HCP for more information.
52
CGM I Inserting and Starting the Sensor
Selecting Your Site
Your sensor can be inserted in any of the shaded areas shown here**. The sensor
insertion site should be at least:
•
5 centimeters from your navel
•
2.5 centimeters from your insulin
pump infusion site
•
2.5 centimeters from any manual
insulin injection site
**Clinical trials for glucose sensors were performed on sensors inserted in these areas.
For good sensor glucose performance, avoid sites:
•
Where clothing may rub or constrict (for example, your beltline)
•
Where your body naturally bends a great deal which may cause the sensor
to pull out
•
That are scarred or have hardened tissue or stretch marks
•
Where there is a great deal of motion or friction
Preparing Your Site
•
Wash your hands with soap and water.
•
Clean the selected site with an alcohol swab and allow the alcohol to dry.
Do not use IV prep or the sensor may not work properly.
53
CGM I Inserting and Starting the Sensor
Inserting Your Sensor
The instructions below only refer to the One-press Serter.
If you have a different serter model, please refer to your serter User Guide for instructions
on how to insert the sensor.
1a. Hold sensor by plastic
pedestal. Remove sensor with
attached pedestal by holding
pedestal only. Place sensor/
pedestal on a clean, flat surface
(such as a table).
4a. Place serter on body. Hold serter steadily
against your cleaned insertion site, without
pushing serter too deeply into skin.
Note: Failing to hold serter securely flat
against body may allow serter to spring
back after pressing buttons and result in
improper insertion of sensor.
1b. Tuck adhesive tab.
Make sure that sensor’s
adhesive tab is tucked
under sensor connector
and snaps.
X
Correct
2. Load sensor into serter.
Grip serter exactly as shown
with thumb on thumbprint marking
on serter. Do not hold side buttons.
Push serter down onto pedestal until
base of serter sits flat on table.
X
Correct
Incorrect
3. Detach serter from pedestal.
To detach serter from pedestal,
grip serter as shown, with
thumb on thumb print on
serter. With other hand, place
two fingers on pedestal arms,
and slowly pull serter straight
up. Note: Make sure that
pedestal is firmly on table
before pulling serter away.
Warning: Do not detach
pedestal from serter in
mid-air as this may
damage sensor.
NOTE: The sensor remains
inside the serter after removing
the pedestal. The arrow on both
sides of serter indicate location
of the sensor needle.
54
Incorrect
4b. Insert sensor. Press and release bump on
both buttons at same time.
4c. Hold serter against body. Continue holding
serter against body to allow adhesive time to
stick to skin.
4d. Remove serter from body. Slowly pull serter
away from skin, making sure buttons are not
pressed.
5. Remove needle housing. Gently hold
base of sensor against skin with one hand.
With other hand, hold needle housing at
top and slowly pull it straight, away from
sensor. Dispose of needle housing in a sharps
container.
Warning: Watch for bleeding at the
insertion site. If bleeding occurs under,
around, or on top of the sensor, apply
steady pressure using sterile gauze or a
clean cloth placed on top of the sensor for
up to three minutes. The use of non-sterile
gauze can cause an infection. If bleeding
does not stop, remove the sensor and apply
steady pressure until the bleeding stops.
6a. Remove adhesive pad liner.
Hold sensor in place and gently remove liner
from under adhesive pad. Do not remove the
adhesive liner from the rectangular adhesive
tab.
6b. Press entire adhesive pad to skin. Firmly
press adhesive against skin and smooth entire
adhesive pad so it sticks to skin.
NOTE: Enlite adhesive is pressure-sensitive.
Continue applying pressure to ensure
sensor remains inserted in skin for whole 6
days of wear.
7a. Untuck adhesive tab. Untuck adhesive tab
from under sensor connector.
7b. Straighten adhesive tab.
Straighten adhesive tab so
it lies flat against your skin,
but do not remove adhesive
liner yet.
CGM I Inserting and Starting the Sensor
Taping Your Sensor
Before you connect the Guardian 2 Link transmitter to your Enlite sensor it is
very important that you properly secure the sensor against your skin using
the sensor overtape.
1. Remove large paper backing
from overtape. Do not
remove two smaller paper
tabs on sides of overtape.
2. Attach the overtape to both
the rounded part of the
sensor and the skin in
front of the sensor.
Important: Make sure there is
overtape on both the rounded
part of the sensor and the skin.
3. Apply rest of overtape,
but do not block sensor
connector with overtape.
Press overtape to your
skin for several seconds.
4. Remove two paper tabs
from sides of overtape.
Press overtape against skin.
5. These images show
overtape applied correctly.
IMPORTANT: All Enlite tapes and adhesives stick best when you apply pressure for several
seconds after putting them on your skin. Doing so helps the Enlite sensor stay securely placed
and fully inserted.
Properly applying the overtape is key to ensuring your success with the Enlite sensor. Due to
the sensor’s small size and flexible nature, the overtape helps to secure it from body motion or
physical activity that can cause it to be pulled out.
55
CGM I Inserting and Starting the Sensor
Connecting your transmitter to your sensor
Before connecting the transmitter, make sure the Sensor feature is On. See page
38 if you need help with these steps.
1.
With one hand, hold sensor
in place. With other hand,
connect transmitter
to sensor.
2.
You will hear a faint “click”
when the two components
are connected. Check for
green light to flash on
transmitter.
3.
Remove the paper on
adhesive tab.
4.
Fold adhesive tab over
transmitter. Be careful not
to pull the adhesive tab
too tightly or it may cause
the transmitter to pull from
the sensor connection.
5.
Press adhesive onto
transmitter.
Apply additional tape over
transmitter as needed.
IMPORTANT: If you do not see
a green light flashing on the
transmitter after it is connected
to the sensor, then disconnect
the transmitter and place it back
on the charger to ensure that it is
fully charged. Then reconnect the
transmitter to the sensor.
If for any reason you disconnect
the transmitter from the sensor,
wait 5 seconds before
reconnecting it to the sensor.
It is very helpful to remember the order of
these three steps when changing your sensor:
1. Insert the sensor.
2. Tape the sensor in place.
3. Connect the transmitter.
56
Strongly Suggested: Applying
an additional piece of tape
over the sensor as shown here
helps to ensure the transmitter
and sensor stay secure and
connected during wear. The
Enlite overtape or any other
medical tape can be used.
Enlite overtape
Medical tape*
*A piece of Tegaderm™ cut in half is shown in this image.
Note: When your transmitter is
connected to your sensor they
form a water-tight seal to a
depth of 2.4 meters for up to 30
minutes. You can shower and
swim without removing them.
CGM I Inserting and Starting the Sensor
Starting the Sensor
Once you have inserted the sensor and connected the transmitter, the pump and
transmitter will begin to communicate. Make sure your pump is on the Home
screen so that the message below (in step 1) will be displayed when the
sensor is ready to be started. This typically takes less than a minute, but may take up
to 10 minutes.
1. Select Start New Sensor.
2. The Sensor warm-up started
message will appear.
3. Press and then to clear. Warm up… will appear on the Home screen until
sensor is ready for the first calibration.
If 15 minutes have passed and the Warm up bar does not appear or it looks like
it is not progressing, look in the Quick Status screen, if you see the time of
Next cal listed, the sensor is in Warm up.
Note: The next time you connect
a transmitter, you will see these
screens. Select Start New Sensor
if you have just inserted a new
sensor. Select Reconnect Sensor
if you have only disconnected
and reconnected the transmitter.
57
CGM I Calibrating
Section 16: Calibrating
Your continuous glucose monitoring system requires blood glucose meter readings in
order to provide you with sensor glucose readings. These BG meter readings are entered
into the pump and are for sensor calibrations. Calibration is essential for optimal CGM
performance. CGM does not eliminate the need for BG meter tests.
To calibrate, you must test your blood glucose on your meter and then enter that value
into your pump. The pump will accept BG meter readings between 2.2 mmol/L and
22.2 mmol/L.
After inserting a new sensor, a calibration is needed:
• Within 2 hours after you connect the transmitter to your sensor and start the Warm up
period. Your pump will notify you with a Calibrate now alert when it is ready for its first
calibration.
• Again within 6 hours (first day of inserting sensor only)
• Again every 12 hours (when a calibration is necessary you will receive a Calibrate now alert).
Important: After the first day, the minimum number of calibrations required is one
every 12 hours. However, calibrating 3-4 times a day is optimal and these can
be done when it is convenient for you. To help you remember to calibrate, think
“before is best” - typically the best times to calibrate are before meals, before taking
insulin, and before bedtime. Also check for arrows - calibrating when there are 2 or
3 arrows may decrease sensor accuracy until the next calibration.
58
CGM I Calibrating
Example of optimal calibration times
Glucose level (mmol/L) Blood glucose reading
Target range
Low limit
Sensor glucose
16.7
11.1
3
5.6
1
4
2
0
0
2
4
6
8
10
12
14
16
18
20
22
Time
Optimal calibration time
Optimal calibration time
Not optimal for calibration
Optimal calibration time
When receiving a Calibrate now alert, if you cannot calibrate
right away, you can set the Snooze to remind you to calibrate in
the time that you set.
If you plan to test BG and calibrate right away, simply select Snooze.
Once you select Snooze, Calibration required will appear on the
Home screen until you enter a BG to calibrate.
Remember: Calibrations are necessary in order to continue to receive sensor
glucose readings, alerts and alarms.
59
CGM I Calibrating
Calibrating the Sensor
There are 5 different ways that you can enter a BG reading to calibrate the sensor.
Calibrating by using the Contour® next LINK 2.4 Meter
When you use the compatible Bayer meter, you will see the meter value automatically
displayed on the home screen, as shown here.
1. Select Calibrate Sensor or if you plan
to give a bolus using Bolus Wizard,
select Bolus.
2. If you have selected Bolus,
select Yes to Calibrate Sensor?
after bolus is delivered.
Calibrating through the Bolus Wizard
In the Bolus Wizard:
1. Select Deliver Bolus.
2. Select Yes to calibrate sensor.
Calibrating through Home Screen Graph
1. Select
press
60
to the sensor graph,
and hold.
2. Press
press
or to enter BG value,
and select Calibrate.
CGM I Calibrating
Other ways to calibrate
The 2 other ways to calibrate your sensor are through:
• Sensor Settings: from the Menu, go to Sensor Settings >
Calibrate Sensor, select BG and press or to enter
BG value > press and select Calibrate.
• Event Markers: from the Menu, go to Event Markers >
BG > Enter BG > press > select Save >
select Yes to calibrate sensor.
Once you have entered a calibration BG, the Home screen
will show you that the system is calibrating.
You will start seeing sensor glucose readings again in 5-15
minutes.
IMPORTANT: If you notice a large difference between your BG meter reading and
sensor glucose readings, wash your hands and do another BG fingerstick test to help
ensure a more accurate reading. Check the sensor site to ensure the sensor overtape
is still holding the sensor in place. If there is still a large difference in glucose readings,
another calibration may be needed to bring the readings closer together again.
You can use the Calibration Reminder to give you notice before the next calibration
is necessary.
The Calibration Reminder defaults On with a reminder time of 1:00 hour and you
can change it by going to the Reminders menu option.
61
CGM I Other Sensor Alerts
Section 17: Other Sensor Alerts
We discussed personalised alerts earlier in Section 12. There are other sensor alerts
that you will receive as well.
The most common alerts that you can expect to receive when using CGM can be
found in the table below.
Alert
Reason
Steps to take
A calibration is needed in order to
receive sensor glucose readings.
Enter BG value into your pump to
calibrate.
Communication between pump and
transmitter has been lost for 30 minutes
during or after warm-up.
Check that the sensor is still inserted
in the skin and the transmitter and
sensor are still connected. Move your
pump closer to your transmitter.
Calibration not
accepted
The BG meter value could not be used
to calibrate; it was too different from
the SG value.
Wait at least 15 minutes for BG to
stabilise. Wash your hands and repeat the
BG test. Use this value to calibrate again.
BG not
received
The transmitter was unable to receive
the calibration BG reading from the
pump.
Move your pump closer to your
transmitter and select OK. The pump
will try sending the BG again.
Sensor expired
Sensor has reached its maximum usage
of 6 full days.
Remove the sensor and follow the
instructions for inserting and starting
a new sensor.
Change sensor
You have received two Calibration
not accepted alerts in a row.
Remove the sensor and follow the
instructions for inserting and starting
a new sensor.
Cannot find
sensor signal
The pump has not received a signal
from the transmitter.
Disconnect and reconnect your
transmitter and sensor and select OK.
Calibrate now
Lost sensor
signal
For a complete list of Alerts and Alarms, refer to the MiniMed 640G System User Guide.
62
Appendix I Charging and Storing your transmitter
Charge the transmitter before each use. When the
transmitter is charging, a green light will flash on
the charger. This green light will turn off when the
transmitter is completely charged. You will need to
charge the transmitter after each sensor use. A fully
charged transmitter can be used for a maximum of six
days without recharging. It can take up to an hour to
fully recharge.
!
Charging and Storing the Guardian™ 2 Link Transmitter
When you remove the transmitter from the charger,
a green light should flash on the transmitter. This
indicates that it has enough battery power to be
connected to the sensor. If you do not see the green
flashing light on the transmitter place it back on the charger until it is fully charged.
Store the transmitter, charger, and test plug in a clean, dry location at room
temperature. Although not required, you may store the transmitter on the charger. If
the transmitter is not in use, you must charge it at least once every 60 days.
If you connect transmitter to charger and you see no lights on the charger: replace
the battery in the charger.
While charging your transmitter you see a flashing red light on the charger: replace
the battery in the charger.
While charging your transmitter you see a mix of short and long flashing red lights
on the charger: replace the battery in the charger and fully charge the transmitter.
Refer to your Guardian 2 Link transmitter and charger User Guides for more
information.
63
Appendix I CareLink™
CareLink™ Personal Software
What is CareLink™ software?
CareLink™ Personal software is a web-based
software that allows you to upload information
from your MiniMed™ 640G system to a secure
online (internet) site for viewing.
CareLink software organises all of your insulin
pump, sensor glucose and blood glucose meter
information into reports (charts, tables and
graphs) that can help you track glucose levels,
insulin usage and carbohydrate intake over time.
With CareLink software, you can grant your healthcare provider online access,
so that your information can be discussed at your next appointment.
Benefits of CareLink software
CareLink Personal software makes it easier to track your glucose levels and see
how they are affected by your insulin delivery, meals and exercise routines.
CareLink Personal provides a secure place to store your information and uncover
patterns in your glucose control that meter and logbooks alone cannot reveal.
Information from CareLink software can help you and your healthcare provider make
more informed therapy decisions aimed at improving your glucose control.
CareLink reports can help you and your healthcare provider make
decisions that improve your control and fit your lifestyle.
The combination of insulin pump therapy, continuous glucose monitoring
and CareLink software provides you with the tools and information you
may need to optimise your therapy.
For more information on how to upload information to CareLink Personal software using
the Contour® Next LINK 2.4 glucose meter from Bayer, see page 24.
64
Appendix I X-rays and Traveling by Air
X-rays, MRI, or CT Scan
If you are going to have an X-ray, MRI, CT scan, or other
type of diagnostic imaging involving radiation exposure,
remove your insulin pump, transmitter, and glucose sensor
and place them outside of the testing area.
Traveling by Air
If you wear a CGM device, you may need to stop the wireless communication between
the transmitter and the pump during the flight.
To temporarily stop wireless communication, turn Airplane Mode on. From the
Menu, go to Utilities > Airplane Mode, select Airplane Mode to turn On and Save.
The transmitter continues to measure glucose levels when in Airplane Mode.
To resume wireless communication, turn Airplane Mode off:
When Airplane Mode is turned off and communication resumes, the transmitter will
send up to 10 hours of sensor data to your pump.
If Airplane Mode was on for <6 hours:
1) Wait 15 minutes for sensor data to appear on pump screen
If Airplane Mode was on for >6 hours:
1) Disconnect transmitter from sensor and then reconnect it.
2) Select Reconnect Sensor when it appears on the pump screen to begin
sensor warm-up.
3) The sensor data (up to 10 hours) will appear on the pump.
4) You will be asked to calibrate in 2 hours to resume sensor readings.
Always remember that it is important when traveling to be extra attentive to
monitoring your glucose and prepared to respond if needed.
65
Appendix I SmartGuard ™ Suspend by Sensor Features
The images below show additional detail
about using the Smartguard suspend by
sensor features of your MiniMed 640G System.
Sensor glucose trend
Estimated sensor glucose trend
Sensor glucose trend during suspend
1) Suspend on low event:
If sensor glucose (SG) reaches your low limit,
insulin delivery will be stopped.
You will always receive a message and alarm
when this occurs.
Low Limit
You will have 10 minutes to respond before the
pump begins to siren and emergency message
appears.
2) Suspend before low event:
To help keep sensor glucose (SG) from reaching
your low limit, insulin delivery will be stopped
if SG is:
• at or within 3.9 mmol/L above the low limit
30 min
• predicted to be approaching the low limit
in 30 minutes
Low Limit
If Alert before low is on, you will receive an
alert when insulin is suspended.
3) Alert on low during Suspend before low:
If insulin delivery has stopped due to Suspend
before low, SG may still reach your low limit.
You will always be alerted when this occurs.
Low Limit
66
You will have 10 minutes to respond before
the pump begins to siren.
Appendix I SmartGuard™ Suspend by Sensor Features
4) Automatic basal resume based on sensor glucose (SG) value:
During Suspend before low or Suspend on
low, basal insulin will automatically resume if:
• SG is above the low limit and trending
upward
Low Limit
30 min
• insulin has been suspended by sensor
for at least 30 minutes
If Resume basal alert is on, you will receive
an alert when this occurs. Remember you can
manually resume basal insulin at any time.
5) Automatic basal resume due to 2 hour maximum suspend:
During either Suspend before low
or Suspend on low, if basal insulin is
not resumed due to SG values, it will
automatically resume after 2 hours.
Low Limit
2 hours
You will always receive an alert when you
reach the 2 hour maximum suspend time,
even if the Resume basal alert is set to off.
Remember you can manually resume basal
insulin at any time.
6) Suspend by sensor unavailable:
Once basal insulin resumes following either
a Suspend before low or a Suspend on low,
there will be a period of time when suspend
by sensor is unavailable.
30 min
Low Limit
This will most often be 30 minutes if you
respond to the suspend alarm, but can
be up to 4 hours. See the User Guide
for more specific information about this
unavailable period.
67
Who to contact and when?
CONTACT MEDTRONIC
Please contact Medtronic for further guidance and technical advice on using
your MiniMed pump.
• If you have any concerns that your pump isn’t functioning correctly.
• If your pump displays a warning sign or alarm which you cannot switch off.
• For more information about a certain pump function.
• For guidance when adjusting your basal insulin dose, as instructed by your doctor.
Visit our website at:
www.medtronic-diabetes.co.uk
Alternatively call our customer
support helpline 01923 205167
CONTACT YOUR HEALTHCARE PROFESSIONAL
Europe
Medtronic International
Trading Sàrl
Route du Molliau 31
Case postale
CH-1131 Tolochenaz
www.medtronic.eu
Tel: +41 (0) 21 802 70 00
Fax: +41 (0) 21 802 79 00
United Kingdom
Medtronic UK Ltd.
Building 9
Croxley Green Business Park
Watford, Hertfordshire
WD18 8WW. UK
www.medtronic.co.uk
www.medtronic-diabetes.co.uk
Tel: +44 (0)1923 212 213
Fax: +44 (0)1923 241 004
Republic of Ireland &
Northern Ireland
Medtronic Ireland Ltd
Unit GA
Swords Business Campus
Balheary Road
Swords
Co Dublin.
www.medtronic.ie
www.medtronic-diabetes.ie
UC201500095aEEREVB ©2015 Medtronic MiniMed, Inc. All rights reserved.
For all other inquiries regarding your health and continuing care please contact
your healthcare professional.
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