COMPANION InPen User manual

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InPen™System
Instructions for Use

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Contents
1. Introduction................................................................4
2. Indications for Use..................................................... 5
3. Contraindications..................................................... 6
4. Supported Devices.................................................... 7
5. Getting Started .......................................................... 8
6. Using the InPen™ App ..............................................18
7. Advanced App Features.........................................25
8. Troubleshooting ...................................................... 33
9. Compatible Insulin and Needles.......................... 39
10. Getting Ready...........................................................39
11. Prepare your InPen.................................................. 39
12. Prime your InPen™ (Before Every Injection)........41
13. Selecting Your Dose ................................................44
14. Injecting the Dose....................................................46
15. How Much Insulin is Left in Your InPen™? ...........49
16. Replacing a Used Insulin Cartridge.....................50
17. Handling and Storage of Your InPen™.................50
18. Cleaning of Your InPen™ .........................................51
19. Disposal .....................................................................52
20. Important Information........................................... 52
21. Supplemental Information....................................54
22. Warranty ...................................................................54

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Symbols in This User Guide
The following symbols are found on the InPen™ or the
package labels. These symbols tell you about the
proper and safe use of the InPen™ System.
Non-ionizing Radiation
Consult Instructions For Use
Caution
Do Not use if Package is Damaged
Temperature Limitation
Humidity Limitation
Pressure Limitation
Keep Dry
Protection Against Insertion of Large Objects
and Dripping Water
Type BF Applied Part
Device Meets European Council
Directive 93/42/EEC
Manufacturer
Authorized Representative in
the European Community
Activate By Date
European Union WEEE Directive 2012/19/EU

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1. Introduction
This user guide will explain how to use your InPen™ and
the InPen™ Application (app). Read it carefully before
you use your InPen™.
You should read this manual before use – even
if you have used the InPen™before. Failure to
follow the instructions may result in too much or too
little insulin being delivered.
Important: Do not share your InPen ™or needles as
infection or disease can be spread from one person to
another.
If any of the parts of your InPen™ appear broken or
damaged, DO NOT USE. Contact Customer Service by
tapping Settings from the Home screen and selecting
Help and Support for a replacement.
InPen™ is not recommended for the blind or visually
impaired without the assistance of a sighted individual
trained to use it. Always carry a spare insulin delivery
device in case your InPen™ is lost or damaged.
The InPen™ App is a diabetes management tool that
helps track your insulin doses, calculate insulin doses
using current glucose and carbohydrates, and share
your therapy with your healthcare professional and
family members.
The insulin dose calculations provided by the app are
meant for patients undergoing subcutaneous multiple
daily injection (MDI) therapy. Dose calculators have
been shown to assist in the optimization of glycemic
control in MDI patients under the supervision of
healthcare professionals experienced in managing
insulin-treated patients. Dose calculators have also
been shown to reduce patient fear of hypoglycemia
and improve patient confidence in diabetes
management.
Dose calculators also track residual bolus insulin to
mitigate insulin stacking.

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System Description
The InPen™ system includes the InPen™ smart
insulin pen and the InPen™ App. The InPen™ system
automatically records dose size and timing of insulin
doses, provides reminders if insulin is not taken,
includes an insulin dose calculator with personalized
settings, tracks insulin on board, and has the ability to
integrate with other diabetes technologies, including a
continuous glucose monitor (CGM).
Key Features:
• View simple, graphical visuals of your diabetes
therapy and active insulin.
• Calculate insulin doses using current glucose
and carbohydrates or meal type and/or size.
• Set reminders so you don’t forget to take
your insulin
• Import glucose data automatically from
supported CGMs and BGMs
• View and share integrated diabetes therapy
reports with your healthcare provider
Support:
• Setup wizard within the app.
• User Guide links within the app
• Instructional videos within the app.
2. Indications for Use
The InPen™ is a home-use reusable pen injector for
single-patient use by people with diabetes under the
supervision of an adult caregiver, or by a patient age
7 and older for the self-injection of a desired dose of
insulin. The pen injector is compatible with Lilly
Humalog® U-100 3.0 mL cartridges, Novo Nordisk
Novolog® U-100 3.0 mL cartridges, and Novo Nordisk
Fiasp® U-100 3.0 mL cartridges and single-use
detachable and disposable pen needles (not
included). The pen injector allows the user to dial the
desired dose from 0.5 to 30 units in one-half (1/2) unit
increments.
The InPen™ dose calculator, a component of the InPen™
App, is indicated for the management of diabetes
by people with diabetes under the supervision of an
adult caregiver, or by a patient age 7 and older for

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calculating an insulin dose or carbohydrate intake
based on user entered data.
For an insulin dose based on amount of carbohydrates,
a healthcare professional must provide patient-
specific target blood glucose, insulin-to-carbohydrate
ratio, and insulin sensitivity parameters to be
programmed into the software prior to use.
For an insulin dose based on fixed/variable meal
sizes, a healthcare professional must provide patient-
specific fixed doses/meal sizes to be programmed into
the software prior to use.
3. Contraindications:
The InPen™ system is not intended for anyone unable
or unwilling to:
• Test blood glucose (BG) levels as
recommended by a healthcare provider
• Maintain sufficient diabetes self-care skills
• Visit a healthcare provider regularly
Caution: US law restricts the sale of the InPen™
System to sale by or on the order of a physician.
Important Pediatric User Information:
The following recommendations are meant to
help younger patients and their caregivers manage
and care for the InPen™ system. Younger children may
inadvertently play with the pen injector or the app,
leading to unintentional logging or delivery of insulin. It
is the responsibility of the healthcare provider and the
caregiver to determine if the patient is appropriate for
treatment with the InPen™ system.
Do not allow small children to chew on or ingest parts,
such as the pen cap and cartridge components.
Small parts could pose a choking hazard. If ingested
or swallowed, these component pieces may cause
internal injury or infection.
For patients who do not self-manage their disease, the
smart device should always be under the supervision
of a caregiver. Inadvertent button presses may lead
to unintentional dose logging or changes to therapy
settings. These changes can potentially lead to

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hypoglycemic or hyperglycemic events which could
result in serious injury or death.
4. Supported Devices
The InPen™ App is compatible with:
• iOS 10 or later
• Android 6 or later
This product should only be used with supported
mobile devices. Refer to your local Medtronic® website
or HelpLine for information about supported devices
and operating systems.
Periodically, the app needs to confirm that it is
compatible with your smart device and operating
system version. You may see system messages with
instructions or warnings. Make sure you have an
internet connection (ensure that Wi-Fi or cellular data
is enabled) whenever possible.
Caution: You must first pair your InPen™with
a smart device and the InPen™App. This will
ensure that doses from your InPen™are sent
wirelessly to the App on your smart device.
Warning: The Bluetooth®feature on your InPen™
sends dose information to your smart device.
To prevent other people’s doses from being sent
to the smart device, do not let anyone else use
your InPen™to dose insulin. The InPen™is for
single patient use only.
Bluetooth®performance varies due to
differences in phone hardware and operating
systems. The InPen™App is not recommended
on Jailbroken or Rooted devices.
Your smart device must have enough memory
storage or the InPen™App will not be able to be
installed or log dose. You may need to delete
files or apps from your smart device.

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5. Getting Started
The following steps will get you started using the
InPen™ App:
1. Download the InPen™ App from the App Store
and install it on your smart device.
2. Open the app.
3. Log in to the app using an existing account or
create a new one.
4. After you log in to the app, follow the steps in
the setup wizard.
5.1 About You
1. Take a moment to tell us about you.
5.2 Therapy Setup
Before the app can be used, you will need your dose
calculator and Long-acting insulin settings from your
healthcare provider. Your healthcare provider may
have already entered these for you at your visit. If not,
you can find these on your InPen Prescription Form.
If you do not have your Therapy Settings you can skip
this section of the wizard and complete it later. The
dose calculator will be locked out until these settings
are entered.
IMPORTANT: To use the dose calculator safely,
it is extremely important that Therapy Settings
are correct. Proceed only after talking to your
health care provider.
IMPORTANT: Once selected and confirmed,
your Meal Therapy cannot be changed. Verify
with your doctor if you are unsure of your Meal
Therapy. If you choose the wrong meal therapy
contact Customer Service by tapping Settings
from the Home screen and selecting Help and
Support.

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There are three different ways to calculate insulin
doses using the InPen™ App. Your healthcare provider
has prescribed you one of the following:
• Fixed Dosing
• Meal Estimation
• Carbohydrate Counting
Once you have your dose calculator settings, tap
on each line to set the correct value. Once you have
selected the correct value, tap the green check mark to
save and the red X to cancel.
To change the Meal Therapy
mode:
1. Go to Therapy Settings,
then proceed after reading
the disclaimer
2. Tap Meal Therapy and
select the new Meal Therapy
mode prescribed by your
healthcare provider.
3. Tap on each line to set the
value to match the settings
provided by your healthcare
provider.
IMPORTANT: Before
changing Meal
Therapy Mode, you
will need your current
Meal Therapy settings
from your healthcare
provider. Previous Meal Therapy settings may
be lost when you change to a new Meal Therapy
type.
IMPORTANT: An updated prescription is required
to increase the precision of your Meal Therapy
mode.

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1. Fixed Dose Mode - Setup
The following settings must be set before you can
begin fixed dosing:
Maximum Calculated Dose – The maximum
calculated dose that your healthcare provider
determines is safe for you. If a single dose
recommendation or the total of recent doses plus the
recommendation exceeds the maximum calculated
dose setting, an alert will be displayed. Refer to the
instructions given by your healthcare provider.
Duration of Insulin Action – This is the amount of time
that insulin is actively lowering your blood glucose. It is
used to calculate Active Insulin.
Target Blood Glucose – This is the blood glucose
value you are trying to achieve. When entering a
blood glucose value into the Dose Calculator, it will
recommend insulin or carbohydrates to return to this
target value.
Insulin Sensitivity Factor – This is the amount your
blood glucose is lowered by 1 unit of insulin.
Time of Day Settings – By default, this is disabled and
Target Blood Glucose and Insulin Sensitivity Factor
are constant throughout the day. By sliding the switch
to the right, you can set these values to four different
values throughout the day. To disable this feature, slide
the switch back to the left.
Each day at the time selected, the values in the column
will be active until the next column’s time is reached.
Tap the time to adjust it. Note that the times must be in
order and cannot overlap.
Time of Day settings are disabled by default. See
Advanced App Features for instructions.
Fixed Dose Settings - This is the dose size your
healthcare provider has determined for the different
meals of the day.

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How to Use
• In Fixed Dose mode the Dose Calculator will
provide a fixed dose insulin recommendation at
meal times.
• After choosing your meal, you can enter a current
glucose for a dose recommendation that includes
a glucose correction if needed.
• Connected BGM may pre-populate through Apple
Health. Only blood glucose values less than 10
minutes old will be pre-populated.
• After tapping Save, the dose recommendation is
shown at the top of the home screen.
• You can tap Cancel to go back without saving the
entry.
See Section 6.2 Calculate an Insulin Dose for more
about the types of recommendations you may receive.
2. Meal Estimation Mode - Setup
The following settings must be set before you can
begin meal estimation dosing:
Maximum Calculated Dose – The maximum
calculated dose that your healthcare provider
determines is safe for you. If a single dose
recommendation or the total of recent doses plus the
recommendation exceeds the maximum calculated
dose setting, an alert will be displayed. Refer to the
instructions given by your healthcare provider.
Duration of Insulin Action – This is the amount of time
that insulin is actively lowering your blood glucose. It is
used to calculate Active Insulin.
Target Blood Glucose – This is the blood glucose
value you are trying to achieve. When entering a
current glucose value into the Dose Calculator, it will
recommend insulin or carbohydrates to return to this
target value.
Insulin Sensitivity Factor – This is the amount your
blood glucose is lowered by 1 unit of insulin.

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Meal Estimation – Slide the switch to the right to select
the dose size for low carb, medium carb, and high
carb meals and snacks. Each day at meal times, the
InPen™ App will ask you what size meal you are eating
and recommend the correct dose. Tap the meal size to
adjust it.
Time of Day Settings – By default, this is disabled and
Target Blood Glucose and Insulin Sensitivity Factor
are constant throughout the day. By sliding the switch
to the right, you can set these values to four different
values throughout the day. To disable this feature,
slide the switch back to the left. Each day at the time
selected, the values in the column will be active until
the next column’s time is reached. Tap the time to
adjust it. Note that the times must be in order and
cannot overlap.
Time of Day settings are disabled by default. See
Advanced App Features for instructions.
How to Use
• In Meal Estimation mode the Dose Calculator will
provide an insulin recommendation based on
meal size at meal times.
• After choosing your meal size, you can enter blood
glucose (BG) for a dose recommendation that
includes a glucose correction if needed.
• Connected BGM may pre-populate through Apple
Health. Only BG values less than 10 minutes old will
be pre-populated.
• After tapping Save, a revised dose
recommendation is shown at the top of the home
screen.
• You can tap Cancel to go back without saving the
entry.
See Section 6.2 Calculate an Insulin Dose for more
about the types of recommendations you may receive.

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3. Carb Counting Mode - Setup
The following settings must be set before you can
begin carb counting dosing:
Maximum Calculated Dose – The maximum
calculated dose that your healthcare provider
determines is safe for you. If a single dose
recommendation or the total of recent doses plus the
recommendation exceeds the maximum calculated
dose setting, an alert will be displayed. Refer to the
instructions given by your healthcare provider.
Duration of Insulin Action – This is the amount of time
that insulin is actively lowering your blood glucose. It is
used to calculate Active Insulin.
Time of Day Settings – By default, this is disabled and
Target Blood Glucose, Insulin-to-carbohydrate Ratio,
and Insulin Sensitivity Factor are constant throughout
the day. By sliding the switch to the right, you can set
these parameters to four different values throughout
the day. To disable this feature, slide the switch back to
the left.
Time of Day (If Time of Day Settings are enabled) –
When enabled, these select the start time for each
new set of parameters. Each day at the time selected,
the parameters in the column beneath it will be active
until the next column’s time is reached. Tap the time
to adjust it. Note that the times must be in order and
cannot overlap.
Target Blood Glucose – This is the blood glucose
value you are trying to achieve. When entering a
current glucose value into the Dose Calculator, it will
recommend insulin or carbohydrate to return to this
target value.
Insulin Sensitivity Factor – This is the amount your
blood glucose is lowered by 1 unit of insulin.
Insulin-to-carbohydrate Ratio – This is the number of
grams of carbohydrate covered by 1 unit of insulin.

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How to Use
• In Carb Counting mode the Dose Calculator
will provide a carbohydrate counting insulin
recommendation once you have entered a current
glucose or carbohydrates (Carbs) only, or both.
• Enter your current glucose and/or the number of
grams of Carbs you are eating or plan to eat and
tap Save.
• Connected BGM may pre-populate through Apple
Health. Only blood glucose values less than 10
minutes old will be pre-populated.
• After tapping Save, a revised dose
recommendation is shown at the top of the home
screen.
• You can tap Cancel to go back without saving the
entry.
See Section 6.2 Calculate an Insulin Dose for more
about the types of recommendations you may receive.
When you have entered all values and carefully
checked that they are correct, tap Next.
4. Long-acting Insulin
The app will remind you to take your Long-acting
insulin. If you log a Long-acting dose prior to the
reminder time the app will not remind you. If no long
acting dose was logged, the app will remind you.
Once you have your long acting insulin settings, tap
on each line to set the correct value. Once you have
selected the correct value, tap the green check mark to
save and the red X to cancel.
The values that must be set are:
Insulin Type – This is the type of Long-acting insulin
that you take.
Doses per Day – This is the number of doses you take
per day.
Usual Amount – This is the dose size you have been
prescribed by your healthcare provider.

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Time – This is the time of day that you are supposed to
take your dose.
When you have entered all values and carefully
checked that they are correct, tap Next.
5.3 Your Schedule
The app will also remind you to take your insulin at
mealtimes and take any action before bed time.
The setup wizard will ask you to enter the earliest
and latest times that you eat breakfast, lunch, and
dinner. Make sure that you consider times during the
week when going to work or school and times on the
weekend which may be different.
5.4 Bedtime
The setup wizard will next ask you when you typically
go to bed. Consider the time before bed when you
would be able to check your glucose and take any
correction doses with InPen™ if needed.
InPen™ reminds you to check your blood glucose
before bedtime and recommends additional insulin
or carbohydrates if needed to help control your blood
glucose.
5.5 Connect InPen
IMPORTANT: To ensure a secure connection, pair
your InPen™and smart device in a secure area
with limited Bluetooth®devices in range.
CAUTION: Make sure you know which InPen™you
are pairing with your smart device.
IMPORTANT: The use of a security code on your
mobile device is recommended.

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1. Place the devices within 3 feet (~1 meter) of
each other before you begin.
2. Make sure Bluetooth®is enabled on your
smart device.
3. Follow the instructions in the app to pair
your InPen™.
4. The InPen™ App will display Pairing Successful
once InPen™ and your smart device are paired.
5. Follow the instructions to name your InPen™.
6. Read the important notes regarding
treatment decisions.
5.5 Install an Insulin Cartridge
Follow the video instructions in the app for an overview
of how to install an insulin cartridge. See Section 11
Prepare your InPen™ for more detailed instructions.
5.6 Taking an Insulin Dose
Follow the video instructions in the app for an overview
of how to take an insulin dose. See Section 12 Prime
your InPen™(Before Every Injection) for more detailed
instructions.
5.7 InPen Support
If you have product support questions, do not call
your doctor. Help and support is available by phone
or email or using our self-service Help Center any
time through Settings > Help and Support > Support.
Check Troubleshooting for explanations of app error
messages and a list of other common issues and
solutions.
5.8 Tutorial
Tap through the tutorial for an overview of the features
of the app. You can review the tutorial and this user
guide at any time through Settings > Help and Support
> Support.

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5.9 Important Smart Device Setup
IMPORTANT: Your smart device must be set up
correctly to work properly and safely with the
InPen System. Your device’s internal settings
override any InPen™App setting. If the settings
on your device are incorrect your InPen System
may not function properly.
IMPORTANT: Enable the security features of your
smart device to prevent unauthorized access to
your data and settings.
To ensure safety and security, utilize virus/malware
scanning software on your smart device.
To receive Alarms or Alerts you must:
• Make sure the notifications are turned on in the
settings menu
• Check that the app hasn’t been shut down by
your smart device
• Make sure to turn on Bluetooth®on your
smart device
• Turn off the Do Not Disturb feature on your
smart device (if available)
• Start the app after your smart device
is restarted
• Set the volume on your smart device at a level
you can hear
• Do not kill or force close the app; always run
the app in the background
• Unplug your headphones when you are done
using them; Alarms and Alerts from the app
cannot be heard through your smart device’s
speakers if headphones are plugged in
The InPen™ alarm and alert vibrations are not any
different from other vibrating apps on your smart
device. Medical device apps, like the InPen™ App, do
not have any special priorities over your smart device’s
features. You cannot determine if a vibration is a
notification from your InPen™ App or another app. The
only way to know is to look at the screen of your device.
The smart device checks and updates the date and
time in your InPen™. Check the date and time on your
device often to be sure it is correct. Check the date and

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Current glucose
measurement
Time and size
of last entry
Current
Active Insulin
(if enabled)
Calculator/
Recommendation
Bar
Notification
icons:
Daily
Timeline
Insulin Temperature
Insulin Age
Low InPen Battery
Rapid-acting Reminder
Long-acting Reminder
Alert
Trend Graph
Notification icons:
time on your device when you travel across time zones.
Keep “set Automatically” enabled and let your smart
device manage the date and time. For instructions on
setting the date and time on your device, see the user
manual for your device.
The InPen™ App is known to be free of malware.
6. Using the InPen App

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6.1 Overview of Your Recent Glucose and
Insulin Usage
The Home screen shows an overview of your recent
glucose and insulin use.
Current Glucose shows the
last glucose you entered or
measured with a connected
BGM or supported CGM. If
the glucose is more than 10
minutes old, the value will
show “---” and you will need to
measure your glucose again.
Active Insulin is an estimate
of the insulin from recent
doses that is still being used
in the body. It is based on the
recent doses you’ve taken,
and your Therapy Settings. If
you take a 5 U dose, there will
initially be a full 5 units in your
body. Over several hours this
will decrease as it is used by
your body and Active Insulin
will reach 0.0 units until more
insulin is taken.
NOTE: Long-acting
insulin is not
considered part of
Active Insulin. Active
Insulin applies to
Rapid-acting or
mealtime insulin only.
The Daily Timeline is a graphical representation of
glucose, carbohydrates meals, and insulin doses
over the last 24 hours. Your most recent glucose,

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carbohydrates/meals and insulin doses will appear
at the top, of the Timeline, and will move down the
timeline as new logbook entries are saved. Only BGM
values and glucose values entered and saved in the
Dose Calculator are shown in the timeline.
The Trend Graph shows your glucose over time from
CGM or BGM. Glucose data from BGM will be shown as
individual points. Glucose data from CGM will be shown
as a series of closely spaced points. Your most recent
glucose will be shown as a hallow circle. By tapping the
Trend Graph you can toggle between 3, 6, 12, and 24
hour views.
6.2 Calculate an Insulin Dose
IMPORTANT: Your Therapy Settings must be set
correctly before using the Dose Calculator. Do
not use the Dose Calculator if you have guessed
settings or believe they may be set incorrectly.
IMPORTANT: All insulin you have recently taken
must be entered to ensure that Active Insulin
is correct. If you have taken any Rapid-acting
or mealtime insulin from a device other than
InPen, it must be logged manually.
IMPORTANT: If you do not enter a current glucose
value, Active Insulin will not be subtracted from
the dose recommendation.
WARNING: Using the Dose Calculator with
incorrect Therapy Settings or without all of
your recent insulin logged may result in unsafe
recommendations, which could lead to severe
hyperglycemia, hypoglycemia, or injury.
WARNING: If your InPen™is out of range of the
smart device the Dose Calculator may not have
all of your recent insulin logged and may result
in unsafe recommendations, which could lead
to severe hyperglycemia, hypoglycemia, or
injury.