COMPANION InPen User manual

User Guide
InPen™ Reusable Pen Injector

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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
v
National Recognized Test
Laboratory
IP22

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Contents
Symbols in This User Guide.............2
1 Introduction ................................5
2 Indications For Use ...................8
3 Contraindications: .....................9
4 Compatible Insulin and
Needles .............................................. 10
5 Getting Ready.......................... 10
6 Preparing your InPen ............ 10
7 Prime your InPen (Before Every
Injection)............................................ 13
8 Selecting Your Dose............... 18
9 Injecting the Dose .................. 20
10 How Much Insulin is Left in
Your InPen?....................................... 26
11 Replacing a Used Insulin
Cartridge............................................ 27
12 Handling and Storage of
Your InPen......................................... 27
13 Cleaning of Your InPen .... 28
14 Replacement........................ 30
15 Disposal................................. 30
16 Supplemental Information31
17 Warranty............................... 32
18 Product Specifications ....... 34

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InPen™User manual
1Introduction
Thank you for choosing InPen, the
insulin pen designed to help make
your insulin treatment easier. This
manual will tell you how to use and
handle your InPen. Read it carefully
before you use your InPen.
InPen is easy to use. It delivers doses
from 0.5 (½) to 30 units of insulin. You
can dial your dose one half (½) unit at
a time. If you dial too many units, you
can correct the dose without wasting
any insulin.
InPen is designed to be used with 3
mL (U-100) insulin cartridges, and
compatible disposable needles.
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.
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 your healthcare provider 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

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insulin delivery device in case your
InPen is lost or damaged.
InPen connects to an optional mobile
device application - the InPen App - via
Bluetooth®. The InPen transmits dose
information so that the application
(“app”) can help you remember the
number of units you received from
your last injection, when the injection
was taken, and other helpful
information.
Download the InPen App from the
Apple Store (iOS) or Google Play
(Android). Refer to the Mobile App
User Guide for instructions of how to
pair your InPen and use the app.
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 stacking.
The dose calculator utilizes the current
blood glucose measurement,
carbohydrate consumption, and active
insulin to calculate the estimated dose.

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1Adapted from Mudaliar et al, Diabetes
Care, Volume 22, Number 9, Sept.
1999, page 1501.
2Indications For Use
The InPen is a home-use reusable pen
injector for single-patient use by
people with diabetes age 12 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 of insulin 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 is a home-use reusable pen
injector for single-patient use by
people with diabetes age 12 and older
for the self-injection of a desired dose
of insulin. The pen injector is
compatible with Novo Nordisk
Novolog® U-100 3.0 mL cartridges of
insulin 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.

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The InPen dose calculator, a
component of the InPen app, is
indicated for the management of
diabetes by people with diabetes age
12 and older by calculating an insulin
dose or carbohydrate intake based on
user entered data. Prior to use, a
healthcare professional must provide
the patient-specific target blood
glucose, insulin-to-carbohydrate ratio,
and insulin sensitivity parameters to be
programmed into the software.
3Contraindications:
The InPen System is not intended for
anyone unable or unwilling to:
•Test blood glucose (BG) levels as
recommended by a healthcare
provider,
•Demonstrate adequate
carbohydrate-counting skills,
•Maintain sufficient diabetes self-
care skills, or
•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.

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4Compatible Insulin and
Needles
InPen is compatible with 3 mL (U-100)
insulin cartridges and disposable
needles (supplied separately). Refer to
the table below to determine
compatible insulin and needles for use
with your InPen:
InPen
Model
Compatible
U-100 3 mL
Cartridges
Compatible
Needles
INPEN-
100EL-
XX
Lilly
Humalog®
BD Ultra-Fine™
and
Novo Nordisk
NovoFine®
INPEN-
100NN-
XX
Novo
Nordisk
Novolog®
5Getting Ready
Wash your hands and make sure you
have the following items available
before beginning:
•InPen
•3 mL U-100 Insulin Cartridge
•New Pen Needle
6Preparing your InPen
6.1 Steps
1. Pull Off Cap
2. Unscrew and Remove the
Cartridge Holder.

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3. Before inserting the Insulin
Cartridge, be sure to inspect your
Insulin Cartridge per the
manufacturer’s instructions. Do
not use the cartridge if it has:
•Expired
•Unusual visual appearance
•Cracks, breaks, or other
damage
4. Insert the small end of the Insulin
Cartridge into the Cartridge
Holder.
5. Attach the Cartridge Holder by
pushing the Cartridge Holder and
InPen Body straight together.
Screw the InPen Body onto the
Cartridge Holder until it clicks and
is secure.

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Caution: If the Cartridge Holder is
not securely attached, the
cartridge may be misaligned and
you may not get your full dose.
6.2 Important Notes
•Your healthcare provider has
prescribed the type of insulin
best for you. Any changes in
insulin should be made only
under medical supervision.
•InPen is for use only with 3
mL U-100 Insulin Cartridges.
•Only use Insulin Cartridges
compatible with your InPen.
•Read and follow the
instructions provided in your
Insulin Cartridge Patient
Information.
•Before each injection, read
the Cartridge Label and be
sure the InPen contains the
correct Insulin Cartridge.
•The color of the InPen is not
intended to indicate insulin
type.
•The numbers on the
Cartridge Holder give an
estimate of the amount of
insulin remaining in the
Cartridge. Do not use these
numbers for measuring an
insulin dose.
•For more information on
InPen and insulin, please refer

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to the Patient Information
provided with your Insulin
Cartridge or contact your
healthcare provider.
6.3 Frequently Asked Questions
about Preparing your InPen
1. What should I do if I can’t attach
the Cartridge Holder to the InPen
body?
Check that the Insulin Cartridge is
fully inserted into the Cartridge
Holder and the Screw is screwed
all the way back inside the InPen.
Then carefully line up the
Cartridge Holder with the InPen
Body and screw together until
secure.
2. Why do I pull the InPen apart
when I try to remove the InPen
cap?
Twisting the InPen Cap may have
unscrewed the Cartridge Holder.
•Remove the cartridge holder
and Insulin cartridge from the
InPen cap.
•Place the Insulin cartridge
into the Cartridge Holder and
screw it back onto the InPen
assembly.
•Be sure to prime the InPen
again before the next use.
7Prime your InPen (Before
Every Injection)
7.1 Steps

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Caution: If you do NOT prime,
you may receive too much or
too little insulin.
1. Remove Paper Tab from the
Needle
2. Attach the Needle by screwing the
Needle straight onto the Cartridge
Holder as shown.
3. Pull off the Outer Cap and the
Inner Cap.
•Discard the Outer Cap.
•Keep the Inner Cap to remove
the Needle after your
injection.
4. Turn the Dose Knob to select
amount to prime:
•Dial 2 units as shown.

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5. Hold the InPen so the needle is
pointing up and tap Cartridge to
collect any air at the top.
6. Prime the InPen by pushing the
Injection Button with your thumb
and holding for eight (8) seconds.
You should see a few drops of
insulin.
7. If no stream is seen, repeat priming
according to steps 4 through 6. A
new Cartridge may need to be
primed several times.
Caution: If no insulin flows after
several attempts, attach a new
Needle, as the one on your
InPen may be clogged.
7.2 Important Notes

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•Only use Needles compatible
with your InPen.
•The directions regarding
Needle handling are not
intended to replace local,
healthcare provider, or
institutional policies.
•Use a new Needle for each
injection. This will help
ensure sterility. It will also
help prevent leakage of
insulin, keep out air bubbles,
and reduce Needle clogs.
7.3 Frequently Asked Questions
about Priming Your InPen
1. Why is it important to prime
before every injection?
If you do NOT prime, you may get
too much or too little insulin.
Priming helps to ensure that the
InPen and Needle are working
properly. Once the InPen is
properly primed, insulin will flow
from the Needle. You may need to
prime several times before you see
insulin.
2. Why can it take several attempts to
prime when a new Cartridge is
inserted?
There may be a gap between the
Screw and the Cartridge Plunger.
Repeating the priming steps will
move the Screw out to touch the
Cartridge Plunger. Once touching,
insulin will flow from the Needle
when priming.

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•Repeat the priming steps until
insulin is seen.
•If you are still unable to see
insulin flow from the Needle,
go to Question 3.
3. Why can’t I see insulin flow from
the Needle tip?
Priming moves the Screw into
contact with the Cartridge Plunger
and gets the air out of the
Cartridge. When you are priming
the InPen:
•You may see no flow at all.
This may be because the
Screw is moving forward to
close a gap between the
Screw and the Cartridge
Plunger.
•If there is air in the Cartridge,
the insulin may sputter or drip
until all the air is removed.
•Insulin will flow as a stream
only when the InPen is
properly primed.
•If the Injection Button is hard
to push, the Needle may be
clogged. Attach a new Needle.
Repeat the priming steps until
a stream of insulin is seen.
If you are still unable to see a
stream of insulin out of the
Needle, do NOT use the InPen.
Contact your healthcare provider
for assistance or to obtain a
replacement.

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4. What should I do if I have an air
bubble in the Cartridge?
Priming your InPen will remove air.
Hold the InPen so that the Needle
is pointing up, and tap the
Cartridge gently with your finger
so any air bubbles can collect near
the top. Repeat the priming steps
until insulin is seen. A small air
bubble may remain in the
Cartridge after completion of the
priming steps. If you have
properly primed the InPen, this
small air bubble will not affect your
insulin dose.
5. Why does no drop of insulin
appear at the needle tip when I
check the insulin flow?
The needle may be blocked.
•Screw on a new needle
•Check the insulin flow until
insulin appears at the needle
tip
8Selecting Your Dose
8.1 Steps
1. Select your dose by turning the
Dose Knob until the desired dose
is lined up with the Dose Indicator.
Half units are shown as lines
between the numbers.

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If you select a wrong dose, simply
change it by turning the dose
button in either direction. If you
change your mind and do not
want to inject a dose, you may
adjust the knob back to the 0 set
point. No insulin will be dispensed
until you press the button.
8.2 Important Notes:
You cannot select a dose larger
than 30 units. If you need more
than 30 units, you must divide
your dose into two injections.
8.3 Frequently Asked Questions
about Selecting Your Dose
1. How do I read the dose indicator?
The InPen can be adjusted in steps
(increments) of 0.5 (½) units. Read
the numbers shown in the
indicator window to see the
current dose setting. If the
indicator is between numbers, this
means that it is set at a ½ unit step
between the numbers. See below
for more examples.

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Set to 0 units. The
indicator line is
aligned with the
“0” mark, which
means nothing
will happen if the
button is pressed.
Store the InPen
this way.
Set to ½ unit. This
is the smallest
dose setting
possible.
Set to 1 unit. The
indicator line is
lined up with the
number “1”.
Set to 1.5 units.
The indicator line
is on the mark
between the “1”
and “2”.
Set to 30 units.
This is the
maximum dose
setting possible.
9Injecting the Dose
9.1 Steps
1. Choose a place on your body to
inject. Make sure your skin is clean
and dry.
2.