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.