COMPANION InPen User Manual

User Guide

InPen™ Reusable Pen Injector

Page 2 of 34

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

Page 3 of 34

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

Page 4 of 34

Page 5 of 34

InPen™ User manual

1 Introduction

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 insulin­treated 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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Page 8 of 34

1

Adapted from Mudaliar et al, Diabetes
Care, Volume 22, Number 9, Sept.
1999, page 1501.

2 Indications 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 single­use 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.

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,

• 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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4 Compatible 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®

5 Getting 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

6 Preparing 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.

7 Prime 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

8 Selecting 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.

9 Injecting the Dose

9.1 Steps

1. Choose a place on your body to

inject. Make sure your skin is clean
and dry.

2.

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3. Insert the needle into your skin as

your healthcare provider has
instructed you.

4. To inject your insulin, place your

thumb on the Injection Button,
then slowly and firmly push the
button until it stops moving.

8 Seconds!

Places to Inject:

Upper arms

Stomach

Thighs

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5. Continue to hold the button for 8

seconds and then remove the
Needle from your skin. Check to
make sure you see a 0 in the Dose
Window to confirm you received
the complete dose.

Note: It is possible to set a dose
larger than the amount of insulin
left in the Cartridge. At the end of
an injection, the number in the
Dose Window should be 0. If it is
not, this number is the amount of
insulin you did NOT receive.
Remember this number, because
you will need to install a new
cartridge and inject this much
insulin to complete your full dose.

6. After you remove the needle from

the skin a drop of insulin may
appear at the needle tip. This is
normal and has no effect on the
delivered dose.

Note: To prevent air from entering
the Cartridge, do not store the
InPen with a Needle attached.

7. Place the cap back onto the

Needle, and remove the capped
Needle by twisting it off.

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8. Put the used Needle in a sharps

container or a hard plastic
container with a secure lid. Do not
throw needles directly into your
household trash.

9. Do not recycle the container of

used needles. The full container
must be disposed of according to
your state and local laws.

Note: For information on how to
dispose of the container properly,
ask your healthcare provider
about options available in your
area or go to the FDA website at:
www.fda.gov/safesharpsdisposal

10. Replace the cap on your InPen.

9.2 Important Notes

• You must PUSH the Injection

Button straight down for the
dose to be delivered.

• You will NOT receive your

insulin by turning the Dose
Knob.

• Do not attempt to change the

dose while injecting.

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• Always remove the used

needle after each injection
and store the InPen without a
needle attached. This
prevents contamination,
infection, and leakage of
insulin and will ensure
accurate dosing.

• Always put the InPen cap

back on after every use.

• Caregivers should be most

careful when handling used
needles to avoid hurting
themselves.

9.3 Frequently Asked Questions

about Injecting the Dose

1. Why does the InPen not deliver

any insulin when I turn the dose
button to inject?

Turning the dose button will not
deliver insulin. You have to press
the dose button to inject.

2. Why is it difficult to push the

Injection Button when I try to
inject?

Your Needle may be clogged. Try
attaching a new Needle, and then
prime the InPen.

Pushing the Injection Button
down quickly may make the
Button harder to push. Pushing
the Button more slowly may make
it easier.

Using a larger diameter Needle
will make it easier to push the

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Injection Button during injection.
Ask your healthcare provider
which Needle is best for you.

If none of the above steps resolves
the problem, your InPen may need
to be replaced.

Your Injection Button may become
harder to push if the inside of your
InPen gets dirty with insulin, food,
drink or other materials. Following
the HANDLING AND STORAGE
instructions below should prevent
this.

3. Why doesn’t the Dose Knob go to

zero when I inject my dose?

This can happen if the Insulin
Cartridge does not have enough
insulin left in it for your entire
dose, or if the needle has become
clogged. To get the rest of your
dose:

• The number in the Dose

Window is the amount you
did NOT receive. Remember
this number, because you still
need to inject this much to
complete your dose.

• Adjust the knob back to the

“0” setting.

• Remove the Needle from the

InPen.

• If the cartridge is empty,

replace it with a new
cartridge. If it is not empty, it is
likely the needle was clogged.

• Install a new Needle.

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• Prime the InPen until insulin is

observed.

Complete your dose by dialing the
amount that you did NOT receive
and inject this amount.

If you are not sure whether you
have received your full dose, you
should check your blood glucose
level more frequently.

10 How Much Insulin is Left in

Your InPen?

The cartridge scale shows an
approximate number of units left
in the Cartridge.

FULL CARTRIDGE

EMPTY CARTRIDGE

It is ok to set a dose greater than the
amount of remaining insulin. The
InPen will deliver as much insulin as is
left in the cartridge and then you can
complete the dose with a new
cartridge. Refer to the INJECTING THE
DOSE section above.

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11 Replacing a Used Insulin

Cartridge

Note: Be sure the needle has been
removed and disposed of properly.

11.1 The Screw will be extended

once you have used the entire
insulin cartridge.

11.2 Hold the InPen body and turn

the Screw counterclockwise into
the InPen Body until it stops.

11.3 Follow the instructions in

PREPARING YOUR INSULIN
INPEN section above. Dispose
of the used cartridge before
installing a new one.

12 Handling and Storage of

Your InPen

When an Insulin Cartridge is
installed in your InPen, store your
InPen at room temperature. Refer
to your insulin manufacturer or
literature that came with your
insulin for information from on
how to store the cartridges and
how long to keep them.

Page 28 of 34

Remove the Needle after every
use. Do not store your InPen with
the Needle attached.

Do not store the InPen in a
refrigerator.

13 Cleaning of Your InPen

Cleaning removes dirt from the
surface of the device. It does not
kill bacteria or viruses. The InPen
should be cleaned whenever it is
visibly dirty.

Clean your InPen as needed only
with a soft cloth moistened with
water, being careful not to get
water inside. Never submerge
the InPen. You may also use an
isopropyl alcohol wipe. If you get
insulin on your InPen, clean it off
right away.

13.1 Important Notes

Your InPen is designed to work
accurately and safely, but you must still
take good care of it.

• Only use your InPen as described

in this manual.

• Handle it with care and do not

drop it or knock it against hard
surfaces.

• Do not try to wash, soak, or

lubricate your InPen as this may
damage it.

• Keep it away from direct sunlight,

water, dust, and dirt.

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• Do not expose your InPen

(without cartridge) to
temperatures below -5 °C (-23°F).

• Do not try to repair a broken InPen

When you receive a battery warning
or the InPen can no longer
communicate with the Application,
contact your healthcare provider to
obtain a prescription for a new InPen.

Frequently asked Questions about
Caring for your InPen

1. What should I do if my InPen has

been dropped or knocked against
a hard surface, or if I am not sure
that it is working properly?

• If you suspect that your InPen

has been damaged or may not
be working properly,
discontinue using it
immediately, and contact your
healthcare provider.

• If you choose to continue

using your InPen, check that
the Insulin cartridge is not
damaged (see the information
provided with the Insulin
cartridge) and install a new
needle.

• Some disposable needles are

supplied with a cap that may
be filled to verify the correct
volume of insulin is being
dispensed. This may be used
for added confirmation that
the InPen is functioning

Page 30 of 34

properly. Refer to the Patient
Information provided with the
Needle for information on this
feature.

14 Replacement

Your InPen will last for at least1
year after first use. Record the
date your InPen was first used
here: ____/____/____. Contact
your healthcare provider to
obtain a prescription for a new
InPen.

15 Disposal

Your InPen contains a lithium
battery and electronic parts, so
you should not throw it out with
your household waste, but do so
in a safe and environmentally
correct way:

• Remove the needle and

cartridge, and throw them
away as your doctor or nurse
has instructed you.

• Throw your InPen away as

specified by your local

authorities.

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16 Supplemental Information

16.1 Essential Performance

Essential Performance, as
defined by IEC 60601-1, is not
applicable to the InPen system.

16.2 Dose Accuracy

InPen fulfils the functional
requirements and specification
limits for dose accuracy
according to ISO 11608-1 Pen­Injectors for Medical use, Part 1:
Requirements and test methods.

16.3 Applied Parts

The InPen is a hand held device
and is considered the applied

part as defined by IEC 60601-1.

16.4 Declaration of Conformity

Companion Medical declares
that this product is in conformity
with the essential requirements
of Directive 1995/5/EC on Radio
and Telecommunications
Terminal Equipment and
Council Directive 93/42/EEC of
14 June 1993 concerning
medical devices (M5).

16.5 FCC Compliance

This device complies with FCC
Part 15 license exempt RSS
standard(s). Operation is subject
to the following two conditions:
(1) this device may not cause
interference, and (2) this device
must accept any interference,

Page 32 of 34

including interference that may
cause undesired operation of
the device.

17 Warranty

Companion Medical warrants the
InPen System against defects in
materials and workmanship for a
period of 1 year from the date of
purchase.

During the warranty period,
Companion Medical will, at its
discretion, replace any defective
device, subject to the conditions
and exclusions stated herein. In
the event that a device is
replaced, the warranty period will
not be extended.

This warranty is valid only if the
InPen System is used in
accordance with the
manufacturer’s instructions and
within the use-by-date. This
warranty will not apply:

• If damage results from

changes or modifications
made to the device.

• If damage results from use of

incompatible cartridges or
needles.

• If damage results from a

Force Majeure or other event
beyond the control of the
manufacturer.

• If damage results from

negligence or improper use,

Page 33 of 34

including but not limited to:
improper storage, submersion
in water or physical abuse,
such as dropping or
otherwise.

This warranty shall apply to the
original user. Any sale or other
transfer or use of the product
covered by this warranty to or by
a user other than the original user
shall cause this warranty to
immediately terminate.

The remedies provided for in this
warranty are the exclusive
remedies available for any breach
hereof. Neither Companion
Medical nor its suppliers or
distributors shall be liable for any
incidental, consequential, or
special damage of any nature or
kind caused by or arising out of a
defect in the product.

All other warranties, expressed or
implied, are excluded, including
the warranties of merchantability
and fitness for a particular
purpose.

Use of the InPen system is subject
at all times to the Companion
Medical Inc. Terms of Service and
Privacy Policy
(https://www.companionmedical.
com/terms-privacy/).

Page 34 of 34

18 Product Specifications

The InPen System is intended for use
by patients at home and in healthcare
facilities.

Operating
Conditions

5 °C (41 °F) to 40 °C (104 °F)
15 % to 93 % RH (non
condensing)

Operating
Altitude

-381 m (-1253 ft) to 3010 m
(9878 ft)

Operating
Pressure

80 kPa – 105 kPa

Storage
Conditions

-5 °C (23 °F) to 40 °C (104 °F)
10 % to 98 % RH (non
condensing)

Dimensions

16.5 cm (6.5”) x ø1.9 cm
(0.8”)

Weight

35 g

Power
Supply

Li-Mn battery (not
replaceable)

Lifetime

1 year from activation

Accuracy

±0.5U below 10U and ±5%
at 10U and above

Moisture
Protection

IP22: Protection against
insertion of large objects and
dripping water

Protection
against
Electrical
Shock

Type BF applied part

For information contact:

Companion Medical, Inc.
16486 Bernardo Center Drive, #300
San Diego, CA 92128 USA
www.companion-medical.com

Cormedics Medizintechnik GmbH
Bahnhofstrasse 32
82041 Deisenhofen Germany

©2017 Companion Medical, Inc. LBL-00020-AL

09-2018