5
4
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Please read and ensure you understand the User
Manual before using your SMARTCLIC Injection
Device.
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Retain this User Manual for future reference.
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You must be over the age of 18 to use your
SMARTCLIC Injection Device.
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SMARTCLIC Injection Device and Enbrel Dose
Dispenser Cartridge will be referred to as “Device”
and “Cartridge” in this User Manual.
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Your reusable Training Cartridge is provided in
the box for you to practice the injection. Your
Training Cartridge can be used up to 20 times.
Your Training Cartridge does not contain a
needle or medication.
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Even after you have received training with your
healthcare professional, you should practice
injecting with your reusable Training Cartridge
before you use your Enbrel Dose Dispenser
Cartridge.
Do not
perform the injection until
you have received training from your healthcare
professional.
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Refer to Chapter 3 on how to use your Training
Cartridge.
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The service life of your Device is 3 years from first
use, 5 years after manufacture, or 160 injections,
whichever is sooner. Your Device will notify
you when it is near the end of its operational
life. Contact your healthcare professional for a
replacement. See “Device Information” in Chapter
5 for information on checking the number of
injections or days left on your Device.
This device is an electrical, auto-injector that is
used with a dedicated Dose Dispenser Cartridge
(DDC) under a home healthcare environment. The
injector is for the self-injection of a subcutaneous
dose of Tumor-Necrosis Factor inhibitors in the
DDC. Patients are separately prescribed the DDC by
healthcare professionals.
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If the operational life has been exceeded, or the
battery has exhausted, or if you want to stop
using your Device, follow the instructions of your
healthcare professional to return your Device.
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Incorrect operation or faults with your Device
may be notified by an error message on your
Device display. For details, carefully read the Error
Messages section in Chapter 6.
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Refer to the Enbrel Dose Dispenser Cartridge
Instructions for Use for a full set of instructions
on how to use your Cartridges.
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If you have any doubts regarding the dose,
display contents, or operation of your Device,
contact your healthcare professional.
Important Information
Getting Started
Warnings
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Only use your Device with prescribed Enbrel
Cartridges.
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Do not
share your Device or allow anyone else to
inject themselves with it, as doing so may result
in injury or infection.
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Your Device generates electromagnetic
waves. Never use or place your Device near an
implantable medical device such as a pacemaker
or implantable Cardioverter Defibrillator. If you
feel ill or find a problem due to your Device
being in close proximity to an active implantable
device contact your healthcare professional
immediately.
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Do not
use your Cartridge if it is damaged in any
way.
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Do not
insert into your Device if your Cartridge is
damaged, abnormal or any part of the label has
peeled away.
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Do not
attempt to repair a faulty Training
Cartridge or Enbrel Dose Dispenser Cartridge.
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Do not
disassemble or modify your Device,
Enbrel Dose Dispenser Cartridge, or your Training
Cartridge.
Important Information
Intended Purpose
