Tandem AutoSoft 90 Mode D'emploi page 8

ENGLISH
Indications for use
The AutoSoft™ 90 infusion set is indicated
for the subcutaneous infusion of insulin
administered by an external pump. The
infusion set is indicated for single use.
INTENDED USE
The infusion set is indicated for subcutaneous
infusion of insulin in the treatment of
diabetes. The infusion set has been tested
to be compatible with insulin approved for
subcutaneous infusion.
PRODUCT DESCRIPTION
AutoSoft™ 90 is an infusion device which
combines an infusion set with an aid for
insertion (serter). As the infusion set is an
integrated part of the serter, AutoSoft
delivered assembled and ready for use as a
single, sterile unit.
CONTRAINDICATIONS
AutoSoft™ 90 is neither intended nor
indicated for use in intravenous infusion of
blood or blood products.
WARNINGS
• Carefully examine the instructions for use
8
before inserting AutoSoft™ 90. Failure to
follow instructions may result in pain or
injury.
• AutoSoft™ 90 infusion sets with t:lock™
tubing connectors should only be used
with Tandem cartridges featuring the
t:lock™ connector.
• AutoSoft™ 90 is only sterile and non-
pyrogenic if the insertion device is
undamaged and unopened. Do not use
if the insertion device is already opened
or has been damaged. Ensure sterility
by checking if the sterile paper and
tamperproof seal are unbroken.
• When using AutoSoft™ 90 for the first
time, do so in the presence of a healthcare
provider. Since different individuals have
varying amounts of subcutaneous layer,
90 is ensure that an appropriate cannula length
TM
is chosen to fit your needs.
• Inaccurate medication delivery, site irritation
or infection may result from improper
insertion or maintenance of your infusion
site.
• Do not re-insert the introducer needle into
the infusion set. This could cause a tearing
or damage of the soft cannula and may
lead to unpredictable medication flow.
• Reuse of the infusion set may cause site
irritation or infection and may lead to
inaccurate medication delivery.
• Be sure that the needle guard is removed
before insertion is made.
• If the soft cannula bends during insertion,
apply a new AutoSoft™ 90 immediately at
a new site.
PRECAUTIONS
• Never try to fill or free a clogged tubing
while the infusion set is inserted. This may
result in unpredictable medication flow.
• When unwinding, release the tubing with
caution as a hard pull of the tubing can
result in damage to the infusion device.
Ensure that the infusion set is properly in
place in the serter when the tubing is fully
released (see figure 8 on page 88).
• Do not leave air in the infusion set. Make
sure to fill the tubing completely. Consult
pump manufacturer's instructions for use.
• AutoSoft™ 90 is a single-use device and
should be disposed of immediately after
use. Do not clean or re-sterilize.
• Do not in any way put disinfectants,
perfumes, deodorants, cosmetics or
other products containing disinfectants
in contact with the connector or the
tubing. This may impact the integrity of the