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ENGLISH
Indications for use
The AutoSoft™ 30 infusion set is indicated for
the subcutaneous infusion of insulin adminis-
tered 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 compat-
ible with insulin approved for subcutaneous
infusion.
PRODUCT DESCRIPTION
AutoSoft™ 30 is an angled infusion set with an
integrated insertion device. The built-in legs
support a 30° insertion angle. This product
is delivered ready for use. Both the insertion
device and the separate tubing are sterile.
CONTRAINDICATIONS
AutoSoft™ 30 is neither intended nor indicated
for use with blood, blood products or intrave-
nous infusion (IV).
WARNINGS
• Carefully examine the instructions for use
before inserting AutoSoft™ 30. Failure to
follow instructions may result in pain or
injury.
• AutoSoft™ 30 infusion sets with t:lock™
tubing connectors should only be used
with Tandem cartridges featuring the
t:lock™ connector.
• AutoSoft™ 30 is only sterile and non-pyro-
genic if the packaging is undamaged and
unopened. Do not use it if the sterile paper
or red seal has been broken.
• When using AutoSoft™ 30 for the first
time, do so in the presence of a healthcare
provider.
• 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.
• If the soft cannula bends during insertion,
apply a new AutoSoft™ 30 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 priming the infusion set, make sure
there are no air bubbles in the tubing. Con-
sult your pump manufacturer's instructions
for use.
• AutoSoft™ 30 is a single-use device and
should be disposed of immediately after
use. Do not clean or re-sterilize.
• Check the infusion set frequently to ensure
that the soft cannula remains firmly in
place. Replace with a new infusion set at a
new site, if the infusion set is not in place.
Since the cannula is soft, it will not cause
any pain if it slips out, and this may happen
without notice. The soft cannula must
always be completely inserted to receive
the full amount of medication.
• Do not put perfumes, deodorants,
