Indications For Use - Tandem AutoSoft 30 Mode D'emploi

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) .
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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,