Indications For Use - Tandem AutoSoft 30 Instrucciones De Uso

ENGLISH

Indications for Use

The AutoSoft 30 infusion set is indicated for
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the subcutaneous infusion of insulin adminis-
tered by an external pump.
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 inserter and
the separate tubing are sterile.
CONTRAINDICATIONS
AutoSoft 30 is neither intended nor indicated for
use with blood, blood products or intravenous
infusion (IV).
WARNINGS
• 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-
pyrogenic if the packaging is unopened and
undamaged. Do not use it if the sterile paper
or red seal has been broken.
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• Go through instructions for use carefully be-
fore inserting AutoSoft 30, as failure to follow
instructions may result in pain or injury.
• Use AutoSoft 30 for the first time in the
presence of your healthcare provider. When
possible, stand or sit upright when using
AutoSoft 30.
• Do not put perfumes, deodorants,
cosmetics or other products containing or
disinfectants contact with the connector or
the tubing. This may affect the integrity of
the infusion set.
• AutoSoft 30 is a single-use device. Do not
clean or re-sterilize.
• Put the lid back on the insertion device for
safe disposal. For available sharps contain-
ers please consult your local pharmacy.
• Remove the needle protector before use.
• When priming, make sure there are no air
bubbles in the tube.
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• Inaccurate insulin delivery, infection and/or
site irritation may result from improper inser-
tion or maintenance of the infusion site.
• Replace the infusion set every 48-72 hours,
or per your healthcare provider's instructions.
• If the soft cannula bends during insertion,
apply a new AutoSoft 30.
• Replace the infusion set if the adhesive tape
comes loose.
• Check the infusion set frequently to ensure
that the soft cannula remains firmly in place.
Replace with new set, if the 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.
• If your infusion site becomes red or
inflamed, replace the infusion set and use a
new site until the first site has healed.
• Do not re-insert the introducer needle into the
infusion set. This could cause tearing of the
soft cannula and unpredictable medication
flow.
• Never try to fill or free clogged tubing while
the infusion set is inserted. This may result
in unpredictable medication flow.
• Wash your hands before disconnecting and
reconnecting the infusion set. Consult your
healthcare provider on how to compensate
for missed medication while disconnected.
• Protect AutoSoft 30 from direct sunlight
and humidity. Store in a dry place at room
temperature.