Tandem AutoSoft 30 - En; English

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ENGLISH ENGLISH
Indications for Use
The AutoSoft
™
30 infusion set is indicated for
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.
• 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 rst 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 aect 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.
• 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 rmly 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
inamed, replace the infusion set and use a
new site until the rst 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
ow.
• Never try to ll or free clogged tubing while
the infusion set is inserted. This may result
in unpredictable medication ow.
• 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.
• Never point a loaded insertion device
towards any body part, where insertion is
not desired.
• Reuse of the infusion set may cause
infection, site irritation, or damage to the
cannula/needle. A damaged cannula/needle
may lead to inaccurate medication delivery.
RECOMMENDATIONS
• For use with insulin: Check your blood
glucose level 1-2 hours after insertion to
ensure correct insertion/ow.
• Check the infusion site several times a day.
• Do not change your infusion set just before
bedtime, unless your blood glucose can be
checked 1-2 hours after insertion.
• If your blood glucose level becomes
unexplainably high or an occlusion alarm
occurs, check for clogs and leaks. If in
doubt, change your infusion set.
• Carefully monitor your blood glucose levels
when disconnected and after reconnecting.
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