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ENGLISH
Indications for Use
The AutoSoft
™
90 infusion set is indicated
for the subcutaneous infusion of insulin
administered by an external pump.
DESCRIPTION
AutoSoft 90 is an infusion device which
combines an infusion set (catheter) with an aid
for insertion (inserter). As the infusion set is an
integrated part of the inserter, AutoSoft 90 is
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
•
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
unopened and undamaged . Do not use
if the insertion device is already opened
or has been damaged. Ensure sterility by
checking if the sterile paper and tamper-
proof seal are unbroken.
•
Carefully examine the instructions for use
before inserting AutoSoft 90. Failure to
follow instructions may result in pain or
injury.
•
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,
ensure that an appropriate cannula length
is chosen to fit your needs.
•
Do not in any way put disinfectants,
perfumes, deodorants, cosmetics or other
products containing disinfectants in contact
with the connector or the tubing. These
may affect the integrity of the infusion set.
•
AutoSoft 90 is a single-use device and
should be disposed of immediately after
use. Do not clean or re-sterilize.
•
AutoSoft 90 can be disposed of safely
after insertion if the lid has been placed
back on. Please consult your local
pharmacy for sharps containers.
•
Be sure that the needle guard is removed
before insertion is made.
•
Release the tubing with caution as a hard
pull of the tubing can result in damage to
the infusion set/introducer needle. Ensure
that the infusion set is properly in place
when the tubing is fully released (see figure
8 on page 84) .
•
Do not leave air in the infusion set. Make
sure to fill AutoSoft 90 completely.
•
Inaccurate medication delivery, infection
and/or site irritation may result from
improper insertion or maintenance of your
infusion site.
•
Replace the infusion set every 48-72
hours, or per your healthcare provider’s
instructions .
•
If the soft cannula bends during insertion,
discard and apply a new AutoSoft 90
immediately.
•
Replace the infusion set if the adhesive
tape becomes loose or is displaced from
its original site. Since the cannula is soft,
it will not cause any pain if it slips out, and
this may take place without notice. The soft
cannula must always be completely inserted
to receive the full amount of medication.
•
If your infusion site becomes inflamed,
replace infusion set and use new site until
the first site has healed.
• Do not re-insert the introducer needle into
the infusion set. This could cause a 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.
•
Always clean the insertion site when
temporarily disconnecting the infusion
set. Consult your healthcare provider on
how to compensate for missed medication
when disconnected. Carefully monitor
blood glucose levels when disconnected
and after reconnecting.
•
Protect the AutoSoft 90 infusion set from
direct sunlight and atmospheric 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
•
Check your blood glucose level 1-2 hours
after introducing AutoSoft 90. Measure
your blood glucose on a regular basis.
Discuss this with your healthcare provider.
•
When using insulin, do not change your
infusion set just prior to bedtime, unless
blood glucose can be checked 1-2 hours
after insertion.
•
When you are infusing insulin and
your blood glucose level becomes
unexplainably high or an occlusion alarm
occurs, check for clogs and leaks. If in
doubt, change your infusion set since
the soft cannula could be dislodged,
crimped or partially clogged. Discuss a
plan for rapid replacement of insulin with
your healthcare provider should any of
these problems arise. Test your blood
glucose level to make sure the problem is
corrected .
•
Carefully monitor your blood glucose level
when disconnected and after reconnecting.
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