
8
E N G L I S H
Indications for use:
The Dana inset
TM
II infusion set is indicated for the
subcutaneous infusion of insulin administered 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 compatible with
insulin approved for subcutaneous infusion.
DESCRIPTION
Dana inset
TM
II is an infusion device which
combines an infusion set with an aid for insertion
(serter). As the infusion set is an integrated part of
the serter, Dana inset™ II is delivered assembled
and ready for use as a single, sterile unit.
CONTRAINDICATIONS
Dana inset
TM
II is neither intended nor indicated
for use in intravenous infusion of blood or blood
products.
WARNINGS
■
Carefully examine the instructions for use
before inserting Dana inset
TM
II. Failure to follow
instructions may result in pain or injury.
■
Dana inset
TM
II is only sterile and non-pyrogenic
if the insertion device is undamaged and
unopened. Do not use if the insertion device is
already open or has been damaged. Ensure
sterility by checking if the sterile paper and
tamper-proof seal are undamaged.
■
When using Dana inset
TM
II 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.
■
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.
■
Be sure that the needle guard is removed
before insertion is made.
■
If the soft cannula bends during insertion, apply
a new Dana inset
TM
II 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 unwinding, release the tubing with
caution as a hard pull of the tubing can result in
damage to the infusion device. Ensure that the
infusion set is properly in place in the serter
when the tubing is fully released – see picture 8.
■
Do not leave air in the infusion set. Make sure to
fill the tubing completely. Consult pump
manufacturer’s instructions for use.
■
Dana inset
TM
II is a single use device and
should be disposed of immediately after use.
Do not clean or re-sterilize.
■
Do not in any way put disinfectants, perfumes,
deodorants, cosmetics or other products
containing disinfectants in contact with the
connector or the tubing. This may impact the
integrity of the infusion set.
■
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