4
ENGLISH (en)
Indications for use:
The inset
TM
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 insulins approved for
subcutaneous infusion.
DESCRIPTION
inset
TM
is a medical device which combines an
infusion set with an aid for infusion (serter). As
the infusion set is an integrated part of the
serter, inset
TM
is delivered assembled and
ready for use as a single, sterile unit.
CONTRAINDICATIONS
inset
TM
is neither intended nor indicated for use
in intravenous infusion of blood or blood
products.
WARNINGS
■ Carefully examine the instructions for use
before inserting inset
TM
. Failure to follow
instructions may result in pain or injury.
■ inset™ is only sterile and non-pyrogenic
if the packaging is undamaged and
unopened. Do not use if inset™ is already
open or has been damaged. Ensure sterility
by checking if the sterile paper and tamper-
proof seal are undamaged.
■ When using inset
TM
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 inset™ 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 serter. 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.
■ inset™ 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
To Next Page
Loading...