Indications For Use; Intended Use; Contraindications - MiniMed Mio 30 Gebrauchsanweisung

Indications for use

The MiniMed Mio 30 infusion set is indicated for the
subcutaneous infusion of insulin from an infusion
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 mellitus. The
infusion set has been tested to be compatible with
insulin approved for subcutaneous infusion.
Description
MiniMed Mio 30 is an angled infusion set with an
integrated insertion device. The built-in legs support a
30° insertion angle. MiniMed Mio 30 is delivered ready
for use. Both MiniMed Mio 30 and the separate tubing
unit are sterile.

Contraindications

The infusion set is indicated for subcutaneous use
only. Do not use the infusion set for intravenous (IV)
infusion. Do not use the infusion set for infusion of
blood or blood products.
Warnings
■ Read all instructions for use before inserting the
infusion set. Failure to follow instructions may
result in pain or injury
■ The infusion set is only sterile and non-pyrogenic
if the package is undamaged and unopened. Do
2
not use the infusion set if the package is open
or damaged. Ensure sterility by checking that
the sterile paper and tamper-proof seal are not
damaged.
■ If using the infusion set for the first time,do so in
the presence of a healthcare professional.
■ Inaccurate medication delivery, site irritation, or
infection may result from improper insertion and
maintenance of the infusion site.
■ Do not reinsert the introducer needle into the
infusion set. Reinsertion may cause damage or
tearing of the soft cannula, which may lead to
unpredictable medication flow.
■ Do not reuse the infusion set. Reuse of the infusion
set may cause site irritation or infection and may
lead to inaccurate medication delivery.
■ Carefully remove the needle guard before inserting
the infusion set. Do not bend the needle prior to
insertion. Do not use the infusion set if the needle
is bent or has been damaged.
■ If insulin or any liquid gets inside the tubing
connector, it can temporarily block the vents that
allow the pump to properly fill the infusion set. This
may result in the delivery of too little or too
much insulin, which can cause hyperglycemia
or hypoglycemia. If this occurs, start over with a
new reservoir and infusion set.
Precautions
■ Never try to fill or free a clogged tubing while
the infusion set is inserted. This may result in
unpredictable medication flow.
■ Do not leave air in the infusion set or the tubing.
Make sure to fill the tubing completely. For filling
instructions, consult the pump manufacturer's
instructions for use.
■ The infusion set is a single-use device which
must be disposed of after use. Do not clean or
resterilize.
■ Check the infusion set frequently to ensure that
the soft cannula remains firmly in place. Since the
cannula is soft, it will not cause any pain if it slips
out, and this can happen without notice. Replace
with a new infusion set at a new site if the infusion
set is not in place. The soft cannula must always
be completely inserted to receive the full amount
of medication.
■ Do not put disinfectants, perfumes, alcohol, or
deodorants on the infusion set, as these may
impact the integrity of the infusion set.
■ Replace the infusion set if the adhesive tape
becomes loose, or if the soft cannula is displaced
from its original site. If the tape is curled, do not
attempt to straighten it. Stretching or pulling on the
tape may affect the cannula under the skin.