Contraindications - Medtronic MiniMed Mio Bedienungsanleitung

E N G L I S H
Indications for use
The MiniMed Mio 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 insulins approved for subcutaneous
infusion.
Description
The MiniMed Mio is an infusion device which
combines an infusion set (catheter) with an aid for
insertion (serter). As the infusion set is an integrated
part of the serter, the infusion set is delivered
assembled and ready for use as a single, sterile unit.

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 carefully before using the
■
infusion set. Failure to follow instructions may
result in pain or injury.
The infusion set is sterile and non-pyrogenic
■
unless the package has been opened or
damaged. Do not use the infusion set if the
package has been opened or damaged.
8
For Medtronic pump users, do not use the infusion
■
set if the tubing connector needle has been
damaged.
Ensure sterility by checking that the sterile paper
■
and tamper-proof seal are not damaged.
If using this infusion set for the first time, do
■
the first set-up 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 re-insert the introducer needle into the
■
infusion set. This can cause tearing or damage
to the soft cannula and can lead to unpredictable
medication flow.
Reuse of the infusion set can cause site irritation
■
or infection and can lead to inaccurate medication
delivery.
Always remove the needle guard before inserting
■
the infusion set.
Before insertion, clean the insertion site with
■
a disinfectant as indicated by a healthcare
professional.
For the MiniMed tubing connector: 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 clogged tubing while
■
the infusion set is inserted. This can result in
unpredictable medication flow.
When unwinding the tubing, release it with
■
caution, because a hard pull on the tubing can
result in damage to the infusion set or introducer
needle. Ensure that the infusion set is properly in
place when the tubing is fully released.
Do not leave air in the infusion set. Make sure
■
to fill the tubing completely. Consult the pump
manufacturer's instructions on how to fill the
tubing.
The infusion set is a single use item, which
■
must be disposed of after use. Do not clean or
re-sterilize.
Do not put disinfectants, perfumes, 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.
Check the infusion site frequently to ensure that
■
the soft cannula remains firmly in place. If the
infusion set is not in place, replace it with a new
one at a new site. Since the cannula is soft, it
will not cause any pain if it slips out, which may
happen without notice. The soft cannula must
always be completely inserted to receive the full
amount of medication.
Replace the infusion set every two to three days,
■
or per a healthcare professional's instructions.