Contraindications; General Instructions - Medtronic MiniMed Mio Advance Gebrauchsanweisung

Indications for use
The MiniMed Mio Advance infusion set is
™ ™
indicated for subcutaneous infusion of medication
administered by an external pump. The infusion set
is indicated for single use.
Description
The MiniMed Mio Advance infusion set has a
90–degree soft cannula. It is delivered ready
to use in a pre–loaded insertion device with
automatic needle retraction. It is provided sterile
and nonpyrogenic.
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.

Contraindications

This infusion set is indicated for subcutaneous use
only. Do not use the infusion set for intravenous
infusion. Do not use the infusion set with blood or
blood products.

General instructions

The infusion set may be worn for a maximum of
three days, or per a healthcare professional's
instructions.
If the infusion set is being used for the first
time, do the first set–up in the presence of a
healthcare professional.
Warnings
Do not use the infusion set if the package is
opened or damaged. An opened or damaged
package may be contaminated. This can cause
2
an infection.
Do not use the infusion set if the disconnect
cover is removed. Use a new infusion set
instead. One purpose of the disconnect cover
is as a safety feature against accidental firing of
the insertion device which could cause injury.
Do not change the infusion set just before
bedtime unless blood glucose can be checked
one to three hours afterwards.
Do not put alcohol, disinfectants, perfumes,
deodorants, cosmetics, or other substances with
solvents on the infusion set. These substances
may damage the integrity of the infusion set.
Never point the insertion device toward any
body part where insertion is not desired.
Always rotate the insertion site when changing
the infusion set. Reusing an insertion site too
often may cause scarring and unpredictable
insulin delivery. Review the pump user guide on
how to rotate insertion sites.
Check the insertion site often through the clear
window. Improper insertion and maintenance of
the insertion site can cause inaccurate insulin
delivery, infection, or site irritation. Replace the
infusion set at a new site if the soft cannula is
not properly inserted.
Check the cannula housing and tubing for blood.
Blood may cause insufficient insulin delivery.
This may result in high blood glucose. Replace
the infusion set at a new site if there is blood.
Fill the tubing completely with insulin before
insertion. Do not leave air in the tubing. An
uncontrolled amount of insulin may be delivered
if air is present.
Check the tubing for clogs or leaks if a blood
glucose reading is high. Clogs or leaks may
restrict insulin delivery and result in high blood
glucose. Replace the infusion set even if a clog
or leak is suspected, but not found.
Do not attempt to clear air or an occlusion in
the tubing while it is connected to the body. An
uncontrolled amount of insulin may be delivered.
This can cause high or low blood glucose.
Disconnect the tubing before adjusting it.
Do not reuse the infusion set. Reuse of the
infusion set may cause damage to the cannula
or needle and may lead to infection, site
irritation, or unpredictable insulin delivery.
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.
For no delivery alarms, refer to the pump user
guide.
Precautions
Do not use another type of infusion set without
consulting a healthcare professional for correct
handling. A healthcare professional should
always be consulted when choosing an infusion
set.
Choose insertion sites as recommended by
a healthcare professional. The choice of site
depends on treatment and patient–specific
factors such as body composition and physical
activity level.
Check that the insertion site is free of skin
irritation, such as redness, scar tissue, or
bleeding. Do not insert the infusion set into