Indications for use
The MiniMed
Mio
Advance infusion set is
™
™
indicated for subcutaneous infusion of medication
administered by an external pump.
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
● You can wear the infusion set for a maximum of
72 hours, or per your healthcare professional's
instructions.
● If you are using the infusion set for the first
time, do the first set–up in the presence of your
healthcare professional.
Warnings
● Do not use if the package is opened or
damaged. An opened or damaged package may
2
be contaminated. This can cause an infection.
This is a single use product.
● Do not use 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 you can check your blood
glucose 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 infusion set. High or low
blood glucose can result if the infusion set is
damaged.
● Never point the insertion device toward any
body part where insertion is not desired.
● Always rotate your insertion site when changing
the infusion set. Reusing an insertion site too
often may cause scarring and inaccurate insulin
delivery. Review your 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 could cause insufficient insulin delivery.
This may result in high blood glucose. Replace
the infusion set at a new site if there is blood.
● Fill 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 your blood
glucose reading is high. Clogs or leaks may
restrict insulin delivery and result in high blood
glucose. Replace the infusion set even if you
are not sure if there is a clog or leak.
● Do not attempt to clear air or an occlusion in
the tubing while it is connected to your body. An
uncontrolled amount of insulin may be delivered.
This can cause high or low blood glucose.
Disconnect the tubing before adjusting it.
● Reuse of the infusion set may cause damage to
the cannula or needle and lead to infection, site
irritation, or inaccurate medication delivery.
● 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.
● For No Delivery Alarms, refer to your pump
user guide.
Precautions
● Do not change to a product you have not
used before without consulting a healthcare
professional for correct handling. The infusion
set product is closely related to insertion
location. Therefore, your healthcare professional
should always be included when choosing an
infusion set product.
● An inaccurate insertion site or inappropriate
site management can result in physical pain,