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User safety
Indications
Pump
The Paradigm 515/715 pump system is indicated for the continuous delivery of insulin, at set and variable rates,
for the management of diabetes mellitus in persons requiring insulin.
Contraindications
Pump therapy is not recommended for people who are unwilling or unable to perform a minimum of four blood
glucose tests per day and to maintain contact with their healthcare professional. Successful insulin pump therapy
requires sufficient vision or hearing to allow recognition of the pump signals and alarms.
Warnings
Reservoir and infusion sets
Standard Luer sets are not compatible with the Medtronic MiniMed Paradigm pump. Medtronic Diabetes Paradigm
reservoir and Paradigm compatible infusion sets are specifically designed for use with the pump. Do not modify
your Paradigm reservoir or Paradigm compatible infusion set.
Do not put any other drugs/medications inside your reservoir to use with this pump. Only insulin that has been
prescribed by your physician can be used in this pump.
Magnetic fields
Do not use pump cases that have a magnetic clasp.
Do not expose your insulin pump to MRI equipment or other devices that generate very strong magnetic fields. The
magnetic fields in the immediate vicinity of these devices can damage the part of the pump’s motor that regulates
insulin delivery, possibly resulting in over-delivery and severe hypoglycemia.
Your pump must be removed and kept outside the room during magnetic resonance imaging (MRI) procedures.
If your pump is inadvertently exposed to a strong magnetic field, discontinue use and contact our 24 Hour HelpLine
for further assistance.
6 Introduction