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The MiniMed 530G System is not intended to be used directly for making therapy
adjustments, but rather to provide an indication of when a nger stick may be
required. All therapy adjustments should be based on measurements obtained
using a home glucose monitor and not on values provided by the MiniMed 530G
System.
The MiniMed 530G System is not intended to be used directly for preventing or
treating hypoglycemia but to suspend insulin delivery when the user is unable to
respond to the Threshold Suspend alarm to take measures to prevent or treat
hypoglycemia themselves. Therapy to prevent or treat hypoglycemia should be
administered according to the recommendations of the users healthcare provider.
Potential risks
Risks related to insulin pump infusion
General risks related to insulin pump infusion set may include:
Localized infection
Skin irritation or redness
Bruising
Discomfort or pain
Bleeding
Irritation
•Rash
Patients should be instructed to follow the provided user guides for insertions and
care of infusion sets. If an infusion site becomes irritated or inamed, the infusion
set should be removed and another placed in a new location.
Risks related to insulin administration and pump use
Due to the use of insulin, there is risk related to the infusion of insulin and the
potential interruptions of insulin delivery. These general risks may include:
•Hypoglycemia
Hyperglycemia
Risks related to the Threshold Suspend feature
General risks related to the Threshold Suspend feature may include:
introduction
Introduction 9
27


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