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For details on pump safety, see User safety, on page 7.
User safety
Indications
MiniMed 670G System
The MiniMed 670G system is intended for continuous delivery of basal insulin (at
user selectable rates) and administration of insulin boluses (in user selectable
amounts) for the management of Type 1 diabetes mellitus in persons age seven
and older requiring insulin as well as for the continuous monitoring and trending
of glucose levels in the fluid under the skin. The MiniMed 670G system includes
SmartGuard technology, which can be programmed to automatically adjust
delivery of basal insulin based on continuous glucose monitoring (CGM), and can
suspend delivery of insulin when the SG value falls below or is predicted to fall
below predefined threshold values.
The Guardian Sensor (3) is not intended to be used directly for making therapy
adjustments, but rather to provide an indication of when a fingerstick may be
required. All therapy adjustments should be based on measurements obtained
using a home glucose monitor and not on values provided by the Guardian
Sensor (3).
Contraindications
Pump therapy is not recommended for people whose vision or hearing does not
allow recognition of pump signals and alarms.
Insulin pump therapy is not recommended for those who are unwilling to perform
at least four BG tests per day. As insulin pumps use rapid acting insulin only, BG
testing is required to help identify rapid glycemic deterioration due to insulin
infusion occlusion, infusion site problems, insulin stability issues, user error, or a
combination of these.
SmartGuard Auto Mode cannot be used for people who require less than eight
units or more than 250 units of total daily insulin dose per day.
Pump therapy is not recommended for people who are unwilling or unable to
maintain contact with their healthcare professional.
Before you begin
Before you begin 7
23


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