Product Info

Sensor life
After the first successful calibration, 72.3% of sensors worn operated more than six
days and up to the full seven days of wear (144 to 168 hours). The mean
functional sensor life for sensors worn in the abdomen insertion site over the
course of the study was 144.2 hours, with a median functional life of 167.6 hours.
The mean functional sensor life for sensors worn in the arm insertion site over the
course of the study was 146.1 hours, with a median functional life of 167.9 hours.
Safety
There were no moderate or severe device-related or procedure-related adverse
events, device-related or procedure-related serious adverse events, or
unanticipated adverse device effects through seven days of use.
C. Alert performance for users 14 years and older
The CGM system enables your device to display SG readings, glucose trend arrows,
glucose trend graphs, and SG alerts (for example, High and Low Limit Threshold
alerts, High and Low Predictive alerts, and Rise and Fall rate-of-change alerts).
The high and low limit alerts (Threshold alerts) let the user know when the SG is at
or above the high limit or at or below the low limit. Using only a high or low limit
alert may reduce the number of false alerts, but does not provide a warning before
reaching a high or low limit.
Predictive alerts notify users that their SG level may soon reach a high or low limit
setting. Users may select how early they would like to be notified before their SG
level reaches a high limit setting. The earliest warning is 30 minutes before
reaching a high limit setting, but users can reduce the amount of warning down
to 5 minutes. Users will receive a warning approximately 30 minutes prior to when
their SG level is predicted to reach their low limit setting. In general, the earlier the
warning, the more time a user will have to react to a potential high or low limit
setting, but this also increases the potential for false alerts.
A predictive alert is simply an estimation of a future SG level compared to the high
or low limit setting. If the predicted SG value is above the high limit or below the
low limit, then a predictive alert is sounded even though the current SG level has
not crossed the high or low limit. The predicted SG level is calculated using the
current SG level, the derivative of previous SG readings (the trend or slope of the
SG readings) and the amount of early warning duration the user selects.
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 343