Product Info
Table Of Contents
- M998590A011DOC_A_FINAL_UserGuide_Part2
- Troubleshooting
- Maintenance
- Product specifications and safety information
- Product specifications
- Alarm and alert escalation
- Altitude range
- Audio frequency
- Backlight
- Basal delivery
- BG Target
- BG meter value
- Bolus delivery
- Bolus Wizard feature default settings
- Bolus Wizard feature specifications
- Carb ratios
- Delivery accuracy
- Easy Bolus feature
- Environmental conditions
- Essential performance
- Filling the infusion set and cannula
- Infusion pressure
- Insulin delivery default settings
- Bolus settings
- Basal settings
- Insulin sensitivity factor
- Low Reservoir reminder
- Max Bolus
- Normal bolus
- Occlusion detection
- Percent temp basal
- Program safety checks
- Pump dimensions
- Pump memory
- Pump weight
- Sensor default settings
- Wireless communication
- FCC notice
- IEC60601-1-2:4th Edition notice
- Guidance and manufacturer's declaration
- Icon glossary
- Product specifications
- 670G Performance Data and Technical Information
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.
F. Alert performance for user ages 7 through 13
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, 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, 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.
The device will always alert the user when the CGM system reads that the user is
below 50 mg/dL, regardless of the high threshold, low threshold, or predictive
alerts that the user sets.
Glucose TRUE Alert Rate
The glucose true alert rate is the rate at which the BG confirmed that the CGM
alert was triggered correctly. For example
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 367