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
Missed detection rates are important because it is necessary that users be notified
when their BG is low (or high), so that they can correct the low (or high) BG. A low
missed detection rate indicates that users can have confidence that they will be
notified by the device if their BG is low or high.
For example, per the following table, the threshold alert, predictive alert, or both
alerts (threshold and predictive) did not sound 36%, 24%, or 24% of the time
within 30 minutes (or 36%, 32%, or 32% within 15 minutes) when the user had BG
less than 50 mg/dL for a sensor inserted in the abdomen.
Table C-4: Glucose Missed Detection Alert Performance using Calibration every 12 hours
Glucose Missed Detection Rate
mg/dL Insertion Site Threshold Only Predictive Only Threshold & Predictive
30 min 15 min 30 min 15 min 30 min 15 min
50 Abdomen 36.0% 36.0% 24.0% 32.0% 24.0% 32.0%
Arm 33.3% 33.3% 4.8% 28.6% 4.8% 23.8%
60 Abdomen 16.7% 17.9% 6.0% 11.9% 6.0% 10.7%
Arm 13.7% 16.4% 1.4% 5.5% 1.4% 2.7%
70 Abdomen 9.5% 9.5% 5.8% 10.2% 5.8% 8.0%
Arm 9.8% 11.4% 7.3% 9.8% 6.5% 8.1%
80 Abdomen 12.8% 12.8% 6.4% 12.8% 6.4% 10.1%
Arm 11.0% 11.6% 5.2% 13.4% 4.1% 7.6%
90 Abdomen 8.9% 11.3% 5.4% 10.5% 4.3% 7.8%
Arm 8.3% 9.6% 3.1% 8.3% 2.2% 4.4%
180 Abdomen 6.9% 8.6% 3.4% 6.6% 3.1% 4.6%
Arm 6.8% 7.8% 1.9% 5.8% 1.3% 3.6%
220 Abdomen 9.9% 10.8% 5.2% 6.5% 4.7% 5.6%
Arm 9.9% 10.8% 3.9% 6.4% 3.9% 4.4%
250 Abdomen 18.5% 19.1% 3.5% 8.7% 3.5% 6.4%
Arm 19.1% 20.4% 3.3% 9.2% 3.3% 8.6%
300 Abdomen 24.7% 24.7% 4.7% 7.1% 4.7% 5.9%
Arm 25.6% 28.2% 6.4% 10.3% 6.4% 10.3%
II. Performance data for users ages 7 through 13
D. Device Performance data for users ages 7 through 13
The SmartGuard technology has two levels that include 1) the Suspend on low
and Suspend before low features that automatically suspends insulin based on the
CGM system and 2) Auto Mode that automatically calculates insulin dosing using
the CGM system. A study was performed to evaluate for safety in a multi-center,
single-arm, home and hotel clinical investigation. Study subjects included persons
348 Chapter 17