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
For example, per the following table, when wearing the sensor in the buttock, the
high glucose threshold alerts would have incorrectly indicated that the user was
above (i.e. threshold only), or predicted to reach above the threshold (i.e.
predictive only), or both (threshold and predictive) 10.3%, 15.2% or 14.3% of the
time within 30 minutes (or 10.3%, 18.2%, or 16.1% of the time within 15 minutes)
when the user had blood glucose less than 180 mg/dL.
Table I-2. Glucose FALSE Alert Performance using Calibration every 12 hours
Glucose FALSE Alert 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 N/A* N/A* N/A* N/A* N/A* N/A*
Buttock 100.0% 100.0% 100.0% 100.0% 100.0% 100.0%
60 Abdomen N/A* N/A* 100.0% 100.0% 100.0% 100.0%
Buttock 0.0% 0.0% 75.0% 75.0% 60.0% 60.0%
70 Abdomen 100.0% 100.0% 100.0% 100.0% 100.0% 100.0%
Buttock 0.0% 0.0% 60.0% 60.0% 42.9% 42.9%
80 Abdomen 75.0% 75.0% 83.3% 100.0% 80.0% 90.0%
Buttock 60.0% 60.0% 66.7% 77.8% 64.3% 71.4%
90 Abdomen 50.0% 50.0% 50.0% 66.7% 50.0% 60.0%
Buttock 0.0% 0.0% 18.2% 36.4% 11.1% 22.2%
180 Abdomen 0.0% 0.0% 20.0% 30.0% 14.3% 21.4%
Buttock 10.3% 10.3% 15.2% 18.2% 14.3% 16.1%
220 Abdomen 0.0% 0.0% 50.0% 50.0% 38.5% 38.5%
Buttock 10.0% 15.0% 37.9% 44.8% 29.5% 36.4%
250 Abdomen 0.0% 0.0% 16.7% 16.7% 9.1% 9.1%
Buttock 20.0% 26.7% 34.8% 43.5% 29.7% 37.8%
300 Abdomen 40.0% 40.0% 60.0% 60.0% 50.0% 50.0%
Buttock 33.3% 33.3% 65.0% 70.0% 57.7% 61.5%
Note: Given the small sample size of data available in the low range, the alert performance in the 50 mg/dL and 60 mg/dL should be interpreted
with caution and may not reflect actual use performance.
*There is no evaluable events in this reference range so it is N/A.
Glucose Correct Detection Rate
Glucose Correct Detection Rate is the rate that the device alerted when it should
have alerted. For example, the blood glucose was below the hypoglycemic
threshold, or above the hyperglycemic threshold, and the device sounded an alert.
396 Chapter 17