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
Table E-29: Trend Accuracy; Calibration 3 or 4 times a day, Buttock
SG Rate Ranges
(mg/dL/min)
Percent of Matched Pairs-in Each YSI Rate Range for Each SG Rate Range
YSI (mg/dL/min)
Numbered of
Paired SG-YSI
<-2 [-2, -1] [-1, 0] [0, 1] [1, 2] >2
[-1, 0] 261 0.0% (0/261) 5.0% (13/261) 71.6% (187/261) 21.1% (55/261) 2.3% (6/261) 0.0% (0/261)
[0, 1] 194 0.0% (0/194) 0.5% (1/194) 22.2% (43/194) 62.9% (122/194) 13.4% (26/194) 1.0% (2/194)
[1, 2] 94 0.0% (0/94) 0.0% (0/94) 4.3% (4/94) 36.2% (34/94) 56.4% (53/94) 3.2% (3/94)
>2 22 0.0% (0/22) 0.0% (0/22) 0.0% (0/22) 22.7% (5/22) 36.4% (8/22) 40.9% (9/22)
Precision
Precision of the system was evaluated by comparing the results from two separate
sensors worn on the same subject at the same time.
Data from two sensors worn at the same time for 11 subjects, both inserted in the
abdomen, provided 772 pairs of CGM measurements, with a mean PARD during
the study of 7.83% and a coefficient of variation (%CV) of 5.7%.
Data from two sensors worn at the same time for 18 subjects, one inserted in the
abdomen and one in the buttock, provided 1302 pairs of CGM measurements,
with a mean PARD during the study of 11.33% and a coefficient of variation (%CV)
of 7.8%.
Data from two sensors worn at the same time for 10 subjects, both inserted in the
buttock, provided 695 pairs of CGM measurements, with a mean PARD during the
study of 10.93% and a coefficient of variation (%CV) of 8.1%.
Sensor life
After the first successful calibration, 64.3% of sensors worn in the abdomen
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 122.1 hours, with a median functional life of
128.4 hours.
After the first successful calibration, 81.3% of sensors worn in the buttock 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 buttock insertion site over the
course of the study was 142.7 hours, with a median functional life of 158.1 hours.
366 Chapter 17