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 H- 8: Agreement (%) of SG-YSI (or BGM) paired points within YSI (or BGM) glucose ranges on Frequent Sample Testing (FST) Days
1, 3, and 7; Calibration 3 or 4 times a day, Buttock
YSI Glucose
Ranges (mg/dL)
Number of Paired
SG-YS
Percent of SG
Within 15/15% of
YSI
Percent of SG
Within 20/20% of
YSI
Percent of SG
Within 30/30% of
YSI
Percent of SG
Within 40/40% of
YSI
Percent of SG
Within >40/40%
of YSI
>60-80* 12 75 91.7 100 100 0
>80-180 78 78.2 83.3 93.6 96.2 3.8
>180-300 60 93.3 95 100 100 0
>300-350 7 100 100 100 100 0
>350-400 ------
*For glucose ranges ≤ 80 mg/dL, agreement was based on 15/20/30/40 mg/dL.
Note: Sensor glucose readings are within 40-400 mg/dL.
Note: For the blank Cells (-), there are no paired points in this reference range.
Table H-9: Agreement (%) of SG-YSI (or BGM) paired points within YSI (or BGM) glucose ranges on Frequent Sample Testing Day 1;
Calibration 3 or 4 times a day, Buttock
YSI Glucose
Ranges (mg/dL)
Number of Paired
SG-YS
Percent of SG
Within 15/15% of
YSI
Percent of SG
Within 20/20% of
YSI
Percent of SG
Within 30/30% of
YSI
Percent of SG
Within 40/40% of
YSI
Percent of SG
Within >40/40%
of YSI
Overall 70 74.3 81.4 94.3 97.1 2.9
≥40-60* 1 100 100 100 100 0
>60-80* 10 80 90 100 100 0
>80-180 37 59.5 70.3 89.2 94.6 5.4
>180-300 19 94.7 94.7 100 100 0
>300-350 3 100 100 100 100 0
>350-400 ------
*For glucose ranges ≤ 80 mg/dL, agreement was based on 15/20/30/40 mg/dL.
Note: Sensor glucose readings are within 40-400 mg/dL.
Note: For the blank Cells (-), there are no paired points in this reference range.
Agreement when CGM reads “Below 40 mg/dL” or “Above 400 mg/dL"
The real-time CGM systems display glucose values between 40 mg/dL and 400
mg/dL. It displays “Below 40 mg/dL” when the SG value detected is below 40
mg/dL. It displays “Above 400 mg/dL” when the SG value detected is above 400
mg/dL. Tables H-10 through H-13 illustrate the number and percentage of the
paired YSI (or BGM) values in different blood glucose levels when the CGM system
displays “Below 40 mg/dL” (LOW) or “Above 400 mg/dL” (HIGH).
382 Chapter 17