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 B-8: Overall agreement (%) of SG-YSI paired points within SG ranges on FST Days 1, 3, and 7; Calibration 3 or 4 times a day, Arm.
SG ranges (mg/dL) Number of paired
SG-YSI
Percent of YSI
within 15/15% of
SG (%)
Percent of YSI
within 20/20% of
SG (%)
Percent of YSI
within 30/30% of
SG (%)
Percent of YSI
within 40/40% of
SG (%)
Percent of YSI
greater than
40/40% of SG (%)
Overall 10771 84.3 91.6 97.3 99.1 0.9
≥40–60* 503 77.1 87.5 96.6 99.6 0.4
>60–80* 1291 89.3 93.4 97.7 99.1 0.9
>80–180 6076 82 90 96.7 98.7 1.3
>180–300 2569 87 94.4 98.3 99.7 0.3
>300–350 271 94.8 98.5 100 100 0
>350–400 61 95.1 96.7 100 100 0
* For reference range ≤80 mg/dL, agreement was based on 15/20/30/40 mg/dL.
Note: SG Readings are within 40–400 mg/dL.
Table B-9: Agreement (%) of SG-YSI paired points within SG ranges on FST Day 1; Calibration 3 or 4 times a day, Arm.
SG ranges (mg/dL) Number of paired
SG-YSI
Percent of YSI
within 15/15% of
SG (%)
Percent of YSI
within 20/20% of
SG (%)
Percent of YSI
within 30/30% of
SG (%)
Percent of YSI
within 40/40% of
SG (%)
Percent of YSI
greater than
40/40% of SG (%)
Overall 3591 76.8 86 95 98.5 1.5
≥40–60* 162 62.3 75.3 91.4 98.8 1.2
>60–80* 346 76.3 81.5 92.8 97.4 2.6
>80–180 2108 75.1 85 94.2 98 2
>180–300 869 81.8 91 97.7 99.9 0.1
>300–350 93 92.5 96.8 100 100 0
>350–400 13 84.6 84.6 100 100 0
* For reference range ≤80 mg/dL, agreement was based on 15/20/30/40 mg/dL.
Note: The overall number of available paired SG-YSI points on FST Day 1 was from 83 subjects. SG Readings are within 40–400 mg/dL.
Agreement when the CGM system 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 B-10, B-11, B-12, and B-13 illustrate the number and percentage
of the paired YSI values in different BG levels when the CGM system displays
“Below 40 mg/dL” (LOW) or “Above 400 mg/dL” (HIGH).
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 333