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-3: Agreement (%) of SG-YSI paired points within YSI glucose ranges on FST Day 1; Calibration every 12 hours, Abdomen
YSI Glucose
Ranges (mg/dL)
Number of Paired
SG-YSI
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
greater than
40/40% of YSI
Overall 403 81.9 90.6 96.5 99 1
≥40-60* 2 100 100 100 100 0
>60-80* 11 63.6 72.7 90.9 100 0
>80-180 196 75.5 84.2 93.4 98 2
>180-300 160 86.9 97.5 100 100 0
>300-350 27 100 100 100 100 0
>350-400 7 100 100 100 100 0
* For glucose ranges ≤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 16 subjects. SG readings are within 40-400 mg/dL.
Table E-4: Agreement (%) of SG-YSI paired points within YSI glucose ranges on FST Days 1, 3, and 7; Calibration 3 or 4 times a day,
Abdomen
YSI Glucose
Ranges (mg/dL)
Number of Paired
SG-YSI
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
greater than
40/40% of YSI
Overall 710 81.7 90 97.2 99.4 0.6
≥40-60* 200501000
>60-80* 18 83.3 88.9 94.4 94.4 5.6
>80-180 367 74.9 84.5 95.1 99.2 0.8
>180-300 282 88.3 96.5 100 100 0
>300-350 32 100 100 100 100 0
>350-400 9 100 100 100 100 0
* For glucose ranges ≤80 mg/dL, agreement was based on 15/20/30/40 mg/dL.
Note: SG readings are within 40-400 mg/dL.
Table E-5: Agreement (%) of SG-YSI paired points within YSI glucose ranges on FST Day 1; Calibration 3 or 4 times a day, Abdomen
YSI Glucose
Ranges (mg/dL)
Number of Paired
SG-YSI
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
greater than
40/40% of YSI
Overall 372 83.9 92.2 97.3 99.5 0.5
>60-80* 9 77.8 88.9 100 100 0
>80-180 182 76.9 86.3 94.5 98.9 1.1
>180-300 147 89.1 98 100 100 0
>300-350 27 100 100 100 100 0
>350-400 7 100 100 100 100 0
* For glucose ranges ≤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 15 subjects. SG readings are within 40-400 mg/dL.
356 Chapter 17