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-6: Agreement (%) of SG-YSI paired points within YSI glucose ranges on FST Days 1, 3, and 7; Calibration every 12 hours,
Buttock
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 84.8 92.3 96.8 98.6 1.4
≥40-60* 7 100 100 100 100 0
>60-80* 34 70.6 79.4 94.1 100 0
>80-180 393 80.9 89.8 94.9 97.5 2.5
>180-300 255 91 96.9 99.6 100 0
>300-350 15 100 100 100 100 0
>350-400 6 100 100 100 100 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-7: Agreement (%) of SG-YSI paired points within YSI glucose ranges on FST Day 1; Calibration every 12 hours, Buttock
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 335 78.8 87.2 93.7 97 3
>60-80* 19 52.6 63.2 89.5 100 0
>80-180 178 71.9 82.6 89.9 94.4 5.6
>180-300 133 91 96.2 99.2 100 0
>300-350 3 100 100 100 100 0
>350-400 2 100 100 100 100 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 14 subjects. SG readings are within 40-400 mg/dL.
Table E-8: Agreement (%) of SG-YSI paired points within YSI glucose ranges on FST Days 1, 3, and 7; Calibration 3 or 4 times a day,
Buttock
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 686 84.7 92.7 97.1 99.1 0.9
≥40-60* 7 100 100 100 100 0
>60-80* 28 85.7 89.3 100 100 0
>80-180 374 82.4 90.4 95.7 98.4 1.6
>180-300 253 87.4 96 98.4 100 0
>300-350 18 83.3 94.4 100 100 0
>350-400 6 100 100 100 100 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.
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 357