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-1: SG MARD Versus YSI or BGM (within YSI glucose ranges)
YSI Glucose
Ranges
(mg/dL)
Abdomen Insertion Site Buttock Insertion Site
Calibration every 12 hours Calibration 3 or 4 times a day Calibration every 12 hours Calibration 3 or 4 times a day
Number of
Paired SG-YSI
Mean
Absolute
Relative
Difference
(%)
Number of
Paired SG-YSI
Mean
Absolute
Relative
Difference
(%)
Number of
Paired SG-YSI
Mean
Absolute
Relative
Difference
(%)
Number of
Paired SG-YSI
Mean
Absolute
Relative
Difference
(%)
*For YSI reference range ≤ 80 mg/dL, the differences in mg/dL are included instead of percent difference (%).
Note: SG Readings are within 40-400 mg/dL.
Note: For the blank Cells (-), there are no paired points in this reference range.
Percent agreement, by number of daily calibrations
In Tables H-2 through 9, the agreement of the SG values to paired YSI (or BGM)
values were assessed by calculating the percentage of SG values that were within
15%, 20%, 30%, 40% and greater than 40% of the paired YSI (or BGM) values. For
readings less than or equal to 80 mg/dL, the absolute difference in mg/dL
between the SG and paired YSI (or BGM) values were calculated.
Results are shown for defined YSI (or BGM) ranges when calibrating every 12 hours
and calibrating three or four times a day for sensors.
Table H-2: 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 every 12 hours, Abdomen
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 62 72.6 85.5 96.8 100 0
≥40-60*------
>60-80* 1 100 100 100 100 0
>80-180 26 80.8 88.5 96.2 100 0
>180-300 30 60 80 96.7 100 0
>300-350 5 100 100 100 100 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-3: Agreement (%) of SG-YSI (or BGM) paired points within YSI (or BGM) glucose ranges on Frequent Sample Testing (FST) Day 1;
Calibration every 12 hours, Abdomen
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 11 72.7 100 100 100 0
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 379