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
Mean absolute relative difference, by number of daily calibrations
Table B-1 shows the sensor accuracy measured by the mean absolute relative
difference (MARD). MARD represents the average relative difference (regardless if
positive or negative) between the SG values and the paired BG values measured
by YSI.
Table B-1: SG MARD Versus YSI (within YSI glucose ranges).
YSI glucose
ranges
(mg/dL)
Abdomen Insertion Site Arm 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
MARD (%) Number of
paired SG-YSI
MARD (%) Number of
paired SG-YSI
MARD (%) Number of
paired SG-YSI
MARD (%)
Overall 12090 10.55 11664 9.64 10526 9.09 10771 8.68
<40* 12 17.03 11 16.41 7 17.24 7 17.24
40–60* 3537.963247.533356.443496.42
61–80* 1445 9.44 1403 8.81 1345 7.76 1372 7.44
81–180 6505 9.94 6342 9.33 5644 8.64 5795 8.35
181–300 327710.0031148.5727668.5827857.95
301–350 3669.633418.133089.093388.27
351–400 1179.581148.561118.471158.23
>400 15 10.85 15 10.92 10 10.71 10 11.44
* 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.
Percent agreement, by number of daily calibrations
In Tables B-2 through B-9, the agreement of the SG values to paired YSI values was
assessed by calculating the percentage of YSI values that were within 15%, 20%,
30%, 40% and greater than 40% of the paired SG values. For readings less than or
equal to 80 mg/dL, the absolute difference in mg/dL between the SG and paired
YSI values was calculated.
Results are shown for defined SG ranges when calibrating every 12 hours and
calibrating three or four times a day for sensors.
Table B-2: Overall agreement (%) of SG-YSI paired points within SG ranges on FST Days 1, 3, and 7; Calibration every 12 hours,
Abdomen.
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 12090 76.6 85.7 94.3 97.3 2.7
≥40–60* 781 57.7 73.2 90.7 96.9 3.1
>60–80* 1350 76.1 83.4 93.4 96.8 3.2
>80–180 6769 76.5 85.3 93.5 96.5 3.5
330 Chapter 17