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-21. Overall concurrence of YSI (or BGM) values and SG readings using YSI (or BGM) ranges on FST Day 1; Calibration 3 or 4
times a day, Buttock
YSI
Glucose
Ranges
(mg/dL)
Percent of Matched Pairs-in Each SG Glucose Range for Each YSI Glucose Range
SG (mg/dL)
Number
of
Paired
SG-YSI
<40 ≥40-60 >60-80 >80-120 >120-16
0
>160-20
0
>200-25
0
>250-30
0
>300-35
0
>350-40
0
>400
I)
>300-350
30.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
66.7%
(2/3)
0.0%
(0/0)
33.3%
(1/3)
0.0%
(0/0)
J)
>350-400
------------
Note: For the blank Cells (-), there are no paired points in this reference range.
Percent Agreement Post Calibration
The agreement of the SG values to paired YSI (or BGM) values was assessed for
every 2-hour period post sensor calibration. 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 was calculated.
Tables H-22 through H-25 show the percent agreement rates post calibration for
sensors inserted into the abdomen and buttock.
Table H-22. Agreement rates for every 2-hour period post calibration period; Calibration every 12 hours, Abdomen
Time after
calibration
No. paired YSI-
sensor points
Percentage (%) Agreement
± 15% (± 15
mg/dL)
± 20% (± 20
mg/dL)
± 30% (± 30
mg/dL)
± 40% (± 40
mg/dL)
> ±40% (± 40
mg/dL)
0-2 hours 20 65 85 100 100 0
2-4 hours 16 68.8 93.8 100 100 0
4-6 hours 11 90.9 90.9 100 100 0
6-8 hours 8 62.5 62.5 87.5 100 0
8–10 hours 6 100 100 100 100 0
10-12 hours 10001000
Table H-23. Agreement rates for every 2-hour period post calibration period; Calibration 3 or 4 times a day, Abdomen
Time after
calibration
No. paired YSI-
sensor points
Percentage (%) Agreement
± 15% (± 15
mg/dL)
± 20% (± 20
mg/dL)
± 30% (± 30
mg/dL)
± 40% (± 40
mg/dL)
> ±40% (± 40
mg/dL)
0-2 hours 24 62.5 79.2 100 100 0
2-4 hours 13 61.5 92.3 100 100 0
4-6 hours 11 90.9 90.9 100 100 0
6-8 hours 8 62.5 62.5 87.5 100 0
8–10 hours 6 100 100 100 100 0
10-12 hours ******
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 389