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-21: Overall concurrence of YSI values and SG readings using YSI 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
Number
of Paired
SG-YSI
SG (mg/dL)
<40 ≥40–60 >60–80 >80–120 >120–
160
>160–
200
>200–
250
>250–
300
>300–
350
>350–
400
>400
B) ≥40-60 4 100.0%
(4/4)
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%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
C) >60-80 15 13.3%
(2/15)
0.0%
(0/0)
40.0%
(6/15)
46.7%
(7/15)
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%
(0/0)
D) >80-120 56 1.8%
(1/56)
3.6%
(2/56)
12.5%
(7/56)
66.1%
(37/56)
16.1%
(9/56)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
E) >120-160 68 0.0% (0/0) 0.0%
(0/0)
4.4%
(3/68)
25.0%
(17/68)
57.4%
(39/68)
13.2%
(9
/68)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
F) >160-200 72 0.0% (0/0) 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
15.3%
(11/72)
75.0%
(54/72)
9.7%
(7/72)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
G)
>200-250
64 0.0% (0/0) 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
1.6%
(1/64)
29.7%
(19/64)
62.5%
(40/64)
6.3%
(4/64)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
H)
>250-300
31 0.0% (0/0) 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
45.2%
(14/31)
29.0%
(9/31)
22.6%
(7/31)
3.2%
(1/31)
0.0%
(0/0)
I) >300-350 60.0% (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)
50.0%
(3/6)
50.0%
(3/6)
0.0%
(0/0)
0.0%
(0/0)
J) >350-400 20.0% (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)
0.0%
(0/0)
50.0%
(1/2)
50.0%
(1/2)
0.0%
(0/0)
Note: The overall number of available paired SG-YSI points on FST Day 1 was from 13 subjects.
Percent Agreement Post Calibration
The agreement of the SG values to paired YSI 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 values was
calculated.
Tables E-22 through E-25 show the percent agreement rates post calibration for
sensors inserted into the abdomen and buttock.
Table E-22: Agreement rates for every 2-hour period post calibration period; Calibration every 12 hours, Abdomen
Time after calibration Number of 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 224 84.4 93.3 98.7 99.6 0.4
2–4 hours 181 77.9 85.1 94.5 98.3 1.7
4–6 hours 145 72.4 84.1 94.5 98.6 1.4
6–8 hours 77 74 83.1 97.4 100 0
8–10 hours 52 80.8 82.7 86.5 96.2 3.8
10–12 hours 54 81.5 94.4 100 100 0
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 363