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-13: The number and percentage of YSI values collected when CGM displays "Above 400 mg/dL" (HIGH); Calibration 3 or 4 times
a day.
CGM Readings Insertion Site CGM-YSI pairs >340 >320 >280 >240 <240 Total
HIGH AbdomenCumulative, n000000
Cumulative %0%0%0%0%0%
ButtocksCumulative, n000000
Cumulative %0%0%0%0%0%
Concurrence of SG and YSI values
The following tables show the percentage of concurring SG readings with FST
reference values.
Table E-14: Overall concurrence of YSI values and SG readings using YSI ranges on FST Days 1, 3, and 7; Calibration every 12 hours,
Abdomen
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) ≥40-60 633.3%
(2/6)
33.3%
(2/6)
0.0% (0/0) 33.3%
(2/6)
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 20 0.0%
(0/0)
10.0%
(2/20)
55.0%
(11/20)
35.0%
(7/20)
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)
D) >80-120 124 0.0%
(0/0)
4.8%
(6/124)
13.7%
(17/124)
66.1%
(82/124)
15.3%
(19/124)
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
169 0.0%
(0/0)
0.0%
(0/0)
0.6%
(1/169)
21.3%
(36/169)
62.1%
(105/169)
15.4%
(26/169)
0.6%
(1/169)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
F)
>160-200
160 0.0%
(0/0)
0.0%
(0/0)
0.0% (0/0) 1.9%
(3/160)
25.0%
(40/160)
64.4%
(103/160)
8.8%
(14/160)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
G)
>200-250
151 0.0%
(0/0)
0.0%
(0/0)
0.0% (0/0) 0.0% (0/0) 1.3%
(2/151)
40.4%
(61/151)
56.3%
(85/151)
2.0%
(3/151)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
H)
>250-300
64 0.0%
(0/0)
0.0%
(0/0)
0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 0.0% (0/0) 32.8%
(21/64)
64.1%
(41/64)
3.1%
(2/64)
0.0%
(0/0)
0.0%
(0/0)
I)
>300-350
32 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) 40.6%
(13/32)
59.4%
(19/32)
0.0%
(0/0)
0.0%
(0/0)
J)
>350-400
90.0%
(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)
88.9%
(8/9)
11.1%
(1/9)
0.0%
(0/0)
Table E-15: Overall concurrence of YSI values and SG readings using YSI ranges on FST Day 1; Calibration every 12 hours, Abdomen
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) ≥40-60 450.0%
(2/4)
50.0%
(2/4)
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)
C) >60-80 11 0.0%
(0/0)
18.2%
(2/11)
45.5%
(5/11)
36.4%
(4/11)
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)
■
670G Performance Data and Technical Information
670G Performance Data and Technical Information 359