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 B-20: Overall concurrence of YSI values and SG readings using SG ranges on FST Days 1, 3, and 7; Calibration 3 or 4 times a day,
Arm.
Percent of matched pairs in each YSI glucose range for each SG range (mg/dL)
SG ranges
(mg/dL)
Number
of paired
SG-YSI
YSI Glucose Range (mg/dL)
<40 ≥40–60 >60–80 >80–120 >120–
160
>160–
200
>200–
250
>250–
300
>300–
350
>350–
400
>400
K) >400 80.0%
(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)
62.5%
(5/8)
37.5%
(3/8)
Table B-21: Concurrence of YSI values and SG readings using SG ranges on FST) Day 1; Calibration 3 or 4 times a day, Arm.
Percent of matched pairs in each YSI glucose range for each SG range (mg/dL)
SG ranges
(mg/dL)
Number
of paired
SG-YSI
YSI Glucose Range (mg/dL)
<40 ≥40–60 >60–80 >80–120 >120–160 >160–
200
>200–
250
>250–
300
>300–
350
>350–
400
>400
A) <40 54 3.7%
(2/54)
29.6%
(16/54)
64.8%
(35/54)
1.9%
(1/54)
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)
B) ≥40–60 162 1.9%
(3/162)
25.3%
(41/162)
61.7%
(100/162)
11.1%
(18/162)
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) >60–80 346 0.6%
(2/346)
11.6%
(40/346)
61.3%
(212/346)
25.7%
(89/346)
0.9%
(3/346)
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) >80–120 899 0.0%
(0/0)
0.3%
(3/899)
6.3%
(57/899)
74.0%
(665/899)
18.2%
(164/899)
1.1%
(10/899)
0.0%
(0
/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
E) >120–160 878 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
10.0%
(88/878)
67.0%
(588/878)
21.0%
(184/878)
2.1%
(18/878)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
F) >160–200 571 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.2%
(1/571)
9.3%
(53/571)
62.3%
(356/571)
27.3%
(156/571)
0.9%
(5/571)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
G) >200–250 427 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.2%
(1/427)
8.2%
(35/427)
62.5%
(267/427)
27.6%
(118/427)
1.4%
(6/427)
0.0%
(0/0)
0.0%
(0/0)
H) >250–300 202 0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
0.0%
(0/0)
9.9%
(20/202)
59.9%
(121/202)
26.7%
(54/202)
3.5%
(7/202)
0.0%
(0/0)
I
) >300–350 93 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)
16.1%
(15/93)
59.1%
(55/93)
22.6%
(21/93)
2.2%
(2/93)
J) >350–400 13 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)
15.4%
(2/13)
7.7%
(1/13)
76.9%
(10/13)
0.0%
(0/0)
K) >400 00.0%
(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)
0.0%
(0/0)
Note: The overall number of available paired SG-YSI points on FST Day 1 was from 83 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.
340 Chapter 17