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-24: Trend accuracy; Calibration every 12 hours, Abdomen.
Percent of Matched Pairs-in Each YSI Rate-of-Change Range for Each SG Rate-of-Change Range
YSI Rate-of-Change Ranges (mg/dL/min)
SG Rate-of-
Change Range
(mg/dL/min)
Number of
Paired SG-YSI
<-2 [-2, -1] [-1, 0] [0, 1] [1, 2] >2
A) <-2 162 38.3% (62/162) 40.1% (65/162) 20.4% (33/162) 0.6% (1/162) 0.6% (1/162) 0.0% (0/162)
B) [-2, -1] 1001 4.8% (48/1001) 39.9% (399/1001) 51.3% (514/1001) 3.7% (37/1001) 0.3% (3/1001) 0.0% (0/1001)
C) [-1, 0] 5960 0.5% (30/5960) 3.8% (228/5960) 77.6%
(4627/5960)
17.1%
(1020/5960)
0.8% (49/5960) 0.1% (6/5960)
D) [0, 1] 3517 0.2% (7/3517) 0.5% (18/3517) 25.7% (903/3517) 63.4%
(2231/3517)
9.3% (326/3517) 0.9% (32/3517)
E) [1, 2] 1059 0.1% (1/1059) 0.4%
(4/1059)
4.5% (48/1059) 37.9% (401/1059) 48.6% (515/1059) 8.5% (90/1059)
F) >2 391 0.0% (0/391) 0.0% (0/391) 2.8% (11/391) 7.4% (29/391) 40.9% (160/391) 48.8% (191/391)
Table B-25: Trend accuracy; Calibration 3 or 4 times a day, Abdomen.
Percent of Matched Pairs-in Each YSI Rate-of-Change Range for Each SG Rate-of-Change Range
YSI Rate-of-Change Ranges (mg/dL/min)
SG Rate-of-
Change Range
(mg/dL/min)
Number of
Paired SG-YSI
<-2 [-2, -1] [-1, 0] [0, 1] [1, 2] >2
A) <-2 159 39.0% (62/159) 39.6% (63/159) 19.5% (31/159) 0.6% (1/159) 1.3% (2/159) 0.0% (0/159)
B) [-2, -1] 967 5.1% (49/967) 38.7% (374/967) 51.9% (502/967) 4.0% (39/967) 0.3% (3/967) 0.0% (0/967)
C) [-1, 0] 5753 0.5% (28/5753) 4.0% (228/5753) 77.5%
(4456/5753)
17.2% (990/5753) 0.8% (46/5753) 0.1% (5/5753)
D) [0, 1] 3387 0.2% (8/3387) 0.5% (18/3387) 26.5% (898/3387) 62.5%
(2118/3387)
9.3% (316/3387) 0.9% (29/3387)
E) [1, 2] 1024 0.0% (0/1024) 0.2% (2/1024) 5.0% (51/1024) 38.8% (397/1024) 47.5% (486/1024) 8.6% (88/1024)
F) >2 374 0.0% (0/374) 0.0% (0/374) 2.4% (9/374) 8.0% (30/374) 42.8% (160/374) 46.8% (175/374)
Precision
Precision of the system was evaluated by comparing the results from two separate
sensors worn in the abdomen on the same subject at the same time. A total of
83 subjects provided 30,350 paired SG-YSI measurements, with a mean Percent
Absolute Relative Difference (PARD) of 9.07% with a coefficient of variation (%CV)
of 6.5%.
Though precision in the arm has not been specifically assessed, arm vs. arm and
arm vs. abdomen is likely comparable to the abdomen precision based on internal
evaluation by Medtronic.
342 Chapter 17