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
• There was no control group for comparison purposes.
• The amount of time the system was used in the Manual Mode was much
shorter than the time it was programmed to the Auto Mode. Additionally, for
each subject, the study period lasted only three months.
Due to these limitations, the results of the clinical trial must be interpreted with
caution and you should understand that your individual results when using the
MiniMed 670G System may be significantly different from those of the subjects
who participated in the trial.
B. Guardian Sensor (3) Performance for 14 years old and older
CGM performance
The use of the Guardian Sensor (3) with the Guardian Link (3) transmitter enables
CGM technology. The transmitter transmits SG values calculated by the real-time
algorithm to a primary display device, allowing you to monitor your SG values.
Clinical study description
The performance of the Guardian Sensor (3) was evaluated in a clinical study.
4
This
inpatient (in-clinic) and outpatient (at home) study included subjects 14 to 75
years in age. The study design was a multi-center, prospective single-sample
correlational design without controls.
All subjects were assigned to treatment. Three sensors were worn at the same
time by each subject.
Each subject was instructed to wear two real-time CGM systems in the abdomen
area:
• One Guardian Sensor (3) connected to the Guardian Link (3) transmitter, which
transmitted to the insulin pump (for display purposes only).
• One Guardian Sensor (3) connected to the Guardian Connect transmitter
which transmitted to the Guardian Connect app, a standalone CGM display
device.
Each subject was also instructed to wear another Guardian Sensor (3) in the arm
area that was connected to a blinded glucose sensor recorder (GSR).
4 Medtronic Inc., A Performance Evaluation of the Enlite™ 3 Glucose Sensor to Support a Full 168 hours
(7 Days) of Use, CER292DOC/F. Oct 2016.
328 Chapter 17