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
The use of the Guardian Sensor (3) with the Guardian Link (3) transmitter enables
CGM technology. The transmitter transmits sensor glucose values calculated by the
real-time algorithm to a primary display device, allowing you to monitor your
sensor glucose values.
Clinical study description
The performance of the Guardian Sensor (3) was evaluated in a clinical study
6
. This
in-patient (in-clinic) and outpatient (at home) study included subjects 2 to 6 years
in age. The study design was a multi-center, prospective single sample
correlational design without controls.
All subjects were assigned to treatment. Each subject was instructed to wear two
Guardian™ Sensor (3) sensors in the abdomen and/or buttock.
1. One Guardian Sensor (3) connected to the Guardian Connect Transmitter,
which transmitted to the Guardian Connect app, a standalone CGM display
device.
2. One Guardian Sensor (3) connected to the Guardian Link (3) transmitter,
which served as a glucose sensor recorder (GSR, transmitter/recorder for
sensor integrated pump systems).
The sensor glucose data collected by the blinded GSRs were retrospectively
processed through the real-time CGM algorithm. This is the same algorithm used
in the Guardian™ Connect and pump CGM systems. Thus, all data is representative
of real-time sensor usage.
The CONTOUR®NEXT LINK 2.4 Wireless Meter was the study meter used for all
calibrations in this study, and was the only meter evaluated with the Guardian
Sensor (3) CGM systems. The sensor has not been tested with other meters.
Therefore, the performance with other blood glucose meters may differ from the
performance with the CONTOUR NEXT LINK 2.4 Wireless Meter described below.
Subjects aged 2-6 years old will be randomly assigned to which day to come in for
the FST but may have their parents choose the area for sensor placement.
Frequent Sample Testing (FST) was performed on day 1, 3, or 7, for 6 hours each,
over the life of the sensor. Reference blood (plasma) glucose values were obtained
with a Blood Glucose Meter (BGM) or Yellow Springs Instrument (YSI®) Glucose
6 Medtronic Inc., A Performance Evaluation of the Enlite™ and Enlite™ 3 Glucose Sensor to Support Use
in Children; CEP249 Data From Subjects 7-13 Years of Age 10901316DOC. May2019.
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670G Performance Data and Technical Information
670G Performance Data and Technical Information 377