User guide
Table Of Contents
- Contents
- Introduction
- The basics
- Entering your settings
- Basic steps
- Setting the time and date
- Selecting the language
- Setting your Alarm/Alert Type
- Entering your glucose monitoring settings
- Turning on the sensor
- Selecting the BG units
- Turning on the Glucose Alerts
- Setting the Glucose Limits
- Setting the Glucose Limits start time
- Setting the High Snooze
- Setting the Low Snooze
- Setting the Predictive glucose alert
- Setting the Rate Alerts
- AUC calculation
- Setting the Alarm Snooze
- Setting the Cal Reminder
- Entering the transmitter identification number
- Setting up the Missed Data option
- Setting the sensor glucose graph timeout
- Reviewing your settings
- Setting up your transmitter and sensor
- Meter option
- Using your system
- Utilities
- Therapy management software
- Troubleshooting and alarms/alerts
- About alarms and alerts
- What to do when you get an alarm/alert
- Sensor alerts
- Viewing your sensor alert history
- System alarms
- Viewing your system alarm history
- Understanding your transmitter, tester, and charger
- Troubleshooting the transmitter
- Troubleshooting the monitor
- My monitor will not display my BG measurement from my meter
- Reconnect old sensor
- Find lost sensor
- What happens if I leave the monitor battery out for more than ten minutes?
- Why doesn't my monitor battery last very long?
- What is a CHECK SETTINGS alarm?
- My screen looks distorted
- I dropped my monitor
- I submerged my monitor in water
- I cannot get to the User Settings screen
- System maintenance
- System specifications
- Alarm/alert types
- Alarm/alert messages and codes
- Alarm/alert history
- Backlight
- Screen and menu timeout
- Sensor glucose graph timeout
- High and low Glucose Limits (CSS7100)
- High and low Glucose Limits (CSS7100K)
- Daily totals
- Default screen
- Default settings
- ENTER BG meter values
- Meter ID entries
- Power supply
- System safety checks
- Radio frequency (RF) communication specifications
- Quality of service
- Data security
- Monitor size
- Monitor weight
- TIME/DATE SET screen
- STATUS screen
- Guidance and manufacturer's declaration
- MiniLink specifications
- Warranty
- Icon table
- Sensor accuracy
- Performance results in adults
- Accuracy of Guardian RT readings
- Precision of Guardian RT readings
- Low and High Alerts in adults
- Guardian RT Sensor Performance and Calibration Stability As a Function of Time
- Effects of calibration frequency
- Performance results in children and adolescents
- Low and High alerts in children and adolescents
- Glossary
- Index
The percent of Guardian RT readings in the previous graph are presented in the following table according
to the percentage of points falling within each zone (A-E). Results are further broken down (stratified)
according to the range of glucose concentrations.
Glucose
Range
(mg/dl)
Number and
(%) of Data
Points
Evaluated
A + B A B C D E
40-80 356 (9) 271 (76.1) 214 (60.1) 57 (16.0) 2 (0.6) 80 (22.5) 3 (0.8)
81-120 769 (20) 768 (99.9) 463 (60.2) 305 (39.7) 1 (0.1)
N/A
a
N/A
121-240 2362 (60) 2352 (99.6) 1476 (62.5) 876 (37.1) 4 (0.2) N/A 6 (0.2)
>240 454 (11) 394 (86.8) 277 (61.0) 117 (25.8) N/A 59 (13.0) 1 (0.2)
Overall 3941 (100) 3785 (96.0) 2430 (61.7) 1355 (34.4) 7 (0.2) 139 (3.5) 10 (0.2)
a. N/A means that the Clarke Error Grid does not consider the possibility of these zones in that concentration range.
Precision of Guardian RT readings
This study was also designed to look at the reproducibility of two sensors worn simultaneously at different
locations on the body. Precision was estimated by comparing the glucose readings from the two Guardian
RT systems. In this study 11,475 paired sensor Guardian RT values were obtained. On average, they were
different by 17.2%. The following figure is an example of how data was paired in this study. In the
graph there are two tracings of Guardian RT values. Each tracing comes from a different Guardian RT unit
worn by one subject during a one-day period.
Appendix A138