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
User safety
This section includes important safety information such as indications, contraindications, safety warnings,
potential adverse reactions, and how to protect the system from radiation exposure damage.
Indications: CSS7100
The Guardian REAL-Time CGM System (CSS7100) is indicated for continuous or periodic monitoring of
glucose levels in the fluid under the skin, in adults (18 years and older) with diabetes mellitus, for the
purpose of improving diabetes management. It alerts if a glucose level falls below, or rises above, pre-set
values. Values are not intended to be used directly for making therapy adjustments, but rather to provide
an indication of when a meter blood glucose measurement may be required. All therapy adjustments
should be based on measurements obtained using a home glucose meter and not on Guardian REAL-Time
CGM System values.
The Guardian REAL-Time CGM System provides real-time glucose values that allow users to track patterns
in glucose concentrations and to possibly identify episodes of low and high blood glucose. It also stores the
data so that it can be analyzed to track patterns. Glucose data can be further downloaded to PC software
for analysis of historical glucose values. The Guardian REAL-Time monitor can be programmed to
automatically receive fingerstick blood glucose calibration values transmitted from Bayer's CONTOUR
®
NEXT LINK Wireless Meter (Model No. 6201/9624), a LifeScan OneTouch
®
UltraLink
®
meter, or a BD
Paradigm Link
®
glucose meter (calibration values from these meters can also be manually entered).
Calibrations from all other glucose meters must be manually entered into the monitor.
The MiniLink transmitter is indicated for use as a component of select Medtronic Diabetes continuous
glucose sensing systems and Medtronic Diabetes sensor-enabled pump systems.
Indications: CSS7100K (pediatric version)
The Guardian REAL-Time system (CSS7100K) is indicated for continuous or periodic monitoring of glucose
levels in the fluid under the skin, in children and adolescents (ages 7 through 17) with diabetes mellitus,
for the purpose of improving diabetes management. It alerts if a glucose level falls below, or rises above,
preset values. Values are not intended to be used directly for making therapy adjustments, but rather to
provide an indication of when a meter blood glucose measurement may be required. All therapy
adjustments should be based on measurements obtained using a home glucose meter and not on Guardian
REAL-Time CGM System values.
Introduction 5
Chapter 1