Dexcom G5 - Calibrate on Schedule; Placement; Prior to Initial Calibration: Data;Alarm;Alert

Dexcom G5 Mobile System User Guide
21Indications for Use and Safety Statement
• Persons on dialysis
Warnings (continued)
The following warnings may result in the consequence of missing severe hypoglycemia (low
blood glucose) or hyperglycemia (high blood glucose) or making a treatment decision that
results in injury:
Do not use the Dexcom G5 Mobile CGM System in critically ill patients. It is
not known how different conditions or medications common to the critically ill
population may affect performance of the system. Sensor glucose readings may be
inaccurate in critically ill patients.
The Dexcom G5 Mobile’s accuracy has not been tested in people within these
groups and the system’s glucose readings may be inaccurate.
Calibrate on Schedule
What is calibrating and why it is important? Calibration is the process of making
sure your sensor continues to be accurate. Your sensor doesn’t automatically know
what your glucose levels are—you have to teach your system what a given BG
value is by entering in a KNOWN glucose value from your BG meter.
Calibrate the Dexcom G5 Mobile at least once every 12 hours. The Dexcom G5
Mobile needs to be calibrated in order to provide accurate readings. Do not use the
Dexcom G5 Mobile for diabetes treatment decisions unless you have followed the
prompts from the device and calibrated every 12 hours after the initial calibration.
Placement
Do not insert the sensor component of the Dexcom G5 Mobile in a site other than
the belly/abdomen (ages 2 years and older) or the upper buttocks (ages 2 to 17
years). The placement and insertion of the sensor component of the Dexcom G5
Mobile is not approved for other sites. If placed in other areas, the Dexcom G5
Mobile may not function properly.
Prior to Initial Calibration: Data/Alarm/Alert
Do not expect sensor glucose readings or Alarms/Alerts from the Dexcom G5
Mobile until after the 2-hour startup. The Dexcom G5 Mobile will NOT provide any
sensor glucose readings or Alarms/Alerts until after the 2-hour startup ends AND
you complete the startup calibration. Use fingerstick glucose values from your
blood glucose meter during the 2-hour startup.