Indications, Contraindications, and Limitations

App

• The app communicates with the sensor via Bluetooth^® Low Energy technology. Devices supporting Bluetooth Low Energy versions prior to version 5.0 might not be compatible.
• The user will only receive alarms if the sensor is connected to the app and notifications are activated by the user.
• The app is not designed for use by persons who can't read information displayed on a mobile device.
• The app doesn't provide medical advice.
• The app notifies you about alarms primarily through sound. In addition, other notification methods can be used, for example, tactile or visual notifications. If you are hard of hearing or deaf, awareness of notifications may be limited. In such cases, only use the notification method for alarms that is appropriate for you.
• The notification of alarms can't be guaranteed in all cases, due to limitations of the alarm system. Don't rely solely on alarms. Otherwise, you can miss severe low blood glucose and/or high blood glucose.
  Open the app on a regular basis to check your glucose levels according to the instructions of your healthcare professional or if you feel that your glucose level may be low or high. Never ignore symptoms of low or high blood glucose.
• The app issues alarms based on CGM values provided by the sensor. If the sensor is in Trend Mode, CGM values may be less accurate. As a result, alarms may be issued even when your true glucose value is normal. It is also possible that no alarms are issued even when your true glucose value is high or low.
• The app displays CGM values provided by the sensor. If the sensor is in Trend Mode, these CGM values may be less accurate. Follow the instructions for use provided with the sensor.

Sensor

• Interstitial fluid glucose levels measured by the sensor may not reflect the actual blood glucose level. This can happen during rapid decreases or increases in glucose levels in the body. The interstitial fluid glucose levels may be higher or lower than the actual blood glucose levels. Such periods can be detected by viewing the Trend arrows and Home graph on the Home screen of the app. In these cases, you must base therapy decisions, such as insulin dosing, on additional blood glucose results obtained with a blood glucose meter.
• If a CGM value doesn't match your symptoms, the value should be verified by a blood glucose test using a blood glucose meter.
• The sensor should only be applied at the indicated application site on the upper arm. Otherwise, the safety of the patient and the accuracy of the CGM data can't be guaranteed.
• The sensor can send information to a mobile device within a range of 6 meters (20 feet) (line of sight). The actual range might be reduced depending on the mobile device and your environment (e.g. other nearby devices).
• Only use CGM values to make therapy decisions, such as insulin dosing, after you have calibrated your sensor as requested by the app. See chapter Calibrating Your Sensor.
• Taking interfering substances may falsely raise CGM values, which could cause you to miss severe hypoglycemia. If you are taking any of the listed interfering substances, consult with your healthcare professional. See chapter Technical Data of the Accu-Chek SmartGuide Device for a list of interfering substances.