General Safety Information
App
Don’t estimate or make assumptions of any missing CGM data. Estimating or assuming any missing CGM data can lead to wrong therapy decisions, such as insulin dosing.
In case of missing CGM data, make sure that your app is set up correctly and your sensor and mobile device are connected. For more information on setting up the app and your sensor correctly, see chapter Getting Started. If you aren’t sure whether the app or the sensor is working properly, use an alternative method for testing your glucose and contact customer support.
Modification of components or failure to follow the instructions for use may prevent the app from working as intended.
Carefully read and follow the instructions for use.
Changes to your diabetes management or overall therapy may only be made by healthcare professionals.
If you have questions about your therapy, consult your healthcare professional.
The app may not always be able to display glucose values. Here are two examples:
- If the battery of your mobile device is dead.
- If you lose your mobile device.
Make sure you have access to alternative methods for testing your glucose.
For example, children or others might accidentally add calibration values. Incorrect calibration values can negatively affect the CGM data provided by the sensor. Follow the instructions for data protection to prevent third parties from gaining access to the app. See section Access Protection.
Mobile devices aren’t dedicated medical devices. Only use mobile devices compatible with the app. See chapter Technical Data of the Accu-Chek SmartGuide App. Don’t operate the app on mobile devices that aren’t compatible or have been manipulated. If in doubt, contact the manufacturer of your mobile device.
Always have alternative methods for testing your glucose available. If you lose your mobile device or in case of a system malfunction, switch to an alternative method for testing your glucose.
For information on environmental conditions of your mobile device, refer to the User’s Manual of your mobile device or the operating system (OS) of your mobile device.
Anybody connecting additional equipment to medical electrical equipment configures a medical system and is therefore responsible for ensuring that the system complies with the requirements for medical electrical systems.
Your mobile device has to comply with the respective IEC or ISO standards (for example, IEC 60950 or IEC 62368). Configurations shall comply with the requirements for medical electrical systems (see clause 16 of the latest valid version of IEC 60601-1). If in doubt, contact the manufacturer of your mobile device.
The app is intended for single-person use only.
Check your mobile device settings before using the app. The app requires sound to properly signal important information. Otherwise, the information can be missed.
Using font sizes other than the default font size for a device may result in the app not working as intended.
Sensor
Take particular note of all safety information in the package insert provided with the device.
Only make therapy decisions, such as insulin dosing, based on multiple current glucose values, and the direction in which your glucose values are trending. Glucose values displayed by the app may not always be accurate. Always check the app’s trend graph prior to making therapy decisions, such as insulin dosing. Also consider your current health condition and physical activity levels when making therapy decisions, such as insulin dosing.
Don’t ignore symptoms of hypoglycemia or hyperglycemia. Don’t make significant changes to your therapy by yourself. If your displayed glucose value doesn’t match how you feel:
- Switch to an alternative method for testing your glucose.
- If your symptoms still don’t match your glucose value, consult your healthcare professional.
For more information, see section General Troubleshooting.
A damaged sensor may not work properly.
If the sensor is exposed to an impact, for example, if it was hit by a ball, visually inspect the sensor for damages. If you notice anything unusual, remove the sensor and apply a new one.
Operate your mobile device only as advised by the manufacturer (for example, don’t use a damaged or manipulated device). If in doubt, contact the manufacturer of your mobile device.
Make sure you don’t miss episodes of low or very high 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.
Follow your regular hygiene routine, but avoid excessive contact of soap and shampoo with the sensor. Use only the minimum amount of soap to keep the sensor clean.
Don’t apply skin care and hygienic products to the sensor or the application site (insect repellent, sunscreen, etc.). These products may damage the sensor or the adhesive pad.
Your body may react to the sensor or the adhesive pad. Inspect the application site regularly for skin irritation or inflammation. If in doubt, or if the application site becomes inflamed or if localized skin reactions (for example, allergic reaction, eczema) occur, remove the sensor immediately and consult your healthcare professional.
If the outer edges of the adhesive pad lift slightly from the skin, the sensor will still function properly. However, if any part of the adhesive pad underneath the sensor lifts from the skin, don’t attempt to reapply the sensor or tape the sensor to the skin. A reapplied sensor may not function properly. Apply a new sensor instead.
If the sensor falls off, don’t apply the used sensor again. A reapplied sensor may not function properly. Apply a new sensor instead.