CareSens Air

CareSens Air

The CareSens Air CGMS (Continuous Glucose Monitoring System) allows for continuous monitoring of blood glucose levels when used with the CareSens Air sensor and app. For more information on how to use CareSens Air, refer to the user manual within the app.

The CareSens Air Continuous Glucose Monitoring System (CareSens Air CGM System) is indicated for continuous monitoring of blood glucose levels via measurement of glucose in the interstitial fluid in persons with diabetes mellitus aged 18 years and older. CareSens Air CGM System is intended to replace standard blood glucose testing for diabetes treatment decisions, unless otherwise indicated. CareSens Air CGM System helps to detect trends such as hyperglycemia and hypoglycemia by providing continuous blood glucose information, to manage changes in blood glucose levels through trend detection and pattern tracking.

Jurisdiction and Regulatory Clearance Notice The associated medical device(s) have obtained regulatory clearance for use in the following jurisdictions:

• European Union: CE marking
• Republic of Korea: MFDS approval

CE-MDR certification is recognized as a valid reference regulatory standard in the following jurisdictions, where the product is officially distributed through authorized local distributor: Nigeria, Qatar, Uganda, Zimbabwe and the United Kingdom The availability of this app is restricted to App Store storefronts in countries where the connected medical device(s) has been officially cleared for sale. Use of this application and the connected medical device outside these jurisdictions may not comply with local regulatory requirements.

The medical hardware (CareSens Air) compatible with this app has received regulatory clearance from the respective authorities in each distribution country. This app is intended for diabetes management support and is not a substitute for professional medical advice. Always consult a healthcare professional before using the app or making any medical decisions.

The CareSens Air app provides the following features:

• Real-time blood glucose measurement recorded every 5 minutes
• Blood glucose trend arrows and statistics
• Low/high blood glucose alerts, rapid changes alerts, and sensor replacement alerts
• Event memos for glucose-related activities.
• Data sharing to the Sens365 app or website
• Compatibility may vary by OS. See website (https://caresensair.com) for details.
• For other technical or customer service issues, please contact the i-SENS customer satisfaction center at +82-80-910-0900.

 "The instructions for use of CareSens Air CGM System are supplied in electronic form" ,  https://caresensair.com/download

This app is integrated with the Health app. This app may transmit blood sugar data it has collected to the Health app so that the Health app can check your blood sugar levels.

CareSens Air supports watchOS Devices

• Displays blood glucose data and chart graphs
• Shows blood glucose alerts
• Check blood sugar level without opening the app via complication ※ The watchOS version of CareSens Air must be connected to the mobile CareSens Air app.