Safety Information & Product Manuals

SAFETY INFORMATION

ALWAYS READ THE LABEL AND FOLLOW THE DIRECTIONS FOR USE.

Ask your health professional if these products are right for you.

Refer to the full user manual (which can be downloaded on this page, under the ‘Support’ tab) for safety information before purchase.

Indications for Use

The CareSens Air continuous glucose monitoring system (CGMS) 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.

Contraindications

• Remove the sensor before an X-ray, MRI, CT scan, radiofrequency ablation, high frequency electrical heat, or high intensity focused ultrasound. Magnetic fields or heat can damage the device, leading to inaccurate glucose level readings or alert errors.
• This product has not been evaluated or approved for the following individuals:
  • Infants and children under 18 years of age
  • Pregnant and breastfeeding women
  • Dialysis patients and critically ill patients

Warnings

This is not a complete list of the warnings, precautions, and instructions for use. Refer to the full user manual for more information.

• If you find that the displayed sensor readings do not accurately reflect your symptoms or expectations, immediately use a blood glucose meter to check and make treatment decisions. Do not ignore symptoms. Take medical action or follow your healthcare professional’s instructions. 
• This product contains a button battery. If swallowed, a lithium button battery can cause severe or fatal injuries within 2 hours. Keep batteries out of reach of children. If you think batteries may have been swallowed or placed inside any part of the body, seek immediate medical attention.
• If you cannot check real-time glucose levels (e.g. during the sensor warm up time, if a system error occurs or when no glucose value is displayed), use a glucose meter to make treatment decisions. 
• Severe hypotension or shock may result in abnormal measurements. 
• Do not use in patients with severe symptoms, as ketoacidosis or a hyperosmolar hyperglycemic nonketotic state may result in abnormally low measurements. 
• Only use and attach the sensor according to the user manual. 
• If you experience any symptoms or adverse events following the use of the sensor, consult your healthcare professional. 
• Keep the desiccant out of reach of infants or children. Do not eat the desiccant. If the contents of the desiccant get in your eyes, wash them thoroughly with running water right away. Consult your healthcare professional. 
• Swallowing the sensor could result in choking. Please supervise children so that they do not touch the sensor. 
• Glucose readings obtained using CareSens Air cannot substitute the care of a healthcare professional and cannot be used to diagnose diabetes. 
• Be aware of potential variations in sensor performance, especially during the early phase after sensor attachment. 
• Caregivers should not make treatment decisions based on data received from the Sens365 app, as the data shared with caregivers may be delayed/not real-time data. 
• Do not calibrate if your blood glucose level is changing rapidly as this may affect the accuracy of the sensor. If the result of the finger prick reading is lower than 0.6 mmol/L or higher than 33.3 mmol/L, or inaccurate, it cannot be used as a calibration value and should not be used to make treatment decisions. 
• Review your notification settings to ensure you receive the visual and audio alerts from your sensor. 
• Disable your smart device's automatic operating system (OS) updates to manually update the OS. Some OS features may affect CareSens Air app’s settings. After an OS update, always check your device settings to ensure the CareSens Air app is functioning properly.