FreeStyle Libre System - Reader

FreeStyle Libre System - Reader when used with a FreeStyle Libre System Sensor (“Sensor”), is indicated for measuring interstitial fluid glucose levels in people (age 4 and older) with diabetes mellitus, including pregnant women. The reader and sensor are designed to replace blood glucose testing in the self-management of diabetes, including dosing of insulin. Use the FreeStyle Libre system and measure glucose discreetly. Don't let routine fingerpricks interrupt your lifestyle

Uses:
It is designed to help monitor glucose and ketone levels in the body. 

Product Specifications and Features:

• With a one-second scan, one can check their glucose level anytime they want. Each scan of the reader over the sensor shows the current glucose reading, the last 8 hours of data and a trend arrow indicating if glucose is going up, down or staying steady

• The reader stores 90 days of glucose data, so the user can see a complete picture of their glucose levels over 3 months

• With FreeStyle Libre, glucose levels are tracked continuously - in order to see patterns and trends

• The test strip port measures blood glucose levels and blood ketone levels

Directions For Use:

• Press the 'Home' button to turn on the reader. If prompted, use the touchscreen to select your preferred language for the reader

• Touch 'OK' to continue

• Set the current date and time using the arrows on the touchscreen

• Touch next to continue

• Set your target glucose range

• Touch 'Done' to go to the home screen

• Scan the sensor applied on the back of the upper arm with the reader

• Glucose levels and trend arrow will be displayed on the screen

Warning:
Do not ignore symptoms that may be due to low or high blood glucose. If you have symptoms that do not match the sensor glucose reading or suspect that your reading may be inaccurate, check the reading by conducting a fingerstick test using a blood glucose meter. If you are experiencing symptoms that are not consistent with your glucose readings, consult your healthcare professional

Safety Information:

• The indication for children (age 4 - 17) is limited to those who are supervised by a caregiver who is at least 18 years of age. The caregiver is responsible for managing or assisting the child to manage the reader and sensor and also for interpreting or assisting the child to interpret sensor glucose readings

• The FreeStyle Libre Flash Glucose Monitoring System (“System”) contains small parts that may be dangerous if swallowed

• Avoid getting dust, dirt, blood, control solution, water, or other substances in the reader’s USB and test strip ports

• Physiological differences between the interstitial fluid and capillary blood may result in differences in glucose readings. Differences in glucose readings between interstitial fluid and capillary blood may be observed during times of rapid change in blood glucose, such as after eating, dosing insulin, or exercising

• Not suitable for re-sterilisation. Further exposure to irradiation may cause inaccurate results