freestyle libre flash glucose monitoring system eu class ii

FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM EU CLASS II SKIN
FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM EU CLASS II SOFTWARE

Other trademarks are the property of their respective owners. The caregiver is responsible for managing or assisting the child to manage the FreeStyle Libre Flash Glucose Monitoring System and also for interpreting or assisting the child to interpret FreeStyle Libre readingsįreeStyle and related brand marks are trademarks of Abbott Diabetes Care Inc. 15 The indication for children (aged 4-17) is limited to those who are supervised by a caregiver who is at least 18 years of age. In a 2013 US study conducted by Abbott Diabetes Care, 93.4% of patients surveyed (n=30) strongly agree or agree that while wearing the sensor, they did not feel any discomfort under their skin.

FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM EU CLASS II SKIN

Data on file.ġ0 The reader can capture data from the sensor when it is within 1cm to 4cm of the sensor.ġ1 Sensor is water-resistant in up to 1 metre (3 feet) of water for a maximum of 30 minutes.ġ2 Reader dimensions 95 mm x 60mm x 16 mm and weight 65 grams.ġ3 To get a complete glycaemic picture over the last three months, the sensor must be replaced every fourteen days and the sensor must be scanned at least once every eight hoursġ4Most people did not feel any discomfort under the skin while wearing the FreeStyle Libre sensor. In a 2013 US study conducted by Abbott Diabetes Care, 95.7 % of patients surveyed (n=30) agreed that the FreeStyle Libre system reduces the hassles of glucose monitoring.

FREESTYLE LIBRE FLASH GLUCOSE MONITORING SYSTEM EU CLASS II SOFTWARE

The FreeStyle Libre software, designed to be used in conjunction with FreeStyle Libre reader and sensor, provides a snapshot of glucose patterns and variability for more information, see the Software page.Ĥ The reader can capture data from the sensor when it is within 1cm to 4cm of the sensor, even through clothing.ĥ Sensor is water-resistant in up to 1 metre (3 feet) of water for a maximum of 30 minutesĩ The FreeStyle Libre system liberates you from the hassles of glucose monitoring. Or if hypoglycemia or impending hypoglycemia is reported or the symptoms do not match the system readings.ģ For a complete glycemic picture, scan once every 8 hours. 9ġ Scanning the sensor to obtain glucose values does not require lancetsĢ A finger prick test using a blood glucose meter is required during times of rapidly changing glucose levels when interstitial fluid glucose levels may not accurately reflect blood glucose levels, The FreeStyle Libre Sensor represents technology that is much less intrusive than traditional blood glucose monitoring and makes glucose testing hassle-free. The reader can even scan through clothing with a thickness of up to 4 mm.

Get reading - Each scan of the reader over the sensor gives a current glucose reading, the last 8-hours of glucose history, and a trend arrow showing if glucose is going up, down, or changing slowly.

The FreeStyle Libre system also offers software to generate concise reports to assist with the analysis of glucose data.

This scan gives you more information than monitoring with blood glucose test strip, without the need for routine finger pricks.

Scan sensor - To obtain a glucose reading, simply perform a quick, painless 1-second scan of the reader over the sensor.

Most people feel no pain when applying the sensor. It is held in place with a small adhesive pad. When the sensor is applied, a thin, flexible and sterile fibre is inserted just under the skin.

Apply the sensor - The FreeStyle Libre sensor is applied on to the back of the upper arm with a simple, disposable device called an applicator.Health professionals and consumers should be aware about the limitations of available scientific evidence for use of this device in any other groups of patients who require diabetes management. The FreeStyle Libre Flash Glucose Monitoring System is a glucose monitoring device indicated for detecting trends and tracking patterns in persons aged 4 and older with insulin dependent diabetes mellitus 15. With every scan you get your current glucose reading, the last 8 hours of glucose data and an arrow showing the direction your glucose is heading.Swim, shower or exercise - the FreeStyle Libre system is designed to be water-resistant and worn while bathing, showering, swimming 5 and exercising.

Freestyle libre flash glucose monitoring system eu class ii