FreeStyle Libre System - Sensor - Continuous Glucose Monitoring Device

FreeStyle Libre System - Sensor

FreeStyle Libre System - Sensor / Diabetes Monitoring Devices / Blood Glucose Monitors is an innovative sensor-based glucose monitoring system. Liberates diabetic patients from the hassles of routine finger-prick testing. It is an accurate, painless and easy-to-use system. The trend arrow indicates if glucose is going up, down or staying steady.

Uses:
It is used to measure glucose levels in the body.

Product Specifications and Features:

• The sensor has been tested to withstand immersion into one metre (3 ft) of water for up to 30 minutes

• It is also protected against the insertion of objects >12mm diameter (IP27)

• Trend arrow indicates if glucose levels have increased, decreased or are staying steady

Directions For Use:

• Select an area of skin on the back of your upper arm that generally stays flat during normal daily activities (no bending or folding). Avoid areas with moles, scarring or tattoos

• Choose a site that is at least 2.5cm (1 inch) away from an insulin injection site. To prevent discomfort or skin irritation, you should select a different site other than the one most recently used. Wash the chosen site with soap and allow the skin to fully dry, before applying the sensor

• Open the sensor pack by peeling off the lid completely. Unscrew the cap from the sensor applicator and set the cap aside. Line up the dark mark on the sensor applicator with the dark mark on the sensor pack. On a hard surface, press firmly down on the sensor applicator until it comes to a stop. Place the sensor applicator over the prepared site and push down firmly to apply the sensor to your body. Gently pull the sensor applicator away from your body. The sensor should now be attached to your skin

• Activate your sensor with FreeStyle LibreLink App. The FreeStyle LibreLink app is only compatible with certain mobile devices and operating systems. Please check the website for more information about device compatibility before using the app. Use of FreeStyle LibreLink may require registration with LibreView

For the alcohol wipe

• Tear the sachet open and remove the swab

• From the site of injection, briskly rub the skin in a circular motion, moving outward

• External use only

• Single-use only

• Discard after use

• Never use to disinfect an invasive medical device

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 sensor pack is sterile unless opened or damaged

• Store the sensor kit between 4°C-25°C. While you don’t need to keep the sensor kit in a refrigerator, you can as long as the refrigerator is between 4°C-25°C

• Do not freeze. Do not use if the expiry date has passed

• Interfering Substances: You can take standard doses of ascorbic acid (vitamin C) and still make treatment decisions with the sensor. Taking higher than the maximum recommended daily allowance (RDA) of ascorbic acid may affect the sensor readings and make them look higher than they really are

• The alcohol wipe is labelled as follows: reliject pre-injection swab | 1 swab |Use for skin cleansing prior to injection | Saturated with Isopropyl Alcohol 70%

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

• Keep away from children

• Keep away from eyes

• If a swab makes contact, rinse with water

• In the event of skin irritation or rash, discontinue use

• Do not use after the expiry date

• Do not reuse

• The sensor must be removed prior to Magnetic Resonance Imaging (MRI)