FreeStyle Libre System - Reader (Abbott)

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

FreeStyle Libre System - Sensor (Abbott)

FreeStyle Libre System - Sensor is the no1 sensor-based glucose monitoring system worldwide. Liberates diabetic patients from the hassles of routine finger-prick testing. It is an accurate, painless and easy to use system. Trend arrow indicates if glucose is going up, down or staying steady. Stores up to 90 days of data.

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)

• It stores up to 90 days of data

• 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

• The sensor glucose readings appear after you scan your sensor with the reader

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)