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• 

Do not reuse Sensors. The Sensor and Sensor Applicator are designed for single use. Reuse may result in no glucose readings and 

infection. Not suitable for re-sterilization. Further exposure to irradiation may cause unreliable low results.

• 

If a Sensor breaks inside your body, call your health care professional.

How to Store the Sensor Kit:

• 

Store the Sensor Kit between 36°F and 82°F. Storage outside of this range may cause inaccurate Sensor glucose readings.

• 

If you suspect that the temperature may exceed 82°F (for example, in an un-airconditioned home in summer), you should refrigerate your 

Sensor Kit. Do not freeze your Sensor Kit.

• 

Store your Sensor Kit in a cool, dry place. Do not store your Sensor Kit in a parked car on a hot day.

• 

Store the Sensor Kit between 10-90% non-condensing humidity.

When not to use the System:

• 

Do NOT use if the Sensor Kit package, Sensor Pack, or Sensor Applicator appear to be damaged or already opened due to risk of no 

results and/or infection.

• 

Do NOT use if Sensor Kit contents are past expiration date.

• 

Do NOT use if the Reader appears to be damaged due to risk of electric shock and/or no results.

What to know before you Apply the Sensor:

• 

The Sensor Pack and Sensor Applicator are packaged as a set (separately from the Reader) and have the same Sensor 

code. Check that the Sensor codes match before using your Sensor Pack and Sensor Applicator. Do not use Sensor Packs 

and Sensor Applicators with different Sensor codes together as this will result in incorrect glucose readings.

• 

Wash application site on the back of your upper arm using a plain soap, dry, and then clean with an alcohol wipe. This will help remove 

any oily residue that may prevent the Sensor from sticking properly. Allow site to air dry before proceeding. Carefully preparing the site 

according to these instructions will help the Sensor stay on your body for the full 14 day wear period and help prevent it from falling off 

early. 

• 

Clean hands prior to Sensor handling/insertion to help prevent infection.

• 

Change the application site for the next Sensor application to prevent discomfort or skin irritation.

• 

Only apply the Sensor to the back of the upper arm. If placed in other areas, the Sensor may not function properly.

• 

Select an appropriate Sensor site to help the Sensor stay attached to the body and prevent discomfort or skin irritation. Avoid areas with 

scars, moles, stretch marks, or lumps. Select an area of skin that generally stays flat during normal daily activities (no bending or folding). 

Choose a site that is at least 1 inch away from an insulin injection site.

When is Sensor Glucose different from Blood Glucose:

• 

Physiological differences between the interstitial fluid and capillary blood may result in differences in glucose readings between the 

System and results from a fingerstick test using a blood glucose meter. Differences in glucose readings between interstitial fluid and 

Important Safety 

Information

Important Safety Information

 

 

 

CODE

FreeStyle L

Sensor Pa

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XXX

YYYY-MM-D

 

Page 4 of 25

Содержание FreeStyle Libre 2

Страница 1: ...if your glucose alarms and readings do not match symptoms or when you see Check Blood Glucose symbol during the first 12 hours See inside for Indications and Important Safety Information FreeStyle Libre 2 System IN SERVICE GUIDE ...

Страница 2: ...closed loop and insulin suspend systems MRI CT Diathermy The System must be removed prior to Magnetic Resonance Imaging MRI Computed Tomography CT scan or high frequency electrical heat diathermy treatment The effect of MRI CT scans or diathermy on the performance of the System has not been evaluated The exposure may damage the Sensor and may impact proper function of the device which could cause ...

Страница 3: ...se readings You must scan the Sensor to get your real time current glucose level as the Reader will not provide this information without a scan In the event that your Sensor stops working and you do not have another Sensor readily available you must use an alternate method to measure your glucose levels and inform your treatment decisions The System is designed to detect certain conditions which m...

Страница 4: ...or Applicators with different Sensor codes together as this will result in incorrect glucose readings Wash application site on the back of your upper arm using a plain soap dry and then clean with an alcohol wipe This will help remove any oily residue that may prevent the Sensor from sticking properly Allow site to air dry before proceeding Carefully preparing the site according to these instructi...

Страница 5: ...ing other test strips with the Reader s built in meter will produce an error or cause the Reader s built in meter to not turn on or start a test The Reader s built in meter does not have ketone testing functionality The Reader s built in meter is not for use on people who are dehydrated hypotensive in shock or for individuals in hyperglycemic hyperosmolar state with or without ketosis The Reader s...

Страница 6: ...e sensor is worn on the back of the upper arm and measures and stores glucose readings every minute Follow the instructions to prepare and apply the sensor The sensor may be worn for up to 14 days with no fingersticks for calibration or insulin dosing Fingersticks are required if your glucose alarms and readings do not match symptoms or when you see Check Blood Glucose symbol during the first 12 h...

Страница 7: ...P 8 Peel lid completely off sensor pack Unscrew cap from sensor applicator CAUTION Sensor codes must match on sensor pack and sensor applicator or glucose readings will be incorrect STEP 3 Sensor applicator is ready to apply sensor CAUTION Sensor applicator now contains a needle Do not touch inside sensor applicator or put it back into sensor pack STEP 6 Make sure sensor is secure by gently pressi...

Страница 8: ...ow to understand the Glucose Trend Arrow included on the Glucose Reading screen When to do a blood glucose test Where to apply the Sensor Why not to take more than 500 mg of Vitamin C supplements per day How to return to the Home Screen from any other screen Hold reader within 1 5 inches 4 cm of sensor to scan it Sensor can be used to check your glucose after 1 hour STEP 3 Start New Sensor Review ...

Страница 9: ...sor is not successfully scanned within 15 seconds the reader displays a prompt to scan the sensor again Touch OK to return to the Home Screen and touch Check Glucose to scan your sensor STEP 2 350 250 150 50 236mg dL 6am 10am 2pm Glucose Going High Reader shows your glucose reading along with your glucose graph and an arrow indicating the direction your glucose is going STEP 3 Press Home Button to...

Страница 10: ...mmunicating with the Reader and that you will not receive Low or High Glucose Alarms When you are finished setting your alarms touch OK Change Alarm Settings Alarm Settings Low Glucose 70 mg dL High Glucose 240 mg dL Signal Loss On OK OK Low Glucose Alarm High Glucose Alarm Signal Loss Alarm Change Alarm Settings Alarms Sound Vibration Time Date Settings 1 3 Alarms Sound Vibration Time Date Settin...

Страница 11: ... change this value between 60 mg dL and 100 mg dL When the alarm is on you will be notified when your glucose crosses below the level you set Touch the slider to turn the alarm off Touch done to save The Low Glucose Alarm notifies you if your glucose crosses below the level you set The alarm does not include your glucose reading so you need to scan your Sensor to check your glucose Touch Dismiss A...

Страница 12: ...et Low Glucose Events Sensor Usage Use the arrows to view the available options STEP 3 Press Home Button to turn on the reader and go to Home Screen STEP 1 References 1 Readings above or below your Target Glucose Range are orange while readings in range are blue 2 The thick black line shows the median midpoint of your glucose readings 3 The gray shading represents a range 10 90 percentiles of your...

Страница 13: ...r until surfaces are wet NOTE Make sure liquid does not get into the test strip and USB ports Allow the reader surfaces to remain wet for 60 seconds After 1 full minute immediately dry with a clean paper towel to remove any residual moisture When finished thoroughly wash your hands with soap and water Maintenance and Disposal Maintenance Disposal Your sensor automatically stops working after 14 da...

Страница 14: ...ng Low GlucoseTrend Arrow Rapid Acting Insulin Note Food Note Current Glucose Current Glucose Target Glucose Range Your Target Glucose Range is not related to your glucose alarm settings Sensor Glucose Readings NOTE The symbol may appear indicating the reader time was changed Gaps in the graph may result or glucose readings may be hidden NOTE While sensor glucose readings are gathered in the syste...

Страница 15: ...r glucose is going Glucose is rising quickly more than 2 mg dL per minute Glucose is rising between 1 and 2 mg dL per minute Glucose is changing slowly less than 1 mg dL per minute Glucose is falling between 1 and 2 mg dL per minute Glucose is falling quickly more than 2 mg dL per minute Page 15 of 25 ...

Страница 16: ...Readings Messages will appear on the Reader when glucose readings are trending If your glucose is projected to be higher than 240 mg dL or lower than 70 mg dL within 15 minutes a message will appear on the screen Touch the message button for more information and set a reminder to check your glucose again m6 m6 DISPLAY WHAT TO DO Page 16 of 25 ...

Страница 17: ... If your glucose is higher than 240 mg dL or lower than 70 mg dL you will see a message on the screen You can touch the message button for more information and set a reminder to check your glucose WHAT TO DO DISPLAY Sensor Readings Low Glucose High Glucose Message 350 250 150 50 2pm 6pm 10pm mg dL 63 Low Glucose Page 17 of 25 ...

Страница 18: ...gh Glucose HI If LO appears on the reader your reading is lower than 40 mg dL If HI appears on the reader your reading is higher than 400 mg dL You can touch the message button for more information Check your blood glucose on your finger with a test strip If you get a second LO or HI result contact your healthcare professional immediately WHAT TO DO DISPLAY Sensor Readings Page 18 of 25 ...

Страница 19: ...ll appear during the first 12 hours of sensor wear When you see the symbol during the first 12 hours of wearing a Sensor this is a reminder that your body might still be getting used to the new Sensor Confirm Sensor glucose readings with a blood glucose test before making treatment decisions Sensor Readings Page 19 of 25 ...

Страница 20: ...rds After lunch Lisa sees her glucose is high but trend arrow is pointing diagonally down indicating glucose could decrease 15 30 mg dL in the next 30 minutes Lisa does not take a correction dose as it is within 2 hours of her meal dose and the trend arrow is pointing downward This could result in insulin stacking and low glucose Lisa sets a reminder to scan again in 30 minutes Before sleep Lisa s...

Страница 21: ...ngs with a blood glucose meter until you understand Sensor accuracy may vary between sensors Sensor accuracy may vary during a sensor wear session Sensor accuracy may vary in different situations meals exercise first day of use etc UNDERSTAND YOUR INSULIN Understand how your insulin works including how long it takes to start working and how long it lasts in your body NOTE Making a treatment decisi...

Страница 22: ...toms that may be due to low or high blood glucose If you re the caregiver pay attention to times when the symptoms of the one you re caring for don t match their Sensor glucose readings When symptoms don t match readings do a blood glucose test and treat based on that result No Current Glucose Number When there is no Current Glucose number such as when you receive an error message or a LO or HI re...

Страница 23: ...m dehydration If bleeding does not stop after removing sensor TREATMENT DECISIONS To determine how you should use your sensor glucose information to help manage your diabetes To determine and set your target glucose range To understand how insulin works To determine when to do nothing scan again later To determine how to use your blood glucose results To discuss what to do if symptoms don t match ...

Страница 24: ... not feel the sensor while it is being worn Can users bathe shower swim or exercise while wearing a sensor Yes The sensor can be worn while bathing showering swimming or exercise The sensor should not be taken below 3 feet of water 1 meter and should not be submerged in water for more than 30 minutes The adhesive is designed to keep the sensor securely and comfortably in place for up to 14 days Ho...

Страница 25: ...of the circle sensor unit FreeStyle Libre and related brand marks are owned by Abbott Other trademarks are the property of their respective owners 2020 Abbott ADC 14821 v1 0 09 20 Learn more at FreeStyleLibre us ...

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