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Freestyle Libre 14 day In-Service Manual

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Your FreeStyle Libre 14 day System
IN-SERVICE GUIDE
See inside for Indications and Important Safety Information.

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Summary of Contents for Freestyle Libre 14 day

  • Page 1 Your FreeStyle Libre 14 day System IN-SERVICE GUIDE See inside for Indications and Important Safety Information.

  • Page 2: Important Safety Information

    Sensor readings may not accurately reflect blood glucose levels. If you are using the FreeStyle LibreLink app, you must also have access to a blood glucose monitoring system as the App does not provide one. •...
  • Page 3 Important Safety Information What to know about Alarms/Alerts: • There are NO alarms or alerts unless you scan the Sensor. What to know before using the System: • Review all product information before use. • Take standard precautions for transmission of blood borne pathogens to avoid contamination. Who should not use the System: •...
  • Page 4 Cautions and Limitations Below are important cautions and limitations to keep in mind so you can use the System safely. They are grouped into categories for easy reference. FreeStyle L What to know before you Apply the Sensor: Sensor Pa •...
  • Page 5 What to know about FreeStyle LibreLink: • FreeStyle LibreLink installed on a smartphone is intended for use by a single person. It must not be used by more than one person due to the risk of misinterpreting glucose information. •...

  • Page 6: Getting To Know Your System

    See User’s Manual for instruction on setting up the reader for the fi rst time. *The FreeStyle LibreLink app and the FreeStyle Libre 14 Day reader have similar but not identical features. Fingersticks are required for treatment decisions when you see Check Blood Glucose symbol, when symptoms do not match system readings, when you suspect readings may be inaccurate, or when you experience symptoms that may be due to high or low blood glucose.

  • Page 7: Sensor Application

    Sensor Application 1 Assemble sensor and apply it to your body STEP 1 STEP 2 STEP 3 Select site on back of your upper Clean application Peel lid completely arm. Do not use other sites as these site with an off sensor pack.
  • Page 8 Start New Sensor 2 Start new sensor with reader STEP 1 STEP 2 STEP 3 Press Home Button Touch Start Hold reader to turn on reader. 10:23pm New Sensor. within 1.5 inches No Active Sensor (4 cm) of sensor NOTE: If using reader to scan it.
  • Page 9 How to do it: Check that your smartphone is connected to a network (WiFi or cellular). Download FreeStyle LibreLink from the App Store or Google Play. Open the App. Swipe left to view some helpful tips or tap GET STARTED NOW.
  • Page 10 Accessing Your Glucose Data You can scan to get a real-time glucose reading anytime. The reader stores up to 90 days of data. Check your glucose STEP 1 STEP 2 STEP 3 Press Home Button to Hold reader within 1.5 inches Both reader and turn on reader OR touch (4 cm) of sensor to scan it.
  • Page 11 Accessing Your Glucose Data You can scan to get a real-time glucose reading anytime. The reader stores up to 90 days of data. Adding notes How to do it with the App: GLUCOSE IN RANGE 8:06 AM Tap the symbol on the My Glucose screen. Select the checkbox next to the note you would like to add.
  • Page 12 App Home Screen The App Home Screen provides access to information about glucose readings and the App. To return to the Home Screen from another screen, go to the Main Menu and tap Home. Main Menu Scan Button Tap to access the Home Screen, Logbook, Tap this symbol or the buttom at the other history options, and the Share option.
  • Page 13 Review Your History The system provides insightful information to identify 7-, 14-, 30-, and 90-day trends. STEP 1 STEP 2 STEP 3 Press Home Button Touch Review History. Use the arrows to Review History to turn on the view the available 10:23pm Ends in 10 days reader and go to...
  • Page 14 Review Your History The system provides insightful information to identify 7-, 14-, 30-, and 90-day trends. Sensor scan results Sensor glucose Sensor glucose from each day. readings from readings collected You can also use each day. in the last 7, 14, 30, the Logbook to and 90 days.

  • Page 15: Maintenance And Disposal

    Maintenance and Disposal Your sensor automatically stops working after 14 days of data is collected and must be replaced. You should also replace your sensor if you notice any irritation or discomfort at the application site or if the reader reports a problem with the sensor currently in use.
  • Page 16 Interpreting Sensor Readings Sensor glucose readings appear after scanning your sensor. Before making treatment decisions, it is important to understand your sensor readings. Use all of the information on the screen when deciding what to do or what treatment decision to make. What you see in the App Message Tap for more...

  • Page 17: Trend Arrows

    Trend Arrows The Glucose Trend Arrow indicates which direction your 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...
  • Page 18 Going High/Low Reading Messages will appear on the Reader when glucose readings are trending. DISPLAY WHAT TO DO If your glucose is projected to be higher than Glucose Going Glucose Going 240 mg/dL or lower than 70 mg/dL within 15 High minutes, a message will appear on the screen.
  • Page 19 High/Low Reading Messages will appear on the Reader when the glucose reading is high or low. DISPLAY WHAT TO DO If your glucose is higher than 240 mg/dL or Low Glucose Low Glucose Low Glucose lower than 70 mg/dL, you will see a message on the screen.
  • Page 20 HI/LO Reading Current Glucose will display HI or LO when glucose readings are outside measuring range. DISPLAY WHAT TO DO If LO appears on the reader, your reading is lower Low Glucose High Glucose than 40 mg/dL. If HI appears on the reader, your reading is higher than 500 mg/dL.
  • Page 21 Treatment Decisions–Getting Started Before you start using the FreeStyle Libre 14 day System for treatment decisions, make sure you have a good understanding of how the system works for your body. • Continue to use your blood glucose meter for treatment decisions until you are comfortable with the information you receive •...
  • Page 22 LO or HI result, you don’t have enough information to make a treatment decision. 10pm that result! During the fi rst 12 hours of wearing a FreeStyle Libre 14 day Sensor During the fi rst 12 hours, you should not use glucose readings from the Sensor to make 10pm treatment decisions.
  • Page 23 Treatment Decisions–Glucose Trend Arrows This table provides some information on how you can factor the Glucose Trend Arrow into your treatment decisions. Remember that you should never make a treatment decision based on the Glucose Trend Arrow alone. Glucose TREATMENT DECISION CONSIDERATIONS Trend Arrow Low Glucose (<...
  • Page 24 Because trend arrow she sees she considers taking a little less insulin. For more scenarios, consult your FreeStyle Libre 14 day System User’s Manual. *FreeStyle Libre 14 day System User’s Manual Treatment Decisions...
  • Page 25 Ambulatory Glucose Profi le (AGP) Report AGP is a summary of glucose values from the report period, with median (50%) and other percentiles shown as if occuring in a single day. Are there patterns of hypoglycemia? Are the readings within target range? Identify glucose variability by the shape of the Median curve.
  • Page 26 When to Contact your Healthcare Professional As instructed by the FreeStyle Libre 14 day labeling. Symptoms • If you are experiencing symptoms that are not consistent with your glucose readings • If you have signifi cant skin irritation around the sensor •...

  • Page 27: Frequently Asked Questions

    The sensor is applied to the back of the upper arm with a simple, disposable device called an applicator. When the sensor is applied, a small (5mm) filament is inserted just under the skin, and held in place with a small adhesive pad. Most patients don’t feel pain when applying the FreeStyle Libre 14 day sensor.* Is it necessary to apply a sensor in a different location if I feel discomfort or in case of a mis-application? To prevent discomfort or skin irritation, you should select a different site other than the one most recently used.
  • Page 28 The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott. App Store is a trademark of Apple Inc. Other trademarks are the property of their respective owners. ©2021 Abbott. ADC-10386 v3.0 07/21...

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