4.6” 4.6” Distributed by: Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502 USA Customer Service: 1-855-632-8658 Monday through Friday, 8AM to 8PM Eastern Standard Time www.FreeStyleLibre.com User’s Manual FreeStyle, Libre, and related brand marks are trademarks of Abbott Diabetes Care Inc. in various jurisdictions. Other trademarks are the property of their respective owners. Patent: https://www.abbott.
4.6” 4.6” Your Name _________________________________________________ .257” DOC40395_rev-A_cover.indd 3-4 .
Contents Important Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 Setting Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 Setting Alarm Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 57 Using Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Important Safety Information Indications For Use The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device indicated for the management of diabetes in persons age 18 and older. It is designed to replace blood glucose testing for diabetes treatment decisions. The System detects trends and tracks patterns aiding in the detection of episodes of hyperglycemia and hypoglycemia, facilitating both acute and long-term therapy adjustments.
WARNINGS: (cont.) • Choking hazard: The System contains small parts that may be dangerous if swallowed. 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. • • • • What to know about Glucose Alarms: For you to receive alarms, they must be on and your Reader should be within 20 feet of you at all times. The transmission range is 20 feet unobstructed.
DOC40395_rev-A_manual.indd 5-6 • • • C 5 • tes • 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. • abe • t Di • How to Store the Sensor Kit: Store the Sensor Kit between 39°F and 77°F. Storage outside of this range may cause inaccurate Sensor glucose readings.
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.
• • • • • What to know about the Reader’s Built-in Meter: The FreeStyle Libre 2 Reader has a built-in blood glucose meter that is designed to be used only with FreeStyle Precision Neo blood glucose test strips and MediSense Glucose and Ketone Control Solution. Using 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.
Symbol What It Means Notes + Add more information to notes Food note Rapid-acting insulin note Time changed on Reader Blood glucose test Settings Control solution test result Low battery Battery charging Sensor too cold Sensor too hot 11 DOC40395_rev-A_manual.indd 11-12 Getting to Know Your System The FreeStyle Libre 2 System (“System”) has two main parts: a handheld Reader and a disposable Sensor that you wear on your body.
Reader Kit Sensor Kit The Reader Kit includes: The Sensor Kit includes: • • • FreeStyle Libre 2 Reader USB Cable Interactive Tutorial on USB • • Power Adapter User’s Manual • • Quick Start Guide Quick Reference Guide • • Sensor Pack Sensor Applicator • • Alcohol wipe Product insert Touchscreen USB Port Used to charge the Reader and connect it to a computer. Home Button Test Strip Port Insert a test strip here to use the built-in meter.
The Reader Home Screen provides access to information about your glucose and the System. You can press the Home Button to get to the Home Screen. Home Screen The Sensor Glucose Readings screen appears after you use the Reader to scan your Sensor. Your Reading includes your Current Glucose, a Glucose Trend Arrow indicating which way your glucose is going, and a graph of your current and stored glucose readings.
FreeStyle Libre Software FreeStyle Libre software can be used to view reports and change Reader settings. The software is compatible with most Windows and Mac operating systems. Go to www.FreeStyleLibre.com and follow onscreen instructions to download and install the software.
Step 3 Action Set the Current Date using the arrows on the touchscreen. Touch next to continue. Current Date 14 back Step 5 Action The Reader now displays important information about key topics to help you use the System: • How to understand the Glucose Trend Arrow included on June 2019 the Glucose Reading screen. • When to do a blood glucose test. • Where to apply the Sensor. • How to return to the Home Screen from any other screen.
Applying Your Sensor Using Your Sensor Step lean application site with an alcohol wipe and C allow site to dry before proceeding. This helps the Sensor stay attached to your body. Note: The area MUST be clean and dry, or the Sensor may not stick to the site. tes 391 abe C DOC40395_rev-A_manual.indd 21-22 2 30 t Di Intense exercise may cause your Sensor to loosen due to are C sweat or movement of the Sensor. Remove and replace DO Ltd K .
Action Step 3 Lid Cap 4 5 23 DOC40395_rev-A_manual.indd 23-24 pen the Sensor Pack by peeling the lid off O completely. Unscrew the cap from the Sensor Applicator and set the cap aside. CAUTION: Do NOT use if the Sensor Pack or the Sensor Applicator seem to be damaged or already opened. Do NOT use if past expiration date. 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.
Action Step 8 Sensor ently pull the Sensor Applicator away from your G body. The Sensor should now be attached to your skin. Note: Applying the Sensor may cause bruising or bleeding. If there is bleeding that does not stop, remove the Sensor and contact your health care professional. Starting Your Sensor Action Step 1 Press the Home Button to turn on the Reader. 2 No Active Sensor Start New Sensor 9 ake sure the Sensor is secure after application. M Put the cap back on the Sensor Applicator.
Checking Your Glucose Step Step Action 1 10:23pm Ends in 14 days OR Check Glucose 2 Review History T urn the Reader on by pressing the Home Button or touch Check Glucose from the Home Screen. Action 3 Glucose Going High 350 236 250 mg dL The Reader displays your current glucose reading along with your glucose graph and an arrow indicating the direction your glucose is going. 150 50 6am 10am 2pm old the Reader within 1.5 inches (4 cm) of your H Sensor to scan it.
Sensor Glucose Readings Glucose Going Low Check Blood Glucose When you see this symbol, do a blood glucose test before making treatment decisions. 350 82 Glucose Trend Arrow Current Glucose DOC40395_rev-A_manual.indd 29-30 Glucose is rising (between 1 and 2 mg/dL per minute) 150 50 2pm 6pm 10pm Notes: • While Sensor glucose readings are gathered in the System range of 40-500 mg/dL, the graph display range is 0-350 mg/dL for ease of review on screen.
The following table shows messages you may see with your glucose readings. Display What To Do 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 500 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 health care professional immediately.
Making Treatment Decisions Work with your health care professional to put together a plan for managing your diabetes that includes when to use the System information for making treatment decisions. WARNING: The System can replace blood glucose testing except in a few situations.
• • • T alk to your health care professional about how your insulin works. The more you understand about your insulin, including how long it takes to start working and how long it lasts in your body, the more likely you will be to make better treatment decisions. Making a treatment decision doesn’t just mean taking insulin. Treatment decisions can also include things like taking fast-acting carbs, eating, or even doing nothing and scanning again later.
No Current Glucose Number When there is no Current Glucose number, such as when you receive an error message or a LO or HI result, you don’t have enough information to make a treatment decision. When there is no Current Glucose you will see symbol. Whenever you see the symbol, do a blood glucose the test and treat based on that result.
Making Treatment Decisions – Advanced fter you scan your Sensor, use all of the information on the A screen when deciding what to do or what treatment decision to make.
Glucose Trend Arrow Treatment Decision Considerations Low Glucose (< 70 mg/dL) You will see the symbol. Do not treat based on Sensor glucose reading. Do a blood glucose test. Glucose in Target Range If you are about to eat, take insulin to cover your meal. If this is between meals, do nothing and scan again later. High Glucose (> 240 mg/dL) If you are about to eat, take insulin to cover your meal. Consider taking a little more since glucose is high.
Example Scenarios Next are some example scenarios to help you understand how to use the information on your screen. Always use all of the information on the screen before deciding what to do or what treatment decision to make. If you are not sure about what to do, consult your health care professional. What you see When you wake-up: Low Glucose 350 65 mg dL 250 What it means When you wake up, your current glucose is 65 mg/dL and the trend arrow shows .
What you see Before lunch: 12:00pm Ends in 3 days 90 350 mg dL What it means When you checked your glucose before lunch, it was 90 mg/dL and rising. Before eating lunch, you took enough insulin to cover the meal and .
What you see After dinner: 7:49pm Ends in 10 days 215 250 150 50 3pm After dinner, your current glucose is 215 mg/dL but there is no trend arrow. There is also the symbol on the screen. mg dL 350 11am What it means 7pm symbol, you should Anytime you see the do a blood glucose test before deciding what to do. Other considerations Deciding how much rapid-acting insulin to take for different meals and situations can be difficult.
Bedtime • How often do you check your glucose before bed? • What do you consider a safe bedtime glucose? • What do you do if your bedtime glucose is high? • What do you do if your bedtime glucose is low? • When should you eat a bedtime snack? • What do you do if your before meal glucose is high? Alarms When in range of the Reader, your Sensor automatically communicates with the Reader to give you Low and High Glucose Alarms. These alarms are on by default.
IMPORTANT: How to prevent missed alarms IMPORTANT: What to know about glucose alarms • Scan your Sensor often to check your glucose. If you get a Low or High Glucose Alarm, you must obtain a glucose result to determine what to do next. • The Low and High Glucose Alarms should not be used exclusively to detect low or high glucose conditions. The glucose alarms should always be used along with your current glucose, glucose trend arrow, and glucose graph.
Setting Alarms Work with your health care professional to determine your alarm settings. Step 1 Action F rom the Home screen, touch the Settings symbol . Touch Alarms. 10:23pm Ends in 14 days Check Glucose Step 3 Action OK Change Alarm Settings Low Glucose Alarm High Glucose Alarm Signal Loss Alarm Review Settings History Alarms Sound & Vibration Select the alarm you want to set or turn off. Low Glucose Alarm: Notifies you when your glucose is below the level you set.
Action Step Alarm High Glucose Alarm How to Set The High Glucose Alarm is on by default. The alarm level is initially set to 240 mg/dL. You can use the arrows to change this value between 120 mg/dL and 400 mg/dL. If the alarm is on, you will be notified when your glucose rises above the level you set. Touch the slider to turn the alarm off.
Setting Alarm Sounds Step 1 Using Alarms Action F rom the Home screen, touch the Settings symbol . Touch Sound & Vibration to change the alarm sounds. 10:23pm Ends in 14 days Check Glucose Review Settings History What you See Low Glucose Alarm Dismiss Alarm & Check Glucose Alarms Sound & Vibration Time & Date What it Means The Low Glucose Alarm notifies you if your glucose drops below the level you set.
What you See Signal Loss Alarm Scan Sensor now? No Yes What it Means The Signal Loss Alarm notifies you if your Sensor has not communicated with the Reader for 20 minutes and you are not receiving Low or High Glucose Alarms. Signal loss could be caused by the Sensor being too far away from the Reader (over 20 feet) or another issue such as an error or problem with your Sensor or Reader. Touch No to dismiss the alarm. Touch Yes or press the Home Button to dismiss the alarm and scan the Sensor.
Step 3 Action Add Notes Rapid-Acting Insulin Long-Acting Insulin Food OK + + + Enter Rapid-Acting Insulin OK 1/4 units After you check the box for food and insulin notes, the + symbol appears to the right of the note. You can touch it to add more specific information to your note. Then touch OK. • Insulin notes: Enter the number of units taken. • Food notes: Enter grams or serving information.
Step 3 Action Use the arrows to view the available options. Review History The Logbook and Daily Graph show detailed information, while other history options show summaries of information over a number of days. Logbook Logbook Daily Graph OK Logbook Daily Patterns 23 Feb Average Glucose Time In Target 1/2 Low Glucose Events Sensor Usage IMPORTANT: Work with your health care professional to understand your glucose history. 63 DOC40395_rev-A_manual.
Daily Graph OK Daily Graph (mg/dL) 350 250 150 50 12 am 6 am 12 pm 22 Feb Wednesday 6 pm 12 am Other History Options A graph of your Sensor glucose readings by day. The graph shows your Target Glucose Range and symbols for food or rapid-acting insulin notes you have entered. Notes: • While Sensor glucose readings are gathered in the System range of 40-500 mg/dL, the Daily Graph display range is 0-350 mg/dL for ease of review on screen. Glucose readings above 350 mg/dL are displayed at 350 mg/dL.
OK Time In Target 34% Above 54% In Target A graph showing the percentage of time your Sensor glucose readings were above, below, or within your Target Glucose Range.
Replacing Your Sensor Your Sensor automatically stops working after 14 days of wear 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. Taking action early can keep small problems from turning into larger ones. Using Reminders You can use Reminders to help you remember things like checking your glucose or taking insulin.
Action Step T ouch to select how often you want the reminder to Repeat: Once, Daily, or Timer. Note: You can set the reminders for a specific time (e.g. 8:30 am) or as a timer (e.g. 3 hours from the current time). 3 S et the reminder Time using the arrows on the touchscreen. Touch save. 4 5 Reminders 8:30am 12:30pm 00:00:00 add new Reminder 8:30am snooze 15 min OK On Off F rom the Reminders screen, you can turn the reminder On/Off or add new reminders.
IMPORTANT: • Use only FreeStyle Precision Neo test strips. Other test strips may produce inaccurate results. • Read all the instructions in this section. Failure to follow instructions may cause incorrect blood glucose results. Practice the testing procedures before using the Reader’s built-in meter. • Read the test strip instructions for use before performing your first blood glucose test as they contain important information.
Blood Glucose Testing You can use the built-in meter to check your blood glucose, whether you are wearing a Sensor or not. Be sure to read the test strip instructions for use prior to using the built-in meter. CAUTION: Test on your fingers in accordance with the Intended Use in this section. 3 Note: Do not use lotion or cream on the test site. Avoid moles, veins, bones, and tendons. Bruising may occur at the test site. If you get a bruise, consider selecting another site. DOC40395_rev-A_manual.
Step 5 Action Apply Blood se your lancing device to obtain a blood drop U and apply blood to the white area at the end of the test strip. Refer to your lancing device instructions for use if you need help using your lancing device. If sounds are turned on, the Reader beeps once to let you know you have applied enough blood. You will see a butterfly on the screen while you wait for your result. Do not remove the test strip while the butterfly is on the screen.
IMPORTANT: The built-in meter displays results from 20 - 500 mg/dL. Low or high blood glucose results can indicate a potentially serious medical condition. The expected glucose range for a non-diabetic, non-pregnant fasting adult is under 100 mg/dL. Two hours after meals, levels should be less than 140 mg/dL.3 Consult your healthcare professional to determine the range that is appropriate for you.
81 DOC40395_rev-A_manual.indd 81-82 1 From the Home Screen, touch the Settings . Scroll down using the arrow and symbol touch Control Solution Test. 10:23pm Ends in 14 days Check Glucose Review History Reminders Control Solution Test Language 2/4 2 3 Check the test strip expiration date. Abbott Diabetes Care Ltd. Range Road Witney, Oxon, OX29 0YL Made in UK. IMPORTANT: • Control solution results should fall within the control solution range printed on the test strip instructions for use.
Action Step 4 5 I nsert the test strip with the three black lines facing up. Push the strip until it stops. Note: The Reader’s built-in meter turns off after 2 minutes of inactivity. Remove and reinsert the unused test strip to restart the built-in meter. Apply Control Solution 83 DOC40395_rev-A_manual.indd 83-84 Shake the control solution bottle to mix the solution. Apply a drop of control solution to the white area at the end of the test strip.
10:23pm 100 mg dL Control Solution Test Example Screen Only Control Solution Results Compare the control solution result to the range printed on the test strip instructions for use. The result on your screen should be in this range. Control solution results are marked on the results screen and in the Logbook with a symbol. Note: Repeat the control solution test if the results are outside of the range printed on the test strip instructions for use.
Changing the Reader Settings You can go to the Settings menu to change many settings on the Reader, like alarm settings, sound & vibration, time & date, and target range. The Settings menu is also where you go to do a Control Solution Test or to check the System Status. Action Step 1 10:23pm Ends in 14 days Check Glucose T o get to the Settings menu, touch the Settings on the Home Screen. symbol Review History Settings Alarms Sound & Vibration Time & Date 1/4 87 DOC40395_rev-A_manual.
Action Step 2 (cont.
Activity What You Need To Know Activity Traveling by Air You may safely use your System at all times while on an aircraft, following any requests from the flight crew. • The Reader is classed as a Medical-Portable Electronic Device (M-PED) that meets all required M-PED emission standards for safe use onboard an aircraft: RTCA/DO160, Section 21, Category M. • Some airport full-body scanners include x-ray or millimeter radio-wave, which you cannot expose your System to.
Maintenance and Disposal Cleaning and Disinfecting the Reader Cleaning and disinfecting your Reader is important to prevent the spread of infectious diseases. The Reader has a mean use life of 3 years and has been validated for 156 cleaning and disinfection cycles (the equivalent of 1 cycle per week for 3 years). You should clean and disinfect the Reader once a week. The Reader should also be cleaned and disinfected prior to being handled by any person providing testing assistance to the user.
To clean and disinfect your Reader, you will need Clorox Healthcare Bleach Germicidal Wipes, EPA Reg. #67619-12. These disinfectant wipes contain a 0.55% Sodium Hypochlorite (NaOCl) solution and have been shown to be safe for use with the Reader. They may be purchased at major online retailers, such as Walmart.com, Amazon.com, and OfficeDepot.com. Note: Additional information about the risks for transmitting bloodborne pathogens to persons undergoing fingerstick procedures for blood sampling can be found.
IMPORTANT: If you require assistance or if you notice any signs of deterioration on the Reader (such as clouding or crazing on the display of the Reader, corroding or eroding of the plastic housing, or cracking of plastic housing or display) or if the Reader does not turn on, discontinue use of the Reader and contact Customer Service at 1-855-632-8658. Troubleshooting This section lists problems or observations that you may have, the possible cause(s), and recommended actions.
Problems at the Sensor Application Site Problem What It May Mean What To Do The Sensor is not sticking to your skin. The site is not free of dirt, oil, hair, or sweat. 1. Remove the Sensor. 2. Consider shaving and/or cleaning the site with soap and water. 3. Follow the instructions in Applying and Starting Your Sensor sections. Skin irritation at the Sensor application site. Seams or other constrictive clothing or accessories causing friction at the site. Ensure that nothing rubs on the site.
What It May Mean What To Do Display What It May Mean What To Do Signal Loss Alarm Sensor has not automatically communicated with the Reader in the last 20 minutes. Make sure the Reader is within 20 feet of the Sensor. Try scanning the Sensor to get a glucose reading. If the Signal Loss Alarm shows again after scanning your Sensor, contact Customer Service. Sensor Error The System is unable to provide a glucose reading. New Sensor Found You scanned a new Sensor before your previous Sensor ended.
Display Sensor Already in Use What It May Mean The Sensor was started by another device. What To Do Your Reader can only be used with a Sensor that it started. Scan the Sensor again with the device that started it. Or, apply and start a new Sensor. Check Sensor The Sensor tip may not be under your skin. Try to start your Sensor again. If Reader displays “Check Sensor” again, your Sensor was not applied properly. Apply and start a new Sensor.
Problem What It May Mean You are not receiving glucose alarms. (cont.) You may have set an alarm level that is higher or lower than you intended. Confirm your alarm settings are appropriate. You have already dismissed this type of alarm. You will receive another alarm when a new low or high glucose episode starts. Your Sensor has ended. Replace your Sensor with a new one. Your Reader battery is dead. Charge your Reader with the included USB cable. 105 DOC40395_rev-A_manual.
Error Message E-3 E-4 What It May Mean What To Do Blood drop is too small. or Incorrect test procedure. or There may be a problem with the test strip. 1. Review the testing instructions. 2. Repeat the test using a new test strip. 3. If the error reappears, contact Customer Service. The blood glucose level may be too high to be read by the system. or There may be a problem with the test strip. 1. Repeat the test using a new test strip. 2.
Error Message E-7 E-9 What It May Mean What To Do Test strip may be damaged, used, or the Reader does not recognize it. 1. Check that you are using the correct test strip for the Reader. (See test strip instructions for use to verify your strip is compatible with the Reader). 2. Repeat the test using a test strip for use with your Reader. 3. If the error reappears, contact Customer Service. Reader error. 109 DOC40395_rev-A_manual.indd 109-110 1. Turn off the Reader. 2.
Problem The test does not start after applying the blood sample. What It May Mean What To Do Blood sample is too small. 1. See test strip instructions for use for re-application instructions. 2. Repeat the test using a new test strip. 3. If the test still does not start, contact Customer Service. Sample applied after the Reader turned off. 1. Review the testing instructions. 2. Repeat the test using a new test strip. 3. If the test still does not start, contact Customer Service.
System Specifications See test strip and control solution instructions for use for additional specifications. Sensor Specifications Sensor glucose assay method Amperometric electrochemical sensor Sensor glucose reading range 40 to 500 mg/dL Sensor size Sensor weight Sensor power source 113 DOC40395_rev-A_manual.
Reader Specifications Blood glucose assay range 20 to 500 mg/dL Reader size 95 mm x 60 mm x 16 mm Reader weight 65 grams Reader power source One lithium-ion rechargeable battery Reader battery life 4 days of typical use Reader memory 90 days of typical use Reader operating temperature 50 °F to 113 °F Reader storage temperature -4 °F to 140 °F Operating and storage relative humidity 10-90%, non-condensing 115 DOC40395_rev-A_manual.
Power Adapter Abbott Diabetes Care PRT25611 Operating temperature: 50 °F to 104 °F USB Cable Abbott Diabetes Care PRT21373 Length: 37 inches (94 cm) * Security measures: The communication between the Reader and Sensor during a scan is a short range Near Field Communication (NFC) method which makes it difficult to interfere with or intercept during transmission. The transmitted data is protected by a proprietary data format, encryption, and memory map.
Not made with natural rubber latex CAUTION: Federal law restricts this device to sale by or on the order of a physician. This product contains electronic equipment, batteries, sharps and materials that may contact bodily fluids during use. Dispose of product in accordance with all applicable local regulations. Performance Characteristics Clinical Study Overview Performance of the FreeStyle Libre 2 Flash Glucose Monitoring System (the System) was evaluated in a clinical study.
Agreement with CGM Glucose Levels Agreement between CGM and venous blood was characterized by using paired CGM and Yellow Springs Instrument measurements (YSI). The accuracy of CGM versus YSI reference was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL. The results are presented in Table 1 for YSI reference. Overall 90.
Overall Accuracy against YSI reference Accuracy was measured by comparing the absolute relative difference between the System and reference YSI glucose values. The absolute relative difference measures the level of disagreement between the System and the reference value, but does not tell you whether the System glucose value was, on average, higher or lower than the reference glucose value.
Overall Accuracy against BG values Accuracy was measured by comparing the absolute relative difference between the System and BG values. The absolute relative difference measures the level of disagreement between the System and the BG value, but does not tell you whether the System glucose value was, on average, higher or lower than the BG value. The Mean Absolute Relative Difference gives an indication of the average percent disagreement between the CGM and the BG value.
Table 6: Concurrence Analysis by Glucose Level YSI Glucose Level (mg/dL) CGM N 81121- 161- 201- 251- 301- 351- 401(mg/dL) <40* 40-60 61-80 >500* 120 160 200 250 300 350 400 500 <40 0.0 44.4 33.3 22.2 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 18 40-60 2.8 31.0 48.3 17.9 0.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 145 61-80 0.2 4.9 34.0 59.0 2.0 0.0 0.0 0.0 0.0 0.0 0.0 0.0 636 81-120 0.0 0.1 2.7 68.1 27.7 1.2 0.1 0.0 0.0 0.0 0.0 0.0 2498 121-160 0.0 0.0 0.0 7.0 71.2 20.7 1.
Agreement with ‘LO’ and ‘HI’ CGM Reading against YSI Reference The System reports glucose concentrations between 40 and 500 mg/dL. When the System determines that glucose level is below 40 mg/dL, it will report as ‘LO’. When the System determines that glucose level is above 500 mg/dL, it will report as ‘HI’. Table 8 displays the concurrence between the CGM and YSI reference glucose when CGM reads ‘LO’.
The accuracy of CGM versus YSI reference and BG reference was assessed by calculating the percentage of System readings that were within 15%, 20%, 30% and 40% for reference values 80 mg/dL and above, and 15 mg/dL, 20 mg/dL, 30 mg/dL and 40 mg/dL for values below 80 mg/dL. The results for CGM vs. YSI reference are presented in Table 11.
Alarm Performance Table 13a and Table 13b show the accuracy of the System’s Low and High Glucose Alarms. The Alarm Rate tells you how often the alarm is right or wrong. The Detection Rate tells you how often the System is able to recognize and notify you about a low or high glucose event.
High Glucose Alarm Performance Table 13b displays the percentages for these parameters: True Alarm Rate Tells you: When you got a high glucose alarm, were you actually high? Definition: Percentage of time the alarm issued and blood glucose was above the alarm level within 15 minutes before or after the alarm.
Precision Precision of the System was evaluated by comparing the results from two separate Sensors worn on the same subject at the same time. Table 14 provides data from two separate Sensors worn on 95 subjects at the same time, providing 15,283 real-time pairs of CGM measurements, with a mean CV of 5.6%. Table 14: Overall between Sensor Precision Mean Glucose (mg/dL) Median CV Mean CV Number of Subjects Number of Paired Readings 164.2 4.2 5.
Guidance and manufacturer’s declaration – electromagnetic emissions Guidance and manufacturer’s declaration – electromagnetic immunity The System is intended for use in the electromagnetic environment specified below. The customer or the user of the System should assure that it is used in such an environment. The System is intended for use in the electromagnetic environment specified below. The customer or the user of the System should assure that it is used in such an environment.
IMMUNITY test IEC 60601 test level Compliance Level Electromagnetic environment – guidance IMMUNITY test IEC 60601 test level Compliance Level Electromagnetic environment – guidance Surge IEC 61000-4-5 ±1 kV differential mode ±2 kV common mode ±1 kV differential mode ±2 kV common mode Mains power quality should be that of a typical domestic, commercial, or hospital environment.
IMMUNITY test Conducted RF IEC 61000-4-6 IEC 60601 test level 6 Vrms 150 kHz to 80 MHz Compliance Level Electromagnetic environment – guidance 6 Vrms Portable and mobile RF communications equipment should be used no closer to any part of the System, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter. Recommended separation distance IMMUNITY test Radiated RF IEC 61000-4-3 IEC 60601 test level 10 V/m 80 MHz to 2.
a b Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey should be considered.
For transmitters rated at a maximum output power not listed above, the recommended separation distance d in meters (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer. NOTE 1 At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies. NOTE 2 These guidelines may not apply in all situations.
DEFINITIONS “Font Software” refers to the set of files released by the Copyright Holder(s) under this license and clearly marked as such. This may include source files, build scripts and documentation. “Reserved Font Name” refers to any names specified as such after the copyright statement(s). “Original Version” refers to the collection of Font Software components as distributed by the Copyright Holder(s).
Limited Warranty We hope that you are happy with your FreeStyle Libre 2 system. Please refer to the User’s Manual before using your Reader for the first time. Abbott Diabetes Care (“Abbott”) warrants that the FreeStyle Libre 2 reader (“Reader”) shall be free from defects in material and workmanship for a period of one (1) year from the date of manufacture or one (1) year from the original date of purchase with proof of purchase (whichever is later).
References: 1 “FDA Public Health Notification: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens: Initial Communication” (2010) http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm224025. htm 2 “CDC Clinical Reminder: Use of Fingerstick Devices on More than One Person Poses Risk for Transmitting Bloodborne Pathogens” (2010) http://www.cdc.gov/injectionsafety/Fingerstick-DevicesBGM.
