4.6” 4.6” Distributed by: Abbott Diabetes Care Inc. 1360 South Loop Road Alameda, CA 94502 USA Customer Service: 1-855-632-8658 7 Days a Week from 8AM to 8PM Eastern Standard Time www.FreeStyleLibre.com User’s Manual The circular shape of the sensor housing, FreeStyle, Libre, and related brand marks are marks of Abbott. Other trademarks are the property of their respective owners. Patent: https://www.abbott.
4.6” 4.6” Your Name _________________________________________________ .257” DOC40703_rev-K_cover.indd 3-4 .
WARNING: Before you use the FreeStyle Libre 2 System, review all the product instructions and the Interactive Tutorial. The Quick Reference Guide and Interactive Tutorial give you quick access to important aspects and limitations of the System. The User’s Manual includes all safety information and instructions for use. Talk to your health care professional about how you should use your Sensor glucose information to help manage your diabetes.
Contents Important Safety Information . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Indications For Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Compatible Devices, Apps, and Software . . . . . . . . . . . . . . . . . . 2 Contraindications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 Warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 Cautions and Limitations . . .
Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 56 Setting Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .59 Setting Alarm Sounds . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 Using Alarms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 Living With Your System . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
Important Safety Information Indications For Use The FreeStyle Libre 2 Flash Glucose Monitoring System is a continuous glucose monitoring (CGM) device with real time alarms capability indicated for the management of diabetes in persons age 4 and older. It is intended to replace blood glucose testing for diabetes treatment decisions, unless otherwise indicated.
WARNINGS: • • • Do not ignore symptoms that may be due to low or high blood glucose: If you are experiencing symptoms that are not consistent with your glucose readings, consult your health care professional. Use your blood glucose meter to make diabetes treatment decisions when you see the symbol during the first 12 hours of wearing a Sensor, if your Sensor glucose reading does not match how you feel, or if the reading does not include a number.
• • • • • What should you know about wearing a Sensor: 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.
/13 YYYY-MM-DD are D Wash application site on the back of your upper arm usingLtd.aRangplain , UK 0Y L e R oa d, Witney, Oxon, OX29 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.
• • • • • 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.
Reader Symbols Symbol Symbol When you see this symbol during the first 12 hours of wearing a Sensor, confirm Sensor glucose readings with a blood glucose test before making treatment decisions. What It Means Active Sensor Direction your glucose is going. See Checking Your Glucose section for more information.
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. You use the Reader to wirelessly scan the Sensor and display your glucose readings. The Reader only works with FreeStyle Libre 2 Sensors and cannot be used with other Sensors. When they’re in range, the Sensor and Reader automatically communicate to give you glucose alarms. These alarms are on by default.
Reader Kit Sensor Kit The Reader Kit includes: • FreeStyle Libre 2 Reader • USB Cable • Interactive Tutorial on USB • • Power Adapter User’s Manual USB Port Used to charge the Reader and connect it to a computer. Test Strip Port Insert a test strip here to use the built-in meter. • • Quick Start Guide Quick Reference Guide DOC40703_rev-K_manual.
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 also allows you to change the name and/or ID that will be printed on the reports. The name and ID will be saved to the Reader but will not be visible on the Reader itself. 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 Action 5 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 2020 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 next supplements per day.
Applying Your Sensor Using Your Sensor Step t Di C DOC40703_rev-K_manual.indd 25-26 ash application site using a plain soap, dry, and W 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. Note: The area MUST be clean and dry following these instructions, or the Sensor may not stay on for the full 14 day wear period. OC 30 tes D td.
Action Step 3 Lid Cap 4 5 27 DOC40703_rev-K_manual.indd 27-28 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 3 ake sure the Sensor is secure after application.
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 350 82 Glucose Trend Arrow mg dL 250 Target Glucose Range Your Target Glucose Range is not related to your glucose alarm settings. 33 Current Glucose 150 50 2pm 6pm 10pm Notes: • The graph displays glucose readings above 350 mg/dL at 350 mg/dL. For sequential readings above 350 mg/dL, a line is displayed at 350 mg/dL. You can get your Current Glucose number up to 400 mg/dL and Glucose Trend Arrow when you scan your Sensor.
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 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 after doing a blood glucose test, 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. You should also talk to your health care professional about the best times to scan your Sensor. Consider scanning your Sensor before a period when you will not be monitoring your glucose, such as before driving, exercise or sleeping.
• • • • S can your Sensor often to see how carbs, medication, exercise, illness, or stress levels impact your Sensor glucose readings. The information you get can help you figure out why your glucose sometimes goes too high or too low, and how to prevent it from doing so in the future. Talk to your health care professional about how your insulin works.
When you see the symbol during the first 12 hours of wearing a Sensor symbol will display, and During the first 12 hours of Sensor wear the you cannot use Sensor values to make treatment decisions during this time. Confirm Sensor glucose readings with a blood glucose test before making treatment decisions during the first 12 hours of Sensor wear when symbol.
Using Your Glucose Reading to Make a Treatment Decision 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 Direction your glucose is going Current Glucose Arrow What it means Glucose rising quickly Message Glucose rising Glucose Going Low 350 82 mg dL 50 2pm Glucose Graph High Glucose (> 240 mg/dL) Treat low glucose according to your health care professional’s recommendation.
Glucose Trend Arrow Treatment Decision Considerations Low Glucose (< 70 mg/dL) Glucose in Target Range High Glucose (> 240 mg/dL) Treat low glucose according to your health care professional’s recommendation. If you are about to eat, take insulin to cover your meal. Consider taking a little more since glucose is rising. If you are about to eat, take insulin to cover your meal. Consider taking a little more since glucose is high and rising.
Glucose Trend Arrow Treatment Decision Considerations Low Glucose (< 70 mg/dL) Treat low glucose according to your health care professional’s recommendation. 47 DOC40703_rev-K_manual.indd 47-48 Glucose in Target Range High Glucose (> 240 mg/dL) If you are about to eat, take insulin to cover your meal. Consider taking a little less since glucose is falling. If you are about to eat, take insulin to cover your meal. Consider taking a little less since glucose is falling.
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: 7:03am Ends in 14 days 110 mg dL What it means When you wake-up on your first day of wearing a Sensor, your current glucose is symbol on the 110 mg/dL.
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 . a little more since your trend arrow was 250 What you see In the afternoon: Glucose Going Low 72 350 mg dL 250 150 150 50 4am 8am After lunch: 1:30pm Ends in 3 days 225 mg dL 350 250 150 50 5am 9am 50 7am 12pm 1pm 90 minutes later, your current glucose is 225 mg/dL.
What you see Before dinner: 7:34pm Ends in 7 days 134 250 150 50 3pm Before dinner, your current glucose is 134 mg/dL. The graph shows that your glucose . is going down and so does the trend arrow mg dL 350 11am What it means 7pm Other considerations Deciding how much rapid-acting insulin to take for different meals and situations can be difficult. Work with your health care professional to discuss different situations and what might work best for you.
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? • What do you do if your before meal glucose is low? Other factors • How do you adjust your insulin dose based on the Glucose Trend Arrow? • How do you adjust your insulin dose for different types of exercise or ac
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 Review Settings History Time & Date 1/4 Alarm Settings OK 3 Action Change Alarm Settings OK Select the alarm you want to set or turn off.
Alarm Low Glucose Alarm Alarm How to Set The Low Glucose Alarm is on by default. The alarm level is initially set to 70 mg/dL. You can use the arrows to change this value between 60 mg/dL and 100 mg/dL. If the alarm is on, you will be notified when your glucose falls below the level you set. Touch the slider to turn the alarm off. Low Glucose Alarm ? High Glucose Alarm 70 mg/dL On done How to Set The High Glucose Alarm is on by default. The alarm level is initially set to 240 mg/dL.
Action Step 4 Change Alarm Settings OK Low Glucose Alarm High Glucose Alarm Signal Loss Alarm Alarm Settings OK When you are finished setting your alarms, touch OK. The Alarms Settings screen now shows your current alarm settings. Touch OK to return to the main settings menu, or touch Change Alarm Settings to make additional updates. Setting Alarm Sounds Step 1 Action F rom the Home screen, touch the Settings symbol . Touch Sound & Vibration to change the alarm sounds.
Using Alarms What you See What you See Low Glucose Alarm Dismiss Alarm & Check Glucose High Glucose Alarm Dismiss Alarm & Check Glucose What it Means The Low Glucose Alarm notifies you if your glucose drops 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 Alarm & Check Glucose or press the Home Button to dismiss the alarm and check your glucose. You will only receive one alarm per low glucose episode.
Step Adding Notes Notes can be saved with your glucose readings. You can add a note at the time of your glucose reading or within 15 minutes after your reading was obtained. You can track food, insulin, exercise, and any medication you take.
Step Reviewing Your History Reviewing and understanding your glucose history can be an important tool for improving your glucose control. The Reader stores about 90 days of information and has several ways to review your past glucose readings, notes, and other information. Step Action 1 Check Glucose Scan Sensor to check glucose. ress the Home Button to turn on P the Reader. Press the Home Button again to go to the Home Screen. 3 Action Use the arrows to view the available options.
The Logbook and Daily Graph show detailed information, while other history options show summaries of information over a number of days. Logbook 23 Feb 143 23 Feb 98 22 Feb 108 10:23am 6:37am 11:09pm mg/dL OK Daily Graph (mg/dL) 350 OK Logbook Daily Graph Entries for each time you scanned your Sensor or performed a blood glucose test. If you entered Notes with a glucose reading, the symbol appears in that row. For more information about the symbols, see Reader Symbols section.
Other History Options Use the arrows to view information about your last 7, 14, 30, or 90 days. OK Average Glucose Average: 119 152 121 mg/dL 134 69 12 am 6 am 12 pm 6 pm 12 am Last 7 Days Information about the average of your Sensor glucose readings. The overall average for the time is displayed above the graph. The average is also shown for four different 6-hour periods of the day. Readings above or below your Target Glucose Range are orange, while readings in range are blue.
Removing Your Sensor Step Action 1 2 Replacing Your Sensor ull up the edge of the adhesive that keeps your P Sensor attached to your skin. Slowly peel away from your skin in one motion. Note: Any remaining adhesive residue on the skin can be removed with warm soapy water or isopropyl alcohol. iscard the used Sensor following directions from your health D care professional. See Maintenance and Disposal section.
You can use Reminders to help you remember things like checking your glucose or taking insulin. You can also set a reminder to remind you to check your alarm settings if you have disabled your alarms temporarily. 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 Action Step 1 Action Step Using Reminders From the Home Screen, touch the Settings .
Using the Reader’s Built-in Meter The Reader has a built-in meter that can be used to test your blood glucose, or to test the meter and strips with control solution. WARNING: Do NOT use the built-in meter while the Reader is connected to an electrical outlet or a computer due to the potential risk of electrical shock.
IMPORTANT: (cont.) • Inaccurate test strip results may occur in severely hypotensive individuals or patients in shock. • • • • • • • Inaccurate test strip results may occur for individuals experiencing a hyperglycemic-hyperosmolar state, with or without ketosis. Observe caution when using around children. Small parts may constitute a choking hazard. You should clean and disinfect the Reader once per week.
Blood Glucose Testing Step 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 ash your hands with warm soapy water for W accurate results. Thoroughly dry your hands. To warm the site, apply a warm dry pad or rub vigorously for a few seconds.
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 normal glucose level for a non-diabetic adult is below 100 mg/dL when fasting, and less than 140 mg/dL within two hours of a meal.3 Consult your health care professional to determine the range that is appropriate for you.
Accuracy of the Reader's built-in meter Results from the Reader's built-in meter may vary slightly from your actual blood glucose value. This may be due to slight differences in technique and natural variation in test technology. The table below shows the results of a study where 119 typical users used the built-in meter to check their blood glucose level. For example, in the study, the built-in meter gave results within 15% of true blood glucose level 115 out of 119 times.
Action Step 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 Action Step 4 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. Review History Reminders Control Solution Test Language 2/4 Blood Glucose Sensor Electrode Abbott Diabetes Care Ltd.
Step 5 (cont.) Action You will see a butterfly on the screen while you wait for the result. Do not remove the test strip while the butterfly is on the screen. If sounds are turned on, the Reader beeps once when the result is ready. If the butterfly does not appear, you may not have applied enough control solution to the test strip. Apply a second drop of control solution to the test strip within 5 seconds of the first drop.
Charging the Reader A fully charged Reader battery should last up to 4 days. Your battery life may vary depending on your usage. A Low Battery message OK Low Battery accompanies your result when you have enough charge remaining for about day of Pleaseone charge the Reader to 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.
Step Action 2 Touch the setting you want to change: Alarms – See Alarms section for information on setting alarms Sound & Vibration – Set Reader sound and vibration.
Living With Your System Your System can be used during a wide variety of activities. Activity What You Need To Know Bathing, Showering, and Swimming The Reader is not water-resistant and should NEVER be submerged in water or other liquid. Your Sensor is water-resistant and can be worn while bathing, showering, or swimming. Note: Do NOT take your Sensor deeper than 3 feet (1 meter) or immerse it longer than 30 minutes in water. Sleeping Your Sensor should not interfere with your sleep.
Activity Traveling by Air (cont.) What You Need To Know • The System can be exposed to common electrostatic (ESD) and electromagnetic interference (EMI), including airport metal detectors. You can keep your Reader on while going through these. Note: If you are changing time zones, you can change the time and date settings on the Reader by touching the Settings symbol from the Home Screen, then Time & Date. Changing the time and date affects the graphs and statistics.
This device is not intended for use with multiple patients in health care or assisted-use settings such as hospitals, physician offices, or long-term care facilities because it has not been cleared by FDA for use in these settings, including for routine assisted testing or as part of glycemic control procedures. Use of this device on multiple patients may lead to transmission of Human Immunodeficiency Virus (HIV), Hepatitis C Virus (HCV), Hepatitis B Virus (HBV), or other bloodborne pathogens.
Step Action 3 For disinfection, use a second bleach wipe to wipe all outside surfaces of the Reader until they are wet. Make sure liquid does not get into the test strip and USB ports. Allow the Reader surfaces to remain wet for 60 seconds. 4 Dry with clean paper towel to remove any residual moisture.
Problems at the Sensor Application Site Troubleshooting This section lists problems or observations that you may have, the possible cause(s), and recommended actions. If the Reader experiences an error, a message will appear on the screen with directions to resolve the error. Problem What It May Mean The Sensor is not sticking to your skin. The site is not free of dirt, oil, hair, or sweat. 1. Remove the Sensor. 2. Clean the site with a plain soap and water and then clean with an alcohol wipe. 3.
Problems Starting Your Sensor or Receiving Sensor Readings Display What It May Mean What To Do New Sensor Starting Up Sensor is not ready to read glucose. Wait until the 60 minute Sensor start-up period has completed. Scan Timeout The Reader is not held close enough to the Sensor. Hold the Reader within 1.5 inches (4 cm) of the Sensor. Bring the screen of the Reader close to the Sensor. Sensor Ended The Sensor life has ended. Apply and start a new Sensor.
Display What It May Mean What To Do Sensor Error The System is unable to provide a glucose reading. Scan again after the duration specified in the message. Note: If you receive this error during your first 12 hours of wearing a Sensor, it may mean that your body is still adjusting to the Sensor. Use a blood glucose meter to check your glucose while you wait. You do not need to remove your Sensor. Glucose Reading Unavailable Your Sensor is too hot or too cold.
Problems Receiving Glucose Alarms Problem You are not receiving glucose alarms. What It May Mean What To Do You have turned alarms off. Touch the Settings symbol and then select Alarms. The Sensor is not communicating with your Reader. or There may be a problem with your Sensor or Reader. The Sensor must be within range (20 feet) of the Reader for you to receive alarms. Make sure that you are within this range.
Blood Glucose Error Messages Error Message E-1 E-2 What It May Mean The temperature is too hot or too cold for the Reader to work correctly. Reader error. What To Do 1. M ove the Reader and test strips to a location where the temperature is within the test strip operating range. (See test strip instructions for use for the appropriate range). 2. Wait for the Reader and test strips to adjust to the new temperature. 3. Repeat the test using a new test strip. 4.
Error Message What It May Mean What To Do E-5 Blood was applied to the test strip too soon. 1. R eview the testing instructions. 2. Repeat the test using a new test strip. 3. If the error reappears, contact Customer Service. E-6 The test strip may not be compatible with the Reader. 1. C heck 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.
Problems Checking Your Blood Glucose Problem What It May Mean What To Do The Reader does not start a test after inserting a test strip. Test strip is not inserted correctly or not inserted fully into the strip port. 1. With the 3 black lines facing up, insert the test strip into the strip port until it stops. 2. If the Reader still does not start a test, contact Customer Service. Reader battery is too low. Charge the Reader. The test strip is damaged, used, or unrecognizable by the Reader.
Perform a Reader Test System Status System Info Reader Test Event Log OK If you think the Reader is not working properly, you can check the Reader by performing a Reader Test. from the Home Touch the Settings symbol Screen, select System Status and then select Reader Test. Note: The Reader Test will perform internal diagnostics and will allow you to check that the display, sounds, and touchscreen are working properly.
Sensor memory 8 hours (glucose readings stored every 15 minutes) Sensor transmission range 20 feet (6 meters) unobstructed Operating temperature 50 °F to 113 °F 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 Sensor Applicator and Sensor Pack storage temperature 36 °F to 82 °F Operating and storage relative humidity 10-90%, non-condensing Reader battery life 4
Reader moisture protection Keep dry Power Adapter Abbott Diabetes Care PRT25611 Operating temperature: 50 °F to 104 °F Operating and storage altitude -1,250 ft (-381 meters) to 10,000 ft (3,048 meters) USB Cable Reader display timeout 60 seconds (120 seconds when test strip is inserted) Abbott Diabetes Care PRT21373 Length: 37 inches (94 cm) Radio Frequency Near Field Communication (13.56 MHz RFID); ASK Modulation; 124 dBuV/m; 1.5 inch communication range 2.402-2.
20 minutes, the Reader alarms the user if the alarm is turned on. If connection is lost between the Sensor and the Reader, up to 8 hours of glucose results can be retrieved by performing a scan with the Reader. The Reader is designed to only accept radio frequency (RF) communications from recognized and paired Sensors. Labeling Symbols CODE 127 DOC40703_rev-K_manual.
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. 129 DOC40703_rev-K_manual.
manipulated per the study protocol to raise or lower glucose. This was done to assess performance of the System over the range that the System measures glucose (40 – 400 mg/dL). 48 subjects were analyzed during the beginning of the Sensor wear period (day 1 or 2), 50 subjects were analyzed during the early middle period (day 7 or 8), 51 subjects were analyzed during the late middle period (day 9 or 12), and 51 subjects were analyzed during the end period (day 13 or 14).
Table 1b: Accuracy to YSI within CGM Glucose Ranges (Adult; n=144) CGM Glucose Level † (mg/dL) † Table 1c: Accuracy to YSI within CGM Glucose Ranges (Pediatric*; n=129) Number Percent Percent Percent Percent Percent Percent Mean of CGMMARD Within Within Within Within Within Within bias Reference (%) ±15 mg/dL ±20 mg/dL ±40 mg/dL ±15% ±20% ±40% (mg/dL) Pairs CGM Glucose Level † (mg/dL) Number Percent Percent Percent Percent Percent Percent Mean of CGMMARD Within Within Within Within Within Within bias R
Table 1d: Accuracy to YSI within YSI Glucose Ranges (Adult; n=144) YSI Glucose Level (mg/dL) Table 1e: Accuracy to YSI within YSI Glucose Ranges (Pediatric*; n=129) Number Percent Percent Percent Percent Percent Percent Mean of CGMMARD Within Within Within Within Within Within bias Reference (%) ±15 mg/dL ±20 mg/dL ±40 mg/dL ±15% ±20% ±40% (mg/dL) Pairs <54 440 91.1 97.5 100.0 7.4 15.5 54-69 3028 94.7 98.6 100.0 1.5 10.2 70-180 7504 77.5 86.9 99.4 -4.8 10.4 181-250 2937 87.9 93.
Agreement with ‘LO’ and ‘HI’ CGM Reading against YSI Reference The System reports glucose concentrations between 40 and 400 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 400 mg/dL, it will report as ‘HI’. Tables 2a and 2b display the concurrence between the CGM and YSI reference glucose when CGM reads ‘LO’.
Concurrence of System and Reference (CGM vs. YSI) The percentage of concurring glucose values (CGM vs. YSI) in each glucose reference range is presented for each CGM range in Tables 3a and 3b and for each YSI range in Tables 3c and 3d. For example, in the Adult study, when the System glucose readings were within the 81 to 120 mg/dL range, actual blood glucose values were between 40 and 60 mg/dL 0.2% of the time, between 61 and 80 mg/dL 11.0% of the time, between 81 and 120 mg/dL 70.
Table 3b: Concurrence Analysis by CGM Glucose Level (Pediatric*; n=129) YSI Glucose Level (mg/dL) CGM Glucose Level 121- 161- 201- 251<40 40-60 61-80 81-120 (mg/dL) 160 200 250 300 301350 Table 3c: Concurrence Analysis by YSI Glucose Level (Adult; n=144) 351>400 400 CGM Glucose Level (mg/dL) N YSI Glucose Level (mg/dL) <40 † 40-60 61-80 81-120 121160 161200 201250 251300 301350 351>400† 400 N <40† . 50.0 50.0 . . . . . . . . 2 <40 12.5 87.5 . . . . . . . . .
Table 3d: Concurrence Analysis by YSI Glucose Level (Pediatric*; n=129) CGM Glucose Level (mg/dL) YSI Glucose Level (mg/dL) <40 <40 . 100.0 . 40-60 0.3 69.2 61-80 0.1 81-120 N 121160 161200 201250 251300 301350 . . . . . . . . 3 30.0 0.5 . . . . . . . 370 24.8 62.6 12.5 . . . . . . . 904 . 3.9 21.0 65.7 9.4 0.1 . . . . . 1057 121-160 . 0.3 1.7 19.3 65.0 13.5 0.2 . . . .
Table 4b: Concurrence Analysis by Glucose Rate of Change (Pediatric*; n=129) YSI (mg/dL/min) CGM (mg/dL/min) <-2 [-2, -1) [-1, 0) [0, 1] (1, 2] >2 <-2 (i) 44.1 44.7 8.8 2.4 . . 170 -2 to -1 (m) 11.4 49.5 32.8 5.2 0.4 0.6 463 -1 to 0 (g) 2.1 11.2 60.0 20.8 3.9 1.9 2587 0 to 1 (g) 1.4 5.6 25.2 43.2 14.8 9.7 2095 1 to 2 (k) 0.2 2.6 10.4 29.7 35.5 21.5 498 >2 (h) . 0.9 4.2 15.0 29.7 50.2 448 N * Includes children 6-17 years of age.
Table 5a: Low Glucose Alarm Performance (Adult; n=144) Low Glucose Alarm level (mg/dL) Alarm Rate High Glucose Alarm Performance Tables 5c and 5d display the percentages for these parameters: Detection Rate Number of Events (n) True Alarm Rate (%) False Alarm Rate (%) Number of Events (n) Correct Detection Rate (%) Missed Detection Rate (%) 60 9861 72.6 27.4 1527 75.7 24.3 70 21504 86.0 14.0 3652 89.3 10.7 80 32784 91.3 8.7 4753 97.3 2.7 90 41299 93.6 6.4 5591 98.5 1.
For example, the Adult study found that for a High Glucose alarm level set to 200 mg/dL: 99.2% of the time a high glucose alarm was received when blood glucose was indeed above the alarm level but 0.8% of the time a high glucose alarm was received when blood glucose wasn’t actually above the alarm level. 97.1% of the time blood glucose was above the alarm level and a high glucose alarm was appropriately issued but 2.9% of the time the glucose event was missed and no alarm was issued.
Table 6a: Sensor Accuracy Relative to YSI over the wear duration (Adult; n=144) Wear Period Number of CGM-reference pairs MARD (%) Within ±15% / ±15 mg/dL Within ±20% / ±20 mg/dL Within ±40% / ±40 mg/dL Beginning 6955 9.9 83.4 90.4 99.3 Early Middle 4522 8.5 87.7 94.5 99.8 Late Middle 3503 8.8 86.8 93.4 99.7 End 3755 9.1 86.4 92.9 100.
Table 7b: Sensor Survival Rate Over Wear Duration (Pediatric; n=139) Table 7a: Sensor Survival Rate Over Wear Duration (Adult; n=146) Number of Sensors Survival Rate (%) 1 137 98.6 2 136 97.8 95.9 3 134 97.1 93.8 4 133 96.4 134 91.8 5 133 96.4 6 133 91.1 6 133 96.4 7 132 90.4 7 133 96.4 8 127 87.0 8 131 94.9 9 123 84.9 9 126 91.3 124 89.9 Day of Wear Number of Sensors Survival Rate (%) 1 145 99.3 2 142 97.
Glucose Reading Availability The System is designed to show a Sensor glucose reading after each scan that is performed throughout the wear period after the start-up time. Tables 8a and 8b show the glucose reading capture rate for each day of the wear duration. Table 8a: Glucose Reading Capture Rate Over Wear Duration (Adult; n=146) Day of Wear Number of Sensors Number of Sensors Capture Rate (%) 1 139 94.6 2 137 94.9 Capture Rate (%) 3 136 95.2 4 133 95.3 5 134 95.5 6 133 95.
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 9a provides data from 146 subjects in the Adult study; Table 9b provides data from 137 subjects in the Pediatric study. For adults, the paired absolute relative difference (PARD) between the two Sensors was 8.1% with coefficient of variation (CV) of 5.7%. For children ages 4-5, PARD was 6.7% with CV of 4.8%. For children ages 6-17, PARD was 8.2% with CV of 5.8%.
Additional notes for Health Care Professionals A clinical study was conducted to evaluate the effect of ascorbic acid on Sensor performance. Data from 57 adult subjects with diabetes was collected over a 13-hour period. Each subject had a one-hour baseline phase where venous blood was collected every 10 minutes. After this first hour, a dose of 1000 mg ascorbic acid was given with a meal and venous samples were collected every 20 minutes for the next four hours. A maximum average sensor bias of 9.
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.
2) Original or Modified Versions of the Font Software may be bundled, redistributed and/or sold with any software, provided that each copy contains the above copyright notice and this license. These can be included either as stand-alone text files, human-readable headers or in the appropriate machine-readable metadata fields within text or binary files as long as those fields can be easily viewed by the user.
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DOC40703_rev-K_manual.
