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Table 5d: High Glucose Alarm Performance (Pediatric*; n=129) 

High Glucose 

Alarm level 

(mg/dL)

Alarm Rate

Detection Rate

Number of 

Events (n)

True Alarm 

Rate

(%)

False Alarm 

Rate

(%)

Number of 

Events (n)

Correct 

Detection 

Rate (%)

Missed 

Detection 

Rate (%)

120

34176

98.8

1.2

4441

98.2

1.8

140

30107

98.0

2.0

3945

98.4

1.6

180

22430

98.4

1.6

3125

98.0

2.0

200

19425

98.0

2.0

2791

98.0

2.0

 220

16371

98.2

1.8

2492

96.9

3.1

240

13559

98.0

2.0

2172

95.7

4.3

300

6064

90.8

9.2

962

91.0

9.0

*

  

Includes children 6-17 years of age. No YSI measurements were obtained for children 4-5 years of age.

Sensor Accuracy Over Time

 

The Sensor can be worn for up to 14 days. The percentage of System readings within YSI values and 

the Mean Absolute Relative Difference (MARD) is presented for the following different wear periods 

in 

Tables 6a and 6b

: Beginning (Adult: 144 Subjects, Day 1, 2 or 3; Pediatric: 48 Subjects, Day 1 

or 2) Early Middle (Adult: 91 Subjects, Day 7 or 8; Pediatric: 50 Subjects, Day 7 or 8), Late Middle 

(Adult: 55 Subjects, Day 9 or 12; Pediatric: 51 Subjects, Day 9 or 12), and End (Adult: 76 Subjects, Day 

13 or 14; Pediatric: 51 Subjects, Day 13 or 14). For values 70 mg/dL and above, the percentage of 

readings within 15%, 20%, and 40% of the YSI value was calculated. For values below 70 mg/dL, the 

percentage of readings within 15 mg/dL, 20 mg/dL, and 40 mg/dL of the YSI value was calculated.

205

Содержание FreeStyle Libre 2

Страница 1: ...User s Manual FLASH GLUCOSE MONITORING SYSTEM CAUTION Federal law restricts this device to sale by or on the order of a physician FreeStyle Libre 2 app A FreeStyle Libre product ...

Страница 2: ...Your Name _________________________________________________ ...

Страница 3: ...re professional about how you should use your Sensor glucose information to help manage your diabetes Failure to use the System according to the instructions for use may result in you missing a severe low blood glucose or high blood glucose event and or making a treatment decision that may result in injury If your glucose alarms and readings from the System do not match symptoms or expectations us...

Страница 4: ... 18 Getting to Know Your System 20 Sensor Kit 22 Reader Kit 23 FreeStyle Libre 2 app 24 Reader Home Screen 25 App Home Screen 26 Reporting Software 27 Setting up Your System for the First Time 28 Reader Setup 28 App Setup 31 Applying Your Sensor 34 Starting Your Sensor 39 Starting Your Sensor with the Reader 39 Starting Your Sensor with the App 41 Checking Your Glucose 44 Checking Your Glucose wit...

Страница 5: ... 80 Setting Reader Alarm Sounds 85 Using Reader Alarms 86 App Alarms 88 Setting App Alarms 94 Using App Alarms 99 Adding Notes to Glucose Readings 103 Adding Notes in the Reader 103 Adding Notes in the App 105 Reviewing Your History 107 Reviewing Your History in the Reader 107 Reviewing Your History in the App 113 Removing Your Sensor 117 Replacing Your Sensor 118 Using Reminders 119 Using Reminde...

Страница 6: ...ce and Disposal 150 Troubleshooting 155 Reader Does Not Power On 156 Problems at the Sensor Application Site 157 Problems Starting Your Sensor or Receiving Sensor Readings 158 Problems Receiving Alarms 164 Blood Glucose Error Messages 169 Problems Checking Your Blood Glucose 173 Perform a Reader Test 175 Customer Service 175 System Specifications 176 Labeling Symbols 183 Performance Characteristic...

Страница 7: ... indicated The System also detects trends and tracks patterns and aids in the detection of episodes of hyperglycemia and hypoglycemia facilitating both acute and long term therapy adjustments Interpretation of the System readings should be based on the glucose trends and several sequential readings over time The System is also intended to autonomously communicate with digitally connected devices T...

Страница 8: ...re information about device compatibility before upgrading your phone or its operating system Contraindications Automated Insulin Dosing The System must not be used with automated insulin dosing AID systems including 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 he...

Страница 9: ...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 If you are using FreeStyle Libre 2 app you must have access to a blood glucose monitoring system as t...

Страница 10: ...ive do not include your glucose reading so you must scan your Sensor to check your glucose What to know about App Alarms For you to receive alarms your phone should be within 20 feet of you at all times The transmission range is 20 feet unobstructed If you are out of range you may not receive alarms If you want to receive the App s optional alarms make sure these are turned on Do not force close t...

Страница 11: ...ne is not configured properly you will not be able to use the App so you will not receive alarms or be able to check your glucose o In the phone settings keep Bluetooth ON o In the phone settings for the App allow the App to access Bluetooth o In the phone settings for the App under Notifications keep Allow Critical Alerts ON If your phone is not configured correctly the App will be in Alarms Unav...

Страница 12: ...s If you are using peripheral devices connected to your phone such as wireless headphones or a smartwatch you may receive alarms on only one device or peripheral not all Keep your phone well charged and turned on Disable your phone s automatic operating system updates After an operating system update open your App and check your device settings to make sure it s working properly Some operating sys...

Страница 13: ...ing or tampering with the System Who should not use the System Do not use the System in people less than 4 years of age The System is not cleared for use in people under 4 years of age Do not use the System if you are pregnant on dialysis or critically ill The System is not cleared for use in these groups and it is not known how different conditions or medications common to these populations may a...

Страница 14: ... for the full 14 day wear period and help prevent it from falling off early The Sensor can be worn for up to 14 days Remember to always have your next Sensor available before your current one ends so you can keep getting your glucose readings You must scan the Sensor to get your real time current glucose level as both the Reader and App will not provide this information without a scan In the event...

Страница 15: ...d to the skin If you notice significant skin irritation around or under your Sensor remove the Sensor and stop using the System Contact your health care professional before continuing to use the System Intense exercise may cause your Sensor to loosen due to sweat or movement of the Sensor If the Sensor is becoming loose or if the Sensor tip is coming out of your skin you may get no readings or unr...

Страница 16: ...age 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 humidit...

Страница 17: ...and FreeStyle Libre 2 Readers do not share data 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 i...

Страница 18: ...s 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 Av...

Страница 19: ...ng What to know about X Rays The Sensor should be removed prior to exposing it to an X ray machine The effect of X rays on the performance of the System has not been evaluated The exposure may damage the Sensor and may impact proper function of the device to detect trends and track patterns in glucose values during the wear period When to remove the Sensor If the Sensor is becoming loose or if the...

Страница 20: ...on 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 The Reader s built in meter is not for use on people who are dehydrated hypotensive in shock or for...

Страница 21: ...peripheral circulation or sensation should use caution at this temperature Interfering Substances Taking ascorbic acid vitamin C supplements while wearing the Sensor may falsely raise Sensor glucose readings Taking more than 500 mg of ascorbic acid per day may affect the Sensor readings which could cause you to miss a severe low glucose event Ascorbic acid can be found in supplements including mul...

Страница 22: ...s going See Understanding Your Glucose Readings section for more information Caution View previous next screen Sound and Vibration ON Sound ON Vibration OFF Sound OFF Vibration ON Sound and Vibration OFF Sensor communicating with Reader Sensor not communicating with Reader 16 ...

Страница 23: ...m Sensor glucose readings with a blood glucose test before making treatment decisions 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 17 ...

Страница 24: ...oing See Understanding Your Glucose Readings section for more information Caution 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 Add edit notes Manually entered blood glucose result note 18 ...

Страница 25: ...Means Add blood glucose result note Food note Insulin Rapid or Long acting note Exercise note Time change Main menu Multiple Custom notes Share report Additional information Calendar Sensor too cold Sensor too hot 19 ...

Страница 26: ...ou start your Sensor choose which device you want to use The Reader and App only work with FreeStyle Libre 2 Sensors and cannot be used with other Sensors When they re in range the Sensor and your device automatically communicate to give you glucose alarms These alarms are on by default Remember that alarms you receive will not include your glucose reading so you need to scan your Sensor to check ...

Страница 27: ...use your Sensor glucose information to help manage your diabetes During the first 12 hours of Sensor wear the symbol will display and 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 you see the symbol When opening your Sensor Kit and Re...

Страница 28: ...adings when worn on your body It initially comes in two parts one part is in the Sensor Pack and the other part is in the Sensor Applicator By following the instructions you prepare and apply the Sensor on the back of your upper arm The Sensor has a small flexible tip that is inserted just under the skin The Sensor can be worn for up to 14 days Note The Sensor Pack is sterile and non pyrogenic unl...

Страница 29: ...you understand how these activities affect your glucose The Reader also includes a built in meter for blood glucose testing To use the built in meter you need FreeStyle Precision Neo blood glucose test strips control solution a lancing device and lancets These items are not included in the Reader kit and must be obtained separately from your FreeStyle Libre 2 System provider pharmacy or mail order...

Страница 30: ... FreeStyleLibre com You must keep Critical Alerts and Bluetooth on If these settings are turned off you will not be able to use the App so you will not receive alarms or be able to check your glucose You are responsible for properly securing and managing your smartphone If you suspect an adverse cybersecurity event related to FreeStyle Libre 2 contact Customer Service FreeStyle Libre 2 is not inte...

Страница 31: ... is on Ends in 14 days 10 23pm Check Glucose Review History Current time set on the Reader Sensor Status Information about your current Sensor Battery charge remaining Sound Vibration setting Signal Status Shows if Sensor is communicating with Reader Settings Touch to access Alarms Reminders and other Reader settings Review History Touch to review information about your past glucose readings Check...

Страница 32: ...he last 24 hours High Glucose Alarm Level Your High Glucose Alarm level Low Glucose Alarm Level Your Low Glucose Alarm level Target Glucose Range The graph shows your target glucose range This is not related to glucose alarm levels Scan Button Tap when you are ready to scan your Sensor You can either tap this symbol or the blue box at the bottom of the Home screen Glucose Graph Graph of your store...

Страница 33: ...s from FreeStyle Libre 2 Sensors Go to www FreeStyleLibre com and follow onscreen instructions to download and install the compatible software You are responsible for keeping your computer secure and up to date for example by using anti virus software and installing system updates 27 ...

Страница 34: ...ith the Sensor or use the Reader s built in meter Step Action 1 Press the Home Button to turn on the Reader 2 If prompted use the touchscreen to select your preferred language for the Reader Touch OK to continue Note Use the pad of your finger Do NOT use your fingernail or any other object on the screen 28 ...

Страница 35: ...ouchscreen Touch next to continue 4 Set the Current Time Touch next to continue 14 back next Current Date June 2021 12am 00 back next Current Time CAUTION It is very important to set the time and date correctly These values affect the Reader data and settings 29 ...

Страница 36: ...hould last up to 4 days but this may vary depending on your usage next back When you scan your Sensor an arrow will indicate your recent glucose trend Rising quickly Rising Changing slowly Falling Falling quickly If you see this symbol do a blood glucose test before making treatment decisions back next If the Sensor glucose reading does not match how you feel do a blood glucose test back next next...

Страница 37: ... phone or its operating system Step Action 1 Check that your iPhone is connected to a network WiFi or cellular You can then install FreeStyle Libre 2 from the App Store Tap the App icon to open the App Note You only need to be connected to a network for setup using LibreView and sharing with other apps You do not need to be connected to scan a Sensor add notes or review your history in the App 2 S...

Страница 38: ... login to your existing account You can continue using an existing Sensor with the App on a compatible phone that is logged into the same LibreView account LibreView Data Management Software is developed by Newyu Inc Use of FreeStyle Libre 2 app requires registration with LibreView a service provided by Abbott and Newyu Inc 5 Confirm your glucose unit of measure and tap NEXT 32 ...

Страница 39: ... notes you enter in the App 7 The App now displays some important information Accept the requested permissions Tap NEXT after reviewing each screen 8 Apply a new Sensor and then tap NEXT Go to Starting Your Sensor section Note If you need help applying your Sensor tap HOW TO APPLY A SENSOR or go to Applying Your Sensor section 33 ...

Страница 40: ...ensor is becoming loose or if the Sensor tip is coming out of your skin you may get no readings or unreliable low readings Remove and replace your Sensor if it starts to loosen and follow the instructions to select an appropriate application site Do not attempt to reinsert the Sensor Contact Customer Service if your Sensor becomes loose or falls off before the end of the wear period Customer Servi...

Страница 41: ... site that is at least 1 inch 2 5 cm away from an insulin injection site To prevent discomfort or skin irritation you should select a different site other than the one most recently used 2 Wash application site 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 ...

Страница 42: ...k 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 5 Lift the Sensor Applicator out of the Sensor Pack Lid Cap 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 36 ...

Страница 43: ...epared site and push down firmly to apply the Sensor to your body CAUTION The Sensor Applicator now contains a needle Do NOT touch inside the Sensor Applicator or put it back into the Sensor Pack CAUTION Do NOT push down on the Sensor Applicator until placed over prepared site to prevent unintended results or injury 37 ...

Страница 44: ...is bleeding that does not stop remove the Sensor and contact your health care professional 9 Make sure the Sensor is secure after application Put the cap back on the Sensor Applicator Discard the used Sensor Pack and Sensor Applicator according to local regulations Note If using the App you can tap Help in the Main Menu to access an in app tutorial on applying a Sensor Sensor 38 ...

Страница 45: ...oose which device you want to use If you start the Sensor with the Reader you will be unable to use the App to check your glucose or receive alarms Step Action 1 Press the Home Button to turn on the Reader 2 Touch Start New Sensor Start New Sensor Review History No Active Sensor 10 23pm 39 ...

Страница 46: ... has been successfully activated The Sensor can be used to check your glucose after 60 minutes Note If the Sensor 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 Start New Sensor to scan your Sensor minutes New Sensor Starting Up 60 Sensor can be used in OK 40 ...

Страница 47: ...pp you should keep your iPhone well charged and be sure you have access to a blood glucose monitoring system When you scan your Sensor you will receive a tone and vibration If your iPhone s volume is turned off you will not hear the tone The NFC Near Field Communication antenna is on the top edge of iPhone Hold this area near your Sensor when you are scanning You may need to adjust your scan dista...

Страница 48: ...ensor this can be done over clothing Do not move your iPhone until you hear a tone and or feel a vibration This completes the scan Note If you need help tap HOW TO SCAN A SENSOR to view an in app tutorial You can also access this later by going to the Main Menu and then tapping Help If your Sensor is not successfully scanned you may receive this Scan Error Your scan was unsuccessful Tap the scan b...

Страница 49: ... Sensor can be used to check your glucose after the start up period While the Sensor is starting up you can navigate away from the App If notifications are enabled you will see a notification when the Sensor is ready 43 ...

Страница 50: ...or to scan it Your Sensor wirelessly sends glucose readings to the Reader If sounds are turned on the Reader beeps when the Sensor has been successfully scanned Note If the Sensor 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 Check Glucose Review History 10 23pm E...

Страница 51: ... 150 50 2pm 6pm 10pm 82mg dL Glucose Going Low GlucoseTrend Arrow Direction your glucose is going Glucose Graph Graph of your current and stored glucose readings Rapid acting Insulin Note Current Glucose Glucose from your latest scan Message Touch for more information Food Note Add Notes Touch to add notes to the glucose reading Target Glucose Range Your Target Glucose Range is not related to your...

Страница 52: ...s 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 symbol may appear indicating the Reader time was changed Gaps in the graph may result or glucose readings may be hidden All available glucose data is used to make your graph so you can expect to see some differences between the graph line ...

Страница 53: ...th the App Step Action 1 Open the App and tap the scan button Note If the Ready to Scan dialog disappears tap the scan button again 2 Hold the top of your iPhone near the Sensor until you hear a tone and or feel a vibration 47 ...

Страница 54: ...Glucose a Glucose Trend Arrow indicating which way your glucose is going and a graph of your current and stored glucose readings Message Add Note Back Current Glucose Scan Button Glucose Graph Target Glucose Range Glucose Trend Arrow High Glucose Alarm Level Low Glucose Alarm Level Note Symbol 48 ...

Страница 55: ...dd notes to the glucose reading Glucose Trend Arrow Direction your glucose is going Note Symbol Tap to review notes you ve entered Glucose Graph Graph of your current and stored glucose readings Target Glucose Range The graph shows your target glucose range This is not related to glucose alarm levels High Glucose Alarm Level Your High Glucose Alarm level Low Glucose Alarm Level Your Low Glucose Al...

Страница 56: ...ged Gaps in the graph may result or glucose readings may be hidden All available glucose data is used to make your graph so you can expect to see some differences between the graph line and previous current glucose readings Your current glucose value determines the background color on the My Glucose screen Orange High glucose above 240 mg dL Yellow Between the Target Glucose Range and high or low ...

Страница 57: ...the 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 more than 2 mg dL per minute 51 ...

Страница 58: ... 250 150 50 2pm 6pm 10pm mg dL High Glucose HI If LO appears your reading is lower than 40 mg dL If HI appears your reading is higher than 400 mg dL You can touch the symbol 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 52 ...

Страница 59: ...re information and set a reminder to check your glucose 350 250 150 50 2pm 6pm 10pm mg dL 72 Glucose Going Low 350 250 150 50 2pm 6pm 10pm 237 mg dL Glucose Going High If your glucose is projected to be higher than 240 mg dL or lower than 70 mg dL within 15 minutes you will see a message on the screen You can touch the symbol for more information and set a reminder to check your glucose Note In th...

Страница 60: ... 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 you see the symbol Note If you are not sure about a message or reading contact your health care professional before you do anything Messages you receive with your glucose readings are not related to your glucose alarm settin...

Страница 61: ... sleeping WARNING The System can replace blood glucose testing except in the below situations These are the times when you need to do a blood glucose test before deciding what to do or what treatment decision to make as Sensor readings may not accurately reflect blood glucose levels Do a blood glucose test if you think your glucose readings are not correct or do not match how you feel Do not ignor...

Страница 62: ...days and in different situations There may be variations between Sensors during the first 12 hours after insertion so pay attention to how each newly inserted Sensor is working for you when deciding whether to make treatment decisions based on your Sensor readings Getting familiar with the System could take days weeks or even months The more you check readings from the System with a blood glucose ...

Страница 63: ...in the future Talk 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 carb...

Страница 64: ...tem do not match your symptoms or expectations use a fingerstick blood glucose value from a blood glucose meter to make diabetes treatment decisions Glucose Rising Quickly BloodGlucose 100mg dL SensorGlucose 95mg dL Glucose Falling Quickly SensorGlucose 80mg dL BloodGlucose 70mg dL When not to use Sensor Glucose readings for treatment decisions No Current Glucose Number When there is no Current Gl...

Страница 65: ... the symbol Think Your Readings are Incorrect Don t trust Sensor glucose readings that you think may be incorrect or that don t match what you would expect based on your recent activity For example if you ate dinner but forgot to take insulin before eating you would expect your glucose to be high If your glucose reading is low then it doesn t match your recent activity so don t use it to make trea...

Страница 66: ... 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 When to do Nothing and Scan Again Later Your health care professional can help you understand when doing nothing and scanning again later is the right treatment decision For example if your glucose is high and going up your first instinct may be to ...

Страница 67: ... 350 250 150 50 mg dL 2pm 6pm 10pm Current Glucose Message Glucose Graph Graph of your current and stored glucose readings Food Note Target Glucose Range Rapid Acting Insulin Note Current Glucose GlucoseTrend Arrow Direction your glucose is going Arrow What it means Glucose rising quickly Glucose rising Glucose changing slowly Glucose falling Glucose falling quickly Glucose Trend Arrow Glucose Gra...

Страница 68: ...rection your glucose is going Arrow What it means Glucose rising quickly Glucose rising Glucose changing slowly Glucose falling Glucose falling quickly Time Target Glucose Range Current Glucose Food Note Rapid Acting Insulin Note Current Glucose Message Glucose Trend Arrow Glucose Graph 62 ...

Страница 69: ...th 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 quickly If you have taken insulin recently do nothing and scan again later Avoid insulin stacking If you are about to eat take insulin to cover your meal Consider taking a little more since glucose is high and rising quickly If this is between meals co...

Страница 70: ...nsider taking a little more since glucose is rising If you have taken insulin recently do nothing and scan again later Avoid insulin stacking If you are about to eat take insulin to cover your meal Consider taking a little more since glucose is high and rising If this is between meals consider taking an insulin correction dose unless you have taken insulin recently If you have taken insulin recent...

Страница 71: ...e about to eat take insulin to cover your meal If this is between meals do nothing and scan again later If you are about to eat take insulin to cover your meal Consider taking a little more since glucose is high If this is between meals consider taking an insulin correction dose unless you have taken insulin recently If you have taken insulin recently do nothing and scan again later Avoid insulin ...

Страница 72: ...o eat take insulin to cover your meal Consider taking a little less since glucose is falling If this is between meals consider eating a snack or fast acting carbohydrates to stay within target and scan again later If you are about to eat take insulin to cover your meal Consider taking a little less since glucose is falling If this is between meals consider doing nothing and scan again later Avoid ...

Страница 73: ...ke insulin to cover your meal Consider taking a little less since glucose is falling quickly If this is between meals consider eating a snack or fast acting carbohydrates to stay within target and scan again later If you are about to eat take insulin to cover your meal Consider taking a little less since glucose is falling quickly If this is between meals consider doing nothing and scan again late...

Страница 74: ...eans When you wake up 350 250 150 50 10pm 2am 6am mg dL 110 Ends in 14 days 7 03am Reader App When you wake up on your first day of wearing a Sensor your current glucose is 110 mg dL There is also the symbol on the screen During the first 12 hours of Sensor wear the symbol will display and you cannot use Sensor values to make treatment decisions during this time Confirm Sensor glucose readings wit...

Страница 75: ...our current glucose is 115 mg dL The graph shows that your glucose is going up and so does the trend arrow Consider what might be causing your glucose to go up and what you might do to prevent a high glucose For example How much insulin should you take before your meal Since you see should you consider taking a little more insulin 69 ...

Страница 76: ...Reader 350 250 150 50 4am 8am 12pm Ends in 3 days 12 00pm mg dL 90 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 70 ...

Страница 77: ... your glucose is still going up and so does the trend arrow Don t take a correction dose within 2 hours of your meal dose This may result in insulin stacking and low glucose Consider what might be causing your glucose to go up and what you might do to prevent a high glucose For example Has the insulin you took for your meal reached its full effect Scan your Sensor again later 71 ...

Страница 78: ...Low Between meals your current glucose is 72 mg dL The Glucose Going Low message tells you that your glucose is projected to be low within 15 minutes Think about what might be causing your glucose to go low Consider eating a snack to stay within target Avoid taking insulin as this can cause low glucose 72 ...

Страница 79: ...m 1pm 5pm Ends in 9 days 5 47pm mg dL 204 After exercising you are feeling shaky sweaty and dizzy symptoms you generally get when you have low glucose But your current glucose is 204 mg dL Anytime you get a reading that doesn t match how you feel do a blood glucose test 73 ...

Страница 80: ...urrent glucose is 134 mg dL The graph shows that your glucose is going down and so does the trend arrow Consider what might be causing your glucose to go down and what you might do to prevent a low glucose For example How much insulin should you take before your meal Since you see should you consider taking a little less insulin 74 ...

Страница 81: ...ore meal glucose is low How much time do you wait to eat after taking your meal insulin Do you adjust the amount of meal insulin based on the number of carbs or how much you are planning to eat Do you adjust your meal insulin dose for high fat foods such as pizza Do you know how to adjust your insulin doses when drinking alcoholic beverages High glucose corrections Do you take extra insulin if you...

Страница 82: ... 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 activities How do you adjust your insulin doses for stress How do you adjust your insulin doses for illness 76 ...

Страница 83: ... example those that have impaired awareness of hypoglycemia or a history of severe hypoglycemia Before you turn alarms off or change their settings please consult your health care professional CAUTION 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 If you are out of range you may not receive gluco...

Страница 84: ...y 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 Low and High Glucose Alarm levels are different from your Target Glucose Range values Low and High Glucose Alarms tell you when your glucose has passed the level you set in the alarm Your Target Glucose Range is displayed on glucose graphs on the...

Страница 85: ...w glucose or high glucose episodes You will see the symbol on the Home screen when the Sensor is not communicating with the Reader Make sure the Signal Loss Alarm is on so you will be notified if your Sensor has not communicated with the Reader for 20 minutes Make sure the Reader s sound and or vibration settings are on and your Reader is near you The Home screen indicates the sound vibration sett...

Страница 86: ... Action 1 From the Home screen touch the Settings symbol Touch Alarms 2 Touch Change Alarm Settings Ends in 14 days Check Glucose Review History 10 23pm Alarms Sound Vibration Time Date Settings 1 4 Change Alarm Settings Alarm Settings Low Glucose 70 mg dL High Glucose 240 mg dL Signal Loss On OK 80 ...

Страница 87: ...lucose Alarm Notifies you when your glucose is below the level you set High Glucose Alarm Notifies you when your glucose is above the level you set Signal Loss Alarm Notifies you when your Sensor is not communicating with the Reader and that you will not receive Low or High Glucose Alarms Low Glucose Alarm High Glucose Alarm Signal Loss Alarm Change Alarm Settings OK 81 ...

Страница 88: ...l 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 Touch done to save On mg dL 70 done Low Glucose Alarm 82 ...

Страница 89: ...ch the slider to turn the alarm off Touch done to save Signal Loss Alarm If the alarm is on you will be notified when your Sensor has not communicated with your Reader for 20 minutes and you are not receiving Low or High Glucose Alarms Touch the slider to turn the alarm off Touch done to save On mg dL 240 done High Glucose Alarm done On Turn On to get notified when the glucose alarms you set are n...

Страница 90: ... Settings Alarm Settings Low Glucose 70 mg dL High Glucose 240 mg dL Signal Loss On 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 84 ...

Страница 91: ...s 2 Touch the sound or vibration setting you would like to change Note These settings apply to the alarms as well as other Reader functions Touch OK to save Ends in 14 days Check Glucose Review History 10 23pm Alarms Sound Vibration Time Date Settings 1 4 High On Off Off Sound Vibration System Sounds Volume Touch Sounds Vibration OK 85 ...

Страница 92: ...press the Home Button to dismiss the alarm and check your glucose You will only receive one alarm per low glucose episode High Glucose Alarm Dismiss Alarm Check Glucose The High Glucose Alarm notifies you if your glucose rises above 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 ...

Страница 93: ...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 Note If you ignore an alarm you will receive it again in 5 minutes if the condition still exists If you receive an alarm while the Reader is connected to a compute...

Страница 94: ...w Glucose Urgent Low Glucose Alarm will be delivered when your glucose goes below 55 mg dL You will receive a visual and audio notification regardless of your phone s sound or Do Not Disturb settings This alarm cannot be turned off or customized Optional Signal Loss Alarm Signal Loss Alarm will be delivered when your Sensor isn t communicating with the App This alarm is turned on by default but it...

Страница 95: ...replaced The App Stopped alarm indicates you have force closed the App You will receive a visual and audio notification regardless of your phone s sound or Do Not Disturb settings These alarms cannot be modified or turned off Please read all the information in this section before setting and using alarms 89 ...

Страница 96: ... your App to make sure it s working properly Glucose alarms you receive do not include your glucose reading so you must scan your Sensor to check your glucose The App will ask for phone permissions which are needed to receive alarms Allow these permissions when requested Check to make sure that you have the correct phone settings and permissions enabled If your phone is not configured properly you...

Страница 97: ...e High Glucose and Signal Loss alarms to ensure you receive audible alarms You should disconnect headphones or speakers from your phone when you are not using them as you may not hear audio for alarms If using headphones keep them in your ears If you are using peripheral devices connected to your phone such as wireless headphones or a smartwatch you may receive alarms on only one device or periphe...

Страница 98: ...Urgent Low 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 Low and High Glucose Alarm levels are different from your Target Glucose Range values Low and High Glucose Alarms tell you when your glucose has passed the level you set in the a...

Страница 99: ...notified if your Sensor has not communicated with the App for 20 minutes If you see symbol you may not receive alarms when the Override Do Not Disturb setting within the App is disabled Confirm your settings are as follows o Allow Notifications is ON o Lock screen or Banner alerts are ON o Notification sounds are ON If alarms are unavailable because of any of these settings you will still be able ...

Страница 100: ...determine your alarm settings Low Glucose Alarm Step Action 1 The Low Glucose Alarm is on by default The alarm level is initially set to 70 mg dL Tap 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 Tap SAVE 2 Choose the sound for this alarm Tap SAVE 94 ...

Страница 101: ...r phone is muted or Do Not Disturb is on Turn OFF if you want the alarm volume to follow your phone s volume setting and be silent with Do Not Disturb setting is enabled The alarm vibration will match your phone System Haptics setting Note You must keep Allow Critical Alerts ON for the App in operating system settings 4 Tap the back button to return to the main alarm settings screen 95 ...

Страница 102: ...sound for this alarm Tap SAVE 3 Override Do Not Disturb for the alarm is on by default Keep Override Do Not Disturb ON if you want the alarm to always play a sound and appear on the lock screen even if your phone is muted or Do Not Disturb is on Turn OFF if you want the alarm volume to follow your phone s volume setting and be silent with Do Not Disturb setting is enabled The alarm vibration will ...

Страница 103: ...en Signal Loss Alarm Step Action 1 If the alarm is on you will be notified when your Sensor has not communicated with the App for 20 minutes and you are not receiving Low or High Glucose Alarms Tap the slider to turn the alarm off 2 Choose the sound for this alarm Tap SAVE 97 ...

Страница 104: ...r phone is muted or Do Not Disturb is on Turn OFF if you want the alarm volume to follow your phone s volume setting and be silent with Do Not Disturb setting is enabled The alarm vibration will match your phone System Haptics setting Note You must Keep Allow Critical Alerts ON for the App in operating system settings 4 Tap the back button to return to the main alarm settings screen 98 ...

Страница 105: ...he alarm and check your glucose You will receive the Urgent Low Glucose alarm every 30 minutes until your glucose reading is at or above 55 mg dL 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 Swipe or tap to dismiss the alarm and check your glucose You will only receive one alarm per ...

Страница 106: ...arm and check your glucose You will only receive one alarm per high glucose episode Notifies you if your Sensor has not communicated with the App for 20 minutes and you are not receiving Urgent Low Low or High Glucose Alarms Signal loss could be caused by the Sensor being too far away from your smartphone over 20 feet or another issue such as an error or problem with your Sensor Swipe or tap to di...

Страница 107: ...t a new Sensor Remove your Sensor and start a new Sensor to check your glucose Swipe or tap to dismiss the alarm Notifies you if your Sensor has ended You will not receive glucose alarms after this time unless you start a new Sensor Remove your Sensor and start a new Sensor to check your glucose Swipe or tap to dismiss the alarm 101 ...

Страница 108: ...be running in the background to receive alarms Tap the alarm to re open the App Note For all alarms except the App Stopped alarm If you ignore an alarm you will receive it again in 5 minutes if the condition still exists Only your most recent alarms will display on your screen 102 ...

Страница 109: ...of your glucose reading or within 15 minutes after your reading was obtained Step Action 1 From the Glucose Reading screen add notes by touching the symbol in the upper right corner of the touchscreen If you do not want to add notes you can press the Home Button to go to the Home screen or hold the Home Button to turn the Reader off 350 250 150 50 236mg dL 6am 10am 2pm Glucose Going High 103 ...

Страница 110: ... note Then touch OK Insulin notes Enter the number of units taken Food notes Enter grams or serving information Note Food and rapid acting insulin notes are shown on your glucose graphs and in your Logbook as symbols 3 Touch OK to save your notes You can review your notes from the Logbook See Reviewing Your History section for more information OK Add Notes 1 4 Rapid Acting Insulin Long Acting Insu...

Страница 111: ...to add After you check the box you can add more specific information to your note Food notes Enter meal type and grams or serving information Insulin notes Enter the number of units taken Exercise notes Enter intensity and duration Note You cannot add a blood glucose result note to a glucose reading See Reviewing Your History section for how to enter blood glucose results in the App s Logbook 105 ...

Страница 112: ...ection for more information about the Logbook To edit a note from the glucose graph tap the symbol and then tap on the information you would like to change Tap DONE when you are finished Food Exercise Insulin Rapid or Long acting Food Insulin Multiple Custom notes indicates different types of notes entered together or notes entered within a short period of time A numbered badge next to the symbol ...

Страница 113: ...ew your past glucose readings notes and other information Reviewing Your History in the Reader Step Action 1 Press the Home Button to turn on the Reader Press the Home Button again to go to the Home screen IMPORTANT Work with your health care professional to understand your glucose history Remember that FreeStyle Libre 2 app and FreeStyle Libre 2 Readers do not share data Check Glucose Scan Sensor...

Страница 114: ...History icon 3 Use the arrows to view the available options Check Glucose Review History 10 23pm Ends in 14 days Logbook Daily Graph Average Glucose Review History 1 2 Daily Patterns Time In Target Low Glucose Events Sensor Usage 108 ...

Страница 115: ...out the symbols see Reader Symbols section Touch the entry to review the detailed information including any Notes you entered You can add or edit change Notes for the most recent Logbook entry provided your glucose reading was within the last 15 minutes and you have not used reporting software to create reports OK Logbook 23 Feb 10 23am 23 Feb 6 37am 22 Feb 11 09pm 143 98 108 mg dL 109 ...

Страница 116: ...e of 40 400 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 For sequential readings above 350 mg dL a line is displayed at 350 mg dL You might see gaps in the graph during times when you have not scanned at least once in 8 hours The symbol may appear indicating the Reader time was changed Gaps in the graph ...

Страница 117: ...ge are blue Daily Patterns A graph showing the pattern and variability of your Sensor glucose over a typical day The thick black line shows the median midpoint of your glucose readings The gray shading represents a range 10 90 percentiles of your Sensor readings Note Daily Patterns needs at least 5 days of glucose data OK Last 7 Days 12 am am am pm pm 6 12 6 12 121 152 134 Average 119 mg dL 69 Ave...

Страница 118: ...ayed above the graph The bar graph displays the low glucose events in four different 6 hour periods of the day Sensor Usage Information about how often you scan your Sensor The Reader reports an average of how many times you scanned your Sensor each day and the percentage of possible Sensor data the Reader recorded from your scans OK 34 54 12 Time In Target Above In Target Below Target Range 80 14...

Страница 119: ...e symbol or use the arrows To add a note to a Logbook entry tap on the entry and then tap the symbol Select your note information and tap DONE To add a note that is independent of a Logbook entry tap the symbol on the main Logbook screen Tap the symbol if you want to add a note on a different date The logbook also allows you to record a blood glucose test you performed To do this tap the symbol an...

Страница 120: ...e range Note Daily Patterns needs at least 5 days of glucose data Time In Target A graph showing the percentage of time your Sensor glucose readings were above below or within your Target Glucose Range Low Glucose Events Information about the number of low glucose events measured by your Sensor A low glucose event is recorded when your Sensor glucose reading is lower than 70 mg dL for longer than ...

Страница 121: ...w orange or red Readings in range are green Daily Graph A graph of your Sensor glucose readings by day The graph shows your Target Glucose Range and symbols for notes you have entered The graph will scale to 400 mg dL to accommodate glucose readings above 350 mg dL You might see gaps in the graph during times when you have not scanned at least once in 8 hours The symbol may appear indicating a tim...

Страница 122: ...entage of possible Sensor data recorded from your scans Note Tap the symbol on any report to share a screenshot of the report Tap the symbol to view a description of the report To view a different report tap the dropdown menu above the report or go to the Main Menu On all reports except the Daily Graph you can select to show information about your last 7 14 30 or 90 days 116 ...

Страница 123: ...rm soapy water or isopropyl alcohol 2 Discard the used Sensor following directions from your health care professional See Maintenance and Disposal section When you are ready to apply a new Sensor follow the instructions in the Applying Your Sensor and Starting Your Sensor sections If you removed your last Sensor before it ended you will be prompted to confirm that you would like to start a new Sen...

Страница 124: ... use Taking action early can keep small problems from turning into larger ones CAUTION If the Sensor is becoming loose or if the Sensor tip is coming out of your skin you may get no readings or unreliable readings which may not match how you feel Check to make sure your Sensor has not come loose If it has come loose remove it apply a new one and contact Customer Service Customer Service is availab...

Страница 125: ...ily Using Reminders in the Reader Step Action 1 Ends in 14 days Check Glucose Review History 10 23pm From the Home screen touch the Settings symbol Scroll down using the arrow and touch Reminders 2 Touch to select which Type of reminder you want to set Check Glucose Take Insulin or Other which is a general reminder to help you remember something Reminders Control Solution Test Language 2 4 cancel ...

Страница 126: ...e touchscreen Touch save 5 From the Reminders screen you can turn the reminder On Off or add new reminders Touch done to return to the Home screen You will get your reminder even if the Reader is turned off Touch OK to dismiss your reminder or snooze to be reminded again in 15 minutes Note Reminders will not appear if the Reader is connected to a computer add new done Reminders 8 30am 12 30pm 00 0...

Страница 127: ...an hear and your smartphone s Do Not Disturb feature is turned off If Do Not Disturb is on you will only see your reminder on the screen Step Action 1 To add a new reminder go to the Main Menu and tap Reminders Tap ADD REMINDER 2 Name your reminder 3 Tap the time fields to set the time for the reminder Note If you would like the reminder to repeat tap the slider to the right You can also select wh...

Страница 128: ...emember to scan your Sensor This Scan Sensor reminder can be changed or disabled but cannot be deleted To turn off a reminder tap the slider to the left To delete a reminder swipe the reminder to the left and tap the symbol The Scan Sensor reminder cannot be deleted Your reminders will be received as notifications that you can swipe or tap to dismiss 122 ...

Страница 129: ...natal blood samples or for the diagnosis or screening of diabetes The FreeStyle Libre 2 Reader s built in meter is indicated for the home lay user in the management of patients with diabetes It is intended to be used by a single person and should not be shared The FreeStyle Precision Neo Blood Glucose Test Strips are for use with the FreeStyle Libre 2 Reader s built in meter to quantitatively meas...

Страница 130: ... how to store and handle the test strips and give you information about sample types 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 built in meter is not for use on neonates in critically ill patients or for diagnosis or screening of diabetes Follow your health ...

Страница 131: ...ected prior to being handled by any person providing testing assistance to the user The Reader is for use by a single person It must not be used on more than one person including other family members due to the risk of spreading infection All parts of the Reader are considered biohazardous and can potentially transmit infectious diseases even after performing the cleaning and disinfection procedur...

Страница 132: ...story options Refer to your lancing device instructions for use for how to use your lancing device 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 pr...

Страница 133: ... 1 Wash your hands with warm soapy water for accurate results Thoroughly dry your hands To warm the site apply a warm dry pad or rub vigorously for a few seconds 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 CAUTION Test on your fingers in accordance with the Intended Use ...

Страница 134: ... test strip immediately after removing from the foil packet 4 Insert the test strip with the three black lines at the end facing up Push the strip in until it stops Note The Reader s built in meter turns off after 2 minutes of inactivity Abbott Diabetes Care Ltd Range Road Witney Oxon OX29 0YL Made in UK Blood Glucose Sensor Electrode Abbott Diabetes Care Ltd Range Road Witney Oxon OX29 0YL Made i...

Страница 135: ... screen while you wait for your result Do not remove the test strip while the butterfly is on the screen If sounds are turned on the Reader beeps once when your result is ready If the butterfly does not appear you may not have applied enough blood to the test strip Apply a second drop of blood to the test strip within 5 seconds of the first drop If the butterfly still does not appear or if more th...

Страница 136: ...for more information 6 After reviewing your result remove and discard the used test strip according to local regulations Your Blood Glucose Results Blood glucose results are marked on the results screen and in the Logbook with the symbol Note Contact your health care professional if you have symptoms that do not match your test results IMPORTANT After performing a blood glucose test wash your hand...

Страница 137: ...cose HI If LO appears on the Reader your result is lower than 20 mg dL If HI appears on the Reader your result is higher than 500 mg dL You can touch the message button for more information Check your blood glucose again with a test strip If you get a second LO or HI result contact your health care professional immediately IMPORTANT The built in meter displays results from 20 500 mg dL Low or high...

Страница 138: ... more information and set a reminder to check your glucose After you get your blood glucose result you can add Notes by touching the symbol If you do not want to add a Note press the Home Button to go to the Home screen or hold the Home Button to turn the Reader off IMPORTANT You should clean and disinfect your Reader once per week Refer to the Maintenance and Disposal section for instructions 132...

Страница 139: ...uilt 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 Accuracy results for all glucose concentrations Difference range between the true blood glucose level and the built in meter result Within 5 mg dL and 5 Within 10 mg dL and 10 Within 15 mg dL and 15 Within 15 mg dL and 20 The number an...

Страница 140: ...t Example open April 15 discard July 15 write the discard date on the side of the bottle The control solution range is a target range for control solution only not for your blood glucose results The control solution test does not reflect your blood glucose level Use only MediSense low medium or high Glucose and Ketone Control Solution with the Reader s built in meter Check that the LOT number prin...

Страница 141: ...e 3 Open the foil test strip packet at the notch and tear down to remove the test strip Ends in 14 days Check Glucose Review History 10 23pm Reminders Control Solution Test Language 2 4 Abbott Diabetes Care Ltd Range Road Witney Oxon OX29 0YL Made in UK Blood Glucose Sensor Electrode Abbott Diabetes Care Ltd Range Road Witney Oxon OX29 0YL Made in UK 4 C 135 ...

Страница 142: ...uilt in meter turns off after 2 minutes of inactivity 5 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 If sounds are turned on the Reader beeps once to let you know that you have applied enough control solution Apply Control Solution 136 ...

Страница 143: ... 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 If the butterfly still does not appear or if more than 5 seconds have passed discard the test strip Turn off the Reader and repeat the steps in this section with a new test strip 13...

Страница 144: ...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 Stop using the built in meter if the control solution results are repeatedly outside of the printed range Contact Customer Service Customer Service is available at 1 855 632 8658 7 Days a Week from 8AM to 8PM Eastern Standard Time 100 mg dL 10 23pm Cont...

Страница 145: ...d 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 139 ...

Страница 146: ... before going to sleep and when you wake up because your Sensor holds only 8 hours of data at a time For example if you sleep for 9 hours without scanning your Sensor 1 hour of data will not be collected and a gap will appear on your glucose graph Place your device nearby so you will receive alarms and any reminders you have set 140 ...

Страница 147: ...andards 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 Sensor to The effect of these scanners has not been evaluated and the exposure may damage the Sensor or cause inaccurate results To avoid removing your Sensor you may request another type of screening If you do choose to go th...

Страница 148: ...may appear on your glucose graph indicating a time change Gaps in the graph may result or glucose readings may be hidden 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 Charging the Reader A fully charged Reader battery should last up to 4 days Your battery life may vary depending on your usa...

Страница 149: ...at allows the power adapter to be easily unplugged Don t block access to the charger due to the potential risk of electrical shock The maximum surface temperature of the Reader and or the power adapter could go as warm as 120 F when it s charging or 117 F during normal use Under these conditions do not hold the Reader or the power adapter for five minutes or more People with disorders of periphera...

Страница 150: ...battery is low to keep using the Reader To fully charge the battery charge the Reader for at least 3 hours Only use the USB cable and power adapter included with the system Fully charge your Reader before storing it for more than 3 months 144 ...

Страница 151: ...d 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 Step Action 1 To get to the Settings menu touch the Settings symbol on the Home screen Ends in 14 days Check Glucose Review History 10 23pm Alarms Sound Vibration Time Date Settings 1 4 145 ...

Страница 152: ...on Test Perform a control solution test Language Change the language on the Reader System Status Check Reader information and performance View System Information The Reader will display information about your System including Current Sensor end date and time Reader serial number and version number Serial numbers and status codes of most recent Sensors up to three Sensor version for most recent Sen...

Страница 153: ...tions are working and the Touchscreen is responding when touched Report Settings Work with your health care professional to set your Target Glucose Range which is displayed on glucose graphs on the Reader and used to calculate your Time In Target Your Target Glucose Range is not related to your alarm settings Reader Basics Review the information screens shown during the Reader setup Dose Increment...

Страница 154: ...ot set glucose alarm levels Tap SAVE when you are done Carbohydrate Units Choose grams or servings for food notes that you enter Tap SAVE when you are done Text to Speech Turn on Text to Speech to have the glucose reading read aloud when you scan the Sensor You will hear only your current glucose value and trend arrow direction Additional information such as the glucose graph and any message is av...

Страница 155: ...an connect with to share your data To connect your data with apps listed in the Connected Apps option select them from the list of apps and follow the onscreen instructions Help View in app tutorials access the product labeling and review the App s legal information You can also view the Event Log which is a list of events recorded by the App This may be used by Customer Service to help troublesho...

Страница 156: ...uld also be cleaned and disinfected prior to being handled by any person providing testing assistance to the user Cleaning is the physical removal of organic soil from the Reader surfaces Keeping the Reader clean helps ensure that it is working properly and that no dirt gets in the device Cleaning allows for successful subsequent disinfection Disinfection is a process that destroys pathogens such ...

Страница 157: ...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 151 ...

Страница 158: ...tailers 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 See References section for more information Step Action 1 Turn off the Reader before you clean and disinfect it 2 Clean the outside surfaces of the Reader with a bleach wipe until vi...

Страница 159: ...ces 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 5 When finished thoroughly wash your hands with soap and water 153 ...

Страница 160: ...no serviceable parts Disposal This product should be disposed of in accordance with all applicable local regulations related to the disposal of electronic equipment batteries sharps and materials potentially exposed to body fluids Contact Customer Service for further information on the appropriate disposal of system components Customer Service is available at 1 855 632 8658 7 Days a Week from 8AM ...

Страница 161: ...ORTANT If you are having issues with the App please keep in mind that uninstalling the App will cause you to lose all historical data and end the Sensor currently in use Please call Customer Service if you have any questions Customer Service is available at 1 855 632 8658 7 Days a Week from 8AM to 8PM Eastern Standard Time 155 ...

Страница 162: ...is too low Charge the Reader Reader is outside of its operating temperature range Move the Reader to a temperature between 50 F and 113 F and then try to power it on If the Reader still does not power on after trying these steps contact Customer Service Customer Service is available at 1 855 632 8658 7 Days a Week from 8AM to 8PM Eastern Standard Time 156 ...

Страница 163: ...Consider shaving the site avoiding use of lotions prior to insertion and applying the Sensor to your non dominant arm 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 You may be sensitive to the adhesive material If the irritation is where the adhesive touches skin contact your healt...

Страница 164: ...ntil the Sensor start up period has completed Scan Timeout Reader only 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 Customer Service 1 855 632 8658 7 Days a Week from 8AM to 8PM Eastern Standard Time 158 ...

Страница 165: ...gnal Loss Alarm shows again after scanning your Sensor contact Customer Service New Sensor Found You scanned a new Sensor before your previous Sensor ended Your device can only be used with one Sensor at a time If you start a new Sensor you will no longer be able to scan your old Sensor If you would like to begin using the new Sensor select Yes and scan again Customer Service 1 855 632 8658 7 Days...

Страница 166: ...lectromagnetic interference Sensor Error The Sensor 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 Customer Servic...

Страница 167: ...or Already in Use The Sensor was started by another device Both the Reader and App 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 you see Check Sensor again your Sensor was not applied properly Apply and start a new Sensor Cu...

Страница 168: ...in a few minutes Sensor Too Cold Your Sensor is too cold to provide a glucose reading Move to a location where the temperature is appropriate and scan again in a few minutes Enable Bluetooth Bluetooth was turned off Follow the instructions on the screen to turn Bluetooth on You will not be able to use the App to check your glucose or start a new Sensor until Bluetooth is turned on Customer Service...

Страница 169: ...on is turned on Allow Access to Critical Alerts Access to Critical Alerts was disabled Follow the instructions on the screen to allow permission for Critical Alerts You will not be able to use the App to check your glucose or start a new Sensor until the permission is allowed Unexpected Application Error The App has detected an unexpected error Shut down the App completely and restart Customer Ser...

Страница 170: ...estions about compatibility call Customer Service Problems Receiving Alarms Problem What It May Mean What To Do You are not receiving alarms You have turned alarms off If using the Reader touch the Settings symbol and then select Alarms If using the App go to the main menu and then select Alarms Customer Service 1 855 632 8658 7 Days a Week from 8AM to 8PM Eastern Standard Time 164 ...

Страница 171: ... see the symbol at the top of the Home screen if using the Reader and the symbol at the top of the screen if using the App when your Sensor has not communicated with your device in 5 minutes If the Signal Loss Alarm is on you will be notified if there has been no communication for 20 minutes Try scanning your Sensor If the Signal Loss Alarm is on and shows again after scanning your Sensor contact ...

Страница 172: ... is turned off in your phone settings Bluetooth App access to Bluetooth Allow Critical Alerts Notifications Lock screen or Banner alerts Notification sounds or general phone sounds or vibration Check to make sure that you have the correct settings and permissions enabled on your phone to receive alarms Go to Setting App Alarms section for more information Customer Service 1 855 632 8658 7 Days a W...

Страница 173: ...er 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 Customer Service 1 855 632 8658 7 Days a Week from 8AM to 8PM Eastern Standard Time 167 ...

Страница 174: ...larms on only one device or peripheral not all Disconnect headphones or peripherals when you are not using them You have closed the App Make sure the App is always open in the background Your device s battery is dead Charge your device If using the Reader use the included USB cable Customer Service 1 855 632 8658 7 Days a Week from 8AM to 8PM Eastern Standard Time 168 ...

Страница 175: ...ng 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 If the error reappears contact Customer Service E 2 Reader error 1 Turn off the Reader 2 Repeat the test using a new test strip 3 If the error reappears contact Customer Service Customer Service 1 855 632 8658 7 Day...

Страница 176: ...st using a new test strip 3 If the error reappears contact Customer Service E 4 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 If the error reappears contact your health care professional immediately Customer Service 1 855 632 8658 7 Days a Week from 8AM to 8PM Eastern Standard Time 170 ...

Страница 177: ...vice E 6 The test strip may not be compatible with the Reader 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 Customer Service 1 855 632 8658 7 Days a Week from 8AM to 8PM Eastern Stan...

Страница 178: ...tructions 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 E 9 Reader error 1 Turn off the Reader 2 Repeat the test using a new test strip 3 If the error reappears contact Customer Service Customer Service 1 855 632 8658 7 Days a Week from 8AM to 8PM Eastern Standard Time 172 ...

Страница 179: ...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 Insert a new FreeStyle Precision Neo test strip Reader is outside of its operating temperature range Move the Reader to a temperature between 50 F and 113 F and then try to power it on Customer ...

Страница 180: ...till 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 Problem with Reader or test strip 1 Repeat the test using a new test strip 2 If the test still does not start contact Customer Service Customer Service 1 855 632 8658 7 Days a W...

Страница 181: ...ader Test Note The Reader Test will perform internal diagnostics and will allow you to check that the display sounds and touchscreen are working properly Customer Service Customer Service is available to answer any questions you may have about your System Customer Service is available at 1 855 632 8658 7 Days a Week from 8AM to 8PM Eastern Standard Time System Info Reader Test Event Log System Sta...

Страница 182: ...onal specifications Sensor Specifications Sensor glucose assay method Amperometric electrochemical sensor Sensor glucose reading range 40 to 400 mg dL Sensor size 5 mm height and 35 mm diameter Sensor weight 5 grams Sensor power source One silver oxide battery Sensor data Up to 14 days 176 ...

Страница 183: ... temperature 36 F to 82 F Operating and storage relative humidity 10 90 non condensing Sensor water resistance and ingress protection IP27 Can withstand immersion into 3 ft one meter of water for up to 30 minutes Protected against insertion of objects 12 mm diameter Operating and storage altitude 1 250 ft 381 meters to 10 000 ft 3 048 meters Radio Frequency 2 402 2 480 GHz BLE GFSK 0dBm EIRP 177 ...

Страница 184: ...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 178 ...

Страница 185: ...ters Reader display timeout 60 seconds 120 seconds when test strip is inserted Radio Frequency Near Field Communication 13 56 MHz RFID ASK Modulation 124 dBuV m 1 5 inch communication range 2 402 2 480 GHz BLE GFSK 2dBm EIRP Data port Micro USB Minimum Computer Requirements System must only be used with EN60950 1 rated computers Mean use life 3 years of typical use 179 ...

Страница 186: ...lt to interfere with or intercept during transmission The transmitted data is protected by a proprietary data format encryption and memory map The integrity of transmitted data is ensured by a cyclic redundancy check CRC generated by the Sensor and verified by the Reader The communication between the Reader and Sensor for Alarm data is a standard Bluetooth Low Energy BLE connection The pairing of ...

Страница 187: ...g activation with an authenticated login procedure that uses an Out of band key exchange NFC This prevents unauthorized devices from connecting to the Sensor The transmitted data is protected by a proprietary data format and encryption This prevents unauthorized devices from accessing the data if they are within range and intercept the transmission Under normal operation the industry standard BLE ...

Страница 188: ...effectiverangeof1cmbetweentheSensorandphone QoSfortheFreeStyleLibre2 app and Sensor wireless communications using BLE is assured at regular 1 minute intervals If connection is lost between the App and Sensor for 5 minutes the alarms unavailable symbol displays If connection is lost for 20 minutes the App alarms the user if the alarm is turned on If connection is lost between the Sensor and the App...

Страница 189: ...cturer Serial number Batch code Keep dry Type BF applied part Non ionizing radiation CODE Sensor code Caution Do not re use Sterilized using irradiation MR unsafe Humidity limitation Contains FCC ID N6C SXSDCAG IC 4908B SXSDCAG FCC Declaration of Conformity mark Do not use if package is damaged 183 ...

Страница 190: ... 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 184 ...

Страница 191: ... study The Adult study was conducted at 5 centers with 146 subjects in total 91 1 Type 1 8 9 Type 2 all aged eighteen and older Subjects had their venous blood glucose analyzed over three separate visits to the clinical center Each visit lasted up to ten hours 144 subjects were analyzed during the beginning of the Sensor wear period day 1 2 or 3 91 subjects were analyzed during the early middle pe...

Страница 192: ... by comparing paired System Glucose Measurement CGM and YSI blood glucose values The percentage of total System readings that were within 20 mg dL forYSI blood glucose values 70 mg dL or 20 ofYSI for blood glucose values 70 mg dL is displayed in Table 1a The Mean Absolute Relative Difference MARD gives an indication of the average percent disagreement between the CGM and the reference For example ...

Страница 193: ... measurements The accuracy of different CGM glucose ranges versusYSI reference was assessed by calculating the percentage of System readings that were within 15 20 and 40 for reference values 70 mg dL and within 15 mg dL 20 mg dL and 40 mg dL for values 70 mg dL For blood glucose values 70 mg dL the difference in mg dL between the CGM andYSI blood glucose values was calculated For values 70 mg dL ...

Страница 194: ... mg dL Percent Within 20 mg dL Percent Within 40 mg dL Percent Within 15 Percent Within 20 Percent Within 40 Mean bias mg dL MARD 54 518 85 9 93 8 99 4 6 4 13 8 54 69 3012 89 5 94 2 99 1 3 3 10 8 70 180 7785 76 5 86 6 99 2 4 8 10 6 181 250 3037 89 1 95 0 99 9 10 1 7 8 250 4383 94 0 97 9 100 0 6 3 6 1 System range is 40 400 mg dL 188 ...

Страница 195: ...40 mg dL Percent Within 15 Percent Within 20 Percent Within 40 Mean bias mg dL MARD 54 139 71 9 79 1 97 1 9 9 17 1 54 69 863 86 4 90 5 97 1 4 9 12 0 70 180 2690 77 4 87 6 98 7 3 4 10 6 181 250 1236 86 0 94 7 99 7 8 9 8 3 250 1618 92 2 97 7 99 8 2 2 7 2 Includes children 6 17 years of age NoYSI measurements were obtained for children 4 5 years of age System range is 40 400 mg dL 189 ...

Страница 196: ...cent Within 15 mg dL Percent Within 20 mg dL Percent Within 40 mg dL Percent Within 15 Percent Within 20 Percent Within 40 Mean bias mg dL MARD 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 7 99 7 8 0 8 0 250 4826 90 9 95 9 99 7 11 8 6 9 190 ...

Страница 197: ...rcent Within 40 mg dL Percent Within 15 Percent Within 20 Percent Within 40 Mean bias mg dL MARD 54 131 93 9 98 5 100 0 6 6 14 2 54 69 751 96 5 98 8 100 0 1 0 9 3 70 180 2743 74 3 84 8 98 0 3 0 11 4 181 250 1104 86 6 92 9 99 0 3 9 8 4 250 1817 90 2 97 5 99 9 10 2 7 6 Includes children 6 17 years of age NoYSI measurements were obtained for children 4 5 years of age 191 ...

Страница 198: ...as LO YSI glucose values were less than 50 mg dL 20 0 of the time less than 60 mg dL 40 0 of the time less than 70 mg dL 40 0 of the time less than 80 mg dL 80 0 of the time and equal to or above 80 mg dL 20 0 of the time Table 2a Concurrence Analysis with LO CGM Reading Adult n 144 CGM Reference Pairs YSI mg dL N 50 60 70 80 80 n 1 2 2 4 1 5 Cumulative 20 0 40 0 40 0 80 0 20 0 Table 2b Concurrenc...

Страница 199: ...of the time above 250 mg dL 100 0 of the time and less than or equal to 250 mg dL 0 0 of the time Table 2c Concurrence Analysis with HI CGM Reading Adult n 144 CGM Reference Pairs YSI mg dL N 350 300 250 250 n 118 121 121 0 121 Cumulative 97 5 100 0 100 0 0 0 Table 2d Concurrence Analysis with HI CGM Reading Pediatric n 129 CGM Reference Pairs YSI mg dL N 350 300 250 250 n 40 43 45 0 45 Cumulative...

Страница 200: ... and 3b and for eachYSI range in Tables 3c and 3d Forexample intheAdultstudy whentheSystemglucosereadingswerewithinthe81to 120mg dLrange actualbloodglucosevalueswerebetween40and60mg dL0 2 ofthetime between61and80mg dL11 0 ofthetime between81and120mg dL70 1 ofthetime between121and160mg dL17 8 ofthetime between161and200mg dL0 8 ofthetime and between201and250mg dL0 1 ofthetime 194 ...

Страница 201: ...0 40 0 20 0 5 40 60 0 4 52 9 43 3 3 3 0 1 1889 61 80 18 9 62 7 18 1 0 4 0 0 3090 81 120 0 2 11 0 70 1 17 8 0 8 0 1 3040 121 160 0 1 9 1 69 9 18 9 1 6 0 3 0 2 2407 161 200 10 6 60 6 26 9 1 6 0 3 1745 201 250 7 0 65 5 25 6 1 9 0 1 2181 251 300 0 1 8 4 66 9 22 7 1 8 0 1 2327 301 350 0 4 13 6 68 8 16 0 1 2 1522 351 400 0 6 27 5 63 3 8 6 534 400 2 5 62 8 34 7 121 Levels out of System dynamic range 195 ...

Страница 202: ... 61 80 12 1 61 9 24 3 1 7 915 81 120 0 2 11 2 69 0 18 2 1 3 0 1 1006 121 160 11 4 71 0 15 8 1 8 868 161 200 0 1 18 2 61 3 20 1 0 3 703 201 250 0 2 9 6 55 3 33 6 1 2 0 1 909 251 300 0 1 14 1 60 8 23 7 1 3 818 301 350 0 3 24 8 58 2 16 5 0 2 593 351 400 1 0 0 5 33 8 59 4 5 3 207 400 4 4 6 7 33 3 55 6 45 Includes children 6 17 years of age NoYSI measurements were obtained for children 4 5 years of age...

Страница 203: ... 5 8 40 60 0 1 62 9 36 6 0 4 1591 61 80 0 1 26 4 62 6 10 8 0 1 3093 81 120 0 0 2 1 18 8 71 7 7 3 2971 121 160 0 5 22 3 69 6 7 7 2418 161 200 0 1 0 1 1 5 26 9 62 5 9 0 0 1 1694 201 250 0 1 1 8 21 9 66 8 9 1 0 3 2139 251 300 0 3 1 2 23 7 66 0 8 8 0 1 2359 301 350 0 3 0 3 2 3 29 8 58 9 8 3 0 2 1777 351 400 0 3 6 1 34 7 48 1 10 8 703 400 1 9 16 7 42 6 38 9 108 Levels out of System dynamic range 197 ...

Страница 204: ...1 24 8 62 6 12 5 904 81 120 3 9 21 0 65 7 9 4 0 1 1057 121 160 0 3 1 7 19 3 65 0 13 5 0 2 948 161 200 1 9 20 4 64 2 13 0 0 1 0 3 671 201 250 0 1 2 1 18 1 64 7 14 8 0 3 778 251 300 0 2 32 0 52 1 15 4 0 1 0 2 954 301 350 1 8 31 1 55 4 11 2 0 5 623 351 400 0 4 4 4 39 5 49 6 6 0 248 400 2 7 29 7 67 6 37 Includes children 6 17 years of age NoYSI measurements were obtained for children 4 5 years of age ...

Страница 205: ...67 1 of the time changing slowly upward 0 to 1 mg dL min 19 7 of the time rising 1 to 2 mg dL min 2 6 of the time and were rising quickly 2 mg dL min 1 2 of the time Digitally connected systems which do not utilize the System s trend arrow calculations may see different glucose rate of change accuracy Table 4a Concurrence Analysis by Glucose Rate of Change Adult n 144 CGM mg dL min YSI mg dL min N...

Страница 206: ... h 0 9 4 2 15 0 29 7 50 2 448 Includes children 6 17 years of age NoYSI measurements were obtained for children 4 5 years of age Alarm Performance The tables in this section 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 ...

Страница 207: ...d the alarm issued within 15 minutes before or after the glucose event MissedDetectionRate Tells you When you were low did you miss a low glucose alarm Definition Percentage of time blood glucose was below the alarm level and the alarm didn t issue within 15 minutes before or after the glucose event For example the Adult study found that for a Low Glucose alarm level set to 70 mg dL 86 0 of the ti...

Страница 208: ...8 7 4753 97 3 2 7 90 41299 93 6 6 4 5591 98 5 1 5 Table 5b Low Glucose Alarm Performance Pediatric n 129 Low Glucose Alarm level mg dL Alarm Rate Detection Rate Number of Events n True Alarm Rate False Alarm Rate Number of Events n Correct Detection Rate Missed Detection Rate 60 2780 62 9 37 1 373 87 4 12 6 70 6363 80 3 19 7 963 93 5 6 5 80 9747 85 6 14 4 1318 96 4 3 6 90 12550 92 2 7 8 1656 97 3 ...

Страница 209: ...e Definition Percentage of time the alarm issued and blood glucose was not above the alarm level within 15 minutes before or after the alarm DetectionRate Tells you When you were high did you get a high glucose alarm Definition Percentage of time blood glucose was above the alarm level and the alarm issued within 15 minutes before or after the glucose event MissedDetectionRate Tells you When you w...

Страница 210: ...ucose alarm was appropriately issued but 2 9 of the time the glucose event was missed and no alarm was issued Table 5c High Glucose Alarm Performance Adult n 144 High Glucose Alarm level mg dL Alarm Rate Detection Rate Number of Events n True Alarm Rate False Alarm Rate Number of Events n Correct Detection Rate Missed Detection Rate 120 105544 99 1 0 9 11417 98 2 1 8 140 93574 99 1 0 9 10152 98 1 ...

Страница 211: ... Accuracy OverTime The Sensor can be worn for up to 14 days The percentage of System readings withinYSI values and the Mean Absolute Relative Difference MARD is presented for the following different wear periods in Tables 6a and 6b Beginning Adult 144 Subjects Day 1 2 or 3 Pediatric 48 Subjects Day 1 or 2 Early Middle Adult 91 Subjects Day 7 or 8 Pediatric 50 Subjects Day 7 or 8 Late Middle Adult ...

Страница 212: ... 8 86 8 93 4 99 7 End 3755 9 1 86 4 92 9 100 0 Table 6b Sensor Accuracy Relative toYSI over the wear duration Pediatric n 129 Wear Period Number of CGM reference pairs MARD Within 15 15 mg dL Within 20 20 mg dL Within 40 40 mg dL Beginning 1828 10 7 79 6 88 5 98 6 Early Middle 1642 8 0 89 5 94 2 98 5 Late Middle 1534 9 7 83 6 92 9 99 5 End 1542 10 2 82 6 91 1 99 3 Includes children 6 17 years of a...

Страница 213: ...hat the Sensors did not function as intended and presented the user with a Replace Sensor message In the Pediatric study 78 1 of the Sensors lasted until the final day of use 3 Sensors 2 2 had early sensor shut off where the Sensor algorithm detected that the Sensors did not function as intended and presented the user with a Replace Sensor message Tables 7a and 7b display the data for each day in ...

Страница 214: ...erWear Duration Adult n 146 Day ofWear Number of Sensors Survival Rate 1 145 99 3 2 142 97 3 3 140 95 9 4 137 93 8 5 134 91 8 6 133 91 1 7 132 90 4 8 127 87 0 9 123 84 9 10 119 82 2 11 112 77 3 12 111 76 6 13 104 71 8 14 100 71 1 208 ...

Страница 215: ...Wear Duration Pediatric n 139 Day ofWear Number of Sensors Survival Rate 1 137 98 6 2 136 97 8 3 134 97 1 4 133 96 4 5 133 96 4 6 133 96 4 7 133 96 4 8 131 94 9 9 126 91 3 10 124 89 9 11 122 88 4 12 120 87 0 13 114 83 4 14 104 78 1 209 ...

Страница 216: ...time Tables 8a and 8b show the glucose reading capture rate for each day of the wear duration Table 8a Glucose Reading Capture Rate OverWear Duration Adult n 146 Day ofWear Number of Sensors Capture Rate 1 146 98 3 2 145 98 1 3 143 98 3 4 140 98 3 5 138 98 4 6 135 98 3 7 134 98 4 8 131 98 4 9 128 98 4 10 123 98 4 11 120 98 4 12 113 98 5 13 112 98 5 14 104 98 6 210 ...

Страница 217: ... OverWear Duration Pediatric n 139 Day ofWear Number of Sensors Capture Rate 1 139 94 6 2 137 94 9 3 136 95 2 4 133 95 3 5 134 95 5 6 133 95 6 7 133 96 0 8 133 95 9 9 130 95 7 10 125 95 6 11 125 95 6 12 122 95 8 13 119 95 9 14 116 95 8 211 ...

Страница 218: ... was 8 2 with CV of 5 8 Paired absolute difference PAD is a measurement of absolute difference in mg dL between paired CGM readings while PARD is the absolute relative difference in between paired CGM readings Table 9a Overall between Sensor Precision Adult n 146 Coefficient of Variation Paired Absolute Difference mg dL Paired Absolute Relative Difference Number of Paired Readings Adults ages 18 5...

Страница 219: ...ascorbic acid per day may affect the Sensor readings which could cause you to miss a severe low glucose event Ascorbic acid can be found in supplements including multivitamins Some supplements including cold remedies such as Airborne and Emergen C may contain high doses of 1000 mg of ascorbic acid and should not be taken while using the Sensor See your health care professional to understand how lo...

Страница 220: ...c acid was then given and study subjects were followed for 4 more hours After the second dose of ascorbic acid the maximum average sensor bias increased with minimal change in sensor bias after the third dose suggesting that saturation had occurred by the second 1000 mg dose of ascorbic acid The maximum average sensor bias after the three 1000 mg doses of ascorbic acid was less than 20 mg dL 214 ...

Страница 221: ...emissions or decreased electromagnetic immunity of the System and result in improper operation The System should not be used adjacent to or stacked with other equipment and that if adjacent or stacked use is necessary the System should be observed to verify normal operation in the configuration in which it will be used The device complies with part 15 of the FCC Rules Operation is subject to the f...

Страница 222: ...oup 1 The System uses RF energy only for its internal function Therefore its RF emissions are very low and are not likely to cause any interference in nearby electronic equipment RF emissions CISPR 11 Class B The System is suitable for use in all establishments including domestic establishments and those directly connected to the public low voltage power supply network that supplies buildings used...

Страница 223: ...ectrostatic discharge ESD IEC 61000 4 2 8 kV contact 15 kV air 8 kV contact 15 kV air Floors should be wood concrete or ceramic tile If floors are covered with synthetic material the relative humidity should be at least 30 Electrical fast transient burst IEC 61000 4 4 2 kV for power supply lines 100kHz frequency 1 kV for signal lines 100kHz frequency 2 kV for power supply lines 100kHz frequency 1 ...

Страница 224: ...y input lines IEC 61000 4 11 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 0 UT 250 300 cycle 0 UT 0 5 cycle At 0 45 90 135 180 225 270 and 315 0 UT 1 cycle and 70 UT 25 30 cycles Single phase at 0 0 UT 250 300 cycle Mains power quality should be that of a typical domestic commercial or hospital environment If the user of the System require...

Страница 225: ... Power frequency 50 60 Hz magnetic field IEC 61000 4 8 30 A m 30 A m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical domestic commercial or hospital environment NOTE UT is the a c mains voltage prior to application of the test level 219 ...

Страница 226: ...A Proximity fields from RF wireless communications equipment IEC 61000 4 3 See table on next page Compliance to the tested levels Portable RF communications equipment including peripherals such as antenna cables and external antennas should be used no closer than 30 cm 12 inches to any part of the System including cables specified by Abbott Diabetes Care Otherwise degradation of the System could r...

Страница 227: ...ere the System may be used Test frequency MHz Band a MHz Service a Modulation b Maximum power W Distance m IMMUNITY TEST LEVEL V m 385 380 390 TETRA 400 Pulse modulation b 18 Hz 1 8 0 3 27 450 430 470 GMRS 460 FRS 460 FM c 5 kHz deviation 1 kHz sine 2 0 3 28 710 704 787 LTE Band 13 17 Pulse modulation b 217 Hz 0 2 0 3 9 745 780 810 800 960 GSM 800 900 TETRA 800 iDEN 820 CDMA 850 LTE Band 5 Pulse m...

Страница 228: ... WLAN 802 11 b g n RFID 2450 LTE Band 7 Pulse modulation b 217 Hz 2 0 3 28 5240 5100 5800 WLAN 802 11 a n Pulse modulation b 217 Hz 0 2 0 3 9 5500 5785 a For some services only the uplink frequencies are included b The carrier shall be modulated using a 50 duty cycle square wave signal c As an alternative to FM modulation 50 pulse modulation at 18 Hz may be used because while it does not represent...

Страница 229: ...M radio broadcast andTV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength in the location in which the System is used exceeds the applicable RF compliance level above the System should be observed to verify normal operation If abnormal pe...

Страница 230: ...re is licensed under the SIL Open Font License Version 1 1 This license is copied below and is also available with a FAQ at http scripts sil org OFL SIL OPEN FONT LICENSE Version 1 1 26 February 2007 PREAMBLE The goals of the Open Font License OFL are to stimulate worldwide development of collaborative font projects to support the font creation efforts of academic and linguistic communities and to...

Страница 231: ...ed and unmodified copies of the Font Software subject to the following conditions 1 Neither the Font Software nor any of its individual components in Original or ModifiedVersions may be sold by itself 2 Original or ModifiedVersions 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 b...

Страница 232: ...SCLAIMER THE FONT SOFTWARE IS PROVIDED AS IS WITHOUTWARRANTY OF ANY KIND EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITEDTO ANYWARRANTIES OF MERCHANTABILITY FITNESS FOR A PARTICULAR PURPOSE AND NONINFRINGEMENT OF COPYRIGHT PATENT TRADEMARK OR OTHER RIGHT IN NO EVENT SHALLTHE COPYRIGHT HOLDER BE LIABLE FOR ANY CLAIM DAMAGES OR OTHER LIABILITY INCLUDING ANY GENERAL SPECIAL INDIRECT INCIDENTAL OR CONSEQU...

Страница 233: ...ment may be a different model or type Abbott may require as a condition of obtaining limited warranty service that you return the Reader postage prepaid with proof of purchase to an address specified by Abbott The Limited Warranty on the replacement Reader will expire on the date of the original Limited Warranty expiration or 90 days after the shipment of a replacement Reader whichever period is l...

Страница 234: ...ing out of or in connection with it shall be governed by and construed in accordance with the laws of Delaware Some states do not allow limitations on how long an implied warranty lasts or the exclusion or limitation of incidental or consequential damages so the above limitations or exclusions may not apply to you Your Rights Under State Law This Limited Warranty gives you specific legal rights an...

Страница 235: ...ttp 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 www cdc gov injectionsafety Fingerstick DevicesBGM html 3 American Diabetes Association 2019 2 Classification and Diagnosis of Diabetes Standards of Medical Care in Diabetes 2019 Diabetes Care 42 Supple...

Страница 236: ...ks are marks of Abbott Other trademarks are the property of their respective owners Patent www abbott com patents Distributed by Abbott Diabetes Care Inc 1360 South Loop Road Alameda CA 94502 USA Customer Service 1 855 632 8658 7 Days aWeek from 8AM to 8PM Eastern StandardTime www FreeStyleLibre com Manufacturer 257 ...

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