eversense CGM Sensor User Manual Download Page 201

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199

Eversense CGM User Guide

Symbol

Explanation

Consult accompanying documents

Caution, consult accompanying
documents

Use by

Manufacturer

Date of manufacture

Storage temperature limits

Lot number

Universal Serial Bus (USB)

Part number

Symbol

Explanation

Serial number

Type BF Applied Part

Non-ionizing electromagnetic
radiation

Not made with natural rubber latex

FCC ID is assigned to all devices
subject to certification

Non-sterile

Magnetic Resonance Imaging (MRI)
procedures are contraindicated for
the smart transmitter
No known hazards for leaving the
sensor inserted in use with MR
with a static magnetic field of 1.5T
or 3.0T

Symbols on Packaging and Devices

LBL-1602-01-001 Rev N_Eversense User Guide_mgdL_R1.indd 199

2/26/20 1:00 PM

Summary of Contents for CGM Sensor

Page 1: ...Eversense Continuous Glucose Monitoring System Mobile App Smart Transmitter Sensor LBL 1602 01 001 Rev N_Eversense User Guide_mgdL_R1 indd 1 LBL 1602 01 001 Rev N_Eversense User Guide_mgdL_R1 indd 1 2...

Page 2: ...LBL 1602 01 001 Rev N_Eversense User Guide_mgdL_R1 indd 2 LBL 1602 01 001 Rev N_Eversense User Guide_mgdL_R1 indd 2 2 26 20 12 58 PM 2 26 20 12 58 PM...

Page 3: ...Eversense App and the Eversense logo are trademarks of Senseonics Incorporated Other brands and their products are trademarks or registered trademarks of their respective holders LBL 1602 01 001 Rev N...

Page 4: ...tep 1 Download and Install the App 24 Step 2 Set up the App Account Creation Pairing and Settings 25 4 Inserting and Linking the Sensor 32 5 Using the Smart Transmitter 35 Daily Use 36 Secure the Smar...

Page 5: ...Setting Temporary Profile 85 Logging out 88 9 Alert Descriptions 89 Alerts and Notifications 89 Alert History 91 Alert Descriptions and Actions 93 10 Event Log 109 Glucose 111 Meals 112 Insulin 113 H...

Page 6: ...Study Performance 169 Eversense Accuracy to YSI in PRECISION Study 171 Sensor Life 188 Safety 190 20 Technical Specifications 191 Sensor 191 Smart Transmitter 192 Power Supply and Charger 193 USB Cab...

Page 7: ...the mobile app will stop displaying non critical alerts and the smart transmitter will stop providing vibratory notifications for non critical alerts Critical alerts will still be provided Many mobile...

Page 8: ...ems like the Eversense CGM System mmol L Millimoles per liter a unit of measure that shows the concentration of a substance in a specific amount of fluid In many countries glucose test results are rep...

Page 9: ...h please visit www eversensediabetes com Congratulations on having Eversense CGM technology to assist you in managing your diabetes Your Eversense CGM System is intended to continually measure glucose...

Page 10: ...els are then calculated by the smart transmitter and sent to the app Eversense Smart Transmitter The removable smart transmitter is worn externally over the sensor and powers the sensor It wirelessly...

Page 11: ...g you do not understand in this User Guide please consult your health care provider For product questions contact Senseonics Customer Support Disposable adhesive patches for daily use are also include...

Page 12: ...transmitter and mobile device Replace the adhesive patch on your smart transmitter daily You can remove the smart transmitter from the upper arm at any time except during calibration Remember that no...

Page 13: ...art transmitter even when mobile device is not nearby Provides readings within 40 400 mg dL range every 5 minutes Trend arrows that show whether your glucose values are rising or falling and how fast...

Page 14: ...d from time to time and are posted at www eversensediabetes com Jailbroken Devices DO NOT use the Eversense Apps on jailbroken iPhones or iPods Jailbroken devices do not provide an acceptable level of...

Page 15: ...um spatial field gradient of 2000 gauss cm 20 T m Maximum MR system reported whole body averaged specific absorption rate SAR of 4 W kg First Level Controlled Operating Mode Under the scan conditions...

Page 16: ...smart transmitter is MR Unsafe and MUST BE REMOVED before undergoing an MRI magnetic resonance imaging procedure For information on the sensor please see MRI Safety Information The system is contrain...

Page 17: ...utes IMPORTANT If your symptoms do not match the glucose alerts and readings from the Eversense CGM System a fingerstick blood glucose check with a home blood glucose meter should be performed prior t...

Page 18: ...have high or low glucose and are unaware of it IMPORTANT If you do not test your glucose with a blood glucose meter when your symptoms are not consistent with the sensor glucose readings you may miss...

Page 19: ...of EMI and check that your mobile device is connected to your smart transmitter Antibiotics of the tetracycline class may falsely lower sensor glucose readings You should not rely on sensor glucose r...

Page 20: ...ll not provide readings during the 24 hour Warm Up Phase and until a second calibration is successful during the Initialization Phase During this time you should monitor your glucose using a home bloo...

Page 21: ...ly localized controlled release device The dexamethasone acetate ring could cause other adverse events not listed or previously seen DO NOT wear the smart transmitter during medical x rays or computed...

Page 22: ...low glucose event Pay attention to the glucose alerts the system provides Failure to appropriately respond to an alert might result in you missing a high or low glucose event The Eversense NOW Remote...

Page 23: ...nloading and installing the Eversense App to your mobile device later in this chapter You may complete the following start up steps before your sensor is inserted so that you can familiarize yourself...

Page 24: ...ansmitter battery Charge your Smart Transmitter 1 Plug the standard end of the USB cable into the adapter on the USB port 2 Plug the micro end of the USB cable into the charging cradle on the USB port...

Page 25: ...outlet Once fully charged a small green LED light appears on the top front of the smart transmitter above the power button Disconnect the power supply from the smart transmitter after it is fully char...

Page 26: ...o the left The app is designed to work with the smart transmitter to automatically receive and display sensor glucose data Eversense App Icon Note Make sure your mobile device is using the latest oper...

Page 27: ...ter by pairing the smart transmitter with your mobile device 2 After you accept the Agreement you will be prompted to create and register an account with an Email and Password You must register an acc...

Page 28: ...o complete registration check the email address you provided and click the link in the email Tap Done to return to the Eversense LOGIN screen 4 Enter your email address and password and tap LOG IN You...

Page 29: ...mode for the mobile device to find the smart transmitter Press the smart transmitter power button three times Make sure your smart transmitter is not plugged into the power supply The LED will blink g...

Page 30: ...the back of the smart transmitter Tap Not Connected to begin pairing process 9 A BLUETOOTH PAIRING REQUEST pop up screen appears Tap Pair to complete the pairing process Note The smart transmitter can...

Page 31: ...UNIT OF MEASUREMENT screen appears and indicates the standard unit of measurement for your region Your glucose readings will always be displayed in this unit of measurement Precaution DO NOT change t...

Page 32: ...ion screens that provide information about when to make treatment decisions with the Eversense CGM System LBL 1602 01 001 Rev N_Eversense User Guide_mgdL_R1 indd 30 LBL 1602 01 001 Rev N_Eversense Use...

Page 33: ...ck blood drop with signal bars will be displayed Once the sensor is inserted by your health care provider and the 24 hour Warm Up Phase is completed you can begin calibration If you have not yet had y...

Page 34: ...that your mobile device has access to the internet Position the smart transmitter directly over the inserted sensor until the Placement Guide in the app shows some connection The Placement Guide page...

Page 35: ...ification 4 The linking process will begin Each step will show a check mark when finished It may take up to 10 minutes for the process to complete DO NOT remove the smart transmitter from your inserti...

Page 36: ...over the sensor with the Eversense adhesive patch The system will prompt you to calibrate using the app IMPORTANT If your smart transmitter is not turned on and paired with the Eversense App and link...

Page 37: ...se data Provides on body vibe alerts when you have reached the glucose alert levels you set Sends glucose data to the app via Bluetooth Can be recharged using the charging cradle USB port to download...

Page 38: ...ng with the sensor When you place the smart transmitter back on the sensor site it will take about 10 minutes for sensor communication to re start and for glucose readings to appear in the app When th...

Page 39: ...side that attaches to the skin Both the skin and smart transmitter surfaces should be clean and dry to secure the adhesive surfaces of the patch Note You will receive adhesive patches from your healt...

Page 40: ...the larger clear backing and position the smart transmitter directly over the sensor For the optimal signal strength the smart transmitter must be placed directly over the sensor Signal strength can...

Page 41: ...so that the patch wings lay horizontally on the arm 6 Use the tab to pull off the remaining clear liner Smooth the adhesive onto the skin Make sure the patch is flat on the skin surface LBL 1602 01 0...

Page 42: ...ll blink once indicating the power is ON At any time you can press the power button once to see if the smart transmitter is ON If the LED appears the smart transmitter is ON If no LED appears the smar...

Page 43: ...according to local regulations Battery Indicator The smart transmitter battery power can be checked using the app or on the smart transmitter itself With the app Tap Menu About My Transmitter Scroll...

Page 44: ...button is pressed 3 times in 5 seconds Discoverable mode Pair smart transmitter with mobile device Does not blink when power button is pressed Smart transmitter off Hold down power button for 5 second...

Page 45: ...the 24 hour Warm Up Phase you must complete 4 fingerstick calibration tests spaced 2 to 12 hours apart Daily Calibration Phase After the Initialization Phase you must complete a fingerstick calibratio...

Page 46: ...e meter manufacturer s instructions to get accurate blood glucose readings for calibration Be sure the code on test strip vial matches the code on your blood glucose meter if coding is required Calibr...

Page 47: ...itter is not turned on and paired with the Eversense App and sensor the system is not able to prompt you to calibrate Re Entering Initialization Phase The following will cause the system to re enter I...

Page 48: ...ve a Calibration Past Due Alert and no glucose values will be displayed until a calibration value is entered After 24 hours without a calibration value entered you will receive a Calibration Expired A...

Page 49: ...to calibrate the system Note You can enter additional calibration readings as long as each calibration is at least one hour apart 1 You can enter the calibration value by tapping Calibrate from the ma...

Page 50: ...value from your fingerstick blood glucose test Tap Done Tap Notes to enter any notes Tap Done Note You cannot enter a calibration value that is older than 10 minutes LBL 1602 01 001 Rev N_Eversense U...

Page 51: ...ar at the top of the screen lets you know when calibration will be complete If the smart transmitter is removed before the calibration is complete you will be prompted to calibrate again 4 The CALIBRA...

Page 52: ...er than 400 mg dL Your smart transmitter was removed or could not collect sensor glucose data during the 15 minutes after you entered your calibration value The glucose value entered will be logged as...

Page 53: ...pp your smart transmitter will not send glucose data to the app until you log back in On the MY GLUCOSE screen you have easy access to Real time sensor glucose measurements Rate and direction of your...

Page 54: ...your mobile device set to Do No Disturb you will not hear any notifications from the Eversense App Check Your Mobile Device Settings You will need a mobile device such as your smartphone to use the Ev...

Page 55: ...to display direction and rate of change You should not make a treatment decision based solely on the sensor glucose value Menu icon Temp Profile icon Date and time Smart Transmitter battery power Cur...

Page 56: ...hange the name by tapping Settings System Current glucose reading Current real time glucose level This is updated every 5 minutes Date and time Current date and time You can scroll left or right to se...

Page 57: ...raph Glucose levels over time You can scroll back and forth to see trends or zoom in to display as few as 3 hours of data or zoom out to see up to 3 days Menu Provides easy navigation to various secti...

Page 58: ...lucose levels and how fast they are changing The app uses the last 20 minutes of continuous glucose data for calculating glucose trends When there are not enough sensor values available to calculate a...

Page 59: ...e treatment decisions Take your time and follow your health care provider s recommendation for when to use Eversense instead of your BG meter Sensor Glucose and Blood Glucose Sensor glucose is measure...

Page 60: ...ons if your smart transmitter is not communicating with your mobile device On body Vibe Alert Your smart transmitter provides vibratory alerts when you have passed the glucose alert levels you set How...

Page 61: ...ose Working with your health care provider to understand the onset peak and duration of your insulin action will help you avoid stacking insulin Stacking insulin is when you take a dose of insulin whi...

Page 62: ...range and glucose alert levels that are right for you Pay careful attention to your Eversense glucose alerts you may need to make a treatment decision When you receive an Out of Range Glucose Alert t...

Page 63: ...information Current sensor glucose value the current glucose value should be displayed in black Trend arrow a trend arrow should be displayed Recent trend information and alerts LBL 1602 01 001 Rev N...

Page 64: ...grey The status bar is displayed in orange You are taking medications of the tetracycline class Note Always refer to the glucose information on your Eversense CGM App on your smartphone to make treat...

Page 65: ...t Indicates Low Glucose High Glucose Glucose in Range No trend arrow Not enough data to calculate glucose trend direction or rate of change Do a fingerstick blood glucose check with your BG meter befo...

Page 66: ...on If you have not recently taken insulin or finished exercise consider adjusting insulin correction dose up Glucose is rising at a moderate rate between 1 0 and 2 0 mg dL minute Your glucose could ri...

Page 67: ...hours ago Should you wait and keep an eye on your glucose value and the arrow before making a treatment decision Should you consider taking carbs to treat the low now What Would You Do This section p...

Page 68: ...our insulin in this situation It s 2pm and you dosed insulin to cover your lunch plus a little extra because of the rapidly rising arrow about 90 minutes ago Since it s only been 90 minutes since you...

Page 69: ...your trend and glucose are more steady Keep a close eye on your glucose number trend arrow and how you feel You ve just finished your workout How does your health care provider recommend you prevent l...

Page 70: ...y would for this meal It s 10pm and you re about to go to bed It s been two and a half hours since you last dosed insulin What might be causing this high glucose How long does it usually take for the...

Page 71: ...target levels will be green Glucose values that are between your glucose target and alert levels will be yellow Press and hold any point in the line graph to view a specific glucose reading for that p...

Page 72: ...w your glucose data through the Eversense NOW Mobile App Placement Guide Check the communication between the smart transmitter and sensor Use this screen whenever you are attaching the smart transmitt...

Page 73: ...lhouette Follow the prompt to either take a new photo or choose an existing photo that is saved on your device The photo you select will be displayed on the Main Menu screen Note You can also change y...

Page 74: ...sense CGM System is designed to provide alerts on your smart transmitter and mobile device when your glucose level has reached the alert levels you set You will decide the settings for your glucose al...

Page 75: ...performing compared to the targets you set You will not receive an alert when you have reached your Glucose Target levels Predictive Low and High Glucose alerts notify you on your mobile device and sm...

Page 76: ...lucose Target and your High Glucose Alert cannot be set below your High Glucose Target Allowable setting Low 60 115 mg dL High 125 350 mg dL On Off setting Low Glucose Alert setting is Always ON High...

Page 77: ...lucose Alert Levels tap High Alert and select the appropriate High Glucose Alert level Tap Done when complete Repeat step to make your Low Alert selection LBL 1602 01 001 Rev N_Eversense User Guide_mg...

Page 78: ...dL High 140 mg dL You can change this target range based on what you and your health care provider agree are the right target levels for you Allowable setting Low 65 120 mg dL High 120 345 mg dL On O...

Page 79: ...cose Target Levels tap High Target and select the appropriate High Glucose Target level Tap Done when complete Repeat step to make your Low Target selection LBL 1602 01 001 Rev N_Eversense User Guide_...

Page 80: ...you have reached the early warning time the smart transmitter vibrates and the mobile app gives an audible alert as well as displays a message on the screen Default setting OFF Allowable setting 10 20...

Page 81: ...utes to select the amount of advance warning Tap Done when complete 1 To turn this feature ON tap Menu Settings Glucose to display the GLUCOSE SETTINGS screen LBL 1602 01 001 Rev N_Eversense User Guid...

Page 82: ...Allowable setting 1 5 5 mg dL per minute On Off setting You can turn these alerts ON and OFF No rate of change alerts will occur until this feature is turned ON Notes Audio notification and visual ale...

Page 83: ...Change to select the rate Tap Done when complete 1 To turn this feature ON tap Menu Settings Glucose to display the GLUCOSE SETTINGS screen LBL 1602 01 001 Rev N_Eversense User Guide_mgdL_R1 indd 81...

Page 84: ...e readings The App must be reinstalled to edit this setting Name The serial number of your smart transmitter You can also tap on the serial number displayed here and give your smart transmitter a cust...

Page 85: ...sounds from the app 2 Tap each alert to select the alert sound Tap Back to get back to the SOUND SETTINGS screen 1 Tap Menu Settings Sound Settings to display the SOUND SETTINGS screen 3 Tap each snoo...

Page 86: ...ease see Alert Descriptions Transmitter Disconnect Setting There may be times when the Bluetooth connection between your smart transmitter and mobile device is interrupted This may be due to the devic...

Page 87: ...ose target and alert settings for the duration you choose When the Temp Profile duration is over the standard glucose settings you entered in Settings Glucose will automatically resume 1 Tap Menu Sett...

Page 88: ...ile is active the Temp Profile icon will be displayed on the MY GLUCOSE screen Temp Profile icon 3 Set the High and Low Alerts and High and Low Target levels desired Tap START LBL 1602 01 001 Rev N_Ev...

Page 89: ...p Profile icon is no longer displayed on the MY GLUCOSE screen To end the Temp Profile earlier than the time you set go to Settings Temp Profile and tap STOP LBL 1602 01 001 Rev N_Eversense User Guide...

Page 90: ...T If you log out no glucose data will be displayed on the app until you log back in using the email and password you entered when you set up your account LBL 1602 01 001 Rev N_Eversense User Guide_mgd...

Page 91: ...s on your app Alerts and Notifications Smart Transmitter Vibration Pattern App Alert Indicators Alerts where no glucose values can be displayed Requires immediate and appropriate action 3 long vibes M...

Page 92: ...PPEARS IN YELLOW Charge Smart Transmitter Alert Your smart transmitter is running low on battery and should be charged 3 quick vibes then 1 long vibe x 2 MESSAGE APPEARS IN YELLOW Notifications Requir...

Page 93: ...Battery Alerts Note When you receive 2 or more alerts that have not been acknowledged the app will display an option to Dismiss All This can happen when your mobile device has been out of range of yo...

Page 94: ...only certain messages alerts and notifications etc for review by tapping selected alert icons Tap ALL then tap icons on top of the screen to select only the types of alerts you want displayed Tap Men...

Page 95: ...enter in sound settings when your sensor glucose reading is at or above the high glucose alert level you set The default repeat interval is 30 minutes Actions Pay close attention to your glucose valu...

Page 96: ...is displayed on the MY GLUCOSE screen Actions Confirm your glucose value with a blood glucose meter test before making a treatment decision Once the sensor glucose value is at or higher than 40 mg dL...

Page 97: ...m returns to the Initialization Phase No glucose reading is displayed until calibration is performed Actions Perform a fingerstick calibration in order to resume displaying glucose values In the Initi...

Page 98: ...r Replacement Appears once when your sensor needs to be replaced No glucose reading can be displayed until the sensor is replaced Actions Charge the smart transmitter immediately Remove the smart tran...

Page 99: ...normal operating conditions Actions Reduce ambient light by doing one or more of the following Move to an area where there is less light exposure Place a dark material over the smart transmitter Wear...

Page 100: ...ansmitter Low Sensor Temperature Appears every 20 minutes when the sensor temperature is too low No glucose reading is displayed until the sensor temperature is within normal operating conditions Acti...

Page 101: ...is displayed until the error is corrected Actions Go to a cooler environment to reduce the sensor temperature Briefly remove the smart transmitter while the sensor temperature cools to between 26 40 C...

Page 102: ...checks detect instability with the sensor which requires a return to calibration Initialization Phase Actions Tap Calibrate to enter a calibration value In the Initialization Phase you must perform 4...

Page 103: ...tions Pay close attention to your glucose values symptoms and trends If your symptoms are different than the sensor glucose values or what the alert indicates confirm your glucose value with a blood g...

Page 104: ...n to your glucose values symptoms and trends If your symptoms are different than the sensor glucose values or what the alert indicates confirm your glucose value with a blood glucose meter test before...

Page 105: ...arge Smart Transmitter Appears when smart transmitter battery power is very low and you need to charge your battery very soon Actions Using the Placement Guide for reference place the smart transmitte...

Page 106: ...nal checks detect a system error No glucose reading is displayed until the error is corrected Actions Re initialization of the system begins in 6 hours Plug the charging cradle with cable into a wall...

Page 107: ...compatible Transmitter Software Appears when the software in your smart transmitter is incompatible with the Eversense CGM Mobile App version on your mobile device Actions Do not remove your transmitt...

Page 108: ...s when it is time for you to calibrate Actions For a list of compatible devices operating systems visit eversensediabetes com Do a fingerstick blood glucose test and enter the reading as your calibrat...

Page 109: ...re your sensor has completed its 90 day wear period as a reminder to replace your sensor Actions Tap Link Sensor to complete the linking process and begin the 24 hour Warm Up Phase You do not need to...

Page 110: ...eded Appears if the calibration value entered is very different from the sensor glucose value After about 1 hour you will receive a Calibrate Now notification Actions Tap Calibrate to enter a new cali...

Page 111: ...ually enter events that will appear on the trend graph and glucose reports to help you find patterns in your glucose profile Types of Events Glucose Meals Insulin Health Exercise Note You can also acc...

Page 112: ...r entered events will be listed You can also select specific event types to view by tapping a selected event type Tap ALL then tap icons on top of the screen to select only the types of events you wan...

Page 113: ...ill be converted to 20 and entries above 600 mg dL will be converted to 600 for calculation and display purposes 5 Tap Save 6 On the Confirm Glucose pop up box tap Submit to confirm the glucose event...

Page 114: ...ap Done 4 Tap Type to enter the type of meal Tap Done 5 Tap Carbs to enter correct number of carbohydrates Tap Done 6 Tap Notes to enter any notes Tap Done 7 Tap Save to save entry and return to EVENT...

Page 115: ...he correct number of Units Tap Done Note The maximum insulin units that can be entered is 200U 5 Tap Type to enter the correct Type of Insulin Tap Done 6 Tap Notes to enter any notes Tap Done 7 Tap Sa...

Page 116: ...e Tap Done 4 Tap Severity to enter Low Medium or High Tap Done 5 Tap Condition to enter the health condition Tap Done 6 Tap Notes to enter any notes Tap Done 7 Tap Save to save entry and return to EVE...

Page 117: ...p Done 4 Tap Intensity to enter Low Medium or High Tap Done 5 Tap Duration to enter the duration Tap Done 6 Tap Notes to enter any notes Tap Done 7 Tap Save to save entry and return to EVENT LOG scree...

Page 118: ...sure to set the mobile device date and time correctly The accuracy of the graphs and reports depends upon the date and time being correct To view the glucose reports tap Menu Reports and swipe to mov...

Page 119: ...et High and Low Glucose Alert levels The green horizontal dotted lines are your pre set High and Low Glucose Target levels This report also provides summary statistics average readings standard deviat...

Page 120: ...You can choose the last 1 7 14 30 or 90 days Glucose Statistics This report shows your average low and high glucose readings along with standard deviation within 6 hour time periods You can choose the...

Page 121: ...ogram go to www eversensediabetes com When you create and register your account during the installation of the Eversense CGM Mobile App an Eversense DMS account is automatically created for you The Ev...

Page 122: ...account about every 5 minutes To manually sync your data tap the START SYNC button Data for the number of days set as your default will be synced You can set the Default Syncing Days to 1 3 7 14 or 3...

Page 123: ...on on this feature see My Circle Remote Monitoring IMPORTANT Both the Eversense CGM Mobile App and the Eversense NOW Remote Monitoring App must be downloaded from the US App Store in order for them to...

Page 124: ...My Transmitter My Sensor or Product Information On the MY TRANSMITTER screen you can find information that includes the serial number calibration information and battery level On the MY SENSOR screen...

Page 125: ...Policy from the About menu Tap Contact Us to send an email to Senseonics Inc To read the End User License Agreement and the Privacy Policy tap either option IMPORTANT This email is not monitored 24 7...

Page 126: ...nnection the Eversense Data Management System DMS the CGM user s smart transmitter out of range of their mobile device or charging their smart transmitter may cause data transfer to be delayed or not...

Page 127: ...d graph of your last three hours of CGM data You can also access the MY GLUCOSE screen if you turn on notifications from Eversense in your Apple Watch settings When you receive a notification you can...

Page 128: ...lay the same data shown as percentages Swipe left to the next screen showing your current glucose with trend arrow your next calibration time the current system calibration phase and battery level of...

Page 129: ...Watch Display Description Low Glucose Appears at the interval you enter in sound settings when your sensor glucose reading is at or below the low glucose alert level you set High Glucose Appears at th...

Page 130: ...er before making a treatment decision Once the sensor glucose value is at or higher than 40 mg dL glucose readings will resume on the display Confirm the alert on your Eversense CGM Mobile App Measure...

Page 131: ...ed in the Eversense CGM Mobile App Actions Confirm the alert on your Eversense CGM Mobile App Perform a ngerstick calibration in order to resume displaying glucose values Confirm the alert on your Eve...

Page 132: ...sensor needs to be replaced No glucose reading can be displayed until the sensor is replaced Actions Confirm the alert on your Eversense CGM Mobile App Charge the smart transmitter immediately Remove...

Page 133: ...firm the alert on your Eversense CGM Mobile App Reduce ambient light by doing one or more of the following Move to an area where there is less light exposure Place a dark material over the smart trans...

Page 134: ...very 20 minutes when the sensor temperature is too low No glucose reading is displayed until the sensor temperature is within normal operating conditions Actions Confirm the alert on your Eversense CG...

Page 135: ...ions Confirm the alert on your Eversense CGM Mobile App Go to a cooler environment to reduce the sensor temperature Briefly remove the smart transmitter while the sensor temperature cools to between 2...

Page 136: ...h requires a return to calibration Initialization Phase Actions Confirm the alert on your Eversense CGM Mobile App Tap Calibrate on your mobile device to enter a calibration value Confirm the alert on...

Page 137: ...Actions Confirm the alert on your Eversense CGM Mobile App Pay close attention to your glucose values symptoms and trends If symptoms do not match the sensor glucose value confirm your glucose value...

Page 138: ...rt on your Eversense CGM Mobile App Pay close attention to your glucose values symptoms and trends If symptoms do not match the sensor glucose value confirm your glucose value with a blood glucose met...

Page 139: ...nsmitter battery power is very low and you need to charge your battery very soon Actions Confirm the alert on your Eversense CGM Mobile App Using the Placement Guide for reference place the smart tran...

Page 140: ...Calibrate Now Appears every 60 minutes when it is time for you to calibrate Actions Confirm the alert on your Eversense CGM Mobile App Re initialization of the system begins in 6 hours Confirm the al...

Page 141: ...eminder to replace your sensor Actions Confirm the alert on your Eversense CGM Mobile App In your mobile app tap Link Sensor to complete the linking process and begin the 24 hour Warm Up Phase You do...

Page 142: ...fferent from the sensor glucose value After 60 minutes you will receive a Calibrate Now notification Actions Confirm the alert on your Eversense CGM Mobile App Tap Calibrate on your mobile device to e...

Page 143: ...ember of your Circle does not have an internet connection your glucose data will not be available for viewing on a secondary display Any problems with mobile devices wireless internet data connection...

Page 144: ...ersense Smart Transmitter The Eversense NOW App cannot change the settings on the Eversense CGM App If the Eversense NOW user does not allow notifications from the Eversense NOW App they will not rece...

Page 145: ...who do not have the Eversense NOW App will not be able to see your data As long as your Eversense CGM System App and the Eversense NOW App have an internet connection your glucose data is synced to t...

Page 146: ...CIRCLE screen in your app Tip Nicknames are optional and are used to help you easily manage your Circle Members If you choose not to give a nickname to a Circle Member their email address will show i...

Page 147: ...name in the Members List or the Invitations Sent List on the MY CIRCLE screen Remove a Member from Your Circle The member you remove will be notified on their Eversense NOW App if they have already ac...

Page 148: ...Share My Data feature for a member that member will not see any of your Eversense CGM System glucose data alerts or event history Members will see your status as Offline on their Eversense NOW App wh...

Page 149: ...se indicating polymer A light emitting diode embedded in the sensor excites the polymer and the polymer then rapidly signals changes in glucose concentration via a change in light output The measureme...

Page 150: ...will be made at the insertion site Step 3 Sensor insertion a subcutaneous pocket will be created under the skin and the sensor will be inserted in this pocket Step 4 Site closure the incision will be...

Page 151: ...leaned disinfected then anesthetized using lidocaine Step 2 Incision a small less than 1 centimeter incision will be made at the sensor site Step 3 Sensor removal the sensor will be removed and discar...

Page 152: ...ical Portable Electronic Device M PED with emission levels that meet FAA mandates for use in all modes while in flight Reference FAA Advisory Circular 21 16G dated 6 22 2011 To use turn your mobile de...

Page 153: ...ter make sure the power button symbol and the LED are lined up in parallel with your arm 2 Use the PLACEMENT GUIDE screen on the app to confirm connection between the sensor and the transmitter Tap Pl...

Page 154: ...A Follow the steps below to troubleshoot the smart transmitter 1 Make sure the smart transmitter is paired with your mobile device 2 Make sure the smart transmitter is charged 3 Check your app for an...

Page 155: ...battery symbol in the upper right corner on the MY GLUCOSE screen A red battery icon indicates the smart transmitter battery is empty 3 Power ON the smart transmitter Press and release the smart trans...

Page 156: ...y be several reasons why you do not have a connection Make sure the Bluetooth setting on your mobile device is ON and the smart transmitter s name or serial number appears on the device list The condi...

Page 157: ...s launched or the smart transmitter is reconnected Once the connection is re established the data collected will sync with the mobile app 3 Press the power button 3 times again to place the smart tran...

Page 158: ...re establish pairing Q What is Discoverable Pairing mode A Discoverable mode is the smart transmitter state that enables it to be located by your mobile device for pairing See Getting Started for more...

Page 159: ...t be negatively impacted if you do more than the required 2 calibrations per day Q What time should I enter on the CALIBRATE screen when I am notified to calibrate A Enter the time you tested your blo...

Page 160: ...ful calibration Your transmitter is disconnected Transmitter is not linked to your sensor Your sensor needs to be replaced Q Where can I find details for Calibration Phase number of calibrations and l...

Page 161: ...ld immediately perform a fingerstick blood glucose test before making a treatment decision Alerts and Notifications Q Can I change the vibration alert pattern on my smart transmitter A Smart transmitt...

Page 162: ...ave been wearing your smart transmitter over your sensor the alerts received during that time will be sent to the app once it is reconnected and synced with the smart transmitter Q How can I sort the...

Page 163: ...k Also if your symptoms do not match the sensor glucose readings you should confirm with a fingerstick blood glucose check Q I am getting in place of sensor glucose readings on the app A You may not g...

Page 164: ...s not have enough data to provide a trend arrow the sensor glucose value may be displayed in grey You should not make a treatment decision based solely on the sensor glucose value Q When should I do a...

Page 165: ...the arrow is not displayed You should not make treatment decisions unless you see a glucose value a trend arrow and consider recent trends and alerts App Q What will happen if I re install the app A...

Page 166: ...pp Note that the Do Not Disturb feature on your smartphone overrides the Do Not Disturb option in the app So if the Do Not Disturb feature on your smartphone is turned on you will not receive the aler...

Page 167: ...t transmitter for the first time but the insertion date and or time do not show when I tap About My Sensor A It may take up to 10 minutes for the linking process to complete Be sure the smart transmit...

Page 168: ...having entered a fingerstick test value 3 or more blood glucose readings are significantly different than the current sensor glucose readings Y our smart transmitter has not been charged within 16 hou...

Page 169: ...hite progress bar across the top of my screen A You will see this syncing progress bar for several reasons Your smart transmitter was out of range of your sensor for a while and it is re syncing You c...

Page 170: ...screen Q Is there a shortcut to the ALERT HISTORY screen A If your smart transmitter is connected to the app you can tap the status bar at the top of the screen to display the ALERT HISTORY screen Q I...

Page 171: ...cipants interacted with the system to calibrate and address notifications not related to glucose data Accuracy was measured during day long clinic visits with blood taken about every 15 minutes These...

Page 172: ...tudy Number of Participants Total Number of Paired CGM and YSI Values Percent Within 15 15 Percent Within 20 20 Percent Within 30 30 Percent Within 40 40 MARD PRECISE II 90 adults 18 years and older 1...

Page 173: ...e between the two results was calculated For values greater than 80 mg dL the mean absolute relative difference was calculated YSI Glucose Ranges mg dL Paired CGM YSI n Mean Absolute Relative Differen...

Page 174: ...99 9 0 1 351 400 951 91 5 95 8 98 6 99 8 0 2 Performance was also measured by calculating the percentage of sensor glucose readings within 15 mg dL or 15 of the YSI reference These tables show the per...

Page 175: ...rcent 30 30 of Reference Percent 40 40 of Reference 40 40 of Reference Overall 2 665 79 1 88 9 95 8 98 5 1 5 40 60 274 86 5 91 2 96 4 97 8 2 2 61 80 378 81 7 87 8 97 1 98 7 1 3 81 180 962 76 7 87 8 95...

Page 176: ...nt 30 30 of Reference Percent 40 40 of Reference 40 40 of Reference Overall 2 926 86 1 93 3 98 1 99 0 1 0 40 60 214 93 0 98 1 99 5 100 0 0 0 61 80 404 87 6 94 3 99 3 99 8 0 2 81 180 1 053 80 0 89 3 96...

Page 177: ...ent 30 30 of Reference Percent 40 40 of Reference 40 40 of Reference Overall 2 997 88 1 94 6 98 8 99 6 0 4 40 60 269 87 0 92 6 96 7 98 9 1 1 61 80 407 84 0 93 4 99 5 100 0 0 0 81 180 999 82 0 91 7 98...

Page 178: ...30 30 of Reference Percent 40 40 of Reference 40 40 of Reference Overall 2 284 88 0 94 3 98 9 100 0 0 0 40 60 209 98 6 99 5 100 0 100 0 0 0 61 80 416 92 8 97 6 100 0 100 0 0 0 81 180 936 81 1 90 0 97...

Page 179: ...30 30 of Reference Percent 40 40 of Reference 40 40 of Reference Overall 2 133 86 9 93 7 98 5 99 6 0 4 40 60 165 98 2 100 0 100 0 100 0 0 0 61 80 176 89 2 96 6 100 0 100 0 0 0 81 180 880 85 9 94 2 98...

Page 180: ...nt 30 30 of Reference Percent 40 40 of Reference 40 40 of Reference Overall 2 165 83 9 92 2 98 5 99 3 0 7 40 60 105 93 3 100 0 100 0 100 0 0 0 61 80 222 90 5 96 8 99 1 99 1 0 9 81 180 956 77 7 86 7 97...

Page 181: ...r glucose values when outside the display range of 40 mg dL to 400 mg dL Reference mg dL CGM Readings CGM Ref pairs 50 60 70 80 80 Total LO n 6 7 9 9 0 9 66 7 77 8 100 100 0 100 Reference mg dL CGM Re...

Page 182: ...CGM System did not present an alert within a 15 minute window of a reference value beyond the alert setting threshold The True Alert Rate shows the percentage of time the alert from the CGM system wa...

Page 183: ...ersense High and Low Glucose Alert Performance Threshold Only in the PRECISION Study The table below shows an assessment of the ability of the Eversense CGM System to detect high and low glucose level...

Page 184: ...w and Predictive Alert Performance Threshold and Predictive in the PRECISION Study The table below shows an assessment of the ability of the Eversense CGM System to detect high low and predictive high...

Page 185: ...4 354 3 0 1 0 25 35 30 10 175 Total 57 155 990 11 137 1 085 288 57 13 769 Eversense Rate of Change Trend Agreement The shaded area of the table below shows agreement between the Eversense glucose tren...

Page 186: ...161 200 1 727 0 0 0 1 24 59 16 0 0 0 0 201 250 1 502 0 0 0 0 1 19 65 14 1 0 0 251 300 1 257 0 0 0 0 0 1 18 51 27 3 0 301 350 1 628 0 0 0 0 0 0 1 10 57 32 1 351 400 951 0 0 0 0 0 0 0 2 26 65 7 Eversen...

Page 187: ...00 40 60 274 1 59 36 4 0 0 0 0 0 0 0 61 80 378 0 14 65 19 1 0 0 0 0 0 0 81 120 516 0 1 23 63 12 0 0 0 0 0 0 121 160 332 0 0 0 17 70 12 1 0 0 0 0 161 200 226 0 0 0 1 23 58 17 0 0 0 0 201 250 268 0 0 0...

Page 188: ...bration Stability Agreement in the PRECISION Study Percent of CGM System Readings Within Time from Calibration Number of Paired CGM YSI Percent 15 15 of Reference Percent 20 20 of Reference Percent 30...

Page 189: ...e by comparing readings between the two sensors worn by each participant As an example the absolute relative difference between the sensors worn by each person is 9 9 and the percent coefficient of va...

Page 190: ...olved Overall the analysis estimated that 91 of sensors remained functioning through 90 days In the PRECISION study all sensors functioned through 90 days Percentage of Sensors that lasted 30 60 and 9...

Page 191: ...276 757 842 814 of Displayed Glucose Values 98 98 96 97 Data Availability A total of 97 821 296 out of expected 842 814 glucose values were available during the 90 day study Table 17 Eversense Data A...

Page 192: ...days and the number of related adverse events was recorded The Eversense CGM System was well tolerated in the studies During the studies 15 921 sensor wear days there were no unanticipated adverse eve...

Page 193: ...ydrogel Platinum Silicone Dexamethasone Acetate epoxy 301 2 Glucose Range 40 400 mg dL Sensor Life Up to 90 days Calibration Commercially available self monitoring blood glucose meter Calibration Rang...

Page 194: ...ion Against Electrical Shock Type BF applied part Charge time using AC adapter 15 minutes to fully charge Communication Distance Between app and smart transmitter is up to 24 9 feet Wireless communica...

Page 195: ...ng If misused the USB cable can pose a strangulation risk The USB cable can be connected to the power supply charger and charged using an AC power outlet To isolate the system unplug the charger power...

Page 196: ...scharge 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...

Page 197: ...affected by absorption and reflection from structures objects and people a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios...

Page 198: ...ow voltage power supply network that supplies buildings used for domestic purposes Recommended Separation Distances Between Other Portable Mobile RF Communications Equipment and the Smartphone Receivi...

Page 199: ...trend line Empty Battery Alert Appears when the smart transmitter battery is empty Low Battery Alert Appears when the smart transmitter battery is less than 10 charged Smart Transmitter Sensor Alert...

Page 200: ...Appears when there are two or more alerts or events in a short interval Event Icons Appear on the glucose trend line and in the EVENT LOG after an event is entered The events that can be entered are G...

Page 201: ...romagnetic radiation Not made with natural rubber latex FCC ID is assigned to all devices subject to certification Non sterile Magnetic Resonance Imaging MRI procedures are contraindicated for the sma...

Page 202: ...Sterilized using Ethylene Oxide U S Federal law restricts the sale of the Eversense CGM System to sale by or on the order of a physician Follow instructions for use Symbols on Packaging and Devices c...

Page 203: ...ived the Smart Transmitter from your health care provider and this warranty will be void with respect to the original Smart Transmitter 2 Exclusions to the limited warranty The limited warranty applie...

Page 204: ...repaired or replacement Smart Transmitter assumes the remaining warranty of the original Smart Transmitter or 30 days from the date of replacement or repair whichever is longer 4 Limits of Senseonics...

Page 205: ...se Data Management Software Application FG 5700 01 300 Eversense Mobile Application iOS FG 5501 01 300 Eversense Mobile Application Android FG 5502 01 300 YOUR EXCLUSIVE REMEDY IF ANY PORTION OF THIS...

Page 206: ...d touch are trademarks of Apple Inc registered in the U S and other countries Google Legal Notice The Android name the Android logo and Google Play are trademarks of Google Inc Legal Notices About Blu...

Page 207: ...delay the transmission of data from your smart transmitter to the app Moving away from or turning off these electronic devices may allow communication The smart transmitter has been tested and found...

Page 208: ...c Resonance Imaging 13 14 My Circle 121 141 MY GLUCOSE screen 31 51 53 70 Notifications 90 106 Pairing smart transmitter and mobile device 25 28 154 Placement guide signal strength 38 70 Power adapter...

Page 209: ...207 Eversense CGM User Guide Notes LBL 1602 01 001 Rev N_Eversense User Guide_mgdL_R1 indd 207 LBL 1602 01 001 Rev N_Eversense User Guide_mgdL_R1 indd 207 2 26 20 1 00 PM 2 26 20 1 00 PM...

Page 210: ...208 Eversense CGM User Guide Notes LBL 1602 01 001 Rev N_Eversense User Guide_mgdL_R1 indd 208 LBL 1602 01 001 Rev N_Eversense User Guide_mgdL_R1 indd 208 2 26 20 1 00 PM 2 26 20 1 00 PM...

Page 211: ...LBL 1602 01 001 Rev N_Eversense User Guide_mgdL_R1 indd 3 LBL 1602 01 001 Rev N_Eversense User Guide_mgdL_R1 indd 3 2 26 20 1 00 PM 2 26 20 1 00 PM...

Page 212: ...SENSE4U 301 515 7260 844 736 7348 Customer Support Hours 8am to 8pm Eastern US Time eversensediabetes com Senseonics Inc 2020 PN LBL 1602 01 001 Rev N 02 2020 LBL 1602 01 001 Rev N_Eversense User Gui...

Page 213: ...r Erin Moody Art Director Ivy Tsang Dimensions Trim 6 75 w X 5 8 h Bleed 0 125 Folded Include folded dimensions if applicable Colors 4 color Spot Name PMS colors if applicable N A LBL 1602 01 001 Rev...

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