Senseonics orporated 3400 The Eversense Smart Transmitter User Manual 2

Senseonics Incorporated The Eversense Smart Transmitter Users Manual 2

Users Manual 2

36Eversense CGM User Guide63. Tap Time and enter the time of day when the fingerstick blood glucose test was taken. • Tap Done.4. Tap Glucose and enter the value from your fingerstick blood glucose test.• Tap Done. 5. The CALIBRATE screen now shows the time and glucose reading you entered. If not correct, repeat steps 3 and 4.• When correct, tap Submit.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 36 7/22/16 11:39 AM
37Eversense CGM User Guide66. A CONFIRM CALIBRATION screen appears. Make sure that the fingerstick blood glucose test result you entered is correct.• Tap Cancel to go back and re-enter the correct time or glucose test result.• When correct, tap Submit.7. The CALIBRATION ACCEPTED screen appears.• Tap OK.8. The MY GLUCOSE screen appears with a red blood drop icon to identify your fingerstick calibration. IMPORTANT: The smart transmitter should not be removed from over the sensor for at least 5 minutes before the test to 15 minutes after the test while calibration is in progress. The Status Bar at the top of the screen lets you know when calibration will be complete.Note: There may be conditions when your calibration result is NOT accepted. See Calibrating the System for more information.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 37 7/22/16 11:39 AM
38Eversense CGM User Guide77. Using the AppThis section describes the Eversense App including the main screen, trend graph, trend arrows, and the menu screen.The app communicates with the smart transmitter to receive and then display glucose data, trends, graphs and alerts. The app also stores your glucose history with up to 90 days of stored data.Note: When you log out of the Eversense app, 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 changing glucose levels.• Graphical trends of your glucose levels.• Alerts (hypoglycemia or hyperglycemia).• Events such as meals, exercise, and medications.Note: A wireless internet connection is required to download or update the Eversense App.Check Your Mobile Device SettingsYou will need a mobile device (such as your smartphone) to use the Eversense CGM System. It is very important that your mobile device is set up properly to ensure accurate display of your glucose data in the app. Follow the manufacturer’s instructions for your mobile device to set up the following:• Time and date.• Bluetooth turned ON (enabled).• Notifications turned on.• Battery is charged.• Geographic zone.• Language.• Mobile device sound should not be on vibrate.• Do Not Disturb should be OFF. If you have your mobile device set to Do No Disturb, you will not hear any notifications from the Eversense app.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 38 7/22/16 11:39 AM
39Eversense CGM User Guide7Get To Know the “My Glucose” ScreenThe MY GLUCOSE screen is the main display screen for the app. It displays a variety of data, including sensor glucose readings, direction and rate of change arrow, trend graph, events, calibrations, alerts and notifications.Note:• If your sensor is not linked to a smart transmitter the smart transmitter connection to sensor icon will appear as a red blood drop with a red X.• You can view a snapshot of the Home screen on your iOS device if you add the Eversense app widget to your widget page. For information on managing widgets, consult your iOS device user guide.• You can view the MY GLUCOSE screen in landscape orientation to access short cut buttons to view the last 7, 14, 30 or 90 days and you can email this view with a single tap.Menu iconTemp ProfileSmart Transmitter IDDate and timeSmart Transmitter battery powerCurrent glucose readingStatus barMultiple events markTrend arrowSmart Transmitter connection to sensorUnit of measurementLow Glucose Alert level (Bottom red dashed line)High Glucose Target level (Top green dashed line)High Glucose Alert level (Top red dashed line)Low Glucose Target level (Bottom green dashed line)Calibration markEvent markLBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 39 7/22/16 11:39 AM
40Eversense CGM User Guide7Status bar Provides important information about your current glucose and system status.Smart Transmitter ID This is the smart transmitter you are now using. You can change 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 see dierent dates and times.Smart Transmitter battery power Indicates battery power left in the smart transmitter.Smart Transmitter connection to sensor Indicates the strength of your smart transmitter connection with the sensor.Trend arrow Shows the direction your glucose levels are moving.Unit of measurement This is the unit of measurement used to display all glucose data.High/Low Glucose alert level The levels set for the high and low glucose alerts.High/Low Glucose target level The levels set for the high and low glucose targets (target range).Multiple events mark Indicates multiple events have occurred at the same time.Event mark Indicates manually entered events (e.g., exercise). See Logging Events for more information.Calibration mark Indicates a blood glucose calibration entry.Glucose trend graph 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 sections of the Eversense App:My Glucose Reports SettingsCalibrate Share My Data AboutAlert History Placement GuideEvent Log ConnectLBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 40 7/22/16 11:39 AM
41Eversense CGM User Guide7Gradually rising or falling glucose levels, falling or rising at a rate between 0.0 mg/dL and 1.0 mg/dL per minute.Moderately rising glucose level, rising at a rate between 1.0 mg/dL and 2.0 mg/dL per minute.Moderately falling glucose levels, falling at a rate between 1.0 mg/dL and 2.0 mg/dL per minute.Very rapidly rising glucose levels, rising at a rate more than 2.0 mg/dL per minute.Very rapidly falling glucose levels, falling at a rate more than 2.0 mg/dL per minute.Trend ArrowsThere are 5 dierent trend arrows that show the current direction of your glucose 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 for the calculation, the arrow is displayed in gray.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 41 7/22/16 11:39 AM
42Eversense CGM User Guide7Trend GraphThe trend graph is used to review and analyze historical data and trends in your glucose values over time. It also displays marks for events you have manually logged in the app (e.g., calibration tests and exercise).There are several ways you can use the trend graph:• Quickly review how well you are doing when compared to the glucose targets and alert levels you set. The red dashed lines indicate your High and Low Glucose Alert levels, and the green dashed lines indicate your high and low glucose target levels (your target range).• Shaded areas of the graph are color coded as follows depending on the glucose settings you enter:– Glucose values that are outside of your glucose alert levels will be red.– Glucose values that are within your glucose 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 point in time.• Tap any of the marks on the app screen to get more information about the event or alert.• Pinch in and out on the screen to display dierent day/time ranges on the trendgraph. You can zoom in and out to display as few as 3 hours or up to 3 days of information.• To view trend graph data for a dierent date, tap the date on the screen and enter the desired date.• You can view the trend graph in either portrait or landscape mode. In landscape mode, there are shortcut buttons to see 7, 14, 30 and 90 day views.Note: All of your glucose data will be stored in the app as long as you have memory available on your mobile device.7LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 42 7/22/16 11:39 AM
43Eversense CGM User Guide7Menu Options DescriptionMy Glucose Main app screen that displays current CGM reading, direction and rate of change, trend graph, events and alerts.Calibrate Enter calibration test values. The CALIBRATION screen automatically appears when it is time to calibrate but you can also enter additional calibration values using this menu option.Alert History Review past alerts and notifications. See Alert Descriptions for more information.Event Log Enter information about activities such as blood glucose tests, meals, insulin, health and exercise. See Event Log for more information. Reports Review a variety of reports about your CGM data. See Glucose Reports and Sharing for more information.Share My Data Download or export your CGM data via a .csv file.Placement GuideCheck the communication between the smart transmitter and sensor. Use this screen whenever you are attaching the smart transmitter to be sure communication is established.Connect Check the connection between the smart transmitter and mobile device. A Bluetooth connection is required to send data to the app.Settings Customize settings such as glucose target levels, alert levels, sounds, temporary profile and calibration reminder times. See Customizing your Settings for more information.About View information about your CGM System, including sensor and smart transmitter ID numbers.Menu OptionsThe Menu icon ( ) appears at the top left corner of all app screens and provides easy navigation to other app features. The following menu items are available: 7LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 43 7/22/16 11:39 AM
44Eversense CGM User Guide88. Customizing your SettingsThis section describes how to customize settings in your Eversense CGM System.Areas where you can customize app settings include:• Glucose – glucose levels and change rates that will trigger an alert.• Daily Calibration – your morning and afternoon calibration reminders.• System – identifies or lets you enter personalized information about your system. • Mealtimes – your times for each meal so that glucose reports can help show how meals may aect readings.• Sound Settings – change the sounds for some glucose alerts, set snooze times and Do No Disturb for the Eversense App.• Temp Profile – set a temporary glucose profile.• Log Out – log out of your Eversense Account.Glucose LevelsThe Eversense 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 alerts, targets, and rates of change based on input from your health care provider.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 44 7/22/16 11:39 AM
45Eversense CGM User Guide8Warning:• Before adjusting treatment for your diabetes, perform a fingerstick blood glucose test to confirm the sensor glucose result.• The Low and High Glucose Alerts are designed to assist you in managing your diabetes and should not be exclusively used to detect hypoglycemia or hyperglycemia. The alerts should always be used in conjunction with other indications of glycemic state such as your glucose level, trend, line graph etc.IMPORTANT:• Low and High Glucose Alerts are dierent from your Low and High Glucose Targets.– Low and High Glucose Alerts notify you on your mobile device and smart transmitter when you have crossed a certain low or high value.– Glucose Targets are used in the reports and line graphs to show how your glucose levels have been performing compared to the targets you set. You will not receive an alert when you have reached your Glucose Target levels.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 45 7/22/16 11:39 AM
46Eversense CGM User Guide8Setting Glucose Target LevelsGlucose Targets are the low and high levels of the range you are aiming for throughout the day. These settings are used in the app to indicate when glucose values are in your target range.1. Tap Menu > Settings > Glucose to display the GLUCOSE SETTINGS screen.2. Under Glucose 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.Default settingLow: 80 mg/dL High: 140 mg/dL You can change this target range based on what you and your physician agree are the right target levels for you. Allowable settingLow: 65 - 120 mg/dLHigh: 120 - 345 mg/dLOn/O settingAlways ON (cannot be turned OFF)Notes Used in graphs and charts on the app to show time spent in target range.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 46 7/22/16 11:39 AM
47Eversense CGM User Guide8Setting Glucose Alert LevelsYour Eversense CGM System will alert you when your glucose levels are outside the alert settings you choose. When you have reached your low and high glucose alert levels, the smart transmitter vibrates, and the mobile app gives an audible alert as well as displays a message on the screen. You should immediately perform a fingerstick blood glucose test before making a treatment decision.Default settingLow: 70 mg/dL High: 200 mg/dL You can change these alert levels based on what you and your physician agree are the right levels for you. Your Low Glucose Alert cannot be set above your Low Glucose Target, and your High Glucose Alert cannot be set below your High Glucose Target.Allowable settingLow: 60 - 115 mg/dLHigh: 125 - 350 mg/dL On/O settingAlways ON (cannot be turned OFF)Notes Audio notification and visual alerts on your mobile device and smart transmitter on-body vibe alerts.1. Tap Menu > Settings > Glucose to display the GLUCOSE SETTINGS screen.2. Under Glucose 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-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 47 7/22/16 11:39 AM
48Eversense CGM User Guide82. Next to Predictive Alerts, slide the OFF button right to ON.3. Tap Minutes to select the amount of advance warning• Tap Done when complete.Setting Predictive AlertsPredictive Alerts let you know in advance that a high or low glucose event is likely to occur if current trends continue.Predictive Alerts use the Low and High Glucose Alert levels to provide an “early” warning. When 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. You should immediately perform a fingerstick blood glucose test before making a treatment decision.1. To turn this feature ON, tap Menu > Settings > Glucose to display the GLUCOSE SETTINGS screen.Default settingOFF Allowable setting 10, 20, or 30 minutes priorOn/O settingYou can turn this feature ON. No predictive alerts will occur until this feature is turned ON. The default is 20 minutes.Notes Audio notification and visual alerts on your mobile device and smart transmitter on-body vibe alerts.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 48 7/22/16 11:39 AM
49Eversense CGM User Guide8Setting Rate of Change AlertsThe Rate of Change Alerts let you know when your glucose level is falling or rising faster than the Rate Alert setting you choose. Default settingOFFAllowable setting 1 - 5 mg/dL per minuteOn/O settingYou can turn this feature ON. No rate of change alerts will occur until this feature is turned ON.Notes Audio notification and visual alerts on your mobile device and transmitter vibration alerts.2. Next to Rate Alerts, slide the OFF button right to ON.3. Tap Rate of 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-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 49 7/22/16 11:39 AM
50Eversense CGM User Guide8Setting Daily Calibration TimesThe morning and evening calibration times are set to remind you when to calibrate. You can calibrate up to 2 hours before your scheduled calibration time. Your morning and evening calibration times must be between 10 and 14 hours apart.1. Tap Menu > Settings > Daily Calibration.2. Tap Morning to set your morning calibration time.• Tap Done when complete.3. Tap Evening to set your evening calibration time. • Tap Done when complete.4. When both times are correct, tap Save.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 50 7/22/16 11:39 AM
51Eversense CGM User Guide8Setting System InformationThe SYSTEM screen lets you view and edit other settings in your Eversense CGM System.1. Tap Menu > Settings > System to display the SYSTEMS screen.2. On the SYSTEMS screen, you can tap each of the following to set:• Glucose Units. The unit of measurement for your glucose 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 custom name.• Linked Sensor. The serial number of the sensor currently linked with the smart transmitter. Tap this feature to access the ability to link or re-link a sensor.Note: For a list of alerts, please see Alert Descriptions.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 51 7/22/16 11:39 AM
52Eversense CGM User Guide8Setting Mealtimes ScheduleThe MEAL TIMES screen displays the time slots for your Breakfast, Lunch, Snack, Dinner and Sleep times. The time intervals set in the MEAL TIMES screen are used on the Reports graph view to indicate the high, low and average CGM values during each mealtime interval.1. Tap Menu > Settings > Meal Times to display the MEAL TIMES screen.2. Tap each meal time listed, then tap Start and End to set a beginning and end mealtime.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 52 7/22/16 11:39 AM
53Eversense CGM User Guide8Setting SoundsThe SOUND SETTINGS screen displays the alert sound settings for Low Glucose and High Glucose. This screen also allows you to enter a snooze setting for the alerts listed.1. Tap Menu > Settings > Sound Settings to display the SOUND SETTINGS screen.2. Tap each alert to select the alert sound. Tap Back to get back to the SOUND SETTINGS screen.IMPORTANT: Be sure the sound on your mobile device is turned on. If you turn the sound on your mobile device o, you will not hear any sounds from the app.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 53 7/22/16 11:39 AM
54Eversense CGM User Guide83. Tap each snooze alert to set how often the alert repeats. Tap Done when complete.The SOUND SETTINGS screen also allows you to enable and disable the Do Not Disturb mode.By setting the snooze alert, you can set how often an alert repeats after you have received a Low Glucose and High Glucose alert.Note: When you enable Do Not Disturb mode on your mobile device you will not receive any alerts or notifications from the Eversense app.• Do Not Disturb. Places the smart transmitter in a “Do Not Disturb” mode.• OFF – ALL notifications – alerts and notifications – regardless of critical nature will be provided by the smart transmitter and app.• ON – ONLY critical alerts will be provided by the smart transmitter’s on-body vibe alerts. All alerts will continue to be provided on the mobile app.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 54 7/22/16 11:39 AM
55Eversense CGM User Guide8Setting Temporary ProfileDuring activities or conditions outside your normal routine, you may wish to temporarily use glucose settings that are dierent from the standard glucose settings you have entered. The TEMP PROFILE screen allows you to temporarily change glucose 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 > Settings > Temp Prole to display the TEMP PROFILE screen.3. Set the High and Low Targets and High and Low Alert levels desired. Tap START.2. Select the duration. You can set a Temp Profile for up to 36 hours in 30 minute increments. LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 55 7/22/16 11:39 AM
56Eversense CGM User Guide8The Temp Profile selections cannot be changed when the duration has been started.When the Temp Profile duration is finished, the app displays a notice and the Temp 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 Prole and tap STOP.While a Temp Profile is active, the Temp Profile icon will be displayed on the MY GLUCOSE screen.Temp Profile iconLBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 56 7/22/16 11:39 AM
57Eversense CGM User Guide8Logging outTo log out of your Eversense account, tap Settings > Log Out.IMPORTANT: If you log out, no glucose data will be displayed on the app until you log back in using the username and password you entered when you set up your account for the first time.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 57 7/22/16 11:39 AM
58Eversense CGM User Guide99. Alert DescriptionsThis section describes the various alerts and notication messages you may see on the Eversense App screens and actions you may need to take.Your CGM System provides you with alerts and notifications related to glucose readings and system status on both your smart transmitter and mobile device. The smart transmitter provides on-body vibe alerts when an alert level has been reached. The mobile device app sounds an alert and displays messages on the MY GLUCOSE screen.The table below describes the vibration patterns on the smart transmitter and the indicators on your app.Alerts and Notifications Smart TransmitterVibration Pattern App Alert IndicatorsAlerts where no glucose values can be displayedRequires immediate and appropriate action. 3 long vibes MESSAGE APPEARS IN YELLOW Alerts related to Low readingsLow Glucose Alert and Out-of-Range Low. Requires immediate and appropriate action.3 short vibes x 3 MESSAGE APPEARS IN YELLOW Alerts related to High readingsHigh Glucose Alert and Out-of-Range High. Requires immediate and appropriate action.1 long vibe then 2 short vibes MESSAGE APPEARS IN YELLOW Alerts related to less critical issuesRequires some action but may not be as critical in nature. See following section for examples.1 short vibe MESSAGE APPEARS IN YELLOW NotificationsRequires some action but not critical in nature. See following section for examples.1 short vibe MESSAGE APPEARS IN BLUE LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 58 7/22/16 11:39 AM

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