Senseonics orporated 3400 The Eversense Smart Transmitter User Manual 3

Senseonics Incorporated The Eversense Smart Transmitter Users Manual 3

Users Manual 3

59Eversense CGM User Guide9Alert HistoryThe ALERT HISTORY screen lists alerts and notifications you have received.1. Tap Menu > Alert History.• The ALERT HISTORY screen will list ALL alerts and notifications for that day.• Tap on any message to get more information.The following icons are used to indicate the severity level of messages.2. You can choose to include 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 Menu when done. AlertsNotificationsMore than 1 Alert in Same PeriodBattery AlertsExample of ALLExample of alerts onlyNote: 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 your smart transmitter and then re-syncs. You can review each alert in Alert History.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 59 7/22/16 11:39 AM
60Eversense CGM User Guide9Alert Descriptions and ActionsThe following table lists the alerts and notifications you may receive on the Eversense App.Note: For each message, you can also tap the information icon to receive additional details about the message.App DisplayDescriptionLow 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 the interval you enter in sound settings when your sensor glucose reading is at or above the high glucose alert level you set.Out of Range Low Glucose*Appears when your glucose reading is lower than 40 mg/dL.No glucose reading can be displayed (only LO is displayed on the MY GLUCOSE screen).ActionsPay close attention to your glucose values, symptoms, and trends. Confirm your glucose value with a blood glucose meter test before making a treatment decision.Pay close attention to your glucose values, symptoms, and trends. Confirm your glucose value with a blood glucose meter test before making a treatment decision.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, glucose readings will resume on the display.AlertsIMPORTANT: On-body vibe alerts for the alerts marked with a * cannot be turned o using DND in the app.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 60 7/22/16 11:39 AM
61Eversense CGM User Guide9App DisplayDescriptionOut of Range High Glucose*Appears when your glucose value is higher than 400 mg/dL.No glucose reading can be displayed (only HI is displayed on the MY GLUCOSE screen).Calibration Past DueAppears when your system is past due for calibration.No glucose readings can be displayed until calibration is performed.Calibration ExpiredAppears when a calibration has not been performed in 24 hours. The system returns to the Initialization Phase.No glucose reading can be displayed until calibration is performed.ActionsMeasure your glucose manually by using your blood glucose meter. Always confirm your glucose value with a blood glucose meter test before making a treatment decision.Once the sensor glucose value is at or lower than 400 mg/dL, glucose readings will resume on the display.Perform a fingerstick calibration in order to resume displaying glucose values.In the Initialization Phase, you must perform 4 fingerstick calibration tests spaced 2 – 12 hours apart. Display of glucose readings will resume after the 2nd successful fingerstick calibration test.Alert Descriptions and Actions (continued)AlertsLBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 61 7/22/16 11:39 AM
62Eversense CGM User Guide9Alert Descriptions and Actions (continued)App DisplayDescriptionBattery Empty*Appears once when your smart transmitter battery is empty and needs to be charged.No glucose reading can be displayed until the smart transmitter is charged.Sensor Replacement (7 days)Appears when your sensor will stop collecting glucose data in 7 days.Sensor ReplacementAppears every 20 minutes when your sensor needs to be replaced.No glucose reading can be displayed until the sensor is replaced.ActionsCharge the smart transmitter immediately. Remove the smart transmitter from your body before connecting it to the power supply. Contact your physician to schedule your sensor removal and insertion of new sensor.Contact your physician to have your sensor replaced.AlertsLBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 62 7/22/16 11:39 AM
63Eversense CGM User Guide9Alert Descriptions and Actions (continued)App DisplayDescriptionHigh Ambient LightAppears every 20 minutes when your smart transmitter is receiving too much ambient light, aecting its ability to communicate with the sensor.No glucose reading can be displayed until ambient light is reduced.High Smart Transmitter Temperature*Appears every 20 minutes when your smart transmitter temperature is too high.No glucose reading is displayed until the smart transmitter temperature is within normal operating conditions.Vibration Motor*Appears every 20 minutes when the vibration motor on your smart transmitter can no longer provide on-body vibe alerts. You will continue to get glucose readings up to 72 hours after receiving the alert message. After 72 hours, you will receive a Transmitter Error Alert every 20 minutes until you replace the smart transmitter.ActionsReduce 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 the smart transmitter under clothing. Reduce the smart transmitter temperature by moving to a cooler environment. Once the smart transmitter temperature is below 42 °C (108 °F), it will resume displaying glucose values.You may temporarily remove the smart transmitter to cool it down. Once the smart transmitter is back to a lower temperature, be sure to replace it over the sensor.Contact Customer Support to have your smart transmitter replaced immediately. AlertsLBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 63 7/22/16 11:39 AM
64Eversense CGM User Guide9Alert Descriptions and Actions (continued)App DisplayDescriptionLow 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.High Sensor Temperature*Appears every 20 minutes when the sensor temperature is too high. No glucose reading is displayed until the sensor temperature is within normal operating conditions.Smart Transmitter Error*Appears when the system’s internal checks detect a smart transmitter error.No glucose reading is displayed until the error is corrected.ActionsGo to a warmer environment to increase the sensor temperature. Keep your smart transmitter turned on so you will start receiving glucose values when the sensor temperature is between 26 - 40 °C (81 - 104 °F).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 (81 - 104 °F). Then put the smart transmitter back on to start receiving glucose values again from the sensor.Follow the steps shown in the Troubleshooting section to reset your smart transmitter. If you are unable to complete the reset, contact Customer Support.AlertsLBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 64 7/22/16 11:39 AM
65Eversense CGM User Guide9App DisplayDescriptionSensor CheckAppears once when the system’s internal checks detect instability with the sensor which requires a return to calibration Initialization Phase.Predicted Low GlucoseAppears every 60 minutes when your glucose values are trending low and will reach your Low Glucose Alert level within the time you entered in Settings.Predicted High GlucoseAppears every 60 minutes when your glucose values are trending high and will reach your High Glucose Alert level within the time you entered in Settings.ActionsIn the Initialization Phase, you must perform 4 fingerstick calibration tests spaced 2 - 12 hours apart. Display of glucose readings will resume after the 2nd successful fingerstick calibration test.Pay close attention to your glucose values, symptoms, and trends. Confirm your glucose value with a blood glucose meter test before making a treatment decision. Pay close attention to your glucose values, symptoms, and trends. Confirm your glucose value with a blood glucose meter test before making a treatment decision. AlertsAlert Descriptions and Actions (continued)LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 65 7/22/16 11:39 AM
66Eversense CGM User Guide9Alert Descriptions and Actions (continued)App DisplayDescriptionRate FallingAppears every 60 minutes when your glucose values are falling at a rate equal to or faster than the rate of change you entered in Settings.Rate RisingAppears every 60 minutes when your glucose value is rising at a rate equal to or faster than the rate of change you entered in Settings.Charge Smart TransmitterAppears when smart transmitter battery power is very low and you need to charge your battery very soon. ActionsPay close attention to your glucose values, symptoms, and trends. Confirm your glucose value with a blood glucose meter test before making a treatment decision. Pay close attention to your glucose values, symptoms and trends. Confirm your glucose value with a blood glucose meter test before making a treatment decision. Charge your smart transmitter as soon as possible.AlertsLBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 66 7/22/16 11:39 AM
67Eversense CGM User Guide9Alert Descriptions and Actions (continued)App DisplayDescriptionSensor SuspendAppears when the system’s internal checks detect a need to restart the Initialization Phase for additional calibrations. Glucose values will be displayed a few minutes after the second successful calibration during the Initialization Phase.Calibration Under ReviewAppears when your calibration value is significantly dierent from your sensor glucose value. Incompatible Firmware VersionAppears when the firmware in your smart transmitter is incompatible with the Eversense mobile app version on your mobile device. ActionsRe-initialization of the system begins in 6hours. Re-calibrate when prompted. Contact Customer Support.AlertsLBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 67 7/22/16 11:39 AM
68Eversense CGM User Guide9Alert Descriptions and Actions (continued)App DisplayDescriptionUpgrade Eversense AppAppears when a newer version of the Eversense app is available to download. Incompatible Device/Operating SystemAppears when an incompatible device/operating system is being used with the app. ActionsTap Yes to install the update. For a list of compatible devices/operating systems visit eversensediabetes.com.AlertsLBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 68 7/22/16 11:39 AM
69Eversense CGM User Guide9Alert Descriptions and Actions (continued)App DisplayDescriptionCalibrate NowAppears when it is time for you to calibrate.New Sensor DetectedAppears when the smart transmitter detects a new sensor. The inserted sensor and the smart transmitter must be linked to begin communication.Sensor ReplacementAppears 30, 14, 7, 3, 2, and 1 day before your sensor has completed its 90-day wear period as a reminder to replace your sensor.ActionsDo a fingerstick blood glucose test and enter the reading as your calibration value. DO NOT use an alternative site (such as forearm) to obtain your blood glucose reading. Tap Link Sensor to complete the linking process and begin the 24-hour Warm-Up Phase. You do not need to wear your smart transmitter over the sensor until the Warm-Up Phase is complete.Contact your physician to schedule the removal and replacement of your sensor.NotificationsLBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 69 7/22/16 11:39 AM
70Eversense CGM User Guide1010. Event LogThis section describes how to review and log events to help better track glucose patterns.The Eversense CGM System allows you to log and track events in addition to continually monitoring glucose levels. You can manually enter events that will appear on the trend graph and glucose reports to help you find patterns in your glucose profile.Types of Events:View EventsYou can view past events entered from the EVENT LOG screen.GlucoseMealsInsulinHealthExercise1. Tap Menu > Event Log.The EVENT LOG screen will appear.2. All your 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 want displayed.Note: You can also access the ADD EVENT screen directly from the MY GLUCOSE screen with a single tap anywhere on the graph area.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 70 7/22/16 11:39 AM
71Eversense CGM User Guide10GlucoseEnter and track blood glucose meter tests (test results other than calibrations).1. Tap Menu > Event Log.2. Add an event using the event icon “+” > Glucose.3. Tap Time to enter the correct date and time. Tap Done.4. Tap Glucose to enter the correct blood glucose value. Tap Done.Note: You can enter a BG value between 20 and 600 mg/dL. Entries < 20 mg/dL will be converted to 20, and entries above 600 mg/dL will be converted to 600 for calculation and display purposes.5. Tap Notes to enter any notes. Tap Done.6. Tap Save.7. On the Confirm Glucose pop up box, tap Submit to confirm the glucose event and return to the EVENT LOG screen, or tap Cancel to exit without saving changes or to edit the information before saving.Note: Glucose Events do not replace calibration measurements. You will still have to enter calibration readings.Log Specific EventsLBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 71 7/22/16 11:39 AM
72Eversense CGM User Guide10MealsEnter the type of meal, date and time and carbohydrate count.1. Tap Menu > Event Log.2. Add an event using the event icon “+” > Meals.3. Tap Time to enter the correct date and time. Tap 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 LOG screen. Tap Cancel to exit without saving changes.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 72 7/22/16 11:39 AM
73Eversense CGM User Guide10InsulinEnter the units of insulin according to Time and Insulin type.1. Tap Menu > Event Log.2. Add an event using the event icon “+” > Insulin.3. Tap Time to enter the correct date and time. Tap Done.4. Tap Units to enter the 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 Save to save entry and return to EVENT LOG screen. Tap Cancel to exit without saving changes.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 73 7/22/16 11:39 AM
74Eversense CGM User Guide10HealthEnter the type of health condition, severity, and date and time.1. Tap Menu > Event Log.2. Add an event using the event icon “+” > Health.3. Tap Time to enter the correct date and time.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 EVENT LOG screen. Tap Cancel to exit without saving changes.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 74 7/22/16 11:39 AM
75Eversense CGM User Guide10ExerciseEnter exercise type, duration, and intensity.1. Tap Menu > Event Log.2. Add an event using the event icon “+” > Exercise.3. Tap Time to enter the correct date and time.Tap 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 screen. Tap Cancel to exit without saving changes.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 75 7/22/16 11:39 AM
76Eversense CGM User Guide1111. Glucose Reports and SharingThis section describes the dierent glucose reports available for a summary of your glucose prole. You may choose specic dates or select pre-selected time ranges. Types of reports• Weekly Modal Summary.• Glucose Pie Chart.• Glucose Statistics.Note: Be 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 move across the three dierent reports. You can also email each report as a pdf file by tapping the email icon in the top right hand corner.LBL-0202-01-001 Rev 1_Eversense User Guide_mgdL_R6.indd 76 7/22/16 11:39 AM

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