Senseonics orporated 3400 The Eversense Smart Transmitter User Manual 2

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Date Submitted	2016-08-26 00:00:00
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3. 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.
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6. A CONFIRM CALIBRATION screen
appears. Make sure that the fingerstick
blood glucose test result you entered is
correct.
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.
•	Tap Cancel to go back and re-enter
the correct time or glucose test result.
•	When correct, tap Submit.
Note: There may be conditions when
your calibration result is NOT accepted.
See Calibrating the System for more
information.
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.
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7. Using the App
This 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 Settings
You 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:
•
•
•
•
•
38
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.
I f you have your mobile device set to Do No Disturb, you will not
hear any notifications from the Eversense app.
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Get To Know the “My Glucose” Screen
The 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.
Menu icon
Temp Profile
Smart Transmitter ID
Current glucose reading
Status bar
Smart Transmitter battery power
Smart Transmitter connection to sensor
Trend arrow
Unit of measurement
Date and time
Calibration mark
Multiple events mark
Event mark
High Glucose Alert level (Top red dashed line)
High Glucose Target level (Top green dashed line)
Low Glucose Target level (Bottom green dashed line)
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.
Low Glucose Alert level (Bottom red dashed line)
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7
Status 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 different 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
Calibrate
Alert History
Event Log
40
Reports
Share My Data
Placement Guide
Connect
Settings
About
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Trend Arrows
There are 5 different trend arrows that show the current direction of your glucose levels, and how fast they are changing.
Gradually 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.
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.
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Trend Graph
The 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 different 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 different 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.
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Menu Options
The Menu icon (
available:
) appears at the top left corner of all app screens and provides easy navigation to other app features. The following menu items are
Menu Options
Description
My 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
Guide
Check 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.
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8. Customizing your Settings
This 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 affect 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 Levels
The 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.
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Warning:
• 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 different 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.
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Setting Glucose Target Levels
Glucose 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.
Default
setting
Low: 8 0 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.
46
Allowable
setting
Low: 65 - 120 mg/dL
On/Off
setting
Always ON
(cannot be turned OFF)
Notes
Used in graphs and charts
on the app to show time
spent in 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.
High: 120 - 345 mg/dL
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Setting Glucose Alert Levels
Your 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
setting
Low: 7 0 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
setting
Low: 6 0 - 115 mg/dL
On/Off
setting
Always 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.
High: 125 - 350 mg/dL
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Setting Predictive Alerts
Predictive 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.
Default
setting
Allowable
setting
10, 20, or 30 minutes prior
On/Off
setting
You can turn this feature ON.
No predictive alerts will
occur until this feature is
turned ON. The default is
20 minutes.
Notes
48
OFF
1. To turn this feature ON, tap Menu >
Settings > Glucose to display the
GLUCOSE SETTINGS screen.
2. 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.
Audio notification and
visual alerts on your mobile
device and smart transmitter
on-body vibe alerts.
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Setting Rate of Change Alerts
The Rate of Change Alerts let you know when your glucose level is falling or rising faster than the Rate Alert setting you choose.
Default
setting
Allowable
setting
On/Off
setting
Notes
OFF
1 - 5 mg/dL per minute
You can turn this feature ON.
No rate of change alerts will
occur until this feature is
turned ON.
1. To turn this feature ON, tap Menu >
Settings > Glucose to display the
GLUCOSE SETTINGS screen.
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.
Audio notification and visual
alerts on your mobile device
and transmitter vibration
alerts.
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Setting Daily Calibration Times
The 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
4. When both times are correct, tap Save.
calibration time.
•	Tap Done when complete.
3. Tap Evening to set your evening
calibration time.
•	Tap Done when complete.
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Setting System Information
The 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.
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Setting Mealtimes Schedule
The 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.
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Setting Sounds
The 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 off, you will not hear any
sounds from the app.
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By setting the snooze alert, you can set how often an alert repeats after
you have received a Low Glucose and High Glucose alert.
The SOUND SETTINGS screen also allows you to enable and
disable the Do Not Disturb mode.
3. Tap each snooze alert to set how often the alert repeats.
• Do Not Disturb. Places the smart transmitter in a “Do Not Disturb”
Tap Done when complete.
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.
Note: When you enable Do Not Disturb mode on your mobile device
you will not receive any alerts or notifications from the Eversense app.
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Setting Temporary Profile
During activities or conditions outside your normal routine, you may wish to temporarily use glucose settings that are different 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 Profile
to display the TEMP PROFILE screen.
2. Select the duration. You can set a Temp
Profile for up to 36 hours in 30 minute
increments.
3. Set the High and Low Targets and High
and Low Alert levels desired.
Tap START.
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The Temp Profile selections cannot be
changed when the duration has been started.
While a Temp Profile is active, the Temp
Profile icon will be displayed on the
MY GLUCOSE screen.
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 Profile
and tap STOP.
Temp
Profile
icon
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Logging out
To 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.
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9. Alert Descriptions
This section describes the various alerts and notification 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.
58
Alerts and Notifications
Smart Transmitter
Vibration Pattern
Alerts where no glucose values can be displayed
Requires immediate and appropriate action.
3 long vibes
MESSAGE APPEARS IN YELLOW
Alerts related to Low readings
Low 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 readings
High 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 issues
Requires some action but may not be as critical in nature. See following
section for examples.
1 short vibe
MESSAGE APPEARS IN YELLOW
Notifications
Requires some action but not critical in nature. See following section for
examples.
1 short vibe
MESSAGE APPEARS IN BLUE
App Alert Indicators
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