User Manual for Android application

User Manual

for

Android application

#i001 • Create an account ...........................................................................................................................8 MINUTES

#i002 • Log in ............................................................................................................................................... 20 SECONDS

#i003.1 • View and edit your profile ...................................................................................................... 30 SECONDS

#i003.2 • Change the time zone ........................................................................................................... 150 SECONDS

#i004 • Obtain additional information ................................................................................................ 10 SECONDS

#i005 • Log out ............................................................................................................................................ 20 SECONDS

#i006 • Accept an invitation .................................................................................................................... 20 SECONDS

#i007 • Invite a contact ............................................................................................................................. 45 SECONDS

#i008 • Give permission to a contact ...................................................................................................60 SECONDS

#i009 • Delete a contact ........................................................................................................................... 20 SECONDS

#i010 • Consult the patient’s dashboard ............................................................................................ 20 SECONDS

#i011 • Quit the patient’s dashboard ................................................................................................... 20 SECONDS

#i012 • Enter blood glucose level without calculating insulin dose ..........................................60 SECONDS

#i013 • Enter missing data .......................................................................................................................40 SECONDS

#i014 • Calculate the insulin dose without carbohydrates ......................................................... 120 SECONDS

#i015 • Calculate the insulin dose with carbohydrates ................................................................ 120 SECONDS

DIABILIVE CORE PRECAUTIONS FOR USE

User Restrictions:

• Not to be used by children under 7 years old.

• Requires sufficient visual acuity, as well as fluency in reading and writing in the language used on the device.

• Requires at least basic computer skills.

• The creation of an insulin therapy protocol, by a doctor or a pharmacist, is essential to activate the calculator.

• Some protocols for insulin pump therapy can’t be used in the application; please contact our support for more information.

Before the first use:

• Read the user manual before any use of the medical device.

• The configuration of the unit of measurement for the protocol in the application must be performed after agreement between the patient and their healthcare professional.

• A connection to the Internet, download and correct installation of the application, as well as payment of the patient’s subscription, are essential for use of the device.

• Remember to test the compatibility of your mobile device or computer by downloading the application DiabiLive, which serves as an interface to the medical device.

• Outside your usual time zone (when traveling with jet lag for example), your insulin calculator is deactivated for security reasons. The DiabiLive team strongly advises you to change the time zone of the application in your profile only when you reach your destination.

• In order to prevent against any computer device failure or any lack of battery, you must always keep the medical prescription in paper format with you.

Conditions of use:

• Rigorous and regular testing of blood glucose level is necessary.

• Remember to always install and use the latest version of the application.

• Use the application preferably in a quiet environment.

• By inviting a caregiver or a healthcare professional to access your account, you agree to give them access to read and enter your medical data.

• Always enter the dose of injected insulin, whether it is the same as or different from the recommended dose and mention the reasons in the associated commentary.

• For better follow-up of your diabetes you should always report to your doctor or to your network the physiological changes, the undesirable effects and any suspicious event such as an abnormal calculated insulin dose.

• In the event of a serious incident related to use of the medical device, contact us immediately and report the incident to the relevant authorities in your country.

• Assistance: for any question or remark, a support service is at your disposal to assist you in the use of the device.

• During maintenance operations, access to the application may be temporarily interrupted.

• Your account data (username, password, credit card ...) must never be communicated under any circumstances. They will never be asked by the manufacturer or distributor. You should never give them this data.

“ Live with diabetes without thinking about the protocol! "

Version of the user manual: v2.2.2Publication date: 04/05/2021

DiabiLive app was designed to help people manage diabetes in their day to day lives.

DiabiLive provides access to the insulin dose calculator DiabiLive Core. It is a medical device designed for any person who has to inject insulin, and all types of diabetes.

DiabiLive Core is used to calculate the basal and mealtime insulin doses to be injected, taking into account all the parameters such as current blood glucose levels, previous blood glucose levels, carbohydrate intake and planned physical activity, according to the medical protocol prescribed by the doctor.

Functions available to the Patient

Functions available to the Caregiver

Functions available to the Healthcare Professional

Functions not available to the Patient

Functions accessible only through DiabiLive Core

Functions not available to the Caregiver

Functions not available to the Healthcare Professional

GO !Download the Diabilive app on the

Apple Store (iOS) or on theGoogle Play (Android).

You can also access the Diabilive Web application at this address:

https://app.diabilive.com

Create your DiabiLive account according to your profile.

Do you need help?Consult the tutorial: #001

Patient Caregiver

Healthcare Professional

Log on to the application DiabiLive with your new user details.

Need help? Consult the tutorial: #002

At the end of your registration, youwill receive a validation email in your inbox. Click on the link to

activate your DiabiLive account.

Pour :

De DiabiLive :

Invite contacts in the application to create your private network, including

healthcare professionals allowed to enter a medical protocol.

Need help? Consult the tutorials: #006 / #007

Patient

CaregiverHealthcare Professional

As a patient connected to a healthcare professional

(diabetologist, doctor,pharmacist), you grant them

permission to manage your medical protocol.

Need help? Consult the tutorial:#008

Patient Healthcare ProfessionalOnce permission has been given,

the healthcare professional can enter the patient’s medical protocol

in the application.

Need help? Consult the web tutorial: #w1000

All users in your network can add data: blood glucose measures, insulin doses,

meals. Serenity Pack: You can now calculate the first dose of insulin.

Need help? Consult the tutorials: #012, #013, #014, #015

Getting started with the DiabiLive application

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5

678

Installation

Ajouter une donnée

Creating an account Validating the account Log in

InvitationsEntering the protocol Accord des droits

The following steps are essential to access the functions available only through DiabiLive Core (the calculator).

#a001 • CREATE AN ACCOUNT IN 10 STEPS

E S T I M A T E D T I M E8 M I N U T E S

2 3 4

5

68910 7

GO !

After launching the application, click on

«Subscribe».

Select your role in the application, then

proceed to the next step.

Enter the information for your profile, then

proceed to the next step.

Fill in the necessary information and create

your login details for the application.

If you are a Patient, enter the information

about your diabetes and enter your glycemic target

Remember to download the Terms of Use, and

tick the box to validate.

Remember to download the Privacy Policy, and tick the

box to acknowledge that you will respect the terms.

Your registration is almost complete, go to your

inbox to open the email containing the activation

link for the account.

Your registration is now completed.

Click on «Sign in» to log in.

Your account is now active; you can log in to the

DiabiLive app!

A

A

BB

AA

BB

#a002 • LOG IN IN 2 STEPS

E S T I M A T E D T I M E2 0 S E C O N D S

Enter your login credentials.On your first entry into

the application, a page is displayed to collect your

consent about the collection of your

navigation data.If you don’t have an account

yet, refer to the tutorial «#a001 Create an account».

If you have forgotten your password, you can request a reset

Welcome, you are logged in.You can now add your first data via the

«+» button, and invite a healthcare professional to enter your medical

protocol in the application.

2

GO !

Journal

AB

#a003.1 • VIEW AND EDIT YOUR PROFILE IN 7 STEPS

Open your profile settings.


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4

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GO !

Edit the information and confirm.

Edit the information and confirm.

B

A

C

Go to the application menu. Click on your profile icon.

#a003.2 • CHANGE THE TIME ZONE

Click on your profile icon.

The application asks you to change the time zone in your profile in order to reactivate the calculator.

E S T I M A T E D T I M E1 5 0 S E C O N D S

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4

67

5

GO !

Open your profile settings.

IN 7 STEPS

Scroll down to find the time zone setting and update it,

then save.

A

B

If there is a time difference detected, the application

informs you that data entry is disabled.

Validate the change in orderfor the application to take into

account the new time zone setting.

Go to the application menu.


2

3

At different locations throughout the application, points of information are

displayed.

#a004 • OBTAIN ADDITIONAL INFORMATION IN 3 STEPS

They provide access to complementary information

(function, calculation, vocabulary, etc.).

GO !


#a005 • LOG OUT IN 3 STEPS

2

3

GO !

Click on «Sign out».

You are disconnected fromthe application.


IN 4 STEPS

2

3

4

GO !

#a006 • ACCEPT AN INVITATION

In the menu, click on «Network».

The invitation request is displayed at the top of the

page. Click on «Yes».

The new contact will appear in the list of your network.

Go to the application menu. Go to the application menu.

#a007 • INVITE A CONTACT IN 6 STEPS


2 3

4

56

GO !

In the menu, click on «Network». Click the «+» icon to add

a contact.

The request will appearunder «Sent invitations»

Go to the application menu.

Enter the email address of a DiabiLive contact.

The invitation request has been sent. Click on «Ok».


IN 5 STEPS

2

3

4

5

#a008 • GIVE PERMISSION TO A CONTACT

Select the contact that you want to edit.

A yellow stamp will appear on the healthcare professionals

who have received your permissions.

Grant the desired permissions, then return

to the contact list.

A

B

GO !


2

3

456

#a009 • DELETE A CONTACT IN 6 STEPS

Select «Delete contact».A confirmation is requested.

The contact will no longer appear in the list of your network. You can return

to the menu.

GO !

In the menu, click on «Network».

In the menu, click on «Network».Go to the application menu. Go to the application menu.

Select the contact that you want to edit.


2

3

From the patient list, click on the desired patient.

Choose a tab to access the patient’s data.

#a010 • CONSULT THE PATIENT’S DASHBOARD IN 3 STEPS

GO !


2

3

This will take you back to your list of patients.

Select «Quit …… profile» located at the bottom of the

screen.

#a011 • QUIT THE PATIENT’S DASHBOARD IN 3 STEPS

GO !

In their dashboard, access the patient menu by clicking the

arrow in the top right.

Access the patient menu by clicking the arrow in the top right.

#a012 • ENTER BLOOD GLUCOSE LEVEL WITHOUT CALCULATING INSULIN DOSE


2 3

4

56

GO !

If «Warning!» appears, refer to tutorial «#a013 Enter Missing Data».

Your blood glucose is compared to the recommendations of your

protocol. Confirm the information received.

From the dashboard, click the (+) at the bottom of the

screen to add data.

Select «Blood glucose».

Enter your blood glucose level in the unit of measurement of your choice. If you wish, you can change the unit of

measurement.

Blood glucose level is automatically entered in both units. The value that is recorded is that of the

medical protocol

You can enter your personal comments.

A B


#a013 • ENTER MISSING DATA IN 5 STEPS

2 3

4

5

If blood glucose data is missing, this message is displayed when you want to calculate your insulin

dose. You can choose to ignore this message or to enter the missing data.

Choose the day and the period you want to complete.

Check the data entry and «Save».

When all data are completed, this message is displayed.

Click on «Ok».

GO !

IN 6 STEPS

If any other data is missing, you are invited to

complete them.You can choose to ignore this request by clicking on «Continue», or complete

the data.

You can now enter your blood glucose level and

calculate the right amount of your insulin dose.

2 3


Select «Bolus Insulin» or «Basal Insulin».

10

GO !

#a014 • CALCULATE THE INSULIN DOSE WITHOUT CARBOHYDRATES IN 10 STEPS

4 5

If necessary, you can specify when your blood glucose was taken by clicking on

«Before» or «After».

6

Your choice is highlighted before validation.

7

8

A new screen will appear if a physical activity has been entered into the protocol.

Indicate if you are planning an activity and validate.

A

B

The result is displayed and explanations of the calculation

are available. Indicate whether you agree with the

recommended dose.

9

You can still adjust the insulin dose by indicating which one

will be injected.

Your blood glucose is compared to the recommendations in your protocol. Click on «Calculate my

insulin dose».


Enter your blood glucose in the unit of measurement

of your choice. You can change the unit by

selecting the second input tab.

Blood glucose is automatically entered in both units. The value that is recorded is that of the

medical protocol.

On the dashboard, click the (+) in the lower right corner of the screen to add data.

Finally, you can enter your personal comments.

A B

2 3


12 11

GO !


#a015 • CALCULATE THE INSULIN DOSE WITH CARBOHYDRATES IN 12 STEPS

4 5 6

7

910

Enter the amount of carbohydrates consumed.Validate the entry.

The result is displayed and explanations of the calculation

are available. Indicate whether you agree with the

recommended dose.

You can still adjust the insulin dose by indicating which one

will be injected.

A new screen will appear if a physical activity has been entered into the protocol.

Indicate if you are planning an activity and validate.

A

B

8

On the dashboard, click the (+) in the lower right corner of the screen to add data.

Select «Bolus Insulin». Enter your blood glucose in the unit of measurement

of your choice. You can change the unit by

selecting the second input tab.

Blood glucose is automatically entered in both units. The value that is recorded is that of the

medical protocol.

If necessary, you can specify when your blood glucose was taken by clicking on

«Before» or «After».

Your choice is highlighted before validation.

Your blood glucose is compared to the

recommendations in your protocol. Click on «Calculate

my insulin dose»

Finally, you can enter your personal comments.

A B

DiabiLive Core:

Version of the medical device: v1.2.0Manufacture date: May 2021

Diabilive Core is a medical device within the meaning of European regulations.This medical device is accessible through the Diabilive applications provided.

This product is developed and maintained by:

AVEC DIABILIVE218-228 Avenue du Haut Lévêque

33600 PESSAC – France

CONTACT :

• For any complaints or malfunctions, please log in to our online support form:https://mirambeauappcare.atlassian.net/servicedesk

• If necessary, you can also contact us at the following email address:[email protected]

ISO 15223-1 :

CE marking To consultinstructions for use

Precautions for useMaker

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User Manual for Android application