user manual for ios application

User manual

for

iOS 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

HealthcareProfessional

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

CaregiverHealthcareProfessional

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 HealthcareProfessionalOnce 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& access to the insulin dose calculator DiabiLive Core

2 3 4

5

678

Installation

Adding data

Creating an account Validating the account Log in

Invitations

Entering the protocol Giving permissions

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

#i001 • 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 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

#i002 • LOG IN

Edit the information and confirm by clicking on

«Save».

2 3

4

GO !

#i003.1 • VIEW AND EDIT YOUR PROFILE

Click on yourprofile icon.

A

B

Your profile has been updated. You can go back to

the dashboard.

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 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

B

A

Open your profile settings.

IN 2 STEPS

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


IN 4 STEPS

2 3

4

56

GO !

#i003.2 • CHANGE THE T IME ZONE

If there is a time difference detected, the application

informs you that data entry is disabled. The application asks you to change the time zone in your profile in order to reactivate the calculator.


Validate the change in order for the application to take into account the new

time zone setting.

Your profile has been updated. You can go back

to the dashboard.

They provide access to complementary information

(function, calculation, vocabulary, etc.).

At different locations throughout the

application, points of information are

displayed.

2

GO !

#i004 • OBTAIN ADDITIONAL INFORMATIONIN 6 STEPS

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

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

BA

IN 2 STEPS


Open your profile settings.

#i005 • LOG OUT

You are disconnected from the application.

2

3

GO !


Scroll down and click on «Sign out».

2

3

4

GO !

In the menu, click on«Network».

When a contact sends you an invitation request, a blue dot is displayed on the bottom right corner of the screen.

Click on your profile icon.

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

#i006 • ACCEPT AN INVITATION

The invitation request is displayed at the top of the

page. Click on «Yes» to accept the invitation request.

IN 3 STEPS


IN 4 STEPS


#i007 • INVITE A CONTACT

Click the «+» icon to add a contact.

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

You return to the Dashboaord.

In the menu, click on«Network».

2 3

4

56

GO !


Enter the email address of a DiabiLive contact.

A

B

IN 6 STEPS


#i008 • GIVE PERMISSION TO A CONTACT

2

3

4

5

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 !


In the menu, click on «Network».

2 3

4

6 5

GO !

A confirmation isrequested.

The contact will no longer appear in the list of your

network. You can return to the menu.

#i009 • DELETE A CONTACT


In the menu, click on «Network».

Select the contact that you want to edit.

Select«Delete the contact».

IN 5 STEPS


IN 6 STEPS


2

3

GO !

From the patient list, click on the desired patient.

In their dashboard, access the patient menu by

clicking the arrow in the top right.

Choose a tab to access the patient’s data.

#i010 • CONSULT THE PATIENT’S DASHBOARD

2

3

GO !

#i011 • QUIT THE PATIENT’S DASHBOARD

This will take you back to your list of patients.

Access the patient menu by clicking the arrow in the

top right.

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

screen.

IN 3 STEPS

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

2 0 S E C O N D S

IN 3 STEPS

GO !

#i012 • ENTER BLOOD GLUCOSE LEVEL WITHOUT CALCULATING INSULIN DOSE

Enter your blood glucose level in the unit of

measurement of your choice. If you wish, you can change the unit of

measurement.

From the dashboard, click the «+» at the bottom of the screen to add data.

2 3

4

56

You can enter your personal comments.

A

B

C

Blood glucose level is automatically entered in

both units. The value that is recorded is that of the

medical protocol.

Your blood glucose is compared to the

recommendations of your protocol. Confirm the information received.

Select “Blood glucose“.

#i013 • ENTER MISSING DATA

D

IN 6 STEPS



IN 5 STEPS

Choose the day and the period you want to

complete.

Fill in the requested data and save.

If any other data is missing, you are invited to

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

data.

You can now enter your blood glucose level and

calculate the right amount of your insulin dose.

When all data are completed, this message

is displayed.Click on «Ok».

2

3

4

5

GO !

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.

A

B

2 3GO !

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

If this message is displayed, go to «#i013 Enter missing

data».

Enter your blood glucose in the unit of measurement

of your choice. You can change the unit by

selecting the second input tab.

#i014 • CALCULATE THE INSULIN DOSE WITHOUT CARBOHYDRATES

10

You can still adjust the insulin dose by indicating

which one will be injected.

Finally, you can enter your personal comments.

A

B

C

D

4 5 6

Blood glucose is automatically entered in


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.

7

89Your blood glucose is compared to the

recommendations in your protocol. Click on «Calculate

my insulin dose».

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

Indicate if you are planning an activity and validate.

The result is displayed and explanations of the calculation are available. Indicate

whether you agree with the recommended dose.

IN 10 STEPS


Select «Bolus Insulin» or «Basal Insulin».

2 3GO !

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

Enter your blood glucose in the unit of measurement

of your choice. You can change the unit by

selecting the second input tab.

#i015 • CALCULATE THE INSULIN DOSE WITH CARBOHYDRATES

12 11

You can still adjust the insulin dose by indicating

which one will be injected.

Finally, you can enter your personal comments.

A

B

C

D

The result is displayed and explanations of the calculation are available. Indicate

whether you agree with the recommended dose.

4 5 6

Blood glucose is automatically entered in


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.

7

8910

Your blood glucose is com-pared to the recommenda-tions in your protocol. Click

on «Calculate my insulin dose».

Enter the amount of carbohydrates consumed.

Validate the entry.

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

Indicate if you are planning an activity and validate.


IN 12 STEPS

If this message is displayed, go to «#i013 Enter missing

data».

Select «Bolus Insulin».

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 mark Consult instructionsfor use

Precautions for useManufacturer

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