Dalia Monitoring

The Dalia patient app supports you daily in managing your depressive symptoms.

With this app, you can:

- Regularly share information about your condition with your healthcare team by completing questionnaires,
- Link your account to the smartwatch provided by your healthcare team,
- View your physiological data collected from your watch and automatically transfer some of it to your healthcare team,
- Receive reminders and access emergency contact information.

Dalia facilitates communication with your healthcare team for personalized monitoring.

General Information:

Dalia Monitoring is a medical device manufactured by Dalia Care (SRN: FR-MF-000046299), located at 16 RUE EUGENE VARLIN 75010 PARIS, France. It is designed for use by healthcare professionals to remotely monitor adult patients with depressive symptoms in their clinical setting.

Not intended for emergency use
Dalia Monitoring is not intended for emergency situations or acute crisis management. The device is not designed for emergency management or crisis intervention.
Patients experiencing suicidal thoughts, severe distress, or acute psychiatric symptoms should immediately contact emergency services: 3114 (French national suicide prevention hotline) or 15/112 (medical emergencies) or their local emergency number.

Use environment:
Dalia Monitoring uses patient input data collected in personal environments: home, workplace, outdoors, etc.
Data collection takes place during everyday life and routine activities.
Collecting input data requires:
• A smartphone (iOS or Android) with internet access for completing questionnaires and synchronizing the connected device - with the following supported versions: Minimum iOS Version: iOS 16.0 or later; Minimum Android Version: Android 12 (API level 31) or higher
• Compatible wearable device for daily activities

Contraindications:

Population-related contraindications
• Patients under 18 years of age - The system is designed and validated exclusively for adult patients. Alternative solutions should be considered for minors.

• Patients unable to understand French - All questionnaires, instructions, and safety information are provided only in French.

Clinical situation-related contraindications
• Acute psychiatric emergencies or crisis situations requiring immediate in-person medical intervention - Dalia Monitoring is not designed for emergency management or crisis intervention. Patients experiencing acute distress, suicidal crisis, or severe psychological decompensation should immediately contact emergency services (3114 in France or their local emergency number).

Technical contraindications
• Patients without reliable internet access - Data transmission requires continuous internet connectivity.

• Patients with severe physical disabilities that prevent them from wearing or using a connected device/mobile application as intended, rendering part of the system unusable despite clinical need.

• Patients unable to wear or maintain a connected device – Physical limitations preventing proper use of the device.

User manual included with the application.

DM V2.1.0
UDI: (01)3760424980025(8012)v2.1.0(11)20260310