Instructions for Use (e-IFU)

1. Intended Purpose and Use

Digipark is a mobile health application (SaMD — Software as a Medical Device) intended for patients with Parkinson's disease and their caregivers. It enables:

• Daily monitoring of motor and non-motor symptoms
• Management and reminders for medication treatments
• Collection of real-world data (PRO — Patient Reported Outcomes)
• Passive activity monitoring via a compatible smartwatch
• Data sharing with healthcare professionals (with consent)
• Access to physical activity programs and therapeutic education

2. Contraindications and Limitations

In case of a medical emergency, immediately call 15 (SAMU) or 112.

Data collected by the application is indicative and cannot substitute for a clinical examination. Therapeutic decisions are the exclusive responsibility of your physician.

3. System Requirements

3.1 — Mobile application

• iOS 15.0 or later (iPhone 8 or newer)
• Android 10.0 or later
• Internet connection (Wi-Fi or mobile data)
• Storage: minimum 200 MB available

3.2 — Smartwatch (optional)

• Apple Watch Series 5 or later (watchOS 8+)
• Compatible Wear OS watches (list available in the application)

4. Installation and First Use

4.1 — Download

Download the Digipark application from the Apple App Store or Google Play Store. The application is free to download.

4.2 — Account Creation

1. Open the application and select "Create an account"
2. Enter your email address and create a secure password
3. Complete your profile (last name, first name, date of birth)
4. Accept the Terms of Use and Privacy Policy
5. Validate your email address by clicking the link sent

4.3 — Initial Setup

On first login, the application guides you through configuring your medical profile: current treatments, desired monitoring frequency, watch connection (optional), and reminder settings.

5. Main Features

5.1 — Smart pillbox

Set up your treatments and receive personalized reminders. Confirm each intake for automatic compliance tracking. Data is available in your history and can be shared with your physician.

5.2 — Symptom journal

Assess your symptoms daily via clinically validated questionnaires: mood, sleep quality, mobility, pain, tremors, fatigue. Each assessment takes approximately 2 to 5 minutes.

5.3 — Activities and well-being

Access physiotherapy exercises in video format, adapted physical activity programs and therapeutic education content. Exercises have been designed with specialized healthcare professionals.

5.4 — Smartwatch monitoring

If you have a compatible smartwatch, activate passive monitoring to automatically collect data on your physical activity, sleep and movements (tremor and bradykinesia detection).

6. Security and Confidentiality

Your health data is encrypted in transit (TLS 1.3) and at rest (AES-256). It is hosted by an HDS-certified host (Health Data Host) located in France.

Access to your data is strictly limited to yourself and the healthcare professionals you have explicitly authorized. You can revoke this access at any time.

7. Vigilance and Reporting

You can also report any incident via the ANSM portal (French National Agency for the Safety of Medicines and Health Products): signalement.social-sante.gouv.fr

8. Maintenance and Updates

DiamPark regularly publishes application updates to fix potential malfunctions, improve performance and add new features. It is recommended to always use the latest available version.

Major updates that may change the behavior of the device are subject to prior notification in the application and an update of this notice.

9. Manufacturer Contact