SERENE is medical remote monitoring software designed to allow healthcare professionals to remotely monitor the health status of their patients. The system is made up of two main elements. First, a web application allowing the practitioner to visualize the evolution of their patients' constants, generating alerts if these constants exceed a threshold, previously defined and personalized by the practitioner. Second, a mobile application allowing the patient to measure their constants with or without connected devices and to complete a questionnaire on their state of health. The main elements that make SERENE a medical device lie in its ability to supervise and generate alerts based on the constants sent by the patient to their practitioner.

The mode of consultation of the Instructions for Use is electronic. Instructions for Use are available in the “Regulatory Information” section at the bottom of the “Definitions” page. When the user clicks on the “SERENE Notice” button, a new browser tab will open. The Instructions for Use are available in PDF format.
Additional information:
- Device name: SERENE
- UDI-DI: (01)03770035627011
- Manufacturer:
- APX Integration operating under the Axians brand
- Address: 2, Avenue de l’Aérodrome de Montaudran
- Postal Code: 31100
- City: Toulouse, FR
- Email: [email protected]

We inform our users that these electronic instructions can be consulted in this digital format on the SERENE web application. However, the user also has the right to request the manufacturer's instructions in paper format at no additional cost.

Minimum recommended hardware for smartphones and tablets:
Operating system: Android 10.0 or iOS 14.0 (or newer).
Processor: Quad-core 2.0 GHz or faster.
RAM: 4 GB or more.
Disk space: 1 GB of free space.
Internet connection: Stable connection of 5 Mbps or more.

Users can view this information on their device: Device settings (computer, smartphone, or tablet) allow users to check the operating system, processor, RAM, and available disk space.

The user must contact the manufacturer using the following email address: [email protected] by requesting the paper format of these electronic instructions. The deadline for obtaining these instructions is 7 days from the user's request.