User Manual

Last updated: April 23, 2026

Ainoha App v1.3.4

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Portuguese (PT) - Instructions for use

Romania (RO) - User Guide

Manufacturer

Ainoha, LLC

Address

25 Beethoven Street, 38400 Saint-Martin-d’Hères, France

SIRET

940 585 953 00018

Contact

romain@ainoha.fr

Device

Ainoha App

Version

v1.3.4

Classification

Class I medical device — CE

UDI

(01) 03770042588008 (11) 1.0.0

EUDAMED SRN

FR

Online User Manual

ainoha.fr/ifu

Publication date

April 23, 2026

IFU Version

1.0

Attached documents

CE Marking Certificate (PDF)

EU Declaration of Conformity (PDF)

⚠ IMPORTANT WARNING — Please read this guide carefully before using the Ainoha app. The Ainoha app is a Class I medical device. It is not a substitute for a professional medical consultation.

1. Destination and Target Audience

The Ainoha app is a personal tracking tool designed for adult women (18 and older) in perimenopause who wish to monitor their symptoms on their own.

The Ainoha app is NOT intended to diagnose, prevent, monitor, treat, or compensate for a disease or disability. It does not provide clinical decision support and is not a substitute for medical advice.

1.1 Intended User

Adult women (18 years and older) in the perimenopausal phase. No medical training is required to use the app.

1.2 Terms of Use

  • Personal and non-clinical use
  • On a personal mobile device (smartphone or tablet)
  • Except in cases of medical emergency
  • With an internet connection for updates and educational content

2. Description of features

2.1 Monitoring of symptoms

The app allows users to record their daily symptoms from a predefined list of 50 items associated with perimenopause, including: hot flashes, night sweats, sleep disturbances, mood swings, fatigue, memory problems, vaginal dryness, joint pain, palpitations, and other related symptoms.

2.2 Data Visualization

The recorded symptoms are displayed as graphs showing changes over time. These graphs are for strictly personal use and may be shared, at the user’s discretion, with a healthcare professional for informational purposes only.

2.3 Well-being Monitoring (Facial Scan)

The facial scan feature uses the mobile device’s front-facing camera to estimate a general indicator of well-being (stress, fatigue). The app displays only a binary result: “within the normal range” or “outside the normal range.”

This indicator is a general estimate and DOES NOT CONSTITUTE a medical diagnosis. It should not be used to initiate, modify, or discontinue treatment.

2.4 Educational Content

The app offers a library of wellness articles and videos created by experts (in nutrition, sophrology, hypnotherapy, hormonal yoga, sexology, etc.). This content is provided for general informational purposes only.

2.5 Aino Chatbot

The Aino chatbot provides general information about perimenopause and personalized encouragement. Aino does not interpret symptoms or provide personalized medical advice.

3. Instructions for Use

3.1 Download and Installation

The Ainoha app is available for free on the App Store (Apple) and the Google Play Store (Google). Search for “Ainoha” in the app stores and follow the standard installation instructions.

3.2 System Requirements

iOS

Version 15 or later

Android

Version 10 or later

Front-facing camera

Required for facial scan

Lighting

Normal conditions (facial scan)

Log in

Recommended Internet connection

3.3 Daily Use

  • Step 1: Open the app and log in
  • Step 2: Select the symptoms you are experiencing from the list of 50 items
  • Step 3: Confirm the daily entries
  • Step 4: View your data trends in the Charts tab
  • Step 5 (optional): Perform the facial scan under normal lighting conditions for 30 seconds

3.4 Facial Scan — Terms of Use

  • Position your face in front of the front-facing camera, about 12–20 inches away
  • Make sure you are in a well-lit room (with even natural or artificial light)
  • Stay still for 30 seconds
  • If no result is available, check the lighting conditions and try again

4. Warnings and Precautions

⚠ This information is not a substitute for medical advice. If you have any concerns about your health, consult your doctor or a healthcare professional.

⚠ If you experience concerning symptoms or your condition worsens, consult a healthcare professional immediately. Do not wait for the app’s results.

⚠ Do not use this app in a medical emergency. Call 15 (SAMU) or 112 in an emergency.

⚠ The well-being indicator derived from the facial scan should never be used to initiate, modify, or discontinue medical treatment or medication.

4.1 Limitations of the application

  • The app does not diagnose any medical conditions
  • The data collected is self-reported and based on the user's personal perception
  • Facial scanning works only under the right lighting conditions
  • The educational content is general information and is not tailored to the individual circumstances of each user
  • The app is not intended for use in clinical or hospital settings

5. Personal Information and Privacy

The health data collected by the app is processed in accordance with Regulation (EU) 2016/679 (GDPR).

5.1 Data Collected

  • Symptoms selected daily
  • Facial scan results (binary indicator only)
  • App usage data (frequency, session duration)

5.2 Storage and Safety

  • The data is stored locally on your device and/or on secure servers
  • Facial scan processing is performed entirely on your device (on-device) — no images are transmitted
  • Communications are encrypted (HTTPS)
  • Your data is protected by authentication

5.3 Your rights

In accordance with the GDPR, you have the right to access, correct, delete, and transfer your data. To exercise these rights: romain@ainoha.fr

Full Privacy Policy: ainoha.fr/privacy-policy

6. Maintenance and Updates

The Ainoha app requires no maintenance on your part. Updates are available through the App Store and the Google Play Store. We recommend keeping the app up to date to take advantage of the latest improvements and bug fixes.

If you encounter a malfunction: contact our support team at romain@ainoha.fr. Do not use the data displayed if the app is behaving abnormally.