User Manual

Last updated: April 23, 2026

Ainoha App v1.3.4

French - Instructions for Use

English (US) - User Manual

Spanish (ES) - Instructions for Use

Finnish (FI) - User Manual

German (DE) - User Manual

Bulgaria (BG) - Instructions for Use

Italian (IT) - User Manual

Lithuania (LT) - User Manual

Poland (PL) - User Manual

Portuguese (PT) - Instructions for Use

Romania (RO) - User Manual

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-MF-000053559

Online Instructions for Use

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 these instructions carefully before using the Ainoha app. The Ainoha app is a Class I medical device. It is not a substitute for professional medical consultation.

1. Purpose and Target Audience

The Ainoha application is a personal tracking tool designed for adult women (18 years and older) in perimenopause who wish to monitor the progression of their symptoms for personal use.

The Ainoha application IS NOT intended to diagnose, prevent, monitor, treat, or compensate for any 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 perimenopause. No medical training is required to use the application.

1.2 Terms of Use

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

2. Description of Features

2.1 Symptom tracking

The application enables daily tracking of symptoms from a predefined list of 50 perimenopause-related items, including: hot flashes, night sweats, sleep disturbances, mood swings, fatigue, memory issues, vaginal dryness, joint pain, palpitations, and other associated symptoms.

2.2 Data Visualization

Recorded symptoms are displayed as graphs showing their evolution 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 stores and follow the standard installation instructions.

3.2 System Requirements

iOS

Version 15 or later

Android

Version 10 or later

Front 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 Daily Input
  • Step 4: View the evolution of your data 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 camera, 30-50 cm away.
  • Make sure you are in a well-lit room (with uniform natural or artificial light)
  • Remain still for 30 seconds
  • If the result is unavailable, 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 a worsening of your health, consult a healthcare professional immediately. Do not wait for the application'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 Limits of the application

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

5. Personal Data 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)
  • Application 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 image is 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/politique-de-confidentialite

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.

In case of malfunction: please contact our support at romain@ainoha.fr. Do not use the displayed data if the application exhibits abnormal behavior.