Instructions for use

Pathmate Coach

1 Introduction

Welcome to the Pathmate Coach!

The Pathmate Coach is a mobile app that supports you in the self-management of cardiovascular risk factors. It provides personalised, evidence-based advice and motivates you to promote healthy lifestyle habits.

This user guide will help you to use the app correctly, understand the functions and ensure that you can realise the full potential of your coaching.

Before using the app, please read the following chapters carefully. They contain important information about:

  • Who produces the app and who is responsible for legal issues
  • Who the app is suitable for and who should not use it
  • How the app works and what functions it offers
  • Security information, possible risks and the correct handling of your data

So, you are well prepared to use the Pathmate Coach safely and effectively.

2 General information

2.1 Manufacturer

The Pathmate Coach is manufactured by Pathmate Technologies AG. The address is: Josefstrasse 219, CH-8005 Zurich

2.2 Authorised representative

The authorised representative for legal and regulatory matters is Pathmate Technologies GmbH, Glücksteinallee 25, 68163 Mannheim.

2.3 Trade name of the medical device

The Pathmate Coach is offered under various names, including:

  • Manoa
  • Sonoa
  • Sanitas Coach

2.4 Contact information

To make sure your start with the app goes smoothly, you can find our contact details here:

E-mail addresses:

Websites:

If you have any questions that are not answered in these instructions for use, you can contact us at any time via these channels.

2.5 Issue date and version of the instructions for use

Date of issue: 26.06.2026 Version: 1.0 (first release)

2.6 Availability of the paper instructions for use

If you would prefer to receive the instructions for use in paper form, please send them by post to the manufacturer's address or by e-mail to the addresses given above. We will send you the printed version within 7 days of receiving your request.

3 Intended purpose

3.1 Intended use

The Pathmate Coach is a smartphone application (app) that provides personalised, evidence-based self-management support for people with cardiovascular risk factors to help them reduce or maintain them.

In the following chapters, the term "digital coach" is used synonymously with Pathmate Coach.

3.2 Intended user and target group

The Pathmate Coach is intended for adults who have an increased risk of cardiovascular disease or want to prevent it.

Excluded from use are

  • Persons under the age of 18
  • Pregnant persons
  • People with mental disabilities
  • People with insufficient language skills

3.3 Clinical indications

The Pathmate Coach was developed to provide personalised, evidence-based self-management support for people with cardiovascular risk factors such as high blood pressure, type 2 diabetes or insomnia.

The app complements existing standard care and in particular helps patients to complete their self-management tasks more easily and regularly.

3.4 Contraindications

The Pathmate Coach is not suitable if one or more of the following conditions exist:

  • Pregnancy: Do not use the app if you are pregnant or think you might be pregnant.

  • Sleep restriction in the sleep module: Do not use the reduced sleep time if one of the following contraindications applies:

    • Epilepsy
    • Bipolar disorder
    • Untreated excessive sleepiness (hypersomnolence)

3.5 Clinical benefit

Using the Pathmate Coach has the following benefits:

  1. Better compliance with self-management activities: The app offers personalised instructions to help you with regular documentation and monitoring, for example when taking blood pressure measurements.
  2. Support with lifestyle changes: The app promotes sustainable changes, for example in exercise and nutrition, through feedback and motivation.
  3. Strengthening self-efficacy: The Pathmate Coach helps you build confidence in your ability to achieve personal health goals and actively manage your cardiovascular risk factors.

3.6 Residual risks and safety instructions

Despite the risk control measures, certain risks remain when using the Pathmate Coach. These include, among others:

  • Incorrect data entry
  • Misinterpretation of the app feedback
  • Limitations of the reminder function
  • Potential threats to data security

Further information on safety instructions can be found in chapter 6.

3.7 Possible side effects

The following side effects may occur when using the Pathmate Coach:

  • Self-monitoring activities, such as taking and recording blood pressure readings, can trigger worrying thoughts.
  • Sleep deprivation can lead to tiredness, drowsiness, memory problems, irritability or difficulty concentrating.

4 Device description

4.1 Device classification

The Pathmate Coach is a mobile application that is considered stand-alone software. According to the requirements of the Medical Device Regulation (MDR, 2017/745) and the Medical Devices Implementation Act (MPDG), the Pathmate Coach is a Class IIa medical device in accordance with Rule 11.

4.2 Supported platforms and system requirements

To use the app, you need a smartphone with the following specifications:

  • Screen resolution of at least 640 x 1136 pixels (portrait format) on a 4" screen
  • Operating system: iOS version 15.0 or higher, or Android version 10.0 or higher
  • Stable internet connection (3G, 4G, Wi-Fi or better)
  • At least 1.5 GB RAM
  • At least 100 MB available free storage space

4.3 Accessories

If you already use one of the following devices or apps to track your blood pressure or activity data, you can connect them to this app:

  • Apple Health
  • Google Fit
  • Fitbit
  • Garmin Connect
  • Health Mate (Withings)
  • Omron Connect
  • Polar Flow

5 Installation and access

5.1 Download and installation

Download the Pathmate Coach app from the Apple App Store or the Google Play Store.

5.2 Registration and login

5.2.1 Registration

To register in the app for the first time, you need an e-mail address that you can access at any time. Please make sure that no other person has access to your e-mail account.

Install and open the app to start the registration process. Select the "Create new account" option on the app's home screen. If you already have an access code (e.g. from your health insurance provider), enter it and follow the instructions in the app. If you do not yet have an access code, you can be notified when your health insurance company offers free access to the app in the future.

Read the terms of use, privacy policy and these instructions for use carefully and confirm in the app if you wish to continue. To complete the registration, enter your e-mail address and choose a secure password. After you have successfully entered your details, you will receive a confirmation email to the address you provided. This may take a few minutes. Please follow the instructions in the email to verify your email address. If you do not receive a confirmation e-mail, check your spam folder ("trash"). If you can't find an email from us there, you can request a new confirmation code in the app. If you repeatedly do not receive an email from us, please contact us directly by email at the relevant address (see above). Once you have successfully confirmed your e-mail address, your registration is complete.

5.2.2 Logging in to the app

If you have already registered in the app with an email address and password (see 5.2.1 Registration), you can log in to the app at any time using your login details. If you change your smartphone, for example,you can log in on your new device with the same login details.

Note: Please remember to only use the app on one smartphone at a time. Simultaneous use on two devices is not possible.

Open the app and select "Log in to existing account" on the home screen to log in with your existing login details. Enter your registered email address and password. In some cases (e.g. after installing the app on a new smartphone), you may need to verify your email address again. In this case, follow the verification process described in section 5.2.1 Registration.

If you have forgotten your password, tap on the option "I have forgotten my password" and follow the instructions in the app. If you have not yet set a password, tap on "I don't have a password" and follow the instructions in the app.

5.3 Connecting additional devices and apps

You can give the app access to compatible fitness trackers, smartwatches or apps so that your blood pressure readings and/or activity data (steps) can be imported and used by the digital coach.

To connect the app to a compatible tracking app, open the "More" menu and select "Connect data sources".

If you have already connected a tracking app or a device to import your data and want to add another data source, you can do this in the "More" menu by selecting "Connect data sources" again.

As soon as you have granted the app access to one of the tracking apps or devices mentioned above, the recorded data is automatically imported into the app. Please note the following information.

  • Please note that your blood pressure and activity data will only be transferred from the moment you activate the connection with the app. All data recorded before this activation will not be imported into the app.
  • The connection enables the automatic import and storage of new blood pressure readings in the app. However, the blood pressure readings in your connected app or device are not continuously synchronised with this app. If you edit or delete data in the connected app, these changes are NOT automatically transferred to this app and must be adjusted manually in the Data section.
  • The transmission of your blood pressure and activity data can vary depending on the manufacturer of your blood pressure monitor, fitness tracker or the connected tracking app. The transfer usually only takes a few minutes, but it can also take up to 60 minutes or even longer in rare cases.
  • Due to technical problems, it may happen that the blood pressure readings are not automatically transferred to the app after a measurement. Always make sure that your readings have been transferred completely and correctly to your blood pressure diary.
  • Make sure that only you use your connected measuring device or fitness tracker and that your device is not connected to multiple accounts. To prevent incorrect data from being imported into the app, do not allow others to use your measuring device or fitness tracker.

6 Warnings and safety instructions

6.1 General safety instructions

The Pathmate Coach is intended as a supportive tool for the self-management of cardiovascular risk factors. It does not replace medical advice, diagnosis or treatment.

  • Always follow the advice of your doctor or medical staff.
  • Do not make independent treatment decisions based solely on app recommendations.
  • Incorrect use of the app (e.g. incorrect data entry, incorrect configuration of reminders) can lead to inappropriate recommendations. Check all entries carefully.

6.2 Data security and protection of privacy

Make sure that the app and the mobile operating system are up to date (install official updates immediately).

To protect personal health data:

  • Use the security functions of your mobile device (e.g. PIN code, biometric authentication).
  • Activate the in-app PIN code function if you want additional access control.
  • Do not pass on your login details or generated access codes to unauthorised persons.
  • Be aware that personal health data may be transferred to third parties when exporting or forwarding reports. Only pass this on to trustworthy recipients, e.g. your doctor.
  • Make sure that your mobile device has adequate protection against malware and unauthorised access.

6.3 Versions of the operating system

The application is only validated for use with official, stable versions of iOS and Android. The use of pre-release versions (e.g. alpha or beta versions) may result in limited functionality or performance changes that may affect the data accuracy or reliability of the device. The manufacturer provides no guarantee and accepts no liability for problems resulting from the use of such versions.

6.4 Restrictions on use

The Pathmate Coach supports you in managing your own health behaviour. Please note the following important information:

  • The Pathmate Coach does not replace medical advice or treatment. The app works with rule*based algorithms and cannot replace an individual assessment by medical professionals.
  • The recommendations in the app are generalised and may not be suitable for everyone. Talk to your doctor before making any significant changes to your medication, lifestyle or therapy.
  • The app does not monitor your vital signs in real time and cannot recognise emergencies or acute medical conditions. If you have health problems or are in an emergency, contact a healthcare professional immediately or call the emergency services.
  • The medication reminder only serves as additional support. Do not rely solely on the app for vital medication. Always follow your doctor's recommendations for taking your medication.
  • In the event of technical problems (e.g. software errors, server failures or a lack of internet connection), the app may temporarily not function properly. Therefore, always check important information from other reliable sources.

7 Maintenance and support

7.1 Software updates and compatibility

To ensure safe and reliable operation, the Pathmate Coach must always be used in its latest available version. Please check the Apple App Store or Google Play Store regularly for updates and install them immediately. Updates may include:

  • Security improvements to protect personal health data,
  • Corrections to known software problems,
  • new or improved functionalities, and
  • Customisations to ensure compatibility with the latest versions of iOS and Android.

If you do not update the app or the mobile device's operating system, functionality may be restricted or data security may be jeopardised.

To ensure safe and reliable use of the application, we recommend regularly updating the iOS or Android operating system on your smartphone. These updates contain important security improvements and ensure the compatibility of Pathmate Coach with current system functions. Please always keep your smartphone up to date to ensure optimum data security and functionality of the Pathmate Coach application.

7.2 Data export and backup

With Pathmate Coach, you can easily export your personal health data (e.g. blood pressure values, blood sugar, HbA1c, sleep data or medication intake). The exported data is created as PDF files. You can save them for your own records or share them with your healthcare professional if required.

We recommend that you export your data regularly - especially before you uninstall the app or delete your account. This will ensure that no important health data is lost.

7.3 Technical support and contact options

If you have technical problems, questions about using the app or requests for help, you can contact Pathmate Technologies AG via the support function integrated in the app or by email (see section 2.4). All enquiries are processed by qualified personnel. Response times may vary depending on the complexity of the enquiry.

8 Operation and functions

8.1 Chat with the digital coach

The chat is the centrepiece of the app. Here you will find all th messages you have exchanged with your digital coach - including pictures, videos or links that your coach has sent you. This chat also provides you with helpful information on how to use the app and its functions.

Note: Your digital coach is not a real person, but a rule-based chatbot - i.e. a text-based dialogue system that you can talk to. The coach tries to accompany you in the conversation and adapt its answers to your needs and habits more and more over time. This can sometimes give the impression that you are talking to a real person - but this is not the case.

Your coach will regularly ask you questions or wait for your feedback. To answer, simply tap on the suggested answer option or use the text field to enter something yourself - for example, text or a number.

8.2 Daily schedule and reminders

Your digital coach helps you to stay on track with your measurements, medication and goals. In the daily plan, you can clearly see all the tasks that are pending for you. When you have completed something, you can simply tick it off - so you can always keep an overview.

Measurement reminders: In your daily schedule, you can set reminders for blood pressure or blood glucose measurements and for recording your sleep. If you have activated push notifications, your Coach will automatically remind you of these tasks.

Medication: If you take medication, you can also enter it in your daily schedule. This allows you to document your intake and the app can remind you to take them if activated. You can switch the medication reminders on or off directly in the daily schedule, depending on what suits you best.

8.3 Personal data and diaries

8.3.1 Personal data

Under "Data" > "Personal data" you will find all the information you have saved about yourself:

  • Name, gender and date of birth
  • Vital data (e.g. weight, height)
  • Details of diagnoses and treatments (e.g. high blood pressure, type 2 diabetes or sleep disorders)
  • Calculated risk values (e.g. heart age)

You can adjust all the details yourself that are not automatically calculated or provided by the app. If you want to update your risk assessments, you can repeat the self-tests under "Programme" as often as you like.

8.3.2 Blood pressure

Under "Data" > "Blood pressure" you will find your blood pressure diary with all your measurements and pulse values as well as notes on your physical well-being.

Add measurement
Tap on "Add entry" to enter a new measurement manually.

  • The date and time are inserted automatically but can be customised.
  • You can optionally add pulse and well-being.
  • The first measurement of the day is automatically marked as the "morning measurement", the second as the "evening measurement". You can change this assignment at any time.

Record measurement with camera
Instead of entering the values manually, you can scan them with the camera on your smartphone:

  1. Tap on "Add entry" and then on the scan symbol at the top right.
  2. Point the camera at the display of your measuring device.
  3. Check in the confirmation dialogue whether the values have been recognised correctly.

For a good result:

  • Ensure there is sufficient light and avoid reflections.
  • Align the measuring device exactly in the marked area.
  • Always check the values before saving.

History and reports
In the overview you can see your history curves and average values for the last 7 days. You can change the period to week, month or year. Via "Export report" you can download a PDF (for saving or printing) or share the report for 48 hours by generating a code for your doctor.

Note: Your doctor can only access the code if you give it to them personally. An internet connection is required to create the code.

Entries and calendar
Under "Entries" you can see all measurements in chronological order. You can edit or delete entries using the pencil symbol. In the measurement calendar, you can see immediately on which days you have taken measurements (left semicircle = morning, right = evening).

8.3.3 Blood sugar

Under "Data" > "Blood glucose" you will find your blood glucose diary with all measured values and your HbA1c history.

Unit and target values
Under "Unit and target values" you can define your measurement unit and your target ranges - in consultation with your doctor or based on the suggested standard values.

Add blood glucose measurement
Tap on "Add entry" to enter your blood glucose value. You can also specify whether the measurement was fasting or after a meal, the time of the measurement (e.g. "Breakfast") and your current well-being. The date and time are automatically applied but can be customised.

Add HbA1c measurement
You can enter your long-term blood glucose under the "HbA1c" tab. You can also change the date and time here.

History and analysis
In the overview you can see trends of your values over the week, month or year:

  • Green = within the target range
  • Orange = above the target area
  • Red = below the target area

Below the diagram you will find a summary of how many values were within the target range.

PDF export and editing
You can save or share your values as a PDF report. You will find all entries under "Entries" in chronological order. You can use the filter to choose between blood glucose and HbA1c values. Use the pencil icon to customise or delete entries.

8.3.4 Sleep

You can document your sleep times and sleep quality under "Data" > "Sleep".

Log your sleep
Tap on "Add entry" to enter your bedtime, wake-up time and sleep duration. You can also enter how you felt in the morning, whether you took a nap and what you did before going to bed. The date and time are set automatically but can be customised.

History and reports
In the overview, you can see your sleep duration, sleep efficiency and average values for the last seven days or longer periods. You can save your sleep diary as a PDF or print it out via "Export report".

Edit entries
Under "Entries" you will find your sleep data in chronological order. You can change or delete entries at any time using the pencil icon.

8.3.5 Medication intake

Under "Data" > "Medication intake" you can see the history of your intakes. You can subsequently mark intakes as "completed" or "not completed" by tapping on the respective intake.

8.4 Personalised programme

8.4.1 Topics and objectives

The digital coach creates an individual coaching programme based on your personal details when you start the app. You can find it under "Programme" > "My topics". There you can see which topic is currently active, which topics will follow next, which topics you have already completed and your progress in each topic. If you tap on a topic, you will receive further information and an overview of your goals. There you will also find behavioural and knowledge goals as well as suitable learning units.

Health programme
In the programme, you can calculate your heart age, assess your risk of type 2 diabetes with a self-test, evaluate your sleep quality and pursue behavioural goals for diet, exercise and relaxation.

Switch topics and goals
You can switch to a different topic or goal at any time:

  1. Select the desired topic under "My topics" or "Other topics".
  2. Tap on "Start topic" and confirm your selection.

If you switch to a new destination, the progress in the current destination is reset - you start again. Only one topic can be active at a time. You can resume paused topics or goals at any time by tapping on the paused goal and selecting "Resume goal".

Repeat topics and goals
If you have completed a topic or goal or a period has expired, you can restart it at any time. The coaching will then start again from the beginning.

Your content
Throughout the coaching programme, the digital coach will provide you with info cards containing important health information. You can find them under "Programme" in the respective module. There you can read info cards at any time, watch videos of the coach and download info cards as a PDF or print them out by tapping on the arrow in the top right-hand corner. This means you always have all the information to hand - even outside the app.

8.5 Further functions

In the "More" menu, you will find various additional areas of the app:

Help
If you have any questions, problems or feedback, you can send us a message directly here. You can also find the instructions for use and frequently asked questions (FAQ) here.

Account
In this section you can change your email address or password, export your data or delete your account. Before you delete your account, we recommend that you export your data so that no important information is lost.

Security
You can activate a PIN code here. If the PIN request is switched on, the app can only be opened after entering your specified code. This protects your data from unauthorised access.

Data protection and legal matters
Here you will find our contact address, the privacy policy, the app's terms of use and an overview of the scientific and professional sources we used to develop the app and its content.

9 Adverse events and reporting

If you notice a serious incident in connection with the app, it is important that you report this immediately.

All serious incidents must be reported to Pathmate Technologies AG and the competent authority in your country.

  • For users in Germany: The Federal Institute for Drugs and Medical Devices (BfArM) is responsible.

    • You can submit reports via the website www.bfarm.de or by e-mail to mp-vigilanz@bfarm.de.

  • For users in Switzerland: Swissmedic is responsible.

    • Notifications are made via the website www.swissmedic.ch or by e-mail to materiovigilance@swissmedic.ch.

By reporting unwanted events, you help to continuously improve the security of the app.

10 Storage and handling

10.1 Requirements for the device

The Pathmate Coach has been developed for mobile devices that fulfil the system requirements listed in chapter 4.3. To ensure that you can use the app safely, make sure that your device fulfils the following requirements:

  • Sufficient free storage space
  • Stable internet connection
  • an operating system version that is supported by the app

10.2 Environmental conditions

The Pathmate Coach is a software-only product and does not require any special storage. The app only works correctly if your device is working properly and the environment is suitable. Please note:

  • Do not use the app in extreme temperatures.
  • Make sure that your device has sufficient battery charge to avoid interruptions.
  • Protect your device from moisture and physical damage.

11 Termination of use

11.1 Duration of use

The digital coaching programme usually runs for 6 to 12 months. If you wish, you can extend the programme. If you decide against an extension, the coaching programme ends automatically. Your user account will be deleted after a transition period in accordance with the privacy policy.

11.2 Deletion of the user account

You can delete your user account at any time via the app. To do this, go to More > Account > Delete account. Here you will also find the option to export your user data beforehand so that no important information is lost.

11.3 Uninstalling the app

To remove the app from your device, please use the corresponding function of the app store from which you originally installed the app (Google Play Store or Apple App Store).

12 Disposal

As the Pathmate Coach is software, there is no physical product to dispose of. The most important points at the end of use relate to data management:

  • Export and save all relevant data before deleting your account or uninstalling the app.
  • After deleting your account, your data will be permanently deleted from the manufacturer's servers in accordance with the applicable retention and data protection regulations.
  • Your mobile device itself must be disposed of in accordance with local regulations for electronic devices.

13 Legal and regulatory information

Pathmate Coach

Basic-UDI: PP 13574 PATHMATECOACH 46

Manoa

Medical device of class IIa
Electronic Instructions for Use (e-IFU):
www.manoa.app/ifu
Manufacturer:
Pathmate Technologies AG, Josefstrasse 219, CH-8005 Zürich
EU Representative:
Pathmate Technologies GmbH, Glücksteinallee 25, 68163 Mannheim
UDI-DI:
1313574MANOA5002
0297 MDR 2017/745

The UDI carrier, build date and serial number, together with the associated symbols, are always available and up to date in the app under More → Data Protection & Legal → Regulatory information.

Sonoa

Medical device of class IIa
Electronic Instructions for Use (e-IFU):
www.sonoa.app/ifu
Manufacturer:
Pathmate Technologies AG, Josefstrasse 219, CH-8005 Zürich
EU Representative:
Pathmate Technologies GmbH, Glücksteinallee 25, 68163 Mannheim
UDI-DI:
1313574SONOA5002
0297 MDR 2017/745

The UDI carrier, build date and serial number, together with the associated symbols, are always available and up to date in the app under More → Data Protection & Legal → Regulatory information.

Sanitas Coach

Medical device of class IIa
Electronic Instructions for Use (e-IFU):
www.sanitas-coach-app.com/ifu
Manufacturer:
Pathmate Technologies AG, Josefstrasse 219, CH-8005 Zürich
EU Representative:
Pathmate Technologies GmbH, Glücksteinallee 25, 68163 Mannheim
UDI-DI:
1313574SANITASCOACH5079
0297 MDR 2017/745

The UDI carrier, build date and serial number, together with the associated symbols, are always available and up to date in the app under More → Data Protection & Legal → Regulatory information.

14 Version history of the instructions for use

Version 1.0 - First release

EUREP

 

 

You can find previous versions of the instructions for use here