Instructions for use

Mindpax M2

 

General information

This guide is for both versions of the Mindpax M2 app: the Android app and the iOS app, as well as the web portal for doctors. It contains important information about the intended use, contraindications, side effects of using the system, basic information about the system, risks and benefits of use, and requirements for use. Please read the entire manual carefully before use. 

Intended purpose and clinical benefit

The Mindpax M2 product is a system for long-term and continuous monitoring of psychiatric patients to provide psychoeducational reports to increase patient competence in self-management, prevent relapse and prolong remission time.

In addition, mental health professionals (doctors, psychiatrists, psychologists, psychotherapists) have access to the data collected for diagnostic and therapeutic support.

Target user groups and indications

The target group is adult patients (age > = 18 years) with the diagnosis:

– Schizophrenia (F20, F25): symptoms of the illness are monitored using early warning symptom questionnaires completed by patients and caregivers.

– Mood disorders (F3x): symptoms of illness are monitored using a commercially available activity meter and patient-completed affective disorder symptom questionnaires.

The properties of Mindpax M2 vary according to the patient’s diagnosis.

Contraindications

There are no contraindications to using the Mindpax M2 system. In the case of dual diagnoses or combinations of specified diagnoses with other diagnoses, the expected outcome of using the system cannot be guaranteed.

In case of serious changes in the patient’s health, including suicidal ideation, it is necessary to consult the use of the system and further appropriate action with the attending psychiatrist.

Details of the intended purpose

The Mindpax M2 system always consists of 2 software components – a mobile application and a web application. Other features of the Mindpax M2 system vary according to the patient’s diagnosis. The relevant information displayed and collected pertaining to a given diagnosis is specifically described below[1] .

F3x:

      • The Mindpax M2 system measures and displays the symptoms of a given disease using a questionnaire in an app installed on the patient’s smartphone.
      • Symptoms of illness are monitored using a commercially available activity meter and questionnaires completed by patients tracking symptoms of affective disorders.
      • Activity and rest are measured by a commercially available activity meter with a specific output. The meters are used as accessories for patients diagnosed with F3x to collect and display physical activity data.
      • The system includes regular receipt of psychoeducational materials relevant to the patient’s diagnosis.

F20, F25

      • The Mindpax M2 system measures and displays the symptoms of a given disease using a questionnaire in an app installed on the patient’s smartphone.
      • Symptoms of the disease are monitored using questionnaires tracking early warning signs of the disease. The questionnaire is completed by patients and their caregivers.
      • The system includes regular receipt of psychoeducational materials relevant to the patient’s diagnosis.

No special maintenance is required for the measurement of symptoms in the Mindpax M2 system and the user does not need to perform any additional calibration of the measurement.

Side effects

There are no known side effects of using Mindpax M2. In the event that any side effects associated with the use of Mindpax M2 are noted, the treating psychiatrist (or specialist) should be contacted and the company contacted at info@mindpax.me.

Using the Mindpax M2 system

The Mindpax M2 system is used to continuously monitor the long-term development of the patient’s disease and provide feedback and psychoeducational suggestions relevant to the course of the disease. The system includes the following:

System components

      • A mobile app used by patients to provide a detailed overview of completed questionnaires, medication, psychosocial factors and visualization of actigraphic data (in case of F3x diagnoses) running on Android or iOS systems. The app provides feedback on measured parameters and displays psychoeducational suggestions relevant to the diagnosis.
      • A web application that shows the doctor all the information relevant to the diagnosis, which the patient enters into the application or the application collects using the attached activity meter.

Accessories

      • Mindpax-approved commercial products providing long-term sleep and physical activity data in a Mindpax-approved format that meets the needs of the Mindpax M2 application, such as actigraphic meters or similar (see Appendix).

Mobile applications

Installation and login

The Mindpax M2 mobile app can be downloaded in the normal way via the designated platform (Google Play or Apple App Store). Information on how to create a user account is provided directly in the app. Once the user account has been successfully created, the user can log in using the selected login credentials. The app is secured with a pin chosen by the patient. This pin (or faceID or touchID) is required by the app after 30 minutes of user inactivity in the app.

Using the application

The Mindpax M2 mobile app enables the collection and display of diagnosis-relevant data. It helps users adhere to timely medication and track important events that may affect the course of their disease. It also displays psychoeducational materials depending on the progression and stage of the patient’s disease.

The use of the application varies depending on the patient’s diagnosis.

Using the application and the data displayed during F3x diagnosis

Displayed data

The app graphically displays the current course of the patient’s disease calculated from the results of the questionnaire and activity meter. This progression is shown for the current period as well as for the historical period. At the same time, relevant data entered by the patient is displayed in the application. The patient is able to enter into the application the medication used and record changes in it, as well as significant events and their tendency to affect his/her health. All data collected by the questionnaire, activity meter or entered by the patient is displayed in separate reports and also in a long-term overview where the impact of medication changes or events on the patient’s health can be compared. 

Psychoeducational messages

The patient receives a short psychoeducational message containing educational material relevant to the patient’s diagnosis on a regular basis. At the same time, based on the collected data from the questionnaire and the activity meter, if the patient deviates from his/her norm, an additional psychoeducational message is sent to the app adjacent to the measured changes in the patient-reported data.

Questionnaires

Questionnaires are objects with a defined pattern for the user interface, consisting of predefined questions and user answers filled in on a regular basis. All questionnaires have automatically set notifications.

User profile

In the application settings, you can change the personal data entered during registration. It is also possible to export and download the patient’s health data or share the data with the attending physician using a unique code. Another section of the settings allows you to link the app to an activity meter.

Any information entered by the patient into the app, results of completed questionnaires or data from the activity meter are also displayed in the treating physician’s web app. The patient must give consent for this linking using a unique code.

Application use and data displayed in F20 and F25 diagnosis:

Displayed data

The application graphically shows the current course of the patient’s disease calculated from the results of the questionnaire. This progression is shown for the current period and for the historical period. At the same time, relevant data entered by the patient is displayed in the application. The patient has the possibility to enter into the application the medication used and to record changes in it, as well as significant events and their tendency to influence his/her health status. All the data collected by the questionnaire or entered by the patient is displayed in separate reports and also in a long-term overview where the impact of medication changes or events on the patient’s health can be compared.

Psychoeducational messages

The patient receives a short psychoeducational message containing educational material relevant to the patient’s diagnosis on a regular basis.

Questionnaires

Questionnaires are objects with a defined pattern for the user interface, consisting of predefined questions and user answers filled in on a regular basis. All questionnaires have automatically set notifications. When a patient exceeds a predefined sensitivity threshold, a so-called alert period of at least 3 weeks is triggered. During this period, the intensity of the displayed questionnaire increases. The patient’s alert period is terminated after a predetermined number of questionnaires reporting a stable state have been sent.

User profile

In the application settings, you can change the personal data entered during registration. It is also possible to export and download the patient’s health data or share the data with the attending physician using a unique code.

Web portal for doctors

Installation and login

The web portal is accessible at the public address clinic.mindpax.me using standard web browsers. Information on creating medical access can be found at www.mindpax.me.

Using the web portal for doctors

The physician portal is used by physicians to manage patients, continuously monitor and evaluate their collected data (questionnaires, actigraphy data, medications, life events).

The user interface contains tabs with individual functionalities accessible by clicking Patient Detail on the patient list page.

The patient list contains basic information about patients and their data. Patient Detail contains detailed data about the patient. All displayed information is entered by the patient using the mobile app or collected by the activity meter (for relevant indications). The patient detail displays relevant information for the diagnoses in the form of a chart or active icons with detail. All information is displayed in a timeline. The information displayed in the patient detail is the same data that the patient sees in the application, adds to the application or collects using questionnaires or activity meters.

The “Patient Information” section then provides an overview of basic physiological data, including other relative data that may affect the course of the patient’s disease.

Risks and benefits

The Mindpax M2 system is designed for use in standard patient living conditions and standard medical care. By using the system, the patient will gain a better understanding of their disease, daily routine and health status. The patient’s awareness can lead to better management of their own disease. When data on the course of disease symptoms is shared with the treating physician, it will support joint decision making about the treatment of the patient’s disease and therefore to achieve possible positive clinical outcomes. The risks identified in the risk analysis are assessed as negligible and do not affect the effectiveness of the system when used as recommended.

The benefits to the patient are not of limited duration. Side effects are unknown.

Important information and warnings for users

Treatment while using Mindpax M2

Mindpax M2 displays basic information relevant to the patient’s diagnosis and its comparison with the reference period. These values are informative and complementary to the patient’s already established treatment. The information from Mindpax M2 does not provide sufficient information to determine the patient’s diagnosis. The determination of the patient’s treatment can be adjusted based on the Mindpax M2 data, but the information from the system should not be the sole determining criterion for the patient’s treatment choice. The Mindpax M2 system does not provide all the relevant data needed to make a decision about the patient’s next course of treatment. The system serves to support the treatment process and to support decision-making about the patient’s future course of treatment. The information from Mindpax M2 does not provide information to predict disease progression.

The data displayed in the web application for doctors is always subjectively overshadowed by the patient’s experience. Therefore, this data cannot be considered an objective assessment of the course or condition of the disease. The patient’s subjective influence on the displayed data must always be taken into account.

The Mindpax M2 system is not used to determine medication doses or to monitor the medication taken by the patient. The Mindpax M2 system should not be used by the patient to change the dose of medication taken. Adjustments to medication are only ever possible in accordance with the decision of the attending physician.

Adjustment of the treatment process and self-management of the disease

Only the attending physician can determine the modification of the treatment process. Data and information from the Mindpax M2 system can be used to help the doctor adjust the treatment process. Displaying the historical course of the disease or visible changes in the patient’s condition following a change in medication or patient life events can assist the physician in determining the next course of treatment.

The patient should always consult his/her treating physician about adjusting his/her regimen. Based on the information from the Mindpax M2 system, it is possible to check the regularity of the patient’s circadian rhythm (for relevant indications), the effect of medication changes or the influence of life events on the patient’s health and disease course. Thanks to this information, the patient himself can learn to better predict the course of his own disease. At the same time, psychoeducational materials sent to the patient’s mobile app are also used to better understand the disease. The patient should always consult the newly acquired knowledge and experience with the treating physician before deciding to modify his/her lifestyle in order to stabilise his/her health.

Use of activity meters for relevant indications

For relevant diagnoses (F3x), the use and wearing of sensors or activity meters (actigraphic meters) is essential. These meters must be approved by Mindpax as compatible devices with the Mindpax M2 system. The meters provide activity and rest information that is relevant to the diagnosis.

The meter must be worn practically continuously. Putting the device away is recommended only in situations that interfere with the safe use of the device (certain sports activities, exposure to excessive temperatures, immersion in water, etc.), or charging or changing the meter battery. These situations may include acute changes in the patient’s health that interfere with the use of the meter (skin problems, broken limbs, acute changes in mental status, etc.). Contraindications to the use of the meter are always mentioned in detail in the document enclosed in the meter package. It is necessary to follow the information enclosed with the specific meter to avoid damage or breakage of the device, or for the patient to avoid harming themselves when using the meter. If the device is not worn continuously (except for necessary removals), proper and snug operation of the Mindpax M2 cannot be guaranteed.

The measured values of the activity meter may change over time due to technical deviations. Fluctuations in values may be due to technical deviations, not necessarily to deviations in the clinical condition of the patient. Possible technical imperfections of the device must be taken into account when evaluating the course of the patient’s disease.

Warning

Before using the Mindpax M2 system, please read the included materials carefully. Failure to do so may result in:

      • improper use of the Mindpax M2 system,
      • misunderstanding of Mindpax M2 information,
      • affecting the proper functioning of the Mindpax M2 system.

Technical safety information for patients

Access to the application is secured using a combination of username and password credentials. Keep your login details confidential and do not share them with third parties. After 30 minutes of inactivity, the patient is logged out of the app. To ensure security, the patient generates a pin code after logging in, which is used to log in to the app after 30 minutes of inactivity.  If you have trouble logging in, technical support is available at info@mindpax.me.

We recommend that you follow these security guidelines when creating your password:

      • minimum 10 characters,
      • do not repeat alphanumeric characters more than twice in a row
      • alternate upper/lower case,
      • use special characters,
      • do not repeat any password or just add a number at the end when changing,
      • no numeric sequences such as 123.

It is recommended to use the application only in a secure environment. Encrypted access is preferred for public WLANs.

The application uses an internet connection to transfer information. Bluetooth is used to connect the activity meter and the app. When the device is disconnected from the internet connection or bluetooth access is denied, it is not possible to transmit and therefore not even to evaluate the patient data. In this case, it is not possible to ensure the functioning of the Mindpax M2 system.

Technical safety information for doctors

If the physician does not have login credentials for the web application, it is necessary to contact support: info@mindpax.me.

After logging into the web portal, you must change your password in accordance with the security policy mentioned above.

Any modifications to the patient ID in the physician’s medical record must be recorded. Mindpax does not have access to personal patient information. We do not recommend entering any personal information about the patient in the Note field as per the Personal Information and Privacy Regulations.

Please note that some of the data displayed is subjective information filled in by the patient. Therefore, they may not correspond to the patient’s actual condition and the physician’s medical records.

The medicines recorded in Mindpax M2 do not replace medical records.

System requirements

The web portal for doctors is compatible with all browsers with HTML5 and JS support.

The Mindpax M2 mobile app is compatible with smartphones:

  • running iOS 13 and above,
  • running Android 8 and above

We recommend that you check regularly to update your application. We recommend enabling notifications for this app in your phone settings.

Support for users

If you have any questions, we recommend contacting support at info@mindpax.me or via the contact form found at www.mindpax.me.

Producer

Mindpax s.r.o.

Branická 26/43

147 00, Prague 4

Czech Republic

 

Contact: info@mindpax.me

 

Catalog No.: Mindpax M2

Software version: 2 (this guide is for all software versions starting with 2)

 

Mindpax M2 is a medical device.

www.mindpax.me

[1] Hereafter referred to in the document as “disease-relevant information”.

Contact Us

If you are interested in our vision and thinking about getting involved yourself, your loved one or investing in a meaningful project do not hesitate to contact us.

Contact Us

Infomail

info@mindpax.me