Instructions for Use & Intended Purpose
On this page you will find the instructions for use and the intended purpose of the medical device mediteo m+.
Instructions for Use for mediteo m+
Instructions for use are defined in the MDR (Medical Device Regulation) as “the information provided by the manufacturer to inform the user of a device’s intended purpose and proper use and of any precautions to be taken”.
The instructions for use of the medical device mediteo m+ are available any time in the app in “More”→”About mediteo m+”. You will additionally find the file here below at your disposal.
Attention
Please note that mediteo m+ may be available in different configurations and app versions. To view the correct instructions for use for you, open the app and check which configuration (“Profile” → “mediteo m+”) and which version (“More” → “About mediteo m+”) you are using. Select the appropriate file.
mediteo m+ (DE)
mediteo m+ is the medical device configuration that you can purchase yourself with a subscription in Germany. You are using this configuration if you see Subscription in the section “Profile”→ “mediteo m+”.
mediteo m+ (FR)
mediteo m+ is the medical device configuration that you can purchase yourself with a subscription in France. You are using this configuration if you see Subscription in the section “Profile”→ “mediteo m+”.
mediteo m+ Study version
mediteo m+ Study version is the configuration of the medical device that is used for medical study and is not freely available. You are using this configuration if you see trial participant in the section “Profile” → “mediteo m+” .
Intended Purpose for mediteo m+
An intended purpose is defined in the MDR (Medical Device Regulation) as “the use for which a device is intended according to the data supplied by the manufacturer on the label, in the instructions for use or in promotional or sales materials or statements and as specified by the manufacturer in the clinical evaluation”.
The intended purpose of the medical device mediteo m+ is available any time in the app in “More”→”About mediteo m+”. You will additionally find the text here below at your disposal.
The medical device is the mobile application (app) mediteo m+. Its target group are adults. No medical expertise is required to use the app. A prerequisite for using the app is an installation of the latest app version.
The aim of the app is to support the user in increasing and maintaining his adherence, also with regard to preventive and health measures. In this context, the health competence and sovereignty of the user are strengthened and his active participation in therapy is promoted.
The user can document information about his therapy and his health status in the app. It is the responsibility of the user to check if the inputs which have been entered are correct and up to date before saving them. These inputs include:
- the user’s medication, associated therapy plans and the status of intakes,
- health parameters, measurements and symptoms (e.g. blood pressure, weight, mood, pain),
- contact details of medical professionals and appointments scheduled with them.
In order to achieve the above, the app uses medical guidelines, scientifically verified information and recommendations from professional societies to evaluate and compare the user’s input with those data. On this basis, in addition to the self-recorded data, the user is provided with situation-related, understandable information and / or recommendations for action that support him in his role as an informed and confident patient, for example for the communication with medical professionals. This can also increase patient safety and improve the health-related quality of life.
The frequency and duration of use of mediteo m+ depend on the needs of the user and can vary from occasional use to using the app multiple times a day over several years. The app can be used on certain mobile devices without affecting the functionality of the device or of other apps.
The app cannot take medical decisions for the user and must not be used as the sole basis for medical decisions. Achieving the above-mentioned goal is the responsibility of the user and the attending healthcare professionals and can only be supported by the app. The user should always consult medical professionals if in doubt, if he needs medical advice or if he wants to change the planned preventive, health or therapeutic measures.