Instruction for use

Prof. Valmed® serves the purpose of providing doctors and healthcare professionals with validated medical information through innovative AI-based technologies. With Prof. Valmed®, we can offer a platform that aims to improve diagnosis and therapy while saving time, ultimately making a significant contribution to the digitalization of the healthcare industry.

Warning

Improper handling and improper use can cause danger and damage. We therefore ask you to read these instructions for use carefully and follow them precisely. Always keep them to hand to avoid possible personal injury and damage to property. If you have any questions about the contents of these instructions for use or the use of the product, please contact us at contact@profvalmed.com. Improper handling and improper use can cause danger and damage. We therefore ask you to read these instructions for use carefully and follow them precisely. Always keep them to hand to avoid possible personal injury and damage to property. If you have any questions about the contents of these instructions for use or the use of the product, please contact us at contact@profvalmed.com.

1. Information on the use of these instructions for use

To avoid personal injury, observe all safety instructions listed. To use the medical device correctly, read and follow these instructions for use.

1.1 Explanation of warnings in these instructions for use

To indicate safety instructions regarding the use of Prof. Valmed®, the following signal words may be used in this instruction for use (IfU):

WARNING: Important information on a potentially dangerous situation resulting in serious damage
CAUTION: Important information about a potentially dangerous situation resulting in minor or moderate damage
NOTE: Additional information to avoid difficulties when operating the medical device.

1.2 Typographical conventions

In this instruction for use specific text formatting is used to highlight system features relevant to the user.

Cursive: Cursive words represent components of the system, such as display areas. These are elements that the user can see but not interact with directly.
Cursive and Bold: Cursive and bold text represents interactive elements such as buttons or selection functions. These are elements that the user can interact with to perform actions within the system.

1.3 Abbreviations and terms

AI: artificial intelligence

Prompt: In the field of artificial intelligence (AI), the term „prompt“ describes short instructions or text fragments that are given to an AI model in order to obtain a desired response or output. Prompts are like tasks that ask the model to generate or understand certain information.

Query: A query is the entry of a search term or question into Prof. Valmed®’s Search or Prompt function to obtain specific medical information. Queries provide access to diagnoses, treatment recommendations and medical guidelines to support clinical decision making.

IfU: Instruction for use

Users: Describes all users that Prof. Valmed® supports by providing validated medical information. See chapter 2.5 Intended users.

Prof. Valmed GmbH: Short for Prof. Valmed – validated medical information GmbH

1.4 Obligation to report incidents

Serious incidents involving this product must be reported to the manufacturer and the competent authorities of the Member State in which the user is established. In case of uncertainties regarding incidents involving Prof. Valmed®, please contact the manufacturer.

Manufacturer contact: contact@profvalmed.com

Competent authorities of the Member States: https://health.ec.europa.eu/medical-devices-sector/new-regulations/contacts_en

2 Use and safety-related information

2.1 Intended use

The Prof. Valmed® software processes natural language questions and inputs and generates natural language answers. It is designed to provide physicians and medical personnel with recommendations for the diagnosis, treatment or monitoring of human diseases.

2.2 Clinical benefit

Prof. Valmed provides information tailored to the user’s specific question regarding diagnosis and treatment of diseases, based on curated, high-quality, validated medical data, while significantly minimizing the occurrence of hallucinations.

2.3 Indications

Prof. Valmed® is designed to support healthcare professionals in various areas:

Diagnostic issues: Prof. Valmed® assists healthcare professionals by providing validated, evidence-based information to aid in diagnosing a broad range of medical conditions.
Therapy decisions: Prof. Valmed® provides data-backed guidance on treatment options, helping healthcare providers make informed therapeutic choices, including drug interactions, treatment protocols, and therapeutic alternatives based on the latest guidelines.

2.4 Contraindications

The following points must be observed when using Prof. Valmed®:

Not suitable for questions in dentistry
Not suitable for questions in veterinary medicine
Not to be used for non-medical issues

2.5 Intended users

Prof. Valmed® may only be used by persons with medical training. Users must have the necessary specialist knowledge and qualifications to correctly interpret and apply the information provided.

The intended users for Prof. Valmed®’s product include:

Healthcare professionals: Doctors, clinicians, nurses, medical assistants, pharmacists, and other healthcare professionals involved in the diagnosis, treatment and monitoring of illnesses and injuries.
Health authorities and regulatory bodies: Health authorities and regulators can use the product to evaluate medical innovations, monitor product quality and develop guidelines and regulations.
Educational institutions: Teachers and students in medical educational institutions can use the product to support their education, carry out research projects and gain practical experience in using AI-based medical tools.

All user groups are hereinafter referred to as „users“.

2.6 Classification

Classification according to Regulation (EU) 2017/745, Annex VIII: Class IIb

2.7 General safety instructions

If the product is used contrary to the information stated in these instructions for use, personal injury may result. Only use the product for the purpose specified under “Intended use“. Read and follow these instructions for use.
The following safety instructions apply to general use of the medical device:

NOTE: Prof. Valmed® includes artificial intelligence (AI).

NOTE: The answers of Prof. Valmed® are based on a limited set of medical guidelines. Variations in procedures and recommendations may occur across different jurisdictions. If necessary, set the filters accordingly.

WARNING: The information provided by Prof. Valmed® is intended to support decision-making on medical issues and is not intended as the sole basis for diagnostic or therapeutic decisions. It may put the patient at risk.

WARNING: Prof. Valmed® is intended for use by healthcare professionals only.

2.8 Limits

The following limitations are known for the software „Prof. Valmed®“:

The information provided by Prof. Valmed® is intended to support decision-making on medical issues and is not intended as the sole basis for diagnostic or therapeutic decisions.
The answers of Prof. Valmed® are based on a limited set of medical guidelines

2.9 Disclaimer

Prof. Valmed®´s aim is to make validated medical information easily available – practical and valuable for healthcare professionals.

Prof. Valmed® processes natural language questions and inputs, generates natural language answers and provides physicians and medical personnel with recommendations for the diagnosis, treatment or monitoring of human diseases.

Prof. Valmed® does not generate patient-specific recommendations but reflects the current state of medical science by analyzing and evaluating the relevant medical literature and guidelines to support research in the diagnostic and therapeutic decision making. Therefore, under no circumstances should the information presented here be considered a substitute for professional advice or treatment by qualified and recognized medical practitioners.

Knowledge base: The relevant medical literature and guidelines as the knowledge base of Prof. Valmed® are fully publicly accessible. Prof. Valmed® has not verified the factual accuracy of the knowledge base. Prof. Valmed® therefore accepts no liability for the accuracy of the output provided by Prof. Valmed® to a user in response to such user’s input or for the use of the information contained therein.

Limited knowledge: The content generated by Prof. Valmed® is AI-based. Please note that Prof. Valmed® aims to be most actual and updates medical information regularly but cannot claim absolute completeness, accuracy, and actuality of all types of information.

No personal information and adverse events: Please note that you should not use any information related to an identified or identifiable natural person (personal information) as input when using Prof. Valmed®, but solely non personal or anonymized data, or use Prof. Valmed® for adverse event reporting purposes.

3 Product description

Prof. Valmed® is a software solution designed to support healthcare professionals in diagnosis and treatment planning. Prof. Valmed® uses artificial intelligence to process natural language input and provide relevant medical information to user queries. The system output is based on the Prof. Valmed® data base containing validated medical data selected and curated under human supervision by Prof. Valmed GmbH. The user interacts with Prof. Valmed® through a browser-based user interface. The layout of the user interface and the user’s interaction with the system is described in chapter 6 Operation.

4 System requirements

Prof. Valmed® is browser-based. An internet-enabled device (desktop, tablet, smartphone) with a modern browser version installed is required for use. Supported browsers are the following versions:

Chrome (Version: 125.0.xx… and newer)
Firefox (Version: 124.xx… and newer)
Edge (Version: 123.x.x… and newer)
Safari (Version: 17.0 and newer)

NOTE: When using Prof. Valmed® via Safari, graphic elements of the user interface may not be displayed correctly. This does not affect the functionality of the system.

Prof. Valmed® is independent of the operating system of the end device used, as the system is browser-based. Compatibility with the Windows and Apple OS operating systems has been tested.

5 Registration

5.1 User registration

Access to Prof. Valmed® can be acquired as individual access or via a company access.

User groups that have access to Prof. Valmed® via a company account are authorized for Prof. Valmed via Microsoft Entra ID groups. Microsoft Entra ID groups allow the access management of group of users to applications, in this case to Prof. Valmed®. The company specific access mechanism is managed by the company’s own IT administration.

For users who access Prof. Valmed® via an individual access, the access is assigned by Prof. Valmed GmbH. The registration process requires a valid e-mail address. This e-mail address is used as a unique identifier for the user. For registration contact contact@profvalmed.com. After registration by Prof. Valmed®, the user(s) will receive an e-mail with further access information.

5.2 Logging in for the first time

Individual access:
Users who access Prof. Valmed® via an individual access receive an e-mail with access information after successful registration. Follow the information provided in this e-mail to access Prof. Valmed® for the first time. When logging in for the first time, the terms of use are displayed and must be confirmed by the user.

In case the user does not already have a Microsoft account associated with the provided email address, the user will be forwarded to the registration page for the Microsoft account. Follow the instructions from Microsoft to create the Microsoft account. Afterwards return to Prof. Valmed® and login with the Microsoft account login credentials.

Company access:
User groups with company access retain their company credentials. When logging in for the first time, the terms of use are displayed and must be confirmed by the user.

6 Operation

6.1 Log in and log out

To log in to Prof. Valmed® proceed as follows:

1. Open the web application through this link https://profvalmed.azurewebsites.net/ via a browser listed in these instructions for use (see chapter 4 System requirements)
2. Depending on the access type, proceed as follows:

Company access:
a) User groups that access Prof. Valmed® via a company account are logged in directly and the main page of Prof. Valmed is displayed.

Individual access:
a) The Microsoft log in window to access Prof. Valmed® appears
b) Enter your e-mail address in the field provided and click next
c) Enter your password in the field provided and click next
d) If the personal login data entered is correct, the main page of Prof. Valmed® will be displayed.

To log out (Company access and Individual access) proceed as follows:

1. On the main page, click on Account
2. In the displayed window click on Logout

The user will be logged out of the system. The Web application can then be closed.

6.2 Main page

The main page is the starting point for executing queries (Prompt or Search). The following table lists the components of the main page and their function.

A – Header bar – Display of system version & incl. various selection buttons to navigate the system (Prompt/Search, New Topic; Label, Info, Account)

B – Filter display – Display and setting of possible filters

C – Input field – Field for entering a query by the user

D – Display field – Display of the system’s response to a user query

E – History display – Display of the accounts query history

Figure 1 Main page Prof. Valmed®

6.3 Executing a query - Prompt and Search

The user can choose between the Prompt and Search mode via the drop-down menu in the Header bar of the main page. The currently selected variant is permanently displayed in the Header bar.

Figure 2 Header bar with expanded drop-down menu Prompt/Search

6.3.1. Prompt

When using the Prompt mode, the user can ask for information in natural language and receives an answer to the formulated query in natural language. In addition, the user is shown the corresponding sources from the Prof. Valmed® underlaying data base on which the given answer is based.

To show the sources, press the Source button at the end of a received system answer. The source display window is expanded. To collapse the source display window click the Source button again. When clicking on a specific source, the source is opened in a separate browser window.

Figure 3 Prof. Valmed® Source button

After executing a query via Prompt, further queries can be executed. The system includes information from the previous queries in the further dialogue. If this is not desired by the user, a new conversation can be started via New Topic.

NOTE: To ensure independence of the system responds regarding previously asked queries, start a new conversation via New Topic.

NOTE: The quality of the response is influenced by the formulation of the query. Observe the information on designing queries in accordance with these instructions for use.

6.3.2. Information on designing queries for Prompt

Please note the following when designing a Prompt:
Do:

- Formulate clear and direct questions using simple, standard medical terminology.
- Be specific and provide necessary context
- Common abbreviations can be used (retry without abbreviations if results are not satisfactory)

Don´t:

- Avoid rare abbreviations
- Avoid multiple or compound questions, personal medical advice, slang, or ambiguous terms
- Ensure prompts are complete and detailed

Format:

- Keep prompts under 25 words, use simple sentence structures, and focus on one concept per query

NOTE: The quality of the response is influenced by the formulation of the query. Observe the information on designing queries in accordance with these instructions for use.

6.3.3. Providing Feedback on system responses

Prof. Valmed® gives the user the opportunity to provide feedback on the received system answers. For this the user can select at the end of a system answer:

- Star rating: Click the stars to rate the given system answer from one (low) to four (high) stars. The selected numbers of stars will be highlighted (yellow). The selected rating can be changed by the user by clicking on more/ less stars
- Free text feedback: When clicking on the speech bubble icon a text field expands. The user can provide feedback in text form (free text field). The user can collapse/expand the text field and change their text

Figure 4 Prof. Valmed® speech bubble icon (left) and star rating (right)

Figure 5 Prof. Valmed® star rating with highlighted starts (three highlighted stars)

Figure 6 Prof. Valmed® expand text field for user feedback (free text field)

6.3.4. Start a new Query - New Topic

The New Topic button in the Header bar can be used to start a new query. The New Topic function is only available for the Prompt mode. When Search mode is selected, the New Topic button is not displayed in the Header bar.

NOTE: Filter settings are retained by the system when a new query is started via New Topic. Filter settings affect the response issued by the system. Change filter settings accordingly prior to further use.

6.3.5. Copy Answer

The user can copy the system answer when using the Prompt mode. When clicking on the Copy Answer button at the end of the system answer the given system answer is copied to the clipboard for use in other systems test processing software, such as Microsoft Word.

Figure 7 Copy Answer button

6.3.6. Select Documents

The user can select individual documents to be considered only when responding to user queries in Prompt mode.

When using the Prompt mode, the user can select the Select Documents button in the query Input field. When selecting the Select Documents button, a separate window opens in which the user can search for individual documents via the search bar.

Then entering a search term in the search bar, relevant documents from the Prof. Valmed®’s database are listed. The user can navigate the search results via the scroll bar and the page navigation. The total number of found results are displayed at the left lower corner of the window.

The user can select individual documents by clicking the check box next to the document name. Select documents will be displayed in blue text above the document list. The user can remove a document from this selection by clicking on the „X“ next to it.

The user can click:

CANCEL to close the window without saving the document selection, or
OK to close the window and save the document selection.

When closing the window via the OK button, a number corresponding to the number of selected individual documents is displayed next to the Select Documents button.

The user can reenter the document selection window any time to adjust the selection.

Selected filters (see chapter 6.4 Search)

When using the Search, the Prof. Valmed® data base is searched for relevant document matches according to the asked query. The user is presented with a list of relevant sources from the Prof. Valmed® date base, sorted by relevance in relation to the formulated query.

NOTE: The quality of the response is influenced by the formulation of the query. Observe the information on designing queries in accordance with these instructions for use.

6.3.7. Information on designing queries for Searches

Please note the following when designing a Search:

Use relevant keywords such as medical terms or specific symptoms

NOTE: The quality of the response is influenced by the formulation of the query. Observe the information on designing queries in accordance with these instructions for use.

Setting filter functions also affects the search results of the select documents window.

Figure 8 Select Documents button

NOTE: The selection of individual documents limits the data basis considered by the system. This affects the response issued by the system to a user’s query.

6.3.8. Search

NOTE: The quality of the response is influenced by the formulation of the query. Observe the information on designing queries in accordance with these instructions for use.

6.3.9. Information on designing queries for Searches

Please note the following when designing a Search:

Use relevant keywords such as medical terms or specific symptoms

NOTE: The quality of the response is influenced by the formulation of the query. Observe the information on designing queries in accordance with these instructions for use.

6.4 Setting filter functions

6.4.1. Default settings

After successful login, the default filter settings are selected. The default filter settings are:

Type: All options selected
Source: All options selected
Publication date: All options selected
Sepeciality: All options selected

NOTE: When a user logs in using their personal login data, a new session is started. When a new session is started, the system’s default filter settings are set. This affects the response issued by the system.

6.4.2. Setting filters

Prof. Valmed offers the option of specifying the data basis that is used for the response to the query entered. Prof. Valmed offers four filter categories for this purpose:

Type: Specifies the data type that is taken into account by the system, e.g. Guidelines or drug information
Source: Specifies the data source that is observed by the system, e.g. German Society of Neurology (DGN)/American Academy of Neurology (AAN)
Publication date: Specifies the time interval of publication of the data source considered by the system
Specialty: Specifies the medical field from which publications are taken into account by the system. e.g. Neurology or Internal Medicine – Angiology

Figure 9 Filter display

The filters of a filter category can be displayed collapsed or expanded. When selecting special filters, the number of selected filters is displayed in a blue bubble next to the filter category name. The number display of the selected filters is retained even if the filter category is collapsed.

The selection of filters in the filter category Type influences the filter selection options under the filter category Source. In the filter category Source, filters are hidden according to the selection under Type.

Navigation of the filters is possible by:

expanding the filter category and using the scroll bar or
using the search bar

When navigating via the search bar relevant hits are displayed. All other filters are hidden in this case. To end navigation via the search bar, either select a displayed filter or empty the search bar.

Selected filters can be deselected by clicking on them again. To reset all filter settings, press CLEAR ALL.

NOTE: The selection of filters limits the data basis considered by the system. This affects the response issued by the system to a user’s query.

6.5 Query history - History

Executed queries are saved in the Prof. Valmed® cloud linked to the user. The entries are visible to the user in the History. They are grouped by time: “Last 7 days”, “Last month” and “older”.

History entries are displayed either with the Prompt or Search icon to indicate under which mode the query was executed.

Only for Prompt queries the user can click on the entry in the History to view the stored query along with the system response. The response to this query is not generated again, but the saved response is displayed.

WARNING: When queries are saved, the set filters are saved too. This affects the response issued by the system. Change filter settings accordingly prior to further use.

WARNING: The saved queries are based on the state of data base at that time of saving. The data base may have changed in the meantime. The system responds may be outdated.

6.5.1. Delete history entries

Individual saved entries in the History can be deleted by the user. To delete an entry, proceed as follows:

Move the cursor over the history entry to be deleted – the system displays the delete icon (bin)
Click on the delete icon – the system asks for confirmation to delete the history entry (Check mark: Delete history entry or X: Cancel)
Confirm deletion – the history entry is deleted

6.6 Account settings

The Account button is located in the Header bar and provides various setting options and information for the user. By clicking on this button, a window with the following options opens:

Switch Between Light and Dark Mode: The user can toggle between a light and a dark version of the app’s interface.
View History: The user can view the History
Access to Help / Frequently Asked Questions (FAQ): The user can find answers to common questions and solutions to frequently encountered problems. Additionally, contact details of the manufacturer in case of further questions are listed.
Access to the medical device label: The user can view the label of Prof. Valmed®, containing information such as the device UDI, the manufacturer details and the CE mark
Access to the Instruction for Use (IfU): The user can directly access the IfU for Prof. Valmed®
Access to the terms of use: The user can directly access the terms of use for Prof. Valmed®
Switch between languages: The user can between English and German.
Logout: The user can securely log out of the system.

Figure 10 Account button

Figure 11 Displayed window when clicking the Account button

NOTE: Do not pass on your personal login data.

6.7 Label

The Label button is located in the Header bar. When clicking on the Label button, a window containing labelling information regarding Prof. Valmed® will be displayed. To close the window, press OK.

Figure 12 Label button

Additionally, the label can be accessed via the Account button by selection Medical Device Label in the account menu.

The label contains information to identify the product and relevant product information, including:

Product name and version
Unique device identifier (UDI)
Lot number
Date of manufacture (corresponds to the release date of the specific software version)
Manufacturer name and contact details
CE-mark and corresponding Notified Body Number
Hint to consult (electronic) IfU, including link to the currently valid version of the IfU

6.7.1. Symbols on the label

Overview of the symbols used on the label:

Symbol	Meaning
	Manufacturer
	Unique device identifier (UDI)
	Lot number
	Date of manufacture
	Consult (electronic) instructions for use
	The product is a medical device (CE conformity assessment procedure)

6.8 Overview database changes

The Information button is located in the Header bar. When clicking on the Information button, a window containing a summary of recent changes to the Prof. Valmed® underlying database will be displayed. To close the window, press OK.

Figure 13 Information button

7 Troubleshooting

7.1 Error display and remedy

The error displays are listed in the following table. In the event of an error display, the table helps to identify the triggering cause and to eliminate it with the intended remedial measures.

Display	Cause	Remedy
Error Details: Retry	An internal error has occurred during processing. This may have to do either with the internally called services or with the query.	Try a different query or wait 1-2 seconds and restart your request.
„Oops: something went terribly wrong“ when logging in	The database is rarely not yet accessible or is still in sleep mode.	Wait 1-2 seconds and try again.
Error when logging in	Your user cannot be identified in the system.	Use the Prof. Valmed service via contact@valmed.com

In case of any account-related problems, please contact Prof. Valmed GmbH at contact@profvalmed.com.

7.2 Problems logging into Prof. Valmed® account

Your Prof. Valmed® access runs via a Microsoft account. Problems with logging in can be resolved using the “Can’t access your account?” button on the Microsoft login screen. Follow the instructions on the Microsoft screen to solve the access problem.
In case the user has forgotten his password, it can be reset by clicking on the „Forgot my password“ button on the Microsoft login screen. Follow the instructions on the Microsoft screen for resetting the password.

8 IT security

Your personal data is secured by state-of-the-art means with the help of MS Entra ID Services. Please use secure combinations for your passwords and, in the case of company access, follow the instructions of your company’s own IT administration.

CAUTION: Do not share your personal login data. Use of the medical device by unqualified personnel possible.

9 Maintenance

9.1 Maintenance of Prof. Valmed®

Maintenance of and updates for Prof. Valmed® is carried out by the manufacturer.

The user is responsible for ensuring a suitable browser (see chapter 4 System requirements) on the end device used to access the web-based interface of Prof. Valmed®.

NOTE: Changes to Prof. Valmed® may lead to changes regarding the system requirements. Consult the current version of the Instruction for Use for the necessary system requirements.

9.2 Prof. Valmed® Database Updates

The database of Prof. Valmed® is regularly updated to ensure it contains the most current and accurate information. However, there may be a time lag between the publication of new information and its incorporation into the database.

Information regarding recent change towards the underlying database can be accessed by the user via the Information button (see chapter 6.8 Overview database change).

WARNING: The Prof. Valmed® underlying database is regularly updated. The system responds may be outdated.

Manufacturer:

Prof. Valmed – validated medical information GmbH
Fasanenweg 2
49838 Langen
Germany

contact@profvalmed.com
www.profvalmed.com

Prof. Valmed GmbH reserves the right to make changes to the medical device without prior notice.

Issue: Version 05.00 from 2025-02-03

Applicable for

Prof. Valmed®

Software version v2.0.n_2.0.n

UDI-DI: 4262455490010