Instructions for use

CorewayInsights: instructions for use (English)

Corin's-25
Versions-ID: 02.00.00.001
UDI: 04170000230380
Multi-application by a Patient:in
Version of the instructions for use: 1
Date of issue: 2025-04-12

Provided by:
coreway UG (with limited liability)
Bishop-Keppler-Straße 9
73525 Schwäbisch Gmünd
Baden-Württemberg
Germany
E-Mail: [email protected]
Website: www.core-way.de

This instruction guide will be provided to you electronically (eIFU), and is at any time in the App under "Support" is available. In the case of Software Updates use the update statement according to. It applies only to the medical device CorewayInsights.

Love CorewayInsights-User, 

CorewayInsights is a digital medicine product for Sufferers of chronic inflammatory bowel disease that serves the self-management of the disease. The App collects data entered to eating habits, and assessments to the well-being and compare these customized with the S3-guidelines for Crohn's disease and ulcerative colitis. The aim is to give recommendations on the basis of the guidelines, and Use the identification of personal shear triggers to make it easier. 

In the following sections, the most important information for optimal use of CorewayInsights are summarized. Your questions should not be answered here, contact our Team [email protected]. 

A lot of fun with CorewayInsights!

This manual contains all the relevant information about the safe and appropriate use of CorewayInsights as a medical product. Please read these instructions completely and carefully before you use the application for the first time. The only way to get the proper handling and minimizing ensure potential risks.

Meaning of this instructions for use:

• It describes the intended use of the product in accordance with the European medical device regulation (EU) 2017/745.
• It contains safety-related warnings and contraindications.
• It explains the technical and medical requirements for the use.
• You will be informed about possible residual risks and gives information on the responsible application.

Building instructions for use

This manual has a modular structure and follows the requirements of the regulation (EU) 2017/745 and the standard DIN EN ISO 20417:2021. It contains all the necessary information for a safe, functional and effective application of CorewayInsights.

The contents are divided into logically sequential to the Chapter, in order to enable a-to-understand Navigation for users:the inside without any medical knowledge. Each Chapter deals with a specific aspect of the use.

The following main areas:

• Product description and purpose: What CorewayInsights is and what it is meant to be?
• Safety instructions and warnings: What is the application?
• Risks, side effects and Incident report: What can happen in exceptional circumstances?
• Technical and organisational conditions: What equipment and skills are needed?
• Registration and use: How does the application work in practice?
• Functionalities at a Glance: What does the App offer?
• Conformity and used standards
• Liability and warranty
• Contact information and legal notices

The instructions for use is regularly updated and is available digitally via the App at any time.

For the use of CorewayInsights, it is necessary that a medical diagnosis of one of the two chronic inflammatory bowel disease is Crohn's disease or ulcerative colitis. If you have not received the diagnosis from the Doctor or your doctor to get this before the use of CorewayInsights. 

Furthermore, you will have the opportunity to address the concerns and questions that relate to the program, as well as its use, to our Team.

Recommended Updates:

A safe and optimal use of CorewayInsights sure to update your App as soon as a new Update is available, as it may contain important content. In order to be always up-to-date, it is recommended to enable automatic Updates for CorewayInsights.

Symbol word	Meaning
WARNING	Possible hazard with serious damage as a result.
CAUTION	Possible hazard with mild or moderate damages as a result.
NOTE	Important information about the usage of the product.

NOTE: Colour coding

A red color-coding in the App is used for the visualization of risks, warnings, and error messages.

Even with the proper application of the CorewayInsights App, can occur in rare cases, the following effects, we want to bring to your attention:

Incorrect Interpretation of the App-results

It may happen that personal recommendations or summaries of the data of the users understood the inside or the users miss or be overstated.

NOTE: App does not replace therapy

Please note that the App is not a substitute for medical diagnosis or treatment. Search in case of doubt, always seek medical advice.

Delay necessary medical treatment

Users could weigh the App incorrectly in security and medical assistance, in addition to hesitate.

WARNING: Sudden Deterioration

In the case of severe symptoms or sudden deterioration of your health condition, you should promptly contact a Physician or a doctor.

Data entry errors by Users

False or incomplete information to the diet, symptoms, or lifestyle of the data can result in erroneous evaluations lead.

NOTEIncorrect and incomplete information

Please make sure you have the correct and complete information – this is crucial for the validity of the App.

Interference due to technical problems

In very rare cases, it can lead to technical problems, such as a crash of the App or loss of data.

NOTERegular Updates

Make sure the App and your device will be updated regularly.

Uncertainty as a result of recommendations

Some Users may be confused by some of the proposals of the App or to feel overwhelmed.

NOTE: Proposals are not mandatory

The proposals are intended to support. There is no obligation to implementation. Question a medical professional if you are unsure.

The safety and satisfaction of our Users is our highest priority. However, in exceptional cases, to the so-called serious incidents in connection with the use of the CorewayInsights App.

A serious incident is when the application is the App for example:

• health problems occur or existing complaints worsen,
• it is a dangerous misconception that medical help is delayed,
• or a potential danger to other people.

Such incidents must be reported in accordance with the statutory regulations (EU regulation 2017/745, MDR) and investigated in order to improve the safety of our products continuously.

To report a serious incident:

Please inform us immediately if you suspect such an event. You can us via:

📧 E-Mail: [email protected]

📞 Telephone (weekdays): +49 (0) 151 55448571

We ask you to be as accurate as possible a description of the incident and, if possible, information such as the date, time, symptoms, and the information you entered. All information will be treated confidentially and exclusively for the quality assurance and compliance with legal requirements.

The App CorewayInsights collects data entered by the patient to eating habits, and assessments to the well-being and compare these customized with the S3-guidelines for Crohn's disease and ulcerative colitis.

CorewayInsights is an interactive software-based medical application for the self-wanwendung by Patient:inner, for self-management of chronic inflammatory bowel disease Crohn's disease (ICD-10-GM: K50) and ulcerative colitis (ICD-10-GM: K51) diseases. 

CorewayInsights is intended for self-use by lay persons from 18 years. It requires no medical training or expertise. CorewayInsights not a substitute for the medical therapy of Crohn's disease and ulcerative colitis.

CAUTION: Contraindications note

Turning CorewayInsights only, if none of these are available to view.

CorewayInsights should not be used if:

Lack of medical diagnosis of CED

CorewayInsights do not use, if you have not received a confirmed diagnosis of chronic inflammatory bowel disease, your doctor or your Doctor.

Other chronic bowel diseases

CorewayInsights do not use if you are affected by other chronic bowel disease, such as irritable bowel syndrome (IBS), a diverticulitis or other gastro inter mediastinal disorder.

Acute severe illness, thrust

CorewayInsights do not use if you are in an acute severe Disease flare are the immediate medical Intervention, such as, for example, requires in-patient treatment.

Other Health Limitations

CorewayInsights do not use if you are the measures recommended for medical reasons not to implement't. This includes for example. dietary restrictions due to other diseases such as renal failure or Diabetes.

In CorewayInsights it is a software-based medical product, which is in the Form of a mobile application for Android as well as iOS-Smartphones with access to the App store or Play store can be used. CorewayInsights is with Android devices Software Version Is Pie (Version 9 and up) compatible. CorewayInsights is with iOS devices (iPhone, iPad) the Software version of iOS 14.0 and upward compatible. For the use of the application requires an Internet connection (mobile data or Wi-Fi), as well as a memory, it is recommended to place at least 100 MB. Additional devices are not required for the use of CorewayInsights.

CorewayInsights can be used in the following countries:

• Germany
• Austria
• Switzerland
• Italy
• Belgium
• Netherlands
• Denmark

No. CorewayInsights is intended for Amateur use, and requires no expert medical knowledge. User:in a Smartphone can use. For the application of CorewayInsights no training or education is required.

To use CorewayInsights, you should, however, the German or English language (level B2) and knowledge in dealing with a Smartphone have.

In CorewayInsights it is a digital medicine product, which can be downloaded on the Smartphone as an application. To start using, is to start a one-time registration is required.

Registration no technical as well as medical expertise is required. It can be carried out in layman use. Imperative is:

• E-Mail address of the register dens

The recommended service life is at least 12 weeks. The Software is designed for safe use over a minimum of 12 months, unless the need for regular Updates to be installed.

1. Download CorewayInsight on your App Store (Apple) or Google Playstore (Android) and open the App. [BN1] 
2. Select the Option “Register”.
3. Enter your E-Mail, your name and a password.
   Note: Password Setting
   Make sure that the password contains at least 8 characters, Uppercase and lowercase letters, and special characters.
4. Click the Register button. 
5. In the terminal, you will be sent a 6-digit Code to the specified E-Mail address. This is used for the verification of your account. Confirm your E-Mail within xx minutes to continue registration. 
   Note: Spam folder check
   Check your Spam folder. You should not E-Mail, please [email protected]. The verification code has expired, click on the Text “try again”. 
6. Once you have your E-Mail address is successfully verified, you will be redirected to answer some General questions.
7. Give in, how old you are and what gender you identify. 
8. Choose what kind of CED did you get diagnosed, and whether you're wearing a Stoma. 
9. Select all symptoms that you are experiencing is typically in the thrust. 
10. If you know personal thrust trigger already, select this also. If you do not know what causes you a boost, then the Option to select “I know my Push button.”
11. Give to, whether you take medication on a regular basis, or other chronic diseases are affected. Should this be the case, select all of the drugs and other diseases. 
12. Specify whether you want to capture your heart rate variability (HRV). 
    Note: Wearable required
    This is a Wearable (e.g. is. Smartwatch, chest strap, or a smart ring) is absolutely necessary. 
13. Voice of the privacy policy, the terms and conditions of use, the Declaration of consent to the processing of your health data, as well as the confidentiality agreement. 
14. After successful registration, you will be redirected to the home page of CorewayInsights.
15. Begin with the use of CorewayInsights.

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 [BN1]For the numbering, since there are individual steps to be followed in this order

After successful registration, you can go directly to the Dashboard of your Central starting point for all functions of the App. Before you deal in depth with all the functions of the App, we recommend that you first Check In.

Your first Check-In

Start with a first Check-In to:

• To document your current condition and symptoms.
• Important health data for the subsequent analysis enter.
• To provide a basis for personalized recommendations.

General Navigation in the Dashboard

From here you can navigate through the entire App:

• Profile: Personal data and manage settings.
• Contributions: information and tips know to CED.
• Daily Check-In: up-to-date Are recorded.
• Recommendations: patterns and fitting tips.

You are not on the Dashboard, you can also do this at any time via the Home Button.

Further Steps

Perform regular entries, in order to obtain meaningful analysis and individual recommendations.

Tip: Activate notifications in order not to forget anything and to be at your Check-Ins remember. 

You have the option to link your Wearable within the CorewayInsights App with the Terra API, to your heart rate variability (HRV) is automatically read out. Thus, the need for manual input.

To associate your Wearable, follow these steps: 

1. After successful registration, a Pop will appear link-up window with the Option “Wearable”.
2. Click on the Button – there is a Browser window will open.
3. Follow the instructions of Terra, in order to establish the connection.
4. Upon completion, you will be automatically directed back to the App. Your Wearable is successfully associated with the App.

If you change the shortcut or cancel, you can do so at any time in the profile settings under “Wearable”.

The App CorewayInsights provides you with various features and content. 

Dashboard

The Dashboard is your Central starting point in CorewayInsights and gives you a quick Overview of all the components. You will be taken directly to the Check-In, where you can your current constitutional capture. In addition, you can reach from here are the logs for stools, and diet, can manage your CED-medical history and individual analyses, as well as obtain recommendations. In addition, knowledge of posts with helpful information about the navigation you bar available.

Daily Check-In 

On the Plus icon in the navigation bar, or the Check-In tile in the Dashboard will take you to the daily Check-In. Here you can Find your current, important life-style factors, as well as all of the disease-relevant information on a daily basis document.

Medical questionnaire (Harvey-Bradshaw Index and Simple Clinical Colitis Activity Index)

The medical questionnaire, you can directly on the corresponding tile in the Dashboard. If you Check-In to indicate that you currently have symptoms, will open the questionnaire automatically within the process. He adapts individually to your CED Form and contains standardized questions that help assess whether you are currently in a flare or not.

Data insight

In the Data access you can access all the information you in the Check-In is documented to have. On the calendar in the Dashboard you will be taken directly to your entries. Click on the desired date or the month, use the view to see older entries to view. If you have a Check-In entry, you can do this up to three days in the past. Simply select the appropriate date and click on “Check-In night protrude”.

Recommendations

Your personalised recommendations you can reach it via the Dashboard. Here you are shown at weekly intervals up to three recommendations based on your personal data. You have implemented a recommendation, you can mark it as complete and assess whether it was helpful for you. The recommendations are displayed, as soon as you Check-in for at least 7 days used to have.

Knowledge contributions

The contributions of Knowledge, you can use the navigation bar to call up. There you will find a variety of blog posts on the topics of the day with CED, nutrition and gut health, Knowledge and research as well as experiences, and Community. Would you like to read a post later on (once again), you can store it with the bookmark. The saved posts you can find then in the tab “saved”.

Profile

In your profile you can reach via the navigation bar. Here, you can manage various settings, including General and medical information, links, and notifications. In addition, you have the option to log out or delete your account. 

NOTERemoval of data

When you Delete your account, all your data will be permanently removed.

Support area

The support area you can find in the navigation bar. There is an FAQ section is available that provides answers to common questions. If you have any further requests or suggestions, you can reach us via the “contact” tab. Just click on “contact”, and your E-Mail program opens automatically. In addition, you can find in the contact area with all the legal documents for future Reference, including the privacy policy, terms of use, your consent to the processing of health data, and the confidentiality agreement.

To support the safe and effective use of CorewayInsights be Notes, Information messages as well as Error messages in the Form of small highlighted boxes within the user interface. These boxes will appear depending on the context – for example, if data are missing, there is a technical Problem, or a function Declaration is required.

In addition to using the App Push-Up Notificationsin order to make it outside of the App usage on important topics and features carefully. These include, for example:

• Memories for data collection

• Information on new content or functions

• Recommendations based on your previous data

You can in the profile area, at any time, set whether you want to get notify, or not.

CorewayInsights is an interactive digital Health app that combines the latest findings from the gastroenterology and Data Science, to a holistic, evidence-based and to ensure personalized application for CED patients.

Evidence-based means that our content guidelines compliant, so on the latest scientific findings and medical recommendations are based. Our Team makes sure that the contents are kept up to date. Holistic means that aspects of different fields, including, for example, nutrition and mental health are addressed. Personalized means that the program is geared to your individual needs. A*friend*in, which also uses CorewayInsights can see, therefore, if necessary, other content as you.

By means of a specially designed and validated questionnaires to collect in the App daily to your data. These data are integrated into an algorithm that calculates which of the recommendations will be provided to you.

Your information will be clarified by answering evidence-based medical questionnaires. These are especially important, as soon as you experience symptoms. This is the Harvey-Bradshaw Index for Crohn's disease, and the Simple Clinical Colitis Activity Index for ulcerative colitis. 

In addition, you can fill in the CED-history, so that the algorithm can evaluate your data and individualized. Questions include stops, among other things, how long is a thrust usually with you. After you fill out the medical history initially, you will be asked every 3 months if your information is still up to date. 

In the daily Check-In, you give in, how strong are your subjective symptoms are and whether you are currently in a thrust. Depending on the result of your recommendations to fit your needs. 

Generally, you can receive recommendations from the following categories: 

• Psychosomatics
• Psychotherapy
• Pain management
• Alternative Therapies
• Checkups
• Fatigue
• Symptom burden
• Nutrition

All the content is given to you in the Form of self-help measures. This means that you implement the recommendations in their own. Once you've done that, you can use the recommendation as completed check and rate if it was helpful for you. 

The daily Filling of the Check-Ins you will receive in addition, an assessment of your current well-being in the Form of the so-called Wellness Scores. This will help you, your CED to better assess.

NOTE: Third-Party Access

Other never let on to your account the CorewayInsights-App access.

Recommended frequency of application and duration of use:

If you did not receive otherwise directed by your doctor, should CorewayInsights be best applied daily. You can apply CorewayInsights over an infinite time framework. The recommended time frame is a minimum of 12 weeks.

The daily Check-In is for the standardized detection of your current health status. This document, among other things, your General well being, symptoms or other CED-relevant information, as well as life-style factors. The information included in the personalized representation of data, and help you to recognize patterns, and to identify correlations between Lifestyle and disease.

We recommend that you Check In once a day to carry out. You can Check-In via the Dashboard or the "+"icon in the navigation bar. 

In addition to the Check-In you will get, depending on your data – asked, standardized health questionnaires to fill out. These are used for the evaluation of your current disease activity.

The following validated instruments:

•  Harvey-Bradshaw Index (HBI) in Crohn's disease
• Simple Clinical Colitis Activity Index (SCCAI) in the case of ulcerative colitis

This is the question you are arcs automatically displayed when you enter in the Check-In symptoms. They help to assess whether or not you are in a thrust, and serve as the basis for specific recommendations. You can also access it via the Dashboard or the “+”icon to the questionnaires and can also fill in at any time, if you are experiencing no symptoms.

About the calendar component in the Dashboard you will find a chronological depiction of your previous entries. You can past Check-Ins, chair and nutrition protocols, as well as your medical questionnaire to see results.

The data are displayed in a calendar. On the month view, you can conveniently select specific time periods and analyze.

Based on your information, you will receive individual recommendations for action. These are based on the current S3 guidelines for the treatment of Crohn's disease and ulcerative colitis. 

Here you can get recommendations from different categories: 

• Psychosomatics
• Psychotherapy
• Pain management
• Alternative Therapies
• Checkups
• Fatigue
• Symptom burden
• Nutrition

All recommendations are as non-medical self-help recommendations to understand and do not replace medical treatment. 

Once you have implemented a recommendation, you can mark it as done and assess whether the recommendation was helpful for you.

In addition to the core functions CorewayInsights offers additional content to support your self-management:

Knowledge contributions

Within the App you can find scientifically based articles on the following categories: 

• Everyday life with CED
• CED-diet and gut health
• CED-Knowledge and research
• CED-experience and Community

FAQs

In the FAQs section of the App you can inform yourself about all topics related to coreway, our study and the App. 

Reminder function

Push notifications for Check-In reminders, in the presence of new recommendations, as well as important Changes you are available.

This content, you can reach out via the menu within the App. 

To remove CorewayInsights, you must delete the Account and the application is uninstalled. To delete your Account, go to delete from the profile settings, and select “account”. According to the privacy statement, then your user data will be cleared.

After that, you can uninstall the application.

A deletion of the account and the user data according to the privacy statement will also be made if an Account for more than 5 years is inactive.

The Software CorewayInsights was developed in accordance with the following standards and rating:

Standard	Title
DIN EN ISO 13485	Medical devices – quality management systems – requirements for regulatory purposes
DIN EN ISO 14971	Medical devices – application of risk management to medical devices
ISO/ IEC 27001	Information security, cyber security and data protection – information security management systems – requirements
DIN EN ISO 20417	Medical devices – requirements for the manufacturer information to be provided
DIN EN ISO 15223-1	Medical products – In the case of inscriptions of medical devices symbols to be used, labelling and information requirements – part 1: General requirements
DIN EN ISO 7010	Graphical symbols – safety colours and safety signs – Registered safety signs
DIN EN ISO/IEC 82079-1	Creation of user information (instructions for use) for products – part 1: principles and General requirements
DIN EN 62366-1	Medical devices – part 1: application of usability in medical products
DIN EN 62304	Medical Device Software- Software Life Cycle Processes
DIN EN 82304-1	Health software – part 1: General requirements for product safety
IEC 81001-5-1	Health software and health IT systems security, effectiveness, and Security – part 5-1: Security activities in the product life cycle
ISO/IEC 25010	Systems and Software Engineering – quality criteria and evaluation of systems and software products (SQuaRE) – product quality model

The CorewayInsights App has been designed with the utmost care and tested. It complies with the applicable legal requirements of the European Union for medical devices (class I to regulation (EU) 2017/745).

Warranty

The manufacturer shall ensure that the App at the time of the provision is free of technical defects, which affect their ability to function considerably.

Please note:

• The warranty is only valid under normal use in accordance with these instructions.
• Changes to the device on which the App is run, as well as improper use can impair the ability to function and to the exclusion of warranty.

Disclaimer

The application of this App is not a substitute for medical advice, diagnosis, or treatment. The manufacturer is not liable for damages caused by faulty or incomplete information provided by the user, misuse or failure to follow these instructions.

Liability for indirect damages (such as consequential damages, loss of data) shall be excluded, unless liability is mandatory (for example, in the case of intent or gross negligence).

If you have questions about the content of this instructions for use or application of the product, please contact us as the manufacturer.

Contact details of the manufacturer:

If you have questions about CorewayInsights or help with the application need to contact you [email protected].

If you've found a technical error, contact you, please contact us immediately [email protected]. 

Manufacturer's address

CorewayInsights 
by coreway UG (with limited liability)
Bishop-Keppler-Straße 9
73525 Schwäbisch Gmünd

You should applying Person a deterioration of your health status to determine which may be with the application of CorewayInsights in touch, please reach out to us immediately.

You should have a paper Version of this user need statement, please also get in touch with us.

CorewayInsights is registered in the European Union as an active class I medical device under the medical device regulation 2017/745/EU.

Abbreviation	Meaning
MDR	Medical Device Regulation (EU) 2017/745
CED	Chronic inflammatory bowel disease
DSGVO	General Data Protection Regulation
EU	European Union
UDI	Unique Device Identifier
UI	User Interface

Glossary

User

A natural Person that the medical product is used as intended.

Chronic inflammatory bowel disease (IBD)

Generic term for diseases such as Crohn's disease and ulcerative colitis, which are characterized by inflammatory processes in the gastrointestinal tract.

Instructions for use

Document accompanying a medical device, with information on the safe and proper application in accordance with MDR Annex I.

Clinical Use

Measurable positive effect of a medical device on the patient's state of health.

Verification and validation (V&V)

Methods for Verification (verifying) whether the requirements have been implemented correctly, and to the validation (testing), that the product is suitable for the intended purpose.

Unique Device Identification (UDI)

Unique product identification for traceability of medical devices under the MDR, article 27.