Patient Instructions for Use (eIFU)

Last updated: 2026-03-09

To ensure you always have the latest version of this document, we recommend viewing it online at https://visibacare.zendesk.com/hc/en-gb/articles/26000208074780. While you can download it as a PDF, the product is digital and subject to updates, so accessing the document online guarantees you see the most current information.

About the product

Patients (or individuals seeking assistance on behalf of someone else, referred to as agents hereafter) exclusively interact with Red Robin through its chatbot interface. This interface is designed to collect initial medical history information required to assist a healthcare professional in performing a triage assessment and guiding the patient or agent to appropriate care. The product does not offer the patient or agent any other outputs, such as suggested diagnoses or treatment recommendations. Any conclusions drawn by the service will be reviewed by a medical professional.
 

This service uses AI technology based on a Bayesian network model to understand your symptoms and provide a triage score for healthcare. The AI asks questions based on urgency and diagnosis probability from your previous answers. This information is then used to deliver both a triage score and a summary of your answers to the healthcare professional.

Intended Use

Red Robin is a software application designed to automate pre-clinical triage and initial medical history-taking, aimed at supporting clinical decision-making and patient management. Red Robin facilitates:

• Remote capture of patient complaints
• Presentation of potential differential diagnoses
• Suggestion of the urgency of the patient case.

The application employs artificial intelligence to structure its logic and is intended to be integrated with Customer Setup systems. These systems can both provide and consume data from the device.

Indications for Use

The product is intended for use by patients over 12 months of age who are experiencing new or recently emerged medical concerns and are seeking medical consultation for their condition. The service can also be used by an agent, a person that is seeking aid on behalf of another. The user of the device should be 13 years or older, from which age users can be considered to be capable of describing their complaints using a digital device on their own. This age limit is based on the common practice of the markets where the device is sold, and local regulations or the healthcare provider may require a higher age limit. For patients between 12 months and 13 years, an agent should operate the device on behalf of the patient.

Contraindications

• The service should not be used in patients that are younger than 12 months of age.
• Patients who know they are pregnant should not use the service.
• The service should not be used in case of an emergency, for example if the patient has the following symptoms:
  • Severe, heavy or crushing chest pain, which may move to jaw, neck, arm, or back, or be associated with sweating, shortness of breath or nausea.
  • Signs of a stroke, which may include facial drooping, inability to hold both arms up, or difficulty speaking.
  • Severe breathing problems.
  • Suspected poisoning.
  • Loss of consciousness or sudden confusion.
  • Sudden difficulty moving such as following a severe injury.
  • Heavy bleeding that won’t stop.

Disclaimers

The service does not treat patients, determine treatment, or provide definitive diagnoses of diseases or conditions. It does not replace thorough medical history-taking and examination, focusing solely on the patient's symptoms and medical history without considering other health conditions or historical patient information.

The service is intended solely to inform healthcare professionals about potential clinical urgency and differential diagnoses based on the patient's signs and symptoms. Healthcare professionals should not primarily rely on such suggestions for decisions regarding disease prevention, diagnosis, or treatment, nor for assessing individual patient conditions.

• The service is primarily, though not exclusively, intended for use by patients experiencing newly emerged symptoms.
• The service is primarily, though not exclusively, designed for primary care use cases.
• The service lacks prior data or knowledge of the patient, including previous or chronic health conditions.
• The service must not be used outside the region for which the product version was designed. Users in other regions shall adhere to local or national guidelines.

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Using the Product

Warnings

In case of an emergency
If you are in an emergency, end the use of this service and immediately call your emergency number to get help (UK: 999, EU: 112, Norway: 113). [Risk 1.2] 

Medical conditions not suitable for Red Robin
Call your emergency number (UK: 999, EU: 112, Norway: 113) if you: 

• have heavy or crushing chest pain, which may move to jaw, neck, arm, or back, shortness of breath or nausea.
• are experiencing facial weakness, inability to hold both arms up, or difficulty speaking.
• have a problem breathing
• are significantly impaired and are having problem moving
• involved in any kind of accident

[Risk 1.3] 

If your condition is getting worse
If you are waiting to be contacted but your condition is progressively getting worse or feel that you need a faster assessment, please contact your healthcare provider. [Risk 1.12] 

Not suitable for children under 12 months
Red Robin does not cater to patients younger than 12 months. If you attempt to seek medical assistance for a patient in this age group, you will not proceed through the automated chat. Instead, you will be directly referred to a healthcare professional in the Customer Setup. [Risk 1.4] 

Instructions

Below is a description of the steps you, as a patient, will go through when using Red Robin. Please note that if you are experiencing an emergency, discontinue using this service and immediately call your emergency number for assistance.

Answer the questions truthfully
Please answer the questions as truthfully as possible. It's OK if you can't answer all the questions with confidence, or can't answer all the questions, however the assessment depends on your responses. 

In case of technical problems
If you’re experiencing technical problems with the service, please contact your healthcare provider directly, or call your emergency number (UK: 999, EU: 112, Norway: 113) if you are in an emergency. 

Select If you're seeking care for yourself or someone else

The automated chat adapts to whether you intend to seek medical assistance for yourself or for another person. The intended patient must be over the age of 12 months. If you are seeking care for a person under the age of 12 months, you will not go through the automated chat and will instead be directly referred to a healthcare professional in the Customer Setup.

If you choose to seek medical assistance for someone other than yourself, this information is conveyed to the healthcare professional who receives your case after you've submitted it. Based on the age of the patient, the language later in the process adapts to refer to the patient as "the child" if they are under 13 years old, or as "the person requiring medical assistance" if they are 13 years or older.

Entering age and biological sex

Enter your age in years and select your biological sex. If you are seeking care for someone else, the age and biological sex are automatically filled in based on information from the person's national identification number or stated date of birth, but can be changed if necessary.

Age and biological sex affect the assessment
Age and biological sex are important pieces of information used to tailor the symptoms and questions presented to you in the automated chat, ensuring a correct assessment. If you select the "Other" option for biological sex, you may encounter questions that are not relevant to you. 

Describe your case in free text

Using your own words, describe the issue in free text. The text you enter will be attached directly to the healthcare professional receiving your case. This text is also used to help identify suggestions for symptoms or other reasons for contact, which can also be found using the symptom finder. Please note that Red Robin is not suited to handle all medical conditions; refer to the warning above: "Medical conditions not suitable for Red Robin.".

How to use the Symptom Finder

Based on your free text in the previous step, you are presented with matching symptoms.

• If you don't see a matching symptom, or all your described symptoms are not displayed, you can search for symptoms or reasons for contact in this view and add them manually.
   
• If your selected symptoms or reasons for contact are of a medical character, you will proceed to the automated chat.
   
• If your selected reasons for contact are of administrative character, such as prescription renewal or request for certificate, you will get information that your case will be handled as non-urgent, and upon proceeding you will bypass the automated chat and proceed directly to contacting a healthcare professional. You can then choose to do so, or in the case you did not add all symptoms you feel need assessment, you can return to the previous step to add them.
   
• If you do not find any symptom suitable for your situation, you can always select the "Other questions"-alternative, meaning you will always be able to proceed and get in contact with a healthcare professional.

Answer follow up questions connected to your issue

In the Initial questions, you will be asked follow-up questions directly connected to your presented symptoms or reasons for contact. The questions are grouped around each symptom and primarily concern how the symptom appeared and how it is evolving.

Having answered the initial questions, you proceed to the chat. There are several different question types in the chat:
 

• Single Option Questions: You are presented with a list of options, and you can select only one option as your answer.
• Multiple Option Questions: You are presented with a list of options, and you can select multiple options as your answers.
• Yes/No Questions: You are asked to respond with a simple "yes" or "no" answer, sometimes with an “I don’t know” alternative.
• Slider Questions: You can slide a visual indicator along a scale (with fixed values) to indicate your response.
• Upload image questions: You are requested to upload an image. When requested to upload an image, you will get additional information on how the image should be taken.
• Open-Ended Question: You are prompted to provide an answer in your own words.

As a final step, you may upload images and add more information as free text, which will be conveyed to the healthcare professional. This final information is not included in the assessment made by Red Robin.

In case you need help answering questions

Sometimes, you have the option to get some more information about a certain symptom that can be tricky to understand, or further instruction on how to respond to a question. The information is reached by clicking the blue info icon. At the end of the information, you can give feedback on whether the information was helpful.

How to proceed when the automated chat is completed

When Red Robin has reached a conclusion based on your responses, you are presented with instructions on how to proceed. If Red Robin determines that your case is urgent, you will be provided with a warning and recommended to call the emergency number. You can choose to continue anyway and submit the case to the healthcare provider. If you are waiting to be contacted but your condition is progressively getting worse or you feel that you need a faster assessment, contact your healthcare provider.
 

In the final step, you are prompted to evaluate the service before proceeding. This evaluation includes assigning a rating from 0 to 5 stars and providing optional comments in a designated field. This information is not provided to the healthcare provider but to Visiba Group AB, the developers of this service.

When to call the emergency number
If Red Robin finds the symptoms you have described to be alarming, you will be prompted with a warning that you should consider calling the emergency number. 

The final question is not assessed by Red Robin
Your response to the last question, about if there is any information you want to add, will be sent unaltered to the healthcare provider. Red Robin will not take this information into account during the assessment of the case. 

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Performance

To ensure that Red Robin continues to be a safe and reliable service, we collect information on how well it performs continuously. We regularly update our reports and conduct studies to ensure that Red Robin meets high standards for safety and efficiency. Below, you will find the results from our most recent evaluations.

Clinical Evaluation

Differential Diagnoses - Sensitivity

Red Robin suggests correct diagnoses with a sensitivity of 94%. This means that in 94% of cases, Red Robin suggests the same diagnosis that your healthcare provider later determines to be correct.

Urgency - Sensitivity

Red Robin assesses the urgency of your healthcare needs and categorizes them into Emergency (urgency level 1-3), 24H (urgency level 4-5), and Routine (urgency level 6-8). The sensitivity for these groups is:

• Emergency: 92%
• 24H: 84%
• Routine: 86%

This means that in these percentages of cases, Red Robin correctly categorized your healthcare needs, as later confirmed by a healthcare provider.

Service Reliability

We strive to ensure that Red Robin is always available when you need it. Over the past year, the service has been available more than 99.9% of the time, meaning it has almost always been up and running as expected.

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Product Specifications

Internet connection required to use the service	Yes
Supported hardware	PCs (including Mac)
	iPhone and iPad
	Smartphones and tablets running Android
Supported operating systems	Windows
	macOS
	iOS (latest 3 major versions)
	Android (latest 4 major versions)
Required software (one of the listed)	Google Chrome (at least up to 1 year old)
	Mozilla Firefox (at least up to 1 year old)
	Microsoft Edge (at least up to 1 year old)
	Mobile Safari (at least up to 1 year old)
	Google Chrome for mobile (at least up to 1 year old)
	Web views inside native mobile apps (using iOS or Android native web views)
Requirements regarding external interfaces	LegitHealth (CE-marked medical device for skin analysis https://legit.health/) requires a minimum of 12 megapixels on the camera used to take a picture analysed by their service. LegitHealth will analyse the quality and content of the image and only return a clinical assessment for images of sufficient quality that contains skin

How to Report Incidents

If you have discovered an issue with Red Robin, do not hesitate to report the issue to Visiba Group AB at [e-mail]. In the event that Red Robin has been involved in any serious situation that may have resulted in a patient or user being injured or harmed in any way (including data security and protection issues), please also report the incident to the competent authority in your country.

Country	Competent Authority	Reported to
Sweden	Läkemedelsverket	[e-mail]
United Kingdom	Medicines and Healthcare products Regulatory Agency	[e-mail]
Finland	Fimea	[e-mail]
Norge	Statens legemiddelverk	[e-mail]

Requesting Instructions for Use in Paper Form

This instruction for use is provided in an electronic form. If you have the need for an instruction for use in paper form, please contact Visiba Group at [e-mail]. Instructions for use in paper form can be obtained within 7 calendar days without additional cost.

Regulatory Information

Red Robin is available in the following regions:

Country	Representative
Sweden	Visiba Group AB
United Kingdom	Visiba UK Limited
Finland	Visiba Group AB
Norway	Visiba AS

UDI-DI: (01)07350137870018(8012)

Manufacturer:

Visiba Group AB
Krokslätts Fabriker 61
431 37 Mölndal
Sweden
[e-mail]
https://www.visibacare.com