Healthcare Instructions for Use (eIFU)

This is our documentation, as well as the electronic Instructions for Use (eIFU) of our medical device. Here you will find resources and instructions that will enable you to use Red Robin, both as a professional user and in the Customer Setup.

To help our technical users, you can show a code panel with JSON examples to the right by clicking the button "Show/hide code panel" in the left menu.

Table of contents

1. Introduction/table of contents
2. General information
   • Label
   • Intended use/purpose
   • Performance
   • Maintenance
   • Installation
   • Regulatory information
3. Healthcare professionals
   • What is Red Robin?
   • Triage endpoint - Urgency
   • Triage endpoint - Potential differential diagnoses
   • Residual risks
   • Hardware and operating system
4. Healthcare API
   • Customer Setup
   • Access
   • Configuration
   • Access Control endpoints
   • Session endpoints
   • Feedback endpoints
   • Webhook
5. Support
   • Healthcare professionals
   • Technical integration

General information

Label

	Red Robin 1.78.0 The software is automatically updated when the next version is released.
	2024-04-18
	Visiba Group AB Krokslätts Fabriker 61 431 37 Mölndal Sweden
	Red Robin is CE-marked (MDD) as a Class I medical device in the European Union
	Red Robin is a Medical Device
	Basic UDI-DI: 07350137870018
	Instructions for use are available in an electronic format

Intended use / Intended purpose

Red Robin is a software application that is intended to automate pre-clinical triage and initial medical history taking, to support clinical decision making and patient management.

Red Robin enables the:

• remote capture of patient complaints,
• presenting potential differential diagnoses, and
• suggested urgency of the patient case.

The application utilizes artificial intelligence to structure its logic, and is intended to be combined with a customer setup. Customer setup systems can provide and consume data from the device.

Healthcare users

The healthcare users consists of healthcare professionals, such as physicians, nurses, psychologists, physiotherapists, or others.

Indications for use

Healthcare providers or other organizations that are in need of an automated system to perform a pre-clinical assessment of the incoming patient cases, in order to prioritize their resources.

Contraindications

• This product is primarily designed for addressing new or emergent healthcare concerns and may not be suitable for healthcare providers primarily engaged in the long-term management of chronic diseases.
• While effective in scenarios involving new or acute medical issues, this product may not be optimal for use in an emergency setting, such as an emergency department.
• Given its focus on newly emerging health concerns, this product may not seamlessly integrate into established routine care practices that do not frequently encounter such issues.
• This product does not take into consideration medicinal information, and can not assess if the conditions described by the patient are expected side effects of any current treatment plan.
• This product is not designed to assess or manage dental conditions.
• This product is not designed to take into consideration the various stages of gestation, such as physiological changes and symptoms experienced during pregnancy.

Patient users

Patients engage with Red Robin exclusively through its chatbot interface, which is designed to gather initial medical history and triage information in a conversational format. These users do not get any access to output data such as suggested differential diagnosis, urgency, nor any recommendations concerning treatment options.

Indications for use

Patients who experience new or recently emerged medical concerns, and are seeking medical consultation for their condition. The patient should be older than 12 months, but the service can be used by a person that is seeking aid on behalf of another (such as a parent seeking aid for their child’s symptoms).

Contraindications

• The service should not be used in case of an emergency (e.g. result of an incident, the patient being unconscious, the patient consuming something dangerous).
• The service will not assess any patients that are younger than 12 months of age.
• Patients who know they are pregnant should not use the service.
• Patients that do not consider themselves to be cisgender (people whose gender identity matches their sex at birth) may get inapplicable questions regarding their condition.
• The service is not suitable if the patient has the following symptoms or are at all concerned;
  • 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 weakness, inability to hold both arms up, or difficulty speaking.
  • Severe breathing problems.
  • Significantly impaired and are having problem moving.

Disclaimers

The service does not treat a patient, determine a patient's treatment, or provide a definitive diagnosis of a patient's disease or condition. The service does not replace a thorough medical history and examination. The service focuses on the presenting complaint (PC) and history of presenting complaint (HPC) and does not factor in comorbidity or prior knowledge of the patient.

The service is only intended to inform the healthcare professional about potential clinical urgency, and potential differential diagnoses that could be the cause of the combination of the patient's signs and symptoms. It is not the intent that the healthcare professional shall rely primarily on any of such suggestions to make decisions about prevention, diagnosis or treatment of a disease, nor assessing the condition for an individual patient.

• The service is primarily, but not exclusively, meant for being used by patients with newly emerged complaints.
• The service is primarily, but not exclusively, built for primary care use cases.
• The service doesn’t have data regarding prior knowledge of the patient, such as previous or chronic health conditions.
• The service must not be used outside of the region which the product version was designed for. These users should follow local or national guidelines.

Performance

Once every three (3) months a Post-Market Surveillance Update Report (PSUR) meeting is conducted. The outcome of this meeting is a report following our Post-Market Surveillance (PMS) Plan. This ensures that new information about safety and performance is proactively collected and can be used as input for risk management, clinical evaluation, and product development of our products. In addition, Post-Market Clinical Follow-up (PMCF) studies which aim to answer specific questions regarding the device's performance are carried out.

Below you'll find key performance metrics from our PMS plan and recent PMCF studies.

Clinical evaluation

Differential diagnoses - Sensitivity

The diagnostic sensitivity of Red Robin is 95%, based on the PSUR report from 2024-01-16. This metric refers to how often the diagnosis by the healthcare professional (HCP) was indicated as correct was suggested by Red Robin.

Urgency - Sensitivity

Grouping Red Robin's triage urgencies into Emergency (urgency 1-3), 24H (urgency 4-5), and Routine (urgency 6-8), the sensitivity for each group was:

• Emergency: 89%
• 24H: 77%
• Routine: 92%

The sensitivity refers to how often the urgency from Red Robin placed the patient here when the urgency indicated by the HCP placed the patient in this group. This data is based on a PMCF study from 2024-02-23.

Data security and vulnerability

Service uptime

The service uptime percentage ensures that the service is up and operational.

The service uptime was >99.9%, based on the PSUR report from 2024-01-16.

Maintenance

To be able to deliver a safe, secure, and stable service, we regularly maintain our hosting environments in a controlled manner. Any updates on our hosting environments will be done in agreed-upon service windows.

Installation

Before use, Red Robin must be integrated with the Customer Setup. The following requirements are placed on the Customer Setup:

• The Customer Setup shall be able to identify each unique completed session to connect the session to a patient
• The Customer Setup shall present to the healthcare professional the following data:
  • presenting complaint(s)
  • history of presenting complaint(s)
  • the patient's description of matter
  • any further information submitted by the patient from the last question
  • triage endpoint: urgency
  • triage endpoint: potential differential diagnoses
• The Customer Setup shall include in the device information regarding alternative ways of contacting healthcare
• The Customer Setup shall be able to handle situations where the device is not functioning
• The Customer Setup shall include a symbol and a link to this eIFU in the system used by the healthcare professionals

Regulatory information

Requesting instructions for use in paper form

This instruction for use is provided in an electronic form. If you need an instruction for use in paper form, please contact Visiba at support@visibacare.com. Instructions for use in paper form can be obtained without additional cost.

How to report issues, incidents, and any vigilance

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

Red Robin is available in the following regions

Manufacturer

Visiba Group AB
Krokslätts Fabriker 61
431 37 Mölndal
Sweden
contact@visibacare.com
https://www.visibacare.com

Healthcare professionals

Manual (HCP)

What is Red Robin?

Red Robin is an automated medical history and triage tool based on a Bayesian network (an AI model created from a combination of data and human expertise). Red Robin is continuously being tested and updated by a medical team. Healthcare organisations are connected to Red Robin in their own choice of system, the Customer Setup.

Red Robin helps to take the medical history of patients seeking medical care or patients (including children aged 12 months and above) whose representatives are seeking medical care on their behalf. In the first step, the patients can express their inquiry in their own words; Red Robin then identifies symptoms so that it can ask relevant follow-up questions about the symptoms and any risk factors. Once the patient has answered all the questions, Red Robin calculates the urgency and the likelihood of various diagnoses. Following that, depending on how the customer setup is configured, the patient might be referred to a particular healthcare consultation setting, such as booking a video consultation, a drop-in waiting room, or an online chat.

Red Robin provides triage endpoints that can be used in the customer setup. The healthcare professional will be given a summary of the patient’s Red Robin chat history, called a Patient summary. Red Robin also provides any images or other files the patient has uploaded, as well as triage endpoints (urgency and potential differential diagnoses) suggested by Red Robin based on the information provided. Please note, that the potential differential diagnosis suggestions are only intended to highlight diagnoses that may be related to the patient’s symptoms and it remains the responsibility of the healthcare provider to assess and diagnose the patient.

After assessing the patient, the healthcare professional can feedback on the urgency, diagnoses, and actions to be taken in the Customer Setup. This information is then used to improve Red Robin’s accuracy and make the application more reliable over time.

Triage endpoint - Urgency

The urgency given is based on the patient's medical history. This means it will be either the highest urgency indicated directly by a symptom or risk factor the patient has confirmed or the urgency exceeding its cumulative probability threshold as a result of the differential diagnoses. By considering both the symptoms themselves, as well as the diagnoses they may be caused by, a more robust urgency assessment can be made compared to only considering either factor alone. This information is intended to aid healthcare professionals in prioritization and triage of new cases, what is called “pre-clinical triage”.

The order of priority has been developed based on accepted advice and medical assessment guidelines. It ranges from priority 1 to 8, where each score can be translated to a suggested maximum waiting time to meet a healthcare professional:

1. 0 min
2. 10 min
3. 60 min
4. 4 hours
5. 1 day
6. 1 week
7. 1 month
8. Self-care

This triage system means that healthcare providers can get a quick summary of incoming cases and see the recommended order in which the cases should be reviewed. The patient cannot see what priority has been recommended, as that information is only visible to the healthcare practitioner.

However, any patients who, after describing their problems and answering questions in the Red Robin chat, are categorised as priority 1, 2, or 3, will see a stop sign in the application informing them that they should be aware and should promptly get in touch with a healthcare provider. Such patients can choose to continue to proceed in the app or call 111, but the app advises them to contact 999 if it is urgent.

In the case of patients classified as priority 4, the app displays a warning and the recommendation to contact healthcare services within 4 hours instead.

These stop signs increase patient safety and mean that healthcare professionals can feel more comfortable using Red Robin even at times when staffing is low and/or outside clinic reception hours.

Please note: Red Robin does not handle cases automatically, but only offers recommendations that healthcare practitioners can use as a decision-making aid. For that reason, patients will not be suggested self-treatment as an option either.

Triage endpoint - Potential differential diagnoses

Red Robin’s suggested diagnoses are intended for assistance and decision-making purposes only, by highlighting diagnoses that may be related to the patient's symptoms. The suggested diagnoses are based on the outcome in Red Robin, i.e. before any clinical examination, lab tests, X-rays, etc. are performed. Red Robin is not intended to replace any healthcare practitioner’s clinical expertise and for that reason, the healthcare practitioner is always responsible for assessing and diagnosing the patient.

The differential diagnoses come with a probability, on a scale from 0% to 100%. It's up to the customer setup how this is presented to the healthcare professional. The probabilities are based on two arguments:

• Individually tailored incidence rates are based on general incidence rates in the respective country and corrected for risk factors such as age, gender, lifestyle, or underlying medical conditions.
• How well the diagnosis explains the symptoms described by the patient.

Residual risks - Healthcare professionals

Hardware and software requirements

Healthcare professionals setup

Final requirements are set by the customer setup, the following is a recommendation

An internet connection is required to use the service.

Recommended hardware:

• PCs (including Mac)
• iPhone and iPad
• Smartphones and tablets running Android

One of the following operating systems is recommended to use the service:

• Windows
• macOS
• iOS (latest 3 major versions)
• Android (latest 4 major versions)

One of the following software is recommended to use the service:

• 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)

Patient interface setup

The following are requirements for the patient interface, please read the patient eIFU for more information.

An internet connection is required to use the service.

The service is supported on the following hardware:

• PCs (including Mac)
• iPhone and iPad
• Smartphones and tablets running Android

One of the following operating systems is needed to use the service:

• Windows
• macOS
• iOS (latest 3 major versions)
• Android (latest 4 major versions)

One of the following software is needed to use the service:

• 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 contain skin.

Triage by Proxy (HCP)

What is Triage by Proxy?

Triage by Proxy is integrated into some Customer Setups using Red Robin. It is designed to enable healthcare providers to conduct patient history-taking and triage remotely. This capability allows designated personnel, such as GP receptionists or other healthcare resources, to assist patients over the phone by guiding them through a structured assessment process.

How it works

Please refer to your professional system help center within the Customer Setup used in your workflow.

Known issues and limitations

Inappropriate questions

Some questions may not be suitable for remote triage over the phone. In such cases, prioritize obtaining the best possible answer based on the information provided by the patient or caller.

Additional information overload

Patients or callers may provide more information than can be accommodated within the device. Take this into consideration when conducting the assessment to ensure an accurate evaluation.

Image upload requirement

If the device prompts for an image upload and it's not feasible to obtain it over the phone, skip the question. However, be aware that the assessment may be affected by the absence of image analysis.

Caller acting on behalf of someone else

If the caller is acting on behalf of another individual, ensure that the patient details are accurately filled in the system. Make a note in the system if the caller is not the actual patient to maintain proper documentation.

NHS Number requirement

Note that an NHS number is required to use the triage by proxy flow. Ensure that this information is collected from the patient or caller before proceeding with the assessment.

Risk management guidelines

Clear communication

Communicate clearly with patients or callers about the limitations of remote triage and the need for accurate information.

Documentation

Document any deviations from the standard triage process, such as skipping questions or noting when the caller is not the actual patient.

Clinical judgement

Exercise clinical judgement when conducting remote triage, taking into account the context of the situation and any limitations in the information provided.

Continual monitoring

Continuously monitor and evaluate the effectiveness of the Triage by Proxy feature, making adjustments as needed to mitigate risks and enhance safety.

Healthcare API

Customer Setup

Red Robin is intended to be used in combination with other software to both initiate and complete the Red Robin session. Therefore, it’s required to have Red Robin implemented in a Customer Setup. This must include at least one other system, such as a virtual care platform.

The system(s) used in the Customer Setup is defined by each customer. The patient summary will be provided and presented to the healthcare professional through the external system(s) in the Customer Setup, and the data will be provided by Red Robin through an API.

Access

To use the Red Robin API, some steps need to be completed before going into production.

1. Provide information about your organisation

Please provide information about your organisation and contact information to the main contact responsible for the integration. We will use this information to be able to give information about upcoming changes and API usage.

2. Contract a license for the use of the API

In this contract, there will be terms of usage, pricing, and other agreements. We will also agree on in which setup the API will be used and validate the use case.

3. Receive the API key

In this step, you'll receive the API key and will be able to start integrating with the API. If needed, technical support will be given. The API key is unique and non-transferable. The key will be used in the HTTP headers of each request as X-Red-Robin-API-Key.

4. Acceptance test

Before going into production and to be used with real patients, an acceptance test must be performed and cleared.

Contact

If you have questions regarding accessing the API, please reach out to one of our sales representatives. If you don't have a sales representative, reach out to support@visibacare.com.

⚙️ Configuration

Available configurations

Red Robin can be configured to be used in two different ways, open or controlled.

Open

If you choose to use it with an open configuration, every user with access to the entrypoint URL will be able to create and fulfil a session. This is default and all you have to do is to link your patients' to Red Robin through the given URL. Once a session is completed, you'll be noticed through a webhook or query parameter in the navigation URL. The connection between the session identifier and the user is something you do on your side since Red Robin doesn't store personal data.

Controlled

In the controlled configuration, you must create a session to let a user in. The session will be given a unique entrypoint URL, which you also will be able to time limit. A use case example would be if you've screened the users before Red Robin, i.e. via telephone.

Access Control endpoints

These endpoints control access to the service, e.g. the ability to create new sessions. In addition, there are endpoints to fetch information about the service that can help when deciding whether or not the service should be opened or closed.

Status - GET /api/v1/AccessControl

response open

{
  "active": true,
  "isOpen": true,
  "closedReason": null
}

response closed

{
  "active": true,
  "isOpen": false,
  "closedReason": 2
}

Retrieve the current status of Access Control

Response types

ClosedReason

Session Count - GET /api/v1/AccessControl/sessionCount

response

{
  "completed": 58,
  "active": 4
}

Example: Count todays sessions

api/v1/AccessControl/sessionCount

Example: Count sessions between "2024-01-16 15:00:00 +01:00" and "2024-01-17 02:15:00 +01:00"

api/v1/AccessControl/sessionCount?start=2024-01-16%2015%3A00%3A00%20%2B01%3A00&end=2024-01-17%2002%3A15%3A00%20%20%2B01%3A00

Get a count of completed and currently active session.

We consider a session that has not been completed and is less then 30 minutes old to be active.

The request takes a query string with two DateTimeOffset parameters, start and end, between which the count is performed. If omitted start is set to midnight in system local time and end is set to 'now', effectively counting sessions created today.

System local time is IANA Europe/London or Eurupe/Berlin depending on what instance of the service you are using.

Query Parameters

Response types

Close - POST /api/v1/AccessControl/close

request body

{
  "closeRequest": {ClosedReason}
}

response

{
  "active": true,
  "isOpen": false,
  "closedReason": 1
}

Disallow public access to the service.

Patients, or lay persons acting as agent for a patient, are not allowed to create new sessions. A session already in progress will be allowed to complete.

Healthcare professionals using proxy features available through Customer Setup are still allowed to create sessions. The Closed state will not affect this functionality and access will be granted as long as the session is not expired.

Response types

ClosedReason

Open - POST /api/v1/AccessControl/open

request body

response

{
  "active": true,
  "isOpen": true,
  "closedReason": null
}

Allow access to the service.

Response types

ClosedReason

Session endpoints

When working with a session you find all the endpoints here. Everything from creating a new session to retrieving the result in the form of a summary.

Session - POST /api/v1/Session

request body

{
  "text": "string",
  "age": 0,
  "sex": 0,
  "languageCode": "string",
  "sessionFlow": 0
}

response

{
  "sessionId": "string",
  "patientEntryUrl": "string"
}

Creates a session with an entry url that is equivalent to a ticket to use the service. This ticket is valid for a limited time.

Request body

Response types

Response parameters

SessionFlow

Status - GET /api/v1/Session/{sessionId}/status

response

{
    "Status": {SessionStatus} 
}

Retrieve status for a session.

Path Parameters

Response types

SessionStatus

Patient Summary - GET /api/v1/Session/{sessionId}/patient_summary?language={languageCode}&translate={translateAnswers}

response

{
    "id": "string",
    "patient": {
        "sex": "string",
        "age": 0,
        "has_representative": false,
        "language": "string",
        "locale": "string"
    },
    "created": "2023-10-27T08:44:42.200017",
    "modified": "2023-10-27T08:45:03.694007",
    "git_hash": "string",
    "observed_answers": [
        {
            "node_id": 0,
            "name": "string",
            "alternative_name": "string",
            "value": true,
            "uncertainty": 0,
            "from_query": true,
            "multibinary_id": 0,
            "question": {
                "node_id": 0,
                "name": "string",
                "alternative_name": "string",
                "text": "string",
                "kind": "string",
                "allow_uncertainty": true,
                "explanatory_asset": {
                    "title": "string",
                    "text": "string",
                    "image": "string"
                },
                "question_type": "string",
                "data": {
                    "uncertainty": "string",
                    "timelines_name": "string",
                    "display_format": "string",
                    "alternatives": [
                        "string"
                    ]
                },
                "special_type": "string"
            },
            "follows": [
                0
            ],
            "implicit": false
        }
    ],
    "completed": true,
    "diagnoses": [
        {
            "node_id": 0,
            "name": "string",
            "probability": 0,
            "icd10": "string"
        }
    ],
    "triage_level": {
        "urgency": 0,
        "profession": "string",
        "visitation_form": "string",
        "referral_group_kind": "string"
    },
    "hcp_feedback": {
        "comments": [],
        "diagnosis_icd10s": [],
        "outcomes": [],
        "urgency_ok": false,
        "urgency_revision": "string",
        "selfcare_recommendation": false,
        "other_outcome": "string"
    },
    "patient_feedback": {
        "comment": "string",
        "evaluation": 0
    },
    "patient_further_information": null,
    "symptom_diagnoses": [
        {
            "node_id": 0,
            "name": "string",
            "probability": 0,
            "icd10": "string"
        }
    ],
    "query": "string"
}

Path Parameters

Query Parameters

Response types

Images - GET /api/v1/Session/{sessionId}/images

response

[
    "string"
]

If the patient uploaded images in their session, you'll be able to fetch them using this endpoint. The response contains a list of download urls, which you'll use to actually fetch the image.

Path Parameters

Response types

Feedback endpoints

Endpoints to provide feedback. This is much appreciated as it helps us improve the service.

Triage Evaluation - POST /api/v1/Session/{sessionId}/triage_evaluation

request body

{
  "diagnosis_icd10s": [
    "string"
  ],
  "outcomes": [
    "{Outcome}"
  ],
  "urgency_ok": true,
  "urgency_revision": 0,
  "selfcare_recommendation": true,
  "other_outcome": "string"
}

response

Using this endpoint, you're able to give clinical outcome feedback about a specific session. This will be received with the medical team at Visiba and analysed as part of the continuous development of Red Robin's medical core.

Path Parameters

Request body

Response types

Outcome

Clinican Feedback - POST /api/v1/Session/{sessionId}/clinican_feedback

request body

{
    "comment": "string",
    "email": "string"
}

response

With this endpoint, you're able to give clinical feedback about a specific session. This will be received by the medical team of Visiba and analysed as part of the continuous development of Red Robin's medical core. If you provide an email, we'll also be able to contact the one who gave feedback with either the solution or follow-up questions.

Request body

Path Parameters

Response types

Webhook

Webhook - request

{
    "sessionId": "string",
    "summaryLink": "string",
    "urgency": "{Urgency}",
    "extendedData": "object"
}

To let your system know when a session is completed. We will register a webhook for you that we will make a POST request to. This page documents what we will send to you in that request. The user will be navigated to a thank you-view.

Security

The webhook can be configured with an authorization token. This will be attached to the Authorization header as Bearer {token}.

Request parameters

Urgency

Residual risks - Technical integration

Support

Healthcare professionals

Professional users can contact Visiba, using one of the following channels:

• Email: support@visibacare.com
• Phone: +46 31 788 59 80

If the user uses the platform Visiba Care, it’s also possible to create a support ticket within the Visiba Care service. Some questions/cases are possible to help by self-help. To answer some of the most common questions, a help center is available at https://visibacare.zendesk.com/hc/en-gb/sections/360005774480-Red-Robin.

Technical integration

If the question relates to technical integration, please contact Visiba using one of the following channels:

• Email: support@visibacare.com
• Phone: +46 31 788 59 80

If needed, we will set up specific channels for the integration project as well.