Healthcare Instructions for Use (eIFU)

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

To help our API 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
   • 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. API Documentation
   • Customer Setup
   • Access
   • Configuration
   • Session endpoints
   • Webhook
5. Support
   • Healthcare professionals
   • Technical integration

General information

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 consist of healthcare professionals, such as physicians, nurses, psychologists, physiotherapists, or others, and API users that will integrate and implement Red Robin in the Customer Setup.

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 display without obstruction or limitation, the full GUI component of the Red Robin Decision Support
• The Customer Setup shall include, external to the medical device, information regarding alternative ways of contacting healthcare in cases where the device isn't functioning
• The Customer Setup shall be able to handle situations where the device is not functioning
• The Customer Setup shall accomodate for a display area that does not hide, or in any way cover or make hard to access, the Label and the eIFU symbol and link that is part of the Red Robin Decision Support GUI

Regulatory information

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 at support@visibacare.com. Instructions for use in paper form can be obtained within 7 calendar days 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 API

Customer Setup

Red Robin is intended to be used in combination with other software to initiate the patient session as well as connect the session to an actual patient. 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 Red Robin Decision Support will be provided and presented to the healthcare professional through the system(s) used in the Customer Setup.

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.

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 Red Robin Decision Support.

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

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

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.