Label
Intended Use
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 an Bayesian model of artificial intelligence to structure its logic, and is intended to be used in combination with one or more supporting systems; both as input to the Bayesian network as well as output from the system.
Intended population
Human beings from the age of 12 months and older, seeking contact with healthcare providers for a presented medical condition.
The Patient interface of the service is intended to be used by the general population (recommended from the age of 13 years old and above).
Intended users
The triage and other clinical information that Red Robin captures or generates is intended to be used by healthcare professionals, in order to make initial assessment of the patient’s condition and coordinate resources.
Kontradiktioner
- The service should not be used in case of an emergency.
- The service should not be used for patient’s younger than 12 months of age.
- 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.
- Significant impairment of general condition.
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 or 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 och chronic health conditions.
Warnings
- The urgency and triage outcomes are based entirely on the answers and data that the patient has been willing to share. The questions asked and the answers given should not be considered as exhaustive nor as unquestionable truths. It's encouraged to always confirm the data provided when interacting with the patient.
- The differential diagnosis suggestions should only be considered to be suggestions, based on a pre-clinical assessment. The differential diagnosis list should not be treated as a comprehensive diagnostic analysis and should be approached with a critical assessment.
- The information produced and presented by Red Robin may or may not need to be recorded in the patient electronic health records. It's the healthcare professional that is responsible for recording the data that is believed to be relevant for the patient case.
- The patient may choose not to disclose certain information, or choose not to share certain data, or data entries may be lost. If so, Red Robin will not make any assumptions, and proceed with the information provided. This may also involve the use of third party assessment tools that Red Robin utilizes.
- The patient may be experiencing one or several medical complaints at the same time, and the answers provided may not all be relating to the same medical concern.
Reporting of an incident: 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), do not hesitate to report the incident to Visiba Care at support@visibacare.com.
Further information
For further clarification regarding Red Robin and how it's to be used, please consult our online help center: https://visibacare.zendesk.com/hc/en-gb/sections/360005774480-Red-Robin
Hardware and operating system
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 (up to 1 year old)
- Mozilla Firefox (up to 1 year old)
- Microsoft Edge (up to 1 year old)
- Mobile Safari
- Google Chrome for mobile
- Web views inside native mobile apps (using iOS or Android native web views)
The following external service(s) are tested and supported for professional usage:
- Visiba Care
- LegitHealth (CE-marked medical device for skin analysis https://legit.health/)
Support
Professional users are able to contact Visiba Care, using one of the following channels:
- Email: support@visibacare.com
- Phone: +46 31 788 59 80
If the user uses 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.
A patient using the service should always contact the health care provider. If the case is sent to Visiba, our support team will make sure that the case is referred to the health care provider and any personal information will be removed from our support systems.
Regulatory information
Red Robin is available in the following regions:
Region
|
Representative
|
European Union and European Economic Area
|
Visiba Group AB
|
United Kingdom
|
Visiba UK Limited
|
Manufacturer
Visiba Group AB
Krokslätts Fabriker 61
431 37 Mölndal
Sweden