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Smart Triage Questions: Instructions for Use and Product Label

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Written by Ben Davies

Smart Triage Questions (STQ) - Instructions for Use

Instructions for Use Version: 1.1

Date of Issue: 04/08/2026

Device Identification

Device name: Smart Triage Questions (STQ)

UDI: 0105056930500009112608048012v3.0.2-f966c4e2

Date of software version: 04/08/2026

Manufacturer: Accurx Ltd

Manufacturer address: 7 Curtain Road, Shoreditch, London, EC2A 3LT, United Kingdom

Manufacturer email: support@accurx.com

Intended Purpose

The Smart Triage Questions (STQ) device is intended for use in a variety of healthcare settings, including primary, secondary and community care, as part of the patient triage pathway for non-urgent care. The software analyses patient responses to screening questions and generates specific follow-up questions to gather additional clinical information that can support triage decisions made external to the device.

Intended Users

The intended users are patients, healthcare professionals and administrative staff.

Intended Patient Population

The intended patient population are patients in primary, secondary and community care settings.

Indications

The device is indicated for use in primary, secondary and community care settings.

Variants

The variant available on the market is for use in primary care.

Contraindications

The device is contraindicated for use by patients requiring urgent medical assistance.

Expected Clinical Benefits

Smart Triage Questions provides the following intended clinical benefit:

  • The device gathers additional clinical information to support triage decisions being made by healthcare providers/staff external to the device.

Summary of Safety and Performance Characteristics

Key safety and performance results from the pre-market Clinical Performance Evaluation:

Clinical Safety

Result

Diagnosis – STQs did not suggest a diagnosis

>99%

Management plan – STQs did not suggest a management plan

100%

Readability and Language – STQs had a reading age of 13 years, used patient understandable language, and had one clear topic per question

92%

Tone and alarm - STQs did not include language that could cause unnecessary alarm to patients

>99%

Clinical Performance

Result

Triage Value – STQ answers would provide useful/partially useful information to assist triaging

>99%

Relevance – STQs were relevant/partially relevant to the patient’s request

>99%

Novelty – STQs sought new/partially new information not contained in the patient's request

>99%

Combined Triage Utility – STQs met all three performance criteria above

>99%

Residual Risks

All residual risks related to the device have been reduced as far as reasonably possible and to acceptable levels through implemented risk control measures.

The device does not replace professional clinical judgement. The device is contraindicated for use by patients requiring urgent medical assistance.

Warnings

The device uses generative AI, which may result in errors or inappropriate questions.

Precautions

  • This software gathers additional clinical information from patients that can support triage decisions made external to the device. It does not replace the clinical judgement of the triaging healthcare professional.

  • Do not copy or transfer unverified content into medical records or prescriptions.

  • Do not use the device for urgent medical queries.

When Patients Should Consult a Healthcare Professional

Patients should not use the device for urgent medical queries, and instead should call their healthcare provider or NHS 111, or if it is an emergency, they should call 999.

System Requirements

The following are required to access the STQs device:

Patients:

  • Internet connectivity

  • A modern web browser (e.g. Chrome) or an up-to-date version of the NHS App (running on Android version 8 and above, or Apple iOS version 15 and above). More information about requirements for the NHS App can be found here.

Healthcare staff:

  • Internet connectivity

  • A modern web browser (e.g. Chrome) or an up-to-date version of the Accurx Toolbar is required to access the device outputs in the Accurx Inbox. More information on system requirements to run the Accurx Toolbar can be found here.

  • Compliance with minimum IT security standards, including protection against unauthorised access.

Serious Incident Reporting

Users and patients should report any serious incident that has occurred in relation to the device to the manufacturer and to the UK competent authority.

  • Manufacturer: support@accurx.com / healthcare professionals can also use the in-product Report feedback tool.

  • United Kingdom competent authority: the Medicines and Healthcare products Regulatory Agency (MHRA), via the Yellow Card scheme (yellowcard.mhra.gov.uk).

Operating Instructions

Patient instructions:

  1. Patient access: the patient accesses the Patient Triage product via a modern web browser (e.g. Chrome) or the NHS App and answers screening questions to describe their medical request. The product should not be used for urgent medical queries.

  2. Follow-up questions: the STQ device analyses the patient's responses to the screening questions and generates specific follow-up questions (in some circumstances the device may not generate any follow-up questions). The patient answers these questions and submits their request.

Healthcare staff instructions:

  1. Access outputs: the healthcare professional or administrative staff member opens the request in the Accurx Inbox using a modern web browser or the Accurx Toolbar.

  2. Review all device outputs: review the patient's original request together with their answers to the STQ follow-up questions before acting on them.

  3. Triage: use the gathered information to support the triage decision, which is made external to the device using professional clinical judgement.

  4. Record keeping: verify all content before it is copied or transferred into medical records or prescriptions; do not copy or transfer unverified content.

Paper Copy

Email Accurx Support at support@accurx.com if you require a paper copy of the Instructions for Use.


Smart Triage Questions (STQ) – Product Label

Product Label Version: 1.1

Date of Issue: 04/08/2026

Device Identification

Device name: Smart Triage Questions (STQ)

Type: Class I - UK MDR 2002

UDI: 0105056930500009112608048012v3.0.2-f966c4e2

Date of software version: 04/08/2026

Manufacturer Information

Manufacturer: Accurx Ltd

Manufacturer Address: 7 Curtain Road, Shoreditch, London, EC2A 3LT, United Kingdom

Manufacturer Email: support@accurx.com

Intended Purpose

The Smart Triage Questions (STQ) device is intended for use in a variety of healthcare settings, including primary, secondary and community care, as part of the patient triage pathway for non-urgent care. The software analyses patient responses to screening questions and generates specific follow-up questions to gather additional clinical information that can support triage decisions made external to the device.

Warnings

The device uses generative AI, which may result in errors or inappropriate questions.

Precautions

  • This software gathers additional clinical information from patients that can support triage decisions made external to the device. It does not replace the clinical judgement of the triaging healthcare professional.

  • Do not copy or transfer unverified content into medical records or prescriptions.

  • Do not use the device for urgent medical queries.

Instructions For Use

Available electronically above. Please email Accurx Support at support@accurx.com if you require a paper copy of the Instructions for Use.


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