Dragon Copilot - Electronic instructions for use

Important

This article isn't relevant for Dragon Copilot (radiologists). The radiologist experience for Dragon Copilot isn't available in the UK.

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The Dragon Copilot web, desktop and mobile apps enable users to access the entire Dragon Copilot workflow.

Dragon Copilot desktop: The Dragon Copilot desktop app for Windows provides you with the most advanced and capable way of delivering content directly into your EHR without integration.

Dragon Copilot mobile: The Dragon Copilot mobile app is always at hand, wherever you go. It offers the best ambient recording experience and also allows for offline recording.

Dragon Copilot web: The Dragon Copilot web app is available wherever you have access to a web browser; it provides the easiest and fastest onboarding and implementation experience because it requires no installation or configuration.

Make sure your device is up to date and running the latest version of the Edge/Chrome browser and the iOS/Windows operating system.

To use Dragon Copilot on your device, follow these instructions:

Use of this product is subject to the Dragon Copilot Terms of Use. It is your responsibility to confirm you understand and accept these terms and conditions as shown.

Product information

Product name

Dragon Copilot

Dragon Copilot is a class I medical device in Great Britain in accordance with UK MDR 2002.

Version

Available in the About section of the application.

date of manufacture icon

Date of manufacture

Available in the About section of the application.

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Manufacturer

Microsoft Corporation
One Microsoft Way
Redmond, WA 98052 USA

United Kingdom responsible person

Emergo Consulting (UK) Limited c/o Cr 360 - UL International
Compass House, Vision Park Histon
Cambridge CB24 9BZ
United Kingdom

Regulatory information

UKCA marking

medical device label

GMDN 36216

Important safety information

Intended purpose

Dragon Copilot is intended to assist healthcare professionals by providing documentation automation and workflow optimization. The system leverages artificial intelligence (AI) to streamline the capture of patient information for review by qualified healthcare professionals.

Dragon Copilot is not intended to make decisions or recommendations for diagnosis, prognosis, monitoring or treatment of individual patients, and is not to be used as a substitute for professional medical advice.

Contraindications

  • Not intended to diagnose, monitor or treat individual patients.

  • Not intended to provide or replace professional medical advice, diagnosis, or treatment.

  • Should not be used in emergency or any environment where a patient(s) are at critical risk.

  • Content includes information generated by AI and should not be included into an electronic health record without review to ensure accuracy.

Intended users

Dragon Copilot is designed for use by healthcare professionals. There is no claimed benefit to individual patients.

Specification of clinical benefits and performance characteristics

  • Promotes clinician wellness with reduced burnout, cognitive load and a better work-life balance.

  • Increases operational efficiency.

  • Enhances the clinician's focus on patients.

Interoperability

Dragon Copilot is a software solution that consists of a client, web, and mobile application as well as an administration center.

Precautions

Dragon Copilot is not designed or intended to be a substitute for professional medical advice, diagnosis, treatment, or judgment and should not be used to replace or as a substitute for professional medical advice, diagnosis, treatment or judgment. Microsoft does not warrant that Microsoft products will be sufficient for any medical purposes or meet the health or medical requirements of any person. Prompts must relate to searching, summarizing, editing and/or creating content. In the UK, Dragon Copilot is self-certified as a Class I Device.

Incident reporting

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the competent authority of the Member State in which the user and/or patient is established.

Known risks

The use of Dragon Copilot has been clinically evaluated and has been demonstrated to be safe and effective for use as intended by the manufacturer. Known risks include:

  • Misclassification or omission of clinical content.

  • Misstatement of clinical facts in summarization due to ASR issues.

  • Introduced errors by inferring details not present in the source data.

  • Drug name or medical type misrepresentation due to ASR.

  • Loss of data due to hospital network errors or server resiliency failure.

Privacy, security and compliance

Additional information about Dragon Copilot privacy, security and compliance can be found here: Microsoft Dragon Copilot white papers

Contact Microsoft

For all incidents, feedback, or for support with the Dragon Copilot app, or to request a paper copy of this manual that will be provided at no additional cost within 7 days, contact Microsoft via the Dragon admin center or reach out to the support team to open a ticket using the UK support phone number: +44 (0) 207 660 8102

Any serious incident that has occurred in relation to the device should be reported to the manufacturer and the national competent authority of the country in which the user and/or patient is established.