Instructions for Use

2. Intended Purpose

The Cerebric Platform is a software platform intended to reduce the administrative burden on qualified healthcare professionals in mental health settings by transcribing clinical consultations and structuring the text into pre-defined templates, and by performing scoring of standardised, non-proprietary screening questionnaires. The platform is intended for use with patients of all age groups undergoing mental health assessments. The device's purpose is to improve administrative efficiency for the clinician; it is not intended for active monitoring, diagnosis, or to suggest or inform a clinical decision.

3. Critical Warnings and Precautions

Clinician Responsibility

The output of this software (including all transcribed text and formatted reports) is a DRAFT and is intended for administrative support only. The clinician retains full professional responsibility for all clinical content. All outputs must be reviewed, edited, and clinically approved by the qualified user before being used for any clinical purpose.

Not a Diagnostic Tool

This device does NOT provide a diagnosis, suggest treatment, or perform clinical interpretation. The titles of report templates are for administrative filing purposes only and do not imply that the software has performed a diagnostic assessment. The scoring of questionnaires is a mathematical calculation only.

Risk of Data Loss

The software requires a continuous, stable internet connection during audio recording and upload. The software does not save audio data locally to your computer first. If your internet connection is lost during a recording or before an upload is complete, the recording will be lost and cannot be recovered.

Patient Consent

The clinician is responsible for obtaining informed consent from the patient before using Cerebric to record or transcribe a consultation.

Transcription Accuracy

The accuracy of the transcription is dependent on audio quality. Factors such as significant background noise, poor microphone quality, multiple people speaking simultaneously, and strong or unusual accents may reduce accuracy. The clinician must verify the transcript against their own recollection of the consultation.

5. System Requirements

Hardware

A desktop or laptop computer with a functional internal or external microphone. For highest accuracy, a dedicated noise-cancelling microphone is recommended.

Operating System

Windows 10 or later, macOS 11 (Big Sur) or later.

Web Browser

A modern, up-to-date web browser (e.g., Google Chrome, Microsoft Edge, Safari). Some features may not be available on certain browsers such as virtual interview recording on Safari.

Connectivity

A stable broadband internet connection. A speed of at least 10 Mbps download / 5 Mbps upload is recommended for optimal performance.

6. Instructions for Operation

6.1 User Training

Before using the Cerebric Platform, you are required to complete the mandatory onboarding training, which consists of watching the training video and reading all provided materials, including the patient information and privacy policies.

6.2 Recording & Transcribing Consultations

• From the main dashboard, select 'New Interview'.
• Choose one of the following options:
  • Record In-person: Uses your device's microphone to capture audio from a face-to-face session.
  • Record Virtual: For telehealth sessions, this option captures your computer's audio. When prompted by your browser, you must select to share 'Tab' audio to ensure sound from both the clinician and the patient is captured.
  • Upload Audio: Select an existing audio file from your computer to be uploaded and transcribed.
• Ensure the recording environment is quiet with minimal background noise for optimal accuracy.
• Once the recording or upload is complete, the software will transcribe the audio.

6.3 Assigning & Scoring Questionnaires

• Navigate to the specific patient's profile.
• Select the 'Questionnaires' tab.
• Click the 'Assign Questionnaires' button.
• Select the desired questionnaire(s) from the pre-defined list.
• The system will send a secure link to the patient and/or informant, allowing them to complete the forms in a secure web portal.
• Once completed, scores will be calculated and will appear in the patient's profile.

6.4 Using Templates & Finalising Reports

• Once transcription is complete, navigate to the 'Reports' tab.
• Select a pre-defined template from the list. The software will populate the sections of the template with the relevant transcribed text.
• Use the 'Split View' to compare the generated report with the source transcript side-by-side for verification.
• Use the search bar to find specific keywords or phrases.
• To make edits, click the 'Edit' button.
• Crucially, you must review and edit all generated text for clinical accuracy and completeness before finalising and exporting the document.
• Use the 'Copy' button to preserve formatting when pasting the report into other systems.

7. Data Protection and Security

Data Controller vs Processor

In the context of the UK GDPR, your clinic is the Data Controller, responsible for the lawful processing of patient data. Cerebric Ltd acts as the Data Processor on behalf of your clinic, as governed by the Data Processing Agreement.

Data Storage

All patient data is securely stored on Amazon Web Services (AWS) servers located within the United Kingdom.

Encryption

All data is encrypted at rest (AES-256) and in transit (TLS 1.2+).

Access Control

Access to patient information is restricted to authorised users at your clinic via secure login. Cerebric staff have no access to patient data except under strictly controlled, logged, and audited conditions for essential system maintenance, governed by strict confidentiality agreements.

Data Retention

The Cerebric platform stores data on behalf of the Data Controller (your clinic). All transcripts and associated data are retained for a period determined by your clinic's own data retention policies. As the Data Controller, you can permanently delete patient records and all associated data from the platform at any time via the user interface.

8. Troubleshooting

If you encounter an issue with the platform, please perform the following basic steps first:

• Refresh your web browser page.
• Log out of the Cerebric Platform and log back in.
• Check that your internet connection is stable.

If the issue persists, please contact Cerebric support via the "Help and Support" function in the software sidebar or by emailing support@cerebric.io. Please provide a description of the problem and, if possible, the name of the patient record you were working on (do not include sensitive patient details in the email).

9. Manufacturer Details

Manufacturer: Cerebric Ltd, 128 City Road, London, United Kingdom, EC1V 2NX

Company Number: 16033558

Email for support and incident reporting: support@cerebric.io

10. Reporting of Serious Incidents

Notice: Any serious incident that has occurred in relation to this device must be reported immediately to the manufacturer, Cerebric Ltd (support@cerebric.io), and to the Medicines and Healthcare products Regulatory Agency (MHRA) via the Yellow Card Scheme at https://yellowcard.mhra.gov.uk/.