DeepPsy Biomarkers: Instructions for Use

Welcome to DeepPsy AG's instructions for use (IFU) page for the DeepPsy Biomarkers Medical Device.

Here you will find all versions of the IFUs and other supporting material.

For support, please contact us at:

+41 44 797 62 29 from 9.00 to 17.00, Monday to Friday except holidays
support@deeppsy.io
Click here for feedback or complaints

For more information, visit our website at: https://deeppsy.io

If you're a medical professional wishing to learn more about how to use the DeepPsy report, refer to the report cheatsheet section.
If you need assistance with how to use the DeepPsy Biomarkers software, refer to the instructive videos section.

Report Cheatsheet

The report cheatsheet is an annotated report containing information on how to interpret its different sections.

It was created to assist medical professionals with a concise and easy to use reference material.

Release Date	MD Version	Link
21/12/2024	v1.1.0 (latest)	view
02/05/2024	v1.0.0	view

Instructive Video

This video briefly showcases the core functionality of the DeepPsy Biomarkers software. It was designed to help operators get up-to-speed with the analysis of EEG/ECG data items using the software.

Release Date	MD Version	Link
02/05/2024	v1.x	view

Instructions for Use

The IFUs are provided in electronic format. You must have installed a compatible PDF reader to view them or have one enabled in your browser. Most modern browsers will have a PDF reader installed (Firefox, Chrome, Edge, Safari, etc.).

You may request IFUs in paper format at no additional cost if you're a DeepPSY operator by contacting us at support@deeppsy.io. Basic information will be requested from you such as your name, company, and contact details for delivery. Any information recorded from you will be used strictly for the purposes of validating your identity and completing the delivery. After delivery, all personal data will be deleted. This is in compliance with the General Data Protection Regulation (GDPR).

Release Date	IFU Version	MD Version	Link
06/03/2025	v1.1.2 latest	v1.4.3	download
03/02/2025	v1.1.1	v1.4.2	download
21/12/2024	v1.1.0	v1.4.1	download
24/06/2024	v1.0.1	v1.1.x	download
02/05/2024	v1.0	v1.0.x	download

Changelog

v1.1.2

Changed label information. Modified the UDI section and included UK Rep logo.

v1.1.1

Updated the UKCA certification information to reflect the new Qserve Group UK Ltd. as the Responsible Person.

v1.1.0

Changed the branding of the IFUs to match the new DeepPsy rebranding.
Added additional information to the labeling section.
Included new information related to the configuration panel.
Updated the cloud analysis window section with information on new analysis result states and the analysis history panel.
Updated the report section with information on the new report layout.
Included information on the report verification panel, used to accept or reject reports at the end of an analysis.

v1.0.1

Included deetails regarding the cybersecurity measures implemented by the medical device.
Made changes to the patient group.
Included a new medical claim the narrows the scope of applicability of the medical device.

v1.0

First release of the DeepPsy Biomarkers IFUs.