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 Guide section.
If you need assistance with how to use the DeepPsy Biomarkers software, refer to the instructive videos section.
If you need assistance with how to use the DeepPsy Biomarkers software, refer to the instructive videos section.
Report Guide
The report guide is a physician handbook containing information on how to interpret the DeepPsy Report. It also contains important safety and regulatory information you're advised to read before using the DeepPsy Report.
The report guide is 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 a physical copy of the report guide at no additional cost by contacting us at support@deeppsy.io. Basic information will be requested from you such as your name, organization, 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).
Changelog
v1.2.1
- Overhauled the report guide to comply with accompanying documentation regulations.
- Added new sections: label information, contact & incidents, limitations, medical indication, among other important safety information.
- Added information for physicians to contact DeepPsy and have a physical copy of the report guide delivered to them.
v1.1.0
- Changed images used in the cheatsheet in order to become consistent with an updated report displaying the organization's new branding.
v1.0.0
- First release of the DeepPsy cheatsheet.
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 |
|---|---|---|---|
| 01/08/2025 | v1.2.0 latest | v1.6.1 | download |
| 04/06/2025 | v1.1.3 | v1.5.1 | download |
| 06/03/2025 | v1.1.2 | 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
v1.2.0
- Updated several sections related to regulatory information, sections: medical indication, intended user, patient group, and manufacturer claims.
- Updated the minimum hardware requirements to run the DeepPsy Biomarkers software, and added recommendations for the best hardware to run it in.
- Updated the IFU to reflect the new DeepPsy Biomarkers software version v1.6.1.
v1.1.3
- Updated the IFU to reflect the new DeepPsy Biomarkers software version v1.5.1 which can produce reports in French.
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.