BESA MRI 3.0 Creating individual BEM and 4-layer FEM models made easy: superior source analysis results considering individual anatomy

We recommend that you read this document carefully before installing, configuring, and using the product. The document contains firstly the Safety Instructions and general product information. To familiarize yourself with the usage of BESA MRI we recommend to carefully read the BESA MRI-User Manual. For further information please refer to the section Instructions for Use within this booklet. Finally, the section on Interaction with BESA Research explains how the two programs are integrated. BESA MRI is designed to make using it as easy as possible. We strive to bring you the latest methods for...

Safety Instructions 11 Intended User 11 • The intended user is a neuroscience professional who is trained in the review of MRI images. He or she is expected to be literate in the usage of computer programs in the Windows environment. • BESA MRI is only to be used by appropriate trained specialist personnel who also have an understanding of English sufficient to enable them to read the User Manual and operate the software. • Users who use BESA MRI in combination with BESA Research must consider the national requirements for EEG and MEG evaluation independently of the manufacturer’s liability....

System Requirements 1) BESA MRI 3.0 is a stand-alone SW product compatible with personal computers running under the following hardware / OS: • Windows ® 10 – 64bit, Touch not supported • Windows ® 7 – 64bit, Touch not supported • CPU: minimum 2 GHz • RAM: minimum 8 GB • Display resolution: minimum 1280 × 1024 pixels • Graphics card: OpenGL 2.0 with 16 M

The product is allowed to be used in combination with following software- or hardware-products: • BESA Research 7.0 • BESA Research 7.1 6 | BESA MRI 3.0

Application Environment 1) a) Definition of Patient Environment IEC 60601-1-Ed.3.1 - Subclause 3.79 - Patient Environment It is difficult for this standard to define dimensions for the volume in which diagnosis, monitoring or treatment occurs. The dimensions for the PATIENT ENVIRONMENT given below have been justified in practice. b) Please Note: It is the User’s responsibility to ensure the safety of combined medical or medical-&-non-medical-devices par ticularly installed in the patient environment (whether in nstii tutes, clinics or practitioners’ location). The user of our product has to ensure...

d) We recommend you to document / retrace our Software version / updates installed in your facility / network in a MPG Medizingeräte-Buch (medical facilities book), similar to those needed for Hardware. e) ESA MRI 3.0 does not affect the possibility of using any B medical computer within patient environment. Our software was tested on the specified IT environment (refer to System Requirements). BESA GmbH is not liable for any use / installation beyond the defined PC network. Exclusions for Use 1) Contraindication to patients: Not applicable. BESA is not liable for the use outside of the rules...

Intended Use 1) • BESA MRI 3.0 is intended for the Use (MDD 93/42/EEC) – For Human Beings – And NOT for Animal Beings • BESA MRI 3.0 is a stand-alone SW product compatible with personal computers running under a Windows operating system. • The purpose of BESA MRI 3.0 is to assist in the analysis of EEG and MEG data by providing tools for the following analysis steps: – Segmentation of MRI data of human heads – Coregistration of EEG and MEG sensor positions with MRI data • The segmentation component of BESA MRI 3.0 imports digital MRI data, segments and labels different brain and head tissues,...

• BESA MRI 3.0 segmentation requires a patient age of at least 10 years. • BESA MRI 3.0 alone does not provide any diagnostic conclusion about the subject’s condition. • BESA MRI 3.0 does not replace the routine EEG data evaluation as specified by the national and international societies for Clinical Neurophysiology. • BESA MRI 3.0 is not for commercial use e.g. fee-based analysis services. • BESA MRI 3.0 and its accessory products are not to be used beyond the scope of the intended use. Life cycle 11 The life cycle of the product ends on 2025-05-25.

BESA MRI 3.0 is a medical product according to MDD 93-42-EEC Article 1; Definitions, scope “medical device” means any instrument, apparatus, appliance, software, material or other article, whether used alone or in combination, including the software intended by its manufacturer to be used specifically for diagnostic and / or therapeutic purposes and necessary for its proper application, intended by the manufacturer to be used for human beings for the purpose of:

MDD 93-42-EEC ANNEX IX CLASSIFICATION CRITERIA

Product Classification According to MDD, Annex IX, III. CLASSIFICATION According to MDD Annex IX, rule 10 indent 3.

According to safety classifications in DIN/EN IEC 62304:2006+AMD2015, BESA MRI 3.0 is a device of: The SOFTWARE SYSTEM is software safety class A if:

It is a pure data analysis software, no physical devices are being controlled or driven by BESA MRI 3.0, nor is any active feedback provided to the patient. Any direct physical damage to the subject can therefore be excluded. BESA MRI 3.0 is a product for analyzing neurophysiological data. • UMDNS code: 16-307 • GMDN: 35163 • GMDN collective term: CT112 (Software, application program)

The BESA license key and the box must be disposed of according to the national guidelines on environmental protection. Environmental conditions for Transport, Storage and Usage 11 • Temperature: -20°C to 60°C • Humidity: 30 % to 85 % Product Labeling 2) Product and accessory products are marked by symbols, as described in: • BESA Product Symbols 16 | BESA MRI 3.0

Installation Instructions The installation, uninstallation and initial setup of BESA MRI must be carried out by an administrator or an experienced technician. • The BESA GmbH assumes no liability for unauthorized access to this product or unauthorized use. Children, laymen and patients shall not use the product. • BESA MRI shall only be installed on PC with password protected user accounts. • Product updates must also be carried out by the system administrator or an authorized person. • If the product is installed on a PC or Notebook within the patient environment, the PC / Notebook must conform...