BESA Connectivity 1.0 The comprehensive toolbox for state-of-the-art brain connectivity analysis in sensor space and source space

Welcome to BESA Connectivity 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 Connectivity we recommend to carefully read the BESA Connectivity - 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 Connectivity is designed to make using it as easy...

Safety Instructions 1) Intended Use 1) The intended user is a neuroscience professional with a reasonable knowledge concerning frequency data generated in neurophysiological recordings of human brain activity. He or she is expected to be literate in the usage of computer programs in the Windows environment. BESA Connectivity 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. The BESA GmbH assumes no liability for unauthorized access to this product or unauthorized...

System Requirements BESA Connectivity 1.0 is a stand-alone SW product compatible with personal computers running under the following hardware/OS: • Windows® 10 - 64bit, Touch not supported • Windows® 8.1 - 64bit, Touch not supported • Windows® 7 - 64bit, Touch not supported • CPU: minimum 2 GHz • RAM: minimum 4 GB • Display resolution: minimum 1280x1024 pixels • Graphics card: OpenGL 2.0 with 16 MB RAM or more Use in combination with other products 11 The product is allowed to be used in combination with following software- or hardware-products: • BESA Research 7.0 • BESA Research 7.1

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) BESA Connectivity 1.0 does not affect the possibility of using any medical computer within patient environment. BESA GMBH is not liable for any use / installation beyond the ed fined PC network. Exclusions for Use 1) Contraindication to patients: Not applicable. BESA is not liable for the use outside of the rules defined in this document.

Intended Use 1) • BESA Connectivity 1.0 is intended for the Use (MDD 93 / 42 / EEC) – For Human Beings – And NOT for Animal Beings • BESA Connectivity 1.0 is a stand-alone software product compatible with personal computers running under a Windows operating system. • The purpose of BESA Connectivity 1.0 is to assist in the analysis of EEG and MEG data by providing tools for the following analysis steps: – Time-frequency analysis – Brain connectivity analysis

• BESA Connectivity 1.0 is intended to be run independently of the EEG and MEG acquisition and review programs of other manufacturers. • BESA Connectivity software is licensed for research use only. It is not allowed to use the BESA Connectivity software directly or indirectly for medical diagnosis and/or treatment of humans. BESA GmbH is not liable for the use of the software beyond the intended research purpose. Life cycle 1) The life cycle of the product ends on 2025-05-25.

BESA Connectivity 1.0 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 12

According to safety classifications in DIN/EN IEC 62304:2006+AMD1:2015, BESA Connectivity 1.0 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 Connectivity 1.0, nor is any active feedback provided to the patient. Any direct physical damage to the subject can therefore be excluded. BESA Connectivity 1.0 is a product for analyzing neurophysiological data. • UMDNS code: 17-222 Information System • GMDN: 17-222 Information System • GMDN collective term: CT112 (Software, application program) 14 | BESA Connectivity

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

Installation Instructions The installation, uninstallation and initial setup of BESA Connectivity 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 Connectivity 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 /...