BESA Research 7.1 The most comprehensive signal processing toolbox for EEG / MEG source localization, classic ERP / ERF and brain connectivity ana

Welcome to BESA Research 7.1 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 Research we recommend to carefully work through the BESA Research-Tutorial. For further information please refer to the section Instructions for Use within this booklet. Finally, the section on Interaction with other BESA Products explains how the different programs are integrated. We strive to bring you the latest methods for advanced...

The intended user is a physician who is a neuroscience professional with a thorough understanding of the mechanisms underlying the generation of electrophysiological potentials in the human brain. He or she is expected to be literate in the usage of computer programs in the Windows environment. Results from working with the following module: • Source Analysis shall only be used for diagnostic purposes if created by an experienced neurologist with profound knowledge concerning the methods used in said application areas. BESA Research 7.1 is only to be used by appropriate trained specialist personnel...

BESA Research 7.1 is a stand-alone SW product compatible with personal computers running under the following hardware/OS: Operating system: • Windows® 10 • Windows® 7 • CPU • RAM • Display resolution • Graphics card 64bit, Touch not supported 64bit, Touch not supported minimum 2 GHz minimum 8 GB minimum 1280 x 1024 pixels OpenGL 2.0 with 16 MB RAM or more Use in Combination With Other Products 11 BESA Research 7.1 is designed to be used for the following hardware/software: • Matlab Version: any major release between 2006a and 2019b • BESA MRI 2.0 • BESA MRI 3.0 • BESA Connectivity 1.0

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) Contraindications to patients: Not applicable. BESA is not liable for the use outside of the rules...

Intended Use 1) • BESA Research 7.1 is intended for the Use (MDD 93/42/EEC) – For Human Beings – And NOT for Animal Beings • BESA Research 7.1 is a software-only product compatible with personal computers running under a Windows operating system. • The purpose of BESA Research 7.1 is to assist in the analysis of EEG and MEG data by providing tools for the following analysis steps: Raw data review Data pre-processing Artifact rejection and correction Data averaging and ERP analysis 2D and 3D Mapping Source analysis Time-frequency analysis • BESA Research 7.1 is intended to be used as an additional...

Surgical decisions must not be based solely on the evalua- tion results of BESA Research 7.1. All clinical decisions must be based on combining and comparing these results with all available clinical findings, including standard EEG or videoEEG evaluation, neuropsychological examinations, and independent imaging methods. • BESA Research 7.1 is intended to be run independently of the EEG and MEG acquisition and review programs of other manufacturers. • BESA Research 7.1 must not be used as monitoring software for vital human functions, for example, in: – Intensive care units – Neurosurgical units...

BESA Research 7.1 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 Research 7.1, nor is any active feedback provided to the patient. Any direct physical damage to the subject can therefore be excluded (see Risk analysis for this product). BESA Research 7.1 is a product for analyzing neurophysiological data that may be used in the field of scientific research, and for providing assisting information supporting the diagnosing of disorders in neural processes by analyzing such data. • UMDNS code: 16-307 • 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 Labelling 2) Product and accessory products are marked by symbols, as described in: • BESA Product Symbols