TruScan Acquisition 7.3 Instructions for Use

Table of Contents

Introduction ...3 Warranty ...4 Trademarks and Regulatory Standards ...5 About the System and Warnings ...7 Connecting the Electrodes ...9 Basic Steps for Recording EEG ...11 Electrode placement according to 10/20 system ...13 Main Interface Controls ...14 TruScan Acquisition overview ...15 Left Panel ...19 Edit patient's card ...23 Create / Edit Patient's data ...26 Move Records screen ...28 Photo-stimulation ...30 Photo - stimulation setup...31 Event Markers ...33 Additional Event Markers ...35 Recording System ...36 Recording System Tab ...37 Montage Editor ...41 Montage Editor Screen ...42 EEG Settings Tab ...45 EEG Settings Tab ...46 Modalities ...49 BrainFeedback ...50 BrainFeedback Main Tab ...51 BFB Main controls ...53 Training settings...57 Session Info / Spectrum ...58 BFB Protocols ...59 Sound ...60 Band ...62 LCC Creator...63 DVD Player with Multi-Parameter Non-Linear Feedback ...64 HD Video and controls ...66 HD Video Settings ...68 PTZ Controls ...70

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INTRODUCTION

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Warranty Warranty Deymed warrants that each product we sell you is free from defects in labor and materials and shall conform to its product specifications as defined in the user documentation. If the product does not function as warranted during the warranty period, we will repair or replace it without charge. If in our judgment we are unable to do so, you may return it to us and we will refund your money. Warranty Period The warranty period is stated in the product user documentation. If you install the product, the warranty period begins on the date of invoice. If we install the product, the warranty period begins on the date of installation but will begin no later than 30 days from the date of invoice. The warranty period for products is 24 months from the date of installation or 25 months from the date of shipment, whichever is less. Misuse, accident, modification, unsuitable physical or operating environment, improper maintenance, or damage caused by a product for which we are not responsible may void the warranty. Certain components may have separate warranty periods as stated in the product user documentation. Consumables are not covered under warranty. THIS WARRANTY REPLACES ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED AND OR ANY OTHER OBLIGATIONS OR LIABILITIES ON THE PART OF DEYMED. WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE OR OTHERWISE, DEYMED SHALL NOT BE LIABLE FOR AND DISCLAIMS ALL CONSEQUENTIAL, INCIDENTAL AND CONTINGENT DAMAGES. Items Not Covered by Warranty We do not warrant uninterrupted or error-free operation of a product. We provide certain non-Deymed products on an “as is” basis. Non-Deymed manufacturers or suppliers may provide their own warranties to you. Customer Responsibility This product and its components will perform reliably only when operated, maintained and stored in accordance with the instructions contained in this manual, accompanying labels and inserts. A defective product should not be used. Parts which may be broken or missing or those that are clearly worn, distorted or contaminated should be replaced immediately with clean, genuine replacement parts that have been manufactured, supplied or approved by Deymed. The responsibility of Deymed Diagnostic for a non-functioning product is limited by the warranty set forth in this guide. Should repair or replacement of this product become necessary after the expiration of the warranty, the customer should seek advice from Deymed prior to such repair or replacement. If this product is in need of repair, it should not be used until all repairs have been made and the unit is functioning properly and is ready for use. The owner of this product has the sole responsibility for any malfunction resulting from improper use or maintenance, or repair done by anyone other than a qualified Deymed Diagnostic representative and from any malfunction caused by any parts that have been damaged or modified by anyone other than a qualified Deymed Diagnostic representative. Attention The information in this document is subject to change without notice. Deymed Diagnostic s.r.o. makes no warranty of any kind with regard to this material, including, but not limited to the implied warranties of merchantability and fitness for a particular purpose. Deymed assumes no responsibility for any errors that may appear in this document. Deymed makes no commitment to update nor to keep current the information contained in this document. No part of this document may be copied or reproduced in any form or by any means without prior written consent of Deymed Diagnostic. © 2016, Deymed Diagnostic. All rights reserved.

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Trademarks and Regulatory Standards Trademarks Deymed Diagnostic has made every effort to supply trademark information about the products mentioned in this document. The following list of trademarks was obtained from various sources: TruScan EEG™ is a trademark of Deymed Diagnostic. Microsoft® is a registered trademark of the Microsoft Corporation. Windows™ is a trademark of the Microsoft Corporation. Regulatory Standards The Deymed TruScan EEG system meets the following standards set by domestic and international regulatory agencies for medical electronic equipment: • IEC/EN 60601-1:1990 • IEC/EN 60601-1-1:2001 • IEC/EN 60601-1-4:1996 • IEC/EN 60601-2-26:2003 • IEC/EN 60601-1-2 ed.2:2007 • IEC/EN 60601-1-6:2010 • IEC/EN ISO 14971:2012 • IEC/EN 10993-1:2009 • IEC/EN ISO 15223-1:2012

Deymed Diagnostic s.r.o. is an ISO 13485-certified corporation. Compliance The CE 1015 Mark identifies compliance with the Medical Device Directive (MDD) 93/42/ EEC. The TruScan EEG is classified as a Class IIa device equipment according to the rules of the Medical Device Directive (MDD) 93/42/ EEC.

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In regards to electrotechnical classification, the TruScan EEG is classified as a Class I electrical device (IEC 60601) equipment in which protection against electric shock does not rely on basic insulation only, but includes a grounding pin on the power cord. For ground reliability always plug the power cord into an AC grounded outlet. Type BF Equipment: The TruScan EEG is a Type B piece of equipment with an F-Type applied part. A Type B piece of equipment is one that provides a particular degree of protection against electric shock, particularly regarding allowable leakage current and reliability of the protective earth connection (grounding). F-Type applied part is one that extends from the patient into the equipment and is isolated from all other parts of the equipment.

EMI, by its very nature, can be a source of possible disturbance to electronic equipment. This device should be used in an environment free* of other equipment that could be affected by interference. *Environment free as described in IEC1000-2-3, Part 2, 1992, First Edition.

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About the System and Warnings About the System Hardware: The TruScan EEG system features a battery powered Amplifier and an easy-to-use dashboard style interface to help simplify operation. A high quality printer generates interpretation reports created with the interpretation editor. The editor includes a function for pre-saved text macros for quick paragraph or sentence insertion to the report. The TruScan EEG FlexiCart has been made to ergonomically accommodate all system components including an integrated computer. Its custom design allows the system cables and wires to be neatly hidden inside the cart while at the same time providing convenient storage for all your supplies. Software: The design of the interface for the TruScan EEG software provides and intuitive 'dashboard' style design that greatly simplifies operation. Users are greeted with a layout that will be familiar in minutes, due to the minimum amount of change in the screen layout from test to test. Additional features of the TruScan EEG system: • Support of up to 256 recording channels • Fiber Optic isolation and battery operation for superior signal • Small footprint and modular for portable or hospital cart operation • High Sample rates of all channels up to 6,000 Hz per channel • Recording of all EEG and Video to hard disk for review • Network ready for connection to HL7 or other hospital data centers Entering Commands Enter commands, text or values by clicking or typing a series keys in the program’s interface. You may also use a mouse to perform these functions by pointing and clicking on any key or button listed on the display area. User Safety In this manual, two labels identify potentially dangerous or destructive conditions or procedures: The WARNING label identifies conditions or practices that may present danger to the patient and/ or user. The CAUTION label identifies conditions or practices that could damage the equipment or cause you to lose data. A third label, NOTES, helps you identify areas of possible confusion and avoid potential problems during system operation. IMPORTANT! Please read and follow all WARNINGS, CAUTIONS and NOTES provided in this guide. To avoid the possibility of injury, damage to your TruScan EEG or lost data, observe these safety precautions during system operation and maintenance. For your information, the WARNINGS and CAUTIONS provided in this manual are listed on the following pages.

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User and System Warnings: This device shall only be used in rooms designated for medical use. Only personnel properly trained to operate the Deymed TruScan EEG should use this system for patient testing. Connect patient electrodes to fully electrically-isolated physiological devices only. Connection of patient electrodes to any other devices or external electrical outlets may result in personal injury. Do not operate the device in close proximity (i.e., less than 1 meter) to a shortwave or microwave therapy device. This practice may lead to electromagnetic interference into the electrode leads and can cause patient burns. Using electrodes with current densities greater than 2 mA r.m.s./cm2 may require the special attention of the operator. This device is not suitable for use in the presence of a flammable anesthetic mixture with air, or in the presence of a flammable anesthetic mixture with oxygen or nitrous oxide.

CAUTIONS Proper use of this device depends on careful reading of all instructions and labels. Installation of this system must be performed only by a qualified Deymed representative. It is not user installable. All non-medical equipment connected to this device, such as printers, must comply with IEC900 and/or all European Directives. All non-medical devices must be connected to the Deymed Isolated Power Supply. Preventive Maintenance Preventive maintenance for the Deymed TruScan EEG consists of periodically cleaning and visually inspecting the exterior of the instrument. Deymed Diagnostic recommends that the typical user follow the preventive maintenance schedule presented in TruScan EEG Service Manual. Your own schedule may vary based on the type and amount of instrument use. Additional Copies Additional copies of this user guide and/or other Deymed Diagnostic literature may be obtained from: Deymed Diagnostic s.r.o. Velky Drevic 94 549 34 Hronov Czech Republic Phone: +420 491 481 038 Fax: +420 491 481 513

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Connecting the Electrodes Connecting the Electrodes The following instructions explain how to connect the recording electrodes to the appropriate TruScan EEG system components. Position the electrodes on your patient according to the international 10/20 or 10/10 electrode positioning system or use your own conventions. Recording Electrodes: #

Position the recording electrodes on the patient.

# If using individual electrodes, connect them to the amplifier as described in the chart at the bottom of this page. If using a Deymed supplied 9mm disc electrodes with touch proof connectors, plug the touch-proof connectors into the corresponding openings with the pins on the front of the amplifier. Individual Electrodes Connection to Amplifier Electrode

Amplifier Channel Connector

Patient Ground

Green pin jack

Red, Orange or Blue (–) (active recording)

Red, Orange or Blue pin jack

Purple (+) Ref (common reference)

Purple pin jack

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Patient Ground Touch-proof connector for individual electrode use, or if not included on an EEG cap. Active Recording Electrodes Active Recording Electroded: Red, Orange or Blue connectors for individual electrodes use. Common Reference Touch-proof connector for individual electrode use. EEG CAP connector To connect compatible EEG cap (Patient Ground and Refecence socket included in the connector)

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Basic Steps for Recording EEG Patient Hookup with Recording Cap 1. Scrub the patient's ears and forehead with Nuprep and wipe off with an alcohol swab. 2. Measure the circumference of the patient's head in order to choose the right recording cap: Green (47-51 cm) Yellow (51-55 cm) Red (54-58 cm) Blue (59-63 cm) 3. Put the cap on the patient's head with the tag in the back. • Make sure FZ, CZ, PZ are centered. • Make sure that CZ lines up with the ears. 4. If using ear electrodes, place tin ear clip electrodes, filled with gel, onto the patient's ears. 5. If using ear electrodes, plug ear electrodes into ear sockets in cap, or if cap does not have ear connectors, plug into A1 and A2 sockets on Headbox. 6. If the recording cap is not a Deymed brand cap, place a ground electrode, filled with paste, onto the patient's forehead in the center of FP1 and FP2, and plug the electrode into the green 'PG' slot on the TruScan Headbox. 7. Plug the cap into the Headbox via the 25 pin connector, preferably using the included wear and tear extension cable to protect the Headbox connector from overuse. 8. Put gel into every hole in the cap but be careful not to overfill. If gel runs down from one electrode to the other, they will short and the signal will be disrupted. 9.Make sure that all of the impedances, including the ground, are below 10Kohm or show as Blue or Green on the impedance display. If any channel is not showing Blue or Green, then the connection is most likely not low enough and precaution should be taken to further lower the impedance. TIP: Take the end of the wooden Q-tip and twist around in the corresponding hole on the cap for the problem electrode. You can also add more gel if necessary while being careful not to overfill. Software Setup and Recording 1. From the Edit Patient's Card tab, add a new patient. Fill in the name fields. Give the patient an ID number. 2. Set the montage to the preferred montage* (on the left side on the screen next to the record and stop buttons) 3. Set the sensitivity to 70µV to start. You may reduce or increase this to facilitate a better visualization of the brainwaves during the recording. Note that this setting does not affect the actual stored data. 4. Hit record when the patient is ready with his or her eyes closed and still. If the patient needs assistance keeping his/her eyes closed then place your fingers over his or her eyes. 5. Look for EMG and movement on the recording and, if necessary, pause and coach the patient. 6. After 10 minutes of recording hit stop. 7. The Patient may now be disconnected and cleaned up. You may now exit the TruScan software.

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* The Montage selection is only for viewing purposes. You can change the Montage at any time during or after the recording with no change to the recorded data.

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Electrode placement according to 10/20 system

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MAIN INTERFACE CONTROLS

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TruScan Acquisition overview The TruScan Acquisition window is the main screen for recording EEG. It allows for numerous auxiliary functions in addition to recording EEG, including annotation of the recordings, adding notes and event markers, changing recording montage, filters and sensitivity settings and many other features.

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Impedance Panel The Impedance panel is one of the most important and useful tools in the TruScan Acquisition program. It shows the impedance status of all channels at all times, before and during the recording. The Impedance for each site is indicated by a number and by the color changing for each individual location. Numerical values representing the impedance are shown in kilo-ohms. The colors used for the various impedance ranges are shown below. Blue

< 5 kΩ

High Quality Connection

Green Yellow Red Grey

5 kΩ to 10 kΩ 11 kΩ to 30 kΩ > 30 kΩ

Good Connection Poor Connection Bad connection / disconnected Reference or Ground not connected

Modalities The modalities panel allows the user to select from a set of various functions or additional tests available in the TruScan Acquisition program.

Photo-stimulation For more details go to Photo-Stimulator

You can find more details on each individual test or program here : Photo-Stimulator VEP P300 BFB Cognitive Markers

System tabs For more details on each system tab, go to the following sections in this user manual: Edit patient's card Recording system HD_Video EEG Settings

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Event Markers For more details go to Event Markers

Left panel

In the left panel, a user can control the recording and change recording settings. The controls include the record, pause and stop buttons. Other settings or control buttons include the time base, sensitivity, filters and montage controls. However, none of these recording settings will affect the actual recorded signal if changed during recording. All signal is recorded to its full bandwidth according to the sample rate set on the 'Recording System' page. The number of channels recorded is also set on the 'Recording System' tab. Click here for more information on the 'Recording System' settings. For more in-depth details on this panel, go to Left panel section of this user manual.

Signal screen The EEG will appear in this main signal screen. Labels for each channel are shown including the active and reference channels for each signal. At the end of each line, the sensitivity setting is displayed. Yellow lines are shown in place of signal if the impedances are not below 50 KOhms. This helps the user identify when there is a good connection and also helps make it obvious in the event that any electrodes lose contact during recording. This feature can be turned off in the recording system tab by turning off the "impedance check" option.

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Patient card Window The patient card area allows user to enter or edit patient info and easily search the database for existing patients. The patient card area also includes a list of recordings for each patient and notes for each selected recording. For more details go to Patient card.

Recordings List Notes Editor All recordings for the selected patient will be displayed in this list. Notes for each recording may be added per recording in the free text area at the bottom of this screen.

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Exit / Minimize Minimize: Minimize the TruScan to a system taskbar. Maximize: Makes the application full scree. Exit Button: Used to exit the program, and shut down the Headbox.

Left Panel

Selected patient This area displays the currently selected patient for recording.

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Record / Pause / Stop From here the recording can be Started, Paused and Stopped. When using the pause button, that EEG file is still part of the same file. If the user clicks on the stop button this will end the recorded file. The user may pause and continue the recording as many times as they wish.

Recording Progress This area displays the recording status. During the recording, the message 'Recording' will be displayed. If the recording has stopped, the message 'Stopped' will be displayed. If the recording is paused, the message 'Paused' will be displayed.

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Paper Speed Legacy measurement of the speed at which the EEG traverses the screen. Speeds of 15, 30, 60 and 120mm/sec are available. 30mm is Default.