TruScan Explorer User Guide 7.0 rev 1b

Table of Contents

Introduction ...3 Warranty ...4 Trademarks and Regulatory Standards...5 About the System and Warnings...7 Basic Steps for Recording EEG ...10 Patient Database ...12 Patient List window ...13 Database search ...17 Open Records window ...19 Interface Controls ...20 EEG Review Screen ...21 EEG Review ToolBar ...23 Interpretation Editor ...28 Editor Window ...29 Maps ...31 Amplitude maps ...32 Frequency maps ...35 Coherency maps ...37 Analysis Tools ...39 Spectral analysis ...40 Numeric spectral analysis window ...42 Band Setup window ...44 Data Export ...45 Export to Deymed format ...46 Export to Lexicor or Ascii ...48 Montage Editor ...50 Montage Editor Screen ...51 Measurement tools ...53 Quick spectrum tool ...54 Setup Configurations ...55 Setup Window ...56 Advanced system settings ...60 SomniPro PSG examination ...62 Overview ...63 Hypnogram ...65 PSG Report...67 PSG Report_new ...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. © 2014, 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.

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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. 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 battery powered Amplifier and 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 at 4,096 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 You 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.

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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. 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 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 Phone: +420 491 481 038

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Fax: +420 491 481 513

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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 Yellow Red Blue

(47-51 cm) (51-55 cm) (54-58 cm) (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 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.

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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. * 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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PATIENT DATABASE

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Patient List window The patient list window gives an overview of all EEG data collected in TruScan Acquisition, including a list of all patients in the database, their recorded files, and any notes written during acquisition. At the bottom of the window is a list of all records which have not yet been interpreted. Icons at the right of the window indicate additional functions, such as import, export or burning of EEG files and video if used, to a CD or DVD. All features of this window are described below:

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Patient list The patient list window allows the user to view all patients listed in the database. The database can be searched to find the patient of interest. To search the list click in the column that you would like to search by, and start typing. ==[The text will appear in the search window as you type and the database list will be sorted to the text entered]. The list can be sorted by any of the columns including surname, name or patient ID. The patient may also be deleted from this menu, which will remove them from the database. To delete a patient, click on the patient's name and hold down the CTRL + Delete. A prompt will then ask you to confirm this action.

Record list The records list includes a list of all recordings that have been made under the patient that is currently selected. The list includes numerous parameters that can be used to sort the list. To sort the list by any of the columns, simply click on that column.

Notes The notes area includes any notes that were input during acquisition. The user can edit or add notes directly in this field at any time. There is one Notes section for each recorded EEG file.

Uninterpreted Records List The uninterpreted records area displays all EEG recordings that have not been finalized with an interpretation. This list can serve as a work list. The EEG files can be opened directly from this list by double-clicking on the file.

==[add more text desc]

A file is marked as interpreted or uninterpreted via the Interpretation Editor from the main EEG review interface. From the Interpretation Editor, the button 'Completed' must be clicked to show the file has been interpreted. Once this has happened the file longer be displayed in this list.

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Data Store Locations The data location of the EEG recorded files can be changed here. The path is shown above each button as a tooltip. The paths can be changed from the Advanced System Settings in TruScan Explorer.

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Save to/ Open from The Save to /Open from toolbar allows the user to import or export data out of the system. The CD icons allow the import or export of data, to or from, a CD-ROM or DVD drive. When exporting data to a CD-ROM or DVD drive, a prompt will open allowing the user to edit the label of the CD or DVD and then burn the data. When burning an EEG file, a TruScan EEG Reader is also included to allow any user to open the EEG file. --> Sends selected file to installed CD or DVD burner. Truscan EEG Reader application is included, which can be used to open the EEG file on any Windows computer.

--> Sends the currently selected file to the external computer, specified in the settings.

--> Deletes selected recording.

--> Deletes only the video file, but keeps the recording.

--> Sends the currently selected file to external flash drive (path to the flash drive can be specified in settings). --> Download a file form external flash drive (path to the flash drive can be specified in settings).

--> ==[Restores the data from backup medium.]

--> ==[Joins two recordings together.]

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Database search Database search window allows user to browse the computer or network for additional EEG recorded files and allows the option of adding EEG recordings, along with the patient information connected to them, into the current patient database. The user can filter the current database as well using the search and filter functions as listed and described below.

Records Date Filter The user can quickly choose a filter by which to show a limited subset of data or recordings. The options are to show any recordings from today, the last 60 days, this year, or all. The user may also filter an exact date range using the dates to and from.

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Filtered Patient Recordings The filtered patient recordings list shows all recordings that meet the criteria as set by the filters on this page. The filters must include a location on the network or hard disk and a date range. This list can further be sorted or filtered by clicking on the column headers. To sort on multiple columns, hold down the SHIFT button while clicking on each column header. A yellow icon with a number will show which column is sorted first, which column is sorted second and so on.

Location The user can select any location on the computer or network to find EEG recordings.

Add Recording/ Patient The Add Recording/Patient button adds the currently selected recording to the patient database, including the patient information connected to the file, if that data is not already listed in the database.

Add All Selected Recordings/ Patients The 'Add All Selected Recordings/Patients' button does the same thing as the Add Recording/Patient button, except with the added ability to add multiple files and patients at once.

Print List of Recordings ==[Click here to print a list of the recordings.]

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Open Records window

Location ==[The user can search any location on the computer or network to find EEG recordings.]

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DigiTrack / BrainScope ==[User can select format with theses options.]

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INTERFACE CONTROLS

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