TruTrace EMG User Guide 7.0 rev 1.1b

SSR ...131 SSR Setup ...134 R-R Interval ...137 R-R Test Setup ...141 Evoked Potentials ...144 AEP ...145 AEP Setup ...149 VEP ...153 VEP Setup ...157 SEP ...161 SEP Setup ...164 General / Cognitive EP ...168 General / Cognitive EP Setup ...172 MEP with F-Wave ...176 MEP Setup ...180 EP Measurements Editor ...184

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Notes

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Introduction

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Warranty Warranty Deymed Diagnostic warrants that each product that we sell to 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, 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, 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 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 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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Symbols Used Classification of Device: Type BF, Class IIa (IEC 60601.1).

Amplifier Input.

Strong radio frequency fields may affect the signal quality of this device.

WARNING! This symbol indicates that by not following these instructions you may harm yourself or other users, or damage your TruScan EMG or other equipment. ATTENTION! This symbol indicates that before using the TruTrace EMG, you must read the operating instructions. Recycle Battery at end of product life.

This symbol indicates that the TruTrace EMG is electric and electronic waste; therefore it cannot be disposed of in normal domestic waste bins, and must be treated as “electronic waste". This symbol indicates that this medical device conforms to the Medical Devices Directive 93/42/EEC. This symbol indicates the upper and lower storage temperature limits recommended by the manufacturer. This symbol indicates the upper and lower limits of humidity recommended by the manufacturer. This symbol identifies the TruTrace EMG catalog code.

Battery powered equipment.

This symbol on the device indicates that this medical device meets the requirements of the Council Directive 93/42/EEC, MDD, Class IIa.

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Trademarks

Trademarks and Regulatory Standards

Deymed Diagnostic s.r.o. 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: TruTrace EMG™ is a trademark of Deymed Diagnostic s.r.o. Microsoft® is a registered trademark of the Microsoft Corporation. Windows™ is a trademark of the Microsoft Corporation. Regulatory Standards The Deymed TruTrace EMG system meets the following standards set by domestic and international regulatory agencies for medical electronic equipment: • IEC/EN 60601-1-4 :1998 • IEC/EN 60601-1-2 :2007 General Requirements • IEC/EN 60601-1-1 ed.2:2001 Systems Requirements • IEC/EN 60601-2-40:1999 Particular Requirements for Electromyographs and Evoked Response Equipment • IEC/EN 60601-1-2 ed.3:2008 • IEC/EN 60950-1 ed.2:2006 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 TruTrace EMG 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 TruTrace EMG 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 TruTrace EMG 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.

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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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Intended Use, About the System and Warnings INTENDED USE The TruTrace EMG is intended for use to acquire, save and display the electrical activity produced by the nerves and muscles to aid the clinician in the diagnosis and prognosis of neuromuscular disease. The device is also intended to measure and display nerve conduction time by applying a stimulus to a patient's nerve (NCV). The device may use electrical stimulus, visual stimulus, sound stimulus or an external stimulator for use in Evoked Potential Studies (EP). The device may be used to determine autonomic responses as physiological indicators by measuring the electrical resistance of the tissue path between two electrodes applied to the body. The device may also measure and record the electrical activity of the patients brain obtained by placing two or more electrodes on the head (EEG). The device is intended for use by medical professionals within a medical facility, or outside of a medical facility, under direct supervision of a medical professional. The device may also be placed in the intensive care unit or operation room for recording. The device is available for use on any patient as determined by the medical professional, including adults and children. About the System (Technical description) Hardware: The TruTrace EMG system features battery powered Amplifiers and stimulators with a dedicated EMG keyboard and easy-to-use dashboard style interface to help simplify operation. A high quality printer generates quick single test reports or summary reports with results from multiple tests. The TruTrace EMG FlexiCart has been made to economically accommodate all system components including an integrated computer. Its custom design allows the 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 TruTrace EMG software provides an 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 TruTrace EMG system: • Support of up to 16 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 50kHz per channel • Recording of all data to hard disk for later review or playback • Full function dedicated keyboard for ease of use • Network ready for connection to HL7 or other hospital data centers Entering Commands User enters commands, text or values and selects functions by pressing a hard key on the EMG Keyboard or by clicking or typing a series of 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 in the display area.

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User Safety

Please read and follow all WARNINGS and CAUTIONS provided in this guide. To avoid the possibility of injury, damage to your TruTrace EMG 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.

WARNINGS:

• This device shall only be used in rooms designated for medical use. • Only personnel properly trained to operate the Deymed TruTrace EMG should use this system for patient testing. • Do not stimulate a patient with an implanted electronic device, such as a cardiac pacemaker, without the approval of a licensed medical practitioner. • 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. • The stimulator probe can deliver electrical output of up to 100 mA or 375 V. This device is intended for use only by or on the order of a licensed medical practitioner. • Do not operate the stimulator 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.

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• For initial electrical stimulation, set the electrical intensity (current or voltage) at a low level. Slowly increase the intensity to the desired level of stimulation to prevent patient discomfort. Preventive Maintenance Preventive maintenance for the Deymed TruTrace EMG consists of periodically cleaning and visually inspecting the exterior of the instrument. Deymed Diagnostic recommends that the typical user follows the preventive maintenance schedule presented in the TruTrace EMG 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 Phone: +420 491 481 038 Fax: +420 491 481 513 [email protected]

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Connecting the Electrodes Connecting the Electrodes The following instructions explain how to connect the recording and stimulating electrodes to the appropriate TruTrace EMG system components. Position the electrodes on your patient according to 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 5 Pin Din electrode, plug it into the corresponding 5 Pin Din on the front of the amplifier. # Negative voltage applied to the black (-) input jack produces an upward deflection on the screen display, as does positive voltage applied to the red (+) input jack. # Use the black input jack as the “active” electrode and the red input jack as the “reference” or “inactive” electrode for a negative-up convention.

Warning

When recording, do not leave unused electrodes plugged into the amplifier. This can be a source of interference and/or risk of shock from an unused electrode falling into an electric source. Individual Electrodes Connection to Amplifier

Electrode

Amplifier Channel Connector

Patient Ground

Green pin jack

Black (–) (active recording)

Black pin jack

Red (+) (reference recording)

Red pin jack

Stimulating Electrodes To connect stimulating electrodes to the TruTrace Electrical Stimulator, plug a Deymed supplied 5 DIN electrode into the corresponding 5 DIN connector on the front of the stimulator.

Warning

Never attach stimulating electrodes to both sides of the patient in such a way as to stimulate across the chest. The current from the electric stimulator may cause fibrillation, which can lead to cardiac arrest.

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Patient Data Home Screen

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Main Patient Screen The Patient Screen is the first screen viewed in the TruTrace application. It contains a list of all Patients, their records and allows for creating reports based on the various examinations. Management of patient data is accessible from here, including adding or editing patient information. Global Setup and system settings are accessible from the Global Setup button on this page. A full description of each feature and button can be found below:

Figure 1: Patient Screen

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Main Toolbar The Main Toolbar is located on the lower left of the screen and is always viewable to the user. It contains shortcuts to the tests that can be performed in the system and is easily accessible for quick selection. The currently selected test or selection is highlighted in orange. Some shortcuts lead to a group of tests which are selectable at the right side of the screen. The first button on the Main Toolbar takes the user to the Global Setup. To learn more about the Global Setup, please see the Global Setup section of this user guide. The next selection on the toolbar is the Patient button. This is the screen currently selected. The Patient screen can be accessed at any time during a test by clicking on the 'Patient' shortcut with the mouse, or by hitting the 'Patient' button on the EMG Keyboard. The rest of the toolbar consists of buttons for all tests, organized by type. The type of tests are grouped as follows: NCS (Nerve Conduction Study) which includes MNC (Motor Nerve Conduction), SNC (Sensory Nerve Conduction), Repetitive Test, F-Wave, H-Reflex and BlinkReflex. The EMG group (any test involving a muscle group) contains Native for Needle EMG, Single Fiber and Macro EMG. The ANS group (Autonomic Nervous System) contains the SSR and R-R interval tests. The EP group (Evoked Potentials) includes AEP (Auditory Evoked Potentials), VEP (Visual Evoked Potentials), SEP (Samatosensory Evoked Potentials), P-300's (cognitive evoked potentials) and MEP (Magnetic Evoked Potentials).

Examination List The Examination list contains a list of all recordings made for each patient. The Examinations are grouped together by session, and the summary reports for each session can be created by clicking on the 'Create Report' button. To show a report of just one test, called 'Quick Report' in the system, select the individual test from the list and click the 'Quick Report' button.

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Patient Window The Patient Window contains the list of all patients entered in the system. The columns display patient data for quick review. Searching Patient Data: To search the list for any parameter, just click on the column heading and type the values you are searching for. The search values that you have typed will automatically show in the search window at the bottom left corner of the screen. On the bottom right of the screen is a count of all patients listed in the system.

Add/Edit Patient The 'New Patient' button and 'Edit Patient's info' button are used to enter and edit patient data in the system. More detailed information on these buttons can be found in the Add/Edit Patient Screen section of this user manual:

Report Buttons The 'Delete Record' button is used to delete the selected recording from the database. The 'Create Report' button is used for creating a summary report of all tests preformed and listed in the current session. Once clicked, a dialog window will open to show further Report Options. The 'Show Report' button will be displayed if a report has been previously generated for the selected session. When clicked, it will open the previously saved report. The 'Quick Report' button opens a single test that is selected. For further information on each of these buttons, go to the Create Summary Report section or Show Quick Report section of this user manual.

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Hardware Indicators The Hardware indicators show if the various hardware components are installed and connected to the system. When properly installed and connected to the system, each icon will be colored and show a green check mark. Each icon represents a key component or accessory. The icons from left to right are as follows: EMG Keyboard, USB Adapter, Foot pedal, VEP goggles, magnetic stimulator, Intelligent Charger and VEP driver. The only icon that must be connected to use the system is the USB adapter icon.

Patient History The Patient History window shows the patient data entered on the Patient Card from the database. It also allows the entry of any relevant text data that needs to be inserted. To enter text, just click anywhere in the white area and begin typing.

Unclosed Exams List The Unclosed Exams list contains a list of any examinations that have not yet been fully interpreted. This list serves as a reminder that work is needed to finish the report for listed examinations. Examinations are listed here until the user has selected 'Examination Closed' in the Summary Report dialog, under 'Edit Conclusion'. To quickly jump to this section, the user may use a keyboard shortcut by pressing F4 as indicated on the top right of this screen.

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Add/Edit Patient The Add/Edit Patient Data screen shows the key values that may be entered for each patient. This dialog will appear when selecting the 'Add Patient' or 'Edit Patient Data' button from the Patient screen. To quickly jump the cursor between each field for fast data entry and without using the mouse, simply use the TAB button on your computer keyboard. The metric or imperial system of measurements may be used for the height and weight values. To change this setting, the user must go to the Global Setup.

Figure 2: Add Patient Screen

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Standard Patient data The Standard Patient Data can be entered here to be saved with the patient records. To start a recording, the only required values needed are Last Name and ID. The ID number is automatically generated but can be changed to any desired number. However, the ID must only contain numeric characters. A Hospital ID field is also available to add a unique patient Hospital ID if needed. NOTE: If the Normative/Reference values module is purchased, then the following Patient Data must be input in order for the normative values to appear in any of the tests that contain normative values: -Date of Birth -Height -Weight -Sex -Handedness

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Patient ID number The Patient ID number is a unique number that cannot be duplicated in the system. If you choose to change the number from the generated one, please be aware that the number may only be numeric and may not contain any alpha characters or spaces. Each patient must be assigned a unique number and this number is used to identify any data files saved in the system for that patient.

Medical data The Medical data can include these additional values. All entered values will be saved in the patient record. Record Created: This field shows the date on which the patient record was created.

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Global Setup The Global Setup screen contains all settings that affect the system in a global manner. Please be aware that many settings require advanced knowledge as indicated in the following sections below:

Figure 3: Global Setup Screen

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