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Preface Indications for use statement The Nicolet EDX is intended for the acquisition, display, analysis, storage, reporting, and management of electrophysiological information from the human nervous and muscular systems including: • Nerve Conduction (NCS) • Electromyography (EMG) • Intra-Operative Monitoring including Electroencephalography (EEG) •...
Middleton, WI USA 53562 1 800-356-0007 1-800-356-0007 Fax: 608-829-8589 madison.helpdesk@natus.com www.Natus.com www.Natus.com Natus EU Authorized Representative International Natus Manufacturing Limited Natus Neurology Incorporated IDA Business Park Phone: 0049 (0) 180 501 5544 Gort, Co.Galway, Ireland Fax: 0049 (0) 89 83942777 Email: service.europe@natus.com...
Consult Operating Instructions. Failure to follow operating instruc- tions could place the patient or operator at risk (ISO 7010 M002). Image on blue background. Consult Operating Instructions. (ISO 7000-1641) European Authorized Representative Natus Neurology Incorporated 3150 Pleasant View Road Middleton, WI USA 53562 608-829-8500 1 800-356-0007 Fax: 608-829-8589 www.natus.com...
Nicolet EDX Read the safety reference guide Please read the Additional Information and Safety Notes for Assorted Nicolet Brand Products Reference Guide on CD furnished with your Nicolet EDX system thoroughly, paying special attention to the Safety information before applying power to and using your Nicolet system. Electromagnetic Compatibility (EMC) Please refer to the Electromagnetic Compatibility Reference Guide on CD furnished with your Nicolet EDX system for information...
WEEE is reused or recycled safely. In line with that commitment Natus may pass along the obligation for take back and recycling to the end user, unless other arrangements have been made.
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Nicolet EDX Natus Neurology Incorporated makes no representations or warranties of any kind whatsoever with respect to this document. Natus Neurology Incorporated disclaims all liabilities for loss or damage arising out of the possession, sale, or use of this document.
$100,000 in fines and 10 years in prison. Unless restricted by an agreement with Natus Neurology Incorporated, you are permitted to: a. Use this software on only one computer and by one user at a time.
Table of Contents Indications for use statement..........................1-a Contact information ............................1-b Labels and symbols ............................1-c Read the safety reference guide ........................1-d Electromagnetic Compatibility (EMC) ......................1-d Safety summary ..............................1-d Inspecting the system ............................1-e Disposal at the end of operating life ......................... 1-e Nicolet EDX Copyright ............................1-f Software copyright protection ............................
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Nicolet EDX SP1/SP2 Stim-Switching Units ........................2-19 Nicolet EDX Base Unit rear panel icons ......................2-20 Nicolet EDX Base Unit front panel icons......................2-22 Nicolet EDX Base Unit label icons ........................2-23 Powering the system ............................2-24 Turning the system on..............................2-24 Turning the printer on and off............................2-24 Logging in................................2-25 Launching the system software ........................2-25 Home page menus.............................2-26...
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Table of Contents Performing an Exam Summary of steps ...............................4-3 Notes ..................................4-3 Example record window summaries.........................4-4 Viking EDX Motor Nerve Conduction Study........................4-4 Synergy EDX Motor Nerve Conduction Study ....................... 4-5 Setting up the system............................4-6 Getting started.................................. 4-6 Turning on the system..............................4-6 Starting / exiting NicVue ..............................
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Nicolet EDX Backing up/restoring settings and importing legacy Viking Settings Setup Backing up settings and test folders........................6-3 Restoring settings and test folders ........................6-3 Importing legacy Viking settings........................6-4 Importing all Viking Tests and System Setup........................6-4 Importing only the selected Viking Setups ........................6-4 Importing only the Viking System Setup.........................
There are no field serviceable assemblies. Replacement units and sub- assemblies are available through your Natus service provider. Specification and accuracy information For specification details, see the system applicable specification sheet 169- 439400 or 169-439500.
Nicolet EDX Nicolet EDX amplifier and system essential performance The Nicolet EDX amplifier and system is designed to function under a wide range of environmental conditions without any compromise in performance specifications. In the event that an environmental artifact (e.g. ESD, line voltage fluctuations, etc.) is of sufficient intensity and/or duration to adversely affect system performance, the system is designed to detect this condition and send a message notifying the operator that an adverse event has occurred.
Introduction Contraindications of use There are no known contraindications under normal clinical use for EMG/NCV/ Please see Intra-Operative Safety Guide 269-48801 and Additional Information and Safety Guide 269-594705 for possible contraindications of use under certain conditions. Using this guide This guide provides the basic information needed to operate your Nicolet EDX. It includes instructions for creating patient files, working with studies and exams and for performing a simple motor nerve conduction (MNC) study.
Nicolet EDX Cleaning Disconnect all leads and electrodes from the patient before proceeding with cleaning the equipment. All external parts of the assembly can be wiped down with the following: Chemical contact will be limited to chemicals specified below to clean the assembly only. Other chemicals may or may not affect the device, but do not fall under tested chemicals for the assembly.
System Basics This chapter introduces you to the basic hardware and software controls used to operate your Nicolet EDX. Using the Easy Riser tray To raise: Grasp sides of unit as shown. Move to desired height. To lower: Grasp sides of unit as shown. Tip UP front of unit. Move to desired height.
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System Basics Viking EDX control panel The control panel is active in all Viking EDX software modes. However, it is not active in NicVue, the Backup/ Restore mode, the Report Program, the internet, or in any Windows application. In these modes, use the mouse or keyboard.
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Nicolet EDX Adjustment dials The adjustment dials include the Volume dial, located on the upper left corner and Stimulus Level dials located on the upper right. Using these dials, you can adjust the speaker sound level and the electrical stimulus intensity level within predetermined ranges.
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System Basics Cursor Wheel Adjusts the position of the active marker on the selected waveform. Also used to highlight patient, settings and file names in the Patients Directory, Select Exam and Exam Review windows. Marker 2 (advance) Activates Cursor 2 and advances it from one waveform to another.Also Marker 2 allows you to activate a special Function Key Area line that allows you to (advance)
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Nicolet EDX Sensitivity Changes the amplifier sensitivity for the recorded data. Press numerically increase the sensitivity, which decreases the size of the displayed waveforms. Press to numerically decrease the sensitivity, which increases the size of the displayed waveforms. These keys can also be used as navigational tools in lists.
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System Basics Switch Starts and stops stimulation. In some tests, it may start the stimulator and Switch data acquisition automatically. Delete Erases the selected waveforms on the Record screen display. Follow the Delete on-screen prompt to select which waveforms you want to delete. Select Anatomy When in any exam mode, displays the Select Anatomy for Settings Select...
Nicolet EDX Synergy EDX control panel The Synergy EDX control panel provides a single control operation for setting essential parameters during a patient examination. The mouse is not active. You should use a mouse connected to the USB port of the computer.
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System Basics Stim B Rotate to adjust the amplitude of the external stimulus. Stimulus Intensity is displayed on the tool bar and also on the Status Panel. Green Light Indicates the control panel has power. Electrical Stim. Disabled when Control Panel is used on EDX. Stim.
Nicolet EDX EMG control panel The EMG control panel provides a single control operation for setting essential parameters during a patient examination. The control panel is active in all Viking/Synergy EDX software modes. Except for the mouse functions (N, D, L), the Control panel is not active in NicVue, the Backup/Restore mode, the Report Program, or in any Windows application.
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System Basics The keypad (H below ) is multifunctional. Enters numerical values when in a numerical entry mode (e.g., distance). Selects assigned function when not in a numerical entry mode. Stimulus duration Increase stimulus duration. Numbers 4 and 7 Decrease stimulus duration. Waveform select Select the next waveform.
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Nicolet EDX Sensitivity Changes the amplifier sensitivity for the recorded data. Press numerically increase the sensitivity, which decreases the size of the displayed waveforms. Press to numerically decrease the sensitivity, which increases the size of the displayed waveforms. These keys can also be used as navigational tools in lists.
System Basics AT2 and AT2+6 amplifier Nicolet Nicolet AT2+6 amplifier AT2 amplifier D E F DE F D E F G H D E F AT2+6 amplifier AT2 amplifier Temperature Probe The temperature probe attaches to this connector for skin temperature Connector measurements.
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Nicolet EDX Run/Standby Indicator When the green light is illuminated, the channel is ON and is ready to receive signals from the patient electrodes. When OFF, the amplifier input jacks are disconnected and grounded internally. Headbox Connector For optional Headbox. 1020 Integrated Headbox The numbers correspond to the montages defined in the software.
System Basics ECR-16 amplifier See Labels and Symbols on page 1-3 in this manual. HB-1 headbox Type BF equipment HB-2 headbox Not implemented at this time. Amplifier interface Equipotentiality January 30, 2020 2-15...
Nicolet EDX HB-6 headbox (AT2+6) Common. See Labels and Symbols on page 1-3 in this manual. Type BF Equipment. Headbox. Not for use in the presence of Electrical Surgical Unit (ESU) without additional patient protection headbox or other in-line protection device. The HB-6 Headbox consists of 1020 head pattern HB-6 and 2 ground jacks.
Nicolet EDX Nicolet EDX electrical stimulator probes Several types of electrical stimulator probes are available for use with the Nicolet EDX. • The S403 probe has remote control for stimulus start / stop and intensity. • Comfort Probe (RS10) • Comfort Probe Plus (WR50) Comfort Probe Plus stimulator icons Stimulation On/Off.
System Basics SP1/SP2 Stim-Switching Units IES-1 (SP-1) IES-1 (SP-2) IES-2 (SP-1) IES-2 (SP-2) С С С С SP-1 SP-2 SP-1 SP-2 Stimulator Probe Input (No external control) Lower Level Pair Stimulator Outputs January 30, 2020 2-19...
Nicolet EDX Nicolet EDX Base Unit rear panel icons Reflex Hammer. USB. Input/output option device port. Trigger 1 / 2 In. Viking EDX Control Panel. Trigger. Synergy EDX Control Panel. Stimulator Option Port. Trigger 1 / 2 Out. Right ear headphone Out. Analog Out.
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System Basics Equipotentiality. Frequency Range. Footswitch for single switch System Power / Output Power only. Amplifier. Attention, consult accompanying documents. January 30, 2020 2-21...
Nicolet EDX Nicolet EDX Base Unit front panel icons To (Touch-proof) Electrical Stimulator. Electrical Stimulator. Positive Output. Isolated Electrical Stimulator 1 (- / +). Type BF Equipment. IES-1 To (Touch-proof) Electrical Stimulator. On (part of a system). Negative Output. Consult Operating Instructions. Failure to Stimulation On/Off.
System Basics Nicolet EDX Base Unit label icons Manufacturing Reference Number. 50 years of life before leakage of contaminates into land fill. Manufacturer. Special Recycling Required. Do not dispose in landfill. Manufacturing Date coded into Lot number. Manufacturer’s Bar Code. CE Mark.
Nicolet EDX Powering the system Turning the system on When you switch on the main power, the system displays several startup and diagnostic messages on the screen. Turning on a Desktop system For the first time you switch on the system power, switch the components on in the following order.
System Basics Logging in After approximately one minute following the power up procedure, the system activates Windows and displays the “Log on to Windows” dialog. 1. The logon information for your Viking EDX/Synergy EDX software was preset at the factory. Unless your system administrator changed the information, it will read as follows: •...
Nicolet EDX Home page menus The Home Page contains seven menus used to access the main areas of the software. New Patient Click New Patient to create a new patient record and finalize any open visits. Patients with matching demographics will be listed, if found in the database Patients Click Patients to select an existing patient for a new session, enter new patient information or edit existing...
System Basics Test screen controls Following are various test screen controls you can use during an exam. The graphics below are representational only. The actual appearance is determined by the software selected (Viking EDX / Synergy EDX) and the test selected. Header bar The Header bar displays the patient’s First and Last name, Age, and the visit Date and Time.
Nicolet EDX Quick Access bar The Quick Access Bar is located above the Function Key Area. It allows you to quickly control NCS and EMG tests. You can end the visit, exit the test, select a new nerve and side, start the next set, and select a different test.
System Basics Using the Acquisition Setup panel Displaying the 1. To display the Acquisition Set panel, use either of the following methods: Acquisition Set panel a. Click Acquisition > Acquisition Setup. b. From the Toolbar, click on Ch. , Low , or High Figure 1.
Nicolet EDX Setting individual This procedure sets changes made on the Acquisition Setup panel only to the selected channel. See Note 1 below Figure 2 on the previous page. channels on the Acquisition Setup 1. Click on Ch. , Low , or High panel 2.
System Basics Applying Filter This procedure sets all of the channels to the same Low / High Filter setting. settings to all channels from the Toolbar Figure 3. 1. Set to All. 2. Click the Low or High Filter show menu arrow 3.
Nicolet EDX Exiting the software To exit the Viking EDX / Synergy EDX program, using either of the following methods: a. Click on the Close icon in the upper right corner of the software window. b. Right-click on the upper left corner of the software window and click Close.
Patient Information This chapter explains how to use the Nicolet EDX Patient Information feature used for working with your patient exam files. January 30, 2020...
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Patient Information The Patients screen Patient Information has sections where you enter specific data about the patient, such as the Patient ID, Gender, Birth Date, and Patient Name as well as physician information, impressions and conclusions. Creating a new patient 1.
Nicolet EDX Editing a visit record 1. Display the Patients window: a. If already viewing the Patients window, continue with step 2. b. If viewing the Select Test, Test Screen, or Test History window, click on the Patients icon and continue with step 2. 2.
Patient Information About NicVue (option) NicVue is a database used to set up and manage your patient information and exams. It allows you to select your patient and the desired test mode for acquisition or a stored exam for review from one screen. When you first enter the program, you will see the NicVue Main window.
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Performing an Exam This chapter provides general instructions for performing a study or exam, using a Motor Nerve Conduction Study (MNC) as an example. You can apply these basic steps to perform most of the exams available on the Viking EDX / Synergy EDX programs.
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Performing an Exam Summary of steps 1. Set up the system. 2. Turn on the system. 3. Create a new patient file or recall an existing patient file. 4. Enter the Viking EDX / Synergy EDX program, select the exam and settings, then enter the test modality.
Nicolet EDX Example record window summaries Viking EDX Motor The following example figure provides a brief description of the various areas you will view when performing an Viking EDX NCS test. Nerve Conduction Study Sections of the Viking EDX MNC Record Mode Screen Patient and Visit Segment Table Superimpose Data /...
Performing an Exam Synergy EDX Motor The following example figure provides a brief description of the various areas you will view when performing a Synergy EDX NCS test. Nerve Conduction Study Sections of the Synergy EDX MNC Record Mode Screen Patient and Visit Segment Table Superimpose Data /...
Nicolet EDX Setting up the system Make sure the components are properly connected to your system. Do not turn on any system power until all cable connections have been connected properly and verified. Please see Chapter 2 in this guide. You will also need the appropriate application software installed on your system.
Performing an Exam Example Motor Nerve Conduction Test Position and secure the electrodes to your patient according to your conventions for the type of test you are performing. Note: The recording electrode is placed on a muscle, even though the interest is in the conduction along the nerve.
Nicolet EDX Motor NCS electrode • The active recording electrode is placed over the endplate zone of a muscle innervated by the tested nerve. placement • The reference electrode is placed nearby in an electrically “quiet” area. • The ground electrode is usually placed between the stimulating and recording electrodes.
Performing an Exam Create / select a Creating a new patient record patient record 1. Create a new patient record using either of the following methods: a. From the Home page, click the New Patient icon. b. From the Home page, click the Patients icon and then click the New Patient icon.
Nicolet EDX Select a test 1. Click the NCS icon at the top of the Select Test window. 2. Click on the desired Side icon to select the exam side (left or right). 3. Click on the desired Test. 4. Display the Test Screen using either of the following methods: a.
Performing an Exam Acquire the data Data is acquired by the instrument, stored in memory and displayed on the screen when the Acquisition mode is on. 1. Set the stimulus intensity to 0. 2. Position the stimulator at the appropriate site. 3.
Nicolet EDX Saving test data Automatic When you go to Patients or Select Test , the data is saved automatically to the hard disk. Manual To save data manually on the hard disk without closing the Test Screen, use either of the following methods: a.
Performing an Exam Capturing screen display images and videos Capturing a screen To capture a copy of the current screen display at any time, use any of the following methods: display image a. Click on the Capture Screen icon for a softcopy (.jpg file). b.
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Common Procedures This chapter describes various operations that are common between the Viking EDX and Synergy EDX systems. The following keys identify to which system the procedures in this chapter applies. Steps apply to both the Viking EDX and Synergy EDX. Steps apply to Viking EDX only.
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Performing an Exam Adding new tests to a You can acquire new tests and add the data to a previous visit. previous visit 1. Click on the Patients icon. 2. Double-click on the Patient record. 3. Click on the Visit into which you want to add and store new tests.
Nicolet EDX Changing the Stimulus To change the Stimulus Duration (0.01 - 1.0 ms) presented to the patient: Duration 1. Use either of the methods below: a. Click on the Stimulator EL1 setting field and click on the new setting from the menu. b.
Performing an Exam Changing the Stimulus To elect the desired Stimulator Repetition Rate, use any of the following methods: Rate a. Click on the Stim Rep Rate field in the toolbar and type the desired rate. b. Click on the Stim Rep Rate show menu arrow click on a commonly used rate.
Nicolet EDX Placing markers You can have the software place markers automatically or place them manually. Placing markers automatically To have the software place markers automatically on the waves at the selected locations when the number of steps have been completed: 1.
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Performing an Exam Moving markers on a trace Measurements update automatically as you move the marker. 1. Click and drag the marker you want to move. 2. Click on the marker you want to move and turn the mouse cursor wheel. Note: Positioning latency marker 1 to the far left of the data display or latency marker 2 to the far right of the data display will exclude that latency from any calculations.
Nicolet EDX Changing the screen To change the screen display before you begin acquiring data or after acquisition display is completed: 1. Use any of the following methods to select how you want to view the screen display: a. Click View > Full Trace Area, or Full Results Area, Trace Area, Right Trace Area, or Trace Area Setup.
Performing an Exam Activating markers To activate a marker, use either of the following methods: 1. Click on the marker you want to activate. It will turn Red. 1. You can activate markers using the Marker hardkeys on the Viking EDX control panel. a.
Nicolet EDX Calculating To calculate and display the conduction velocity of specific segments: Conduction Velocities 1. Click Edit > Site Setup. 2. Check the Velocity checkbox(es) to select which segments will display the velocity in the Segments results table. 3. Click OK. 4.
Performing an Exam Changing the nerve To change the nerve label from either the Record or Review mode. name 1. Right-click anywhere in the Results Table area at the right of the Data display area. 2. Click on Change Nerve Label from the popup menu. 3.
Nicolet EDX Erasing data The following steps will erase data: Using the Toolbar 1. Click on the trace you want to erase. 2. Click on the Erase button. 3. To restore the trace you just erased, click on the Unerase button.
Performing an Exam Capturing a video You can capture a video of the screen display during an exam. 1. Click on the Capture Video icon to start the video recording. 2. Click on the Capture Video again to stop the video recording.
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Backing up/restoring settings and importing legacy Viking Settings Setup This chapter contains instructions for backing up and restoring your Settings and Test Folders as well as importing legacy Viking Settings Setup. Note:The procedures in this chapter do not back up data acquired from exams. January 30, 2020...
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Archiving Data Backing up settings and test folders 1. Click on Start > All Programs > Natus > Emg > Utilities > Backup Settings. 2. Click Yes on the EMG Settings Backup dialog. 3. Create a Name for the Settings folder.
Nicolet EDX Importing legacy Viking settings This procedure imports previously created legacy Viking settings. 1. From any Viking window other than the Test window, click File > Import > Viking Settings. 2. Browse to the locaton of your Viking Settings (for example, C:\Nicolet\VikDir\Settings.Sel).
Archiving Data Importing only the This procedure imports only the Viking System Setup settings, which includes the Look and Feel, Producer, Printer, Regional Settings, etc. Viking System Setup 1. From the Viking Import Setup window, click Expand to display the Import Viking Settings pane, which allows you select specific Setup files for import.
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Index Electromagnetic Compatibility (EMC) 1-d Equipment classifications 1-4 About the system 1-5 Erasing data 5-11, 5-12 Accuracy information 1-3 Example Motor Nerve Conduction Study 4-7 Acquire the data 4-11 Example record window summaries 4-4 Acquisition Setup panel 2-29 Synergy EDX 21 Motor Nerve Conduction Study 4-5 Applying Filter settings to all channels 2-30 Viking EDX 21 Motor Nerve Conduction Study 4-4 Setting all channels on the Acquisition Setup panel 2-30...
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Nicolet EDX Measuring patient temperature 5-10 Starting / exiting NicVue 4-6 Menu bar 2-27 Turning on the system 4-6 Side - Choosing for the exam 5-11 Single sweep acquisition 5-5 Software copyright protection 1-g Nerve list - Viewing 5-11 SP1/SP2 Stim-Switching Units 2-19 Nerve name - Changing 5-11 Specification and accuracy information 1-3 New Patient 2-26...
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Questions and answers
How do I add or change the normal values for the nerve conduction studies ?