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30 January, 2020

Preface

Labels and symbols

The following labels and symbols may be affixed to the

Nicolet EDX

system:

When applied on device:

Attention: Consult Accompanying Doc-

umentation (ISO 7000-0434A)

When used in documentation:

Caution, Warning or Precaution

follows.

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

Disposal at end of operating life instructions.

Medical Device Regulation (MDR) product certified to comply to
EC Regulation 2017/745.

CE Mark and Notified Body

Type BF equipment.

Class II device.

RX Only

CAUTION:

USA Federal law restricts this device to sale or on the

order of a licensed Neurology practitioner.

Содержание Nicolet Viking EDX

Страница 1: ...al Incorporated or one of its subsidiaries All rights reserved Natus is a registered trademark of Natus Medical Incorporated All product names appearing on this document are trademarks or registered t...

Страница 2: ......

Страница 3: ...c responses to physiologic stimuli by measuring the change in electrical resistance between two electrodes Galvanic Skin Response and Sympathetic Skin Response Autonomic testing also includes assessme...

Страница 4: ...ical Support Domestic Natus Neurology Incorporated 3150 Pleasant View Road Middleton WI USA 53562 1 800 356 0007 madison helpdesk natus com www Natus com International Natus Neurology Incorporated Pho...

Страница 5: ...ator 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 US...

Страница 6: ...hed with your Nicolet EDX system for information concerning your Nicolet EDX system Safety summary In this manual two labels identify potentially dangerous or destructive conditions and procedures The...

Страница 7: ...d and recycled safely Users of electrical and electronic equipment must not discard WEEE together with other wastes Users must use the municipal collection schemes or the producer importers take back...

Страница 8: ...rranties 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 www n...

Страница 9: ...n only one computer and by one user at a time b Make one copy of this software provided that i the copy is created as an essential step in the utilization of this software in conjunction with your mac...

Страница 10: ...Nicolet EDX h 30 January 2020 Blank page...

Страница 11: ...and accuracy information 1 3 Nicolet EDX amplifier and system essential performance 1 4 Protective and equipment classifications 1 4 Intended operator 1 4 Intended use 1 4 Contraindications of use 1...

Страница 12: ...g the Acquisition Setup panel 2 29 Displaying the Acquisition Set panel 2 29 Setting individual channels on the Acquisition Setup panel 2 30 Setting all channels on the Acquisition Setup panel 2 30 Ap...

Страница 13: ...12 Printing a standard data report 4 12 Capturing screen display images and videos 4 13 Capturing a screen display image 4 13 Capturing a test screen video 4 13 Reviewing a captured test screen video...

Страница 14: ...y 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...

Страница 15: ...January 30 2020 1 1 1 Introduction...

Страница 16: ...Nicolet EDX 1 2 January 30 2020 Blank page...

Страница 17: ...that you perform regular electrical continuity tests from exposed conductive materials on the medical system to the protective ground on the medical system Regular testing will help ensure that prope...

Страница 18: ...ate If this type of condition causes persistent messages please contact your local service representative Protective and equipment classifications 1 This system is intended for continuous operation an...

Страница 19: ...re program is installed About the system Nicolet EDX systems feature a dedicated control panel and easy to use Windows based interfaces to simplify operation Innovative software features and an intuit...

Страница 20: ...ly Other chemicals may or may not affect the device but do not fall under tested chemicals for the assembly Water Isopropyl Alcohol 70 90 concentration in water PDI SaniClothPlus Q89702 HB Quat 3M Mil...

Страница 21: ...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...

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Страница 23: ...4 EP IOM MMP 5 6 1 2 3 0 Back Space Studies To Do NCS EMG Average Calibrate Impedance Cancel Disable Delete Distance Enter Exam Overview Functions KeyLine Latency Amplitude Marker 2 advance Marker 1...

Страница 24: ...e Selects the top Function Key Area Selects the bottom Function Key Area D Functions When in an exam mode displays the data manipulation functions e g baseline correct smooth trace move trace delay E...

Страница 25: ...Horiz Positions the second trigger marker in the SFEMG test Also sets the window dual level trigger in the EMG exams SPA and AMUP P Superimpose Overlays the selected waveforms on the screen display Q...

Страница 26: ...lculations in NCS Exam modes press this key and enter the distance in mm between the stimulation sites 1 Numeric keypad Enters numeric data for test calculations and patient files Also selects the win...

Страница 27: ...ile and or a different exam type 11 Side Selects the exam side left or right 12 Settings Displays the Settings Overview window or Page One of the currently active settings file which contains the para...

Страница 28: ...o output B Sensitivity Rotate to adjust the display sensitivity of the selected trace or traces If no trace is selected to deselect a trace click away from it the sensitivity of all the traces in the...

Страница 29: ...timulus Stimulus Intensity is displayed on the tool bar and also on the Status Panel L Stim On Off Press to toggle Stimulus On and Off without acquiring If Acquire is On pushing this button has no aff...

Страница 30: ...e mode the Report Program or in any Windows application In these modes use the mouse or keyboard A Battery charge Not implemented at this time B Volume Increases or decreases the speaker volume Press...

Страница 31: ...n2 Number 2 Programmable via the Hardware Controls Setup menu per test type Impedance check Number 3 Start end electrode impedance check Do not measure the impedance of needle electrodes with needles...

Страница 32: ...ges the time base for the displayed trace Press to increase the time base which compresses the waveform s and increases the total sweep time Press to decrease the time base which expands the waveform...

Страница 33: ...ck on the amplifier Both connections are at ground connection D Active Electrode Patient recording electrodes connect to the red and black pin jacks Negative voltages applied to the black input jack p...

Страница 34: ...nally I Headbox Connector For optional Headbox J 1020 Integrated Headbox The numbers correspond to the montages defined in the software K Type BF Equipment L See Labels and Symbols on page 1 3 in this...

Страница 35: ...20 2 15 System Basics ECR 16 amplifier A See Labels and Symbols on page 1 3 in this manual B HB 1 headbox C Type BF equipment D HB 2 headbox E Not implemented at this time F Amplifier interface G Equi...

Страница 36: ...u to secure the Headbox on or near your patient A Common B See Labels and Symbols on page 1 3 in this manual C Type BF Equipment D Headbox E Designed for use in the presence of Electrical Surgical Uni...

Страница 37: ...HB 1 and HB 2 headbox ECR16 A See Labels and Symbols on page 1 3 in this manual B Type BF Equipment C Electrode inputs HB 1 1 20 HB 2 21 40 D Reference HB 1 1 2 HB 2 3 4 E Common HB 1 1 2 HB 2 3 4 F H...

Страница 38: ...Comfort Probe Plus stimulator icons B C E F G S1 S2 S3 A D _ H I J J A Stimulation On Off B Press wheel to start stop stimulation Rotate wheel to increase decrease stimulus intensity C Variability In...

Страница 39: ...P2 Stim Switching Units 1 2 3 4 5 6 7 8 9 10 11 12 LL IES 1 SP 1 IES 1 SP 2 1 2 3 4 5 6 LL IES 2 SP 1 A B A B SP 1 SP 2 SP 1 7 8 9 10 11 12 IES 2 SP 2 SP 2 A Stimulator Probe Input No external control...

Страница 40: ...1 2 Out T Right ear headphone Out F Analog Out U Headphones G See Labels and Symbols on page c in this manual V Left ear headphone Out H Audio Out Voltage Label Input voltage of 100VAC 120VAC or 230VA...

Страница 41: ...January 30 2020 2 21 System Basics M Equipotentiality W Frequency Range N Footswitch for single switch only W System Power Output Power O Amplifier W Attention consult accompanying documents Hz VA...

Страница 42: ...C To Touch proof Electrical Stimulator Negative Output H On part of a system D Consult Operating Instructions Failure to follow operating instructions could place the patient or operator at risk Image...

Страница 43: ...icons A Manufacturing Reference Number E 50 years of life before leakage of contaminates into land fill B Manufacturer F Special Recycling Required Do not dispose in landfill C Manufacturing Date cod...

Страница 44: ...Portable system The first time you switch on system power switch the components on in the following order 1 Base Unit 2 Laptop Computer Turning the printer on and off Press the printer Power button t...

Страница 45: ...ollows The user name should be Nicolet There is no password Note If you have difficulty logging in consult with your system administrator 2 Press the Enter key The system displays the Windows desktop...

Страница 46: ...o select an existing patient for a new session enter new patient information or edit existing patient information Select Test Click Select Test to choose the Test or Study that you want to perform on...

Страница 47: ...displays the patient s First and Last name Age and the visit Date and Time Menu bar The Menu bar contains menus that when clicked displays a list of options from which you can choose to perform vario...

Страница 48: ...and side start the next set and select a different test Function Key Area The Function Key Area at the bottom of the Test window lists the options available in the current operating mode If the Funct...

Страница 49: ...t panel use either of the following methods a Click Acquisition Acquisition Setup b From the Toolbar click on Ch Low or High Figure 1 Figure 2 Note Changes made to the settings outlined at the left in...

Страница 50: ...etc you want to edit 3 Make your changes and click OK Changes you made are applied only to the selected channel Setting all channels on the Acquisition Setup panel This procedure sets changes made on...

Страница 51: ...ick on the desired Filter setting The new Filter setting is applied to all of the channels Applying Filter settings to a single channel from the Toolbar This procedure sets only the selected channel t...

Страница 52: ...ware window and click Close Note To return to NicVue click on the Patients icon in the EMG application Turning the Viking EDX Synergy EDX system off Desktop system You can switch system power off usin...

Страница 53: ...January 30 2020 3 1 3 Patient Information This chapter explains how to use the Nicolet EDX Patient Information feature used for working with your patient exam files...

Страница 54: ...Nicolet EDX 3 2 January 30 2020 Blank page...

Страница 55: ...ent s information Note Required fields are highlighted in yellow Patient ID 1 character minimum 11 characters maximum 3 Click OK when finished Editing a patient information record 1 Display the Patien...

Страница 56: ...n the Patient you want to edit 3 Click on the Edit Visit icon 4 Edit the Visit information as necessary Deleting a patient information record This procedure permanently erases information which can no...

Страница 57: ...this bar depend on the number and type of programs that are installed on your system s hard drive The remaining sections of the NicVue main window consist of two lists Patient Information lists all p...

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Страница 59: ...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...

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Страница 61: ...t others are either different or not used at all 1 Attach the electrodes accordingly for the individual tests 2 Different types of stimulators are used for different tests 3 Ensure that the stimulus u...

Страница 62: ...Visit Information I Segment Table Q Superimpose Data Display the Screen Area Setup Stores Panel B Selected Test J Results Graphs Area R Test Site C Data Area K Monitor Area S Nerve Step Numbers D Nav...

Страница 63: ...mation I Segment Table Q Superimpose Data Display the Screen Area Setup Stores Panel B Selected Test J Results Graphs Area R Test Site C Data Area K Monitor Area S Nerve Step Numbers D Navigation Icon...

Страница 64: ...cation software installed on your system Getting started Please refer to Chapter 2 in this guide for instructions on Power the system Log in Launch the system software Turning on the system When you s...

Страница 65: ...sites where the nerve is located superficially The stimulator is oriented so that the cathode of the stimulator faces the active recording electrode Negative voltage applied to the black input jack pr...

Страница 66: ...hen recording from a deep muscle one may use a concentric or monopolar needle for recording Sensory NCS electrode placement Surface disk or ring electrodes are placed over the skin where the tested ne...

Страница 67: ...nt icon 2 Enter the patient information yellow fields are required 3 Click OK 4 The Select Test window opens automatically Selecting an existing patient record 1 Click the Patients icon to display the...

Страница 68: ...ed Test 4 Display the Test Screen using either of the following methods a Double click on the desired Anatomy b Click on the desired Anatomy and then on theTest Screen icon 5 The Test Screen is displa...

Страница 69: ...lly increase the intensity of the electrical stimulus until it is supramaximal 5 When an acceptable response is observed stop stimulation and acquisition using any of the following methods a Press the...

Страница 70: ...ntrol base Creating updating a report Automatic When you go to Select Test New Patient or Patient List the report is updated automatically Manual To create update a report manually on the hard disk wi...

Страница 71: ...printed hardcopy c Press Screen Copy on the Viking EDX control panel for a printed hardcopy Capturing a test screen video To capture a video of the test screen display use either of the following met...

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Страница 73: ...keys identify to which system the procedures in this chapter applies Note Various operations can also be performed using the Function Key Areabuttons located at the bottom of Test Review windows Thes...

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Страница 75: ...store new tests 4 Click on the Acquire Visit icon located above the list of previous visits 5 Click on the NCS EMG EP or IOM icon for the test you want to perform 6 Select the Test 7 Double click on t...

Страница 76: ...increase or S2 button to decrease the stimulation duration 1 Rotate the Stim Duration control 1 Press the Trace upper or lower hardkey on the Viking EDX Control Panel to select the trace 2 Use either...

Страница 77: ...lbar and type the desired rate b Click on the Stim Rep Rate show menu arrow and click on a commonly used rate 1 Click on the Stimulus Delivery icon to select the setting Delivers a single stimulus and...

Страница 78: ...arkers 3 Ensure the Auto checkboxes for the markers you want placed automatically are also checked 1 Click the Marker Bar On Off button 1 Click on View Panels Marker Panel 1 From the Markers panel use...

Страница 79: ...an NR for No Response on the Results table Resetting the markers If you have manually repositioned markers that were placed automatically by the system you can return those markers to their original...

Страница 80: ...play a Click View Full Trace Area or Full Results Area Trace Area Right Trace Area or Trace Area Setup b Press the Display softkey to show your data display options c Press the Screen softkey to toggl...

Страница 81: ...atency or amplitude marker on the next trace b Press Marker 2 advance to activate the second latency or amplitude marker on a trace Press this key again to activate the second latency or amplitude mar...

Страница 82: ...temperature probe to an appropriate location on the patient s skin 2 Connect the temperature probe to the amplifier 3 Use either method below to display the Results Table Setup panel a Click Edit Resu...

Страница 83: ...thods 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 Click on the Nerve name with which you want to replace...

Страница 84: ...ur options 2 To delete all displayed responses press All Responses The system clears the screen of all traces and measurement data or To delete a single trace highlight the unwanted trace using the cu...

Страница 85: ...he Patients window From the Test screen 1 Click on the Capture Video icon to start the video recording 2 Click on the Capture Video again to stop the video recording 1 Click on the Patients icon 2 Cli...

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Страница 87: ...orting 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...

Страница 88: ...Nicolet EDX 6 2 January 30 2020 Blank page...

Страница 89: ...Click OK on the EMG Settings Backup dialog which identifies the location of your backed up Settings folder Restoring settings and test folders From the Desktop 1 Click on Start All Programs Natus Emg...

Страница 90: ...ault label of the Test Folder into which the setting s will be imported type in the desired label 2 Click Import Importing only the selected Viking Setups This method imports only the selected Viking...

Страница 91: ...g Settings pane which allows you select specific Setup files for import 2 Click Import System Setup 3 An Import status dialog appears a If the import was successful click Close b If the import could o...

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Страница 93: ...enance and installation test 1 3 Display Prompt Area DPA 2 28 Displaying the Acquisition Set panel 2 29 Disposal at the end of operating life 1 e DPA Display Prompt Area 2 28 E Easy Riser tray 2 1 ECR...

Страница 94: ...de 1 d Safety summary 1 d Saving test data 4 12 Screen display 5 8 Screen display Changing 5 8 Select a test 4 10 Select Test 2 26 Selecting Repetitive or Single sweep acquisition 5 5 Sensitivity SNS...

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