natus Nicolet Viking EDX User manual

Nicolet EDX System
Nicolet™ Viking EDX and
Synergy EDX User Guide
Issued January 30, 2020
Version 21 or Newer
269-658300 Rev 04
Nicolet EDX System User Guide
© 2016 - 2020 Natus Medical 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 trademarks owned, licensed to, promoted or distributed by Natus Medical Incorporated,
its subsidiaries or affiliates. All other trademarks are the property of their respective owners.

30 January, 2020 a
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)
•Evoked Potentials (EP) includes Visual Evoked Potentials (VEP), Auditory
Evoked Potentials (AEP), Somatosensory Evoked Potentials (SEP)
•Electroretinography (ERG)
•Electrooculography (EOG)
•P300
•Contingent Negative Variation (CNV)
•Motor Evoked Potentials (MEP)
The Nicolet EDX may be used to determine autonomic 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 assessment of RR Interval variability.
The Synergy EDX / Viking EDX software is used to detect changes in the
functional state of the nervous system, for the location of neural structures during
surgery and to support the diagnosis of neuromuscular disease or condition.
The listed modalities include overlap in functionality. In general,
•Nerve Conduction Studies measure the electrical responses of the nerve.
•Electromyography measures the electrical activity of the muscle.
•Evoked Potentials measure electrical activity from the Central Nervous
System.
The Nicolet Synergy EDX / Viking EDX software is intended to be used by a
qualified healthcare provider.

Nicolet EDX
b30 January, 2020
Contact information
Natus Neurology Incorporated
3150 Pleasant View Road
Middleton, WI USA 53562-3530
608-829-8500
1 800-356-0007
Fax: [phone]
www.Natus.com
Technical Support
Domestic
Natus Neurology Incorporated
3150 Pleasant View Road
Middleton, WI USA 53562
1-800-356-0007
[e-mail]
www.Natus.com
International
Natus Neurology Incorporated
Phone: [phone]
Fax: [phone]
Email: [email protected]
www.Natus.com
Natus EU Authorized Representative
Natus Manufacturing Limited
IDA Business Park
Gort, Co.Galway, Ireland

30 January, 2020 c
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: [phone]
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.

Nicolet EDX
d30 January, 2020
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
concerning your Nicolet EDX system.
Safety summary
In this manual, two labels identify potentially dangerous or destructive
conditions and 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 result in
damage to the equipment.
NOTE: Notes help you identify areas of possible confusion and avoid potential
problems during system operation.
Do NOT use outside of the published specification ranges. Use of device outside
of the specified ranges may result in inaccurate results.

30 January, 2020 e
Preface
Inspecting the system
Routinely check the instrument for exterior damage.
Follow your medical facilities safety guidelines.
Disposal at the end of operating life
Natus is committed to meeting the requirements of the European Union WEEE
(Waste Electrical and Electronic Equipment) Regulations 2014. These
regulations state that electrical and electronic waste must be separately collected
for the proper treatment and recovery to ensure that 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.
Please contact us for details on the collection and recovery systems available to
you in your region at www.natus.com
Electrical and electronic equipment (EEE) contains materials, components and
substances that may be hazardous and present a risk to human health and the
environment when WEEE is not handled correctly. Therefore, end users also
have a role to play in ensuring that WEEE is reused 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 obligation or licensed waste carriers to reduce adverse
environmental impacts in connection with disposal of waste electrical and
electronic equipment and to increase opportunities for reuse, recycling and
recovery of waste electrical and electronic equipment.
Equipment marked with the below crossed-out wheeled bin is electrical and
electronic equipment. The crossed-out wheeled bin symbol indicates that waste
electrical and electronic equipment should not be discarded together with
unseparated waste but must be collected separately.
Nicolet EDX Copyright
All rights reserved. This manual contains proprietary information, which is
protected by copyright and may not be copied in whole or in part except with the
prior written permission of Natus Neurology Incorporated. The copyright and the
foregoing restrictions on the copyright use extend to all media in which this
information is preserved.
This copy of the User Manual shall be used only in accordance with the
conditions of sale of Natus Neurology Incorporated or its distributors.

Nicolet EDX
f30 January, 2020
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.
www.natus.com
Natus Neurology Incorporated
3150 Pleasant View Road
Middleton, WI USA 53562-3530

30 January, 2020 g
Preface
Software copyright
protection
This software is protected by state, U.S. and international copyright treaty
provisions. These copyright provisions apply to your use of this software
regardless of whether or not you agree to the following terms. Under law,
copyright infringers may be liable for actual damages sustained by the copyright
owner and for punitive damages of up to $100,000 per infringement.
Unauthorized copying of computer software, and attempts to do so, are also
criminal violations, with penalties that may exceed $100,000 in fines and 10
years in prison.
1. 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.
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 machine and that it is used in no other
manner, or
(ii) that the copy is for archival purposes only and that all archival
copies are destroyed in the event that your continued possession of this
software should cease to be rightful.
c. Sell this software, and any archival copy, only as part of the sale of all of
your rights in this software, except that adaptations so prepared may be
transferred only with the authorization of Natus Neurology
Incorporated.
2. You are not permitted to:
a. Make copies of this software or documentation except as described
above.
b. Alter, modify or adapt this software or documentation except as
described above.
c. Distribute, lease, rent or sublicense this software or documentation.

Nicolet EDX
h30 January, 2020
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January 30, 2020 1
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 ......................................................................................................................................... 1-g
Introduction
Technical description .........................................................................................................................................1-3
Installation and servicing instructions .............................................................................................................1-3
Device continuity maintenance and installation test........................................................................................................ 1-3
Specification 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 ....................................................................................................................................1-5
Using this guide...................................................................................................................................................1-5
About the system ................................................................................................................................................1-5
Synergy/Viking Software - Warning and Error Codes ...................................................................................1-5
Cleaning...............................................................................................................................................................1-6
Connecting the system components ..................................................................................................................1-6
System Basics
Using the Easy Riser tray ..................................................................................................................................2-1
Viking EDX control panel..................................................................................................................................2-3
Synergy EDX control panel...............................................................................................................................2-8
EMG control panel...........................................................................................................................................2-10
AT2 and AT2+6 amplifier ................................................................................................................................2-13
ECR-16 amplifier .............................................................................................................................................2-15
HB-6 headbox (AT2+6) ....................................................................................................................................2-16
HB-7 headbox (AT2+6) ....................................................................................................................................2-16
HB-1 and HB-2 headbox (ECR16)..................................................................................................................2-17
Nicolet EDX electrical stimulator probes.......................................................................................................2-18
Comfort Probe Plus stimulator icons .............................................................................................................2-18

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2January 30, 2020
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
Test screen controls...........................................................................................................................................2-27
Header bar...................................................................................................................................................................... 2-27
Menu bar ........................................................................................................................................................................ 2-27
Toolbar ........................................................................................................................................................................... 2-27
Quick Access bar ........................................................................................................................................................... 2-28
Function Key Area ......................................................................................................................................................... 2-28
Using 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
Applying Filter settings to all channels from the Toolbar ............................................................................................. 2-31
Applying Filter settings to a single channel from the Toolbar....................................................................................... 2-31
Exiting the software..........................................................................................................................................2-32
Turning the Viking EDX / Synergy EDX system off .....................................................................................2-32
Desktop system .............................................................................................................................................................. 2-32
Portable system .............................................................................................................................................................. 2-32
Patient Information
The Patients screen.............................................................................................................................................3-3
Creating a new patient information record ...................................................................................................................... 3-3
Editing a patient information record ................................................................................................................................ 3-3
Editing a visit record........................................................................................................................................................ 3-4
Deleting a patient information record.............................................................................................................................. 3-4
About NicVue (option)........................................................................................................................................3-5

January 30, 2020 3
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 ................................................................................................................................................. 4-6
Example Motor Nerve Conduction Test...........................................................................................................4-7
Motor NCS electrode placement...................................................................................................................................... 4-8
Sensory NCS electrode placement .................................................................................................................................. 4-8
Connect the stimulating electrodes .................................................................................................................................. 4-8
Create / select a patient record......................................................................................................................................... 4-9
Select a test .................................................................................................................................................................... 4-10
Acquire the data ..............................................................................................................................................................4-11
Saving test data.................................................................................................................................................4-12
Creating / updating a report............................................................................................................................4-12
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......................................................................................................................... 4-13
Common Procedures
Adding new tests to a previous visit ................................................................................................................................ 5-3
Adding new data to a previous test.................................................................................................................................. 5-3
Changing the Stimulus Duration...................................................................................................................................... 5-4
Changing the Sensitivity (SNS)....................................................................................................................................... 5-4
Changing the Stimulus Rate ............................................................................................................................................ 5-5
Selecting Repetitive or Single sweep acquisition ............................................................................................................ 5-5
Placing markers................................................................................................................................................................ 5-6
Changing the screen display ............................................................................................................................................ 5-8
Activating markers........................................................................................................................................................... 5-9
Superimposing traces....................................................................................................................................................... 5-9
Calculating Conduction Velocities................................................................................................................................. 5-10
Measuring patient temperature ...................................................................................................................................... 5-10
Changing the nerve name ...............................................................................................................................................5-11
Viewing the nerve list .....................................................................................................................................................5-11
Choosing a side for the exam..........................................................................................................................................5-11
Erasing data.................................................................................................................................................................... 5-12
Capturing a video........................................................................................................................................................... 5-13
Setting up a report.......................................................................................................................................................... 5-13

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4January 30, 2020
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......................................................................................................................... 6-5

January 30, 2020 1-1
1Introduction

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1-2 January 30, 2020
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January 30, 2020 1-3
Introduction
Technical description
Your Nicolet EDX allows you to perform a wide range of Nerve Conduction
Studies (NCS), Electromyography (EMG), Evoked Potential (EP) Studies and
Autonomic Studies as well as Multimodality Programs such as Intra-operative
Monitoring (IOM). Separate software programs and optional accessories let you
customize your Nicolet EDX to meet your specific clinical and O.R. monitoring
needs.
Installation and servicing instructions
Device continuity
maintenance and
installation test
During installation, assembly and operation, some protective
ground connection points are susceptible to becoming electrically detached
or not properly connected. This can pose a safety hazard to both the user
and patient.
It is recommended/required 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 proper protective grounding is maintained. This test should always be
performed after installation and maintenance. Additionally, this test should
be performed on a regular maintenance basis.
No part of the system should be serviced while in use with a patient.
Maintenance and Service only while not in use with a patient. Disconnect
and remove the system from the patient vicinity before proceeding with
service or maintenance.
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.
For accuracy information see Additional Information and Safety Guide 269-
594705.

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1-4 January 30, 2020
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. Once the operator has
cleared this message, the system will indicate that acquisition can resume with
the settings restored to the previous state.
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 and has an IEC 60601-1
protective classification of Class I, Type BF and Type B applied parts,
ordinary equipment, not suitable for use in the presence of flammable
anesthetics.
2. The MDD equipment classification is IIb.
Intended operator
The Nicolet EDX with Synergy / Viking software is intended to be used by a
qualified healthcare provider.
Intended use
See the Indications for use as listed in the beginning of this guide. The system is
expected to typically be in use for 8-10 hours per day. It would be expected that
while in use (patient connected, the system would be interacted with by qualified
healthcare personnel performing the various studies listed in the indications for
use.

January 30, 2020 1-5
Introduction
Contraindications of use
There are no known contraindications under normal clinical use for EMG/NCV/
EP.
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.
Your system includes a computer on which the Nicolet EDX software 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 intuitive interface simplify operation. The
Automated-Study feature allows you to link and perform assorted protocols with
a simple button press, producing faster, more accurate test results and improved
repeatability. The Anatomy Database allows you to select individual muscles or
nerves for exams and view innervation roots.
Synergy/Viking Software - Warning and Error Codes
In the Synergy/Viking Application, errors and other informational messages are
designed to be self-explanatory.
However, additional information and suggested user actions are provided in
document 022210 found on the User Guide disk 482-651400.

Nicolet EDX
1-6 January 30, 2020
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.
•Water
•Isopropyl Alcohol (70-90% concentration in water)
•PDI SaniClothPlus #Q89702
•HB Quat (3M)
•Mild soap solution such as Basis, Cetaphil, Dove in water solution
•Ethyl alcohol (70-90% concentration)
•A solution of 1 part household bleach (5-6% concentrate sodium
hypocholorite) and 50 parts water.
Connecting the system components
Please refer to the Nicolet EDX Installation Guide for cabling instructions.