Intra-Operative Safety Guidelines

For Intra-Operative Monitoring when using

Nicolet™ Brand EEG systems (Chapter 1)
and
For Intra-Operative Monitoring when using
Nicolet™ Brand EP/EMG/IOM systems (Chapter 2)

IMPORTANT SAFETY INFORMATION

Please Read Carefully
August 18, 2016

Part Number 269-488001 Rev 09

© 2010 - 2016 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.
Natus Neurology Incorporated

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 Safety Guidlines for Natus Neurology Incorporated EEG Intra-Operative Monitoring

Contact information
Technical Support
Natus Neurology Incorporated
3150 Pleasant View Road Domestic
Middleton, WI USA 53562-3530 Natus Neurology Incorporated
608-829-8500 3150 Pleasant View
1 800-356-0007 Middleton, WI USA 53562
Fax: 608-829-8589 1-800-356-0007
www.Natus.com madison.helpdesk@natus.com
www.Natus.com
Natus EU Authorized Representative
Natus Manufacturing Limited International
IDA Business Park Natus Neurology Incorporated
Gort, Co.Galway, Ireland Phone: 0049 (0) 180 501 5544
Fax: 0049 (0) 89 83942777
Email: service.europe@natus.com
www.Natus.com

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 Table of Contents

Contact information.............................................................................................................................................iii

For Intra-Operative Monitoring Using Nicolet EEG Systems 1-1

Safety precautions ..............................................................................................................................................1-3
Summary .............................................................................................................................................................1-4
Introduction ........................................................................................................................................................1-4
Electrical safety features of the monitoring system ........................................................................................1-5
Risks associated with the use of electrosurgical units.....................................................................................1-6
Selection of recording and stimulating electrodes.........................................................................................1-10
Positioning of recording and stimulating electrodes .....................................................................................1-11
Nicolet Cortical Stimulator..............................................................................................................................1-12

For Intra-Operative Monitoring Using Nicolet EP/EMG/IOM Systems 2-1

Safety precautions ..............................................................................................................................................2-3
Summary .............................................................................................................................................................2-4
Introduction ........................................................................................................................................................2-4
Electrical safety features of the monitoring system ........................................................................................2-5
Risks associated with the use of electrosurgical units.....................................................................................2-6
Selection of recording and stimulating electrodes...........................................................................................2-9
Positioning of recording and stimulating electrodes .....................................................................................2-10
Connection of external custom electrode and/or stimulus switching devices .............................................2-11

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 1 For Intra-Operative Monitoring When
Using Nicolet EEG Systems

This chapter is intended for the following Nicolet brand systems:

• Nicolet EEG System:
Used with and without the Nicolet Cortical Stimulator
• Stand-alone Nicolet Cortical Stimulator
Also see the “1 - Safety Guidelines for Nicolet EEG Intra-Operative
Monitoring” card at the end of this guide.

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 Safety Guidlines for Natus Neurology Incorporated EEG Intra-Operative Monitoring

Safety precautions
The following items are suitable for the Intra-Operative patient environment: EEG main
unit, Nicolet VikingQuest Combo EEG, OR amplifiers - including Nicolet EEGwireless
32/64 channel amplifier, Nicolet Cortical Stimulator, Natus Neurology Incorporated cart,
Natus Neurology Incorporated isolation transformer, and all approved Natus Neurology
Incorporated cables for use with the system. Only Natus Neurology Incorporated
approved peripheral devices should be used with this system. Devices not specifically
approved by Natus Neurology Incorporated are not suitable for the Intra-Operative patient
environment.
Do not use extension cords to power the system. Extension cords can cause system to be
over the ground integrity and leakage current limits.
When used simultaneously with high frequency surgical equipment, burns may occur at
the site of any recording or stimulation electrode.
Electrodes of inadequate size or unsuitable application could provoke skin reactions or
burns. Natus Neurology Incorporated recommends the use of disposable, pre-gelled,
silver/silver chloride electrodes with a contact area of 20 mm diameter or larger. These
electrodes contain an adhesive that maintains the electrode skin position and contact
during electrical stimulation and contact during recording and electrical stimulation.
During direct nerve stimulation with the Nicolet VikingQuest EEG combo unit (i.e.,
stimulation of an exposed nerve or nerve root), it is recommended that a "low level
stimulator output" be used if available. If not, limit the duration to 100 us or less and the
intensity to 10 mA or less. Avoid using constant voltage.
Electrode burns to the patient are variable due to numerous conditions that must be
understood and monitored during the use of the equipment. Some variables to be aware of,
but not limited to, are:
• Time of exposure (All connections should be checked periodically when used in excess
of 30 minutes in one place.
• Concentration of currents (burns are caused by current density). Always use the
largest possible of contact surface.
• Patient condition.

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Summary
This document is intended to inform you about some of the most commonly applicable
safety precautions as they relate to the use of Nicolet brand EEG monitoring systems for
Intra-Operative Monitoring applications. As more electrical and electronic devices are
introduced into this hostile environment, there will be the potential for harm to you and/or
the patient.
At Natus Neurology Incorporated, commitment to safety and quality is paramount. For
this reason, we are providing the following information about the use of Nicolet brand
EEG systems for neurophysiological monitoring during various surgical procedures.
Please refer to IOM Safety Guide and Card for additional details.

Introduction
There are a number of unique requirements related to the surgical monitoring environment
that must be satisfied before a monitoring system can be used safely for Intra-operative
Monitoring. These requirements concern the safety of both the patient and the person
operating the monitoring system. Remember to follow all the cautions and warnings for
your system. The reason we suggest using the OR head-box for intra-operative monitoring
is to provide the patient with protection from potential burns at the electrode skin tissue
sites caused by radio frequency currents from the electro-surgical units. Remember to
follow all the cautions and warnings for your system.
We believe that the risk of an accident or an injury to either person can be minimized if
you are knowledgeable about the safety issues and guidelines discussed on the following
pages.

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 Safety Guidlines for Natus Neurology Incorporated EEG Intra-Operative Monitoring

Electrical safety features of the monitoring system

Every hospital requires that electrodiagnostic systems be safety-inspected by qualified
biomedical engineering personnel prior to use for any Intra-operative Monitoring.
Typically, this inspection includes, but may not be limited to:
• Evaluation of the ground connection on the system’s line power cord,
• Measurement of the system’s leakage current to ground,
• Measurement of the source and sink leakage current of the patient isolation section of
the amplifier subsystem.
Procedures for making these assessments and levels of acceptable leakage have been
defined in the United States (UL 60601 standard) and internationally (IEC/EN 60601-1
standard). If your biomedical personnel are not familiar with these standards or cannot
make leakage current measurements, please contact either Natus Neurology
Incorporated’s Technical Support in Middleton, Wisconsin, or your local Natus Neurology
Incorporated representative for assistance.
All system components that the operator can contact are either grounded or isolated. In
addition, the amplifier and electrical stimulator subsystems meet safety isolation
requirements to protect the patient. It is important, however, that the integrity of the
ground lead on the system main power cable be maintained at all times.
For this reason, it is important that system ground lead integrity be checked and verified
before a system is used for Intra-operative Monitoring. We also recommend that ground
lead integrity be checked at least every six months. Depending on how often the system is
used for monitoring and how often it is moved, more frequent verification of ground lead
integrity may be warranted.
Although most surgical facilities’ power lines conform to the hospital building safety
codes, we recommend that you always insure that any line power outlets or receptacles
that provide the power to the system be properly grounded in accordance with IEC 60601-
1-1.
The isolation circuits in the amplifier subsystem are evaluated by measuring their leakage
current. Although Natus Neurology Incorporated measures and documents the leakage
current of each system prior to shipment, we expect you to have leakage current checked
by biomedical personnel prior to any Intra-operative Monitoring usage.
Source and sink leakage current should be measured for both the physiological amplifier
subsystem and the electrical stimulating subsystem because both subsystems connect to
the patient through the recording and stimulating electrodes, respectively.

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Risks associated with the use of electrosurgical units

Electrosurgical units (ESUs) typically use radio frequency (RF) signals to perform ESU
and electrocoagulation. The energy of these RF signals applied to the patient is
substantial. There is a potential risk for tissue to be heated, and a burn(s) to occur on the
patient in areas other than where the ESU is intentionally applied, especially if there is
improper usage of the ESU devices, which is discussed later in this section.
ESUs are typically described as being either of the monopolar or bipolar type according to
the way in which the signal is applied to the patient. Some ESUs may even contain both
monopolar and bipolar types of circuitry within a single instrument.
Bipolar units present the RF signal through a bipolar, forceps-like hand piece held by the
surgeon. Since both the active and return electrodes are mounted in the same hand piece,
the amount of tissue involved in the electrosurgical circuit is limited. That is, most of the
current in the RF signal entering the patient is localized to the small area where the hand
piece contacts the patient. Bipolar applications usually involve only surgical desiccation in
confined areas where the surgeon desires to control and limit the desiccation. Because
delicate tissues require less heat to desiccate, bipolar applications are typically done using
much lower power as compared to the monopolar applications (described below).
While it may be said that bipolar ESUs are far less likely to produce burns at any of the
electrode sites connected to the system, it must not be assumed that such burns will never
be caused by bipolar applications.
Monopolar units apply the RF signal through a unipolar hand piece, thereby requiring a
separate return electrode or connection to the patient. This ESU return electrode is often
referred to as the “Bovie ground.” However, it is not a “ground” electrode because it
makes no connection to earth ground.
Furthermore, this electrode cannot serve as the patient ground for the amplifier subsystem.
The ESU return electrode is an extremely important item in terms of:
a. Its function to the ESU.
b. Its connection to the patient.
c. Its location relative to the location of the systems’s stimulating and recording
electrodes.
In general, the ESU return electrode is a large pad-like electrode. The large surface area
serves to provide a low-impedance connection to the patient. This electrode is often
positioned on the thigh or buttocks of a patient.

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Although some ESUs contain circuitry that will detect if the return electrode is not making
proper contact with the patient and will activate an alarm in such cases, we strongly
recommend that you independently verify the return electrode status. In the event of loss
of the return electrode connection, the RF signal from the ESU will seek another pathway
back to the ESU.
As a result, any and all electrodes (both stimulating and recording), which connect the
patient to the system, or any other device connected to the patient, could potentially
provide such a pathway. If the ESU signal flows through these EEG electrodes, then a
high density RF current may flow through the tissue to the EEG electrode interface and an
“electrode burn” can result.

Electrode burns to the patient are variable due to numerous conditions that must be
understood and monitored during the use of the equipment. Some variables to be aware of,
but not limited to, are:
• Time of exposure (All connections should be checked periodically when used in
excess of 30 minutes in one place.
• Concentration of currents (burns are caused by current density). Always use the
largest possible of contact surface.
• Patient condition.
Also, it should never be assumed that there is no possibility of an electrode burn
occurring when the system power is off. Even when the system is turned off, a passive
pathway for RF currents to flow may exist and allow the ESU signal to produce electrode
burns.
All system components that the operator can contact are either grounded or isolated. In
addition, the amplifier and electrical stimulator subsystems meet safety isolation
requirements to protect the patient. Natus Neurology Incorporated has designed the
system to minimize the risk of such pathways being established and causing burns.

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Natus Neurology Incorporated has designed the system to minimize the risk of such
pathways being established and causing burns.
a. First, in every amplifier subsystem, the patient is safety isolated from earth
ground.
b. Second, special RF choke or resistive devices, which act to inhibit the flow of RF
currents through the recording electrodes, are included as part of Natus
Neurology Incorporated’s “O.R. approved Amplifiers and Head boxes.” Models
of these head boxes specifically designed for Natus Neurology Incorporated
products are:
• Nicolet EEG System:
1. C64 OR Amplifier
2. C64 OR/SSU Amplifier
3. Nic36 OR Headbox and Amplifier
4. V44 OR Headbox
5. Nicolet Cortical Stimulator
6. Nicolet EEG Wireless Amplifier 32/64 Channel
• Nicolet Cortical Stimulator:
As a stand alone unit

c. Third, use of these amplifiers or head boxes is mandatory in all Intra-operative

Monitoring uses of the systems, and all recording electrodes must be plugged into
these.
d. Finally, RF choke devices have also been included in the electrical stimulator
subsystem. Use of this approved stimulator is mandatory any time Nicolet brand
systems are used for Intra-operative Monitoring.

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As stated previously, misuse of the ESU by members of the surgical team can also cause
burns at the electrode locations. For example, unnecessary and prolonged activation of the
ESU should be avoided to reduce the possibility of burns caused by RF leakage currents.
Also, activation of the ESU when the hand piece either is not making contact with the
patient (i.e., "open circuit" usage) or is applied very near (for example, less than 20 cm)
to any of the recording and stimulating electrodes should never be done.
It is also highly recommended to minimize electrode length before the protective
headbox. A maximum electrode length of 12 inches (30 cm) is recommended to
minimize RF leakage currents.
Most ESU manufacturers’ user documentation advises that the patient should not come
into direct contact with any grounded metal objects (for example, the surgical table frame,
instrument table, etc.). In some surgical procedures (for example, those involving the use
of non-insulated head frames), it may not be possible to prevent contact between the
patient and a grounded metal object. Use of extreme caution to maximize patient safety is
advised in these situations.
Never intentionally “ground” a patient by connecting them to a grounded metal object
or earth ground in order to overcome interference problems in your monitoring.
On occasion, two or more ESUs may be connected to a patient and in use simultaneously.
For dual monopolar ESU applications, the location of each ESU return electrode is
particularly important. ESU manufacturers advise that each ESU return electrode should
be positioned as close as possible to the respective site of surgery (that is, the point of
application of the ESU signal to the patient) and care should be taken to avoid the
possibility of the two ESU return electrodes touching.
Given that the responsibility of the set up and use of the ESUs lies with the surgical team,
assurance that these and other cautions against ESU misuse (as described by the ESU
manufacturers) are heeded and followed is not the responsibility of the person performing
neurophysiological monitoring. Being aware of these cautions, however, may help you to
minimize the risks of injury to the patient.

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Selection of recording and stimulating electrodes

In the event of failures/disconnection of the ESU return electrode or the occurrence of
any other condition in which there is stray current applied to the patient, there is a
potential for a burn to occur at each electrode site. If the surface area of the electrode is
small, such as is the case for needle and “hook-wire” electrodes, the degree of a burn
could be quite severe, because the current density at the tissue-to-electrode interface is
high. Heating occurs due to the high contact impedance between the electrode and tissue.
In contrast, surface electrodes having larger surface areas and lower contact impedance
would be less likely to cause burns because the current is spread over a larger area, thereby
reducing the heat. User documentation from at least one ESU device manufacturer does
not recommend the use of needle electrodes as monitoring electrodes connected to
monitoring systems during electrosurgical procedures.
Regardless of whether needle, hook-wire, or surface electrodes are selected for
monitoring, we strongly recommend that the electrode used for the system patient
ground has the largest of a tissue-to-electrode contact area as is practically feasible.
However, you should never assume that using only surface electrodes is a 100% guarantee
against electrode burns.
We also recommend that the surface electrodes used for recording be disposable,
nonmetallic, self-stick type. Use of reusable metallic surface electrodes increases the
likelihood of RF burns since the tissue contact area and the distribution of the electrolyte
gel may not be uniform. This may result in an electrode inducing a high impedance
“point” contact with the patient resulting in higher current density and possible RF burns.

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Positioning of recording and stimulating electrodes

Natus Neurology Incorporated recommends that all recording electrodes connected to the
Nicolet brand system be positioned, if practical, as far away as possible from the ESU
return electrode. The user documentation from one ESU manufacturer specifically
recommends that both recording electrodes and probes (that is, stimulating electrodes)
should be placed as far from the electrosurgical site and from the ESU return electrode as
possible.
In some cases, this recommendation means that the ESU return electrode may have to be
positioned somewhere on the patient other than the thigh or buttocks. Simple
communication with the surgical team may be all that is necessary to get the ESU return
electrode positioned to a place that is more optimal in terms of patient safety. The nicolet
brand system patient "ground" electrode should never be positioned beneath or further
away from the recording site than the ESU return electrode.
We also recommend, when it is consistent with clinical practice, that the Nicolet brand
system patient "ground" electrode not be positioned between the ESU return and the site
where the ESU monopolar hand piece is applied to the patient.
While electrical interference from a variety of sources within the surgical monitoring
environment may interfere with the signals being recorded on the system, you must never
attempt to overcome such interference by connecting the system patient "ground"
electrode directly to earth ground.
Connecting this electrode, or any other stimulating or recording electrode having a direct
connection to earth ground, should always be avoided, regardless of the problems
experienced with noise or interference.

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Nicolet Cortical Stimulator

The Nicolet Cortical Stimulator can be used as a stand alone unit without interfacing it to
a Nicolet EEG system. In this case, a disposable Nicolet Cortical Stimulator Bipolar probe
is used, which has red and black cathode bands and a 2.2 mm gold plated ball tip. The
probe should be placed firmly against the brain to confirm a stable charge density. When
using the probe, a continuous stimulating mode is available. The Cortical stimulator as a
stand alone unit with probe is not a functional brain stimulator that is intended to be
therapeutic or restore body function. This is a device to support transient cortical mapping.
Electrical cortical stimulation has become the standard of care for functional localization
of at risk eloquent brain structures prior to neurosurgical resection. It is understood the
clinician applies cortical stimulation as a tool to support mapping of eloquent brain
function to preserve as much eloquent brain tissue as possible.

Stimulus/electrode switching device

The C64-OR SSU (Stimulus Switching Unit) amplifier includes the ability to
automatically switch the stimulus to different electrodes.

Current Limit
A current limit circuit controls the maximum amount of stimulating current that may flow
out of the Stimulus Control Unit. The current may be limited to ±15 mA. It may also be
decided in some intraoperative monitoring applications to switch between different
electrical stimulating sites.
Use of a custom-made or commercially-available stimulus switching apparatus for
these applications can introduce a safety risk to the patient in several ways.
Such devices typically are simply connected to the output jacks of the electrical stimulator
subsystem on a Nicolet brand system. Since these outputs are isolated for reasons of
patient safety, the switching device therefore must not provide any connection to earth
ground to avoid defeating the safety isolation. Natus Neurology Incorporated has
approved electrode and stimulus switching devices available.
The wiring and cabling associated with the switching device may also introduce additional
capacitance to earth ground and in turn increase current leakage, thereby making the
stimulator subsystem no longer conform to the safety standards. Even when packing and
cabling for the switching device is carefully managed, the device can still represent a
patient safety hazard because it may provide a low impedance path to earth ground for RF
currents. The use of a stimulus switching device can affect the system functionality
because additional capacitance in the switching device can act to distort the shape of the
electrical stimulus pulse being delivered to the patient, thereby altering its effectiveness as
a stimulus.

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Use only Natus Neurology Incorporated-supplied and/or approved electrode and stimulus
switching devices. Please see the third paragraph on this page.
The applicable stimulation probe is the Natus Neurology Incorporated Bipolar
Stimulation Probe with 2.2mm diameter tips. The applicable stimulation electrodes are
any commercially available 2.3mm diameter Strip and Grid Electrodes. In the United
States only, the stimulation electrodes and stimulation probes must have been cleared to
market by the Food and Drug Administration (FDA).

Stimulus Control Unit (SCU)

The Stimulus Control Unit (SCU) is equipped with built-in controls and a display. It
provides isolated constant current stimulation and may be connected to the Acquisition
system via a Serial port on the Desktop, Laptop, or Panel PC computer. The Stimulus
Control Unit (SCU) can deliver the following stimuli:
• Bi-phasic
• Constant current
• Stimulation pulses
• Trains of stimulation pulses

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 2 For Intra-Operative Monitoring When
Using Nicolet EP/EMG/IOM Systems

This chapter is intended for the following Nicolet brand systems:

• Synergy EDX
• Nicolet Viking EDX
• Nicolet VikingSelect
• Nicolet Viking II, II3, III and IV
• Nicolet Endeavor O.R.
• Nicolet Endeavor CR
Also see “2 - Safety Guidelines for Nicolet Brand Intra-operative Monitoring
EP/EMG/IOM” card at the end of this guide.

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Safety precautions
The following items are suitable for the patient environment: Main unit, Natus Neurology
Incorporated cart, Natus Neurology Incorporated isolation transformer, and all approved
Natus Neurology Incorporated transducers for use with the system. Only Natus Neurology
Incorporated approved peripheral devices should be used with this system. Devices not
specifically approved by Natus Neurology Incorporated are not suitable for the patient
environment.
Do not use extension cords to power the system. Extension cords can cause ground
integrity and impedance problems.
When used simultaneously with high frequency surgical equipment, burns may occur at
the site of any recording or stimulation electrode.
Electrodes of inadequate size or unsuitable application could provoke skin reactions or
burns. Natus Neurology Incorporated recommends the use of disposable, pre-gelled,
silver/silver chloride electrodes with a contact area of 20 mm diameter or larger. These
electrodes contain an adhesive that maintains the electrode skin position and contact
during electrical stimulation.
During direct nerve stimulation (i.e., stimulation of an exposed nerve or nerve root), it is
recommended that a "low level stimulator output" be used if available. If not, limit the
duration to 100 us or less and the intensity to 10 mA or less. Avoid using constant voltage.
Transcranial electrical motor evoked potential stimulation is not recommended for use on
patients that meet the following exclusion criteria:
a. History of head injury, stroke, seizures, epilepsy or other neurologic or
psychiatric disorders.
b. History of cerebral aneurysm (i.e., with an intracerebral vascular clip).
c. Subjects with any type of implanted biomedical device (i.e., pacemaker, infusion
pump).
d. Subjects with metal fragments or plates in their head.
Patient movement may occur as a result of transcranial electrical motor evoked potential
stimulation.
Electrode burns are variable that occur on patients due to numerous conditions that must
be understood and monitored during the use of the equipment. Some variables to be aware
of, but not limited to, are:
• Time of exposure (All connections should be checked periodically when used in
excess of 30 minutes in on place.
• Concentration of currents (Burns are caused by current density). Always use as large
of contact surface as possible.
• Patient condition.

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Natus Neurology Incorporated

Summary
This document is intended to inform you about some of the most commonly applicable
safety precautions as they relate to the use of monitoring systems for Intra-Operative
Monitoring applications. As more electrical and electronic devices are introduced into this
environment, there will continue to be the potential for harm to you and/or the patient.
In order to minimize these risks, you should be as informed as possible about the system
and its monitoring capabilities and to communicate effectively with members of the
surgical team and biomedical electronics personnel in your facility about the safety
requirements necessary to perform monitoring effectively.

Introduction
At Natus Neurology Incorporated, commitment to safety and quality is paramount. For
this reason, we are providing the following information about the use of Nicolet EP/EMG/
IOM systems for neurophysiological monitoring during various surgical procedures.
There are a number of unique requirements related to the surgical monitoring environment
that must be satisfied before a monitoring system can be used safely for Intra-Operative
Monitoring. These requirements concern the safety of both the patient and the person
operating the monitoring system. Remember to follow all the cautions and warnings for
your system.
We believe that the risk of an accident or an injury to either person can be minimized if
you are knowledgeable about the safety issues and guidelines discussed in the following
pages.

2-4 August 18, 2016

 Safety Guidlines for EP/EMG Intra-Operative Monitoring

Electrical safety features of the monitoring system

Every hospital requires that electrodiagnostic systems be safety-inspected by qualified
biomedical electronics personnel prior to use for any Intra-Operative monitoring.
Typically, this inspection includes, but may not be limited to:
• Evaluation of the ground connection on the system’s line power cord,
• Measurement of the system’s leakage current to ground,
• Measurement of the source and sink leakage current of the patient isolation section of
the amplifier subsystem.
Procedures for making these assessments and levels of acceptable leakage have been
defined in the United States (UL 60601 standard) and internationally
(IEC/EN 60601-1 standard). If your biomedical personnel are not familiar with these
standards or cannot make leakage current measurements, please contact either Natus
Neurology Incorporated’s Technical Information Center in Middleton, Wisconsin, or your
local Natus Neurology Incorporated representative for assistance.
Moreover, Electronics Testing Laboratory has certified conformance of the Nicolet Brand
Systems to UL 2601. Similarly, the system's performance is internationally certified to
IEC 60601-1, IEC 60601-1-1, IEC 60601-2-26 and IEC 60601-2-40.
All system components that the operator can contact are either grounded or isolated. In
addition, the amplifier and electrical stimulator subsystems meet safety isolation
requirements to protect the patient. It is important, however, that the integrity of the
ground lead on the system main power cable be maintained at all times.
For this reason, it is important that system ground lead integrity be checked and verified
before a system is used for monitoring. We also recommend that ground lead integrity
be checked at least every six months. Depending on how often the system is used for
monitoring and how often it is moved, more frequent verification of ground lead integrity
checked may be warranted.
Although most surgical facilities’ power lines conform to the hospital building safety
codes, we recommend that you always insure that any line power outlets or receptacles
that provide the power to the system be properly grounded in accordance with IEC 60601-
1-1.
The isolation circuits in the amplifier subsystem are evaluated by measuring their leakage
current. Although Natus Neurology Incorporated measures and documents the leakage
current prior to shipment, we expect you to have leakage current checked by biomedical
personnel prior to any monitoring usage.
Source and sink leakage current should be measured for both the physiological amplifier
subsystem and the electrical stimulating subsystem because both subsystems connect to
the patient through the recording and stimulating electrodes, respectively.

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Risks associated with the use of electrosurgical units

Electrosurgical units (ESUs) typically use radio frequency (RF) signals to perform ESU
and electrocoagulation. The energy of these RF signals applied to the patient is
substantial. There is a potential risk for tissue to be heated, and a burn(s) to occur on the
patient in areas other than where the ESU is intentionally applied, especially if there is
improper usage of the ESU devices, which is discussed later in this section.
ESUs are typically described as being either of the monopolar or bipolar type according to
the way in which the signal is applied to the patient. Some ESUs may even contain both
monopolar and bipolar types of circuitry within a single instrument.
Bipolar units present the RF signal through a bipolar, forceps-like hand piece held by the
surgeon. Since both the active and return electrodes are mounted in the same hand piece,
the amount of tissue involved in the electrosurgical circuit is limited. That is, most of the
current in the RF signal entering the patient is localized to the small area where the hand
piece contacts the patient. Bipolar applications usually involve only surgical desiccation in
confined areas where the surgeon desires to control and limit the desiccation. Because
delicate tissues require less heat to desiccate, bipolar applications are typically done using
much lower power as compared to the monopolar applications (described below).
While it may be said that bipolar ESUs are far less likely to produce burns at any of the
electrode sites connected to the system, it must not be assumed that such burns will never
be caused by bipolar applications.
Monopolar units apply the RF signal through a unipolar hand piece, thereby requiring a
separate return electrode or connection to the patient. This ESU return electrode is often
referred to as the “Bovie ground.” However, it is not a “ground” electrode because it
makes no connection to earth ground.
Furthermore, this electrode cannot serve as the patient ground for the amplifier subsystem.
The ESU return electrode is an extremely important item in terms of:
a. Its function to the ESU.
b. Its connection to the patient.
c. Its location relative to the location of the systems’s stimulating and recording
electrodes.
In general, the ESU return electrode is a large pad-like electrode. The large surface area
serves to provide a low-impedance connection to the patient. This electrode is often
positioned on the thigh or buttocks of a patient.

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 Safety Guidlines for EP/EMG Intra-Operative Monitoring

Although some ESUs contain circuitry that will detect if the return electrode is not making
proper contact with the patient and will activate an alarm in such cases, we strongly
recommend that you independently verify the return electrode status. In the event of loss
of the return electrode connection, the RF signal from the ESU will seek another pathway
back to the ESU.
As a result, any and all electrodes (both stimulating and recording), which connect the
patient to the system, or any other device connected to the patient, could potentially
provide such a pathway. If the ESU signal is able to flow through these electrodes, then a
high density RF current may flow through the tissue-to-electrode interface and an
“electrode burn” can result.
Also, it should never be assumed that there is no possibility of an electrode burn
occurring when the system power is off. Even when the system is turned off, a passive
pathway for RF currents to flow may exist and allow the ESU signal to produce electrode
burns.
Natus Neurology Incorporated has designed the system to minimize the risk of such
pathways being established and causing burns.
a. First, in every amplifier subsystem, the patient common is safety isolated from
earth ground.
b. Second, special RF choke or resistive devices, which act to inhibit the flow of
RF currents through the recording electrodes, are included as part of Natus
Neurology Incorporated’s “O.R. Electrode Headboxes.” Models of these head
boxes specifically designed for and Natus Neurology Incorporated products are:
• For the Nicolet EDX: HB-7 Headbox
• For the Nicolet VikingSelect: Nicolet brand ET 16A, ET 16B, and ET 208
Headboxes and the IES D9 Stimulus Switching Unit
• For the Nicolet Viking II, II3, III and IV: Nicolet brand ET 206, ET 207,
ET 208, and ET 216 Headboxes and the IES 9 Stimulus Switching Unit
• For Nicolet Endeavor O.R.: Adaptors and the Headboxes 1 & 2
• For Nicolet Endeavor CR: HB-1 and 2 Headboxes, SP1 and 2 Stimulus
Switching Unit
Use of these head boxes or in-line RF filter is mandatory in all Intra-Operative
Monitoring uses of the systems, and all recording electrodes must be plugged
into these head boxes. Never connect even a single electrode directly onto the
amplifier subsystem during any monitoring application.

August 18, 2016 2-7

Natus Neurology Incorporated

c. Third, RF choke devices have also been included in the electrical stimulator
subsystem. Special stimulator switching output boxes, the IES-D9, IES- 16, SP-1
or SP-2 contain the RF chokes and are available for use on Nicolet Viking,
Nicolet EDX and Nicolet Endeavor CR systems. Use of this of approved
stimulator is mandatory any time these Nicolet brand systems are used for
intra-operative monitoring.
As stated previously, misuse of the ESU by members of the surgical team can also cause
burns at the electrode locations. For example, unnecessary and prolonged activation of the
ESU should be avoided to reduce the possibility of burns caused by RF leakage currents.
Also, activation of the ESU when the hand piece either is not making contact with the
patient (i.e., "open circuit" usage) or is applied very near (for example, less than 20 cm)
to any of the recording and stimulating electrodes should never be done.
It is highly recommended to minimize electrode length between the patient and the
protected headbox.
A maximum electrode length of 12” (30 cm) is recommended to minimize RF leakage
currents.
Most ESU manufacturers’ user documentation advises that the patient should not come
into direct contact with any grounded metal objects (for example, the surgical table frame,
instrument table, etc.). In some surgical procedures (for example, those involving the use
of non-insulated head frames), it may not be possible to prevent contact between the
patient and a grounded metal object. Use of extreme caution to maximize patient safety is
advised in these situations.
Never intentionally “ground” a patient by connecting them to a grounded metal object
or earth ground in order to overcome interference problems in your monitoring.
On occasion, two or more ESUs may be connected to a patient and in use simultaneously.
For dual monopolar ESU applications, the location of each ESU return electrode is
particularly important. ESU manufacturers advise that each ESU return electrode should
be positioned as close as possible to the respective site of surgery (that is, the point of
application of the ESU signal to the patient) and care should be taken to avoid the
possibility of the two ESU return electrodes touching.
Given that the responsibility of the set up and use of the ESUs lies with the surgical team,
assurance that these and other cautions against ESU misuse (as described by the ESU
manufacturers) are heeded and followed is not the responsibility of the person performing
neurophysiological monitoring. Being aware of these cautions, however, may help you to
minimize the risks of injury to the patient.

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 Safety Guidlines for EP/EMG Intra-Operative Monitoring

Selection of recording and stimulating electrodes

In the event of failures/disconnection of the ESU return electrode or the occurrence of
any other condition in which there is stray current applied to the patient, there is a
potential for a burn to occur at each electrode site.
If the surface area of the electrode is small, such as is the case for needle and “hook-wire”
electrodes, the degree of a burn could be quite severe, because the current density at the
tissue-to-electrode interface is high. Heating occurs due to the high contact impedance
between the electrode and tissue.
In contrast, surface electrodes having larger surface areas and lower contact impedance
would be less likely to cause burns because the current is spread over a larger area, thereby
reducing the heat. User documentation from at least one ESU device manufacturer does
not recommend the use of needle electrodes as monitoring electrodes connected to
monitoring systems during electrosurgical procedures.
Regardless of whether needle, hook-wire, or surface electrodes are selected for
monitoring, we strongly recommend that the electrode used for the system patient
ground has as large of a tissue-to-electrode contact areas as is practically feasible.
However, you should never assume that using only surface electrodes is a 100% guarantee
against electrode burns.
We also recommend that the surface electrodes used for recording and stimulating be of
the disposable, nonmetallic, self-stick type. Use of reusable metallic surface electrodes
increases the likelihood of RF burns since the tissue contact area and the distribution of
the electrolyte gel may not be uniform. This may result in an electrode inducing a high
impedance “point” contact with the patient resulting in higher current density and possible
RF burns.
Transcranial electrical motor evoked potential stimulation delivery is dependent on
electrode impedance. Electrode impedance along with stimulation settings can impact the
ability to produce an evoked potential response.

August 18, 2016 2-9

Natus Neurology Incorporated

Positioning of recording and stimulating electrodes

Natus Neurology Incorporated recommends that all recording and stimulating electrodes
connected to the Nicolet brand system be positioned, if practical, as far away as possible
from the ESU return electrode. The user documentation from one ESU manufacturer
specifically recommends that both recording electrodes and probes (that is, stimulating
electrodes) should be placed as far from the electrosurgical site and from the ESU return
electrode as possible.
In some cases, this recommendation means that the ESU return electrode may have to be
positioned somewhere on the patient other than the thigh or buttocks. Simple
communication with the surgical team may be all that is necessary to get the ESU return
electrode positioned to a place that is more optimal in terms of patient safety.
The Nicolet brand system patient common electrode should never be positioned beneath
the ESU return electrode.
We also recommend, when it is consistent with clinical practice, that the Nicolet brand
system patient ground electrode not be positioned between the ESU return and the site
where the ESU monopolar hand piece is applied to the patient.
While electrical interference from a variety of sources within the surgical monitoring
environment may interfere with the signals being recorded on the system, you must never
attempt to overcome such interference by connecting the system patient common
electrode directly to earth ground.
Connecting this electrode, or any other stimulating or recording electrode that is
connected to the system, in such a way so as to have a direct connection to earth ground,
should always be avoided, regardless of the problems experienced with noise interference.

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 Safety Guidlines for EP/EMG Intra-Operative Monitoring

Connection of external custom electrode and/or stimulus switching devices

In some intraoperative monitoring applications, it may be decided to switch between
different recording electrode montages. In these cases, some users have either built a
custom-made switching apparatus or purchased a commercially available switching
device. When connected to a Nicolet brand system, these devices typically are connected
to the input jacks of the amplifier subsystem.
These electrode switching devices can introduce a safety risk to the patient in several
different ways.
1. Since the Natus Neurology Incorporated amplifier inputs are optically isolated for
patient safety, any external switching device, which compromises or defeats the
isolation barrier by creating a connection to earth ground, creates a safety risk to the
patient.

2. Adding an electrode switching box can increase current leakage to ground, thereby
making the system no longer conform to the safety standards (as described initially in
this document). Specifically, the wiring and cabling associated with the switching
device may introduce additional capacitance to earth ground which in turn increases
leakage.

3. Even if one takes care to “electrically isolate” an electrode switching device by

packaging it in an insulated case, etc., the device can still represent a safety hazard to
the patient, because it may still provide a low impedance path to earth ground for RF
currents.
The addition of an electrode switching box can also increase the inherent system noise
making it more difficult, if not impossible, to make “clean” recordings of the
electrophysiological signals being monitored.
It may also be decided in some intraoperative monitoring applications to switch between
different electrical stimulating sites.
Use of a custom-made or commercially-available stimulus switching apparatus for
these applications can introduce a safety risk to the patient in several ways.
Such devices typically are simply connected to the output jacks of the electrical stimulator
subsystem on a Nicolet brand system. Since these outputs are isolated for reasons of
patient safety, the switching device therefore must not provide any connection to earth
ground to avoid defeating the safety isolation. Natus Neurology Incorporated has
approved electrode and stimulus switching devices available.

August 18, 2016 2-11

Natus Neurology Incorporated

The wiring and cabling associated with the switching device may also introduce additional
capacitance to earth ground and in turn increase current leakage, thereby making the
stimulator subsystem no longer conform to the safety standards. Even when packing and
cabling for the switching device is carefully managed, the device can still represent a
patient safety hazard because it may provide a low impedance path to earth ground for RF
currents. The use of a stimulus switching device can affect the system functionality
because additional capacitance in the switching device can act to distort the shape of the
electrical stimulus pulse being delivered to the patient, thereby altering its effectiveness as
a stimulus.
Use only Natus Neurology Incorporated-supplied and/or approved electrode and stimulus
switching devices. Please see the last paragraph on page 2-11.

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 -1-
Safety Guidelines for Nicolet Brand
Intra-Operative Monitoring EEG Systems
This side is for use with the following Nicolet Brand Systems:
• Nicolet EEG Systems
• Nicolet Cortical Stimulator (Used as a stand-alone unit or interfaced to a Nicolet C64-OR EEG system)

Please keep these safety guidelines on or near your Nicolet EEG Monitoring system.
• Use only approved devices for recording or stimulating electrode switching on Nicolet brand
systems.
• Never use an extension cord to power the system.
• Always use the appropriate Natus Neurology Incorporated O.R. Electrode Headboxes and
Amplifiers for connecting all recording electrodes to the Nicolet brand system.
• Always use the largest electrode possible for the Nicolet brand system’s patient "ground",
especially when used with needle or hookwire electrodes. Never use the ESU return electrode
as the Nicolet brand system patient ground, or place the Nicolet brand system patient
"ground" electrode beneath or further away than the ESU return electrode. Never directly
connect the patient or the Nicolet system patient "ground" electrode to grounded metal objects
or to earth ground.
• Minimize electrode length between patient and protected headbox.
• Verify that the ESU return electrode is optimally on and properly applied to the patient.
• Advise the surgeon to avoid prolonged ESU activation. Never activate the ESU when the ESU
probe is not in contact with the patient.
• Avoid ESU use close to the monitoring electrodes.
• Turning the Nicolet brand system power off does not eliminate the possibility of current flow
through the monitoring electrodes.
• Periodically check the system ground integrity, the system leakage current and the leakage
current of the amplifier and electrical stimulator subsystems. Verify that line power
receptacles are properly grounded.

P/N 269-488001 Rev 09

 -2-
Safety Guidelines for Nicolet Brand
Intra-Operative Monitoring EP/EMG/IOM Systems
This side is for use with the following Nicolet Brand Systems:
Nicolet Synergy EDX / Nicolet Viking EDX / Nicolet VikingSelect /
Nicolet Viking II, IIE, III and IV / Nicolet Endeavor O.R. / Nicolet Endeavor CR

Please keep these safety guidelines on or near your Nicolet brand system.
• Verify that the ESU return electrode is optimally located on and properly applied to the
patient.
• Advise the surgeon to avoid prolonged ESU activation. Never activate ESU when the ESU
pencil is not in contact with the patient.
• Avoid ESU use close to the monitoring electrodes.
• Always use the appropriate Natus Neurology Incorporated O.R. Electrode Headboxes for
connecting all recording electrodes to the Nicolet brand system. Always use the appropriate
Natus Neurology Incorporated O.R. Stimulator boxes for connecting all stimulating
electrodes.
• Always use the largest electrode possible for the Nicolet brand system’s patient common,
especially when used with needle or hookwire electrodes. Never use the ESU return electrode
as the Nicolet brand system patient ground, or place the Nicolet brand system patient common
electrode beneath the ESU return electrode. Never directly connect the patient or the Nicolet
system patient common electrode to grounded metal objects or to earth ground.
• Minimize electrode length between patient and protected headbox.
• Turning the system power off does not eliminate the possibility of current flow through the
monitoring electrodes.
• Use only approved devices for recording or stimulating electrode switching on Nicolet brand
systems.
• Periodically check the system ground integrity, the system leakage current and the leakage
current of the amplifier and electrical stimulator subsystems. Verify that line power
receptacles are properly grounded.

P/N 269-488001 Rev 09