natus Nicolet User manual

Nicolet System
Nicolet™ Cortical Stimulator
User Guide
November 29, 2018
Nicolet Cortical Stimulator User Guide
269-621500 Rev 07
© 2018 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 Incorpo-
rated, its subsidiaries or affiliates. All other trademarks are the property of their respective owners.

Revised 11/21/18 1
Table of Contents
Table of contents
About the Nicolet Cortical Stimulator...............................................................................................................1-i
About the Acquisition systems ...........................................................................................................................1-i
Natus EU authorized representative.................................................................................................................1-ii
CE mark ..............................................................................................................................................................1-ii
Technical support ...............................................................................................................................................1-ii
Labels and symbols ...........................................................................................................................................1-iii
Copyright ...........................................................................................................................................................1-iv
General Information
Intended readers.................................................................................................................................................1-3
Intended use ........................................................................................................................................................1-3
Amplifier terminology........................................................................................................................................1-4
C64-OR Amplifier............................................................................................................................................1-4
Natus Quantum.................................................................................................................................................1-4
Basic organization ..............................................................................................................................................1-5
Read the Safety Reference guides .....................................................................................................................1-5
Additional manuals available............................................................................................................................1-5
Safety summary ..................................................................................................................................................1-6
Contraindications ...............................................................................................................................................1-6
Cautions and Warnings......................................................................................................................................1-7
Product specifications ........................................................................................................................................1-9
Nicolet customers .............................................................................................................................................1-9
Xltek customers................................................................................................................................................1-9
System configuration disclaimers.....................................................................................................................1-9
Weight and dimensions ....................................................................................................................................1-10
Input requirements...........................................................................................................................................1-10
Output specifications........................................................................................................................................1-10
Environmental considerations (operating) .................................................................................................... 1-11
Environmental considerations (non-operating)............................................................................................. 1-11
Regulatory standards....................................................................................................................................... 1-11
Preventive maintenance ...................................................................................................................................1-12
Inspecting the system .....................................................................................................................................1-12
Cleaning instructions ......................................................................................................................................1-12
Cleaning the system........................................................................................................................................1-12
Storage............................................................................................................................................................1-12
Instructions for disposal at end of operating life...........................................................................................1-12

Nicolet Cortical Stimulator
2Revised 11/21/18
Nicolet Cortical Stimulator Overview
The Nicolet Cortical compatible amplifiers .....................................................................................................2-3
Stimulus Control Unit (SCU) ...........................................................................................................................2-4
Nicolet Cortical Stimulator symbols ................................................................................................................2-8
Stimulus Switching Unit (SSU) .....................................................................................................................2-10
C64-OR amplifier...........................................................................................................................................2-10
Natus Quantum amplifier ............................................................................................................................... 2-11
Hand-held stimulating probes.........................................................................................................................2-12
Nicolet system ................................................................................................................................................2-12
NeuroWorks system........................................................................................................................................2-12
System components ..........................................................................................................................................2-13
Block diagrams .................................................................................................................................................2-14
OR probe biphasic mode ................................................................................................................................2-14
OR probe biphasic mode - Nicolet desktop....................................................................................................2-15
Electrode biphasic modes...............................................................................................................................2-16
Performing a Cortical Stimulation Study
Introduction ........................................................................................................................................................3-3
Cortical Stimulator cabling diagrams ..............................................................................................................3-4
OR Probe Biphasic Mode.................................................................................................................................3-5
Electrode Mode - Nicolet Desktop...................................................................................................................3-6
Probe Mode - Nicolet Desktop.........................................................................................................................3-8
Connect the options/accessories ......................................................................................................................3-10
Apply power to the Stimulus Control Unit (SCU)......................................................................................... 3-11
Using the Nicolet Cortical Stimulator to set the Cortical Stimulator parameters .....................................3-12
Using the Nicolet system to set the Cortical Stimulation parameters .........................................................3-16
Start the study using the Nicolet system.........................................................................................................3-18
To start a stimulation using NeuroWorks ......................................................................................................3-18
Using the NeuroWorks system to set the Cortical Stimulation parameters ...............................................3-19
Display the Cortical stimulation window .......................................................................................................3-21
To start a stimulation .......................................................................................................................................3-23
Recommended workflow................................................................................................................................3-24
Stopping/interrupting stimulation ..................................................................................................................3-26
Reviewing the recorded EEG ..........................................................................................................................3-26
Turning Off the Stimulus Control Unit (SCU) ..............................................................................................3-26

Revised 11/21/18 3
Table of Contents
Electromagnetic Compatibility (EMC)
Nicolet Cortical Stimulator................................................................................................................................4-3
Safety and standards conformity......................................................................................................................4-4
Essential performance ......................................................................................................................................4-4
Safety standards................................................................................................................................................4-4
Declaration of compliance for IEC 60601-1-2: Ed. 4.0 (2014)........................................................................4-5
Table 1 - Electromagnetic emissions ................................................................................................................4-5
Table 4 - Immunity Test Levels - Enclosure Port.............................................................................................4-5
Table 5 – Immunity Test Levels – Input A.C. Power Port................................................................................4-6
Table 7 – Patient Coupling Port........................................................................................................................4-6
Table 8 – Immunity Test Levels - Signal Input / Output Parts Port ................................................................4-7
Table 9 - Test specifications for Enclosure Port Immunity to RF wireless communications equipment.........4-8
Error Codes
Error codes..........................................................................................................................................................5-3

Nicolet Cortical Stimulator
4Revised 11/21/18
Blank page.

Revised 11/21/18 i
Preface
About the Nicolet Cortical Stimulator
The Nicolet Cortical Stimulator can be used as an independent device or as an
option for use with the Nicolet system. It is used to support brain mapping
procedures.
The Nicolet Cortical Stimulator enhances a physician’s ability to conduct cortical
stimulation studies during surgical evaluations for epilepsy and tumors. During
the study, an electrical current is applied directly to the cortex using paired, intra-
cranial electrodes or using a hand held bipolar stimulator probe. The acquisition
system records EEG signals directly from the cortex via intracranial electrodes.
By observing the patient in person or through reviewing of video and analyzing
the recorded EEG and clinical behavior, the physician can evaluate the
epileptiform focus as well as cortical structures and brain function near tumors.
About the Acquisition systems
The Natus range of EEG systems has been designed and manufactured by Natus
Neurology Incorporated, which has always had an enviable reputation for
innovation and quality of its products.
Natus Neurology Incorporated quality management system has been certified to
comply with ISO 13485:2016.

Nicolet Cortical Stimulator
ii Revised 11/21/18
Natus EU authorized representative
Natus Manufacturing Limited
IDA Business Park
Gort, Co.Galway, Ireland
CE mark
Compliant to Medical Device Directive 93/42/EEC
Technical support
Domestic International
Natus Neurology Incorporated
3150 Pleasant View Road
Middleton, WI USA 53562
1-800-356-0007
[email protected]
www.Natus.com
Natus Neurology Incorporated
Phone: [phone]
Fax: [phone]
[email protected]
www.Natus.com

Revised 11/21/18 iii
Preface
Labels and symbols
The following labels and symbols may be affixed to the Nicolet Cortical Stimulator:
When applied on device: Attention: Consult Accompanying Docu-
mentation. (ISO 7000-0434A)
When used in documentation: Caution, Warning or Precaution fol-
lows.
Consult Operating Instructions. Failure to follow operating instructions
could place the patient or operator at risk. Image on blue background.
(ISO 7010 M002)
Consult Operating Instructions. (ISO 7000-1641)
European Authorized Representative.
Manufacturer.
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.
When the equipment comes to the end of its operating life, it should be
disposed of in accordance with local waste regulation authority, which
is typically within the local government office.
CE Mark and Notified Body.
(Compliant to Medical Device Directive 93/42/EEC)
Type BF equipment.
Electrostatic sensitive device (IEC 60417-5134)
RX Only CAUTION: USA Federal law restricts this device to sale or on the
order of a licensed Neurology practitioner.

Nicolet Cortical Stimulator
iv Revised 11/21/18
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.
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.
All other trademarks and product names are the property of their relevant owners.
www.natus.com
Natus Neurology Incorporated
3150 Pleasant View Road
Middleton, WI USA 53562-3530

Revised 11/21/18 1-1
1General Information

Nicolet Cortical Stimulator
1-2 Revised 11/21/18
Blank Page

Revised 11/21/18 1-3
General Information
Intended readers
The Nicolet Cortical Stimulator can be used as an independent device or as an
option for use with the Nicolet or Xltek System. The Nicolet or Xltek System
facilitates the capture and review of electroneurophysiological data. This manual
has been written for those experienced in this field – administrative staff, nurses,
technicians, physicians, Neurosurgeons and Neurophysiologists who will be
using this application. Because Nicolet and Xltek Systems are designed for the
Microsoft® Windows® operating system, you will need to be familiar with its
basic features. Refer to the documentation supplied with Microsoft® Windows®.
Intended use
The Nicolet Cortical Stimulator is intended for use in functional brain mapping
procedures during the treatment of patients, providing stimulation via electrode
pairs or a hand held bipolar probe.

Nicolet Cortical Stimulator
1-4 Revised 11/21/18
Amplifier terminology
C64-OR Amplifier The C64-OR Amplifier may be used when stimulus to the patient is delivered
from the Stimulus Control Unit (SCU) via a hand held bipolar probe. This is
referred to as the Bipolar Probe Mode on the SCU “Setup” field.
The C64-OR SSU Amplifier may also be used when stimulus to the patient is
delivered from the Stimulus Switching Unit (SSU) via the Stimulus Control Unit
(SCU) control panel or by computer control via the Stimulus Switching Unit
(SSU). This is referred to as the Electrode Biphasic Mode, which provides an
electronic method of selecting electrode pairs to stimulate the patient without
disconnecting the electrodes from the amplifier.
NOTE: For simplicity, the amplifier will be referred to hereafter as the C64-OR
Amplifier.
The stimulus can be delivered from the Stimulus Switching Unit (SSU)
independent of the Nicolet System. This is referred to as the Electrode Biphasic
Mode on the SCU “Setup” field.
Natus Quantum The Natus Quantum Amplifier may be used when stimulus to the patient is
delivered from the Stimulus Control Unit (SCU) via a hand held bipolar probe.
This is referred to as the Bipolar Probe Mode on the SCU “Setup” field.
The Natus Quantum Amplifier may also be used when stimulus to the patient is
delivered via implanted electrodes from the Stimulus Control Unit (SCU) control
panel or by computer control via the Stimulus Switching Unit (SSU). This is
referred to as the Electrode Biphasic Mode, which provides an electronic
method of selecting electrode pairs to stimulate the patient without disconnecting
the electrodes from the amplifier.

Revised 11/21/18 1-5
General Information
Basic organization
This manual covers all aspects of using the system for day-to-day operations.
Chapter 1 provides general introductory information, including preventive
maintenance.
Chapter 2 provides an overview of the Stimulus Control Unit (SCU), Stimulus
Switching Unit (SSU), Natus Quantum and C64-OR Amplifier as well as general
information on the software and Nicolet/Xltek System. Also included in this
chapter is a block diagram showing a possible example configuration scenario.
Chapter 3 provides instructions on how to use the Cortical Stimulator equipment
during a Cortical Stimulation Study.
Read the Safety Reference guides
•Please read the Additional Information and Safety Notes in the Natus
Quantum User and Service Manual (014556) and the NeuroWorks 9
Reference Manual (023933) thoroughly, paying special attention to the
Safety information before applying power to and using your NeuroWorks
system and its options/ accessories.
Additional manuals available
Additional manuals are available providing more detailed information on your
system’s software operation:
•269-604503 - Nicolet Information for Use Guide.
•269-617100 - Nicolet Pocket Guide
•269-604601 - Nicolet Software Reference Guide on CD (482-639403)
•014556 – Natus Quantum User and Service Manual
•023933 – NeuroWorks 9 Reference Manual

Nicolet Cortical Stimulator
1-6 Revised 11/21/18
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.
IMPORTANT: Read and follow all WARNINGS, CAUTIONS and NOTES
provided in Additional Information and Safety Notes for Assorted Nicolet
Brand Products Reference Guide 269-594705 on CD part number 482-638702
as well as the NeuroWorks 9 Reference Manual (023933) and Natus
Quantum User and Service Manual (014556). To avoid the possibility of
injury, damage to your system or lost data, always observe these safety
precautions during system operation.
Contraindications
DO NOT operate in the presence of flammable anesthetics.
DO NOT plug in or unplug power cord in the presence of combustible gas.
DO NOT operate in close proximity to radio transmitting equipment such as
cellular phones.
DO NOT operate in close proximity to short-wave or micro-wave devices.
DO NOT operate in close proximity to X-ray or diathermy devices.
DO NOT operate in the presence of high frequency surgical equipment.
DO NOT operate if the power cord or plug is damaged.
DO NOT use with non-Natus Neurology Incorporated supplied or recommended
components or accessories. Use of non-Natus Neurology Brand device(s) could
introduce source currents to the patient, which may cause electrical shock.

Revised 11/21/18 1-7
General Information
Cautions and Warnings
Use of the Nicolet Cortical Stimulator product is restricted to medical
professionals trained in the use of cortical stimulation.
It is strongly recommended that users be trained in the use of the Nicolet
Cortical Stimulator product prior to initial use.
When in use, the Nicolet Cortical Stimulator must be attended at all times
by medical professionals trained in cortical stimulation.
The Nicolet Cortical Stimulator product should be cleaned by medical
professionals who are trained in techniques to prevent cross-contamination
and infection.
Avoid trans-thoracic stimulation.
Any device connecting to the Trigger Output port must maintain the IEC
60601-1 approvals of the Nicolet Cortical Stimulator.
Portable RF communications equipment (including peripherals such as
antenna cables and external antennas) should be used no closer than 30 cm
(12 inches) to any part of the Nicolet Cortical Stimulator, including cables
specified by the manufacturer. Otherwise, degradation of the performance
of this equipment could result.
When an APPLIANCE COUPLER or separable plug is used as isolation
means, ME EQUIPMENT must be positioned such that the disconnection
device is easy to operate.
To avoid risk of electric shock, this equipment must only be connected to a
supply mains with protective earth.
Use only stimulus probes and electrodes that are specifically designed for
direct contact with brain tissue.

Nicolet Cortical Stimulator
1-8 Revised 11/21/18
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).
Begin with a low current level and increase in small increments.
When stimulating with a hand-held probe, keep the probe in firm contact
with cortical tissue.
Place the stimulator probe in contact with the neural tissue before starting
the stimulation pulse train and stop the stimulation pulse train before
removing the stimulator probe. This will ensure the effective surface area of
the stimulator probe will not be reduced.
DO NOT touch stimulation probes or stimulation electrodes or monitoring
electrodes to other conductive parts, including earth.
DO NOT use cables with unattended and unsupervised children.
DO NOT wrap cables around your neck.
DO NOT modify this equipment without written authorization of the
manufacturer.

Revised 11/21/18 1-9
General Information
Product specifications
Nicolet customers Refer to Nicolet with LTM Module Product Specification Sheet (P/N 169-
432900) for a complete set of technical specifications.
Xltek customers Refer to Natus Quantum Product Specification Sheet (P/N 015467E) and the
NeuroWorks 9 Reference Manual (023933) and for a complete set of technical
specifications.
System configuration
disclaimers
a) Antivirus and third party software and hardware
Natus Neurology Incorporated manufactures hardware and software to be used
on or with standard PC-compatible computers and operating software. Natus
Neurology Incorporated, however, assumes no responsibility for the use or
reliability of its software or hardware with equipment that is not furnished by
third-party manufacturers accepted by Natus Neurology Incorporated at the date
of purchase. This includes third-party software packages that are installed on
Natus Neurology Incorporated products or affect Natus Neurology Incorporated
products through operation over a network.
Active scanning with Anti-Virus Software is not recommended on any Natus
Neurology Incorporated instrument. Active and Normal scanning are not allowed
during acquisition of patient data. Anti-Virus software will interrupt the
recording, resulting in complete or partial inability to record patient data. Natus
Neurology Incorporated network consultants can recommend network and
antivirus software configurations for Natus Neurology Incorporated equipment
which will be secure without the use of active or normal scanning. Failure to
follow these guidelines may void the system warranty.
b) Microsoft updates
Natus Neurology Incorporated verifies and validates it software with all
Microsoft Service Pack updates available at the time of Natus Neurology
Incorporated software release. Customer Group Policy should isolate Natus
Neurology Incorporated systems from getting Microsoft updates pushed
automatically and / or a System “Restore Point” should be established before any
Microsoft updates are done to ensure that those updates can be rolled back if they
conflict with the Natus Neurology Incorporated clinical applications. Contact a
Natus Neurology Incorporated Service representative to determine which
Microsoft Service Packs have been verified and validated with Natus Neurology
Incorporated software.

Nicolet Cortical Stimulator
1-10 Revised 11/21/18
Weight and dimensions
9.9in (230mm)
5.5in (130mm)
Input requirements
The Nicolet Cortical Stimulator may be operated as an independent device or
through the Nicolet hardware platform.
Output specifications
Note: The Nicolet Cortical Stimulator is calibrated at the factory, and then is self-
monitoring. If the unit is out of calibration, it will display an error code and must
be replaced. (See Chapter 5 for error codes and actions.)
Stimulus Control Unit (SCU)
Weight Less than 2.2lb (1kg)
Dimensions
•Length:
•Width:
•Height:
Maximum
3.3in (75mm)
System Power 15V @ 3A (45W)
Frequency Range 47 - 63Hz
AC Voltage/Current 100 - 240VAC/1.35A
Current output Bi-phasic constant current of up to 15 mA
Stimulus levels 0 to 15 mA
Train durations 0.1 to continuous Secs (±20%) in Bipolar Probe mode.
0.1 to 30 Secs (±20%) in Electrode Switching mode.
Single stimulation pulses also available.
Pulse frequency 1 to 100 Hz (±10%)
Pulse duration 100 to 1000 usecs/phase (±25 usecs)
Pulse intensity 1.0 mA to 15 mA (±20% or 0.05mA, whichever is
larger). 15 mA maximum current limit at 1K load.