natus Nicolet SCU User manual

Nicolet System
Nicolet™ Cortical
Stimulator User Guide
March, 2010
Nicolet Cortical Stimulator User Guide
269-621500 Rev 03
© 2013 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 8/27/13 1
Table of Contents
About the Nicolet Cortical Stimulator................................................................... i
About the Nicolet system......................................................................................... i
European authorized representative..................................................................... ii
CE mark .................................................................................................................. ii
Technical support ................................................................................................... ii
Labels and symbols ...............................................................................................iii
Copyright................................................................................................................ iv
General Information
Intended readers..................................................................................................1-3
Intended use .........................................................................................................1-3
C64-OR amplifier terminology ..........................................................................1-3
Basic organization ...............................................................................................1-4
Read the Safety Reference guides ......................................................................1-4
Additional manuals available .............................................................................1-4
Safety summary ...................................................................................................1-5
Cautions and Warnings.......................................................................................1-6
Product specifications .........................................................................................1-7
System configuration disclaimers ....................................................................1-8
a) Antivirus and third party software and hardware ...................................1-8
b) Microsoft updates ................................................................................... 1-8
Weight and dimensions .......................................................................................1-9
Input requirements..............................................................................................1-9
Output specifications...........................................................................................1-9
Environmental considerations (operating)......................................................1-10
Environmental considerations (non-operating).............................................. 1-10
Regulatory standards ........................................................................................1-10
Preventive maintenance .................................................................................... 1-11
Inspecting the system ..................................................................................... 1-11
Cleaning instructions...................................................................................... 1-11
Cleaning the system........................................................................................1-12
Storage............................................................................................................1-12

Nicolet Cortical Stimulator
2Revised 8/27/13
Nicolet Cortical Stimulator Overview
The Nicolet Cortical Stimulator components....................................................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
Hand-held stimulating probes ........................................................................ 2-11
Nicolet system ................................................................................................ 2-11
Block diagrams ..................................................................................................2-12
OR probe biphasic mode ................................................................................2-12
OR probe biphasic mode - Nicolet desktop....................................................2-13
Electrode biphasic modes...............................................................................2-14
Electrode biphasic switching mode - Nicolet desktop..............................2-14
Electrode biphasic switching mode - Nicolet Laptop...............................2-15
Electrode biphasic switching mode - Nicolet Panel PC ...........................2-16
Performing a Cortical Stimulation Study
Cortical Stimulator cabling diagrams ...............................................................3-3
OR Probe Biphasic Mode.................................................................................3-4
Electrode Mode - Nicolet Desktop...................................................................3-5
Electrode Biphasic mode - Nicolet Laptop ......................................................3-6
Probe Mode - Nicolet Desktop.........................................................................3-7
Probe stimulation system - Nicolet Laptop ......................................................3-8
Connect the options/accessories .........................................................................3-9
Apply power to the Stimulus Control Unit (SCU)..........................................3-10
Using the Nicolet Cortical Stimulator to set the Cortical Stimulator
parameters.......................................................................................................... 3-11
Using the Nicolet system to set the Cortical Stimulation parameters...........3-15
Start the study ....................................................................................................3-17
Stopping/interrupting stimulation ...................................................................3-18
Reviewing the recorded EEG ........................................................................... 3-18
Electromagnetic Compatibility (EMC)
Nicolet Cortical Stimulator.................................................................................4-3
Nicolet Cortical Stimulator with Nicolet LTM.................................................4-4
Error Codes
Error codes...........................................................................................................5-3

Revised 8/27/13 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 Nicolet
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 Nicolet system
The Nicolet range of Multimedia 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 by
Kema to comply with ISO 13485:2003.

Nicolet Cortical Stimulator
ii Revised 8/27/13
European authorized representative
Natus Europe GmbH
Robert-Koch-Str. 1
82152 Planegg
Germany
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 8/27/13 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.
CE Mark and Notified Body.
(Compliant to Medical Device Directive 93/42/EEC)
Type BF equipment.
Not for use in Operating Rooms.
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 8/27/13
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 8/27/13 1-1
1General Information

Nicolet Cortical Stimulator
1-2 Revised 8/27/13
Blank Page

Revised 8/27/13 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 System. The Nicolet 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 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.
C64-OR amplifier terminology
The C64-OR Amplifier my 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 Switching 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 Bipolar Probe
Mode on the SCU “Setup” field.

Nicolet Cortical Stimulator
1-4 Revised 8/27/13
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), and C64-OR Amplifier as well as general information on
the software and Nicolet 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 for Assorted
Nicolet Brand Products Reference Guide 269-594705 on CD part number
482-638702 thoroughly, paying special attention to the Safety information
before applying power to and using your Nicolet 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)

Revised 8/27/13 1-5
General Information
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. To avoid the possibility of injury, damage to your system or lost
data, always observe these safety precautions during system operation.

Nicolet Cortical Stimulator
1-6 Revised 8/27/13
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.

Revised 8/27/13 1-7
General Information
Use only stimulus probes and electrodes that are specifically designed for
direct contact with brain tissue.
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 use cables with unattended and unsupervised children.
Do NOT wrap cables around your neck.
Product specifications
Refer to Nicolet with LTM Module Product Specification Sheet (P/N 169-
432900) for a complete set of technical specifications.
Refer to the next page for the Nicolet Cortical Stimulator specifications.

Nicolet Cortical Stimulator
1-8 Revised 8/27/13
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.

Revised 8/27/13 1-9
General Information
Weight and dimensions
9in (230mm)
5in (130mm)
2in (51mm)
5.5in (138mm)
Input requirements
The Nicolet Cortical Stimulator may be operated as an independent device or
through the Nicolet hardware platform.
Output specifications
Stimulus Control
Unit (SCU)
Stimulus
Switching Unit
(SSU)
C64-OR
Amplifier
Weight Less than 2.2lb (1kg) 0.25 b (0.1 kg) -
Dimensions
•Length:
•Width:
•Height: 3in (75mm) 1in (25mm)
4.5in (115mm)
3in (76mm)
1.7in (45mm)
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 or Trigger stimulation pulses also available.
Pulse frequency 1 to 100 Hz (±10%)
Pulse duration 100 to 1000 usecs/phase
Pulse intensity 1.0 mA to 15 mA (±20% or 0.05mA, whichever is
larger). 15 mA maximum current limit at 1K load.

Nicolet Cortical Stimulator
1-10 Revised 8/27/13
Environmental considerations (operating)
Environmental considerations (non-operating)
Regulatory standards
The Nicolet Cortical Stimulator meets the following safety standards set by
domestic and international regulatory agencies for Medical Electrical Equipment.
Type BF applied device.
Temperature 15.6°C to 32.2°C (60°F to 90°F)
Relative Humidity 20% - 80% (non-condensing)
Altitude 0-3 km (0-10,000 ft)
Temperature 17.7°C to 55°C (0°F to 132°F)
Relative Humidity 10% - 90% (non-condensing)
Altitude 0-12 km (0-40,000 ft)
UL 60601-1 Medical Electrical Safety Standard (USA)
CAN/CSA-C22.2 no.
601.1-M90
Medical Electrical Safety Standard (Canada)
EN/IEC 60601-1 Medical Electrical Safety of Medical Equipment
(International and Europe)
IEC 60601-2-26 Particular safety of electroencephalographs equipment
IEC 60601-2-40 Particular safety of electromyography and evoked response
equipment
EN 60601-1-2 Collateral safety standard for EMC
CE Mark

Revised 8/27/13 1-11
General Information
Preventive maintenance
Preventive maintenance does not require access to the interior of the components
and may be performed by the user.
Preventive maintenance consists of periodically cleaning and inspecting the
exterior of the instrument as well as inspect all cables. It is recommended that
you develop a schedule for these purposes.
Inspecting the
system
Routinely check the components for exterior damage.
Periodically check the system ground integrity, the system leakage current and
the patient leakage current. Follow your medical facilities safety guidelines.
Cleaning
instructions
According to the CDC, the Cortical Stimulator is a non-critical medical device.
The proper cleaning method for non-critical medical devices permits the use of
70% isopropyl/ethyl solution.
The Nicolet Cortical Stimulator product should be cleaned by medical
professionals who are trained in techniques to prevent cross-contamination
and infection.

Nicolet Cortical Stimulator
1-12 Revised 8/27/13
Cleaning the
system
Turn OFF the system power before cleaning the instrument. Do not permit
solutions to seep into the electronic portions of the components. Take special care
around controls, connectors and panel edges. Do not use any abrasive cleaners.
The proper cleaning method for non-critical medical devices permits the use of
70% isopropyl/ethyl solution.
Remove any dust from the exterior of the components with a soft brush or cloth.
Use a brush to dislodge any dirt on or around the connectors and panel edges.
Storage
Store the Nicolet Cortical Stimulator components in a cool, dry place.