natus Nicolet V Series Specification sheet

Nicolet Systems
Nicolet™ V Series Amplifier
Information For Use
August 11, 2016
018964 Rev 01
Nicolet V Series Amplifier Information For Use Guide
© 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.

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Table of Contents
Introduction
Intended use.................................................................................................................................................1-3
Intended readers..........................................................................................................................................1-3
Important.....................................................................................................................................................1-3
Manufacturer..............................................................................................................................................1-4
Natus EU Authorized Representative .......................................................................................................1-4
CE mark.......................................................................................................................................................1-4
Technical support ........................................................................................................................................1-4
Regulatory notices.......................................................................................................................................1-5
Equipment classifications..........................................................................................................................1-5
Safety Summary ..........................................................................................................................................1-6
Warnings ......................................................................................................................................................1-7
Additional Warnings and EMC information............................................................................................1-9
Read the safety reference guide.................................................................................................................1-9
Electromagnetic Compatibility (EMC) .....................................................................................................1-9
Labels and symbols ...................................................................................................................................1-10
Copyright ................................................................................................................................................... 1-11
Product Description
Product description.....................................................................................................................................2-3
Functional components...............................................................................................................................2-4
Amplifiers..................................................................................................................................................2-5
Headboxes .................................................................................................................................................2-7
PSU-v32 power supply..............................................................................................................................2-9
Installation
Locating the system.....................................................................................................................................3-3
Warnings ......................................................................................................................................................3-4
Electric shock hazard.................................................................................................................................3-4
Explosion hazard .......................................................................................................................................3-4
Patient safety .............................................................................................................................................3-5
Installation ...................................................................................................................................................3-6
Cabling ......................................................................................................................................................3-6
Isolation transformer .................................................................................................................................3-6
Network interface card ..............................................................................................................................3-6
PSU-v32 power supply..............................................................................................................................3-6
v32/v44 amplifier ......................................................................................................................................3-7
Headbox.....................................................................................................................................................3-7
Summary of v32/v44 amplifier functions..................................................................................................3-8

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Cabling diagrams ........................................................................................................................................3-9
v32 EEG amplifier system.........................................................................................................................3-9
v44 sleep amplifier system #1 .................................................................................................................3-10
v32 or v44 sleep amplifier system #2 ......................................................................................................3-12
Set up the host computer ..........................................................................................................................3-13
Configure the NicoletOne software .........................................................................................................3-13
V-Series IP address setup.........................................................................................................................3-14
NetWork Interface Card (NIC) IP address setup .....................................................................................3-15
Operation
Introduction .................................................................................................................................................4-3
Patient safety..............................................................................................................................................4-3
Controls ........................................................................................................................................................4-4
Indicators .....................................................................................................................................................4-5
Calibration ...................................................................................................................................................4-6
Event pushbutton ........................................................................................................................................4-6
Photic stimulation........................................................................................................................................4-6
Maintenance
Maintenance.................................................................................................................................................5-3
Cleaning.....................................................................................................................................................5-3
Storage and transportation .........................................................................................................................5-4
End-of-life disposal ...................................................................................................................................5-4
Calibration .................................................................................................................................................5-4

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1Introduction

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August 11, 2016 1-3
Introduction
Intended use
The intended use of the NicoletOne System V32 Amplifier with Oximetry is:
The NicoletOne System V32 Amplifier is a stand alone electroencephalography
(EEG) amplifier for the recording of electrical signals from the brain. An
optional feature of pulse oximetry (Sp02) is available.
Intended readers
The Nicolet V Series amplifiers facilitate the recording, review, and reporting of
electroneurophysiological data. This manual has been produced for those
experienced in this field – technologists, physicians, administrative staff, nurses
who will be using this application. As 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®.
Important
This manual is subject to periodic review, update, and revision. Customers are
cautioned to verify that the manual’s information applies to the product software
and hardware present in the equipment before using the product.
This product is intended to perform as described in this manual, and in
accompanying labels and/or inserts, when assembled, operated, maintained, and
repaired in accordance with the instructions provided.

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Manufacturer
Natus Neurology Incorporated
3150 Pleasant View Road
Middleton, WI USA 53562
608-829-8500
1 800-356-0007
Fax: [phone]
www.natus.com
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
madison.helpde[email protected]
www.Natus.com
Natus Neurology Incorporated
Phone: [phone]
Fax: [phone]
[email protected]
www.Natus.com

August 11, 2016 1-5
Introduction
Regulatory notices
This device has been designed and certified to comply with the requirements of
the international standard IEC 60601-1, IEC 60601-1-1, IEC 60601-1-2, IEC
60601-1-4, IEC 60601-1-6, IEC 60601-2-26 the United States standard
UL60601-1, and the Canadian standard CAN/CSA22.2 No.601.1.
The device is classified: CLASS IIA, Type BF
100-250 VAC, 50/60 Hz, 80 VA
The above classification is based on the condition that this device is installed and
configured according to the instructions supplied. In order for the complete
system to maintain compliance with the relevant standards, the host computer
must be approved to the Nationally Recognized Testing Laboratory IEC60950-1
2nd Edition standard.
Equipment classifications
Shock Prevention: Class 1
Degree of Protection Against Harmful Ingress of Water: Ordinary
Equipment, IPX0
Degree of Safety in the Presence of Flammable Anesthetic Mixture with Air
or with Oxygen or Nitrous Oxide: Equipment not suitable for use in the
presence of a flammable anesthetic mixture with air, oxygen, or nitrous oxide.
Mode of Operation: Continuous
Federal law restricts this device to sale by or on the order of
a licensed physician.

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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 V Series Amplifier operation.
IMPORTANT: Read and follow all WARNINGS, CAUTIONS and NOTES
provided in the Additional Information and Safety Notes for Assorted Natus
Neurology Incorporated Products Reference Guide 269-594705 on CD part
number 482-638702. To avoid the possibility of injury, damage to your
system components or lost data, always observe these safety precautions
during operation.

August 11, 2016 1-7
Introduction
Warnings
The following is an overview of Warnings pertaining to the V Series Amplifier.
Additional Warnings and Cautions are located in the various sections of this User
guide. Please read and understand the information in this User guide and any
accompanying documentation thoroughly before using the V Series Amplifier.
Disconnect all power sources from all system components before servicing.
Conductive parts of electrodes and their connectors are not to contact other
conductive parts and earth.
The V Series Amplifier is NOT intended for use with High Frequency
Surgical Equipment.
To avoid possible safety hazards caused by the summation of leakage
currents when several system components are interconnected, other
equipment connected to the V Series Amplifier should be powered by the
isolation transformer.
Connecting other medical equipment, such as a cardiac pacemaker or other
electrical stimulators, simultaneously to the same patient may constitute a
safety hazard. The V Series Amplifier is not defibrillator proof. The
Headbox and amplifier (electrode input device) should be disconnected
before using a defibrillator.
If repair or replacement becomes necessary, call or write to request service
advice from Natus Neurology.

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This product must be cleaned and checked periodically. Do not use a
defective product. Parts that are broken, missing, worn, or contaminated
should be replaced immediately.
This product must not be altered without the prior written approval of
Natus Neurology. The user of this product shall have the sole responsibility
for any malfunction that results from improper use, faulty maintenance,
improper repair, unauthorized service, or alteration by anyone other than
Natus Neurology.
The safety, reliability, and performance of this device can only be assured
under the following conditions:
•If the device has been used according to the accompanying operating
instructions.
•If changes or repairs have been carried out by Natus Neurology
Incorporated.
•If it is used in buildings having ground equalization wiring that
complies with relevant UL, CSA, IEC or other local standards and
regulations.

August 11, 2016 1-9
Introduction
Additional Warnings and EMC information
Read the safety reference guide
Please read the Additional Information and Safety Notes for Assorted Nicolet
Brand Products Reference Guide 269-594705 on CD part number 482-638702
furnished with your Nicolet system thoroughly, paying special attention to the
Safety information before applying power to and using your V Series Amplifier.
Electromagnetic Compatibility (EMC)
Please refer to the Electromagnetic Compatibility Reference Guide 269-596201
on CD part number 482-638702 furnished with your Nicolet V Series Amplifier
for information concerning your Nicolet system.

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Labels and symbols
The following labels and symbols may be affixed to the system:
When applied on device: Attention: Consult Accompanying Documentation. (ISO 7000-0434A)
When used in documentation: Caution, Warning or Precaution follows.
Consult Operating Instructions. Failure to follow operating instructions could place the patient or oper-
ator at risk. Image on blue background. (ISO 7010 M002)
Consult Operating Instructions. (ISO
7000-1641)
Protective earth
European Authorized Representative. Alternating current
Manufacturer. On (only for a part of the equipment)
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.
Off (only for a part of the equipment)
CE Mark and Notified Body.
(Compliant to Neurology Device Direc-
tive 93/42/EEC)
Dangerous voltage
Type BF equipment. 
(Isolated inputs)
Equipotentiality
Direct current RX Only CAUTION: USA Federal law restricts
this device to sale or on the order of a
licensed Neurology practitioner.

August 11, 2016 1-11
Introduction
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.
Printed in the United States of America

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8/11/16 2-1
2Product Description

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8/11/16 2-3
Product Description
Product description
The V-Series systems are designed specifically for the EEG and PSG monitoring lab.
These systems feature the v32 or v44 amplifier with headbox and Natus software. The V-
Series amplifiers are compact AC amplifier units with up to 32 (v32) or 44 (v44) channels
for EEG and PSG recording applications. The easy to use Natus software provides data
acquisition, recording and review capabilities in one flexible package.
NOTE: Styles/models shown below may vary.
v32 amplifier v44 amplifier
HB-3 headbox. HB-4/V44 Headcap headbox. HB-5 headbox.
PSU-v32 power supply LED photic stimulator and
power supply
Lamp photic stimulator
and power supply
Patient event button
Photic swivel arm NONIN pulse oximeter
NONIN XPOD and Sensor
OR

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Functional components
The amplifier systems consist of the following main functional components.
Main component description Used with:
v32 v44
HB-3 clinical headbox x -
HB-4 clinical non-OR headbox with impedance check display, no headcap
adapter
-x
HB-5 OR headbox - x
V44 clinical, non-OR headbox, impedance check display with headcap
adapter
-x
PSU-32 Medical-grade power supply xx
Optional LED photic stimulator and power supply xx
Optional Lamp photic stimulator and power supply xx
Nonin XPOD with sensor x -
Nonin sensor only - x
Optional isolated patient event button xx