natus Nicolet EEGwireless32 User manual
Nicolet™EEGwireless32/64 Amplifier
User Guide
April 27, 2015
Part Number 269-641500 Rev 07
Nicolet EEGwireless32/64 Amplifier User Guide
© 2013 - 2015 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.
April 27, 2015 a
Preface
Intended use statement
The device is intended to be used as a front end Nicolet EEGwireless32/64
amplifier with the Nicolet Neurodiagnostic system to record, measure, store,
analyze and display cerebral and extracerebral physiologic data for EEG and
Sleep studies with or without synchronous digital video. This data includes but is
not limited to EEG, EOG, EMG, ECG, respiration, body position, snore, heart
rate, oxygen saturation and other physiologic signals. All ages of patients are
served, including infants either within a medical facility or outside a medical
facility. It is intended for use only under the supervision of medically trained and
qualified professionals who will use all available information to aid in the
diagnosis of Sleep, Epilepsy and other related disorders. While the Nicolet
Neurodiagnostic systems are capable of displaying signals, such as Sp02 and
ECG, the system is NOT intended for monitoring such signals for the
preservation of life.
Nicolet Systems
bApril 27, 2015
Copyright
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.
www.natus.com
Natus Neurology Incorporated
3150 Pleasant View Road
Middleton, WI 53562-3530
USA
About the Nicolet brand system
The range of Multimedia EEG Nicolet brand systems have been designed and
manufactured by Natus Neurology Incorporated, which has always had an
enviable reputation for innovation and quality of its products.
CE Mark
Compliant to Medical Device Directive 93/42/EEC
April 27, 2015 c
Preface
Declaration of Conformity
R & TTE Directive - Radio and Telecommunications Terminal Equipment
Hereby, Natus Neurology Incorporated declares that the Nicolet EEGwireless32/
64 amplifier, it’s derivatives, and its accessories are in compliance with the
essential requirements and the other relevant provisions of Directive 1999/5/EC.
[The following signed (and translated) declaration of conformity]:
We, Natus Neurology Incorporated, at 3150 Pleasant View Road, Middleton, WI,
USA, declare under our own responsibility that the Nicolet EEGwireless32/64
amplifier to which this declaration refers conforms with the relevant standards or
other standardizing documents of EN 50371:2002 according to regulations in
Directive 1999/5/EC.
Dan Lombardi, 11 Oct 2010
Director of Hardware Development and Intellectual Property
Middleton, WI USA 53562
Nicolet Systems
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FCC wireless compliance
FCC Identifier:
Name of Grantee:
Equipment Class:
FCC Rule Parts:
XGU-515-015X00A
Natus Neurology Incorporated
Digital transmission system
15C
Frequency Range (MHz): 2412.0 - 2462.0
Transmission Power Levels:
NOTE: The Nicolet EEGwireless32/64 amplifier is approved for body worn
application. With transmitter enabled, the maximum spatial peak SAR
(Specific Absorption Rate) valueis 0.0154 W/kg.
This hardware uses the FreeRTOS operating system. Go to www.freertos.org for
more information.
THIS DEVICE COMPLIES WITH PART 15 OF THE FCC RULES. OPERATION IS
SUBJECT TO THE FOLLOWING TWO CONDITIONS: (1) THIS DEVICE MAY NOT
CAUSE HARMFUL INTERFERENCE, AND (2) THIS DEVICE MUST ACCEPT ANY
INTERFERENCE RECEIVED, INCLUDING INTERFERENCE THAT MAY CAUSE
UNDESIRED OPERATION.
THE MANUFACTURER IS NOT RESPONSIBLE FOR ANY RADIO OR TV
INTERFERENCE CAUSED BY UNAUTHORIZED MODIFICATIONS TO THIS
EQUIPMENT. SUCH MODIFICATIONS COULD VOID THE USER’S AUTHORITY TO
OPERATE THE EQUIPMENT
April 27, 2015 e
Preface
Safety summary
In this manual, two labels identify potentially dangerous or destructive
conditions and procedures:
The WARNING label identifies conditions or practices that may present danger
to the patient and/or user.
The CAUTION label identifies conditions or practices that could result in
damage to the equipment.
NOTE: Notes help you identify areas of possible confusion and avoid potential
problems during system operation.
Do NOT use cables with unattended and unsupervised children.
Do NOT wrap cables around your neck.
Keep batteries away from children.
Conductive parts or electrodes and their connectors, including the neutral
electrode for type BF or cf electroencephalographs are not to contact other
conductive parts and earth ground.
Do NOT use outside of the published specification ranges. Use of device
outside of the specified ranges may result in inaccurate results.
Do not wrap the Nicolet EEGwireless amplifier in blankets or place under
pillows during use.
Nicolet Systems
fApril 27, 2015
Use with other equipment
Defibrillators and High Frequency surgical equipment
The amplifier is not defibrillator proof. The system must be
disconnected from the patient prior to defibrillation.
MRI equipment
The Nicolet EEGwireless32/64 amplifier or patient electrodes
are not to be worn by a patient during an MRI study.
Other patient-connected equipment
When used simultaneously with other patient-connected
equipment, for example, a cardiac pacemaker or other electrical stimulator,
it is unlikely that a safety hazard will arise. However, always consult the
documentation supplied with the other patient-connected equipment to
ensure all hazards, warnings and cautions are considered before the
equipment is used with the amplifier.
It should be noted that other electrical stimulators can cause noise in the
EEG data.
April 27, 2015 g
Preface
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
thoroughly, paying special attention to the Safety information before applying
power to and using your Nicolet Brand system.
Fixed installation guide
Please see the Fixed Installation guide Section 3 - 269-620300 and Section 5 -
269-620500 for installation information.
IT requirements
Please see the Site IT Requirements document 269-644000 for information on
wired and wireless networking specifications for operation of the Nicolet
EEGwireless32/64 amplifier.
Nicolet Systems
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Specification sheet
Please see Specification sheet 169-438800 for information regarding technical
specifications of the EEGwireless32/64 amplifier.
Inspecting the system
Routinely check the instrument for exterior damage.
Follow your medical facilities safety guidelines.
Recycling / disposal
Many local laws and regulations consider electric equipment-related waste
as hazardous or requiring special procedures to recycle or dispose of. This
includes batteries, printed circuit boards, electronic components, wiring and
other elements of electronic devices. Follow all of your respective local laws
and regulations for the proper disposal of batteries and any other parts of
your system, such as monitors, amplifiers, keyboards, electrodes, etc.D
Refer to the natus.com website for recommended instructions and addresses
for proper return or disposal of electronic wastes relating to Natus
Neurology Incorporated products in Europe and other localities.
The contact information for the Waste Electrical and Electronic
Equipment (WEEE) - In Europe
European authority representative
Natus Europe GmbH
Robert-Koch-Str. 1
82152 Planegg
Germany
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