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.
April 27, 2015a
Nicolet Systems
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
bApril 27, 2015
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
Preface
Middleton, WI USA 53562
April 27, 2015c
Nicolet Systems
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 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 T
OPERATE THE EQUIPMENT
This hardware uses the FreeRTOS operating system. Go to www.freertos.org for
more information.
dApril 27, 2015
O
Safety summary
Preface
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.
April 27, 2015e
Nicolet Systems
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.
fApril 27, 2015
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.
Preface
April 27, 2015g
Nicolet Systems
Specification sheet
Inspecting the system
Recycling / disposal
Please see Specification sheet 169-438800 for information regarding technical
specifications of the EEGwireless32/64 amplifier.
Routinely check the instrument for exterior damage.
Follow your medical facilities safety guidelines.
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
hApril 27, 2015
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
DomesticInternational
Natus Neurology Incorporated
3150 Pleasant View Road
Middleton, WI USA 53562
1-800-356-0007
madison.helpdesk@natus.com
The following labels and symbols may be affixed to the Nicolet EEGwireless32/64
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 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: 608-829-8589
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.
RX Only
CAUTION: USA Federal law restricts this device to sale or on the
order of a licensed medical practitioner.
jApril 27, 2015
Table of Contents
Intended use statement........................................................................................................................... a
About the Nicolet brand system ............................................................................................................ b
CE Mark .................................................................................................................................................. b
Declaration of Conformity ..................................................................................................................... c
R & TTE Directive - Radio and Telecommunications Terminal Equipment .................................... c
FCC wireless compliance ....................................................................................................................... d
Safety summary....................................................................................................................................... e
Use with other equipment .......................................................................................................................f
Defibrillators and High Frequency surgical equipment......................................................................f
Other patient-connected equipment.................................................................................................... f
Read the Safety Reference guide ........................................................................................................... g
Fixed installation guide .......................................................................................................................... g
IT requirements ...................................................................................................................................... g
Inspecting the system..............................................................................................................................h
Recycling / disposal................................................................................................................................. h
European Authorized Representative....................................................................................................i
CE Mark ................................................................................................................................................... i
Technical support..................................................................................................................................... i
Labels and symbols..................................................................................................................................j
April 27, 20151
Nicolet Systems
Introduction
About the Nicolet EEGwireless32/64 amplifier unit .........................................................................1-3
The Nicolet EEGwireless32/64 amplifier.......................................................................................1-3
Operating system ............................................................................................................................1-3
Power source...................................................................................................................................1-4
Starting a study.....................................................................................................................................5-5
Select the amplifier for the study....................................................................................................5-5
Select a protocol..............................................................................................................................5-6
Change/View the sampling rate......................................................................................................5-6
Check the impedance ......................................................................................................................5-7
Enabling automatic impedance testing after changing the montage.............................................5-10
Edit the parameters .......................................................................................................................5-10
Display the Reader window (optional) .........................................................................................5-14
Splitting long recordings into multiple files .................................................................................5-15
Data catch up......................................................................................................................................5-16
Data catch up (disconnected less than 10 minutes) .....................................................................5-17
Data catch up (disconnected more than 10 minutes) ...................................................................5-18
Changing the sampling rate ..........................................................................................................5-19
Power LED color codes .....................................................................................................................11-4
April 27, 20155
Nicolet Systems
Frequently Asked Questions (FAQ)
Question 1: Why can't I select my amplifier from the amplifier selection screen? .....................12-3
Question 2: What happens if I try and review an exam that is incomplete?................................12-6
Question 3: How do I know if an exam has been completely downloaded by looking in NicVue?....
12-6
Question 4: Why does a single exam have multiple exam files? ....................................................12-6
Question 5: What is an "overflow error"? ......................................................................................12-7
Question 6: What if my memory card fills up and I am still recording?......................................12-7
6April 27, 2015
1Introduction
This guide describes how to operate the Nicolet EEGwireless32/64 amplifier in
conjunction with the Nicolet EEG system and software.
April 27, 20151-1
Nicolet Systems
Blank page.
1-2 April 27, 2015
About the Nicolet EEGwireless32/64 amplifier unit
The Nicolet EEGwireless32 and Nicolet EEGwireless64 amplifiers are unique
amplifiers and are referred to as Nicolet EEGwireless32/64 amplifier in this manual.
The Nicolet EEGwireless32/64 amplifier is a 32/64 channel EEG amplifier that
connects to a Nicolet Brand system via wireless transmission or a standard network
port. The Nicolet EEGwireless32/64 amplifier can be used in a hospital setting
without the addition of custom network infrastructure.
Introduction
The Nicolet
EEGwireless32/64
amplifier
• captures all signals needed to perform LTM monitoring, EEG, Sleep studies,
research, Ambulatory and ICU monitoring.
• provides low signal amplification (alternating current ‘AC’ recording) of
physiological signals, and is designed specifically to amplify EEG and intracranial
EEG signals.
• provides wired Ethernet or wireless Ethernet transmission of digitized signals,
which interfaces to a Nicolet Acquisition system.
• provides a Stand Alone Mode feature for urgent recording situations.
• provides user selectable parameters including sampling rates and filters.
• includes built in SpO2, patient event button, and provides referential, bipolar
recording.
• the amplifier is compact and lightweight with a custom garment wearable by the
patient.
Operating systemThe Nicolet EEGwireless32/64 amplifier uses FreeRTOS™ as its operating system.
For FreeRTOS™ licensing details, please visit www.freertos.org/a00114.html.
FreeRTOS™ is a trademark of Real Time Engineers Ltd.
April 27, 20151-3
Nicolet Systems
Power sourceThe Nicolet EEGwireless32/64 amplifier can derive its power from either an AC
outlet through the medical grade power supply, from one or two external battery
packs, or in the case of a fixed installation, wallplate power.
The Nicolet EEGwireless32/64 amplifier has a second power port, which allows the
addition of a second battery pack for longer recording time or a medical grade power
supply. If the medical grade power supply is plugged in while a battery is also
plugged in, the battery pack will charge.
There is an internal battery in the Nicolet EEGwireless32/64 amplifier that allows
switching the external battery pack while in the middle of a study. When the external
battery pack requires changing, it can be removed without interfering with the study
as long as it is replaced within 10 minutes of removal.
If an external battery or AC power is connected to the Nicolet EEGwireless32/64
amplifier, the internal battery will be charged.
CommunicationEEG data can be transmitted to the Nicolet acquisition system either by an Ethernet
cable or wirelessly using a recommended 802.11 b/g access point. The Nicolet
EEGwireless32/64 amplifier is IP addressable and can connect directly to a hospital
network or private LAN.
Memory cardThe Nicolet EEGwireless32/64 amplifier also provides onboard storage of EEG. The
Nicolet EEGwireless32/64 amplifier has an onboard memory card used to record
data. When the memory card reaches within 10 minutes of its capacity, the Nicolet
EEGwireless32/64 amplifier produces an audible alert.
When operating at 12 kHz Sample Rate, ensure the electrode lead cover is connected.
Also, do not wrap the Nicolet EEGwireless32/64 amplifier in a blanket or place under
a pillow.
1-4 April 27, 2015
Nicolet EEGwireless32/64 amplifier symbols and components
Power input for external batteries
or power supply
LED - Power connectivity
I
G
L
M
K
L-
M-
N
O
P
Q
N O P
T
S
Q
R
U
V
Refer to page j in this manual.
Disconnect headbox latch
Electrode leads cover
SpO2
Electrostatic sensitive
Event button input
Type BF equipment
Nicolet wirelessEEG32A
W X Y
U-
V
W
X
Y
Z
AA
AA
Z
AC
Electrode inputs (each side)
Power on/off button
LED - Wireless transmission on
Start recording button
Stop recording button
Impedance check button
LEDs - Impedance range
H-
I
J-
LED - Power connectivity
Power input for external batteries
or power supply
32 or 64 headbox
R
S
T
Trigger output (for Photic, etc.)
Trigger input
Refer to page j in this manual.
AB-
AC-
Battery door, under headbox
LEDs - Impedance check
NOTE: External power from Inputs F and I are interchangeable between two external batteries and a medical power supply.
April 27, 20151-5
Nicolet Systems
Activate the internal batteries
1. The first time the Nicolet EEGwireless32/64 amplifier is used, you must pull the
two plastic strips out from the battery compartment (Figure 1) to activate the
internal batteries for use with the Nicolet EEGwireless32/64 amplifier.
strip labeled
Pull the plastic strip labeled
2 second to guard against damaging the amplifier.
1 first and then pull the plastic
1
1
Nicolet EEGwireless32A
Figure 1
NOTE: The batteries arrive at 40%.
Contact Natus Neurology Incorporated customer service if you
believe your amplifier’s internal batteries need to be replaced.
If the amplifier is going to be stored for extended periods of time (>2
weeks) after pulling the plastic strips, it is recommended to connect the amplifier
to an AC power brick or an external battery pack so that the amplifier can be
used immediately when needed. If the amplifier will be stored on a cart that is
not powered, the amplifier needs to be connected to an external battery pack
during storage.
2
Do not transfer your amplifier’s internal batteries to another
amplifier.
1-6 April 27, 2015
Removing the electrode leads plastic cover
Nicolet wirelessEEG32A
1. Grasp the plastic cover on both sides with one hand.
2. Grasp the Nicolet EEGwireless32/64 amplifier with the other hand.
3. Carefully slide the plastic cover off the Nicolet EEGwireless32/64 amplifier
(Figure 2).
Introduction
Figure 2
April 27, 20151-7
Nicolet Systems
Separating the headbox from the Nicolet EEGwireless32/64 amplifier
1. Press downward on the release latch (Figure 1).
2. While firmly holding the Nicolet EEGwireless32/64 amplifier and headbox, pull
the headbox towards yourself.
3. Carefully lift off the Nicolet EEGwireless32/64 amplifier from the headbox.
Nicolet wirelessEEG32A
2
1
Figure 1
Headbox interchangeability
You cannot use a 64 channel headbox with a 32 channel amplifier, but you can use a
32 channel headbox with a 64 channel amplifier.
NOTE: Montage setups between 32 channel configurations and 64 channel
configurations are not interchangeable.
1-8 April 27, 2015
Electrode labels
Introduction
The electrode label has an area for writing customized electrode nomenclature. For
temporary markings, use an erasable dry marker. Use Isopropyl Alcohol to remove
the temporary markings from the labels.
Figure 1: 32 channel electrode label.
Figure 2: 64 channel electrode label.
NOTE: The two grounds are linked together in the Nicolet EEGwireless32/64
amplifier. You do not need to provide two grounds, but they are available for
redundancy. The auxiliary reference is currently disabled, but will be functional in
future releases.
Headbox dry erase
label information
• Apply the label to the back of the Headbox.
• The overlay is removable and reusable.
• Use only dry erase markers & cleaners on overlay.
• DO NOT use permanent markers.
April 27, 20151-9
Nicolet Systems
Inspecting the system
Routinely check the system for exterior damage. Periodically check the system
ground integrity, the system leakage current and the leakage current of the Nicolet
EEGwireless32/64 amplifier and accessories.
Cleaning instructions
We recommend that you consult with your hospital infection control department and
follow all appropriate policies. Routine equipment cleaning recommendations are
provided below.
Cleaning the Nicolet
EEGwireless32/64
amplifier
The Nicolet EEGwireless32/64 amplifier and accessories are classified as a
noncritical item for infection control purposes.
Do not use propanone (acetone) on any part of the equipment. No part of the system
may be autoclaved or sterilized by any means. According to the CDC, the proper
cleaning method for non-critical medical devices includes the following:
• A456-N
• A428-N
• Cavacide
• 3MQuat
• 70% isopropyl alcohol.
1-10 April 27, 2015
Introduction
Cleaning the system Turn OFF the system power before cleaning the instrument. Do not permit solutions
or cleaning agents to seep into the electronic portions of the system. Take special care
around controls, connectors and panel edges. Do not use any abrasive cleaners.
Remove any dust from the exterior of the system with a soft brush or clean cloth. Use
a brush to dislodge any dirt on or around the connectors and panel edges. Remove
stubborn dirt with a clean soft cloth slightly dampened with a mild detergent (soap)
or low level disinfectant detergent solution. Allow the items to air dry before next
use.
Use of detergent-disinfectants on skin may cause adverse reactions; therefore, gloves
are recommended when cleaning with these products.
Cleaning the monitor
screen
When the monitor is on, the screen has a slight static charge, which attracts dust. To
remove any dust accumulation, wipe the display screen with a soft brush or lint-free
cloth. You may use an antistatic spray on the screen to reduce static buildup.
April 27, 20151-11
Nicolet Systems
Cleaning the
keyboard
Cleaning the
garment
Cleaning recording
equipment and
supplies after
contact with Jacob
Creutzfeld disease
Disinfect computer keyboards daily, when visibly soiled, or when they become
contaminated with blood. Quaternary ammonium-containing disinfectants may be
used on keyboard (Rutala et al. 2006).
Before using the disinfecting agent, perform a test on only one key
or on an old keyboard to guard against possible bleaching or discoloration of the
keys.
If a keyboard cover is used, Rutala et al. (2006) recommends it be disinfected daily.
We recommend that mobile computers used by patients be disinfected before the next
patient uses it.
Wash contaminated garments with laundry detergent and hot water or with a phenolic
household detergent. The garment should be washed and rinsed a second time without
the phenolic.
Air dry the garment only.
Ancillary electroneurodiagnostic supplies and equipment such as
cables, marking pencil, and recording instrument should be wiped down with
undiluted bleach or a 1 N sodium hydroxide solution (Airman 2000). If items
cannot be disinfected in this manner, they should be disposed of and not reused.
We recommend that you follow your internal infection control policies.
1-12 April 27, 2015
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