Nihon Kohden ZR-101AA, ZB-101AA User Manual
OPERATOR’S MANUAL
WIRELESS INPUT UNIT
WEE-1000A
CONTENTS
Contents
GENERAL HANDLING PRECAUTIONS ....................................................................... i
WARRANTY POLICY ................................................................................................... ii
FCC Part 15 Subpart B Class B .................................................................................. iii
EMC RLATED CAUTION ..............................................................................................v
Conventions Used in this Manual and Instrument........................................................ vi
Dangers, Warnings, Cautions and Notes ........................................................... vi
Precautions for Input Jack Use ................................................................................... vii
Section 1 General ...................................................................................1C.1
Introduction ......................................................................................................................... 1.1
Composition ........................................................................................................................ 1.4
General Safety information ................................................................................................. 1.5
Panel Descriptions ............................................................................................................ 1.15
ZB-101AA Telemetry Unit ....................................................................................... 1.15
ZR-101AA Access Point ......................................................................................... 1.17
JE-011A/JE-012A Electrode Junction Box.............................................................. 1.18
SC-101A Isolator .................................................................................................... 1.19
Section 2 Installation/Preparation .........................................................2C.1
System Location ................................................................................................................. 2.1
Installation Flowchart .......................................................................................................... 2.3
Installing the Access point .................................................................................................. 2.4
Attaching the Access Point to the Wall ...................................................................... 2.5
Attaching the Access Point to the Rack .................................................................... 2.5
Cable Connection ............................................................................................................... 2.6
Connecting the Access point and Electroencephalograph........................................ 2.6
Connecting the Power Cord ................................................................................................ 2.7
Connecting the Power Cord ...................................................................................... 2.7
Equipotential Grounding ........................................................................................... 2.7
Upgrading the EEG System Program ................................................................................. 2.8
Preparing the Telemetry Unit .............................................................................................. 2.9
General ..................................................................................................................... 2.9
Using a Battery ......................................................................................................... 2.9
Inserting the Battery ............................................................................................... 2.11
Charging the Lithium-ion Rechargeable Battery ........................................... 2.12
Remaining Battery Power ............................................................................. 2.13
Connecting the Telemetry unit to the Access point with the Isolator ....................... 2.14
Power On/Off Procedure .................................................................................................. 2.15
Power On Procedure .............................................................................................. 2.15
Power Off Procedure .............................................................................................. 2.17
General Requirements for Connecting in Medical Electrical Systems .............................. 2.18
Operator's Manual WEE-1000 C.1
CONTENTS
Section 3 EEG/PSG Measurement.........................................................3C.1
General ............................................................................................................................... 3.1
EEG Waveform Acquisition ....................................................................................... 3.4
About Polysomnography ........................................................................................... 3.4
Flowchart of Waveform Measurement ...................................................................... 3.5
Attaching the Electrodes (EEG Measurement) ................................................................... 3.6
Guidelines for Input Jack Use ................................................................................... 3.6
Required Electrodes ....................................................................................... 3.6
Input Jack Z .................................................................................................... 3.6
Input Jacks C3 and C4 ................................................................................... 3.6
Input Jacks A1 and A2 .................................................................................... 3.6
Checking Original Electrode Potentials for All Active Electrodes .................... 3.6
Introduction to Electrode Position, Derivation and Montage ..................................... 3.7
Electrode Position ........................................................................................... 3.7
Derivation ....................................................................................................... 3.7
Monopolar Derivations (Referential Derivation) .............................................. 3.7
Bipolar Derivation ........................................................................................... 3.8
Montage (Pattern) ........................................................................................... 3.8
Attaching the Electrodes to the Patient ..................................................................... 3.9
EEG Scalp Disk Electrodes .......................................................................... 3.10
Electrode Positions ....................................................................................... 3.10
Earlobe Electrodes ....................................................................................... 3.11
Attaching the Electrodes and Sensors (PSG Measurement) ............................................ 3.12
Measurement Parameters and Attachment Sites ................................................... 3.12
Electroencephalogram (EEG) ....................................................................... 3.12
Electrooculogram (EOG) .............................................................................. 3.12
Electromyogram (EMG) ................................................................................ 3.12
Electrocardiogram (ECG) ............................................................................. 3.12
Attaching the Electrode ................................................................................ 3.13
Respiration (Airflow, Chest, Abdomen) ......................................................... 3.15
Snore ............................................................................................................ 3.16
Body Position ................................................................................................ 3.16
Periodic Limb Movements (PLM) .................................................................. 3.16
Oxygen Saturation (SpO2) ............................................................................ 3.17
Connecting the Electrodes and Sensors to the Electrode Junction Box ........................... 3.19
EEG Measurement ................................................................................................. 3.20
PSG Measurement ................................................................................................. 3.20
Attaching the Telemetry Unit to the Patient ............................................................. 3.21
Changing the Measurement Settings ................................................................................ 3.22
Measuring Waveforms ...................................................................................................... 3.23
C.2 Operator's Manual WEE-1000
GENERAL HANDLING PRECAUTIONS
This device is intended for use only by qualified medical personnel.
Use only Nihon Kohden approved products with this device. Use of non-approved products or
in a non-approved manner may affect the performance specifications of the device. This
includes, but is not limited to, batteries, recording paper, pens, extension cables, electrode
leads, input boxes and AC power.
Please read these precautions thoroughly before attempting to operate the instrument.
1. To safely and effectively use the instrument, its operation must be fully understood.
2. When installing or storing the instrument, take the following precautions:
(1) Avoid moisture or contact with water, dust, extreme atmospheric pressure, excessive humidity and temperatures,
poorly ventilated areas, and saline or sulphuric air.
(2) Place the instrument on an even, level floor. Avoid vibration and mechanical shock, even during transport.
(3) Avoid placing in an area where chemicals are stored or where there is danger of gas leakage.
(4) The power line source to be applied to the instrument must correspond in frequency and voltage to product
specifications, and have sufficient current capacity.
(5) Choose a room where a proper grounding facility is available.
3. Before Operation
(1) Check that the instrument is in perfect operating order.
(2) Check that the instrument is grounded properly.
(3) Check that all cords are connected properly.
(4) Pay extra attention when the instrument is in combination with other instruments to avoid misdiagnosis or other
problems.
(5) All circuitry used for direct patient connection must be doubly checked.
(6) Check that battery level is acceptable and battery condition is good when using battery-operated models.
4. During Operation
(1) Both the instrument and the patient must receive continual, careful attention.
(2) Turn power off or remove electrodes and/or transducers when necessary to assure the patient’s safety.
(3) Avoid direct contact between the instrument housing and the patient.
5. To Shutdown After Use
(1) Turn power off with all controls returned to their original positions.
(2) Remove the cords gently; do not use force to remove them.
(3) Clean the instrument together with all accessories for their next use.
6. The instrument must receive expert, professional attention for maintenance and repairs. When the instrument is
not functioning properly, it should be clearly marked to avoid operation while it is out of order.
7. The instrument must not be altered or modified in any way.
8. Maintenance and Inspection:
(1) The instrument and parts must undergo regular maintenance inspection at least every 6 months.
(2) If stored for extended periods without being used, make sure prior to operation that the instrument is in perfect
operating condition.
Operator's Manual WEE-1000 i
(3) Technical information such as parts list, descriptions, calibration instructions or other information is available for
qualified user technical personnel upon request from your Nihon Kohden distributor.
9. When the instrument is used with an electrosurgical instrument, pay careful attention to the application and/or
location of electrodes and/or transducers to avoid possible burn to the patient.
10. When the instrument is used with a defibrillator, make sure that the instrument is protected against defibrillator
discharge. If not, remove patient cables and/or transducers from the instrument to avoid possible damage.
WARRANTY POLICY
Nihon Kohden Corporation (NKC) shall warrant its products against all defects in materials and workmanship for one year
from the date of delivery. However, consumable materials such as recording paper, ink, stylus and battery are excluded from
the warranty.
NKC or its authorized agents will repair or replace any products which prove to be defective during the warranty period,
provided these products are used as prescribed by the operating instructions given in the operator’s and service manuals.
No other party is authorized to make any warranty or assume liability for NKC’s products. NKC will not recognize any other
warranty, either implied or in writing. In addition, service, technical modification or any other product change performed by
someone other than NKC or its authorized agents without prior consent of NKC may be cause for voiding this warranty.
Defective products or parts must be returned to NKC or its authorized agents, along with an explanation of the failure.
Shipping costs must be pre-paid.
This warranty does not apply to products that have been modified, disassembled, reinstalled or repaired without Nihon
Kohden approval or which have been subjected to neglect or accident, damage due to accident, fire, lightning, vandalism,
water or other casualty, improper installation or application, or on which the original identification marks have been
removed.
In the USA and Canada other warranty policies may apply.
CAUTION
United States law restricts this device to sale by or on the order of a physician.
ii Operator's Manual WEE-1000
FCC Part 15 Subpart B Class B
NOTICE
This equipment has been tested and found to comply with the limits for a Class B digital device,
pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference in a residential installation.
This equipment generates, uses and can radiate radio frequency energy and, if not installed and used
in accordance with the instructions, may cause harmful interference to radio communications.
However, there is no guarantee that interference will not occur in a particular installation. If this
equipment does cause harmful interference to radio or television reception, which can be determined
by turning the equipment off and on, the user is encouraged to try to correct the interference by one or
more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and the receiver.
• Connect the equipment into an outlet on a circuit different from that to which the receiver is
connected.
• Consult the dealer or an experienced radio/TV technician for help.
FCC WARNING
Changes or modifications not expressly approved by the party responsible for compliance could void
the user’s authority to operate the equipment.
Properly shielded an grounded cables and connectors must be used for connection to host computer and/or
peripherals in order to meet FCC emission limits.
Operator's Manual WEE-1000 iii
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.
FCC Radiation Exposure Statement
Telemetry Unit (ZB-101AA):
The available scientific evidence does not show that any health problems are
associated with using low power wireless devices. There is no proof, however, that
these low power wireless devices are absolutely safe. Low power Wireless devices
emit low levels of radio frequency energy (RF) in the microwave range while being
used. Whereas high levels of RF can produce health effects (by heating tissue),
exposure to low level RF that does not produce heating effects causes no known
adverse health effects. Many studies of low level RF exposures have not found any
biological effects. Some studies have suggested that some biological effects
might occur, but such findings have not been confirmed by additional research.
The Telemetry Unit (ZB-101AA) has been tested and found to comply with the
Federal Communications Commission (FCC) guidelines on radio frequency energy
(RF) exposures. The maximum SAR levels tested for the Telemetry Unit (ZB-101AA)
has been shown to be 0.736 W/kg at Body.
Use of other installation may not ensure compliance with FCC RF exposure
guidelines.
Access Point (ZR-101AA):
CAUTION
This equipment complies with FCC radiation exposure limits set forth for an
uncontrolled environment.
This equipment should be installed and operated with minimum distance 20cm
between the radiator and body (excluding extremities: hands, wrists and feet)
and must not be co-located or operated with any antenna or transmitter.
iv Operator's Manual WEE-1000
EMC RELATED CAUTION
This equipment and/or system complies with the International Standard IEC 60601-1-2 for electromagnetic
compatibility for medical electrical equipment and/or system. However, an electromagnetic environment
that exceeds the limits or levels stipulated in the IEC 60601-1-2, can cause harmful interference to the
equipment and/or system or cause the equipment and/or system to fail to perform its intended function or
degrade its intended performance. Therefore, during the operation of the equipment and/or system, if
there is any undesired deviation from its intended operational performance, you must avoid, identify and
resolve the adverse electromagnetic effect before continuing to use the equipment and/or system.
The following describes some common interference sources and remedial actions:
1.Strong electromagnetic interference from a nearby emitter source such as an authorized radio station or
cellular phone:
Install the equipment and/or system at another location if it is interfered with by an emitter source such
as an authorized radio station. Keep the emitter source such as cellular phone away from the equipment
and/or system.
2.Radio-frequency interference from other equipment through the AC power supply of the equipment and/
or system:
Identify the cause of this interference and if possible remove this interference source. If this is not
possible, use a different power supply.
3.Effect of direct or indirect electrostatic discharge:
Make sure all users and patients in contact with the equipment and/or system are free from direct or
indirect electrostatic energy before using it.
4.Electromagnetic interference with any radio wave receiver such as radio or television:
If the equipment and/or system interferes with any radio wave receiver, locate the equipment and/or
system as far as possible from the radio wave receiver.
If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden
Corporation subsidiary or distributor for additional suggestions.
Operator's Manual WEE-1000 v
Conventions Used in this Manual and Instrument
Dangers, Warnings, Cautions and Notes
Warnings, cautions and notes are used in this manual to alert or signal the reader to specific information.
DANGER
A danger is used to alert the user to a hazardous situation which will cause death or serious injury.
WARNING
A warning alerts the user to possible injury or death associated with the use or misuse of the instrument.
CAUTION
A caution alerts the user to possible injury or problems with the instrument associated with its use or
misuse such as instrument malfunction, instrument failure, damage to the instrument, or damage to other
property.
NOTE
A note provides specific information, in the form of recommendations, prerequirements, alternative
methods or supplemental information.
vi Operator's Manual WEE-1000
Precautions for Input Jack Use
NOTE
Do not perform EEG measurement without the Z, C3, C4, A1 and A2 electrodes.
Use of input jack Z
Connect the lead from the electrode (Z electrode) attached on the patient’s nasion to the input jack Z on the electrode
junction box. The purpose of this input jack is to eliminate AC interference positively.
NOTE
The input jack Z is also used for checking electrode impedance.
Use of input jacks C3 and C4
Connect the leads from the electrodes attached on the positions C3 and C4 to the input jacks C3 and C4 respectively.
NOTE
• The C3 and C4 electrodes are the system reference electrodes for EEG measurement.
• The input jacks C3 and C4 must be attached for EEG measurement even when the C3 and C4 are not
programmed in any montage.
Use of input jacks A1 and A2, C3 and C4 during skin-electrode impedance check
When checking each electrode impedance, connect the leads from the electrode attached on the positions A1, A2, C3
and C4 to the input jacks A1, A2, C3 and C4 respectively.
NOTE
• The A1 and A2 electrodes are the reference electrodes for skin-electrode impedance check.
• The input jacks A1 and A2 in addition to the Z, C3 and C4 must be attached for the electrode impedance
check.
Checking electrode potentials for all active electrodes
Check the original electrode potential for all active electrodes by programming a montage with the system reference
electrode (Use the pattern VA (factory default setting) or select the 0 V button for reference electrode on the Montage
dialog box). Refer to “Programming Patterns” in Section 4 of the operator’s manual of the electroencephalograph.
The digital EEG displays the EEG waveform in each channel by subtracting two electrode potentials selected to a
montage. The subtracted result will be incorrect, if the electrode attachment is not correct, the original electrode
potential is flat or unstable, or artifact is superimposed on the original electrode potential. Omit the measurement result
if the displayed EEG waveform is incorrect.
Operator's Manual WEE-1000 vii
Section 1 General
Introduction ......................................................................................................................... 1.1
Composition ........................................................................................................................ 1.4
General Safety information .................................................................................................. 1.5
Panel Descriptions............................................................................................................. 1.15
ZB-101AA Telemetry Unit ........................................................................................ 1.15
ZR-101AA Access Point.......................................................................................... 1.17
JE-011A/JE-012A Electrode Junction Box ..............................................................1.18
SC-101A Isolator .....................................................................................................1.19
Operator's Manual WEE-1000 1C.1
Introduction
1. GENERAL
The WEE-1000A Wireless Input Unit lets you compose a wireless EEG/PSG
measuring system with an EEG-1100/9100/9200 Series Electroencephalograph.
The wireless input unit consists of an electrode junction box, telemetry unit,
access point and isolator. The telemetry unit measures EEG waveforms, ECG
waveforms, EMG waveforms, respiration waveforms, SpO2 and other parameters
and transmits them to the access point by wireless transmission (IEEE 802.11b
compliant) or by cable transmission through the isolator. The access point is
connected to the electroencephalograph by LAN. The electroencephalograph
displays and saves the measurement data.
Features
• Compact and lightweight electrode junction box/telemetry unit
The telemetry unit can be worn by the patient in a pochette and electrode
junction box is contained in the shoulder strap so that the patient is free from an
electroencephalograph and examination room.
• Up to 32 channels of waveforms can be measured.
JE-011A Electrode Junction Box and ZB-101AA Telemetry Unit:
30 channels of EEG waveforms or 22 channels of EEG waveforms, 8 channels of
bipolar signals and 2 channels of DC input signals
• SpO2 measurement
An optional SpO2 probe can directly be connected to the telemetry unit with the
JL-101A SpO2 Adapter (option).
• JE-012A Electrode Junction Box for polysomnogram (PSG) measurement
• Battery operation
The telemetry unit can operate on battery power for 24 hours or more on a
lithium-ion rechargeable battery.
• Backup of transmitted data
The transmitted data is backed up in the telemetry unit to guard against
accidental signal loss
• Communication with the Electroencephalograph
The access point communicates with the electroencephalograph through LAN
(10/100Base T). The measurement data from the telemetry unit can be
transferred to a distant electroencephalograph by LAN.
• Direct connection with the SC-101A Isolator.
The telemetry unit can also be directly connected to the access point with an
SC-101A Isolator. The isolator is useful when there is a lot of radio frequency
interference or to save battery power when the patient is sleeping. DC power is
supplied to the telemetry unit from the access point through the isolator.
Operator's Manual WEE-1000 1.1
1. GENERAL
• Easy skin-electrode contact impedance check
The skin-electrode contact impedance check can be performed on both the
telemetry unit and electroencephalograph. The impedance check result is
displayed on the LCD display on the telemetry unit or on the screen on the
electroencephalograph.
• LCD display
The LCD display on the telemetry unit displays the operation status,
communication status and remaining battery power.
• Pochette
The pochette contains the telemetry unit, electrode junction box and isolator for
stable measurement. It reduces the patient burden and during measurement, the
patient can freely move around while wearing the telemetry unit.
NOTE
Use only Nihon Kohden recommended parts and accessories to assure
maximum performance from your instrument.
Trademark
Windows is a registered trade mark of Microsoft Corporation.
1.2 Operator's Manual WEE-1000
1. GENERAL
Frequency Band and Channels
The WEE-1000A Wireless Input Unit is a radio wave transmission method used in
small wireless devices such as a PHS or cellular telephone. It uses the 2.4 GHz
radio frequency band and transmits data up to 11 Mbps. This band is
internationally assigned for wireless LAN IEEE 802.11b standard. The frequency
band is divided into 11 channels every 5 MHz. Each channel uses about 22 MHz
frequency bandwidth. However, all channels cannot be used at the same time
because overlapping channels interfere each other.
Channel 5
(2.432)
Channel 4
(2.427)
Channel 3
(2.422)
Channel 2
(2.417)
Channel 1
(2.412)
2.400 2.410 2.420 2.430 2.440 2.450 2.460 2.470 2.480
The WEE-1000 Wireless Input Unit covers channels 1 to 11 and uses up to three
non-overlapping channels (for example, channel 1, channel 6 and channel 11) at
the same time.
The 2.4 GHz frequency band, which is called ISM (Industry Science Medical), is
used for medical devices, ham radio and microwave ovens in addition to wireless
LAN. To prevent radio interference, the wireless input unit uses a spread spectrum
technology.
Channel 6
(2.437)
Channel 8
Channel 7
(2.442)
Channel 10
(2.457)
Channel 9
(2.452)
(2.447)
Channel 11
(2.462)
( ): Center frequency
GHz
WARNING
The wireless input unit complies with radio frequency standards.
• Do not disassemble, repair or modify the wireless input unit.
• Do not peel off the radio frequency standard certification label. If the
label is peeled off, this may result in illegal modification.
Operator's Manual WEE-1000 1.3
1. GENERAL
Composition
Electrode junction box,
JE-011A/JE-012A
Telemetry unit, ZB-101AA
Event marker
Video camera
Isolator,
SC-101A
Digital video unit
SpO2 adapter
Pochette, strap, belt
Access point,
ZR-101AA
Electroencephalograph, EEG-1100
EEG-9100/9200
1.4 Operator's Manual WEE-1000
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