Nihon Kohden Meb 9400 Service Manual
Nihon Kohden Meb 9400 Service Manual
EMG/EP
Measuring System
MEB-9400
MEB-9400A
MEB-9400K
MEB-9402C
MEB-9404C
0634-900068G
Printed: 2018/01/29
EMG/EP
Measuring System
MEB-9400
MEB-9400A
MEB-9400K
MEB-9402C
MEB-9404C
Keep this manual near the instrument or in the reach of the operator and refer to it whenever the operation is unclear.
This product stores personal patient information. Manage and operate the information appropriately.
Patient names on the screen shots and recording examples in this manual are fictional and any resemblance to any
person living or dead is purely coincidental.
Copyright Notice
The entire contents of this manual are copyrighted by Nihon Kohden. All rights are reserved. No part of this document
may be reproduced, stored, or transmitted in any form or by any means (electronic, mechanical, photocopied, recorded,
or otherwise) without the prior written permission of Nihon Kohden.
Trademark
Microsoft and Windows are registered trademarks of Microsoft Corporation.
Other models and trademarks are the property of their respective owners.
Contents 1
7
Section 1 General.................................................................................... 1.1
Introduction....................................................................................................................... 1.3
Service Policy, Service Parts and Patient Safety Checks................................................. 1.4
Service Policy......................................................................................................... 1.4
Service Parts.......................................................................................................... 1.4
Patient Safety Checks............................................................................................. 1.5
Maintenance Equipment/Tools............................................................................... 1.5
General Information on Servicing..................................................................................... 1.6
Important Safety Information............................................................................................ 1.8
General................................................................................................................... 1.8
Installation.............................................................................................................. 1.8
Operation................................................................................................................ 1.9
Other..................................................................................................................... 1.10
MO Disk/CD-R Disk Handling and Storing........................................................... 1.11
Specifications.................................................................................................................. 1.12
Amplifiers.............................................................................................................. 1.12
Averager............................................................................................................... 1.12
Stimulator Common Functions............................................................................. 1.12
Electric Stimulators..................................................................................... 1.13
Auditory Stimulators................................................................................... 1.13
Visual Stimulators....................................................................................... 1.13
Temperature Measurement................................................................................... 1.14
Dimensions and Weight of System Components.................................................. 1.14
Total Weight of the System................................................................................... 1.14
Power Requirements............................................................................................ 1.14
Environment......................................................................................................... 1.14
Safety.................................................................................................................... 1.15
Electromagnetic Compatibility.............................................................................. 1.15
Electromagnetic Emissions.................................................................................. 1.16
Electromagnetic Immunity.................................................................................... 1.16
Recommended Separation Distances between Portable and Mobile RF
Communications Equipment and the MEB-9400A/K............................................ 1.18
System Composition for EMC Test....................................................................... 1.18
Panel Descriptions.......................................................................................................... 1.19
Components......................................................................................................... 1.19
Main Unit, DC-940BA/BC/BK............................................................................... 1.20
Operation Panel.......................................................................................... 1.20
1. To safely and effectively use the instrument, its operation must be fully understood.
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.
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.
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.
CAUTION
United States law restricts this product to sale by or on the order of a physician.
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. Keep the emitter source such as cellular phone
away from the equipment and/or system, or turn off the cellular phone.
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.
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.
5. Interference of lightning:
When lightning occurs near the location where the equipment and/or system is installed, it may induce
an excessive voltage in the equipment and/or system. In such a case, disconnect the AC power cord
from the equipment and/or system and operate the equipment and/or system by battery power, or use
an uninterruptible power supply.
If the above suggested remedial actions do not solve the problem, consult your Nihon Kohden
representative for additional suggestions.
For EMC compliance, refer to “Specifications - Electromagnetic Compatibility” in the General section.
The CE mark is a protected conformity mark of the European Community. Products with the CE mark comply
with the requirements of the Medical Device Directive 93/42/EEC.
MEB-9400A complies with International Standard IEC 60601-1-2: 2001 and Amendment 1: 2004.
MEB-9400K complies with International Standard IEC 60601-1-2: 2007.
NOTE about Waste Electrical and Electronic Equipment (WEEE) Directive 2002/96/EC
For the member states of the European Union only:
The purpose of WEEE directive 2002/96/EC is, as a first priority, the prevention of waste electrical and
electronic equipment (WEEE), and in addition, the reuse, recycling and other forms of recovery of such
wastes so as to reduce the disposal of waste. Contact your Nihon Kohden representative for disposal.
WARNING
A warning alerts the user to the 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.
cCSAus mark
Electrode junction box
(DC-940BA only)
NOTE
Do not touch the Auditory connector. Otherwise, the static electricity may cause malfunction. Before
connecting, be sure to discharge the static electricity by touching the grounded metallic parts.
On Screen
Transport Package
KD-026A Cart
No pushing No sitting
Introduction........................................................................................................................................................... 1.3
Service Policy, Service Parts and Patient Safety Checks..................................................................................... 1.4
Service Policy............................................................................................................................................. 1.4
Service Parts.............................................................................................................................................. 1.4
Patient Safety Checks................................................................................................................................ 1.5
Maintenance Equipment/Tools................................................................................................................... 1.5
General Information on Servicing......................................................................................................................... 1.6
Important Safety Information................................................................................................................................ 1.8
General....................................................................................................................................................... 1.8
Installation.................................................................................................................................................. 1.8
Operation.................................................................................................................................................... 1.9
Other........................................................................................................................................................ 1.10
MO Disk/CD-R Disk Handling and Storing............................................................................................... 1.11
Specifications..................................................................................................................................................... 1.12
Amplifiers.................................................................................................................................................. 1.12
Averager................................................................................................................................................... 1.12
Stimulator Common Functions................................................................................................................. 1.12
Electric Stimulators........................................................................................................................ 1.13
Auditory Stimulators....................................................................................................................... 1.13
Visual Stimulators.......................................................................................................................... 1.13
Temperature Measurement...................................................................................................................... 1.14
Dimensions and Weight of System Components..................................................................................... 1.14
Total Weight of the System....................................................................................................................... 1.14
Power Requirements................................................................................................................................ 1.14
Environment............................................................................................................................................. 1.14
Safety....................................................................................................................................................... 1.15
Electromagnetic Compatibility.................................................................................................................. 1.15
Electromagnetic Emissions...................................................................................................................... 1.16
Electromagnetic Immunity........................................................................................................................ 1.16
Recommended Separation Distances between Portable and Mobile RF Communications Equipment
and the MEB-9400A/K.............................................................................................................................. 1.18
System Composition for EMC Test........................................................................................................... 1.18
Panel Descriptions.............................................................................................................................................. 1.19
Components............................................................................................................................................. 1.19
Main Unit, DC-940BA/BC/BK................................................................................................................... 1.20
Operation Panel............................................................................................................................. 1.20
Right Side Panel............................................................................................................................ 1.21
Rear Panel..................................................................................................................................... 1.21
Isolation Unit, SM-930AA/AJ/AK (option)................................................................................................. 1.22
Electrode Junction Box, JB-942BK, JB-944BK........................................................................................ 1.22
Foot Switch, RY-482B............................................................................................................................... 1.23
Somato Control Box, RY-441B (option).................................................................................................... 1.23
Composition........................................................................................................................................................ 1.24
1
Introduction
*1 Essential performance in EMC The Neuropack MEB-9400A EMG/EP Measuring System measures and averages
standard EMG, electric/auditory/visual evoked potential and nerve conduction.*1
*2 Essential performance of the EMG/ The Neuropack MEB-9400K EMG/EP measuring system displays information
EP measuring system from continuous or intermittent somatosensory, auditory and visual evoked
potential measurement, EMG and EEG measurement, and limb temperature to
support neuromuscular and brain function testing*2 in the examination room,
OR, ICU and other areas.
All replaceable parts or units of this system are clearly listed with exploded
illustrations to help you locate the parts quickly.
The maintenance section in this service manual only describes the maintenance
that should be performed by qualified service personnel. The maintenance
section in the operator’s manual describes the maintenance that can be performed
by the user.
The information in the operator’s manual is primarily for the user. However, it
is important for service personnel to thoroughly read the operator’s manual and
service manual before starting to troubleshoot, service, maintain or repair this
system. This is because service personnel needs to understand the operation of
the system in order to effectively use the information in the service manual.
NOTE
Use Nihon Kohden parts and accessories to assure maximum performance
from your system.
Service Policy
Our technical service policy for this system is to replace the faulty unit, board
or part or damaged mechanical part with a new one. Do not perform electrical
device or component level repair of the multilayer board or unit. We do not
support component level repair outside the factory for the following reasons.
• Most of the boards are multilayer boards with surface mount electrical devices,
so the mounting density of the board is too high.
• A special tool or high degree of repair skill is required to repair the multilayer
boards with surface mount electrical devices.
Service Parts
Refer to the “Replaceable Parts List” section in this manual for the service parts
for technical service that we provide.
NOTE
When ordering parts or accessories from your Nihon Kohden
representative, please quote the code number and part name which is
listed in this service manual, and the name or model of the unit in which
the required part is located. This will help us to promptly attend to your
needs. Always use parts and accessories recommended or supplied by
Nihon Kohden Corporation to assure maximum performance from your
system.
Nihon Kohden Corporation (NKC) shall stock repair parts (parts necessary to
maintain the performance of the instrument) for a period of 8 years (PC unit: 4
years) from the date of delivery. In that period, NKC or its authorized agents will
repair the instrument. This period may be shorter than 8 years (PC unit: 4 years)
if the board or part necessary for the faulty section is not available. After 4 years,
if the PC unit becomes faulty, replace it with a specified one.
For patient safety checks, perform the following checks as described in the
IEC 60601-1 “Medical electrical equipment - Part 1: General requirements for
safety”.
• Earth leakage current check: 0.5 mA or less
• Enclosure leakage current check: 0.1 mA or less
• Patient leakage current check: 0.1 mA or less
Maintenance Equipment/Tools
Test equipment
When repairing or calibrating the system, the following test equipment is
required.
• Oscilloscope
2 channels or more for input signal, 50 mV to 5 V input range, 1/10 attenuating
probe and 100 MHz or more frequency response characteristic must be provided.
• Power supply
• Oscillator
Standard type
• Digital voltmeter
Standard type (An oscilloscope can be used instead of the digital voltmeter.)
• Isolation transformer
Checking tool
When checking the stimulation intensity and skin-electrode impedance check
function, the checking tools are necessary. Refer to Section 4 “Maintenance”.
CAUTION
Safety
• There is the possibility that the outside surface of the system, such
as the operation keys, could be contaminated by contagious germs,
so disinfect and clean the system before servicing it. When servicing
the system, wear rubber gloves to protect yourself from infection.
• There is the possibility that when the lithium battery is broken, a
solvent inside the lithium battery could flow out or a toxic substance
inside it could come out. If the solvent or toxic substance touches
your skin or gets into your eyes or mouth, immediately wash it with a
lot of water and see a physician.
Liquid ingress
The system is not waterproof, so do not install the system where water
or liquid can get into or fall on the system. If liquid accidentally gets into
the system or the system accidentally drops into liquid, disassemble
the system, clean it with clean water and dry it completely. After
reassembling, verify that there is nothing wrong with the patient safety
checks and function/performance checks. If there is something wrong
with the system, contact your Nihon Kohden representative for repair.
Environmental safeguards
Depending on the local laws in your community, it may be illegal to
dispose of the lithium battery in the regular waste collection. Check
with your local officials for proper disposal procedures.
Transport
1
• Use the specified shipment container and packing material to
transport the system. If necessary, double pack the system. Also,
put the system into the shipment container after packing so that
the buffer material does not get inside the system.
• When transporting a board or unit of the system, be sure to use
a conductive bag on. Never use an aluminum bag to transport a
board or unit which a lithium battery is mounted. Also, never use
a styrene foam or plastic bag which generates static electricity to
wrap the board or unit of the system.
General
WARNING WARNING
Never use the system in the presence of any Never use the system in a hyperbaric oxygen
flammable anesthetic gas or high concentration chamber. Failure to follow this warning may cause
oxygen atmosphere. Failure to follow this warning explosion or fire.
may cause explosion or fire.
MRI examination
WARNING
Never use this system in an MRI examination
room. The system may not operate properly due
to high frequency magnetic noise from the MRI.
Installation
WARNING WARNING
Only use a 3-prong power cord and connect it to When several medical instruments are used
a 3-pin AC outlet which is properly grounded. together, ground all instruments to the same one-
Otherwise, it may result in electrical shock or point ground. Any potential difference between
injury to the patient and operator. instruments may cause electrical shock to the
patient and operator.
WARNING WARNING
When connecting an external instrument to the When connecting external equipment to this
connectors marked with of the system, the system, ensure that the external equipment
external instrument and system must be connected complies with the IEC 60601-1 safety standard
according to the IEC 60601-1-1 “Medical electrical for medical equipment and CISPR11 Group 1
equipment - Part 1-1: General requirements for and Class B standard, or the equivalent. When
safety - Collateral standard: Safety requirements the external equipment does not comply with the
for medical electrical systems”. Failure to follow this IEC 60601-1 safety standard, use a locally
warning may cause electrical shock to the patient available medical use isolation transformer unit
and operator. between the external equipment and the AC
outlet.
1
WARNING WARNING
Before connecting or disconnecting instruments, When the system is connected to a network,
make sure that each instrument is turned off and electrically isolate the network components with
the power cord is disconnected from the AC an isolation transformer or use a wireless LAN
socket. Otherwise, the patient or operator may system. Only use a hub which complies with IEC
receive electrical shock or injury. 60950 Safety Information Technology Equipment.
CAUTION CAUTION
Select an installation location where patient Only install the specified software in the system.
information cannot be seen or accessed by Unspecified software may cause the system to
unauthorized personnel. malfunction. Nihon Kohden has no responsibility
for any problem caused by unspecified software.
CAUTION CAUTION
Only use File Utility to delete files. If you delete a Do not apply over 8 kg of force on the mouse
system file using other tools such as Windows table of the KD-019A or KD-026A Cart. The
Explorer, the EMG/EP measuring system might mouse table may break and cause injury.
not operate correctly.
CAUTION CAUTION
When moving the system, select a flat path and • Do not move the cart with the casters locked.
move the system carefully to prevent it from The cart may tip over.
tipping over or components falling off. • When moving the cart, hold the handle of
the cart. Never hold the arm for the electrode
junction box.
CAUTION CAUTION
Do not carelessly touch connectors on the Avoid locations where the system may receive
system components. The system may strong electromagnetic interference and high-
malfunction due to electrostatic energy. Everyone frequency electric interference such as radio or
who uses this system must be trained in the TV stations, cellular phones or mobile two-way
prevention of electrostatic discharge (ESD). radios. Otherwise, the display may flicker or the
displayed waveform trace may be thicker.
Operation
Unused connectors on the electrode junction box Using a cup containing water
WARNING WARNING
During measurement, do not touch any connector Do not put a water cup where it can spill on the
that an electrode is not connected to. If an system. It may cause electrical shock to the patient
instrument that is connected to the patient is faulty, and operator and cause system malfunction.
the patient and operator may get electrical shock.
WARNING
When electrical stimulation is performed for a long
period, the EEG paste gets dry and electrical
stimulation may cause skin burn because the
dried paste increases the skin-electrode contact
impedance. Therefore, periodically check that the
paste is moist.
Other
WARNING
To prevent infection, autoclave the needle
electrodes before and after use.
CAUTION CAUTION
Before disposing of needle electrodes, check with When using the instrument for brain death
your local solid waste officials about proper diagnosis, before examination, check and adjust
disposal. the date and time of the system. The date and
time on the screen and recording result are part
of important information for the medical record.
CAUTION CAUTION
During measurement, do not change the date Do not turn the power off when any program is
and time. This makes the order of the saved running. When turning the system off, follow the
event data and the time of the saved waveforms procedure in “Power Off Procedure” in Section 2
incorrect. of the operator’s manual.
CAUTION
Do not use the Windows remote desktop function.
This function allows unauthorized people to
remotely access this system.
WARNING
The QP-945BK System Program is protected by
copyright law and international treaties.
Unauthorized reproduction or distribution of this
software, or any portion of it, may result in severe
civil and criminal penalties, and will be
prosecuted to the maximum extent possible
under law.
CAUTION CAUTION
Keep the disk away from strong magnetic objects Do not insert or remove a disk while the lamp on
such as a magnet, TV set or speaker. Otherwise, the disk unit is lit.
data in the disk may be lost.
CAUTION CAUTION
Do not touch the disk surface of the recorded Keep the disk away from direct sunlight and high
side (CD-R: opposite side of the label side). If the temperature. Otherwise, the disk may become
surface of the disk becomes contaminated with deformed.
any foreign substances such as fingerprints,
reading data may be impossible.
CAUTION CAUTION
Do not handle the disk while smoking or eating. Do not get the disk wet.
CAUTION CAUTION
Do not put a label on top of another label. Do not write on the label after the label is
Remove the old label before applying a new label. attached on the disk. Otherwise, the disk may be
damaged and reading may be impossible.
CAUTION CAUTION
Do not bend the disk, put heavy material on the Clean the disk with a disk cleaner. Do not use
disk, or give a strong impact to the disk. organic solvents such as acetone.
CAUTION
The program disk is not an audio CD and cannot
be played with an audio CD player.
NOTE
• When using the MEB-9400 application program, close all other
programs. Otherwise, the system program may not function properly.
• Turn off any screen saver before opening the MEB-9400 application
program.
• Periodically back up data in the system. Otherwise you may lose data if
the computer crashes.
Specifications
Amplifiers
Input impedance: 200 MΩ ±10% (Differential mode), ≥ 1000 MΩ (Common mode)
Noise: < 0.6 µVrms or less at 1 Hz to 10 kHz with input shorted
Common mode rejection ratio: ≥ 106 dB (Balanced mode), ≥ 112 dB (Isolation mode)
Sensitivity: 1, 2, 5, 10, 20, 50, 100, 200, 500 µV/div, 1, 2, 5, 10 mV/div ±5%
Low-cut filter: 0.01, 0.02, 0.05, 0.1, 0.2, 0.5, 1, 2, 5, 10, 20, 50, 100, 200, 500 Hz,
1, 2, 3 kHz at 6 dB/oct (±20%)
High-cut filter: 10, 20, 50, 100, 200, 500 Hz, 1, 1.5, 2, 3, 5, 10, 20 kHz at 12 dB/oct (±20%)
AC interference notch filter: 50 or 60 Hz (Rejection ratio: < 1/20)
Amplitude calibration: 1, 10, 100 µV, 1, 10 mV (within ±5%)
Skin-electrode contact impedance check: 2, 5, 10, 20 kΩ indication (within ±20%)
Averager
A/D converter: 16 bits
Conversion speed: 10 µs/channel max.
Monitor time base: 5, 10, 20, 30, 50 ms/div, 0.1, 0.2, 0.5, 1 s/div (within ±5%)
Analysis time base: With a list box:
0.1, 0.2, 0.5, 1, 2, 3, 5, 10, 20, 30, 50 ms/div, 0.1, 0.2, 0.5, 1 s/div (within ±5%)
With a keyboard:
0.1 to 0.9 ms in 0.1 ms steps (within ±5%)
1 to 99 ms in 1.0 ms steps (within ±5%)
100 to 1000 ms in 10 ms steps (within ±5%)
Time base modes: Individually selected for each channel
Number of averages: 1 to 9999
Artifact reject inhibit range: ±1, ±2, ±3, ±4 to ±5 div on screen or off (No artifact rejection)
Electric Stimulators 1
Stimulation intensity: 0.1 to 100 mA (in 0.1, 0.2 or 1 mA steps)
2.1 mA to 100 mA: within ±5%
When set to 2 mA or less, the delivered intensity must not exceed the selected
stimulation intensity setting.
Stimulation pulse duration: 1, 0.5, 0.3, 0.2, 0.1, 0.05, 0.03, 0.02, 0.01 ms
0.1 ms to 1 ms: within ±10%
0.05 ms: within ±20%
0.03 ms or less or when stimulation intensity is set to 2 mA or less:
the stimulation pulse duration must not exceed the selected stimulation pulse
duration setting.
Range of load resistance: R = V/I (0 Ω ≤ R ≤ 50 kΩ)
R: load resistance
V: internal voltage
I: stimulation intensity
Auditory Stimulators
Output type: Headphone, earphone
Stimulation waveform: Click, Tone burst
Stimulation phase (polarity): Condensation (positive), Rarefaction (negative), Alternating
Stimulation intensity: 0 to 135 dB SPL in 1 or 5 dB steps (within ±2 dB)
Contralateral white noise masking: 0, −10, −20, −30, −40 dB or off (no masking) (within ±5 dB)
Click pulse duration: 0.1 to 1.0 ms in 0.1 ms steps (within ±5%)
Tone burst frequency: With a keyboard:
50 to 125 Hz in 25 Hz steps (within ±5%)
150 to 450 Hz in 50 Hz steps (within ±5%)
500 Hz to 2.9 kHz in 100 Hz steps (within ±5%)
3 to 10 kHz in 500 Hz steps (within ±5%)
With a list box:
125, 250, 500 Hz, 1k, 1.5 k, 2 k, 3 k, 4 k, 6 k, 8 kHz (within ±5%)
Plateau time of tone burst: With a keyboard:
0 to 1,000 ms in 1 ms steps (within ±5%)
With a list box:
0, 1, 2, 5, 10, 20, 50, 100, 200, 500, 1000 ms (within ±5%)
Rise/fall time of tone burst: With a keyboard:
0.1 to 9.9 ms in 0.1 ms steps (within ±5%)
10 to 3,000 ms in 1 ms steps (within ±5%)
With a list box:
0.1, 0.2, 0.3, 0.5, 1, 2, 3, 10 ms (within ±5%)
Visual Stimulators
Stimulation modes: Pattern reversal, LED goggles, External visual stimulation
Pattern reversal:
Field format: Full, left half, right half, upper half, lower half, upper left, lower left, upper right
and lower right field
Patterns: Checkerboard, horizontal bars, vertical bars
Number of horizontal divisions: 4, 8, 16, 32, 64, 128
Display time (duration): 20 to 1,000 ms in 10 ms steps
Temperature Measurement
MEB-9400A: 0 to 45°C (32 to 113°F) ±0.1°C (0.18°F)
Isolation unit: 150 (W) × 140 (H) × 320 (D) mm, 12 kg (Depends on the model)
Power Requirements
Line voltage and frequency:
MEB-9400A: 117 V AC ±10%, 60 Hz
MEB-9400K: 100 to 240 V, 50/60 Hz
Environment
Operating temperature: 10 to 35°C (50 to 95°F)
Operating humidity: 30% to 80% (noncondensing)
Operating atmospheric pressure: 70 to 106 kPa
Safety 1
Safety standard
MEB-9400A: IEC 60601-1: 1988 IEC 60601-1 Amendment 1: 1991
IEC 60601-1 Amendment 2: 1995 IEC 60601-1-1: 2000
IEC 60601-2-40: 1998 IEC 60601-1-2: 2001
IEC 60601-1-2 Amendment 1: 2004 EN 60601-1: 1990
EN 60601-1: Amendment 1: 1993 EN 60601-1: Amendment 2: 1995
EN 60601-1-1: 2001 EN 60601-1-2: 2001
EN 60601-1-2 Amendment 1: 2006 EN 60601-2-40: 1998
UL 60601-1: 2003 CAN/CSA-C22.2 No. 601.1-M90
CAN/CSA-C22.2 No. 601.1S1-94 CAN/CSA-C22.2 No. 601.1B-90 (R2002)
CAN/CSA-C22.2 No. 60601-1-1-02 CAN/CSA-C22.2 No. 60601-1-1-03
CAN/CSA-C22.2 No. 60601-2-40-01
MEB-9400K: IEC 60601-1:2005+Amendment 1:2012
IEC 60601-1-2:2007
IEC 60601-1-6:2010+Amendment 1:2013
IEC 60601-1-9:2007+Amendment 1:2013
IEC 60601-2-40: 1998
IEC 62366:2007+Amendment 1:2014
Electromagnetic Compatibility
MEB-9400A: IEC 60601-1-2: 2001
IEC 60601-1-2 Amendment 1: 2004
IEC 60601-2-40: 1998
IEC 60601-2-10: 1987
IEC 60601-2-10 Amendment 1: 2001
MEB-9400K: IEC 60601-1-2: 2007
IEC 60601-2-40: 1998
Electromagnetic Emissions
This MEB-9400A/K is intended for use in the electromagnetic environment specified below.
The customer or the user of the MEB-9400A/K should assure that it is used in such an environment.
Electromagnetic Immunity
This MEB-9400A/K is intended for use in the electromagnetic environment specified below.
The customer or the user of the MEB-9400A/K should assure that it is used in such an environment.
Electromagnetic environment -
Immunity test IEC 60601 test level Compliance level
guidance
Electrostatic discharge ±6 kV contact ±6 kV contact Floors should be wood, concrete or
(ESD) ±8 kV air ±8 kV air ceramic tile. If floors are covered
IEC 61000-4-2 with synthetic material, the relative
humidity should be at least 30%.
Electrical fast transient/ ±2 kV for power supply ±2 kV for power supply Mains power quality should be that
burst lines lines of a typical commercial or hospital
IEC 61000-4-4 ±1 kV for input/output ±1 kV for input/output environment.
lines lines
Surge ±1 kV differential mode Mains power quality should be that
±1 kV differential mode
IEC 61000-4-5 ±2 kV common mode ±2 kV common mode of a typical commercial or hospital
environment.
Voltage dips, short <5% UT (>95% dip in UT) <5% UT (>95% dip in UT) Mains power quality should be that
interruptions and voltage for 0.5 cycles for 0.5 cycles of a typical commercial or hospital
variations on power environment.
supply input lines 40% UT (60% dip in UT) 40% UT (60% dip in UT) If the user of the MEB-9400A/K
IEC 61000-4-11 for 5 cycles for 5 cycles requires continued operation during
power mains interruptions, it is
70% UT (30% dip in UT) 70% UT (30% dip in UT) recommended that the MEB-9400A/K
for 25 cycles for 25 cycles be powered from an uninterruptible
power supply.
<5% UT (>95% dip in UT) <5% UT (>95% dip in UT)
for 5 s for 5 s
Power frequency 3 A/m 3 A/m Power frequency magnetic fields
(50/60 Hz) should be at levels characteristic
magnetic field of a typical location in a typical
IEC 61000-4-8 commercial or hospital environment.
NOTE: UT is the AC mains voltage prior to application of the test level.
NOTE 1: At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
*1 There is more noise interference in EP measurement than in EEG measurement because the high-cut frequency is high.
However, 1 V/m is applied because evoked potential waveforms are averaged.
*2 Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless) telephones and land
mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with
accuracy. To assess the electromagnetic environment due to fixed RF transmitters, an electromagnetic site survey
should be considered, If the measured field strength in the location in which the MEB-9400A/K is used exceeds the
applicable RF compliance level above, the MEB-9400A/K should be observed to verify normal operation. If abnormal
performance is observed, additional measures may be necessary, such as re-orienting or relocating the MEB-9400A/K.
*3 Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 1 V/m for EP measurement.
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m for EMG measurement.
NOTE 1: At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2: These guidelines may not apply in all situations. Electromagnetic propagation is affected by absorption and
reflection from structures, objects and people.
1
Panel Descriptions
Components
Desktop PC
LCD display
(Locally purchased)
Keyboard
PC unit
Isolation unit
Laptop PC
PC unit
Main unit
Printer
(Locally purchased)
Isolation unit
CAUTION CAUTION
When connecting an external instrument to the Connect only the specified equipment to the
connectors marked with of the system, the connectors marked with by following the
external instrument and system must be specified procedure. Otherwise, electrical leakage
connected according to the IEC 60601-1-1 current may harm the patient and operator.
“Medical electrical equipment - Part 1-1: General
requirements for safety - Collateral standard:
CAUTION
Safety requirements for medical electrical
When the cords and cables are not used or when
systems”. Failure to follow this warning may
moving the system, disconnect the cords and
cause electrical shock to the patient and operator.
cables from the system.
3 2 1 4 13 15 14 16 18 17 21
19
20
26
22
23
25 24
5 6 7 8 9 10 11 12
No. Name
1 SOMATO connector
2 AUDITORY connector
3 GOGGLE connector
4 PATTERN connector
5 TEMP connector (MEB-9400A only)
Rear Panel
T 2.0AL / 250V
1 2 3 4 5 6 7 8 9 10
No. Name
1 External speaker connector
2 Junction box connector
3 TRIGGER IN/OUT connector
4 Protective ground terminal
5 USB connector
6 Equipotential ground terminal
7 Foot switch connector
8 AC SOURCE socket
9 Fuse holder
10 Power switch
3 4
No. Name
1 OUTPUT (AC outlet)
2 Protective ground terminal
3 AC SOURCE socket
4 Equipotential ground terminal
5 BREAKER
12 12
1 1
11 11
2 2
3 3
4 4
10 10
5 5
6 6
8 7 9 8 7 9
JB-942BK JB-944BK
No. Name
1 IMP (kΩ) key (Impedance preset key)
2 IMP TEST key (Impedance check key)
3 Input ON/OFF key/lamp
4 Electrode impedance display LED
5 Electrode jack (DIN type)
6 Electrode lead jack
7 EXT connector
8 E jack (patient ground, 2-pin jack, DIN type)
9 Patient ground (1-pin jack, DIN type)
10 Cord hanger
11 Needle electrode holder
12 Electrode junction box connector
1
2
No. Name
1 Foot switch R, L
2 Main unit connector
3
1 2 4
No. Name
1 Stimulation probes
2 Stimulation on/off buttons
3 Stimulation intensity adjust buttons
4 Connector
Composition
Standard Components
MEB-9400A
The power unit (code No. 550013D) is included in the main unit.
MEB-9400K/9402C/9404C
MEB-9400K
DC-940BC Main unit for C version
MEB-9402C
DC-940BK Main unit for K version
MEB-9404C
The power unit (code No. 550013D) is included in the main unit.
Options 1
CC-941BK PC unit (desktop)
DR-531B-14 Headphone
YE-103J Earphone
1
Unit/Board Location
Main Unit
Power unit
Main board
Speaker
Panel board
Temp board*
NOTE
When replacing the panel board, replace the EMI gasket STG10-10,
L=200 (Code No. 6114-901688) together with the panel board.
How to Troubleshoot
This section explains error messages and how to locate, identify and solve a
problem in the system. The troubleshooting tables in this section are divided into
general problem and displayed error messages.
• System
• Waveform acquisition
• Printing
• Data storage
• Acquiring clear waveforms
• Analog circuit
• Stimulation
• Power supply
2. In the “Problem” or “Error Message” column, find the trouble item that
matches the problem or error message.
3. Do the action recommended in the “Action” column. (Do the first action
recommended in the “Action” column.
5. If none of the actions solve the problem, contact your Nihon Kohden
representative.
NOTE
Before contacting your Nihon Kohden representative for technical
support, please complete a copy of the Maintenance Check Sheet (the
original copy is provided at the end of Section 4 “Maintenance”), and if
possible, provide additional detailed information on the problem.
Send the complete copy of the Maintenance Check Sheet to your Nihon
Kohden representative. This will allow your Nihon Kohden representative
to provide you with the best support.
Troubleshooting
2
System
Problem Possible Cause Action
The power of the PC unit cannot be The power switch is locked. Refer to the PC unit operator’s manual
turned on. (CC-942BK laptop PC unit to release the power switch lock.
only)
When the power is turned on, the The AC power cord is not connected to Connect the AC power cord correctly.
system does not operate. the main unit.
The AC power cord of the PC unit is Connect the AC power cord to the
not connected to the isolation unit. isolation unit correctly.
When the power is turned on, nothing The brightness or contrast of the Adjust the brightness or contrast. Refer
is displayed on the screen. display is not appropriate. to the operator’s manual of the PC unit
or LCD display.
The USB cable is not connected to the Connect the USB cable correctly.
PC unit or main unit.
When the power is turned on, Windows A floppy disk is inserted into the floppy Remove the floppy disk.
does not start. disk drive.
An examination program cannot be Thirteen or more examination Up to twelve examination programs
opened. programs are opened. can be opened simultaneously. Close
unnecessary examination programs.
An examination program does not A screen saver program is active. Close the screen saver program.
operate correctly. Another Windows application program Delete the other Windows application
is installed and it conflicts with the program. Only Word and Excel can be
MEB-9400 application program. used with the MEB-9400 application
program.
The USB cable is disconnected during Close the MEB-9400 application
measurement. program.*
The resume mode is active. Set the resume mode to off. Refer to
the PC unit operator’s manual.
The mouse does not function. The mouse is not connected to the PC Turn the power off, then connect the
unit mouse cable to the PC unit correctly.
The date and time is not correct. The date and time setting is not correct. Set the correct date and time. Refer to
the Windows online help.
The backup battery of the PC unit is Contact your Nihon Kohden
discharged. representative.
Waveform Acquisition
Problem Possible Cause Action
The waveform is flat or the amplitude The Input ON/OFF key on the Press the Input ON/OFF key. The Input
is small. electrode junction box is not pressed. ON/OFF lamp lights.
The input sensitivity is low. Select the correct sensitivity.
The measurement electrode and Remove unnecessary paste around the
grounding electrode are shorted by measurement electrode and grounding
paste. electrode.
The waveform cannot be returned to The input sensitivity is high. Reduce the input sensitivity.
the baseline.
The waveforms cannot be averaged by The amplitude of the waveform is Select the low sensitivity.
the rejection function. large.
Large artifact such as stimulation signal Remove the artifact.
is superimposed on the waveform. Change the Reject Level setting or set
it to off. Refer to “Reject Level” (Set
Conditions window → Acquisition
page).
Change the number of waveforms for
average. Refer to “Preset Count” (Set
Conditions window → Acquisition
page).
The “Incorrect junction box is currently The connected electrode junction boxes The JB-942BK/JB-944BK Electrode
connected. Input select is set to OFF” cannot be used with this system. Junction box can be used with this
message appears. system.
Printing
Problem Possible Cause Action
It takes a long time to print. The printed waveforms have high
—
sampling rate.
The One Frame printing cannot be Screen Wave is selected in the Review Select One Frame.
performed. Print dialog box.
The number of saved waveforms Refer to “Printing the Stop, Saved or
exceeds the limitation for the one frame Gather Window Waveforms and Data”
printing. in Section 8 of the operator’s manual
for the number of waveforms which
can be printed.
The report printing cannot be The document template setting is not Correct the document template setting
performed. correct. on Word or Excel.
Word or Excel is not installed. Install Word or Excel.
Data Storage
Problem Possible Cause Action
Cannot save a file in the floppy disk. The floppy disk is not formatted. Format the floppy disk.
The floppy disk is write-protected. Release the write-protect.
Cannot save a file in the MO disk. The MO disk is not formatted. Format the MO disk.
The MO disk is write-protected. Release the write-protect.
The MO disk drive is not connected to Connect the MO disk drive to the PC
the PC unit. unit correctly.
The MO disk drive is not recognized Check that the MO disk drive is
by the PC unit because the MO disk recognized as a Removable Drive in
drive is not turned on, or it is turned on the My computer. If not, turn the MO
after the system is turned on. disk drive on then turn the system on.
NOTE
• When the interference is small, click the AC Interference button on the
Tool bar to check whether it is caused by AC interference.
• When using electric stimulation, set “AC Filter” to “Off” because the AC
filter distorts acquired waveforms.
• The default filter frequency is 60 Hz. When using the system in a region
with 50 Hz AC power, set it to 50 Hz.
Spike Noise
Other Noise
EMG interference
Analog Circuit
Problem Possible Cause Action
Displayed waveform is The electrode position is not correct. Attach the electrode to the correct position.
flat or very small on the The sensitivity, filter, analysis time or vertical Check all the measurement settings.
screen. range setting is not correct.
The Input ON/OFF key on the electrode Press the Input ON/OFF key. The Input ON/
junction box is not pressed. OFF lamp lights.
Faulty electrode Replace the electrode.
Faulty connection between the electrode Connect the electrode junction box cable to
junction box and main unit. the JUNCTION BOX connector on the rear
panel of the main unit by pushing the two
connector locks firmly.
Faulty J. box board if no calibration waveform Replace the J. box board.
appears.
Faulty main board. Replace the main board.
Skin-electrode contact Faulty electrode if the impedance check result Replace the electrode.
impedance check is as follows.
function does not work Open circuit between the input and another
normally. input jack:
The electrodes are displayed in black on
orange (no measured impedance).
Closed circuit between the input jack and
another input jack with a short lead:
The electrodes are displayed in green with the
measured impedance.
Skin-electrode contact The impedance check signal is not correctly Adjust the impedance check signal
impedance check result is adjusted. correctly. Refer to “Signal Input Circuit
not correct. Check/Adjustment - Skin-electrode Contact
Impedance Check Signal Adjustment” in
Section 4.
No triggered waveform The trigger channel setting is not correct. The signal trigger channel is set in Signal
appears in the signal Trigger Channel (Set Conditions window
trigger mode when the → Trigger Page). Check the signal trigger
STIM/SWEEP key is channel and set Input Select of this channel to
pressed. JB (Set Conditions window → Amp page).
The trigger level is not correct. Select the trigger level correctly.
Faulty J. box board. Replace the J. Box board.
NOTE
To perform the skin-electrode contact impedance check, select any
examination menu except EMG related, ERG and Micro-N menus.
Stimulation
Problem Possible Cause Action
Electrical stimulation is Stimulator for Trigger is not set to Somato 1. Set Stimulator for Trigger to Somato 1. 2
not output. (Set conditions window → Trigger page)
Trigger Mode is set to EXT 1 even when an Select the correct Trigger Mode.
external trigger is not used 1. (Set conditions
window → Trigger page)
The F131 (fuse) on the main board blows Replace the fuse*.
if the “Electrical stimulator is faulty. This * Fuse (10mA, Fast-acting fuse)
stimulator is automatically stopped to prevent Ampere rating: 10 mA
abnormal output. Turn off the main unit and Voltage rating: 250 V
contact your Nihon Kohden representative” Size: 5 × 20 mm
message is displayed. Code No.: 274383
Faulty main board. Replace the main board.
Auditory stimulation is Stimulator for Trigger is not set to Auditory 1. Set Stimulator for Trigger to Auditory 1.
not output. (Set conditions window → Trigger page)
Auditory stimulation output intensity is not Adjust the auditory output intensity correctly.
adjusted correctly. Refer to “Auditory Stimulation Output
Intensity Check/Adjustment” in Section 4.
Faulty headphone or earphone. Replace the headphone or earphone.
Faulty main board. Replace the main board.
Reversal pattern on The following controls on the video monitor Adjust the controls correctly.
the video monitor is are not adjusted correctly: Brightness,
abnormal. Contrast, V-Hold, H-Hold
The TV monitor mode does not match the Select the correct TV monitor mode with
connected video monitor. Pattern Reversal Mode in the System
Condition dialog box.
Faulty main board Replace the main board.
LED goggles do not Faulty LED goggles Replace the LED goggles. Use “Visual
blink. Stimulation Check” in Section 4 to check the
visual stimulation output.
Faulty main board Replace the main board.
Power Unit
Problem Possible Cause Action
Neither the power lamp on the front The AC power cord is not connected to Connect the AC power cord to the main
panel of the main unit nor on the the main unit. unit correctly.
electrode junction box lights. The main fuse in the main unit blows. Replace the fuse*.
* Fuse (2A, Time-Lag fuse)
Ampere rating: 2A
Voltage rating: 250 V
Breaking capacity: 35 A, 250 V
Size: 5 × 20 mm
Code No.: 104522
Faulty power cable connection between Connect the power cable correctly.
the main board and power unit. (Code No. 686437)
Faulty flat cable connection between Connect the flat cable correctly.
the main board and panel board. (Code No. 640422)
Faulty power unit Replace the power unit in the main
unit. (Code No. 550013D)
When the PC unit is turned on, the Faulty USB connection between the Connect the USB cable correctly.
“Cannot open device driver.” message main unit and PC unit.
appears and the MEB-9400 program Faulty main board. Replace the main board.
does not start.
Error Messages
2
Overview
Error messages are displayed when an error occurs in the MEB-9400 system
during operation or in the power on self check for the main unit. Some of the
display error messages have a “Command code” and “PC-ACQ API error
code” which will be the key to solve the problem. When an error is detected in
the power on self check for the main unit, the PC-ACQ API error code has an
“additional information” code.
PC-MPU error code: Error code which indicates the cause of the error
message.
The “additional information” is a 32 bit hex code which is displayed with the
Command code and PC-ACQ API error code when the initialization program
in the flash memory detects an error during the power on self check of the main
unit. The bit combination indicates the problem.
The leftmost bit of the additional information is bit 31; the rightmost bit is bit 0.
In the following example, bit 31 is 9 and; bit 0 is 1.
Additional Information = 9003 0404 0101 0000 0000 0000 0000 0021
Bits 0 to 13
• When bits 0 to 13 are 0, no errors are present and bits 14 to 31 are also 0.
• When bits 0 to 13 are between 0x01 and 0x3fff, bits 0 to 13 represent the error
type.
Bits 14 and 15
• When bit 15 is 1,
- and bit 14 is 1, an error occurred during boot.
- and bit 14 is 0, an error occurred after boot.
• When bit 15 is 0 (The error is detected by the PC ACQ unit interface program
on the PC unit side.),
- and bit 14 is 1, an error occurred in device driver.
- and bit 14 is 0, an error occurred in PC ACQ API DLL file.
Bits 20 to 23
When an error occurs, bits 23 to 20 are set to 0, 1, 0, and 1, respectively.
Bits 24 to 27
These bits indicate the key check result at power on self check for the main unit.
If no key check errors are detected, bits 27 to 24 are 0, 0, 0 and 0, respectively. If
a key check error is detected, the combination of bits 27 to 24 varies according
to the detected error as described in the next sub section “Display Error Message
after Power On Self Check for Main unit”.
Bits 28 to 31
These bits indicate a power on self check error.
The following check item are checked in the power on self check for the main
unit.
2
ROM Error
This item checks the ROM by comparing the lowest single byte of the sum value
between all data with the exception of the last address (0x1fff) value and 0xff
value with the 0x1ffff value. If the values are not the same, an error message
with the additional information (bits 31 to 28: 9001) is displayed.
If this error message appears, the ROM in the main unit is faulty.
RAM Error
This item checks the RAMs by comparing the test patterns that are written to the
RAM with the test patterns that are read from it. If there is a difference, an error
message with the additional information (bits 31 to 28: 9002) is displayed. The
checked RAMs are the main RAM for MPU and share memory for MPU and PC
unit.
If this error message appears, the RAMs in the main unit are faulty.
If this error message appears, the MPU in the main unit is faulty.
DSP Error
This item checks if the communication between the DSP and MPU in the main
unit works correctly or not. If the communication does not work correctly, an
error message with the additional information (bits 31 to 28: 9005) is displayed.
NOTE
Messages are alphabetized by the first word in the error message.
3.2
Electrode junction box
Electrical stimulator
Somato control box
Dual port memory
3. BOARD DESCRIPTION
Printer
To external speaker
Startup Sequence
The PC unit controls the entire MEB-9400 system by communicating with the 3
main unit. When the power is turned on, the PC unit downloads the main unit
operation programs to the main unit.
Downloads the main unit program “MPU.dwn” from The MPU starts downloading.
C:\Program Files\NPK\AcqBox to the main memory
in the main unit. The “Loading...” message appears.
When the download is complete, the “Waiting The MPU starts communication with the DSP via
for condition when MPU will be ready” message the host interface.
appears.
When the download is complete, opens the Main The DSP starts the operation.
Menu window.
Main Unit
The main unit consists of the main board, panel board, temp board* and jack
board*. The main board acquires the waveform from an electrode junction box,
processes the waveform with the digital signal processor, and controls the trigger,
auditory visual stimulation blocks and temperature measurement block*. The
main unit communicates with the PC unit by USB communication.
* MEB-9400A only
Main Board
The main board consists of the following blocks.
• MPU block
Controls the main unit, electrode junction box.
• DSP block
Processes the waveform data from the electrode junction box.
• USB block
Communication between the MPU and PC unit is performed via the USB
controller.
• Trigger block
The trigger block consists of the trigger control block and stimulation interface
block. The trigger control block generates trigger signals for the electrical,
auditory and visual stimulations. The stimulation interface block controls each
setting for the electrical stimulator.
Panel Board
The panel board receives the inputs from the key switch and operation dial on the
operation panel then sends the corresponding key code to the main board. The
power lamp lights when the power is turned on. The trigger lamp lights when the
3
trigger signal is output.
Intensity
Position
Cursor
UPD5555
1 kHz
Counter
Counter
Counter
+5 VD
K
POWER_LED
+5 VD
+5 VD
+5 VD
DGND
DGND
DGND
+5 VD
DGND
´8
´8
´8
+5 VD
+5 VD
+5 VD
+5 VD
DGND
DGND
DGND
DGND
PC10-PC17
PC00-PC07
PB10-PB17
PB00-PB07
PA10-PA17
PA00-PA07
TKS825×2
74HC244
+5 VD
DGND
B C
TRIG_KED A
E
Chip selector
SP-OUT-GND
LED_ON
SP-OUT
Address
Control
SP-VR
Data
Power Unit
The power required for the MEB-9400 system is supplied from the power unit.
The power unit generates +15 V DC power with the switching regulator and
supplies it to the main board. The power block on the main unit generates the
following DC voltages from the +15 V DC power.
Voltage For
+3.3 V Digital circuit on the main board
• Digital circuit on the main board
+15 V • Panel board
• Electrode junction box
±5 V Analog circuit on the main board
• Electrical stimulation block
±12V • Auditory stimulation block
• Visual stimulation block
The temperature measurement control signal from the main board is latched in
the non-isolated circuit and sent to the multiplexer through a photocoupler. This
signal changes the multiplexer switch every second to select the voltage from the
temperature measurement, calibration and reference voltages.
The following electrode junction boxes can be used with the MEB-9400 system. 3
• JB-942BK
• JB-944BK
Circuit Composition
• Signal input circuit
• Skin-electrode impedance measurement signal distributor
• Differential amplifier
• Low cut filter
• Fast recovery circuit
• Reset circuit
• Second stage amplifier
• Attenuator
• Third stage amplifier
• Fourth stage amplifier
• Anti-aliasing filter
• A/D converter
• Serial to parallel data converter
• Skin-electrode impedance measurement signal generator
• Optical isolator
• Floating power supply
3.8
TCS4460-01-4151
Floating circuit Non-floating circuit
Low cut filter Attenuator
0.01, 0.5, ´1/1250
Ch 1 4 1, 10 Hz ´1/500 Anti-aliasing filter,
3 ´4
(-6 dB/oct) ´1/50
´8 ´1/5 ´20.6 ´16 5, 10, 30 kHz (-18 dB/oct)
1 Ch 1 250 kHz
F ´1
2 ´31 ±17.5 Vf 1/2
±5 Vf
INST
Ch 1 (-)
1 Differential +15 VD
amplifier FGND FGND FGND
Ch 1 (+)
2
3. BOARD DESCRIPTION
2 Ch 2 (+)
Ch 3 (-)
1 This area is not
mounted on UT-0800.
Ch 3 (+)
2
Ch 4 4
3
1 Ch 4
Optical isolator
2
Electrode Junction Box Block Diagram
Serial to parallel
converter
Ch 4 (-)
1
Ch 4 (+)
2
Function Outline
• Signal input circuit
Signals are input from the eight electrode jacks (JB-944BK, four electrode jacks:
JB-942BK) for disk electrodes and four electrode lead jacks (JB-944BK, two
electrode lead jacks: JB-942BK). Each input circuit provides 200 MΩ resistor 3
as input impedance. Zener diodes and arrestors are provided for protecting
the input circuit from excessive voltage caused by static energy or electrical
surgery unit. A 16 Hz, 8 Vp-p skin-electrode contact impedance measurement
signal is applied to the patient.
• Differential amplifier
Acquired waveform is amplified about 32 times. The buffer amplifier for
common mode component feedback is connected to pin 11 (COM) of each
differential amplifier. The buffer amplifier for shield feedback is connected to
pin 10 and pin 12 (–FB, +FB) of each differential amplifier.
• Reset circuit
When the RESET button on the Tool bar on an examination window is clicked,
the input of the second stage amplifier is connected to the floating ground.
• Attenuator
The attenuation ratio (×1, ×1/5, ×1/50, ×1/500, ×1/1250) is set according to
“Sens” setting of the Amplifier page of the Set Conditions window.
• Anti-aliasing filter
High cut frequency is 5, 10 or 30 kHz (–18 dB/oct). The high cut frequency
automatically changes according to the number of channels used.
• A/D converter
Converts the multiplexed four channel analog signal to digital data. The A/D
converter is 16-bit, 10 μs sampling, serial type A/D converter. The multiplexer
and A/D converter are controlled by the signals from the main unit. The
converted digital data is sent to the DSP on the main unit at the 6.6 MHz
transfer rate.
• Optical isolator
Four high-speed type photocouplers are used for transferring the digital
data from the floating circuit to the non-floating circuit. The other three
photocouplers are used for the serial communication between the signal input
block and receiving the status signal from the main unit.
4
Periodic Inspection............................................................................................................................................... 4.2
Signal Input Circuit Check/Adjustment................................................................................................................. 4.3
Gain Check/Adjustment.............................................................................................................................. 4.3
Electrode-skin Contact Impedance Check Signal Adjustment................................................................... 4.4
Auditory Stimulation Output Intensity Check/Adjustment..................................................................................... 4.5
Electrical Stimulation Output Intensity Check....................................................................................................... 4.7
Visual Stimulation Check...................................................................................................................................... 4.8
Temperature Measurement Check/Adjustment (MEB-9400A only)...................................................................... 4.9
Power Unit Check............................................................................................................................................... 4.10
Maintenance Check Sheet................................................................................................................................. 4.11
Overview.................................................................................................................................................. 4.11
Safety....................................................................................................................................................... 4.12
Input Circuit and Amplifiers...................................................................................................................... 4.12
Operation.................................................................................................................................................. 4.13
Stimulation................................................................................................................................................ 4.13
Others....................................................................................................................................................... 4.14
Periodic Inspection
This section explains the check procedure and adjustment procedure for the
following items.
Service personnel should perform the periodic inspection at least once every
year. Make sure that the EMG/EP measuring system operates properly and
replace the consumables.
For periodic inspection, use the Maintenance Check Sheet in this section. This
check sheet is useful to check the operation of the system after check/adjustment
or board/unit replacement.
Gain Check/Adjustment
Test Equipment
Oscillator 4
Connection
5 (E) 1. Connect the plus and minus terminals of an oscillator to the following pins
1 (−)
of the electrode lead jack on electrode junction box with jumper leads as in
2 (+) the illustration below.
• Plus terminal to pin 2 of the electrode lead jack
• Minus terminal to pin 1 of the electrode lead jack
Electrode lead jack
• Ground terminal to pin 5 of the electrode lead jack
2 +
+ E
1 −
−
Check Procedure
1. Start monitoring by pressing the MONITOR key on the operation panel.
2. Make sure that the amplitude of the sine waves is within 6 ±0.3 divisions. If
the amplitude is out of range, adjust the gain of the electrode junction box
according to the following adjustment procedure.
Adjustment Procedure
Adjust the following volume in the electrode junction box so that the amplitude
of the sine waves is within 6 ±0.3 divisions on the Monitor screen. The variable
resistor depends on the model.
Volume
Channel JB-902BK JB-904BK
1 VR041 VR041
2 VR042 VR042
3 — VR051
4 — VR052
Connection
Connect the oscilloscope probe and grounding lead to the test points in the
electrode junction box as follows.
• Oscilloscope probe: Test point “16Hz” (TP061)
• Grounding lead: Test point “FGND” (TP094)
Adjustment Procedure
1. Click the Impedance check button on the tool bar or press the IMPEDANCE
CHECK key on the operation panel.
2. Adjust the volume “16 Hz” (VR061) in the electrode junction box so that the
amplitude of the 16 Hz sine waves is within 8 Vp-p ±5% on the oscilloscope.
Make the dummy load resistor jig as shown below (bottom view).
Right Left
3 1
+ +
5 4
10 2 10
− −
Connection
1. Connect the dummy load resistor jig to the AUDITORY connector on the
right side panel of the main unit.
2. Connect the first channel of the oscilloscope across the resistor connected to
the stimulation side of the dummy load resistor jig and the second channel of
the oscilloscope across the resistor connected to the opposite side against the
stimulation side of the dummy load resistor jig, using the oscilloscope probe
and ground lead.
Check Procedure
1. Start stimulating by pressing the STIM/SWEEP key on the operation panel.
Adjustment Procedure
1. Adjust VR201 volume on the main board so that the amplitude of the click
waveform on the stimulation side is within 6.33 Vp-p ±18%.
2. Adjust VR202 volume on the main board so that the amplitude of the mask
noise waveform on the opposite side against the stimulation side is within
6.33 Vp-p ±77%.
+
1 1k
−
Connection
1. Connect the dummy load resistor jigs to the SOMATO connectors on the
right side panel of the main unit.
2. Connect the first channel of the oscilloscope across the resistor of the
dummy load resistor jig for the SOMATO connector using the oscilloscope
probe and ground lead.
Check Procedure
1. Start stimulating by pressing the STIM key.
2. Check that the amplitude of the output waveform from the SOMATO
connectors is within ±5% of the set intensity current value.
4 1
− −
3 2
V V
+ +
Connection
Connect the jig to the GOGGLE connector on the rear panel of the main unit.
Check Procedure
1. Start stimulating by pressing the STIM/SWEEP key.
2. Connect the tester to the stimulation side and check that the output voltage is
within 22.5 V ±10%.
Jig 4
• Dummy load
Make the dummy load jig as shown below.
Connection
Connect the dummy load resistor jig to the TEMP connector on the main unit.
Check Procedure
Check that the measured temperature is within the range shown below. The
measured temperature value varies according to the load resistor value and its
tolerance.
Load Resistor Value (kΩ) Tolerance (%) Temperature (°C)
1.5 1 34.2 to 34.8
1.5 5 33.3 to 35.7
1.5 10 32.2 to 37.1
2.0 1 27.4 to 28.0
2.0 5 26.6 to 28.9
2.0 10 25.5 to 30.2
Adjust VR101 [TEMP] volume on the temp board so that the measured
temperature is within the specified temperature range.
Measure the output voltage from the 3-prong AC outlet on the power unit after
power on and make sure that the measured voltage is within ±10% of the line
voltage.
Make sure that correct voltage is output from the test pins on main board after
power on as shown below.
The maintenance check sheet is provided at the end of this subsection. Make a
copy of this check sheet before using it. The check sheet contains the check items
grouped as follows. 4
• Overview
• Safety
• Input Circuit and Amplifiers
• Operation
• Stimulation
• Others
The rest of this section describes how to check each of the above items.
Overview
Item Check Procedure Action
Dirt Check if the outside of the components of the If the outside of the components is dirty, clean
MEB-9400 system is dirty. it with a cloth moistened with neutral soap or
alcohol.
Loose screws Check if there are any loose screws. If any screw is loose, tighten it.
Damaged or bent parts Check if there is any physically damaged If any part is damaged or bent, replace it.
or bent parts. This includes the pins on the
connector or socket.
Installation Check if the components of the MEB-9400 If the components of the MEB-9400 system
system are set on the cart correctly. are not set on the cart correctly, set them on
the cart correctly.
Safety
Item Check Procedure Action
Power cord Check if the 3-prong power cord which has If the 3-prong power cord is not used, replace
three terminals (hot, neutral and ground) is it.
used.
Power cord and Check if the power cord or connection cable is If the power cord or connection cable is
connection cable damaged. damaged, replace it.
Equipotential grounding Check if the MEB-9400 system is grounded to If the system is not grounded, use the provided
a dedicated equipotential ground terminal in ground cable to ground the system a dedicated
the facility. equipotential ground terminal.
Equipment connected Check if any equipment other than the PC If any equipment other than a PC, display,
to medical isolation unit, display and laser printer is connected laser printer and optional video monitor is
transformer to the 3-prong AC outlets on the medical connected to the 3-prong AC outlets on the
isolation transformer. rear of the main unit, disconnect it.
Fuse in main unit Remove the fuse from the fuse holder of the If any condition described in the left column is
AC inlet on the rear of the main unit and not satisfied, replace the fuse.
check the following.
• There is no physically damaged site on the
fuse.
• Time-lag type.
• The fuse rating is 2 A.
Operation
Item Check Procedure Action
Startup Check if the MEB-9400 system is correctly If the system does not correctly start up after
started up after power on. power on, restart it.
Operation Panel Check if the operation panel works correctly.If the operation panel does not work correctly,
replace the panel board.
Mouse Check if the mouse works correctly. If the mouse does not work correctly, replace 4
it.
Display Check if the screen is displayed correctly. If the screen is not displayed correctly, contact
your Nihon Kohden representative.
Printing Check if the system prints correctly. If the system does not print correctly, contact
your Nihon Kohden representative.
Backup function Check if the measurement settings and system If these settings are not backed up after the
settings are backed up after the power is power is turned off then on, reinstall the
turned off then on. MEB-9400 system software.
MONITOR function Check if the MONITOR function works If the MONITOR function does not work
correctly when the CAL mode is selected. correctly when the CAL mode is selected,
contact your Nihon Kohden representative.
STIM/SWEEP function Check if the STIM/SWEEP function works If the STIM/SWEEP function does not work
correctly when the CAL mode is selected. correctly when the CAL mode is selected,
contact your Nihon Kohden representative.
ANALYSIS function Check if the ANALYSIS function works If the ANALYSIS function does not work
correctly when the CAL mode is selected. correctly when the CAL mode is selected,
contact your Nihon Kohden representative.
Stimulation
Item Check Procedure Action
Auditory Stimulation Check if the auditory stimulation is generated If the auditory stimulation is not generated
correctly by following “Auditory Stimulation correctly, troubleshoot by following
Output Intensity Check/Adjustment” of this “Stimulation” in Section 2.
section.
Electric Stimulation Check if the electric stimulation generates If the electric stimulation is not generated
correctly by following “Electric Stimulation correctly, troubleshoot by following
Output Intensity Check” of this section. “Stimulation” in Section 2.
Visual Stimulation Check if the visual stimulation generates If the visual stimulation is not generated
correctly by following “Visual Stimulation correctly, troubleshoot by following
Check” of this section. “Stimulation” in Section 2.”
Others
Item Check Procedure Action
Electrode lead With a tester, check if the electrode lead is not If the electrode lead is worn out, replace it.
worn out.
Sound volume dial Check if the monitor sound volume is If the monitor sound volume is not correctly
correctly adjusted by the sound volume dial. adjusted by the sound volume dial, replace the
operation panel.
Hard disk Check if the data is read from/written to the If the data is not read from/written to the hard
hard disk correctly. disk correctly, check the hard disk with the
Windows disk check function.
Foot switch Check if the foot switch works correctly. If the foot switch does not work correctly,
replace it.
Customer:
Customer Address:
Service Personnel: Service Company:
Model: Serial Number: 4
Hardware Revision: Software Revision:
Overview
Outside of instrument is clean. Yes No
All screws are tight. Yes No
Any component of the MEB-9400 system is not physically damaged
and has no bent parts. Yes No
MEB-9400 system is installed correctly. Yes No
Safety
3-prong power cord is used. Yes No
Power cord and connection cable are not damaged. Yes No
Equipotential grounding is constructed for instrument. Yes No
Correct equipment is connected to instrument. Yes No
Undamaged and correct fuse is used for main unit. Yes No
Operation
System starts up correctly. Yes No
Operation panel works correctly. Yes No
Mouse works correctly. Yes No
Screen is displayed correctly. Yes No
System prints correctly. Yes No
Measurement settings and system settings are backed up correctly. Yes No
MONITOR function works correctly. Yes No
STIM/SWEEP function works correctly. Yes No
ANALYSIS function works correctly. Yes No
Stimulation
Auditory stimulation is generated correctly. Yes No
Electrical stimulation is generated correctly. Yes No
Visual stimulation is generated correctly. Yes No
Others
Electrode lead is not worn out. Yes No
Sound volume dial works correctly. Yes No
Hard disk is checked with check disk function and have no bad sectors. Yes No
Foot switch works correctly. Yes No
The procedures in this section explain how to remove, replace and install major
components in the system.
• To remove the components from the KD-026A Cart or KD-019A Cart, refer to
the MEB-9400 operator’s manual.
• To remove, replace and install the components in the PC unit, refer to the
personal computer documentation.
• To remove the connection cables, refer to “Cable Connection” in Section 2 of
the MEB-9400 operator’s manual.
WARNING WARNING
To avoid the possibility of injury to yourself or To avoid accidental discharge of static electricity
damage to the MEB-9400 system, do not install or which could damage the MEB-9400 system
remove any component or change switch settings components, use a grounded wrist strap when
while the power is on. installing or removing any component of the
system.
CAUTION WARNING
Before connecting or disconnecting a cable, close Fuses cut off the power when an abnormality
the MEB-9400 system program and examination occurs in the MEB-9400 system. Eliminate the
program, shut down Windows, turn off the system malfunction before replacing the fuse. Use the
and unplug the AC power cord from the system. correct fuse only. The fuse rating is shown on the
holder.
CAUTION CAUTION
Removal and replacement of any components in Only use parts recommended by Nihon Kohden to
the MEB-9400 system should be done by assure maximum performance from your MEB-
qualified service personnel. 9400 system.
Required Tools
• Antistatic bench mat
• Wrist ground strap
• Phillips screw driver (insulated type, for M2.6 and M3 screws)
• Hex (Allen) wrench or hexagon keys (for M3 set screws)
• Hex socket driver (for M3 nuts)
• Tweezers
Foot switch
CN012
PATTERN connector
LED goggles
Power unit
CN003
GOGGLES connector
Main board
Head phone
CN002
AUDITORY connector
CN010
Somato control box
CN001
CN011 CN012 CN013 SOMATO connector
* MEB-9400A only
Printer USB
5.3
5
5. DISASSEMBLY
Main Unit
2. Remove the seven M3 × 8 binding head screws with toothlock washers from
the bottom cover and remove the bottom cover. The main board and power
unit are attached to the bottom cover.
NOTE
When removing the bottom cover, do not pull the flat cable.
Panel board
Flat cable
Flat cable
Knob
4. Remove the nine M3 × 6 pan screws with spring washers from the panel
board to remove the panel board from the chassis.
EMI gasket
NOTE
When replacing the panel board, replace the EMI gasket STG10-10,
L=200 (Code No. 6114-901688) together with the panel board.
2. Remove the twelve M3 × 8 pan screws with spring washers and remove the
top shield cover.
Main board
3. Disconnect the flat cable, power cable and speaker cable from the main
board.
4. Remove the three M3 × 8 pan screws with spring washers and two M3 × 8
binding head screws with toothlock washers and remove the main board
from the bottom cover.
M3 × 8 pan screw with spring washer
Power cable
Speaker cable
Flat cable
Main board
Isolation sheet
Bottom cover
5. Remove the six spacer bolts (L=21) and five M3 × 8 pan head screws with
the spring washers.
Main board
Spacer bolt
on PATTERN connector
6. Remove the two M2.6 × 8 pan screws with spring washers and two spacer
bolts on the PATTERN connector.
2. Remove the three cables: main board - temp board connection cable, temp
board - jack board connection cable, and flat cable.
3. Remove the four M3 × 8 pan screws with spring washers to remove the temp
board.
4. Remove the four M3 × 8 pan screws with spring washers to remove the jack
board.
Jack board
Flat cable
2. Disconnect the AC power cable and power cable from the power unit.
5
M3 × 8 pan screw
with spring washer
3. Remove the four M3 × 8 pan screws with spring washers to remove the
power unit.
4. Remove the two M3 × 8 pan screws with spring washers and washers to
remove the power unit insulator from the power unit.
M3 × 8 pan screw
with spring washer
Washer
Power unit insulator
1. Remove the four M3 × 8 binding head screws with spring washers to remove
the rear cover.
M3 × 8 binding head screw
with spring washer
Rear cover
Example: JB-944BK
2. Remove the M3 × 6 binding head screw with spring washer ro remove the
needle electrode clamp.
3. Remove the two M3 × 8 pan screws with spring washers which secure the J.
box board to the front cover.
Cable flange
5
Keytop (Ø11) M3 × 8 pan screw
with spring washer
J. box board
Shield sheet
Front cover
4. Remove the J. box board and shield sheet from the front cover.
NOTE
• The three keytops (Ø11) are only inserted into the keytop holes on
the front cover. Make sure not to lose the keytops.
• The cable flange is inserted into the slot on the front cover.
5. Remove the six M3 × 6 pan screws with spring washers and washers to
remove the shield sheet.
M3 pan screw
with spring washer
Shield sheet
J. box board
6. Remove the three spacer nuts (L=10) and spacer bolts (L=6) from the J. box
board.
Electrode junction box cable
J. box board
7. Remove the M3 × 14 pan screw with spring washer and disconnect the
electrode junction box cable from the J.box board.
When ordering parts from your Nihon Kohden representative, please quote the
NK code number and part name which are listed in this service manual, and the
name or model of the unit in which the required part is located. This will help
us to promptly attend to your needs. Always use Nihon Kohden parts to assure
maximum performance from your MEB-9400 system.
Service Manual MEB-9400 6.1
6. REPLACEABLE PARTS LIST
Main Unit
NOTE
When replacing the panel board, replace the EMI gasket STG10-10,
L=200 (Code No. 6114-901688) together with the panel board.
11
17
10
12
E
C
16
a
14
I
6
D
13
B
G
15
F
J
9
5
a
1
6
8
7
2
A
4
3
A UT-0800 1
J. box board (2CH) for JB-942BK
UT-0801 1 J. box board (4CH) for JB-944BK
B 687409 1 Electrode junction box cable,
NKD-0092-1 (C18PEMI9-5), L=5000
JB-942BK
4
3
9
2
1
JB-944BK
7
5
11
A
6
8
4
10
3
2
1
WARNING
When connecting external equipment to the following connectors
with mark, ensure that the external equipment complies with the
IEC 60601-1 safety standard for medical equipment and CISPR 11
Second Edition 1990-1999 Group 1 and Class B standard, or the
equivalent. When the external equipment does not comply with the
IEC 60601-1 safety standard, use a locally available medical use
isolation transformer unit between the external equipment and the
AC outlet.
AUDITORY Connector
GOGGLE Connector
PATTERN Connector
1
Pin No. Signal Pin No. Signal
6 1 Red 9 Not used
11 2 Green 10 DGND
3 Blue 11 Not used
4 Not used 12 Not used
5 DGND 13 H-SYNC
6 DGND 14 V-SYNC
7 DGND 15 Not used
8 DGND
7
TEMP Connector (MEB-9400A only)
TEMP
GND
External Speaker
Cable connector: Ø3.5 mono plug
Speaker: Input range ≥ 4 W, input impedance = 8 Ω
36 19
Foot SW Connector
DGND
USB Connector
2 1
Pin No. Signal
1 VBus
2 D–
3 4 3 D+
4 DGND
Contact information is accurate as of April 2017. Visit www.nihonkohden.com for the latest information.
The model and serial number of your instrument are identified on the rear or bottom of the unit.
Write the model and serial number in the spaces provided below. Whenever you call your representative concerning
this instrument, mention these two pieces of information for quick and accurate service.
Your Representative