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0051
Operator Manual
B8350047611
Galileo System
MIZAR-LIGHT
Digital EEG-EP Multifunction System
28 Channel (Wide Band)
Operator Manual
(Booklet)
0051
EDITION:
July 2007
EBNeuro
- FLORENCE -
ITALY
MIZAR LIGHT Operator Manual
TABLE OF CONTENTS
CHAPTER 6 – INSTALLATION
6.1 SYSTEM COMPOSITION 6-1
6.1.1 MAINS ISOLATION MODULE 6-1
6.1.2 A4 THERMAL PRINTER (OPTIONAL) 6-1
6.1.3 WORKING MONITOR 6-3
6.1.4 PERSONAL COMPUTER 6-5
6.1.5 KEYBOARD 6-7
6.1.6 MOUSE 6-7
6.1.7 SINGLE PAGE PRINTER (OPTIONAL) 6-8
6.1.8 BE LIGHT AMPLIFIER AND FLASH LED STIMULATOR
SUPPORTING ARMS 6-9
6.1.9 BE LIGHT ACQUISITION MODULE 6-11
6.1.10 EXTERNAL STAND FOR ACQUISITION BOX AND
FLASH STIMULATOR 6-16
6.1.11 LED FLASH STIMULATOR (OPTIONAL) 6-18
6.1.12 MMS MULTIMODAL STIMULATOR MODULE (OPTIONAL) 6-19
6.1.13 EXTERNAL PATTERN STIMULATOR MODULE (OPTIONAL) 6-20
6.1.14 PATTERN STIMULATOR MONITOR (OPTIONAL) 6-20
6.1.15 VIDEO-EEG CONTROL SYSTEM (OPTIONAL) 6-21
6.1.16 LAN NETWORK (OPTIONAL) 6-22
6.1.17 PCMCIA INTERFACE MODULE 6-23
6.1.18 BE NET INTERFACE MODULE 6-23
6.1.19 SYSTEM GENERAL POWERING 6-24
6.2 GENERAL INTERNAL CABLING DIAGRAM 6-25
6.2.1 BASE CONFIGURATION 6-27
6.2.2 MMS CONFIGURATION 6-31
6.2.3 CONFIGURATION WITH THERMAL PRINTER 6-32
6.2.4 PATTERN STIMULATOR CONFIGURATION 6-33
6.2.5 LAPTOP COMPUTER CONFIGURATION 6-34
6.2.6 LAPTOP COMPUTER
AND THERMALPRINTER CONFIGURATION 6-36
6.2.7 EXTERNAL POWERED STAND 6-37
6.3 SYSTEM POWERING-UP 6-38
CHAPTER 8 - MAINTENANCE
8.1 GENERAL INFORMATION ABOUT MAINTENANCE 8-1
8.2 REPLACING FUSES 8-2
8.3 REPLACING THE THERMAL PRINTER PAPER 8-5
8.4 PERIODIC CALIBRATION 8-8
8.4.1 “PHYSICAL” SYSTEM CALIBRATION 8-8
8.4.2 “RECORDING” SYSTEM CALIBRATION 8-9
8.5 TEST OF PATTERN STIMULATOR MONITOR 8-10
8.6 SAFETY CHECKS 8-12
8.6.1 ENVIRONMENT ELECTRICAL EQUIPMENT 8-12
8.6.2 INTERCONNECTION CABLES AND CONNECTORS 8-13
8.6.3 MAINS CABLE 8-13
8.7 CLEANING THE DEVICE 8-14
8.7.1 FIBER OPTIC CONNECTORS 8-15
8.7.2 ELECTRODES, INTERCONNECTING CABLES
ELECTRODE/PATIENT INPUT BOX AND ACCESSORIES 8-16
8.7.3 OPTICAL DISK READER, CD-ROM AND
REMOVABLE CARTRIDGES 8-16
8.7.4 MEMORY SUPPORTS 8-17
8.7.5 WRITE HEAD OF THE THERMAL PRINTER 8-18
8.8 PARTICULAR WARNINGS FOR CRITICAL COMPONENTS 8-20
CHAPTER 1
INFORMATION ABOUT SAFETY
Issues:
The observance of the operating procedures and of the warnings described in this
Manual is a basic requirement for the correct working of the equipment and to
guarantee the patient’s and the user’s safety.
The Manual must be read in every part in front of the equipment before using it,
in order to become familiar with the operating procedures, the commands, the
connections to the peripheral instruments, and the precautions for a correct and
safe usage.
The Operator Manual should be kept, complete and readable in every part, in a
safe place, and, at the same time, it should be rapidly accessible to the user when
using the equipment.
The equipment Service Manual is available on request. This Manual contains all
information directed to the qualified staff in charge for servicing.
1.1.1 CONVENTIONS
NOTE
The NOTE messages contain important informations, which must be noticeable
with respect to the regular text. Usually they have useful information for the
operator: detailed data on the correct operating procedures of the instrument.
WARNING
The WARNING messages show in the manual before operations and procedures,
which must be strictly observed in order to avoid possible loss of data or damage
to the equipment.
ATTENTION
The ATTENTION messages show in the manual in correlation with the description
of procedures and operations, which could cause injury to the operator or to the
patient, if not correctly performed.
• The equipment must be opened and its internal parts must be accessed to by
maintenance qualified staff only expressly authorized by EBNeuro.
• The environment where the equipment is used must be in compliance with the
safety prescriptions.
• The electric wiring of the building must be designed according to the standards
and perfectly working.
• Parts of the equipment that can be replaced by the user and accessories must be
replaced with items of the same kind and with the same characteristics.
ATTENTION
Prior to usage, verify that all the safety requirements are satisfied.
The equipment must not be supplied by or connected to other instruments until
such safety conditions are restored.
WARNING
It is strongly recommended to check the overall functionality of the system before
starting any recording.
In case any anomalies or malfunctioning should be noticed, immediately
disconnect the patient from the system (if a patient is already connected), switch
off the system and ask for service to qualified personnel.
In particular (for example) if, with a patient connected to the system, some “flat”
tracing should be noticed on the monitor during recording : in this case if the
problem should not be easily solved (poor electrode connection, broken lead etc)
immediately acts as above, disconnect the patient, do not se the system and ask
for servicing.
WARNING
During “long term recording” (more than one hour) it is strongly recommended to
periodically check that all the system works regularly without any sign of
malfunctioning.
If any anomalies or flat traces should be noted act as in the previous warning.
In particular any electrode site used for long term must be checked for irritation
and redness. Check each electrode periodically to evaluate the skin condition
under the electrode. Redness, blistering and permanent skin scarring can occur if
electrode are not regularly monitored.
Leakage current
The maximum patient leakage current from the equipment, measured according to
the IEC 601-1 standard (for Class I Type CF) is less than 10 μA.
However take care when using the equipment at the same time with other
instruments. In the event the patient is connected to several instruments at the
same time, it is necessary to remember that the sum of the dispersion currents
determined by each instrument may exceeds this value.
Patient Connection
All patient connections to the equipment are trough the device using the input
sockets provided, or trough the dedicated connector for pre-wired headset. Any
patient electrodes connected to the device by any other means constitutes an
unsafe condition that could result in injury or death to the patient.
ATTENTION
All connections on the headbox are isolated from AC power ground.
Do NOT join these connections to earth ground or AC power ground since such an
action constitute an unsafe condition that could result in serious injury or
accidental death to the patient.
ATTENTION
The electrode and sensor through which the signal is captured from the body of
the patient are not part of the amplifier system, in any case it is MANDATORY to
use only electrode or sensor approved for commercial use by FDA (USA) or CE
marked (93/42EEC directive)
To ensure the safety of the patient and the operator, please follow all the warnings
and caution listed in this manual.
Connect to the equipment the proper specified power supply only. In order
to guarantee the electrical safety requirements, the equipment must be by
means the proper medical AC/DC adapter only. The power supply is supplied
by EBNeuro with the equipment
• Take care when using the equipment at the same time with other
instruments. In the event the patient is connected to several instruments at the
same time, it is necessary to remember that the sum of the dispersion currents
determined by each instrument may endanger his life.
• Take care when using the equipment at the same time with other radio-
frequency instruments. In the event the equipment is used in a surgery room
at the same time with a radio knife (Radio-Frequency instrument = RF), it is
necessary to hold the radio knife point as far as possible from the electrodes, in
order to reduce as much as possible the risk of RF currents making on such
electrodes and the consequent burns. Therefore it is necessary to use electrodes
with a larger surface contacting the patient body, in order to limit the RF
current density to acceptable values. In case it is not possible to use the proper
electrodes, it is recommended to disconnect the patient from the equipment
before using radio-frequency instruments.
• Avoid contact of patient and electrodes with conductive metal items. When
the equipment is connected to other instruments supplied by the mains, the
whole input circuit to which the patient is connected is electrically isolated
(floating isolation). It is necessary to avoid the patient and any conductive part
connected to the patient (electrodes, connectors, and transducers) coming into
contact with conductive parts (ground included). Please observe this precaution
to avoid compromising the equipment isolation level. This precaution must be
observed in order to avoid that accessible metal parts of the device get in touch
with external conductive parts thus damaging the isolation level of the
equipment.
• Do not connect items (accessories and peripherals) which are not specified
as part of the system by EBNeuro. In order to guarantee all the safety
requirements, it is necessary to use only the accessories and peripherals
specified in this Manual as part of the system, which have been tested with the
equipment. The usage of accessories and consumer goods supplied by other
manufacturers or not specifically indicated by EBNeuro does not guarantee the
safety and the correct working of the equipment. Use only peripherals in
compliance with the standards of the class they belong to.
• The equipment and its internal parts are not protected against the inflow
of liquids. Avoid submitting the equipment to the risk of water dripping,
sprinkling or immersion and using the equipment where such risks are present.
Devices in which liquids have accidentally penetrated must be immediately
cleaned and checked by authorized qualified staff.
WARNING
Keep the original CD-ROM of the GALILEO_NT software in a safe place.
WARNING
EBNeuro does not guarantee the compatibility of this software with packages of
other manufacturers and is not responsible for the consequence of any
incompatibility.
Viruses are sometimes designed to be latent for a certain period after they have
been introduced. Once they become active they can appear as harmless sudden
humorous messages on the screen or as a catastrophic contamination and
complete destruction of all the programs contained in the hard disk.
Viruses generally spread by detecting when a floppy disk is being used, and
including a hidden copy of themself on it. When that disk is used on another
system, the latter will be infected as well. Best protection against all kind of
viruses is prevention.
You must be very careful if you want to add more software packages to
GALILEO_NT on the system hard disk. Make sure that such packages are
accompanied by the licence of their software houses. Do not use diskettes of
uncertain or unknown origin.
In the case the system begins to function incorrectly and strangely, immediately
isolate it together with all the other computers usually connected to it for data
exchange.
In this case it is necessary to have the system checked by qualified technical staff
in order to establish whether it is really infected by a virus or if its malfunctioning
is due to different causes (for ex the hardware is damaged).
WARNING
EBNeuro guarantees that the original copies of the GALILEO_NT software supplied
with the system and every successive software upgrade are virus-free.
EBNeuro is not responsible for the consequences of any third party virus
introduction.
For location of the ATTENTION symbols placed on the equipment, please refer
to chapter 5 “Connections, Commands and Controls” and chapter 6 “Installation”
of this Operator Manual. This chapter shows the pictures of the equipment panels
with the corresponding commands, connections, symbols, and labels. Each
attention symbol comes with a detailed explanation of its meaning.
The separate collection and recycling of your waste equipment must be accorded
to the current directives on waste collection and treatment.
For more information about where you can drop off at “End of Life” your waste
equipment for recycling, please contact the appropriate public office ( Ecology
and Nature department), your household waste disposal service or the shop where
you purchased the product or contact the manufacturer of device at
www.ebneuro.com or at support@ebneuro.com or contact the EBNeuro main
office (par 9.2 of the manual).
Safety, performances and effectiveness of device and availability of its spare parts
are guaranteed by the manufacturer until device “End of Life”.
EBNeuro, as manufacturer, define the “End of Life” time for MIZAR LIGHT
module in 7 (seven) years starting from the production date (see identification
label).
The form shall be sent either directly or through any subsidiary or the nearest
authorized distributor to the Quality Assurance Department of any EBNeuro
operating office. The list of the main EBNeuro head and branch offices in Italy
and abroad is contained in chapter “Request for assistance” of this manual.
To the purpose of helping EBNeuro take any timely and effective corrective
measure, it is extremely important that the user performs a careful inspection of
the equipment performances in order to identify or foresee any dangerous
situation for the patient’s and the user’s health.
For this reason, the user shall give immediate communication of any malfunction
or deterioration of the characteristics or the performances of the equipment or any
mistake found in these instructions that caused or could cause serious damages to
the patient’s and the user’s health.
In this case, the user may send a photocopy of the proper duly filled-in Post-
Marketing Vigilance Form (see enclosure 1.8), or communicate in writing the
data indicated in the form.
The form shall be sent either directly or through any subsidiary or the nearest
authorized distributor to the Quality Assurance Department of any EBNeuro
operating office. The list of the main EBNeuro head and branch offices in Italy
and abroad is contained in chapter “Request for assistance” of this manual.
enclosure 1-7
System/device name……….................................................................................................
Date:...........................
Signature
...............................................
enclosure 1-8
System/device name.......................................................................................………..........
User’s address....................................................................................................................
Phone......................................................... Fax .............................................…................
Data:...........................
Signature
...............................................
Packaging materials were conceived and produced so as to allow the re-usage and
the salvage, including recycling, of most part of materials and to reduce the
quantity of garbage or residual products for discharge as much as possible. In
particular, packaging materials have been produced so as to limit the presence of
harmful metals and of other dangerous substances to minimum quantities in
emissions, ashes or lixiviation residual products. The total concentration levels of
heavy metals such as Lead, Cadmium, Mercury and hexavalent Chrome contained
in the packaging materials are in accordance with the limits established by the
directives in force related to this subject.
ATTENTION
Please refer to local codes and laws for proper disposal/recycle requirements of
packaging and consumer materials and of the device when at its “end of life”.
70 % of rated voltage
(voltage dip 30 %)
IEC 61000-4-11 for 25 cycles
0 % of rated voltage
(voltage dip 100 %)
for 5 cycles
Magnetic fields 3 A/m
at mains
frequency
(50/60 Hz)
IEC 61000-4-8
Radiated RF Non-life-supporting IEC 60601-1-2 Residential
fields equipment
3 V/m Test Levels (Note 4)
IEC 61000-4-3 from 80 MHz to 2.5 GHz
Radiated RF Non-life-supporting
fields equipment
3 Vm
IEC 61000-4-6 from 150 kHz to 80 MHz
Measures to be taken
Note 1: The foor should be in antistatic material (wood, ceramic, ect.). If covered by
syntetic material, relative humidity should be maintained at least at 30%
Note 2: The quality of the electrical power supply and the mains frequency magnetic
fields should be typical of domestic, commercial and hospital environments.
Note 3: If the operator has to work without a break while power supply is interrupted, it
is necessary to have power supplied through a UPS (Uninterruptible Power Supply) unit.
Note 4: Mobile or portable radio frequency (RF) communication appliance should be
used at longer distances than those indicated on the following Table 3.
Electromagnetic transient can happens near appliances bearing the symbol shown below
The following table shows the minimum distances in meters, according to the
maximum power at RF system output.
The operator must remember that the intensity of the electromagnetic fields
generated by fixed transmitters (radio-base stations for cellular or cordless phone,
TV and radio transmissions, amateur radio transmission, etc.) cannot be
predicated on theoretical basis.
Since it is supposed that the reusable electrodes are used on the intact skin, the
risk for infection propagation is very low. It will be sufficient to follow the
disinfecting and sterilization procedures described in the manual.
We remind that the disposable electrodes provided with the instrument are to be
used exclusively on intact skin.
ATTENTION
The residual products of every exam (disposable electrodes, gel or paste residues,
etc.) must be considered as potentially infected and therefore treated as special
waste. Please refer to local codes for proper disposal of such materials.
0051
The MIZAR LIGHT medical system has been manufactured by applying the
quality guarantee system approved for design, manufacturing and final check of
the product and meets the requirements of Annex II of the 93/42/EEC Directive
on Medical Devices (MDD). For these reasons the medical system is marked with
the CE mark.
The approval is issued by IMQ S.p.A. (Milan – Italy) as Notified Body notified by
European Commission. IMQ Notified Body identifier number is 0051.
The BE LIGHT equipment (acquisition and amplification box), included into the
system, is marked with the cCSAus quality mark. This safety mark is valid both
Canadian and U.S. market.
CHAPTER 2
GENERAL DESCRIPTION
The good compromise between number of channels (28 channels standard) and
the very small overall dimension, together with the high quality of the signal (low
noise, high sensitivity, large dynamic and optimal CMRR) makes the BE_LIGHT
the ideal tool for both the researcher and the clinical neurophysiologist.
Cognitive Potentials from P300 to the CNV (using virtually any stimulation
protocol) can be recorded, thus allowing for topographic mapping and source
localisation techniques to be used. The high-resolution BE_LIGHT recordings are
invaluable in the neurosurgery, both for high-resolution EEG and Cortical EEG
recording protocols.
The fiber optic communications cable allows the acquisition module (BE_LIGHT
patient input box) to be located up to 500 meters from the control room where the
main system resides. This provides an ideal solution for long-term Video EEG
and Sleep recordings.
In order to allow the user to control the acquisition module remotely, BE_LIGHT
includes a built-in ohmeter display that (through a LED matrix and a control key)
allows the user to check electrode impedance.
All this without the need to walk back and forth from the patient to the monitoring
room!
The acquired tracings can be saved on the system hard disk or on a removable
hard disk cartridge (WORM or M.O. rewritable). The acquired tracings can be
directly transferred to the main archive via the installed network.
MIZAR-LIGHT is a computer-based system for the acquisition and the digital re-
reading of electroencephalographic signals. The control of functionalities of the
MIZAR-LIGHT system is achieved in two levels:
The first one is represented by dedicated electronics devices created by EBNeuro,
that perform the acquisition and amplification of the signals and the stimulation
(for EP methodologies), the second one is represented by personal computer
which manage digital processing of the signal, the display and storing of acquired
tracings . The PC also manages the network, the peripherals and the archives and
above all performs all the post-processing of acquired signals and statistical
evaluation.
• An ordered and compact archive, thanks to the storage on high capacity supports
and the computerised managing. The standard system is provided with a 10GB
hard disk, with possibility to insert optional high capacity supports such as
removable hard disk (a lot of GB) and drivers for magnetic-optical disk or DVD.
• Possibility to get the previously stored EEG signals in the analogic form to
perform elaboration jobs and analysis.
• Display on high resolution monitors with the limits of the Video Board of PC
only, with the possibility to change the number of traces, to enlarge a segment
and perform instrumental measures. The standard system is provided with 15”
LCD colour monitor, with the possibility to connect optional bigger monitors.
• Usage of pen-less printers able to change the number and dimensions of the
tracings and to edit comments and diagrams.
• Network connection for the access to the archive of more than one station at
the same time. The system can be configured as a network server and as a
Client, or work disconnected from the network as a Stand Alone station.
The following figure describes all the standard and optional elements/modules of
the MIZAR-LIGHT system:
The following figure 2.3 describes the “logical” connections among the listed
elements/modules.
FIBER OPTIC
Safety PATIENT
CONNECTION LOGIC/SIGNAL
PATTERN STIMULATOR CONNECTIONS
The whole system is developed and built in compliance with the IEC 601-1-1
international standard. The system is Class I and applied part provide a isolation:
- CF type patient input BE LIGHT
ACOUSTIC STIMULATOR
- BF type stimulators outputMODULE MICROPHONE ACOUSTIC
SPEAKER
- B type auxiliary input/output
ELECTRIC STIMULATOR
STIMULATOR
port
MANAGEMENT BOX MONITOR
LED VISUAL
STIMULATOR
KEYBOARD
FLASH STIMULATOR The system is CE marked according 93/42/EEC directive on Medical Devices.
(XENON)
The marking procedures is in according to Annex II of directive for Class IIb
ANALOGIC
devices.
CAMERA
For these reasons the system is marked with CE0051 mark.
OUTPUT
THERMAL
PRINTER
110/220 VAC IEC 601-1
PC
CAMERA MOVEMENT CONTROLL PRINTER
(OUTSIDE THE PATIENT AREA)
110/220 VAC
(**) SOFTWARE
GALILEO NT
ISOLATION
TRANSFORMER (*) To the Pattern stimulator when
used inside the patient area
Safety
The whole system is developed and built in compliance with the IEC 601-1-1
international standard. The system is Class I and applied part provide a BF type
isolation.
CHAPTER 3
TECHNICAL CHARACTERISTICS
Working mode
Continuous, within the specified limits
External dimensions and weight (complete system with monitor and printer)
Max height: ~ 1400 mm
Max width: ~ 650 mm
Max depth: ~ 650 mm
Max weight: ~ 80 Kg
Working mode
Continuous, within the specified limits
External dimensions and weight (complete system with monitor and printer)
Max height: ~ 35 mm
Max width: ~ 135 mm
Max depth: ~ 105 mm
EP bipolar channels 4
High-Pass filters
EEG monopolar channels (1,2,3…21)
0.099Hz 1st order filter
EP bipolar channels (A,B,C e D)
0.099Hz 1st order filter
Polygraphic monopolar channels (22,23,24)
DC or 0.099Hz 1st order filter
Sampling Skew
All acquired channels will be sampled simultaneously
(no sampling skew)
93µs max (for EEG polygraphic monopolar
channels)
0µs (for bipolar channels)
CMMR >100 dB
IMRR >120 dB
Sensitivity
Setting: Adjustable via software for each channel
in “single trace” mode or “general
master” mode
Values: 0.5 – 0.7 – 1 – 1.4 – 2 – 5 – 7 – 10 – 20 -
50 – 70 – 100 – 140 – 200 (µV/mm) e
5 – 10 – 50 – 100 – 500 (mV/mm)
Technical characteristics 3-9
Operator Manual MIZAR LIGHT
HF filtering system
Setting: Adjustable via software for each channel
in “single trace” mode or “general
master” mode
Default freq. values: 30 – 50 – 70 – 150 (Hz)
Attenuation charact.: -3dB slope –12dB/octave
LF filtering system
Setting: Adjustable via software for each channel
in “single trace” mode or “general
master” mode
Default freq. values: 0.016 – 0.53 – 1.6 – 5.3 (Hz)
Time constants: 1 – 0.3 – 0.1 – 0.03 (sec)
Attenuation charact.: -3dB slope –6dB/octave
Calibration signal
Wave form: Square wave internally generated
frequency = 0.5 Hz automatic or manual
Amplitude: 5 – 10 – 20 – 50 – 100 – 200 – 500 – 1k
(µV) Toll. 5%
Standards applied
93/42/EEC Medical Device European Directive
(MDD);
EN 60601-1 General safety standard for
Electromedical equipments (CEI 62-5)
EN 60601-1-1 Collateral safety standard for
Electromedical systems (CEI 62-51)
EN 60601-1-2 Collateral safety standard for Electro
Magnetic Compatibility (EMC)
EN 60601-1-4 Safety standard for equipment containing
programmable systems
EN 60601-2-26 Particular safety standard for
Electroencephaographs
Interfaces:
Rx/Tx HP 10/100 Mbit fibre-optic cable for amplificator
module link
RJ45 for Ethernet 10/100 bT Network link.
Triad F/M 4+1 per external power supply SW173
MCH Triad - HiRose HR12-10R-8SDL connector for RS232,
Trigger I/O, power supply
QM10-8R-PR HiRose connector for analogic output of digital
signals.
Signals:
2x RS232 capable of 115200 bps (Tx/Rx)
TTL trigger out
TTL trigger in
TTL flash out
10/100 Mbit Tx /10 Mbit Rx fibre optic cable
10/100 bT Ethernet LAN
Analog out for serial digital differential analog out.
Capacity:
Corresponding IEEE 802.3 CSMA/CD.
TCP/IP and DHCP supported.
Automatic recognition of BE Net modules connected to the
LAN.
Software control upload.
Power supply:
External AC/DC adapter (IEC 601-1 Class I Type B).
Single power supply possibility for BE NET module and
amplificator module with suitable cable.
Other interfaces:
Green led: 3.3 V power on.
“*” Yellow led : EtherNet. Auto-negotation controller.
“#” Yellow led : EtherNet. Link 10 /100 Mbit controller.
“o" Yellow led: EtherNet. LAN controller.
Consumption:
200 mA @15V (typ)
Case:
Material: ABS Plastic
Dimension: 137x78x19 mm
Weight: 0.2 Kg
Isolation
Fiber optic link with EBN amplificator module.
1500 Vrms isolation transformer (through impulses) for LAN
link.
Model SW173
Model MW160
Output 15VDC @ 3A
Model MPU50-106
Output 15VDC @ 3A
Working mode
Continuous, within the specified limits
External dimensions
Max height: ~ 110 mm
Max width: ~ 325 mm (with handles)
Max depth: ~ 220 mm
Weight 9 Kg
Working conditions
- Temperature +5°C ÷ +35°C
- Relative humidity 30% ÷ 75% RH
- Atmospheric pressure 700hPA ÷ 1060hPA
External size
- Max height ~ 180mm
- Max width ~ 280mm
- Max depth ~ 330mm
Weight 8 Kg
Number of channels 24
Number of channels 8
Working mode
Continuous, within the specified limits
External dimensions and weight (complete system with monitor and printer)
Max height: ~ 100 mm
Max width: ~ 170 mm
Max depth: ~ 175 mm
Stimulators
Electric: Double current stimulator
Acoustic: Acoustic stimulator (click, tone)
Visual: LED flash stimulator
LED Goggles stimulator
Pattern stimulator
τ
R=1000Ω
Where:
τ = duration of stimulation impulse
T = repetition rate
I = stimulation intensity
R = load resistance
The electric stimulator can deliver, for a single pulse, a maximum peck current
IMAX = 100mA with a max Duty Cycle = 1%
From the following formula we learn that the RMS value of the maximum
deliverable current, independently of the load, is:
IMAXRMS = 10mA
The electric stimulator supplies a maximum peak power PMAX = 2.5W on a load of
2500Ω, on which it at the same time delivers VMAX = 250V and IMAX = 100mA.
The maximum RMS power is:
PMAXRMS = R x (IMAXRMS)²
PMAXRMS = 0.25W
The following diagram shows the trend of the RMS maximum power expressed in
W, depending on the load measured in KΩ for a single stimulation pulse
delivered.
PMAXRMS
(W)
0,3
0,25
0,2
0,15
0,1
0,05
Load
(KΩ)
0
0 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16
Numeric section:
Sampling frequency: 48kHz
Minimum resolution: 12 bit
Analogic section :
Stimulation intensity range: 10 ÷ 132 dB SPL
Masking intensity range: -40 ÷ +10 dB REL
Intensity resolution: 1 dB
R 1/F P
Available masking :
White noise
Pink noise Band @ -6dB:
125, 250, 500, 750, 1000, 2000
3000, 4000, 6000, 8000 Hz
Applied Standards
93/42/EEC Medical Device European Directive (MDD)
EN 60601-1 General safety standard for electro medical systems;
EN 60601-1-2 Collateral safety standard for devices EMC test;
Adjustment :
From PC via software
Not classified
Common (IP20)
Operational mode
Continuous, within the specified limits
Working mode
Continuous, within the specified limits
Line period: 32 µs
Frame frequency: 60 Hz
Colours setting:
Regular colour: Adjustable among 16 millions of colors
Chessboard: B/W or two selectable colours
Horiz./Vertical bars B/W or two selectable colours
Sinus. Horiz./Vertical bars B/W or one selectable colour
Sectors Two selectable colours for each sector,
with possibility to select two different
colours for each sector
Fixation point:
Colour: User adjustable
Size: User adjustable
Position: User adjustable
Shape: - Circle
- House
- Boat
- Fish
- Face
Image masking:
Colour: Black
Dimension: User adjustable
T/2
T
Stimuli actuators
Dedicated VGA monitor
RAM 256MByte
Controls Keyboard
Mouse
CHAPTER 4
COMPONENTS AND ACCESSORIES
STANDARD COMPONENTS
Operator Manual:
B8350047611 MIZAR-LIGHT Operator Manual – ENG 1
B8350047612 MIZAR-LIGHT Operator Manual – GER 1
B8350047613 MIZAR-LIGHT Operator Manual – FRE 1
B8350047614 MIZAR-LIGHT Operator Manual – SPA 1
B8350047616 MIZAR-LIGHT Operator Manual – DUT 1
Monitor:
B9730200022 15” LCD monitor Kit 1
B9730200023 17” LCD monitor Kit 1
B9730200024 19” LCD monitor Kit 1
B9730200025 multimedial LCD monitor Kit 1
Personal Computer:
B9730601046 minidesk PC Kit (DELL) 1
B9730601047 desk PC Kit (DELL) 1
B9730601048 laptop PC Kit DELL (entry level) 1
B9730601049 laptop PC Kit DELL (high level) 1
Software Option:
B9740540050 OFFICE XP software Kit CD ENG
B9740540055 OFFICE XP software Kit CD GER
B9740540060 OFFICE XP software Kit CD FRE
B9740540065 OFFICE XP software Kit CD SPA
B9740540070 OFFICE XP software Kit CD DUT
B9740540095 WORD XP software Kit CD ENG
B9740540100 WORD XP software Kit CD GER
B9740540105 WORD XP software Kit CD FRE
B9740540110 WORD XP software Kit CD SPA
B9740540115 WORD XP software Kit CD DUT
Stimulators Option:
B9730200008 Stand alone visual Pattern stimulator kit with 17” monitor
B9100420200 Stand alone visual Pattern stimulator kit no monitor
B9100581240 kit MMS stimulators module for BE LIGHT
B9100460500 MMS visual Pattern stimulator kit
B9100460300 MMS audio stimulator kit
B9100460400 MMS first electric stimulator kit
B9100460410 MMS second electric stimulator kit
B9100630300 LED flash stimulator kit for BE
B9100630310 LED flash stimulator kit for BE with pantograph arm
B9700033000 Goggles visual stimulator for BE
CD/DVD Writer:
B9109000016 Internal CD-ROM Writer Kit
B9109000017 External CD-ROM Writer Kit
B9109000030 DVD-ROM Writer Kit
B9730650034 Writable CD (682 MB)
B9730651044 DVD ROM 4.7 GB DVD-R
PC Expansion :
B9730680009 HD Kit >100 GB EIDE
E9730650025 Kit PCMCIA Driver - 2 front slot
UPS option:
B9730301000 UPS 700VA - 220V/50Hz
B9730301001 UPS 1000VA - 220V/50Hz
B9730301002 UPS 1500VA - 220V/50Hz
B9730301003 UPS 2000VA - 220V/50H
Service Manual:
B831004700 BE_LIGHT amplifier Service Manual - English
CHAPTER 5
CONNECTIONS, COMMANDS AND CONTROLS
1. Trolley
2. BE-LIGHT acquisition module
3. Flash a LED Stimulator
4. Monitor
5. PC
6. PC Keyboard
7. Mouse
8. Printer
9. Multimodal Stimulator Module (MMS)
10. Amplifier support
11. Pantograph arm
12. Rear panel connectors
13. Isolation Transformer
14. Rear Panel
15. A4 Thermal Printer
16. Pullout shelf for thermal paper
17. Pullout Keyboard shelf
18. Loudspeakers
11
17
7
2
10
5
2 4
18
12
14
10
13
17
15
16
19
23
24
22
25
28
26
27
23
24
19
21
20
28
21
Where:
25. Connector for fiber optic connection to the system PC through the PCMCIA
interface
27. Connector for serial connection to specified optional peripherals (i.e. Flash
Led Stimulator)
The following figure shows the 40 patient input sockets configuration in which
the different type of inputs are indicated:
• 21 sockets for EEG monopolar inputs with common reference (AC coupling)
In the following two paragraphs the patient input sockets will be explained in
details for two EEG inputs configurations: the standard 10-20 system
configuration and the "mirror" configuration.
EEG Monopolar Inputs : labelled with numbers ranging from “1” to “21” and
with the corresponding 10-20 system names, displayed on the cover of the BE
LIGHT acquisition module (see the following table of correspondence). These
inputs accept AC coupled signals only, directly coming from acquisition sites on
the patient.. The amplified signal is the difference of potential between each of the
electrodes and the “common reference” electrode for EEG signals (connected to a
NE socket).
1 A1 11 C3
2 Fp1 12 Cz
3 Fp2 13 C4
4 A2 14 T4
5 F7 15 T5
6 F3 16 P3
7 Fz 17 Pz
8 F4 18 P4
9 F8 19 T6
10 T3 20 O1
21 O2
Polygraphic Monopolar Inputs : labelled with the numbers “22”, “23” and “24”.
These inputs accept AC or DC coupled signals, directly coming from acquisition
sites on the patient.. The amplified signal is the difference of potential between
each of the electrodes and the “separate reference” electrode for Polygraphic
signals (connected to the NEP socket).
Bipolar Inputs : labelled with the letters “A”, “B”, “C” and “D”. These inputs
accept signals directly coming from acquisition sites on the patient.. The
amplified signal is the difference of potential between the “+” and “-“ electrode
of each of the inputs.
Calibration : this two sockets labelled with the proper dedicated symbol, are
provided for outputting the internal calibration signal: this may be used to connect
the signal to any inputs to test the whole amplifier chain including the lead used
for the connection.
ATTENTION
All the patient applied parts and corresponding input sockets of the BE LIGHT
acquisition module (patient inputs and pre-wired headset connector) are
electrically isolated from the mains according to IEC 601-1 standard requirements
for Class I, Type CF equipments. This characteristic is indicated to the operator by
the proper symbol placed on the external cover of the device in correspondence of
the input sockets (see description of par. 1.4 of the manual).
ATTENTION
All the 40 input sockets of BE LIGHT acquisition module accept Female 1.5mm
standard safety connectors (complying the DIN 42802 standards).
EEG Monopolar Inputs : labelled with numbers ranging from “1” to “21” and
with the corresponding 10-20 system names swapping the left side with the right
side of the patient's head (see the following table of correspondence). To get the
configuration of these labels on the plastic cover of the BE LIGHT, place the
related stickers provided together with the BE LIGHT acquisition module. These
inputs accept AC coupled signals only, directly coming from acquisition sites on
the patient.. The amplified signal is the difference of potential between each of the
electrodes and the “common reference” electrode for EEG signals (connected to a
NE socket).
1 A2 11 C4
2 Fp2 12 Cz
3 Fp1 13 C3
4 A4 14 T3
5 F8 15 T6
6 F4 16 P4
7 Fz 17 Pz
8 F3 18 P3
9 F7 19 T5
10 T4 20 O2
21 O1
The other input sockets have the same technical characteristics explained in the
previous paragraph.
30 29 31 32
Where:
32. AUX I/O connector (circular 8 contacts Female type). This connector is used
to connect external devices or peripherals which use the UART serial
protocol and are expressly indicated and authorised by EBNeuro.
ATTENTION
Power up the BE LIGHT acquisition module through the proper “DC IN” connector
by using exclusively the specified medical AC/DC adapter compliant with the IEC
60601-1 safety standard (model AULT SW173 - code B9100470000, provided
standard by EBNeuro with the equipment)
ATTENTION
The “AUX I/O” connector is electrically wired to the isolated part of the BE LIGHT
acquisition module (type B protection level).
This connector is intended to be used for connection with the EBNeuro Led Flash
Stimulator (code B9700063000) or with the EBNeuro Goggles Stimulator (code
B9700033000) or with other optional equipments and peripherals expressly
indicated by EBNeuro only.
Do not connect any other device since such an action may constitute an unsafe
condition that could result in serious injury or accidental death of the patient..
ATTENTION
The “DC IN” and “AUX I/O” connectors are exactly the same. The involuntary
inverted connection of the external AC/DC adapter and optional stimulator (or other
peripheral) to the proper connectors respectively, do not compromise the patient
and user safety and do not compromise the correctly working of the device.
ATTENTION
In order to meet IEC 60601-1 standard requirements and to guarantee the patient
safety, when not used, the “PATIENT LINK” connector must be covered by the
proper plastic protection cover.
When this connector is used, remove the cover using the proper tool and then
perform the connection. The connector must be protected again when the
connection will be removed.
ATTENTION
The fibre optic link (through “OPTICAL LINK” connector) achieves an “absolute”
level of electrical isolation between the system PC and the BE LIGHT acquisition
box. In this way the system trolley should be placed far from the “patient area”
where the BE LIGHT acquisition box is placed without technical problems about
data transferring velocity and data quality/reliability.
The following figure shows the multifunction signalling Led placed on the front
cover of the BE LIGHT acquisition module.
The multifunction signalling Led is blue coloured and it is labelled on the device
cover with the “*” symbol. This Led has the function to signal to the operator
several “status” conditions of the equipment.
The Led status are managed under the control of the GALILEO_NT software
which is installed on the system PC.
The following figure shows the multifunction control button placed on the front
cover of the BE LIGHT acquisition module.
The multifunction control button is labelled on the device cover with the “#”
symbol. This button allows the operator to activate and control several functions
of the equipment.
The button functions are managed under the control of the GALILEO_NT
software which is installed on the system PC.
5.2.5 OHMMETER
The following figure shows the Ohmmeter section placed on the front cover of the
BE LIGHT acquisition module.
Each Led has the function to signal the status of the corresponding electrodes
placed on the patient about its impedance value (electrode-skin contact resistance)
according to an adjustable threshold level. The adjustable threshold level is
general and equal for all the electrodes.
The Ohmmeter function is activated by pressing the control button for a long time
(longer than 2 seconds) When the Ohmmeter function is activated, the device will
automatically and cyclically measure the impedance value of each patient
connection. The results of the measure is displayed on the Led matrix according to
the threshold level currently set.
When the Led is off, it means that the measured impedance value is lower than the
set threshold.
When the Led is on, it means that the measured impedance value is higher than
the set threshold.
The threshold level is software settable and it is made by a Led bar placed below
the Led matrix. The threshold level selected is indicated by the lit Led (on) and it
represents the reference value for the impedance measurement.
The Ohmmeter function is deactivated by pressing the control button for a long
time (longer than 2 seconds). All the Matrix Led and threshold Led will be
switched off.
The mains isolation module has the function to power the whole MIZAR-LIGHT
system and, at the same time, to perform the electrical isolation from the mains.
The mains isolation box guarantees the compliant of the whole system to the limit
and requirement of concerning medical standards.
The following figure shows the mains isolation module of MIZAR-LIGHT system
and its parts: The mains isolation module is factory mounted on the bottom part
of the trolley.
38 39
41
35
34
37
36
Figure 5-13 – Mains Isolation Module (rear view)
33
40
Figure 5-14 – Mains Isolation Module rete (front view))
42 43
44
45
NOTE
The TRG IN connector (ref. n° 44) allows to detect a TTL external trigger signal
(impulse minimum duration: min 50µs). The TTL signal can be programmed low-
level active or high-level active during the first installation of the system (jumper
setting on the internal interconnection board).
TRG OUT connector (ref. n° 45) issues in output an high-active TTL internal trigger
signal (impulse duration: min 50µs - max 100µs).
ATTENTION
The MMS/PATTERN connector (ref. n° 42) must be used only to connect one of the
two EBNeuro stimulation options:
- MSS Multimodal Stimulator Module (EBNeuro code B9700046000)
- External Pattern Stimulator Module (EBNeuro code B9700042000)
56. ANALOG IN CH 25-32 connector for analog input (channels 25 to 32) – Not
used
57. DIGITAL I/O – PARALLEL connector for parallel linking – Not used
61. MARKER IN connector for external trigger signal input. - Not used.
The optional thermal printer kit contains the Thermal Printer, the Analog Output
Module( which is described in the next section) and a special support on which
both the printer and the analog module are placed.
46
47
50
48
49
51
52
60
61
54 53 55 56 57 59 58 62
Figures 5-16 e 5-17 – Front and rear panel of the Thermal Printer
NOTE
Notice that the Thermal Printer option is available only with MIZAR-LIGHT systems
provided with the BE NET Interface
NOTE
The Thermal Printer is allocated on a special support placed on the trolley (see fig.
5,4). All the related connection with the BE NET Interface and the PC inside the
trolley are to be considered as internal connections not accessible to the operator
and should be performed by qualified personnel during system first installation
The following figures show the Analog Out module included into the optional A4
thermal printer kit of the MIZAR-LIGHT and its parts:
NOTE
The Analog Output Module is part of the Thermal Printer optional kit.
All the related connection with the THERMALPRINTER, the BE NET Interface and
the PC inside the trolley are to be considered as internal connections, not
accessible to the operator and should be performed by qualified personnel during
system first installation
63
65 64
79
77
72
78
71 73
66
67
80
68 69 70 81 74 75 76
87
82
86
83
84 85
Figures 5-20 and 5-21 – Front and rear panel of the MMS module
ATTENTION
During the electric stimulation the yellow led (ref. n° 71 and n° 77 for stimulator
“A” and “B” respectively) is intermittent in correspondence to each electric
stimulation delivered in accordance with the set characteristics (duration, intensity,
etc.) for the current active stimulator.
If in correspondence to the stimulation generation the OVERLOAD red led goes on
(ref. n° 72 and n° 78 for stimulator “A” and “B” respectively), it means that an
overload situation has occurred.
If the contact resistance between the electric stimulator and the patient becomes
too high, the stimulator is requested to generate a too high voltage (constant
current). In this case the stimulator will issue a stimulation automatically limited to
the maximum applicable power and will signal such a situation (stimulation not
responding to the characteristics set by the user).
NOTE
Please note that the knob for the manual control of the electric stimulation
intensity is a worm encoder. This implies that at each test the stimulation intensity
is set to zero and must be adjusted newly by the user, thus avoiding the possibility
of involuntarily stimulating the patient with an intensity not desired.
NOTE
The TRIGGER IN connector (ref. n° 84) allows to detect a low-level active TTL
external trigger signal (impulse minimum duration: min 50µs).
TRIGGER OUT connector (ref. n° 85) issues in output a high-level active TTL
internal trigger signal (impulse duration: min 50µs - max 100µs).
WARNING
The MMS module is mounted on a special support directly on the jointed arm of
the MIZAR-LIGHT system, immediately below the BE_LIGHT Amplifier (see fig 5-3).
In this arrangement all the connection related to the MMS module and the other
module of the system are performed by qualified personnel during system
installation.
When the MMS module should be used in a “stand alone” configuration (not
mounted directly on the jointed arm) the same connection are suitable trough the
trolley internal wiring using the rear panel connectors ( see fig 5-15 – ref 42, 43, 44
and 45.
ATTENTION
The PHOTIC LINK connector (ref. n° 80) must be used only to connect one of the
two EBNeuro stimulation options:
- Led Flash Stimulator (EBNeuro code B9700063000)
- Led Goggles Stimulator (EBNeuro code B9700033000)
ATTENTION
The DC IN connector (ref. n° 87) allows to externally power up the MMS Multimodal
Stimulator Module. This connector is not used in all the configurations of MIZAR-
LIGHT.
In particular the MMS stimulator module, when connected to the MIZAR-LIGHT, is
always powered by the medical AC/DC adapter of the system by means of the
SERIAL connection on the MMS module rear panel (ref. n° 83).
The DC IN connector is used when the MMS stimulator module is connected to
other systems which are not able to provide the power (+15 Vdc) through the
SERIAL connection.
88. SERIAL connector for powering and control signals connection from
MIZAR-LIGHT to external Pattern stimulator module. (see section 6.2)
89. TRIGGER IN connector (RCA type) for external Trigger signal input.
90. TRIGGER OUT connector (RCA type) for internal Trigger signal output.
91. PATTERN connector (mini D – 15 pin FMM type) for connection to
Pattern Stimulator Monitor.
92. Equipotential terminal.
93. Green Led indicating power on (external Pattern stimulation module is
ON)
94. DC IN connector for Pattern module powering (+15 Vdc). This connector
is not used in all the configurations of the MIZAR-LIGHT, due to the fact
that the connection to the proper connector on the rear of the system
trolley assures both control signals and needed power.
88 89 90 91
92 93 94
NOTE
The TRIGGER IN connector (ref. n° 89) allows to detect a low-level active TTL
external trigger signal (impulse minimum duration: min 50µs).
TRIGGER OUT connector (ref. n° 90) issues in output an high-level active TTL
internal trigger signal (impulse duration: min 50µs - max 100µs).
ATTENTION
The DC IN connector (ref. n° 94) allows to externally power up the external Pattern
Stimulator Module. This connector is not used in all the configurations of MIZAR-
LIGHT.
In particular the Pattern stimulator module, when connected to the MIZAR-LIGHT,
is always powered by the medical AC/DC adapter of the system by means of the
SERIAL connection on the Pattern module rear panel (ref. n° 88),
The DC IN connector is used when the external Pattern stimulator module is
connected to other systems which are not able to provide power (+15 Vdc) through
the SERIAL connection.
96
97
95
98
99
Figures 5-24 and 5-25 –PCMCIA Interface and fibre optic cable
108 109
100
106
101
107
102
Figures 5-26 and 5-27 – BE NET Interface – front and bottom view
100
102
101
107
106
Where:
100. DC Out connector (Triad 8 pins Male type). Output power supply
connector.
101. DC IN connector (Triad 8 pins Female type). Input isolation power supply
connector.
103. A - Aux I/O auxiliary serial I/O port (8 pins Female type) connector. This
connector connects the conversion system with possible peripherals or
devices which use an RS232 serial protocol expressly authorized by
EBNeuro.
104. B - Aux I/O auxiliary serial I/O port (8 pins Female type) connector. This
connector connects the conversion system with possible peripherals or
devices which use an UART serial protocol expressly authorized by
EBNeuro.
106. Analog Out link connector (digital connection with the optional analogical
outputs module)
NOTE
The AC/DC Adapter showed in the fig. 5-30 is related to one of the model specified
by EBNeuro as “alternative”. The showed parts are in any case equivalent in all
specified models.
For details related to the specified models refer to chapter 4 “Components and
Accessories” of the present manual
CHAPTER 6
INSTALLATION
ATTENTION
Before interconnecting the standard parts and optional modules composing the
MIZAR LIGHT system, make sure that none of them is connected to the mains and
that all the power switches of each module are in OFF (O) position.
The Mains Isolation Module is placed in the lower part of the system trolley. This
module is already mounted on the trolley by EBNeuro staff during the system
configuration phase. No installation procedure is required by the operator.
Connection between the various module fed directly by the Isolation Mdule are
described in the related section of this manual.
The Thermal Printer (when provided) is allocated on the bottom shelf of the
trolley.
The optional A4-format thermal printer is provided with its proper dedicated
package. The Thermal Printer kit contains the printer module, the Analog Out
module and several connection cables.
NOTE : the Thermal Printer option ever contemplates the BE NET Interface.
For details about replacing thermal paper to the printer, please check the chapter 7
“Maintenance” of the present manual.
Installation 6-1
Operator Manual MIZAR-LIGHT
The Thermal Printed will be placed on a special support which contains also the
“Analog Output” interface ( I on schematics in section 6.2 and 6.2) the shelf to
store the thermal paper (Fig 6-1a)
The Analog Output module is already installed in factory.
“15”
“I”
6-2 Installation
MIZAR-LIGHT Operator Manual
The system working monitor is provided separately from the trolley in the proper
original package with the exception of the monitor support which is factory
installed on the top of trolley (see figure 6.2a below)
- Insert the monitor LCD on its support (fig 6.2b) and then fix it to the support
by means of the provided 4 screws.(fig 6.2c). The final assembly should result
as showed in fig 6.2d.
- Connect the power cable (21 on schematics in section 6.2) between the mains
input connector of the monitor and the isolation transformer (any of the
J1…J4 output).
Installation 6-3
Operator Manual MIZAR-LIGHT
Figure 6-2e
6-4 Installation
MIZAR-LIGHT Operator Manual
The Personal Computer is provided separately from the trolley in the proper
original package.
The installation of the PC on the trolley and its connection to the other parts of the
system is performed by EBNeuro qualified technical personnel during the system
first installation with the customer. No installation and connection procedure is
normally required by the operator.
The following instruction are reported in the manual only for a complete
information and documentation of the equipment.
In any case, for more information and details about the connection between PC
and other parts of the MIZAR-LIGHT system, please refer to the general cabling
diagrams described in paragraph 6.2 of this chapter.
The various connection to the computer are performed trough the connector
placed on the rear panel of the computer.
The figures which follow illustrates the typical assembly of these connection in a
standard configuration.
Normally there are ever used the connection for keyboard, mouse, the VGA
output to drive the system monitor and one USB port to control the mains
isolation module.
The figures refer to a particular type of computer, but the situation is quite similar
with other type of computer due to the standardization of the identification of the
various connector one can find in the computer panel.
Basing on the exact configuration f the system the figures in section 6.2 detail the
various connections.
For further detail you can also refer to the original user manual of the computer
provided with the system.
Installation 6-5
Operator Manual MIZAR-LIGHT
CD (DVD)
driver
USB (front)
Floppy Disk
Headphones
on/off switch
Mouse Audio
LAN
COM1
(serial)
VGA USB
(monitor) (4 ports)
Keyboard
6-6 Installation
MIZAR-LIGHT Operator Manual
6.1.5 KEYBOARD
When the PC is a desktop type, the PC keyboard is provided with the trolley in its
proper original package.
Place the PC keyboard on the proper dedicated shelf of the trolley. No mechanical
fixing system to the trolley is present for the keyboard.
With reference to the general cabling diagrams (see paragraph 6.2), the cable
coming from the keyboard is connected to the proper KEYBOARD connector of
the rear panel of system PC (denoted by the keyboard symbol and by the blue
colour, see figure 6-4)
6.1.6 MOUSE
The mouse of the PC is provided with the trolley in it’s proper original package.
Place the PC mouse and its mouse-pad on the proper shelf of the trolley.
With reference to the general cabling diagrams (see paragraph 6.2), the cable
coming from the mouse is connected to the proper MOUSE connector of the
system PC(denoted by the mouse symbol and by the green colour, see figure 6-4)
Installation 6-7
Operator Manual MIZAR-LIGHT
The optional single page printer (B/W DeskJet or Colour Ink-Jet) is provided
separately from the trolley in the proper original package.
Place the printer on the lower shelf of the trolley. No mechanical fixing system to
the trolley is present for the printer.
The installation of the printer on the trolley and its connection to the other parts of
the system is performed by EBNeuro qualified technical personnel during the
system first installation with the customer. No installation and connection
procedure is normally required by the operator.
The following instruction are reported in the manual only for a complete
information and documentation of the equipment.
- Connect one end of the signal cable (11 on the schematics in section 6.2)
provided as standard with the printer to the proper connector of the printer.
With reference to the internal cabling diagrams (see paragraph 6.2), connect
the signal cable coming from the printer to one USB connector of the system
PC.
- Connect the power cable (12 on the schematics in section 6.2) between the
mains input connector of the printer and the isolation transformer (any of the
J1…J4 output). According to the printer model (laser or deskjet type), some
printers are powered by means of a specified proper AC/DC adapter. In this
case connect the output cable coming from the adapter to the input voltage
connector of the printer and the power cable between the adapter and the
mains isolation transformer.
6-8 Installation
MIZAR-LIGHT Operator Manual
The trolley can be optionally equipped with an arm supporting the acquisition
subsystem.
The arm supporting the acquisition subsystem (BE LIGHT amplifier and,
optionally, the multimodal stimulator (MMS) is factory mounted on the right side
of the trolley. However the trolley is designed to allow mounting the arm in any
case to mount the arm in both side of the trolley.
The arm can be positioned at different height : simply unlock the proper two
knobs, regulates the arm to the wanted height an then fix again the locking knob.
The pantograph arm supporting the optional Flash Led Stimulator is inserted in its
proper cylindrical support provided in the top part of the support column of the
trolley (see figure below) .
Also the flash led support can be mounted on both sides of the trolley.
The following figure shows the Trolley with the BE LIGHT acquisition system
and flash stimulator:
Installation 6-9
Operator Manual MIZAR-LIGHT
5 3
6-10 Installation
MIZAR-LIGHT Operator Manual
The BE LIGHT acquisition box is placed on the trolley arm or on the external
stand by means a proper fast coupling support plate provided with a safety locking
system.
Both the trolley jointed arm and the external stand are delivered with the amplifer
support already mounted in the proper position.
The connection of the fibre optic cable and BE LIGHT power cable on the trolley
side are intended as “internal links” performed by EBNeuro qualified technical
personnel during the system first installation to the customer (see section 6.2)
The following figure shows operations to be done for installing the acquisition
module on its proper support.
Insert the cables coming from the arm (ref 6) inside the support, taking care to
insert the cables through the dedicated rear input window of support (ref 7).
Extract the cables on the front side of support for all the available length.
Installation 6-11
Operator Manual MIZAR-LIGHT
Place the BE LIGHT module on the support by inserting the upper and lower two
plastic key of the module in the corresponding inserting slides of the support (ref
8)
Push the BE LIGHT module on the support for two-three centimeters in order to
make the module stable position and to keep enough free space which is necessary
for the following cable connecting operation.
On BE LIGHT side, connect the two cables coming from the arm and previously
inserted inside the support (fibre optic cable and BE LIGHT power cable).
Connect the fibre optic cable (ref 9) should be connected to the OPTICAL LINK
connector of the acquisition module. The correct insertion is signalled by a click
of the connector block system. This operation is very important in order to avoid
accidental disconnection of the power cable during the usage of the equipment.
Connect the power cable (ref 10) to the DC IN connector of the acquisition
module taking care to verify the correct inserting direction
11
10
12
Figure 6-8
The previous figure shows the BE LIGHT module with connected cables. Please
note the presence of Led Flash stimulator cables (ref 11), described in the
following, and the insertion of cables coming from the pantograph arm inside the
support.
When the cables are connected to the acquisition module, proceed to the complete
insertion of module on support.
The complete and correct insertion of acquisition module on support is signalled
by a click of the unlock button (ref 12) which the support is equipped with.
When the acquisition module is inserted on its proper support, the connectors of
connecting cables are hidden and protected by the side cover of support.
6-12 Installation
MIZAR-LIGHT Operator Manual
Figure 6-9
In order to quickly remove the BE LIGHT module from the pantograph arm, press
the unlocking button and, at the same time, pull outward the BE LIGHT module
sliding it on the support. Remove the connection cables and then extract
completely the module from the support.
Installation 6-13
Operator Manual MIZAR-LIGHT
During the system moving (trolley with all options and modules installed), be
careful to the system overall dimensions in order to avoid damages to its
projecting parts and injuries to people or things in the environment and to avoid
possible tilting of the trolley.
During the normal usage of the equipment the two pantograph arms (for BE
LIGHT module and Flash stimulator) and the telescopic pole are normally in
extended position. Moreover during the normal usage the keyboard shelf and the
thermal printer paper basket are pulled out.
This configuration corresponds to maximum system overall dimensions and
minimum trolley stability situations.
In case of system moving, it is necessary place the whole system in “carrying
position”. This position has telescopic pole lowered and the two pantograph arms
(for BE LIGHT module and Flash stimulator) retracted. Moreover carrying
position has the keyboard shelf and the thermal printer paper basket pulled in.
This configuration corresponds to minimum system overall dimensions and
maximum trolley stability situations.
The following two figures respectively show the whole MIZAR-LIGHT system in
“normal usage position” and “carrying position”.
6-14 Installation
MIZAR-LIGHT Operator Manual
Installation 6-15
Operator Manual MIZAR-LIGHT
6
5
3 1
1. Telescopic pole
2. Medical AC/DC adapter for BE LIGHT acquisition module
3. Power cable for BE LIGHT acquisition module
4. Five wheels stand base
5. Arm holder for Flash Stimulator
6. Support plate for BE LIGHT acquisition module
NOTE
For details regarding a MIZAR LIGHT system with external stand and BE NET
Interface refer to section 6.2.6
6-16 Installation
MIZAR-LIGHT Operator Manual
The coupling and blocking modalities of the BE LIGHT module on the dedicated
support plate and its linking to the MIZAR LIGHT are the same as previously
described for the trolley stand system option.
Please check paragraph 6.2.13 for further details.
During moving the stand, be careful about the stand stability in order to avoid
possible tilting of the stand.
During the normal usage, with extended pantograph arm and telescopic pole
(minimum stability situation), avoid tilting the stand with inclination angles larger
than 5° (steps or sloping floor).
During moving the stand, put it in “carrying position”. This configuration has the
telescopic pole lowered and the flash stimulator pantograph arm retracted
(maximum stability situation).
When carrying the stand, avoid tilting it with inclination angles larger than 10°.
For this purpose, we recommend to move the stand holding it below the metal
ring for the telescopic pole height adjustment and avoid pushing or pulling the
stand by the acquisition box or by the pantograph arm.
The following figures respectively show the external stand in “normal usage
position” and “carrying position”.
Figures 6-13a / 6-13b – stand in normal position (left) and in carrying position (right)
Installation 6-17
Operator Manual MIZAR-LIGHT
The Led Flash stimulator and its pantograph arm are provided separately from the
trolley in their proper package.
Place the pantograph arm on the support column of the trolley (or on the external
stand) inserting the pivot of the arm into the proper hole of the holder.
Connect the cable coming from the flash stimulator to the AUX I/O of BE LIGHT
acquisition module. (check the paragraph 6.2. for further details).
Position the flash stimulator cable following the flash arm taking care to insert it
under the proper velcro-strap covers.
Then, cable the remaining part of the flash stimulator cable following the BE
LIGHT arm, taking care to insert it inside the plastic loops alongside to the
already present acquisition module cables previously cabled on the arm.
For a correct cabling and to make easy the usage and carrying operations for the
MIZAR LIGHT , it is necessary to leave 20-25cm of the flash stimulator cable
between the two arms.
From the stimulator side the cable will result already connected in factory so none
operation is required.
6-18 Installation
MIZAR-LIGHT Operator Manual
The installation of the MMS Module and its connection to the other parts of the
system is performed by EBNeuro qualified technical personnel during the system
first installation with the customer. No installation and connection procedure is
normally required by the operator.
The following instruction are reported in the manual only for a complete
information and documentation of the equipment.
Place the MMS stimulator module on the apposite support attached to the end of
the arm (when the system is provided with the MMS option the support is factory
mounted.)
Connect the cable code B8830460070 following the schematic diagram
illustrated in the section 6.2
BE LIGHT
Amplifier
MMS
Module
Installation 6-19
Operator Manual MIZAR-LIGHT
- Place the external Pattern Stimulator Module on a stable surface near the
patient and the Pattern stimulator Monitor.
- Connect the control/power cable between the MMS/PATTEREN connector on
rear panel of the MIZAR LIGHT trolley and the SERIAL connector situated
on the rear panel of the external pattern stimulator.
- Connect the signal cable coming from the Pattern stimulator Monitor to the
PATTERN connector situated on the front panel of the external pattern
stimulator.
The optional Pattern Stimulator Monitor is provided separated from the trolley in
its proper original package.
Place the Pattern Stimulator Monitor on a strong and stable surface near the
patient. Adjust the correct distance between stimulator monitor and patient.
Perform one of the two following connections according to the stimulator option
which the MIZAR LIGHT is equipped with:
- Connect the signal cable coming from the Pattern stimulator monitor to the
PATTERN connector situated on the external Pattern stimulator module front
panel.
- Connect the signal cable coming from the Pattern stimulator monitor to the
PATTERN connector situated on the front panel of external MMS Multimodal
Stimulator Module.
For a description of connectors and other commands and control devices of the
stimulation monitor, please refer to the manufacturer’s documentation provided
standard with the device.
6-20 Installation
MIZAR-LIGHT Operator Manual
For a safe usage of the stimulator monitor inside the “Patient Area” it is necessary
to perform a correct connection of the monitor to the mains in order to guarantee
the compliance with the isolation and leakage currents limits of medical safety
standards (EN 60601-1 and EN 60601-1-1) applicable for electromedical
equipments and electromedical systems.
Perform the placing and powering of the Pattern stimulator monitor according to
one of the following three configurations:
- Direct connection of monitor power cable to an environment mains outlet. The
monitor must be exclusively placed outside “patient area”.
- Connection of monitor power cable to a isolated mains output connector of
MIZAR- LIGHT system trolley. The monitor can be used both inside and
outside “patient area”.
- Connection of monitor power cable to an environment mains outlet through a
medical isolation transformer module. The monitor can be used both inside
and outside “patient area”.
These precautions must be taken also when the monitor is powered by means a
proper AC/DC adapter (LCD monitor models).
For definition of “Patient Area” term, please refer to EN 60601-1 international
safety standard (equivalent to CEI 62-5 Italian standard).
All these devices of the VIDEO-EEG control system are provided separately in
their proper packages.
The installation of VIDEO-EEG devices and the cabling of their connection
cables to the MIZAR-LIGHT is performed by EBNeuro qualified technical
personnel during the system first installation with the customer. No installation
and connection procedure is required by the operator.
All the devices of VIDEO-EEG control system are system peripherals compliant
with the EN 60950 safety standard applicable for their own class (Information
Technology Equipments).
Installation 6-21
Operator Manual MIZAR-LIGHT
Perform the installation and powering of each peripheral device according to one
of the following three configurations:
- Direct connection of device power cable to an environment mains outlet. The
device must be exclusively placed outside “patient area”.
- Connection of device power cable to a isolated mains output connector of
MIZAR-LIGHT system trolley. The device can be used both inside and
outside “patient area”.
- Connection of device power cable to an environment mains outlet through a
medical isolation transformer module. The device can be used both inside and
outside “patient area”.
These precautions must be taken also when the devices are powered by means a
proper AC/DC adapters.
For definition of “Patient Area” term, please refer to EN 60601-1 international
safety standard (equivalent to CEI 62-5 Italian standard).
For a description of connectors and other commands and controls of each device
composing the VIDEO-EEG control system, please refer to the manufacturer’s
documentation provided standard with each device.
Connect the local network cable to the LAN connector placed on connectors rear
panel of MIZAR-LIGHT system.
For the network connection use exclusively CAT5 type cables with RJ45 type
connectors. EBNeuro provides pre-assembled network cables which are available
in several length. EBNeuro also provides on request the network cable and
connectors not assembled. This option is useful for network cabling in specific
environment or customised cabling.
6-22 Installation
MIZAR-LIGHT Operator Manual
The installation of the PCMCIA Interface Module in the PC system and its
connection to the other parts of the system is performed by EBNeuro qualified
technical personnel during the system first installation to the customer. No
installation and connection procedure is required by the operator.
For more information and details about PCMCIA interface installation in PC slot
and its connection with the other parts of MIZAR LIGHT system, please refer to
the internal cabling diagrams described in paragraph 6.2 of this chapter.
Connections of the BE NET Interface Module to the other parts of the system is
performed by EBNeuro qualified technical personnel during the system first
installation to the customer. No installation and connection procedure is required
by the operator.
In some particular application (BE LIGHT Amplifier mounted on an external,
powered stand, the BE NET Interface too is allocated on the external stand placed
in a suitable holder.
However also in this case connections of the BE NET Interface Module is
performed by EBNeuro qualified technical personnel during the system first
installation to the customer.
Section 6.2 details the connections and cables to be used in this configuration
Installation 6-23
Operator Manual MIZAR-LIGHT
Connect the power cable provided standard with the equipment (EURO-type
connector or ITA-type connector) to the mains input connector of the mains
isolation transformer.
For further details check the description in chapter 5 of the present manual.
All the external devices and peripherals which are not powered directly by the
system through the mains isolation module, must be connected to the mains
according to one of the following two procedures:
These precautions must be taken in order to avoid the loss of electric isolation
level of the system and thus to compromise the patient and operator safety.
All the system peripherals are not compliant with the medical safety standards.
6-24 Installation
MIZAR-LIGHT Operator Manual
System assembly and the wiring of the various cables interconnecting the
system’s module are performed by qualified personnel during the first installation
to the customer.
Normally there are no reason for the user to deal about these connection and to
need access to the internal wiring.
The described connections are to be intended as “internal links” and normally it
should not be any reason that they became accessible for the operator. Access to
the internal parts is possible only by means of a proper tool (rear panel unlock
key) and this access is intended to be reserved only to qualified personnel.
The following diagrams are included in the manual only for a complete
information and documentation of the equipment.
WARNING
Such connections are removable only by means of proper tools; hovewer do not
disconnect these connections for any reason since such an action may constitute
an unsafe condition that could result in serious injury or accidental death to the
patient.
Installation 6-25
Operator Manual MIZAR-LIGHT
In the following schematic diagram and figures module and cables are identified
with uppercase letter and numbers as in the following table
6-26 Installation
MIZAR-LIGHT Operator Manual
The following figure shows the internal cabling diagram of MIZAR LIGHT
system in base configuration without optional modules:
NOTE
In the following figures letters and numbers have the same meaning as in table 6.1
Installation 6-27
Operator Manual MIZAR-LIGHT
D
C
A 4
Mouse
3
Keyb.
22
VGA 9
11
1
7
3 B
8 6
Figure 6-17 – PC rear panel and BE NET Interface cabling
6-28 Installation
MIZAR-LIGHT Operator Manual
B
1
7
7
3
6
2
16
from C
C 5 6
Figure 6-18 – BE NET Interface and Interconnection boards particular
6 (remote contr.)
Mains input
(220-240
5 VAC)
4
21 (to PC)
Installation 6-29
Operator Manual MIZAR-LIGHT
6-30 Installation
MIZAR-LIGHT Operator Manual
The following figure shows the internal cabling diagram of MIZAR LIGHT
system with MMS Multimodal stimulator Module in internal trolley
configuration:
Installation 6-31
Operator Manual MIZAR-LIGHT
6-32 Installation
MIZAR-LIGHT Operator Manual
NOTE
External PATTERN STIMULATOR (J) and Auxiliary DC Inputs (K) module are
mutually exclusive.
Installation 6-33
Operator Manual MIZAR-LIGHT
6-34 Installation
MIZAR-LIGHT Operator Manual
Installation 6-35
Operator Manual MIZAR-LIGHT
6-36 Installation
MIZAR-LIGHT Operator Manual
NOTE
Cable denoted wit (*) in the above figure may be connected or directly to the PC on
the trolley or to a LAN (Local Area Network) socket when using an external
existing LAN network.
In the first case (direct connection to the MIZAR-LIGHT PC) use a “crossed” RJ45
LAN patch; in the second case use a “straight” RJ45 LAN patch).
Installation 6-37
Operator Manual MIZAR-LIGHT
• Make sure that the power switch of mains isolation module on trolley is on
OFF (O) position.
• Make sure that the power switch of the PC is in OFF (O) position.
• Make sure that the power switch of the working monitor is in OFF (O)
position.
• Make sure that the power switch of the thermal printer (if present) is on OFF
(O) position.
• Make sure that the power switch of Pattern stimulator monitor (if present) is in
OFF (O) position.
• Make sure that the power switch of the single-page printer (if present) is in
OFF (O) position.
• Connect the power cable coming from the mains isolation module of the
trolley to the room mains outlet.
ATTENTION
The room mains outlet must be necessarily be provided with a protective ground
terminal. The local electrical equipment must guarantee an efficient grounding and
it must comply to local laws and the international safety standards for electrical
equipments in medical environment.
• Turn the power switch of the mains isolation box to ON (I) position
• Make sure that the power switch of the PC on its rear panel is in ON (I)
position.
• Turn the power switch of the working monitor to ON (I) position
• Turn the power switch of the thermal printer (if present) to ON (I) position
• Turn the power switch of the Pattern stimulator monitor (if present) to ON (I)
position
• Turn the power switch of the single-page printer (if present) to ON (I) position
• Turn the power switch of whole MIZAR-LIGHT system (coincident with the
front panel power pushbutton of PC) to ON (I) position.
6-38 Installation
MIZAR-LIGHT Operator Manual
WARNING
The mains switch on the isolation module panel controls the mains to the whole
MIZAR LIGHT system.
The ON (I) position and the lighted green lamp denotes that the mains is applied
to the system.
WARNING
When the mains switch of the isolation module is in ON (I) position, the general
on/off switch of the system coincides with the on/off switch of the Personal
Computer. This switch allows the mains to feed all the module of the system (PC,
working monitor, Thermal printer, Laser Printer, BE_LIGHT amplifier and any other
optional monitor) allowing all the modules are switched on or off simultaneously
acting on a single on/off switch.
Installation 6-39
Operator Manual MIZAR-LIGHT
6-40 Installation
MIZAR-LIGHT Operator Manual
CHAPTER 7
WORKING MODE
7.1 CAUTIONS
WARNING
It is strongly recommended to check the overall functionality of the system before
starting any recording.
In case any anomalies or malfunctioning should be noticed, immediately
disconnect the patient from the system (if a patient is already connected), switch
off the system and ask for service to qualified personnel.
In particular (for example) if, with a patient connected to the system, some “flat”
tracing should be noticed on the monitor during recording : in this case if the
problem should not be easily solved (poor electrode connection, broken lead etc)
immediately acts as above, disconnect the patient, do not se the system and ask
for servicing.
WARNING
During “long term recording” (more than one hour) it is strongly recommended to
periodically check that all the system works regularly without any sign of
malfunctioning.
If any anomalies or flat traces should be noted act as in the previous warning.
In particular any electrode site used for long term must be checked for irritation
and redness. Check each electrode periodically to evaluate the skin condition
under the electrode. Redness, blistering and permanent skin scarring can occur if
electrode are not regularly monitored.
• Impedance check
The following Figure 7-2 shows the position of the 21 standard sites on the scalp.
The operator will have to find and mark the correct positions for electrodes
directly on the patient's scalp with use of a dermographic pencil, dividers and
flexible rules. For further information we recommend to consult relevant medical
literature.
The phase of preparation of the scalp has an important role in establishing a good
electric contact, thus allowing the best kind of recording.
• Each patient should wash his hair before being tested and avoid grease, gel or
spray products.
• Once the positions of the electrodes have been established, each part should be
cleaned with a wad of cotton wool soaked ether, acetone, alcohol or specific
abrasive paste for EEG in order to reduce the natural fat of the skin.
• During this operation pay attention not to cancel the signs previously made on
the skin with the dermograph. Use ether, acetone and alcohol with most care
near the patient's eyes, nose and mouth.
• If you use needle electrodes during the recording, disinfect the skin to reduce
the risks of infection.
The compact bridge electrodes are made of a small plate with a diameter of about
1 centimeter, connected to a short cylindrical bar mounted on an insulating piece
of plastic.
The small plate is covered with a small disk of cotton-wool or gauze soaked with
a salt solution and fixed by means of an elastic ring.
The conductor cable connects the patient input box to the electrode by means of a
crocodile-shaped clamp as shown in the following Figure 7-3.
The electrodes are kept fixed on the scalp, in correspondence of the pre-
established sites, by means of a headset made of a lot small tubes of flexible
material connected to one another by means of adjustable joints allowing to adjust
the headset on the size and form of the patient's head.
The following Figure 7-3a shows an example of a set of bridge electrodes kept
together by means of an adjustable headset.
a) b)
Figure 7-3 a) Bridge electrode
b) Set of bridge electrodes and adjustable headset
After preparing the scalp as described above, place the electrodes as indicated
below:
a) Put the rubber headset on the patient's head and adjust it to fit to its form
and size. Tighten it as much as possible using the chin lace, taking care not
to bother the patient.
b) After soaking the pieces of gauze in the salt solution (NaCl 0.9%), prepare
all necessary compact bridge electrodes using the proper accessories.
c) Place all the electrodes on the scalp on the pre-established sites, and insert
them under the single rubber segments of the headset (see figure 7-3.b), so
that they are fixed and in contact with the skin. If necessary, adjust the
headset using the proper laces.
d) Connect the one end of each interconnection cable to the upper end of an
electrode using the crocodile-shaped clap (see fig. 7-3.a) and connect the
other end to the jack of the patient input box corresponding to the position
of that electrode.
e) Connect the other electrodes to the patient input box as described above.
f) Connect the one end of each ear electrode to the patient's ear lobes using
the proper clap and the other end to the patient input box using the
corresponding jacks
If the operator uses a pre-cabled headset instead of the single electrodes end
interconnection cables, it is necessary to connect the headset cable to the
PATIENT LINK connector placed on the front panel of patient input box.
The measurement and the maintenance of a good contact resistance between the
electrode and the scalp is extremely important in order to obtain a good recording,
and a reliable arctifact-free acquisition.
It is very important perform an impedance check before recording start and, for
long recordings, perform the test again during the acquisition.
In theory, impedance should be low (up to max 10 Kohm values for EEG and up
to max 5 Kohm values for Evoked Potentials)
High resistance values may cause an attenuation of the signals. On the other side,
an extremely low resistance, lower than 100 ohm, create a “shunt” or short-
circuit, and causes an attenuation of the signal as well.
It is thus important to obtain low impedance values, but even more important is to
obtain a balance among the values of the different electrodes.
WARNING
In order to perform a correct impedance check with reliable results, it is necessary
connect both the reference electrode (Neutral Electrode) and the ground electrode
(Patient GND) before start the impedance check function.
The results of the performed reading will be displayed on the screen of the system
monitor, both in the graphical and in the numeric form.
It is possible for the user to adjust a threshold level on the chosen impedance
value and then obtain in real time a general information about all electrodes.
The equipment software repeats the impedance measurement in a cyclic way for
all electrodes, and each time displays the new results.
In this way you can change the position of any electrode with high contact
resistance and check the improvement of such values in real time.
For more details about Impedance Check functioning procedures, refer to the
“GALILEO_NT program functioning” section and “EP_NT program functioning”
section of the MIZAR-LIGHT operator manual.
CHAPTER 8
MAINTENANCE
• Perform a sight inspection of all the components, the accessories, and the
connections of the device to the peripherals in order to identify any traces of
failure, damage, or disconnection.
• Verify that all labels and any warning or instructions printed on the device are
readable.
• Check that the performances and the working of the device are correct.
• Clean the external surface of the device carefully with the recommended
products only.
• Replace parts or accessories only with other having the same characteristics or
expressly indicated by EBNeuro.
• Discard replaced parts, accessories, and the device at its “end of life” according
to the local standards and directives currently in force.
For all ordinary maintenance operations pertaining the devices of the MIZAR
LIGHT (GALILEO BE_LIGHT to which the instrument is connected or auxiliary
components not produced by EBNeuro such as personal computers, monitors,
printers, isolation transformer and consumers accessories and so on), please refer
to the corresponding user’s manual provided with them.
Maintenance 8-1
Operator Manual MIZAR LIGHT
In this case have the burned fuse replaced as the described below.
In this case contact the nearest Service Center to have the PC fuse replaced (the
fuse cannot be accessed and replaced by the user).
• If either the monitor of the thermal printer or the BE LIGHT acquisition box do
not start when the system and the isolation transformer module are powered up,
it means that the fuses of the inactive element is burned.
In this case contact the nearest Service Center to have the fuse replaced (the fuses
cannot be accessed and replaced by the user).
8-2 Maintenance
MIZAR LIGHT Operator Manual
Replace the burned fuse of the mains isolation box following the indicated
procedure:
a) Turn the power switch of the isolation transformer module to OFF (O)
position and disconnect the mains cable from the input connector of the
box itself.
b) Extract the fuse holder from the rear panel of the isolation transformer
module. In order to extract the fuse holder insert the tip of a screwdriver
alternatively under the lateral blocking flags and lever outwards in figure
8-1 above.
c) Identify and replace the burned fuse. The burned fuse is the one with the
interrupted filament inside. Always replace fuse only with other fuses
having the same characteristics
- (n° 2 T5A fuses, size 5x20mm, delayed - code E26222100023 for
220V/50Hz version)
- (n° 2 T10A fuses, size 5x20mm, delayed - code E2600000101 for
115V/60Hz version)
Maintenance 8-3
Operator Manual MIZAR LIGHT
d) Insert the fuse holder back into its case following the direction indicated
by the small key, then thoroughly. The correct insertion will produce a
click.
e) Insert the mains cable back into the input connector of the isolation
transformer module and turn the power switch to ON (I) position.
• If now the green led of the power switch of the isolation transformer module is
on and whole system is powered, you can use the device.
• On the contrary, if upon replacement of the fuse the green led indicating
"mains on line" is still off ore the fuse starts burning again, contact the nearest
Service Center.
8-4 Maintenance
MIZAR LIGHT Operator Manual
b) Pull the lid of the paper tray downwards until it is completely opened.
Now the write head is kept away from the paper roller.
c) Prepare a new pack of paper, making sure that paper format and type is
that expressly indicated by EBNeuro: (code E9690023000 A4-format)
Put the pack of paper in front of you, so that the marks are on your left and
the EBNeuro logo in on your right; fold the first sheet of paper on the two
corners so that the paper mark can be easily seen and the successive paper
feeding is made easier (see Fig. 8-2)
In brand new packs of paper such folds have been already made for you.
d) Insert the pack of paper into the proper tray, holding the folded side of the
first sheet with a hand, so that remains outside the printer (see Fig. 8-3).
Before inserting the paper into the tray, make sure that it is on the right
side (paper mark on the left and EBNeuro logo on the right) and that all
sheets are aligned in a compact pack.
e) Insert the paper between the roller and the write head putting the folded
end of the first sheet outwards. The fold made previously will make easier
to insert the paper (see Fig. 8-4). Gently pull the paper a few centimeters
outwards, holding the folded side, so as to check whether alignment and
flowability on the roller are correct.
WARNING
Use only paper expressly indicated by EBNeuro:
(code E9690023000 A4-format)
WARNING
During the test print make sure the paper runs perfectly perpendicular with the
paper roller.
An incorrect alignment of the paper would damage it and could cause a paper jam
NOTE
The last five sheets of each pack of paper are marked with a red line. When red line
appears on the printed pages, be ready of feed the printer with new paper.
Maintenance 8-5
Operator Manual MIZAR LIGHT
FOLD PAPER ON
DASHED LINE
PAPER MARK
LOGO
8-6 Maintenance
MIZAR LIGHT Operator Manual
Figure 8-4 – Paper position between the paper roller and the write head
Maintenance 8-7
Operator Manual MIZAR LIGHT
From this acquired data the corrective factors (calibration constants) are
calculated in order to uniform the gain of each channel.
The calibration constants are stored in a flash memory on the BE_LIGHT
acquisition box and then transmitted to the BE NET ( or PCMCIA) interface. The
calibration constants are applied during each acquisition and they will be valid
until the next physical calibration is made.
8-8 Maintenance
MIZAR LIGHT Operator Manual
For technical reasons (noise reduction and hardware minimization), there are no
internal automatic switches for all the inputs of physical calibration signal. Please
follows the below described procedure to perform the physical calibration:
• Run the software procedure from the system PC (please check the relevant
documentation about host system PC control software - ref. testing software
code B8690039000);
NOTE
If the physical calibration process is activated when the patient is still connected to
the amplifier box, no safety hazard for the patient health is present.
In this case the amplifiers will add the signals coming from the patient to the
internal generated calibration signal.
This kind of calibration is normally performed at the beginning and/or at the end
of each recording.
The calibration activation is under the operator’s management and responsibility.
Under the GALILEO_NT software control, the amplifier system generates the
calibration signal (square wave 1Hz frequency – 50uV amplitude).
This signal is sent to the BE NET (or PCMCIA) interface and it allows to check
the signal transferring chain, the communication protocol with host system PC
and digital processing chain (digital filters, digital gain, etc.).
Maintenance 8-9
Operator Manual MIZAR LIGHT
We suggest to perform the stimulator monitor test twice a mouth and always when
the stimulation image seems incorrect or distorted.
At the system start-up, the Pattern stimulator monitor will display the test image
as shown in the following figure:
• Make sure that no electric or electronic instrument placed near the stimulator
monitor causes interference and thus instability of the image on the screen.
• Degauss the monitor screen using the proper DEGAUSS command on the
monitor. This procedure will eliminate any alterations of the correct scanning
of the electron beam within the cathod-ray tube (CRT) of monitor.
8-10 Maintenance
MIZAR LIGHT Operator Manual
• Correct the “Cushion” effect of the screen, if any, using the proper monitor
command. This procedure allows to correct the curve that can appear on the
ends of the image, both outward and inward.
• Centre the stimulation figure on the screen using the proper horizontal/vertical
positioning commands of the monitor
• Size the test image on the screen so that width and height are in the right
proportion using the proper commands for the horizontal/vertical width control
of the monitor. In order to correctly perform this operation, refer to the
proportion among the chessboard and correct the circle in case it has get
squashed or stretched. Please make sure that the test image is displayed within
the monitor screen and that it covers all the available surface.
• Check for the correct setting of contrast and brightness parameters of the
monitor.
WARNING
Do not modify the “Contrast” and “Brightness” parameters setting of stimulation
monitor.
WARNING
For further information about the adjustment modalities of monitor parameters
(cushion effect, degauss, horizontal/vertical size and position of image, contrast
and brightness), please refers to monitor manufacturer user manual provided with
the equipment.
Maintenance 8-11
Operator Manual MIZAR LIGHT
A sight inspection of the interconnection cables, with particular care for the cables
between equipment and acquisition box and for all the power cords (mains cable),
can be performed also by medical or paramedical staff in order to remark any
breaking or disconnection. In case of need, immediately contact a qualified
technician to solve the problem detected before continuing to use the equipment
or connecting it to other devices. For the technical assistance request procedures,
please refer to chapter “Request for assistance” of the manual.
ATTENTION
Safety checks must be accurately performed periodically and at least twice a year.
A danger for the patient’s health is determined, first of all, by the efficiency of the
electrical equipment of the building where the equipment is used. The isolation
safety guaranteed by Class I to which the device belongs is useless, if the wiring is
not provided with a good earth plate, accessible though the mains outlet.
ATTENTION
If the integrity of the environment’s electrical equipment, and in particular the
protective earth, is not reliable for safety, do not supply and use the equipment
until the safety conditions are restored.
8-12 Maintenance
MIZAR LIGHT Operator Manual
The system mains cable not only connects the system to the phases of the
electrical network, it also connect the chassis and the accessible metal or
conductive parts to the ground, according to the building criteria of Class I to
which the device belongs.
The protection conduction belonging to the mains cable can be recognised from
its yellow-green isolation coating. Any interruption of this conductor frustrates the
safety of the device and cause danger for the patient's and user's health.
It is necessary to periodically check the integrity of the ground conductor and its
correct connection to the central pin of the mains plug. The cable integrity can be
checked with X-rays, indispensable when the cable is sealed and therefore cannot
be opened.
Elementary precautions in use can avoid premature breaking or damaging of the
cable. Avoid twisting or pulling it violently, especially when unplugging the
terminal plug of the mains cable. During this operation avoid pulling the cable
hold the plug in your hand and unplug resolutely without twisting. Similar
precautions must be taken when drawing the mains cable out of the mains input
connector placed on the device.
WARNING
If the mains cable is not reliable for safety, do not connect the system to the mains
until the cable has been replaced and safety conditions are repristinated.
Maintenance 8-13
Operator Manual MIZAR LIGHT
WARNING
Do not immerse the equipment nor its parts in liquids, do not oil any part of it and
avoid cleaning the external surface with alcoholic disinfectants that could cause
damages and decolorization of the printed surfaces
ATTENTION
Before cleaning any part of the equipment disconnect the equipment from the
power supply or remove the internal batteries (if battery option is installed) and
disconnect the device from any other equipment or external devices.
ATTENTION
Make sure no liquid seeps into the instrument and check it’s complete dryness
before to reconnect to the power supply (or inserting the batteries) or before
connecting it with other devices, thus switching it on.
8-14 Maintenance
MIZAR LIGHT Operator Manual
In order to guarantee the correct functionality of the BE-LIGHT Amplifier and its
interfaces, it is necessary preserve the full functionality of the fiber optic
connectors functionality. Fiber optic connectors are placed on BE_LIGHT
Amplifier panel and on PCMCIA and BE NET interface ones
Dust deposit or other foreign bodies, including smoke, entered inside the fiber
optic connectors can compromise the linking functionality of the optical
connection between BE_LIGHT Amplifier and its BE NET or PCMCIA
interfaces. In this case the correctly working of system may be compromised.
WARNING
Avoid inserting any kind of foreign bodies inside the fiber optic connectors of the
Amplifier and of its interface modules.
Perform the optical connection between Amplifier and its interface modules by
using exclusively the proper fiber optic cable provided by EBNeuro
Do not smoke near the fiber optic connectors, The smoke may stain the connector
inside parts and damage the material it is made.
The internal part of fiber optic connector can be easily scratched and damaged,
therefore it is necessary to protect it with much care.
For this scope, all the fiber optic connectors, provided by EBNeuro, are covered
by two proper rubber protection tips. These tips use is intended to avoid the entry
of little objects or dust inside the fiber optic connectors when they are not used.
WARNING
In order to guarantee the correctly working of the equipment, when not used, the
fiber optic connectors of devices must be covered by the proper rubber protection
tips.
When these connectors are used, remove the rubber protection tips and then
perform the connection by means the fiber optic cable. The fiber optic connectors
must be protected again when the optic connection will be removed.
EBNeuro suggest to clean the fiber optic connectors twice a year. To this purpose,
use a compressed aerosol bomb available on the market for we suggest some
brands: TexWipe, Dust-Off and Falon.
WARNING
Some aerosol products use Freon gas as propellant. Use such products with much
care and after carefully reading the instructions, because, if you use them at wrong
distance and wrong inclination, the Freon gas will spill out and stain the
application surface with a white film.
Maintenance 8-15
Operator Manual MIZAR LIGHT
WARNING
If it is necessary to sterilize the electrodes, the corresponding interconnection
cables patient input box/electrodes and other accessories, do it with gas (ethylene
oxide) only and however according to the instruction notes provided by the
manufacturer with each single device.
WARNING
Use either Amocid, Lisoformin, Alhyndex or Incidin GC or equivalent products in
order to disinfect electrodes, the corresponding cables and the headset without
immersing them into the liquids. Use products according to directives and
regulations of the country in which the device is used.
WARNING
All disposable must be destroyed after using them and cannot be used again in
any way. Please refer to the directives and regulations concerning disposable
requirements of the country in which the device is used.
Dust deposit or other foreign bodies, included finger prints, can damage the read
and write functionality of the laser head of the cartridge and CD-ROM. The
extractable optical cartridge, made of plastic, can be easily scratched and
damaged, therefore handle it with much care.
WARNING
Avoid touching the surface of the optical disk and CD-ROM with your fingers.
WARNING
Do not smoke near the optical disk. The smoke may stain the disk and damage the
plastic material it is made of.
8-16 Maintenance
MIZAR LIGHT Operator Manual
EBNeuro suggests to clean the optical reader once a month. To this purpose, use
the proper cleaning cartridge or compressed air aerosol bomb available on the
market for which we suggest some brands: TexWipe, Dust-Off and Falon.
WARNING
Some aerosol products use Freon gas as a propellant. Use such products with
much care and after carefully reading the instructions, because, if you use them at
a wrong distance and wrong inclination, the Freon gas will spill out and stain the
application surfaces with a white film.
• Do not use or keep the memory support under the following environment
conditions (conform to the values range of the support furnished by the
manufacturer):
- Places with high humidity percentage
- Places directly exposed to direct sun light
- Places with excess shocks or vibrations
• Never insert objects in the drives other than the appropriate memory supports.
• Never remove the memory support from the drive during a read/recording
operation
• Always remove the memory support from their drive before transporting the
PC.
• Carefully insert and remove the memory support from the drive.
• Always protect the memory supports with appropriate covers once they have
been removed from the drive to be moved or stored and avoid laying objects on
them.
• Keep the memory supports away from magnetic fields and heat sources.
• Avoid installing software packages on the PC’s Hard Disk which are not the
GALILEO_NT software (with exclusion of the required Operative System) and
Maintenance 8-17
Operator Manual MIZAR LIGHT
WARNING
EBNeuro is not responsible for damages due to loss of stored data caused by the
non-observance of the above described recommendations.
It is advisable to clean the write head of the thermal printer when dirty stains
appear on the paper. Dirtiness can accumulate while the equipment is working,
especially at a low paper speed. We recommend to periodically clean the write
head, at least once a month, and to use only paper supplied by EBNeuro.
Clean the write thermal head following the indicated procedure and Figure 8-6.
a) Switch off the system and disconnect it from the mains outlet.
b) Make sure the print head is cold (wait at least one minute after the
switching off of the system).
c) Pull down the paper tray lid until it is completely open Now the write head
is kept away from the paper roller.
d) Remove (if any) the sheet of paper present between the paper roller and
the write head.
e) Use a cotton stick soaked with alcohol to clean the whole lenght of the
head, which is behind the paper roller and under the paper brush.
f) Wait a few minutes for the alcohol to evaporate and then insert the paper
again as described above in Par. 8.3.
g) Connect the equipment to the mains, switch on the system and perform a
test print.
8-18 Maintenance
MIZAR LIGHT Operator Manual
WRITE HEAD
PAPER BRUSH
PAPER ROLLER
PAPER
Maintenance 8-19
Operator Manual MIZAR LIGHT
In order to avoid personal injuries and to reduce the negative impact on the
environment, make sure you carefully follow these instructions:
LDC Display:
• The LCD is fragile (glass) and must be treated with much care: for this reason
we recommend to protect the device with the proper original package during
transportation or when it is not used.
• In the event the LCD glass should break and liquid spill out of it, make sure
you do not touch it. Wash with water for at least 15 minutes any body part that
may have been in contact with it carefully. Should you experience any
symptom after this period, ask for immediate medical help.
8-20 Maintenance
MIZAR LIGHT Operator Manual
CHAPTER 9
REQUEST FOR ASSISTANCE
ATTENTION
In case of failure of the device or if it starts working in a way not complying with
what is written in the manual, especially as far as safety is concerned, STOP USING
IT IMMEDIATELY and contact the technical service. Do not use the device until the
safety conditions have been checked and restored.
NOTE
In order to speed up the procedures to start the intervention of the technical
service and to make it easier for the specialized technical staff to identify the
problem on the first phone call by the customer, please fill in the form below in this
page.
The equipment data may be found on the equipment identification label.
OPERATING OFFICES