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MIZAR-LIGHT

DIGITAL EEG-EP MULTIFUNCTION SYSTEM

0051

Operator Manual
B8350047611
Galileo System

MIZAR-LIGHT
Digital EEG-EP Multifunction System
28 Channel (Wide Band)

Operator Manual

B830 0047 611


Rev. C

(Booklet)

0051

EDITION:

July 2007

EBNeuro
- FLORENCE -
ITALY
MIZAR LIGHT Operator Manual

TABLE OF CONTENTS

CHAPTER 1 - INFORMATION ABOUT THE MANUAL


1.1 INFORMATION ABOUT THE MANUAL 1-1
1.1.1 CONVENTIONS 1-2
1.2 DECLARATION OF RESPONSIBILITY BY THE MANUFACTURER 1-3
1.3 USAGE RESTRICTIONS AND SAFETY PRECAUTIONS 1-4
1.3.1 ELECTRIC SAFETY 1-4
1.3.2 SAFETY OF THE OPERATIONAL ENVIRONMENT 1-7
1.3.3 SAFETY OF GALILEO_NT SOFTWARE 1-9
1.4 GRAPHIC SYMBOLS IN COMPLIANCE WITH THE IEC 601-1
STANDARDS (CEI 62-5) 1-10
1.5 OTHER GRAPHIC SYMBOLS 1-11
1.6 ATTENTION SYMBOL 1-13
1.7 CROSSED-OUT WHEELED BIN 1-14
1.8 PRODUCT TRACEABILITY 1-15
1.9 VIGILANCE SYSTEM 1-15
1.10 INFORMATION ABOUT RECYCLING OF MATERIALS 1-18
1.11 ELECTROMAGNETIC COMPATIBILITY 1-19
1.11.1 RECOMMENDED DISTANCES FROM RADIOFREQUENCY
(RF) COMMUNICATION SYSTEMS 1-21
1.12 BIOCOMPATIBILITY AND INFECTIONS CONTROL 1-23
1.13 DECLARATION OF CONFORMITY 1-23
1.14 CAUTION FOR THE U.S. MARKET 1-23

CHAPTER 2 - GENERAL DESCRIPTION


2.1 GALILEO BE_LIGHT SYSTEM 2-1
2.2 MIZAR-LIGHT SYSTEM 2-2

CHAPTER 3 – TECHNICAL CHARATTERISTICS


3.1 COMPLETE SYSTEM 3-1
3.2 BE LIGHT ACQUISITION MODULE 3-4
3.3 ACQUISITION AND PROCESSING OF THE SIGNAL
(GALILEO_NT SOFTWARE) 3-9
3.4 PCMCIA INTERFACE 3-11
3.5 BE NET INTERFACE 3-11
3.6 AC/DC ADAPTER 3-14
3.6.1 MODEL AULT SW173 3-14
3.6.2 MODEL AULT MW160 3-14
3.6.3 MODEL SIMPRO MPU50 3-15
3.7 ISOLATION TRANSFORMER MODULE 3-16
3.8 THERMAL PRINTER 3-19
3.9 ANALOG OUT MODULE 3-21
3.10 DC AUXILIARY INPUT MODULE 3-21
3.11 MULTIMODAL STIMULATOR MODULE 3-22
3.11.1 ELECTRIC STIMULATOR 3-24
3.11.1.1 Trend of the supplied power in relation to the load 3-26
3.11.2 ACOUSTIC STIMULATOR 3-27
3.12 LED FLASH STIMULATOR 3-29
3.13 PATTERN STIMULATOR MODULE 3-32
3.14 MINIMUM REQUIREMENTS FOR SYSTEM COMPUTER 3-37
3.15 MINIMUM REQUIREMENTS FOR OTHER PC PERIPHERALS
(MONITOR AND PRINTER) 3-38

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Operator Manual MIZAR LIGHT

CHAPTER 4 – COMPONENTS AND ACCESSORIES


4.1 MIZAR-LIGHT EEG-EP SYSTEM - B9800047600 4-1

CHAPTER 5 – CONNECTIONS, COMMANDS AND CONTROLS


5.1 COMPLETE SYSTEM 5-1
5.2 BE LIGHT ACQUISITION BOX DESCRIPTION 5-6
5.2.1 PATIENT INPUT SOCKET DESCRIPTION 5-7
5.2.1.1 Standard 10-20 sistem configuration 5-9
5.2.1.2 “Mirror” configuration 5-11
5.2.2 CONNECTRORS DESCRIPTION 5-12
5.2.3 MULTIFUNCTION SIGNALLING LED 5-14
5.2.4 MULTIFUNCTION CONTROLBUTTON 5-15
5.2.5 OHMMETER 5-16
5.3 MAINS ISOLATION MODULE 5-18
5.4 REAR PANEL CONNECTORS 5-19
5.5 THERMAL PRINTER 5-20
5.5.1 ANALOG OUTPUT MODULE 5-22
5.6 MULTIMODAL STIMULATOR MODULE (MMS) 5-24
5.7 EXTERNAL PATTERN STIMULATOR 5-28
5.8 PCMCIA INTERFACE 5-30
5.9 BE NET INTERFCAE 5-31
5.10 MEDICAL AC/DC ADAPTER 5-33
5.11 FLASH LED STIMULATOR 5-34

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

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MIZAR LIGHT Operator Manual

CHAPTER 7 – WORKING MODE


7.1 CAUTIONS 7-1
7.2 PREPARING THE PATIENT 7-2
7.2.1 ASSIGNING THE ELECTRODES APPLICATION SITES
(SYSTEM 10-20) 7-2
7.2.2 PREPARING THE SCALP 7-4
7.2.3 PLACING THE EEG ACQUISITION ELECTRODES 7-4
7.2.4 IMPEDANCE CHECK 7-6

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 9 – REQUEST FOR ASSISTANCE


9.1 OBTAINING SERVICE 9-1
9.2 EBNEURO MAIN OFFICES 9-2

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Operator Manual MIZAR LIGHT

For your notes:

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MIZAR-LIGHT Operator Manual

CHAPTER 1
INFORMATION ABOUT SAFETY

1.1 INFORMATION ABOUT THE MANUAL


This document contains proprietary information. No part of this publication may
be photocopied or reproduced without the prior written permission of EBNeuro.
Information in this document is subject to change and revision without notice.

Issues:

First edition: B830 0047 611 - Rev. A June 2003


Second edition: B830 0047 611 - Rev. B March 2005
Third edition: B830 0047 611 - Rev. C July 2007

This manual is to be considered as a component of the equipment. When installing


the equipment for the first time, the user should accurately check the content of
the Manual in order to verify its integrity and completeness.
In the event the Operator Manual should be ruined, incomplete or inadequate,
please contact EBNeuro in order to immediately restore or replace the
uncompliant Manual.

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.

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Operator Manual MIZAR-LIGHT

1.1.1 CONVENTIONS

In this Operator Manual the following conventions are used:

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.

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MIZAR-LIGHT Operator Manual

1.2 DECLARATION OF RESPONSIBILITY BY THE MANUFACTURER


MANUFACTURER: EBNeuro S.p.A.
Operative office:
FIRENZE
Via Pietro Fanfani, 97/A
50127 - Firenze
Phone +39 055 4565111
Fax +39 055 4565123
Website: www. ebneuro.com

EBNeuro is responsible for safety, reliability and performances of the equipment


only when the equipment is used in compliance with the following conditions:

• Calibrations, modifications or servicing must be performed by qualified staff


expressly authorized by EBNeuro.

• 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.

• The connection of the equipment with peripherals or other instruments supplied


by the mains must be performed according to the EN 60601-1-1 standards
(standards for Electro-medical systems) and to the EN 60601-1-2 standards
(standards for electromagnetic compatibility).

• Usage and maintenance of the equipment and of its accessories must be


performed in compliance with the instructions described in this Manual.

• This Manual must be kept complete and readable in every part.

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Operator Manual MIZAR-LIGHT

1.3 USAGE RESTRICTIONS AND SAFETY PRECAUTIONS


In order to guarantee the patient’s and the user’s safety as well as a correct
working of the equipment, it is necessary to operate within the consented
restrictions and adopt all the precautions listed below:

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.

1.3.1 ELECTRIC SAFETY

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.

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MIZAR-LIGHT Operator Manual

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.

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Operator Manual MIZAR-LIGHT

• The equipment is not protected against the defibrillator discharges. Please


remember that the equipment is not protected against the defibrillator
discharges; for this reason, in the event it should be necessary to use the
defibrillator, it is necessary to disconnect the patient from the equipment in
order to avoid the patient being burned in the electrode contact areas and the
equipment undergoing sever and irreversible damages.

• 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 additional Multiple Portable Socket-Outlet or extension


cord. Multiple portable socket-outlet or extension cord shall not be connected
to the system.

• Observe the EN 60601-1-1 and the EN 60601-1-2 standards in case of


connection with other instruments. The connection of the equipment with
other devices is allowed only when the safety requirements for the patient, the
user and the environment are not compromised. If the Manual does not contain
enough information about the possibility of interconnection with other devices,
the user should contact the manufacturer or the nearest authorized servicing
center to have information about the effects that coupling devices may have on
the patient, the user and the environment.

• Replace damaged parts immediately. Cables, connectors, accessories, or


other parts of the equipment must be replaced immediately when damaged or
not working correctly. In these cases, contact the nearest authorized servicing
center.

• 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.

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MIZAR-LIGHT Operator Manual

1.3.2 SAFETY OF THE OPERATIONAL ENVIRONMENT

• The equipment is not designed to be used in locations with inflammable


vapors or gases that may cause explosions. The equipment must not be used
in atmospheres with a high concentration of oxygen or in buildings where
inflammable substances or anesthetic agents are present. The atmosphere is
considered as oxygen-saturated when the oxygen or nitrous oxide (NO2)
concentration contained in the environment is over 24%.

• 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.

• Use the equipment within the environmental limits of specified


temperature, humidity and pressure. The equipment is designed to work in
environmental conditions that, in compliance with the IEC 601-1 directions,
are defined as standard:
− Temperature +5°C / +40°C
− relative humidity 30% / 75% RH
− atmospheric pressure 700 / 1060 hPa

• Be careful using the equipment when it is moved between locations with


different temperatures to avoid any possible condensation phenomenon. If
the equipment is stored or kept in a cold place and is rapidly moved to be used
in a warmer building, condensation phenomena may occur (humidity or
misting over the internal or external surface of the equipment). In this case it is
necessary to wait for humidity to be completely evaporated before supplying
and using the equipment.

• Make sure the electric wiring of the building is efficient in case of


connection to other mains powered devices. When the equipment is
connected to peripherals or other mains powered devices, make sure that the
latter are connected only to mains outlets with protective grounding. This
protection is fundamental for the patient’s and the user’s safety: therefore, it is
necessary that the electric wiring of the building guarantees an efficient
protective grounding.

• Be careful using the equipment in locations disturbed by strong magnetic


fields. The equipment is compliant with the EMC requirements
(Electromagnetic Compatibility) according to what specified by the
89/336/EEC European Directive. In every case it is recommended to keep the
equipment away from disturbance sources and induced electromagnetic fields
surpassing the values prescribed by the standard in order to avoid any possible
instabilities and malfunctioning of the equipment

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Operator Manual MIZAR-LIGHT

• Be careful using the equipment near short-wave or micro-wave devices. If


the equipment is used in an area where there are also therapeutic short-wave or
micro-wave devices, it is necessary to remember that these may cause
instability and interfere with the correct working of the equipment. Do not
place the equipment near X-ray or diathermy devices

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MIZAR-LIGHT Operator Manual

1.3.3 SAFETY OF GALILEO_NT SOFTWARE

It is not allowed to install the GALILEO_NT software on any machine without


the prior written permission of EBNeuro.

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.

A “software virus” is a form of computer-based practical joke. It is a program


created to spread from a computer to another one without the user being of it.

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.

Information about safety 1-9


Operator Manual MIZAR-LIGHT

1.4 GRAPHIC SYMBOLS IN COMPLIANCE WITH THE IEC 601-1


STANDARDS (CEI 62-5)
The following table shows description and localization of all graphic symbols in
compliance with the IEC 601-1 (CEI 62-5) safety standards present on the
equipment panels and on any other instruments or external devices to which the
equipment may be connected.

SYMBOL DESCRIPTION POSITION


IEC 601-1
Alternate current Symbol placed on the connection
points between the equipment and
the mains.

Equipotential terminal Symbol placed on the outlet


connecting the equipment to the
equipotential node of the building, if
any.

Protective earth Symbol placed on the connection


points between the equipment and
the protective grounding.

High voltage Symbol placed on circuits or


equipment parts with high voltage.

Attention! Refer to the Symbol placed on items for which


attached instructions. it is important to read the Owner’s
manual for relevant information
(see ATTENTION paragraph).

Off device (disconnected from Symbol placed on the off/on


the mains) positions of the single device
power switch.

On device (connected to the Symbol placed on the off/on


mains) positions of the single device
power switch.

Device with BF-type applied Symbol placed on items applied to


items the patient with a BF-protection
level.

Device with B-type applied Symbol placed on items applied to


items the patient with a B-protection
level.

Device with CF-type applied Symbol placed on items applied to


items the patient with a CF-protection
level (see NOTE below).

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MIZAR-LIGHT Operator Manual

1.5 OTHER GRAPHIC SYMBOLS


The following table shows description and localization of all symbols placed on
the equipment panels and on any other instruments or external devices to which
the equipment may be connected.

SYMBOL DESCRIPTION POSITION


Input Symbol placed on the signal input or main
voltage input connectors of the equipment.

Output Symbol placed on the signal output or the


main voltage output connectors of the
equipment.

Reference number Symbol placed on the identification label of


REF the medical device together with the device
reference number.

Serial number Symbol placed on the identification label of


SN the medical device together with the device
serial number.

Date of manufacture Symbol placed on the identification label


of the medical device together with the
device manufacture date.

Manufacturer Symbol placed on the identification label of


the medical device together with the name
and address of the device Manufacturer

Authorized Symbol placed on the identification label of


Representative in the the medical device together with the name
European Community and address of the device Authorized
Representative in the European
Community.

Symbol placed on the identification label of


Crossed-out wheeled bin the medical device. This symbol indicates
the prohibition of throw the medical device
in the household wheeled bin device when
at its “end of life”.

Lot number Symbol placed on the identification label of


the medical device together with the device
lot number.

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Operator Manual MIZAR-LIGHT

Use by Symbol placed on the identification label of


the medical device together with the device
expiration date.

Do not reuse Symbol placed on the identification label of


the medical device. This symbol indicates
that the device is a disposable one and
cannot be used more than once.

Sterile Symbol placed on the identification label of


the medical device indicating a sterile
device.

Sterilization with steam Symbol placed on the identification label of


or dry heat the medical device indicating a sterile
device and the sterilization method used
(steam or dry heat).

Sterilization with ethylene Symbol placed on the identification label of


oxide the medical device indicating a sterile
device and the sterilization method used
(ethylene oxide).

Sterilization by irradiation Symbol placed on the identification label of


the medical device indicating a sterile
device and the sterilization method used
(irradiation).

Refer to the instructions Symbol placed on the identification label of


for Use/functioning. the medical device recommending to refer
to the instruction for use/functioning for
more information about the usage of the
device.

Temperature Limit Symbol placed on the identification label of


the medical device together with the
indication of temperature limits (high and
low limits) for the usage/storage of device

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MIZAR-LIGHT Operator Manual

1.6 ATTENTION SYMBOL


The ATTENTION symbol shown below, placed on the equipment casing, refers
the user to the Operator Manual for information, warnings and suggestions which
are particularly important for a correct and safe use of the equipment.

In particular, when it is placed on points connecting cables to peripherals, this


symbol refers the user to carefully read the Operator Manual for instructions
concerning the nature of such cables and peripherals and the modalities for a
correct and safe connection.

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.

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Operator Manual MIZAR-LIGHT

1.7 CROSSED-OUT WHEELED BIN


This product is according to Waste of Electrical and Electronic Equipment
(WEEE) directive (2002/96/EEC).
Ensuring this product will be correctly collected , you will help to avoid possible
negative effects on natural resources and human health , that could occur through
a wrong treatment of the product at its “End of Life”.
The symbol shown below placed on the product or on its packaging indicates that
this product must not be disposed of with your other household waste; it will be
handed over to a designated collection point for the recycling of waste electrical
and electronic equipment.

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).

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MIZAR-LIGHT Operator Manual

1.8 PRODUCT TRACEABILITY


In order to guarantee the traceability of the product, according to what stated in
the ISO 13485 quality standards and the 93/42/EEC European Directive on
Medical Devices, EBNeuro kindly requests the original owner of the equipment to
give communication to our main offices of any conveyance of the product to third
parts, by sending a photocopy of the proper duly filled-in Product traceability
form (see enclosure 1.7), or by communicating in writing the data indicated in the
form.
The data concerning the device can be found on its 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.

1.9 VIGILANCE SYSTEM


The device is subject to a vigilance system (post-marketing vigilance) that
EBNeuro and their distributors and retailers apply to the products they put on the
market to safeguard the patient and the physician from serious or potentially
serious hazards during the normal use of the equipment, in order to be able to
remove the source of such hazards with the best efficiency and timing.

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 instrument’s data can be collected from it’s 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.

Information about safety 1-15


Operator Manual MIZAR-LIGHT

enclosure 1-7

PRODUCT TRACEABILITY FORM

To: EBNeuro S.p.A.


Quality Assurance Department
Via Pietro Fanfani, 97/A
50127 Florence

System/device name……….................................................................................................

Device code / reference number (REF) .........................................................................…..

Device serial (SN) / lot number (LOT) .................................................................................

Name and address of the former owner .................................................................……....


.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................

Name and address of the present owner .................................................................….......


.....................................................................................................................................….......
................................................................................................................…............................
..................................................................................................................…..........…............

Date:...........................

Signature

...............................................

(please name in full)

(ref. Operator Manual code B830 0047 611)

1-16 Information about safety


MIZAR-LIGHT Operator Manual

enclosure 1-8

POST-MARKETING VIGILANCE FORM

To: EBNeuro S.p.A.


Quality Assurance Department
Via Pietro Fanfani, 111/A
50127 Florence

System/device name.......................................................................................………..........

Device code/reference number (REF) ................................................................................

Device serial (SN)/lot number(LOT) .....................................…....................................…….

Description of the real or potential hazard……………………………………………………..


.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................

User’s comments/suggestions ............................................................................................


.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................
.............................................................................................................................................

User’s address....................................................................................................................
Phone......................................................... Fax .............................................…................

Department where the device is installed.............................................................................


Person in charge of the department.....................................................................................

Data:...........................

Signature

...............................................

(please name in full)

(ref. Operator Manual code B830 0047 611)

Information about safety 1-17


Operator Manual MIZAR-LIGHT

1.10 INFORMATION ABOUT RECYCLING OF MATERIALS


In accordance with the specific European directives, EBNeuro aims to
continuously improve the design and the fitting of electromedical devices in order
to reduce as much as possible any negative impact on the environment caused by
the management of component parts, consumer materials, packaging and
discharge of devices when at their “end of life”.

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.

In order to cause minimum consequences to the environment, the design of the


device includes the highest possible miniaturization of the circuits, with the least
possible differentiation of materials and components, with a selection of
substances that guarantee the highest possibility to recycle and re-use the
components and to discharge them without risks for the environment.

The device is designed to guarantee the easy separation or disassembling of the


materials containing polluting substances from the others, in particular during the
operations of servicing and replacing parts. In particular, the largest plastic
components are marked according to their plastic contents in order to make it
easier to recycle the product.

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”.

1-18 Information about safety


MIZAR-LIGHT Operator Manual

1.11 ELECTROMAGNETIC COMPATIBILITY


This medical device is designed for use in the electromagnetic environments
declared in the tables below, in compliance with the IEC 60601-1-2:2001 (second
edition) standard. The operator must assure that the medical device is used in an
environment compliant to this standard.

Table 1 - Electromagnetic Emissions

Emission Test Compliance Electromagnetic Environment


Radiated and Class B The medical device is suitable for use in
conducted RF domestic establishment and in all
emission establishments directly connected to the low
voltage power supply network (electrical
mains) which supplies buildings used for
CISPR 11 domestic purpose.
Group 1 The medical device use RF energy only for its
internal function and to operate. Therefore, the
RF emission is very low and not likely to cause
any interference in nearby electronic
equipment.
Harmonic emission Complies The medical device is suitable for use in
establishments directly connected to a public
low voltage power supply network (electrical
IEC 61000-3-2 mains)

Voltage fluctuations/ Complies The medical device is suitable for use in


flicker emissions establishments directly connected to a public
low voltage power supply network (electrical
mains)
IEC 61000-3-3

Table 2 - Electromagnetic Immunity

Immunity Test IEC 60601-1-2 Test Compliance Electromagnetic


Level environment
Electrostatic 6 kV in contact IEC 60601-1-2 Residential
Discharge
(ESD) Test Levels (Note 1)

IEC 61000-4-2 8 kV on air

Electrical fast 2 kV for power supply IEC 60601-1-2 Residential


transient/burst line
Test Levels (Note 2)
(Note 3)
IEC 61000-4-4 1 kV for input/output
lines >3m

Information about safety 1-19


Operator Manual MIZAR-LIGHT

Surge 1 kv differential mode IEC 60601-1-2 Residential


2 kV common mode Test Levels (Note 2)
IEC 61000-4-5 (Note 3)
Voltage dips, 0 % of rated voltage
short (voltage dip 100 %)for
interruptions 0.5 cycles
and voltage
variation on 40 % of rated voltage
power supply (voltage dip 60 %)
input lines for 5 cycles

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

1-20 Information about safety


MIZAR-LIGHT Operator Manual

1.11.1 RECOMMENDED DISTANCES FROM RADIOFREQUENCY (RF)


COMMUNICATION SYSTEMS

As stated in this chapter 1 “Information about safety” of device operator manual,


it is recommended to not use Radiofrequency (RF) transmission system near the
medical device. RF systems can cause interference which may cause instability
and interfere with the correct working of the medical device and it may alters the
signal acquired tracings.

The operator can prevent interference caused by electromagnetic field by


maintaining a minimum distance between the medical device and the RF
communication system being used (cell phones, mobile phones, etc,).

The following table shows the minimum distances in meters, according to the
maximum power at RF system output.

Table 3 – Recommended separation distances from RF sources

RF Source Typical Rated Distance


Power
(m)
(W)
Microcellular phone CT1, CT2, CT3 0.01 0.3
DECT cellular phone, Wireless Information 0.25 2
Technology equipments (modems, LANs)
Cellular phone, hand-held (USA) 0.6 2
Cellular phone, hand-held (e.g. GSM and NMT, 2 4
Europe DECS 1800)
8 7
Walkie-talkie (rescue, police, fire, maintenance) 5 3
Cellular phone, bag 16 10
Mobile radio (rescue, police, fire) 100 30
For transmitters the maximum output power of which is not within the values range in
the table, the recommended minimum distance can be estimated by analyzing the
equation in the table applicable to the transmitter frequency:
For transmitters using frequencies range from 150 kHz to 80 MHz and from 80 MHz
to 800 MHz, the distance can be estimated using the equation:
d = 1.2√P
For transmitters using frequencies range from 800 MHz to 2.5 GHz, the distance can be
estimated using the equation:
d = 2.3√P
where P is the rated power of the transmitter in Watt (W) according to the transmitter
manufacturer specifications.
Note: As a precaution, always apply the greater distance supplied by the table.
Note: Electromagnetic fields are subjected to absorption and reflection in the presence of
structures, objects and people. The values in the table are general guidelines.

Information about safety 1-21


Operator Manual MIZAR-LIGHT

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.

Consequently, a direct measure may be necessary in the used environment of


medical device.

If the intensity of the electromagnetic fields exceeds that specified in the


immunity levels shown in the previous tables, and the medical device behaves
incorrectly working, additional measures may be necessary. I.e. orienting or
locating the medical device in a different way.

1-22 Information about safety


MIZAR-LIGHT Operator Manual

1.12 BIOCOMPATIBILITY AND INFECTIONS CONTROL


The system components (and the recommended disposable materials) coming into
contact with the patient comply with the European requirements related to this
subject.

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.

1.13 DECLARATION OF CONFORMITY

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.

1.14 CAUTION FOR THE U.S. MARKET


Federal law restricts this device to sale by or on the order of a physician.

Information about safety 1-23


Operator Manual MIZAR-LIGHT

For your notes:

1-24 Information about safety


MIZAR-LIGHT Operator Manual

CHAPTER 2
GENERAL DESCRIPTION

2.1 GALILEO BE_LIGHT SYSTEM


The GALILEO BE_LIGHT “digital electroencephalograph” realise the new
EBNeuro DIGITAL EEG/EP line.

GALILEO BE_LIGHT can be defined as "the universal recorder" because of its


ability to acquire any neurophisiological signal. The extremely large bandwidth of
the BE_LIGHT Amplifier (DC to 20 KHz) together with it’s multifrequency
feature, allows the hardware to manage EEG (and digital Video EEG), as well as
other physiological signals such as Polygraphy, Evoked Potentials (EP) on all
channels while in multimodal monitoring.

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!

General description 2-1


Operator Manual MIZAR-LIGHT

2.2 MIZAR-LIGHT SYSTEM


MIZAR-LIGHT is a console-like digital electroencephalograph with a standard
number of 28 channels, which can autonomously work both as a single stand
alone station and connected to the network with other GALILEO stations.

In addition to the sophisticated functions of acquisition, display and analysis, the


MIZAR-LIGHT system is provided with important auxiliary functions, such as
the Evoked Potentials, the Video EEG, Sleep Analysis, Spectral Analysis and
Amplitude Brain Mapping.

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.

The MIZAR-LIGHT system offers all of the main characteristics of a digital


electroencephalograph including reformatting of montages, patient’s reports
management, entering of annotations on the tracing and fast pages reply, all
functions that can be defined by the user.
The MIZAR-LIGHT system represents a new stage for electroencephalography
by integrating the fundamental aspects of traditional methodologies with all the
advantages of digital technology.

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.

The MIZAR-LIGHT system carries out all performances of digital


electroencephalography. In particular:

• 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.

• Off-line reconstruction of montages (reformatting)

• 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.

2-2 General description


MIZAR-LIGHT Operator Manual

• Usage of pen-less printers able to change the number and dimensions of the
tracings and to edit comments and diagrams.

• The system can be equipped with an optional built-in A4-format Thermal


Printer. The system can be also equipped with optional Laser printers or
DeskJet printers (B/W or colour) for the printout of patient’s reports, tracings
and brain maps.

• 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 MIZAR-LIGHT system is composed by a PC in which is installed the


“GALILEO_NT” Digital EEG software , by the “BE_LIGHT” bioelectrical
signals acquisition and amplification module and by a trolley provided with
isolation transformer.
On the base elements of the system (trolley, PC, BE_LIGHT), can be installed
several optional devices such as thermal printer, flash stimulator, and so on.

Figure 2-1 - MIZAR-LIGHT system (example)

General description 2-3


Operator Manual MIZAR-LIGHT

The following figure describes all the standard and optional elements/modules of
the MIZAR-LIGHT system:

Figure 2-2 - elements/modules of MIZAR-LIGHT system

The standard elements/modules of MIZAR-LIGHT system are:


1. Trolley.
2. Power supply module (Isolation Transformer )
3. Personal Computer ( minidisk, desktop or laptop).
4. Monitor (15”, 17” LCD monitor; not present with laptop type PC)
5. Standard PC Keyboard (and mouse); not present with laptop type PC
6. BE_LIGHT acquisition module

The optional device/accessories are:


7. A4-format Thermal Printer.
8. Standard PC Printer (Laser o DeskJet )
9. Multimodal Stimulator module (one audio stim. and two electric stim.)
10. Xenon Flash visual stimulator module
11. “Analogic Output and Auxiliary Input” modules
12. Led visual stimulator
13. Pattern Reversal visual stimulator.
14. Acoustic stimulation actuator (headphones TDH-39 )
15. Electric stimulation actuators (bridge, rings)
16. Xenon flash lamp stimulation actuator (pantograph arm and lamp)
17. Camera VIDEO-EEG recordings
18. PC acoustic speakers for tracings replay
19. Pantograph arms for acquisition module and visual stimulator
20. Stand for acquisition module and visual stimulator

2-4 General description


MIZAR-LIGHT Operator Manual

The following figure 2.3 describes the “logical” connections among the listed
elements/modules.

Figure 2-3 - Connections MAINS


110/220VAC
110/220 VAC LOW VOLTAGE
(*) (9...15VDC)

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

Figure 2-3 - Connections

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.

The system is CE marked according 93/42/EEC directive on Medical Devices.


The marking procedures is in according to Annex II of directive for Class IIb
devices. For these reasons the system is marked with CE0051 mark.

General description 2-5


Operator Manual MIZAR-LIGHT

For your notes:

2-6 General description


MIZAR LIGHT Operator Manual

CHAPTER 3
TECHNICAL CHARACTERISTICS

3.1 COMPLETE SYSTEM


Product name MIZAR-LIGHT

Description Console-like digital multifunction EEG-EP, Video EEG


system with 28 wide band channels.
The MIZAR-LIGHT system can be divided into the
following parts:
- Acquisition and amplification of the signals module
(BE_LIGHT)
- Trolley containing inside all the connection, the
power supplies, the interfaces among the single
modules
- Isolation transformer module
- Personal Computer, keyboard and mouse
- Dedicated PCMCIA or BE NET interface
- Monitor
- A4-format Thermal Printer (optional) with Analog
Output module
- Multimodal stimulator Module (optional)
- Laser printer or DeskJet colour printer (optionals).
- Xenon flash stimulator (optional) with internal
control module
- Led visual stimulator (optional)
- Pattern stimulator (optional) with external control
module
- EEG and EP accessories kits
- GALILEO_NT software

Intended use Active, Diagnostic, not invasive Medical Device,


intended for short term application (24h<<30gg).
Employed for particular application to release energy to
the human body. Device employed for the monitoring,
acquisition, recording and processing of bioelectrical
signals generated by central nervous system.

Classification according to MDD 93/42/EEC


Class II b

Technical characteristics 3-1


Operator Manual MIZAR LIGHT

Standards and Directives 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
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
electroencephalographs equipments
EN 60601-2-40 Particular safety standard for
electromyographs and evoked potential
equipments
EN 30993-1 Standard for the biological evaluation of
medical devices (bio-compatibility)

Type of protection against electric shocks


Class I

Level of protection against direct and indirect electric contacts


CF-type (patient input)
BF-type (multimodal stimulators)
B-type (auxiliary input/output port)

Level of protection against inflow of solid and liquids


Not protected (IP20)

Working mode
Continuous, within the specified limits

Environment working conditions


Temperature: from +5°C to +40°C
Relative Humidity: from 30% to 75% RH
Atmospheric Pressure: from 700hPA to 1060hPA

Environment storing conditions (max 15 weeks)


Temperature: from -30°C to +60°C
Relative Humidity: from 5% to 95% RH
(excluding condensation)
Atmospheric Pressure: from 500hPA to 1060hPA

3-2 Technical characteristics


MIZAR LIGHT Operator Manual

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

System rated values


Manufacturer: EBNeuro S.p.A.
Model: MIZAR-LIGHT
Code (REF): B9800047600
Voltage rating: 220-240V / 50Hz
(115V / 60Hz)
Absorption rating: 550 VA
Year of manufacture
CE0051 mark (93/42/EEC)

Technical characteristics 3-3


Operator Manual MIZAR LIGHT

3.2 BE_LIGHT ACQUISITION MODULE


Product name BE_LIGHT

Description Bioelectrical signals acquisition and


amplification module, connected to the data
processing and storing system by means a fiber
optic link. Provided with removable patient
input box.

Intended use Active, not invasive Medical Device.


Employed for acquisition, amplification,
analogic conditioning, numeric conversion and
data transferring to a host PC system of
bioelectrical signals generated by the human
body.

Classification according to MDD 93/42/EEC


Class II b

Standards and Directives applied


93/42/EEC Medical Device European Directive
(MDD);
EN 60601-1 General safety standard for
Electromedical equipments (CEI 62-5)
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
electroencephalographs equipments

Type of protection against electric shocks


Class I, powered by proper power supply
(models AULT SW173 o AULT MW160 o SINPRO
MPU50-106)

Level of protection against direct and indirect electric contacts


CF-type (patient input)
B-type (auxiliary input/output port)

Level of protection against inflow of solid and liquids


Not protected (IP20)

3-4 Technical characteristics


MIZAR LIGHT Operator Manual

Working mode
Continuous, within the specified limits

Environment working conditions


Temperature: from +5°C to +40°C
Relative Humidity: from 30% to 75% RH
Atmospheric Pressure: from 700hPA to 1060hPA

Environment storing conditions (max 15 weeks)


Temperature: from -30°C to +60°C
Relative Humidity: from 5% to 95% RH
(excluding condensation)
Atmospheric Pressure: from 500hPA to 1060hPA

External dimensions and weight (complete system with monitor and printer)
Max height: ~ 35 mm
Max width: ~ 135 mm
Max depth: ~ 105 mm

Max weight: ~ 350 g

Device rated values


Manufacturer: EBNeuro S.p.A.
Model: BE_LIGHT
Code (REF): B9700047000
Year of manufacture
Serial Number (SN)
CE0051 mark (93/42/EEC)
cCSAus mark

EEG monopolar channels 21 standard


28 using bipolar and polygraphic
channels as EEG channel

Polygraphic AC/DC monopolar channels


3

EP bipolar channels 4

Impedance measurement By means of injected current


(20 Hz - 0.01 µA/electrode)

Technical characteristics 3-5


Operator Manual MIZAR LIGHT

A/D conversion 16 bits SAR A/D

Resolution, Dynamic and Noise


EEG monopolar channels (1,2,3…..21)
EP bipolar channels (A,B,C e D)

Gain Setting / Dynamic Noise


Resolution (0.1Hz-70Hz)

High 8000 µVpp ≤ 0.3 µVrms


1/8 µV/bit

Polygraphic monopolar chann. (22,23,24)

Gain Setting / Dynamic Noise


Resolution (0.1Hz-70Hz)

High 8000 µVpp ≤ 0.3 µVrms


1/8 µV/bit
Low 128 mVpp ≤ 5 µVrms
2 µV/bit

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

Low-Pass filters (A/D converter output)


Frequency cut 0.45 fs (fs = current sampling rate)
Attenuation 80dB f ≥ 0.55 fs

Anti-aliasing Low-Pass filters (3th order filter)


Frequency cut 1KHz (for EEG monopolar channels and
Polygraphic channels)
2KHz (for EP bipolar channels)
Attenuation 24dB/octave

Selectable Sampling Rate


128,256,512,1024,2048,4096 and 8192 Hz

3-6 Technical characteristics


MIZAR LIGHT Operator Manual

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

Max DC Offset (AC mode) ± 300 mV

Amplifier box – PC interface PCMCIA or BE NET


(by means of fiber optic link)

Electrode connections 3 active – one connection for each input


(polygraphic monopolar)
21 active – one connection for each input
(EEG monopolar)
8 active – two connection for each input
(EP bipolar)
2 for Common Reference electrode
(for EEG monopolar electrodes)
1 for Polygraphic Reference electrode
(for polygraphic monopolar electrodes)
4 for isolated patient ground
1 for calibration signal output

Other interface n° 1 orange signalling Led


n° 1 functions control key
n° 1 Led matrix for ohmmeter
(n° 36 blue Led)
n° 1 connection for prewired headset

Power supply external AC/DC adapter


(IEC 601-1 Class I Type B)

Technical characteristics 3-7


Operator Manual MIZAR LIGHT

Consumption 260 mA @ 15VDC typical

Case Material: Polycarbonate Plastic


Dimensions: 130 x 100 x 35 mm
Weight: < 300 g

Isolation Fiber optic link

3-8 Technical characteristics


MIZAR LIGHT Operator Manual

3.3 ACQUISITION AND PROCESSING OF THE SIGNAL


(GALILEO_NT SOFTWARE)
Data acquisition Up to 28 channels that can be acquired at
the same time

Graphic unit Directly managed by the PC and


depending on PC graphic board installed.

Traces resolution 1024 x 768 dpi (minimum)


1240 x 1024 dpi
1600 x 1200 dpi

EEG displaying during acquisition Paper-like Real time scrolling


(panning mode )
Equivalent on monitor speed:
5 – 10 – 20 – 30 – 60 (sec/pag)
0.75 – 1.5 – 3 – 6 (cm/sec)

Real time reproduction on thermal


printer. Paper scrolling speed:
2.5 – 7.5 – 10 – 15 – 30 – 60 (mm/sec)

EEG displaying during replay Paper-like Real time scrolling


(panning mode )
Equivalent on monitor speed:
5 – 10 – 20 – 30 – 60 (sec/pag)
0.75 – 1.5 – 3 – 6 (cm/sec)

Real time reproduction on thermal


printer. Paper scrolling speed:
2.5 – 7.5 – 10 – 15 – 30 – 60 (mm/sec)

“Single pages” displaying mode


with automatic or adjustable manual
scrolling steps

Zoom function available on selected


tracing (zoom x 4)

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

Notch filtering system


Frequency values: 50Hz or 60Hz
Attenuation charact.: Freq. -3dB (band 1Hz)
Min attenuation –40dB

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%

Recording and storing system of acquired signal


PC Hard Disk of system
Hard Disk of central network server

Data Back Up system CD-ROM / DVD ROM


Magnetic-Optic disk

Paper recording system


A4-format Thermal Printer (Real time)
Laser B/N printer (OFF line)
DeskJet colour printer (OFF line)

3-10 Technical characteristics


MIZAR LIGHT Operator Manual

3.4 PCMCIA INTERFACE


Case Standard: Type III PCMCIA Interface
Dimensions: 105 x 55 x 11 mm

Power supply 3.3 V @ 100 mA


Directly from PCMCIA bus connector

Device Rated values


Manufacturer: EBNeuro S.p.A.
Model: PCMCIA Interface
Code (REF): B9100370500
Year of manufacture
Serial Number (SN)

3.5 BE NET INTERFACE

Product name LAN interface for electrophisiological


system - BE Net

Description Active, non-invasive accessory device for medical


device

Intended use Conversion and data transferring module between an


amplifier module for the acquisition (EBNeuro
Amplifier) and the Ethernet 10/100 bT Network.

Classification according MDD 93/42/EEC


Classe II b

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

Type of protection against electric shocks


Class I equipment powered by specified power supply

Technical characteristics 3-11


Operator Manual MIZAR LIGHT

Protection level against electrical direct and indirect contacts


Not Classified (auxiliary Input/Output port)

Protection level against inflow of solids and liquids


Common (IP20)

Operational mode Continuous, within the specified limits

Environment working conditions


Temperature: from +5°C to +40°C
Relative Humidity: from 30% to 75% RH
Atmospheric Pressure: from 700hPA to 1060hPA

Environment storing conditions (max 15 weeks)


Temperature: from -30°C to +60°C
Relative Humidity: from 5% to 95% RH
(excluding condensation)
Atmospheric Pressure: from 500hPA to 1060hPA

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.

3-12 Technical characteristics


MIZAR LIGHT Operator Manual

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.

Device rated values


Manufacturer: EBNeuro S.p.A.
Module: BE NET
Code (REF): B9700053000
Year of manufacture
Serial Numbe
CE0051 mark (93/42/EEC)

Technical characteristics 3-13


Operator Manual MIZAR LIGHT

3.6 AC/DC ADAPTER


Depending on the configuration the system may be provided with one of the
following AC/DC Adapter

3.6.1 MODEL AULT SW173

Manufacturer AULT inc.

Model SW173

Input 100-240VAC - 50/60Hz

Output 15VDC @ 2.2A

Safety standards IEC 601-1 (EN 60601-1)


89/336/EEC (EMC)
73/23/EEC (Low Voltage)

Quality mark CE, TUV, CSA, UL

Electrical protection level Class I , B-Type

Case Material: Plastic


Dimensions: 129 x 77 x 40 mm

3.6.2 MODEL AULT MW160

Manufacturer AULT inc.

Model MW160

Input 100-240VAC - 50/60Hz

Output 15VDC @ 3A

Safety standards IEC 601-1 (EN 60601-1)


89/336/EEC (EMC)
73/23/EEC (Low Voltage)

Quality mark CE, TUV, cULus

Electrical protection level Class I , B-Type

Case Material: Plastic


Dimensions: 100 x 65 x 40 mm

3-14 Technical characteristics


MIZAR LIGHT Operator Manual

3.6.3 MODEL SINPRO MPU50

Manufacturer SINPRO Electronic Co LDT..

Model MPU50-106

Input 90-264VAC - 50/60Hz

Output 15VDC @ 3A

Safety standards IEC 601-1 (EN 60601-1)


EN 55011
EN 60601-1-2

Quality mark CE, TUV, cULus

Electrical protection level Class I , B-Type

Case Material: Plastic


Dimensions: 146 x 76 x 43 mm

Technical characteristics 3-15


Operator Manual MIZAR LIGHT

3.7 ISOLATION TRANSFORMER MODULE

Description and Intended use


Active medical device (accessory for) not diagnostic,
Not invasive, employed for the usage as power supply
module for not medical and medical equipments or
Peripherals in order to build electromedical systems
according to the safety standards for medical
equipments.

Classification according to MDD 93/42/EEC


As accessory for medical devices

Standards and Directives 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
EN 60601-1-2 Collateral safety standard for Electro
Magnetic Compatibility (EMC)

Type of protection against electric shocks (according to IEC 601-1)


Class I

Level of protection against direct and indirect electric contacts


(according to IEC 601-1)
B-type (no applied parts)

Level of protection against inflow of solid and liquids


Not protected (IP20)

Working mode
Continuous, within the specified limits

Environment working conditions


Temperature: from +5°C to +40°C
Relative Humidity: from 30% to 75% RH
Non condensing
Atmospheric Pressure: from 700hPA to 1060hPA

3-16 Technical characteristics


MIZAR LIGHT Operator Manual

Environment storing conditions


Temperature: from -30°C to +60°C
Relative Humidity: from 5% to 95% RH
Non condensing
Atmospheric Pressure: from 500hPA to 1060hPA

(Vers. 220V) (Vers. 115V)

Voltage rating 220-240V/50Hz 115V/60Hz

Usage range 220-240V/±10% 115V//±10%

Absorption rating 575VA 575VA

Max power output 500VA 500VA

Primary-secondary isolation voltage > = 4kV

Primary-secondary surface distance > = 8mm

Leakage current < = 100µA

Protection against short-circuit 2xT5A Fuse, dim 5x20 mm,


(for 220V-50Hz)
2xT10A Fuse, dim 5x20mm
(for 115V-60Hz)

Protection against overload Thermal switch with working


temperature of 110°C

Input n° 1 Mains voltage input outlet


n° 1 Auxiliary connector for the
ON/OFF management of auxiliary controlled outlet
n°1 Equipotential terminal

Output n° 4 Auxiliary isolated mains outlets managed


ON/OFF under control of external signal
n° 1 Isolated direct mains outlet (not ON/OFF
controlled by external signal)

Technical characteristics 3-17


Operator Manual MIZAR LIGHT

External ON/OFF remote control


+12VDC (150mA max) voltage applied between
pin 1 (+) and pin 2 (-) of remote control connector
Short circuit between pin 3 and pin 4 of remote
control connector.

External dimensions
Max height: ~ 110 mm
Max width: ~ 325 mm (with handles)
Max depth: ~ 220 mm

Weight 9 Kg

Device rated values


Manufacture EBNeuro S.p.A.
Model ISOLATION TRANSFORMER “GP”
Code (REF): B970 0041 000 (Vers. 220-240V/50Hz)
B970 0041 001 (Vers. 115V/60Hz)
Year of manufacture
Serial Number (SN)
CE mark (93/42/EEC – Class I)

3-18 Technical characteristics


MIZAR LIGHT Operator Manual

3.8 THERMAL PRINTER


Description The A4-format thermal printer is the MIZAR-LIGHT
system printing unit that can be managed directly from
the elettroencephalograph software.

Safety standards IEC 60601-1

Type of protection against electric dangers


Class I

Type of protection against the inflow of solid and liquids


IP20

Power supply rating 220-240V/50Hz (115V/60Hz)

Absorption rating 130VA

Fuses 2 x T2A, size 5x20 mm for 220V/50Hz


2 x T4A, size 5x20 mm for 115V/60Hz

Working mode Continuous, within the specified limits.

Working conditions
- Temperature +5°C ÷ +35°C
- Relative humidity 30% ÷ 75% RH
- Atmospheric pressure 700hPA ÷ 1060hPA

Storing conditions (max 15 weeks)


- Temperature –30°C ÷ +60°C
- Relative humidity 5% ÷ 95% RH
- Atmospheric pressure 500hPA ÷ 1060hPA

External size
- Max height ~ 180mm
- Max width ~ 280mm
- Max depth ~ 330mm

Weight 8 Kg

Building technology of heads Thick film

Thermal head size


- Format A4
- Width 216mm
- Number of dots 1728

Thermal head resolution 8 dots/mm (amplitude axes resolution)

Technical characteristics 3-19


Operator Manual MIZAR LIGHT

Minimum time resolution 16 dots/mm (time axes resolution)

Print frequency 1024Hz

Paper sheet size 215 x 300mm

Paper type Z-folder thermal paper

Paper feeding actuator Motor in DC

Paper feeding speed 2 – 5 – 7.5 – 10 – 15 – 30 – 60 (mm/sec)

Number of traces max. 32

Print-acquisition delay < 100msec

Sampling system Flash 32 channel

Sampling rate 1024Hz (settable from SW)

Writing system Double alphagraphic

Resolution 4 dots/mm x 1280 dots per page on time


axis

Input 32 direct analogic inputs


IRIG (1V equivalent)

Interface Parallel interface (Centronics type)

3-20 Technical characteristics


MIZAR LIGHT Operator Manual

3.9 ANALOG OUT MODULE


Conversion D/A with reconstruction filtering

Number of channels 24

Frequency band 0–100 Hz at –3dB (Toll. 2%)

Equivalent Sensitivity 1V/cm (IRIG)

Output impedance ≤ 100 Ohm

Device Rated values


Manufacturer: EBNeuro S.p.A.
Model: ANALOG OUT 24 CH
Code (REF): B9700030000
Year of manufacture
Serial Number (SN)

3.10 DC AUXILIARY INPUT MODULE

Number of channels 8

Frequency band 0–16 Hz

Equivalent Sensitivity 1V/cm (IRIG)

Input impedance >100 KOhm

Device Rated values


Manufacturer: EBNeuro S.p.A.
Model: DC EXPANSION
Code (REF): B9700040000
Year of manufacture
Serial Number (SN)

Technical characteristics 3-21


Operator Manual MIZAR LIGHT

3.11 MULTIMODAL STIMULATOR MODULE


Product name MMS (Multi Modal Stimulator)

Description Multisensorial Stimulator Module containing


the dedicated electronic board which generate
and manage visual, acoustic and electrical
(somatosensorial) stimuli
The module is placed inside dedicated support
of system trolley. It is possible to extract the
module in order to use it near the patient body.

Intended use Active, not invasive Medical Device,


employed for release energy to the human body
(electric, light, acoustic energy) for the detection
of correlated evoked potentials.

Classification according to MDD 93/42/EEC


Class II b
(as module of MIZAR-LIGHT system)

Standards and Directives applied


93/42/EEC Medical Device European Directive
(MDD);
EN 60601-1 General safety standard for
Electromedical equipments (CEI 62-5)
EN 60601-1-2 Collateral safety standard for Electro
Magnetic Compatibility (EMC)
EN 60601-1-4 Safety standard for equipment containing
programmable systems
EN 60601-2-40 Particular safety standard for
Electroemyograph and evoked potential
equipments

Type of protection against electric shocks


Class I, powered by proper power supply
(models AULT SW173, AULT MW160, SINPRO
MPU50-106)

Level of protection against direct and indirect electric contacts


BF-type (all the stimulators)

Level of protection against inflow of solid and liquids


Not protected (IP20)

3-22 Technical characteristics


MIZAR LIGHT Operator Manual

Working mode
Continuous, within the specified limits

Environment working conditions


Temperature: from +5°C to +40°C
Relative Humidity: from 30% to 75% RH
Atmospheric Pressure: from 700hPA to 1060hPA

Environment storing conditions (max 15 weeks)


Temperature: from -30°C to +60°C
Relative Humidity: from 5% to 95% RH
(excluding condensation)
Atmospheric Pressure: from 500hPA to 1060hPA

External dimensions and weight (complete system with monitor and printer)
Max height: ~ 100 mm
Max width: ~ 170 mm
Max depth: ~ 175 mm

Max weight: ~ 1.1 Kg

Device rated values


Manufacturer: EBNeuro S.p.A.
Model: MMS Stimulator
Code (REF): B9700046000
Year of manufacture
Serial Number (SN)

Stimulators
Electric: Double current stimulator
Acoustic: Acoustic stimulator (click, tone)
Visual: LED flash stimulator
LED Goggles stimulator
Pattern stimulator

Technical characteristics 3-23


Operator Manual MIZAR LIGHT

3.11.1 ELECTRIC STIMULATOR

Number of stimulator: n° 2 (stimulator A and stimulator B)

Type: Constant current

Stimulation modality: - Single impulse


- Impulse train

Stimulator management: - Activation via software with


Control from PC
- Single stimulator A
- Single stimulator B
- Stimulator A and B with delay

Stimulation intensity: 0-100 mA with resolution 0.1 mA


Toll. 5% offset range.

Max Voltage: 250 V

First failure max. current: < 200 % of set value.

Load resistance range: 100-2000 Ohm

Test resistance load: 1000 Ohm // 200 pF

Duration of stimulation impulse: 10-1000 µs with resolution 10 µs

Repetition rate: 100 ms - 10 s with resolution of 10 ms

Isolation: 1500 Vac for 1 minute

Max current delivered (mean value or rms value):


1 mA

Max energy delivered for each single stimulation impulse:


10 mJ

3-24 Technical characteristics


MIZAR LIGHT Operator Manual

Signalling led: yellow “Active” (stimulation delivered)


red “Overload” (voltage overload)

Stimulation intensity adjustment:


- By knob on front panel;
- By knob on muscle stimulator;
- Via software with control from PC
keyboard/mouse
- Issued current displayed on the PC
monitor.

Stimulation delivery: - By knob on front panel (pressing);


- By button on muscle stimulator;
- Via software with control from PC
keyboard/mouse

Duration and stimul. rate adjustm.:


- Via software with control from PC

τ
R=1000Ω

Where:
τ = duration of stimulation impulse
T = repetition rate
I = stimulation intensity
R = load resistance

Technical characteristics 3-25


Operator Manual MIZAR LIGHT

3.11.1.1 TREND OF THE SUPPLIED POWER IN RELATION TO THE LOAD

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 = SQR [ (τ/T) x (IMAX)² ]

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

3-26 Technical characteristics


MIZAR LIGHT Operator Manual

3.11.2 ACOUSTIC STIMULATOR

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

Available stimulus : Click


Tone

Click: Polarity: Compressed/Alternate/Rarefied (P)


Duration: 1-100 µs , step 1 µs (D)
Cadence: 1-100 Hz , step 1Hz (C)

Tone: Plateau: 1-200 ms , step 1 ms (P)


Rise/Fall: 1-100 ms , step 1 ms (R)
Cadence: 1-100 Hz , step 1 Hz (C)
Frequency: 125, 250, 500, 750, 1000, 2000,
3000, 4000, 6000, 8000 Hz (F)

R 1/F P

Technical characteristics 3-27


Operator Manual MIZAR LIGHT

Available masking :
White noise
Pink noise Band @ -6dB:
125, 250, 500, 750, 1000, 2000
3000, 4000, 6000, 8000 Hz

Adjustment : From PC via software

Stimuli actuators: Telephonics TDH-39 headphones

3-28 Technical characteristics


MIZAR LIGHT Operator Manual

3.12 LED FLASH STIMULATOR


Product Name Flash LED Stimulator

Description Medical Device accessory, Active, Not Invasive

Intended Use Visual Stimulation during EEG or Evoked Potential


(EP) Recording

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;

EN 60825-1 General safety standard for Laser Equipment and


classification

Classification according to MDD 93/42/EEC


Class I

Classification according to EN 60825-1


Class 1 LED radiation equipment

Optical band: see following diagram:

Relative intensity of the emitted light as function of the light wave-lenght


Sensibility of human eye as function of the light wave-lenght

Technical characteristics 3-29


Operator Manual MIZAR LIGHT

Luminous flux: 144.0 lm (minimum)


182.4 lm (typical)
230.4 lm (maximum)

Luminous intensity: 43.2 ÷ 86.4 cd

Angle of view at 50% of light intensity: 120°

Duration: 1-20 ms , steps 1 ms (D)

Cadence: 20ms /10s , steps 10ms (C)

Adjustment :
From PC via software

Type of protection against electric shocks

Class I equipment powered by specified


devices

Protection level against electrical direct and indirect contacts

Not classified

Protection level against inflow of solids and liquids

Common (IP20)

Interfaces: TRIAD male connector – 5 pin


Power supply, controlling signal (trigger)

3-30 Technical characteristics


MIZAR LIGHT Operator Manual

Trigger: TTL LEVEL (LOW : OFF / HIGH : ON )

Power Supply: 15 VDC (±5%) @ 500 mA (max)


From EBNeuro specified devices

Dimension Diameter (max) ~ 60 mm


Length ~ 220 mm
Weigth: ~ 0,3 Kg

Operational mode
Continuous, within the specified limits

Environmental conditions for usage


Temperature: from +5°C to +40°C
Relative humidity: from 30% to 75% RH
Atmospheric pressure: from 700hPA to 1060hPA

Environmental conditions for storage (max. 15 weeks)


Temperature: from -30°C to +60°C
Relative humidity: from 5% to 95% RH
(excluding condensation)
Atmospheric pressure: from 500hPA to 1060hPA

Device rated values

Manufacturer: EBNeuro S.p.A.


Model: Flash LED Stimulator
Code (REF): B9700063000
Year of manufacture
Serial Number (SN)
CE Mark (93/42/EEC

Technical characteristics 3-31


Operator Manual MIZAR LIGHT

3.13 PATTERN STIMULATOR MODULE


Product name PATTERN STIMULATOR

Description Pattern Stimulator Module containing the


dedicated electronic board which pattern
reversal visual stimuli and manages an external
stimulus actuator (monitor).

Intended use Active, not invasive Medical Device,


employed for release energy to the human body
(light energy) for the detection of correlated
evoked potentials.

Classification according to MDD 93/42/EEC


Class II b
(as module of MIZAR-LIGHT system)

Standards and Directives applied


93/42/EEC Medical Device European Directive
(MDD);
EN 60601-1 General safety standard for
Electromedical equipments (CEI 62-5)
EN 60601-1-2 Collateral safety standard for Electro
Magnetic Compatibility (EMC)
EN 60601-1-4 Safety standard for equipment containing
programmable systems
EN 60601-2-40 Particular safety standard for
Electroemyograph and evoked potential
equipments

Type of protection against electric shocks


Class I, powered by proper power supply
(models AULT SW173, AULT MW160, SINPRO
MPU50-106)

Level of protection against direct and indirect electric contacts


BF-type (no applied parts)

Level of protection against inflow of solid and liquids


Not protected (IP20)

3-32 Technical characteristics


MIZAR LIGHT Operator Manual

Working mode
Continuous, within the specified limits

Environment working conditions


Temperature: from +5°C to +40°C
Relative Humidity: from 30% to 75% RH
Atmospheric Pressure: from 700hPA to 1060hPA

Environment storing conditions (max 15 weeks)


Temperature: from -30°C to +60°C
Relative Humidity: from 5% to 95% RH
(excluding condensation)
Atmospheric Pressure: from 500hPA to 1060hPA

Stimulation image structure: BIT-MAP format

Characteristics of Video signal: Standard VGA

Line period: 32 µs

Frame frequency: 60 Hz

Signal amplitude: 1 Vpp

Image matrix: 640 x 480 dpi

Image subdivision: n°4 independent sectors with


User adjustable dimensions

Contents of the four sectors: - Regular colour


- Chessboard
- Horizontal bars
- Vertical bars
- Sinusoidal horizontal bars
- Sinusoidal vertical bars

Technical characteristics 3-33


Operator Manual MIZAR LIGHT

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

Contrast adjustment: Contrast between each couple of colours


from 0% to 100% with of 10%

Contrast adjustment disabled for


sinusoidal bars modes

Chessboard and bars dimensions adjustment:


User adjustable via software according to the following parameters:
- Distance between patient and stimuli actuators
(monitor)
- Screen size of stimuli actuators (monitor)
- Visual angle
- Spatial frequency (cycles/degrade)

These parameters are correlated and dependent among their.


The software automatically verifies the values of each parameter and
limits its range of adjustment according to the values set of other
parameters.

Fixation point:
Colour: User adjustable
Size: User adjustable
Position: User adjustable
Shape: - Circle
- House
- Boat
- Fish
- Face

Stimulation mode: - Alternate (pattern A / pattern B)


- Reverse (pattern A or B / its reverse)

Size and shape of stimulation image: - Rectangular (full screen)


- Circular (with masking)

3-34 Technical characteristics


MIZAR LIGHT Operator Manual

Image masking:
Colour: Black
Dimension: User adjustable

Free-Running stimulation mode:


Fixed alternation of the two A and B patters or a pattern with its
reverse pattern at a selected frequency
Frequency: User adjustable (T/2)
from 100ms to 10s at steps of 1ms
Trigger: User adjustable on T or T/2

Pattern Pattern Pattern Pattern


A B A B

T/2
T

One-Shot stimulation mode:


Random alternation of the two A and B patters or a pattern with its
reverse pattern under automatic software control. Software changes
alternation times within the adjusted acquisition time base.
Time Base: from 10ms to 5 s

External dimensions and weight


Max height: ~ 60 mm
Max width: ~ 160 mm
Max depth: ~ 140 mm

Max weight: ~ 0.4 Kg

Stimuli actuators
Dedicated VGA monitor

Pattern stimulator module housing


- Electronic board mounted inside the Multimodal Stimulator
Module (MSS) on MIZAR-LIGHT system trolley
- Independent external module

Technical characteristics 3-35


Operator Manual MIZAR LIGHT

Device rated values (for external module)


Manufacturer: EBNeuro S.p.A.
Model: PATTERN STIMULATOR
Code (REF): B9700042000
Year of manufacture
Serial Number (SN)

3-36 Technical characteristics


MIZAR LIGHT Operator Manual

3.14 MINIMUM REQUIREMENTS FOR SYSTEM COMPUTER


Processor Pentium 4 – 1,8GHz

RAM 256MByte

Hard Disk 40GByte

Video Board Resolution 1280x1024

Slot 1 slot PCMCIA III-type


(CARBUS compatible) (when using PCMCIA
Interface)

Drive CD-ROM 48X Reader


CD-ROM 24X Writer

Port 1 Parallel port (ECP/EPP or IEEE1284)


2 Serial port
2 USB 2.0 port
1 LAN (ETHERNET 10/100 Mbit) port

Controls Keyboard
Mouse

Operating System WINDOWS XP PRO

Standards and directives


conformity IEC 690 (EN 60950)
89/336/EEC (EMC)
73/23/EEC (Low Voltage)

CE Mark CE mark according to above listed European


directive

Safety Mark at least one of the following:


IMQ, TÜV, BSI, CSA, UL,
SEMKO, NEMKO, etc.

Technical characteristics 3-37


Operator Manual MIZAR LIGHT

3.15 MINIMUM REQUIREMENTS FOR OTHER PC PERIPHERALS


(MONITOR AND PRINTER)
Standards and directives conformity IEC 690 (EN 60950)
89/336/EEC (EMC)
73/23/EEC (Low Voltage)

CE Mark CE mark for the above listed


European directives

Safety Mark almost one of these:


MQ, TUV, BSI, CSA, UL,
SEMKO, NEMK

3-38 Technical characteristics


MIZAR-LIGHT Operator Manual

CHAPTER 4
COMPONENTS AND ACCESSORIES

4.1 EEG-EP MIZAR LIGHT SYSTEM - B9800047600

CODE DESCRIPTION QUANTITY

STANDARD COMPONENTS

B9700047000 BE LIGHT Base acquisition module – CE/CSA version 1


B9700058000 complete CIMET trolley 1
B9400047000 BE LIGHT complete package 1
B8659000000 Advanced Database Software activation 1
B8659001000 EEG Viewer Software activation 1
B8659011000 Mizar Standard Software activation 1
B9100450440 Power cables Kit MIZAR-LIGHT 1
E79100000285 Mains power cord ITA (1)
E79100000278 Mains power cord EURO (1)
B8830580000 USB Remote control cable (1)
E99240085133 Mains jumper. L =1m (1)

STANDARD SALES COMPONENTS

Modulo di Alimentazione e Isolamento:


B9700041000 Isolat. Transform. “GP” Trolley 220V/50Hz - 500VA 1
B9700041001 Isolat. Transform. “GP” Trolley 115V/60Hz - 500VA 1
E2600000101 Fusibile 5x20 ritardato T5 A 2
E26222100023 Fusibile 5x20 ritardato T10 A 2

Alimentatore AC/DC medicale:


B9100370140 Assieme alimentatore AC/DC Medicale 1
B9730651006 AC/DC Adapter - AULT SW173 15Vdc
B9730651033 AC/DC Adapter - AULT MW160 15Vdc
B9730651051 AC/DC Medical Adapter SINPRO MPU50-106

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

Components and accessories 4-1


Operator Manual MIZAR-LIGHT

GALILEO Line Software:


B8640053000 GALILEO LINE CD-ROM software - multilanguage 1

Acquistion Module support:


B9100581401 jointed arm Kit / BE NET-LIGHT 1
B9100580911 stand Kit / BE NET (BE-LIGHT) 1
B9100580921 powered stand Kit / BE NET (BE-LIGHT) 1
B9100580931 jointed arm Kit / PCMCIA (BE-LIGHT) 1
B9100580941 stand Kit / PCMCIA (BE-LIGHT) 1
B9100580951 powered stand Kit / PCMCIA (BE-LIGHT) 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

Language Kit (Windows XP PRO Operating System / Keyboard)


B9730900001 Kit ITALIAN
B9730900002 Kit. ENGLISH
B9730900003 Kit. GERMAN
B9730900004 Kit. FRENCH
B9730900005 Kit. SPANISH
B9730900007 Kit. DUTCH

4-2 Components and accessories


MIZAR-LIGHT Operator Manual

OPTIONAL SALES COMPONENTS

EEG accessories Kit:


E9610008500 GALILEO EEG accessories kit 1
E84800013653 EEG silicon headset (medium size) (1)
E99260021139 EEG adult electrode (1 piece) (24)
E99220005133 Accessories kit for bridge electrode (1)
E9610026501 Bridge electrode cable (24)
E9610027601 Ear electrode (1 piece) (2)
E9610017500 Safety jumper cable (package of 5 pieces) 1
E9610018601 Ag/AgCl cup electrode (1 piece) 24
B9690001100 Electroconductive cream tube – Cogel 250ml 1
E9690028000 Adhesive and conductive paste bottle – TEN 20 114gr 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

Post-analysis Software Option:


B9712540000 MRI3D View Advanced EEG Analysis Galileo Line
B9713040000 EEGMAGINE EEG Software Galileo Line
B9710540100 Sandman Elite Sleep Diagnostic Data Review
B9710540200 Sandman Elite Sleep Diagn. Collection and Analysis
B9710540300 Sandman Elite Sleep Diagnostic Analysis Software
B9109000023 Kit acquisiszione video SANDMAN Collection

Components and accessories 4-3


Operator Manual MIZAR-LIGHT

Thermal Printer Option:


B9100581100 A4 Thermal Printer kit for peripheral 220V/50Hz
B9100581110 A4 Thermal Printer kit for peripheral 110V/60Hz

Single Page Printer Option:


B9730100008 B/W LaserJet printer kit for MIZAR-LIGHT
B9730100009 Colour InkJet printer kit for MIZAR-LIGHT

Network Connection Option:


B9730650028 Network adapter 10/100 BASE-T PCI RJ45
B9730651052 Network adapter 10/100 BASE-T half hight
B9730650030 Fast Ethernet Switch - 5 ports
B9730650031 Fast Ethernet Switch - 8 ports
B9730660010 CAT 5 Patch not shielded assembled cable L=3m
B9730660011 CAT 5 Patch not shielded assembled cable L=5m
B9730660012 CAT 5 Patch not shielded assembled cable L=10m
B9730660013 CAT 5 Cross cable network direct connection L=5m
B9730660014 CAT 5 Patch not shielded assembled cable L=1,5m
B9730660017 CAT 5 Patch not shielded assembled cable L=0.5m
B9730660018 CAT 5 Cross cable network direct connection L=1m
B9109000005 2 RJ45connectros kit for cabling
B2200000039 UTP CAT 5 cable – 4 twisted couple AWG24 cable

GALILEO Line Software Activation:


B8659004000 EDF/ASCII IMP-EXP Software Activation
B8659005000 CSA Software Activation
B8659006000 HRV Software Activation
B8659007000 VIDEO-EEG STANDARD Software Activation
B8659008000 VIDEO-EEG READER Software Activation
B8659011000 BASIS BE STANDARD Software Activation
B8659012000 BASIS BE DC CH EXT Software Activation
B8659017000 EP STANDARD Software Activation
B8659018000 EP READER ONLY Software Activation
B8659019000 EP MONITORING Software Activation
B8659020000 EP CHANNEL EXTENSION Software Activation
B8659021000 EP DOUBLE ELECTRIC STIM Software Activation
B8659022000 EP PATTERN STIM Software Activation
B8659023000 EP P300 Software Activation
B8659024000 EP CNV Software Activation
B8659025000 EP ERP Software Activation
B8659026000 EP BACK AVERAGER Software Activation
B8659027000 SPECTRAL ANALISYS Software Activation
B8659009000 Halley DEEG Software Activation
B8659010000 Halley Holter Software Activation
B8659015000 Persyst Interface Software Activation
B8659016000 EMSE Interface Software Activation
B8659028000 EEG Browser Software Activation
B8659029000 EMG Standard Software Activation
B8659030000 Trend e Burst Suppression Software Activation
B8659031000 Open DATABASE Software Activation

4-4 Components and accessories


MIZAR-LIGHT Operator Manual

Hardware Expansion BE/BE Light


B9100581500 Kit DC AUX Inputs - BE NET connection
B9100400020 Kit DC AUX Inputs – PC connection
B8833000014 Serial Cable 9pin MCH-FMM L=120cm

EEG/EP Accessories Options:


B8839000005 Equipotential ground cable double Angle-Socket L=5m
B8839100001 Equipotential ground cable single Angle-Socket L=5m
B9600037000 PSG accessories Kit MIZAR
B9610043000 EEG Head cap 10 electrodes meas. 1 MIZAR
B9610043100 EEG Head cap 10 electrodes meas. 2 MIZAR
B9610043200 EEG Head cap 10 electrodes meas. 3 MIZAR
B9610044000 EEG Head cap 21 electrodes meas. 4 MIZAR
B9610044100 EEG Head cap 21 electrodes meas. 5 MIZAR
B9610044200 EEG Head cap 21 electrodes meas. 6 MIZAR
B9610044300 EEG Head cap 21 electrodes meas. 7 MIZAR
B9610045000 Head cap adapter from BASIS BE to BE Light
B9610045100 Head cap adapter from BE Light to BASIS BE
B9690001100 Electro conductive cream tube. 250ml COGEL Litio 1%
E9610008500 EEG accessories Kit “Galileo” FMM
E9610034500 EP accessories Kit Galileo FMM

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

Isolation Transformer Module:


B9800041000 GP Portable Isolation Transf. Module 500VA - 220V/50Hz
B9800041001 GP Portable Isolation Transf. Module 500VA - 115V/60Hz
B8839000005 Equipotential ground cable double Angle-Socket L=5m
B8839100001 Equipotential ground cable single Angle-Socket L=5m
E8820005000 Mains power jumper L= 1,5m
E99240084134 Mains power jumper L= 0,5m
E99240085133 Mains power jumper L= 1,0m

UPS option:
B9730301000 UPS 700VA - 220V/50Hz
B9730301001 UPS 1000VA - 220V/50Hz
B9730301002 UPS 1500VA - 220V/50Hz
B9730301003 UPS 2000VA - 220V/50H

Components and accessories 4-5


Operator Manual MIZAR-LIGHT

Analog Video-EEG option:


B9109000019 Kit Video-EEG WIN XP (STANDARD)
B9109000011 Video-EEG Reader Kit GALILEO NT
E9730800030 B/W Camera - CCD 1/3”
B9730801004 Auto-change Color / Infrared Camera – CCD 1/2”
E9730801013 Colour Camera – EVI D70P “PTZ”
B8833000011 RCA-RCA connection cable L=5m
E8830252001 BNC-RCA 75-ohm cable L=5m
E9730810005 Autoiris Zoom 10X Lens - CCD 1/3”
B9730811001 Autoiris Zoom 10X Lens CCD1/2”
B9730811002 Autoiris Zoom 6X Lens CCD 1/2”
E9730810006 Autoiris Lens CCD 1/3”
B9730800003 Infrared Lamp Projector kit with transformer
E9100903000 Horizontal./vertical Tilting kit for camera 220V/50Hz
B7900000012 Tripode Telescopico per Photo/Video
B9109000036 Kit Vide-EEG standard (PCI)
B9730901007 Mixer digitale audio/video PAL

Digital Video-EEG option:


B9109000021 Video-EEG Kit WIN XP (FIREWIRE) (PC desk)
B9109000020 Video-EEG Kit WIN XP (WEBCAM)
B9109000032 Video EEG Kit Firewire (Laptop)
B9109000033 Video EEG Kit Firewire (Desktop) - area paziente
B9109000034 Video EEG Kit Firewire (Laptop) - area paziente
B9109000020 Video EEG Kit webcam
B9730661014 IEEE 1394 Firewire 4M4M cable L=1,8m
B9730661015 IEEE 1394 Firewire 9M4M cable L=1,8m
B9730661017 IEEE 1394 Firewire 6M4M cable L=4,5m
B9730661018 IEEE 1394 Firewire 4M4M cable L=4,5m
B9109000011 Reader Kit Video-EEG Galileo NT
B9730801001 Infrared Lamp Projector DPI 20W 830nmt
B9730801002 Foot-switch with transformer for projector
E9730820001 Tilting module with fixing support
E9730820002 Tilting control module

Service Manual:
B831004700 BE_LIGHT amplifier Service Manual - English

4-6 Components and accessories


MIZAR LIGHT Operator Manual

CHAPTER 5
CONNECTIONS, COMMANDS AND CONTROLS

5.1 COMPLETE SYSTEM


The following figures show the main modules, the panels and the linking
connectors of the complete MIZAR-LIGHT system.

Each single component of the system is described in the following list:

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

Connections, commands and controls 5-1


Operator Manual MIZAR LIGHT

11
17

7
2

10
5

Figure 5-1 – MIZAR-LIGHT system (example)

5-2 Connections, commands and controls


MIZAR LIGHT Operator Manual

2 4

18

12
14

Figure 5-2 –MIZAR LIGHT system – rear view

Connections, commands and controls 5-3


Operator Manual MIZAR LIGHT

10

13

Figure 5-3 – MIZAR LIGHT system front view


(with Laser Printer )

5-4 Connections, commands and controls


MIZAR LIGHT Operator Manual

17

15

16

Figure 5-4 – MIZAR LIGHT system – side view


(with Thermal Printer)

Connections, commands and controls 5-5


Operator Manual MIZAR LIGHT

5.2 BE LIGHT ACQUISITION BOX DESCRIPTION


The following figures show the BE LIGHT acquisition box in which the main
parts are indicated:

19
23

24

22

25

28
26

27
23

24

19

21

20
28

21

Figures 5-5 and 5-6 – BE LIGHT acquisition box

5-6 Connections, commands and controls


MIZAR LIGHT Operator Manual

Where:

19. Patient inputs section (40 sockets)

20. Connector for acquisition pre-wired headset

21. Neck strap fixing hole

22. Ohmmeter section

23. Multifunction signalling Led

24. Multifunction control button

25. Connector for fiber optic connection to the system PC through the PCMCIA
interface

26. Connector for isolated power supply input

27. Connector for serial connection to specified optional peripherals (i.e. Flash
Led Stimulator)

28. Plastic inserting-key for acquisition box mounting on proper support

Connections, commands and controls 5-7


Operator Manual MIZAR LIGHT

5.2.1 PATIENT INPUT SOCKETS DESCRIPTION

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)

• 3 sockets for polygraphic monopolar inputs with proper reference (AC or DC


coupling, settable via software).

• 8 sockets for 4 bipolar inputs (AC coupling).

• 4 sockets for isolated patient ground.

• 1 socket for separate reference of 3 monopolar inputs with AC or DC


coupling.

• 2 sockets for common reference of 21 monopolar inputs with AC coupling.

• 1 socket for calibration signal.

Figure 5-7 – Patient input sockets

5-8 Connections, commands and controls


MIZAR LIGHT Operator Manual

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.

5.2.1.1 Standard 10-20 system 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.

EEG signals Common Reference : two paralleled sockets labelled “NE”


(Neutral Electrode). These electrodes accept the Common Reference signals
directly coming from reference sites on the patient. The 21 EEG Monopolar
Inputs are referenced to this signal.

Connections, commands and controls 5-9


Operator Manual MIZAR LIGHT

Polygraphic signals Reference : This socket, labelled “NEP” (Neutral Electrode


Polygraphic), accepts the Separate Poligraphic Reference signal directly coming
from reference sites on the patient. The 3 Polygraphic Inputs are referenced to this
signal..

Isolated Ground : four paralleled sockets labelled “ISOGN”. These sockets


represent the isolated ground inputs; They may be used to connect the patient
ground or to create patient ground referenced inputs for electrodes and sensors.

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).

5-10 Connections, commands and controls


MIZAR LIGHT Operator Manual

5.2.1.2 "Mirror" configuration

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.

Connections, commands and controls 5-11


Operator Manual MIZAR LIGHT

5.2.2 CONNECTORS DESCRIPTION

The following figures show in details the connectors of BE LIGHT acquisition


module:

30 29 31 32

Figures 5-8 and 5-9 – Acquisition module connectors

Where:

29. PATIENT LINK connector (Microelectronics SCSI II 36 pin Female type).


This connector is used to connect a pre-wired headset for signals acquisition
from the patient.

30. OPTICAL LINK connector (fibre-optic type). This connector is used to


connect the fibre optic cable to the PCMCIA interface which is inserted into
the proper “slot” of the PC system.

31. DC IN connector (circular 8 contacts Female type). This connector is used to


connect the external specific power supply which provides the isolated input
voltage for the functioning of the BE LIGHT acquisition module.

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.

5-12 Connections, commands and controls


MIZAR LIGHT Operator Manual

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.

Connections, commands and controls 5-13


Operator Manual MIZAR LIGHT

5.2.3 MULTIFUNCTION SIGNALLING LED

The following figure shows the multifunction signalling Led placed on the front
cover of the BE LIGHT acquisition module.

Figure 5-10 – Multifunction signalling Led

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.

Several functions are associated by the GALILEO_NT software to a different


status of the signalling Led according to the operating function of the complete
system.

In the following table these status conditions are described:

N° Led status Function Description

1 On Deselected device The device is powered but it is not


correctly selected by the system or
not correctly connected to it.

2 Off Selected device The device is powered and it is


correctly connected and selected
by the system.

3 Flashing Selected device. The device is selected by the


Function in progress system and a specific function is in
progress.

4 Single flash Power-up routine The device has correctly


terminated the initial self-test
power-up routine

5-14 Connections, commands and controls


MIZAR LIGHT Operator Manual

5.2.4 MULTIFUNCTION CONTROL BUTTON

The following figure shows the multifunction control button placed on the front
cover of the BE LIGHT acquisition module.

Figure 5-11 – Multifunction control button

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.

Several functions are associated by the GALILEO_NT software to the control


button according to the operating function of the complete system.

In the following table these functions are described:

N° Action on Function Description


button

1 Long pressure Ohmmeter The Ohmmeter function is


Activation/deactivation activate/deactivate by pressing the
control button for a long time
(longer than 2 seconds)

2 Short pressure Trigger signal When the Ohmmeter function is


(with Ohmmeter OFF, it is possible to send a
in OFF state) Trigger signal in order to mark an
event on the acquiring signal, by
pressing the control button for a
short time

3 Short pressure Selection of threshold When the Ohmmeter function is


(with Ohmmeter level of the Ohmmeter ON, it is possible to cyclically
in ON state) change the threshold level for
impedance measure, by pressing
the control button for a short time..

Connections, commands and controls 5-15


Operator Manual MIZAR LIGHT

5.2.5 OHMMETER

The following figure shows the Ohmmeter section placed on the front cover of the
BE LIGHT acquisition module.

Figure 5-12 – Ohmmeter section

The Ohmmeter function is an optional function provided on request. The labelling


of the Ohmmeter section is always present on the external side of the device cover
also when the Ohmmeter option is not installed.

The Ohmmeter section is made up by a Led matrix which reproduces in reduced


scale the patient inputs (sockets) configuration present on the 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.

At the activation of the Ohmmeter function a 20Ω threshold level will be


automatically set. It is possible to adjust the threshold level by pressing the control
button for a short time. Each single pressing of the button key allows to skip to the
next lower threshold value allowable on the scale. When the lowest value of the
scale is selected (1kΩ), a successive pressing of the button will skip the threshold
level to the highest value of the scale (90kΩ).

5-16 Connections, commands and controls


MIZAR LIGHT Operator Manual

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 active when a threshold level Led is on.

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.

Connections, commands and controls 5-17


Operator Manual MIZAR LIGHT

5.3 MAIN ISOLATION MODULE

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))

The various part showed in the figures are the following:


33. Mains power switch with green led indicating “mains on line” situation
34. Mains input connector
35. Fuses holder
36. mains output socket to power the PC
37. auxiliary mains output socket (under remote control)
38. Isolation module remote control
39. Equipotential terminal
40. Rated values label of MIZAR-LIGHT system
41. Mains fuses label

5-18 Connections, commands and controls


MIZAR LIGHT Operator Manual

5.4 REAR PANEL CONNECTORS


The following figure shows the connectors rear panel of MIZAR-LIGHT system
and its parts:

42. STIM LINK (mini D – 9 pin FMM) reserved to connect an exyernal


PATTERN stimulator or an externalMMS module
43. SERIAL I/O. RISERVED
44. TRIGGER IN ( RCA type connector) external Trigger input.
45. TRIGGER OUT ( RCA type connector) internal Trigger output

42 43

44
45

Figure 5-15 – Rear panelconnectors

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)

The SERIAL I/O connector is RESERVED. It should be used only to connect to


EBNeureo devices if explicitly authorized and following the related official
documentation.

Connections, commands and controls 5-19


Operator Manual MIZAR LIGHT

5.5 THERMAL PRINTER


The following figures respectively show the front and rear panels of the optional
A4 Thermal Printer of the MIZAR-LIGHT system and its parts:

46. Paper roller

47. Paper tray lid handle

48. Paper tray lid

49. Printed Paper shelf

50. Printer power switch

51. Air intakes

52. +12 VDC voltage output connector

53. Fuses holder

54. Mains input connector

55. ANALOG IN CH 1-24 connector for analog input (channels 1 - 24)

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

58. DIGITAL I/O – SERIAL connector for serial linking

59. Identification label

60. RESET button – Not used

61. MARKER IN connector for external trigger signal input. - Not used.

62. Equipotential terminal

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.

5-20 Connections, commands and controls


MIZAR LIGHT Operator Manual

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

Connections, commands and controls 5-21


Operator Manual MIZAR LIGHT

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

5.5.1 ANALOG OUT MODULE

The following figures show the Analog Out module included into the optional A4
thermal printer kit of the MIZAR-LIGHT and its parts:

63. ANALOG OUT – J1 connector for analogue signal output

64. ANALOG OUT LINK – J3 connector for digital signal interfacing

65. J2 input voltage connector for module powering up

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

5-22 Connections, commands and controls


MIZAR LIGHT Operator Manual

63

65 64

Figures 5-18 and 5-19 – Analog output module

Connections, commands and controls 5-23


Operator Manual MIZAR LIGHT

5.6 MULTIMODAL STIMULATOR MODULE (MMS)


The following figures respectively show the front panel and the rear panel of the
optional MMS Multimodal Stimulator Module of the MIZAR-LIGHT and their
parts:

66. Green Led indicating power on (MMS module is ON)


67. Connector for electric stimulator “A” (Tuckel DIN 180° connector type)
68. Electric stimulator “A” – Negative electrode socket (-) (Safety, female 2mm,
black colour connector type).
69. Electric stimulator “A” – Shield electrode socket (Safety, female 2mm, green
colour connector type).
70. Electric stimulator “A” – Positive electrode socket (+) (Safety, female 2mm,
red colour connector type).
71. Electric stimulator “A” – Yellow Led indicating the stimulation issue.
72. Electric stimulator “A” – Red Led indicating an overload situation.
73. Connector for electrical stimulator “B” (Tuckel DIN 180° connector type)
74. Electric stimulator “B” – Negative electrode socket (-) (Safety, female 2mm,
black colour connector type).
75. Electric stimulator “B” – Shield electrode socket (Safety, female 2mm, green
colour connector type).
76. Electric stimulator “B” – Positive electrode socket (+) (Safety, female 2mm,
red colour connector type).
77. Electric stimulator “B” – Yellow Led indicating the stimulation issue.
78. Electric stimulator “A” – Red Led indicating an overload situation.
79. Acoustic stimulator – Connector for stimulation headphone
80. PHOTIC LINK connector for Led Flash Stimulator connection
81. Electric stimulator manual intensity adjustment knob (for current active
stimulator).
82. Equipotential terminal.
83. SERIAL connector for powering and control signals connection when the
MMS module is used outside the trolley (stand-alone version).
84. TRIGGER IN connector (RCA type) for external Trigger signal input.
85. TRIGGER OUT connector (RCA type) for internal Trigger signal output.
86. PATTERN connector (mini D – 15 pin FMM type) for connection to Pattern
Stimulator Monitor when the MMS module is used outside the trolley
(stand-alone version).
87. DC IN connector for MMS module powering (+15 Vdc). This connector is
not used in all the configurations of the MIZAR-LIGHT

5-24 Connections, commands and controls


MIZAR LIGHT Operator Manual

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

Connections, commands and controls 5-25


Operator Manual MIZAR LIGHT

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.

5-26 Connections, commands and controls


MIZAR LIGHT Operator Manual

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.

Connections, commands and controls 5-27


Operator Manual MIZAR LIGHT

5.7 EXTERNAL PATTERN STIMULATOR


The following figures respectively show the front panel and the rear panel of the
optional External Pattern Stimulator Module of the MIZAR-LIGHT and their
parts.

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

Figure 5-22 – Pattern Stimulator – Front panel

5-28 Connections, commands and controls


MIZAR LIGHT Operator Manual

92 93 94

Figure 5-23 – Pattern Stimulator – rear panel

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.

Connections, commands and controls 5-29


Operator Manual MIZAR LIGHT

5.8 PCMCIA INTERFACE


The following figures respectively show the PCMCIA dedicated interface and the
fibre optic cable including in the base kit of the MIZAR-LIGHT system and their
parts:

95. Connector for fibre optic cable

96. Connector for PCMCIA slot

97. Connector for Trigger signal

98. Double fibre optic cable

99. Fibre optic cable terminal connector

96
97

95

98

99

Figures 5-24 and 5-25 –PCMCIA Interface and fibre optic cable

5-30 Connections, commands and controls


MIZAR LIGHT Operator Manual

5.9 BE NET INTERFACE


The following figure shows the BE NET optional interface box of the MIZAR-
LIGHT sytem and its parts:

108 109

100

106

101

107
102

103 104 105

Figures 5-26 and 5-27 – BE NET Interface – front and bottom view

Connections, commands and controls 5-31


Operator Manual MIZAR LIGHT

100
102

101

107
106

Fig. 5-28 - 5-29 – BE NET Interface – side views

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.

102. LAN (Local Area Network) 10/100 bT 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.

105. Trigger I/O connector.

106. Analog Out link connector (digital connection with the optional analogical
outputs module)

107. Optical Link connector (HP fiber-optic type).

108. Power on LED (Power on indicator).

109. LAN LEDs (LAN activity indicators).

5-32 Connections, commands and controls


MIZAR LIGHT Operator Manual

5.10 MEDICAL AC/DC ADAPTER


The following figure shows the medical AC/DC adapter for BE_LIGHT
acquisition module powering up, including in the base kit of the MIZAR-LIGHT
system and their parts:

110. Medical AC/DC adapter

111. Mains input connector

112. Isolated voltage output connector with cable

110 111 112

Figure 5-30 – Medical AC/DC adapter

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

Connections, commands and controls 5-33


Operator Manual MIZAR LIGHT

5.11 FLASH LED STIMULATOR


The following figure shows the Flash LED stimulator and its most significant
parts:

113. Flash LED Stimulator

114. LED matrix

115. Connection cable

116. cable connector (BE_LIGHT side)

117. cable connector (Stimulator side)

118. coupling flange to secure the stimulator to supporting arm

119. Identification Label

113 116 114 115

Figure 5-31 – Flash LED stimulator – front view

5-34 Connections, commands and controls


MIZAR LIGHT Operator Manual

118 117 116 119

Figure 5-32 – Flash LED stimulator – rear view

Connections, commands and controls 5-35


Operator Manual MIZAR LIGHT

For your notes:

5-36 Connections, commands and controls


MIZAR-LIGHT Operator 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.

6.1 SYSTEM COMPOSITION


With reference to the figures of the previous chapter 5, build the system following
the procedure described below:

6.1.1 MAINS ISOLATION MODULE

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.

6.1.2 A4 THERMAL PRINTER (OPTIONAL)

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.

Thermal printer installation is normally executed by trained personnel during the


first installation of the MIZAR LIGHT system.. No installation procedure is
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 further details regarding the connections between the printer and
the other part of the MIZAR LIGHT system please refer to section 6.2 of the
present manual.

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”

Figure 6-1a Figure 6-1b

To connect the printer act as follow

- Connect the B883030007 cable (17 on schematics in section 6.2 ) to the


CH1-24 connector on the printer and to the J1 connector on the Anlaog Output
module.
- Connect the B8830530100 cable (15 on schematics in section 6.2 ) between
the J3 connector on the Analog Output module and eh “Ana Out” connector of
the BE Net module inside the trolley
- Connect the B8830530000 cable (16 on schematics in section 6.2 ) between
the SERIAL connector on the printer and the AUX I/O (A) connector of the
BE Net module inside the trolley
- Connect the mains cable (12 on schematics in section 6.2 ) between the mains
socket on the printer and any of J1,..J4 connector on the Isolation Module.

“16” “12” “17”

Figure 6-1c Figure 6-1d

6-2 Installation
MIZAR-LIGHT Operator Manual

6.1.3 WORKING MONITOR

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)

Monitor positioning and related connections are normally executed by trained


personnel during the first installation of the MIZAR-LIGHT system. The
following instruction are reported in the manual only for a complete information
and documentation of the equipment.

- 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.

Figure 6-2a Figure 6-2b

Figure 6-2c Figure 6-2d

- Referring to the schematic diagrams illustrated in section 6.2,connect the


signal cable of the monitor to the VGA output of the video adapter board on
the rear panel of the PC.

- 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

- According to the monitor model, some monitors 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 monitor and the power
cable between the adapter and the mains isolation transformer.

Cable “21” Signal Cable


(power)

Figure 6-2e

6-4 Installation
MIZAR-LIGHT Operator Manual

6.1.4 PERSONAL COMPUTER

The Personal Computer is provided separately from the trolley in the proper
original package.

The Personal Computer of DESK/MINIDESK type will be placed on the shelf of


the trolley immediately below the keyboard support shelf. (see figures in the
following ) The computer is fixed to the shelf by means of 4 pieces of “Velcro”
straps already prepared in factory during trolley assembly.
Notice that when the system provides a desk or minidisk computer type the trolley
I s provided with shelf for the monitor, the computer, the (optional) printer and for
the keyboard.
When the system provides a LAPTOP type computer, it is allocated on the top
shelf of the trolley. In this case the trolley is provided without the desk computer
and the keyboard shelf.

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

Figure 6-3a - Personal Computer (front)

Mouse Audio

LAN
COM1
(serial)

VGA USB
(monitor) (4 ports)

Keyboard

Figure 6-3b – Personal computer (rear)

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)

Mouse connector Keyboard Connector

Figure 6-4 – Mouse and keyboard connections.

Installation 6-7
Operator Manual MIZAR-LIGHT

6.1.7 SINGLE PAGE PRINTER (OPTIONAL)

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.

“11” (control) “12” (power)

Figure 6-5a – 6-5b

6-8 Installation
MIZAR-LIGHT Operator Manual

6.1.8 BE LIGHT AMPLIFIER AND FLASH LED STIMULATOR SUPPORTING


ARMS

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 arm is provided only if the system configuration provides it : alternatively it


is possible that the system provides different supports as a an external stand.

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:

1. Arm for acquisition system


2. Blocking knobs for arm
3. Internal cable output
4. Arm for Led Flash Stimulator
5. Acquisition leads support

Installation 6-9
Operator Manual MIZAR-LIGHT

5 3

Figure 6-6 – Trolley with acquisition system support arm

6-10 Installation
MIZAR-LIGHT Operator Manual

6.1.9 BE LIGHT ACQUISITION MODULE

The BE LIGHT acquisition module is provided separately from the trolley in a


proper package.

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 BE LIGHT acquisition box is powered by means of a specific proper AC/DC


medical adapter which is connected to an output connector of the mains isolation
transformer of the system.

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.

Figure 6-7 –BE LIGHT Amplifier support

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.

The position adjustment of the BE LIGHT module is performed by means of the


pantograph arm extension and its rotation on the stand system. When the
acquisition module is placed in the chosen position, please make sure to strongly
blocking it with the proper knobs and levers. This operation is very important in
order to guarantee a good arm stabling during the normal usage of the equipment
and even during the device moving.

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”.

Figure 6-10 – MIZAR-LIGHT system in ”normal use” position

6-14 Installation
MIZAR-LIGHT Operator Manual

Figure 6-11 – MIZAR-LIGHT system in ”carrying” position

Installation 6-15
Operator Manual MIZAR-LIGHT

6.1.10 EXTERNAL STAND FOR ACQUISITION BOX AND FLASH STIMULATOR

The “stand-alone” external stand is provided separately from the trolley. It


represents the alternative to the jointed arm fixed to the trolley previously
described.
The optional external stand is mounted by EBNeuro staff during the system
assembling and configuration phase. No installation procedure is required by the
operator.
The following figure shows the “stand-alone” external stand and its parts:

6
5

3 1

Figure 6-12 – BE Light external stand

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.

Connect the medical AC/DC adapter of BE LIGHT module to an environment


mains outlet through the standard power cable provided with the stand option.
In order to avoid an accidental disconnection of the power cable during the usage
of the device, make sure to block the power cable connector inserted into the
AC/DC adapter mains input with the proper retainer.

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

6.1.11 LED FLASH STIMULATOR (OPTIONAL)

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

6.1.12 MMS MULTIMODAL STIMULATOR MODULE (OPTIONAL)

The MMS Stimulator Module (when provided by the system configuration) is


provided in its proper package.

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

Figure 6-14 –MMS Module position

Installation 6-19
Operator Manual MIZAR-LIGHT

6.1.13 EXTERNAL PATTERN STIMULATOR MODULE (OPTIONAL)

The external Pattern Stimulator Module is provided in its proper package.


The external Pattern Stimulator Module in stand-alone configuration is placed
near the stimulator monitor and then near the patient.
The Pattern stimulator module is powered directly from the MIZAR LIGHT by
means of its SERIAL connection.
No connection must be performed to the DC IN connector placed on the Pattern
stimulator module rear panel.
For the installation of the Pattern stimulator module follows the schematic
diagram showed in the section 6.2

- 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.

6.1.14 PATTERN STIMULATOR MONITOR (OPTIONAL)

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.

According to the system configuration, with particular reference to the usage of


the Pattern stimulator monitor inside or outside the patient area some different
ways to connect the stimulator monitor to the mains are required.

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.

The Pattern stimulator monitor is a peripheral of MIZAR-LIGHT system. The


Pattern stimulator monitor is a peripheral compliant with the EN 60950 safety
standard applicable for its own class (Information Technology Equipments).

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).

6.1.15 VIDEO-EEG CONTROL SYSTEM (OPTIONAL)

The VIDEO-EEG control system is composed of several optional electrical


devices. In particular:

- B/W cameras, colour cameras, infrared cameras or auto-tracking cameras


- Tilting control module
- audio/video mixer
- Video recorder

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).

For a safe usage of these devices it is necessary to perform a correct connection of


them to the mains in order to guarantee the compliance of the whole system 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.

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.

6.1.16 LAN INTERFACE (NETWORK) OPTIONAL

Connect the local network cable to the LAN connector placed on connectors rear
panel of MIZAR-LIGHT system.

This connection must be performed when the system is configured in network


with other Galileo Line equipments only.

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

6.1.17 PCMCIA INTERFACE MODULE

The PCMCIA Interface Module (when provided by system configuration) is


provided together the BE LIGHT acquisition module in a proper dedicated
package.

The PCMCIA interface is installed in a dedicated free slot of system PC.

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.

6.1.18 BE NET INTERFACE MODULE

Normally the BE NET Interface (when provided by system configuration) will be


installed in factory internally tot eh MIZAR LIGHT trolley

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

6.1.19 SYSTEM GENERAL POWERING

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:

- Connection of the device’s power cable to an environment mains outlet. The


device must be exclusively placed outside the “patient area”.

- Connection of the device’s power cable to an environment mains outlet


through a medical isolation transformer module. The device can be used both
inside and outside the “patient area”.

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.

For a safe usage of these devices it is necessary to perform a correct connection of


them to the mains in order to guarantee the compliance of the whole system with
the isolation and leakage current limits indicated by medical safety standards (EN
60601-1 and EN 60601-1-1) and applicable for electromedical equipments and
electromedical systems.

6-24 Installation
MIZAR-LIGHT Operator Manual

6.2 GENERAL INTERNAL CABLING DIAGRAMS


The schematics (and figures) showed in the next sections illustrate the
interconnections (cabling) among the various module of the MIZAR LIGHT
system.
Of course in some part the cabling depends on the presence of some optional
module

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

Some parts of the trolley are connected by means of yellow-green conductors to


some point marked with the two labels

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

# Description Code # Description Code


A Personal Computer -- 1 Fibre optic cable B2654000001
BE Net – BE LIGHT
B BE Net Interface B9700053000 2 BE LIGHT power B8839000013

C AC/DC Adapter B9100370140 3 internal LAN connection B9730660018


(PC-BE Net) (RJ45 cross)
D Interconnection boards B9500146000 4 PC power supply E99240085133
B9500147000
E Isolation Transformer B9700041000 5 AC/DC Adapter E99240085133
(B9700041001)
F BE LIGHT Amplifier B9700047000 6 External Trigger I/O – BE B9690015000
Net
G Flash Led Stimulator B9700063000 7 BE Net power B8839000012

H MMS Module B9700046000 8 BE Net – Interc. boards B8830530021


(Multimodal Stimulator) (ext PATTERN STIM )
I Analog Output module B9700030000 9 Isolation Transf. remote B8839000024
control
L Thermal Printer E9703030600 10 Flash led stimul. control B8830440002
(E9703030601) cable
J PATTERN Stimulator B9700042000 11 Laser printer control cable --

K DC Auxiliary Inputs B9700040000 12 Laser printer power --


Module
M Laptop Computer -- 13 System mains cable E79100000285
E79100000278
N Laptop Power Supply -- 14 MMS-BBE LIGHT B8830460050
connection cable
O PCMCIA Interface B9100370500 15 BE Net – Analog output B8830530010
(signals)
16 BE Net – Thermal Printer B8830530000
(control)
17 Analog Output – Thermal B8830300007
Printer (analog signals)
18 External Trigger I/O – B9690015000
PCMCIA
19 PATTERN stimulator B9730661006
Control/power
20 DC AUX INPUTS B8830530030
Control/power
21 LCD Monitor power E8820005000

X External LAN (option – 22 PC Serial port – Interc. B8833000014


RJ45 straight) Boards (option)

Table 6-1 – Modules and Interconnection cables identifier

6-26 Installation
MIZAR-LIGHT Operator Manual

6.2.1 BASE CONFIGURATION

The following figure shows the internal cabling diagram of MIZAR LIGHT
system in base configuration without optional modules:

Figure 6-15 – Base configuration wiring

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

Figure 6-16 – Trolley without PC and Monitor (rear view)

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

15 (to thermal printer – option)

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)

Figure 6-19 – Isolation Module particular

Installation 6-29
Operator Manual MIZAR-LIGHT

Figure 6-20 – Cabling general view

6-30 Installation
MIZAR-LIGHT Operator Manual

6.2.2 MMS CONFIGURATION

The following figure shows the internal cabling diagram of MIZAR LIGHT
system with MMS Multimodal stimulator Module in internal trolley
configuration:

Figure 6-21 – MMS Configuration wiring

Installation 6-31
Operator Manual MIZAR-LIGHT

6.2.3 CONFIGURATION WITH THERMAL PRINTER

The following figure shows the internal cabling diagram of MIZAR-LIGHT


system in configuration with A4 Thermal Printer:

Figure 6-22 – MMS and ThermalPrinter configuration wiring

6-32 Installation
MIZAR-LIGHT Operator Manual

6.2.4 PATTERN STIMULATOR CONFIGURATION

Figure 6-23. PATTERN STIMULATOR (or DC AUXIN) wiring

NOTE
External PATTERN STIMULATOR (J) and Auxiliary DC Inputs (K) module are
mutually exclusive.

Installation 6-33
Operator Manual MIZAR-LIGHT

6.2.5 LAPTOP COMPUTER CONFIGURATION

Figure 6-24 – Laptop Computer configuration wiring

6-34 Installation
MIZAR-LIGHT Operator Manual

From laptop Power 9 Æ USB 1 ÆUSB


18 1 8 supply (to DC IN)

Figure 6-25 – Laptop Computer connection cables

USB LAN LPT VGA COM1

Figure 6-26 – Laptop Computer rear panel (tipical)

Installation 6-35
Operator Manual MIZAR-LIGHT

6.2.6 LAPTOP COMPUTER AND THERMAL PRINTER CONFIGURATION

Figure 6-27 – Laptop computer and Thermal printer configuration wiring

6-36 Installation
MIZAR-LIGHT Operator Manual

6.2.7 EXTERNAL POWERED STAND

Figure 6-28 – Powered stand wiring

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

6.3 SYSTEM POWERING-UP


With reference to the figures and descriptions of the previous chapter 5, perform
the powering-up of the MIZAR-LIGHT according to the following procedure:

• 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

For your notes:

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.

Working mode 7-1


Operator Manual MIZAR-LIGHT

7.2 PREPARING THE PATIENT


The stage of preparation of the patient is very important in order to obtain a good
acquisition of the EEG signals and can be divided in the following phases:

• Identification of the electrodes application sites (system 10-20 or system 10-10)

• Preparation of the skin

• Application of the acquisition electrodes.

• Impedance check

7.2.1 ASSIGNING THE ELECTRODES APPLICATION SITES (SYSTEM 10-20)

The acquisition electrodes should be placed on the patient's scalp in pre-


established positions the names of which have been standardised in the "System
10-20" and "System 10-10" by the International Federation for EEG.
The terms "10-20" and "10-10" refer to the fact that the electrodes are placed in
various positions of the scalp at distances of 10% and 20% of the whole length of
ideal lines starting from extract reference points, which are "Nasion" and "Inion"
for the front-rear median line and the pre-ear for the latero-lateral coronal line.
The following Figure 7-1 shows the assignment of the placing sites by indicating
the percentage of the scalp according to the "system 10-20".

This system allows to identify 21 standard positions of electrodes, including the


electrodes of the median line in the front, central and parietal areas and both the
ear electrodes. Each electrode can be identified with reference to the
corresponding body area and more precisely by the means of letters (referred to
the body parts) in addition to numbers to distinct the right (even number) and the
left hemisphere (uneven number).

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.

7-2 Working mode


MIZAR-LIGHT Operator Manual

Figure 7-1 - Assignment of the electrodes application sites

Figure 7-2 - Positions of the electrodes on the scalp

Working mode 7-3


Operator Manual MIZAR-LIGHT

7.2.2 PREPARING THE SCALP

The phase of preparation of the scalp has an important role in establishing a good
electric contact, thus allowing the best kind of recording.

Following the indicated procedure:

• 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.

• In some patients it can be extremely difficult to reduce the contact resistance


by removing the grease from the scalp surface. In these cases it could be
necessary to scarify the skin by gently rubbing the area with a piece of very
fine glass-paper in order to better remove the surface film of the skin.

7.2.3 PLACING THE EEG ACQUISITION ELECTRODES

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.

7-4 Working mode


MIZAR-LIGHT Operator Manual

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.

Working mode 7-5


Operator Manual MIZAR-LIGHT

7.2.4 IMPEDANCE CHECK

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.

Different values between two electrodes may cause asymmetric conduction or


artifacts.

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.

Not correctly applied electrodes, improper preparation of the patient’s skin,


patient’s sweating, too much electroconductive creme, damaged electrodes or
different kinds of electrodes used at the same time, may be the causes of high
impedance values and unbalances.

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.

7-6 Working mode


MIZAR LIGHT Operator Manual

CHAPTER 8
MAINTENANCE

8.1 GENERAL INFORMATION ABOUT MAINTENANCE


In order to keep the device working for a long time and to ensure the patient’s and
the operator’s safety, it is necessary that the general checks indicated below are
periodically performed by medical or paramedical qualified staff or by technical
staff authorized by EBNeuro.

• 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

8.2 REPLACING FUSES


If at power-up whole system or parts of it remain completely inactive, it may be
due to a burned fuse in which case it is necessary to replace it.

The following cases indicated in the following table may occour:

ISOLAT. PC BE_LIGHT MONITOR THERMAL FUSE SOLUTION


TRASF. BOX (OR OTHER
MODULE PERIFER.) PRINTER

ISOLATION Replace fuses


OFF OFF OFF OFF OFF TRASFORM.
MODULE
Contact service
ON OFF ON ON ON PC Center

BE_LIGHT BOX Contact service


ON ON OFF ON ON (AC/DC Center
ADAPTER)
MONITOR Contact service
ON ON ON OFF ON (OR OTHER Center
PERIFERAL)
THERMAL Replace fuses
ON ON ON ON OFF PRINTER

• If no part of the system (isolation transformer module, personal computer, BE


LIGHT acquisition box, monitor and thermal printer) is powered when you
turn on the system, it means that there is a burned fuse in the mains isolation
box.

Such a condition is confirmed if the main switch of isolation transformer


module is on ON (I position), but the green led indicating "mains on line" is
off.

In this case have the burned fuse replaced as the described below.

• If no part of the system except the isolation transformer module is powered


when you turn on the system, it means that there is a burned fuse in the
Personal Computer. Such a condition is confirmed if the switch of the isolation
transformer module is on ON (I position) with the green led indicating "mains
on line" on, but nether PC nor the other parts are supplied.

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

Figure 8-1 - Replacement of the mains fuses

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

8.3 REPLACING THE THERMAL PRINTER PAPER


The following instructions and the following Figures 8-2, 8-3 and 8-4 will help
you replace the thermal print paper:

a) Make sure no print job is running

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.

f) Close the paper tray lid and perform a test print.

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

Figure 8-2 - Paper preparation

8-6 Maintenance
MIZAR LIGHT Operator Manual

Figure 8-3 – Insertion of the pack into the paper tray

Figure 8-4 – Paper position between the paper roller and the write head

Maintenance 8-7
Operator Manual MIZAR LIGHT

8.4 PERIODIC CALIBRATION


The following paragraphs respectively describe the “physical calibration” and
“recording calibration” procedures for the acquisition system in order to check the
correct working of whole acquisition and amplification chains.

8.4.1 “PHYSICAL” SYSTEM CALIBRATION

This is standard calibration procedure. A physical signal (its amplitude and


frequency are known) is injected into the input of each channel. The results of the
entire processing (analog and digital) are measured and evaluated in order to
verify that the signal processing chain is correctly working.
This kind of calibration allows to “adjust” the possible small gain values
differences among the channels.
It is very important to have an uniformity of channels gain because the EEG traces
are the result of numeric differences between the acquired channels.

When physical calibration is activated (under control of GALILEO_NT software),


an amplitude-known sinusoidal signal is generated by the amplifiers and then
injected into the inputs of each channel through a proper adapter.
The processing results are elaborated on the system PC by a dedicated software
procedure. The signals are filtered and averaged in order to eliminate the noise.
Then, the real gain of each channel is calculated.

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.

It is not necessary to activate the physical system calibration frequently.


We suggest to perform the physical calibration after the device has been serviced
or replaced.
The calibration date is stored on the flash memory of BE_LIGHT acquisition box
together the calibration constants.

The “physical” calibration operations must be performed exclusively by qualified


personnel authorised by EBNeuro.
The calibration procedure below described is intended for general information and
documentation of the MIZAR LIGHT. This procedure is not intended to be
performed by the user.

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:

Follows the below described procedure to perform the physical calibration:

• Insert the proper “BE_LIGHT Channels Calibration” device code


B9500114000 (provided to authorized technical personnel) in the PATIENT
LINK connector of the amplifier box;

• Run the software procedure from the system PC (please check the relevant
documentation about host system PC control software - ref. testing software
code B8690039000);

• At the end of calibration process, remove the “BE_LIGHT Channels


Calibration”.

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.

8.4.2 “RECORDING” SYSTEM CALIBRATION

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.).

For further information about “recording” calibration, please check the


“GALILEO_NT software functioning” section of the system operator manual.

Maintenance 8-9
Operator Manual MIZAR LIGHT

8.5 TEST OF PATTERN STIMULATOR MONITOR


Before starting acquisition and stimulation of the visual evoked potentials it is
possible to perform a test of the Pattern stimulator monitor.
By means this test you can check the geometric images displayed on the monitor
and, if necessary, correct the squaring and proportions between the X and Y axes
of a stimulation image.

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:

Figure 8-5 – Test image

Perform the monitor test according to the following procedure:

• 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.

The contrast and brightness adjustment of stimulator monitor must be not


modified by the operator. These values are adjusted by EBNeuro during the
system configuration and testing phase, when the contrast and brightness of image
are measured with proper calibrated instruments.

In case contrast and brightness parameters are accidentally modified, we


recommend to restore them on the EBNeuro original values.
The EBNeuro original values of contrast and brightness parameters are shown in
the dedicate “EBNeuro Factory Setting” label placed on the rear panel of 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

8.6 SAFETY CHECKS


It is essential to periodically check the equipment and the devices or systems it is
connected to and all the interconnection cables in order to ensure that the
equipment continues working efficiently and safely. It is also necessary to check
the equipment to remove any dust deposits. Preventive or corrective maintenance
operations must be performed by qualified technical staff expressly authorized by
EBNeuro.

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.

8.6.1 ENVIRONMENT ELECTRICAL EQUIPMENT

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.

It is fundamental that qualified technicians check the electric wiring periodically


(efficiency of the main outlets and of the power 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

8.6.2 INTERCONNECTION CABLES AND CONNECTORS

It is necessary to check periodically the integrity of the interconnection cables


between the instrument and the other devices that compose the system with
particular care for the fiber-optic cable which connects the acquisition box to the
BE NET (or PCMCIA) interface (installed into PC of the system).
Elementary precautions may prevent prematurely breaking or deteriorating of the
cables. Be careful when removing the cables from the corresponding connectors
on the equipment panel; take the cable terminal connector resolutely, though with
delicacy, out of the connector. Avoid twisting or tearing cables, which may cause
breaks and interruptions to the conductors.
Monthly check cables for abrasion and wear. Replace any cable with exposed wire
or shield.
Check the connectors on the ends of cable for bent or broken pins. Replace the
cable with damaged connector.
Check the connector on the acquisition box and on optional modules and
peripherals for broken or damaged contacts. If you find a damaged connector refer
to qualified technical support service.

8.6.3 MAINS CABLE

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

8.7 CLEANING THE DEVICE


It is necessary to keep the equipment clean in order to avoid dust deposits, which
could interfere with the efficiency of all the system components.

It is possible to clean the equipment external surface with a cloth lightly


moistened with warm water and soap. Wipe the washed parts with a dry cloth.

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

8.7.1 FIBER OPTIC CONNECTORS

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

8.7.2 ELECTRODES, INTERCONNECTING CABLES ELECTRODE/PATIENT INPUT


BOX AND ACCESSORIES

After each recording, carefully clean the acquisition electrodes, the


interconnection small cables and accessories with warm water and soap to remove
any residual electroconductive creme, collodium or other foreign bodies.

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.

8.7.3 OPTICAL DISK READER, CD-ROM AND REMOVABLE CARTRIDGES

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.

8.7.4 MEMORY SUPPORTS

The MIZAR-LIGHT uses removable memory supports. In order to avoid any


damage to the memory supports and to their drives that could loss of stored data it
is recommended to comply with the following directions and warnings:

• 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 attempt to disassemble drives or memory supports etc.

• 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

• Never disconnect cables, connectors when the instrument is power supplied.

• 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

in any case non-original software packages on dubious diskettes that could


insert a virus and thus contaminate the stored data.

WARNING
EBNeuro is not responsible for damages due to loss of stored data caused by the
non-observance of the above described recommendations.

8.7.5 WRITE HEAD OF THE THERMAL PRINTER

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

PAPER TRAY LID

Figure 8-6 – Cleaning of the write head of the thermal printer

Maintenance 8-19
Operator Manual MIZAR LIGHT

8.8 PARTICULAR WARNINGS FOR CRITICAL COMPONENTS


The instrument can be provided with a LCD monitor (Liquid Crystal Display),
which contains small quantities of toxic materials.

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

9.1 OBTAINING SERVICE


In case of problems such as failure of the device or anyway in case of partial or
incorrect working that cannot be solved through usual maintenance operations,
please contact one of the main offices or branches of EBNeuro or the nearest
retailer or authorized servicing centre.

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.

REQUEST FOR ASSISTANCE

EBNeuro Device/system name.....................................................................................

EBNeuro Device code/reference number (REF) .......................................................

Serial number (SN) or lot number (LOT) ....................................................................

Current software version (Rel) ....................................................................................

Request for assistance 9-1


Operator Manual MIZAR LIGHT

9.2 EBNEURO MAIN OFFICES


Please find below the addresses of the EBNeuro main offices.

OPERATING OFFICES

EBNeuro S.p.A. EBNeuro S.p.A.


Operating office: Operating office:
FIRENZE VERONA
Via Pietro Fanfani, 97/A Via Bologna, 1
50127 - Firenze 37020 - Arbizzano di Valpolicella (VR)
Phone +39 055 4565111 Phone +39 045 6028111
Fax +39 055 4565123 Fax +39 045 6028100
Website www.ebneuro.com

9-2 Request for assistance

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