Beruflich Dokumente
Kultur Dokumente
S Y S T E M F O R EP A N D OAE
N EURO -A UDIO
T ECHNICAL M ANUAL
NSFT 032999.001 TM
Technical Manual
TABLE OF CONTENT
Introduction..................................................................................................................................... 4
1.
Neuro-Audio Digital System Description and Operation ................................................ 5
1.1. Neuro-Audio Digital System Function ............................................................................ 5
1.2. Neuro-Audio Specifications............................................................................................. 5
1.3. Neuro-Audio Delivery Set ............................................................................................... 7
1.4. Neuro-Audio Digital System Arrangement and Operation.............................................. 8
2.
Neuro-Audio Digital System Mounting and Installation................................................. 9
2.1. Requirements to the Personnel Conducting Neuro-Audio Digital System Installation... 9
2.2. Room Selection and Placement ........................................................................................ 9
2.3. Unpacking and Check of Delivery Set ........................................................................... 12
2.4. Mounting and Connection to PC .................................................................................... 13
2.5. Software Installation. Computer Requirements ............................................................. 15
3.
Neuro-Audio Digital System Proper Use....................................................................... 17
3.1. Safety Measures When Using Neuro-Audio Digital System......................................... 17
3.2. Neuro-Audio Digital System Setting-up Procedures ..................................................... 17
3.3. Troubleshooting.............................................................................................................. 18
3.4. Checkups Execution Using Neuro-Audio Digital System............................................. 21
3.5. Actions in the Emergency .............................................................................................. 21
4.
Neuro-Audio Digital System Servicing ......................................................................... 22
4.1. General Requirements .................................................................................................... 22
4.2. Neuro-Audio Digital System Conservation ................................................................... 22
5.
Neuro-Audio Digital System Current Repairs ............................................................... 23
5.1. General Requirements .................................................................................................... 23
5.2. Cables, Adapters and Linkers Repair ............................................................................. 23
5.3. Computer Interface Cable Repair (USB Cable) ............................................................. 24
5.4. Auditory Stimulator Repair ............................................................................................ 25
5.5. OAE Probe Repair.......................................................................................................... 26
6.
Neuro-Audio Digital System Packing and Transportation ............................................ 27
7.
Neuro-Audio Storage Regulations ................................................................................. 27
I NTRODUCTION
This technical manual (further manual) is the combined document describing operation and
servicing of multifunctional digital neurophysiological system for EP and OAE Neuro-Audio (further
Neuro-Audio digital system) intended for objective audiometry carrying out by 1-2 channels and
otoacoustic emission (OAE) study.
The document certifies technical parameters of Neuro-Audio digital system, which are
guaranteed by the manufacturer.
You can send your responses and recommendations to the following address:
P.O. Box 10, Ivanovo, 153000, Russia or by e-mail: help@neurosoft.ru.
Technical Manual
1.
AND
O PERATION
N E U R O -A U D I O D I G I T A L S Y S T E M F U N C T I O N
Neuro-Audio digital system is intended for study of auditory evoked potentials (EP),
ototacoustic emission (OAE) by biopotentials registration and input to PC by 1-2 channels and
measurement, calculation and analysis of its parameters.
Neuro-Audio digital systems can be used in patient care institutions, diagnostics centers,
neurosurgical hospitals and experimental laboratories of the research institutions for:
brain functional state study;
auditory tract study.
The general properties of the digital system software:
biopotentials registration by 1-2 channels in any unshielded room;
auditory stimulation carrying out;
auditory EP registration;
OAE study;
checkup report generation;
review, store and print of the recorded traces, results of their analysis and checkup reports.
1.2.
N E U R O -A U D I O S P E C I F I C A T I O N S
Table 1.1
Parameters
Values
EP Channels
Number of channels
Sampling rate per channel
A/D converter
Input impedance
Noise level
High pass filter
Low pass filter
On/off notch filter 50 or 60 Hz (switchable)
Common-mode rejection ratio
2
200 Hz80 kHz
16 bit
not less than 90 M
not more than 5 V
0.023000
1010000
not less than 25 dB
not less than 100 dB
Auditory Stimulator
Stimulation level
Stimulation frequency
Tone stimulation:
Tone
Stimulus duration
0.12530 ms
Parameters
Values
Click stimulation:
Stimulus duration
Left/right/double-sided stimulation
10030000 s
yes
OAE Probe
Stimulus intensity
5080 dB
Telephone bandpass
flatness:
5 V DC
220\230 V AC (50 Hz), 110 V AC (60 Hz)
220\230 V AC (50 Hz), 110 V AC (60 Hz)/
Int. battery
Dimensions:
Electronic unit
Footswitch
Weight:
Electronic unit
Footswitch
Safety
19014050 mm
10327343 mm
not more than 1.0 kg
not more than 1.0 kg
BF type
Technical Manual
1.3.
N E U R O -A U D I O D E L I V E R Y S E T
Neuro-Audio delivery set includes amplifier electronic unit, patient button, footswitch and
software which can be can be supplied to the customer both jointly and separately, and also accessories
and bought articles. The delivery set is given in Table 1.2.
Table 1.2
Number,
pieces
NSFT 032201.003
NSFT 028201.005
1 1)
1
3. Footswitch
NSFT 028353.002
4. Assembled holder
NSFT 016201.021
TDH-39
ER-5A
ER3-14A
NSFT 032103.001
B-71
NSFT 032103.002
NSFT 006355.002
ER 100-RPT
ER 34-KIT
NSFT 006201.008
TC 9398-011-34616468-2002
Every, Italy
NSFT 006999.001 SW
NSFT 006999.001 SW
Name
2)
2)
Number,
pieces
Laser or jet
TC 3413-004-13218158-2004
IEC 601-1-88
NSFT 032999.XXX RC
NSFT 032999.XXX TM
NSFT 006999.XXX UM
Name
3)
10.2. Printer 3)
Notes:
1) The number of components included in the base delivery set is marked by bold font.
2) Analogous type accessories and components permitted in the country of equipment operation can be used.
3) All the computer equipment should conform to IEC 950-86 and CISPR 22 for B class requirements.
4) The supply with another transformer which is certified according to IEC 601-1-88 with analogous input and output
characteristics is permitted.
1.4.
N E U R O -A U D I O D I G I T A L S Y S T E M A R R A N G E M E N T
AND
OPERATION
Neuro-Audio digital system mode of operation is based on the registration and input into PC of
biopotentials of muscles, nerves, brain and other physiological signals for its analysis.
Neuro-Audio digital system operates under control of PC (IBM PC type) with the mouse,
keyboard, laser or jet printer and installed licensed Windows operating system.
Neuro-Audio digital system can include patient button and footswitch. All the electronic units
are connected to PC by USB cable.
Physiological signals processing, displaying and presentation in different modes after
mathematical analysis, then storing of the initial data on the hard disc, checkup report generation and
printing is done using PC.
Technical Manual
2.
Neuro-Audio digital system mounting and installation should be carried out by the person who is
empowered by the manufacturer or the technical personnel of the medical institution which is going to
use it. It is necessary to remember that Neuro-Audio digital system mounting accuracy defines safety
and quality of operation. Further mounting and installation requirements which define the product
safety will be marked by bold and italic font in the text.
2.2.
R O O M S EL E C T I O N
AND
PLACEMENT
Before mounting and installation of Neuro-Audio digital system, it is necessary to select a place
for it, taking into consideration power wiring and protective ground in the room, and also to read the
following requirements and recommendations:
The use of electric mains in which the neutral conductor and protective ground are
combined is prohibited strongly.
It is recommended to place the electronic unit on the maximum possible distance from power
cables, switchboards, and different powerful electrical devices which can emit electromagnetic fields
of mains frequency.
The recommended distance from the electronic unit to the nearest electric mains is not less
than 3 meters.
The location of electronic unit in the immediate vicinity (less than 5 meters) to short-wave or
microwave therapeutic equipment is not permitted (it can lead to its unstable operation).
Computers used as a part of the system should correspond to medical safety requirements
(IEC 601-1-88) or be connected through isolation transformer (notebook PC requires special power
unit) also corresponding to aforesaid requirements.
The use of multi-socket electric mains extender without additional protective actions is
prohibited. The fact is that the probable break of the circuit of the protective ground of the multisocket electric mains extender can lead to summation of leakage current in all connected units on
their metal parts to dangerous values. In case the multi-socket electrical mains extender is
necessary, its modification should be done. The additional copper conductor with the section which is
equal to not less than 1 mm2 should be linked up to the extender ground bus and the CONSTANT
connection to stationary circuit of the protective ground should be kept. The recommended color of
cable isolation is yellow and green.
Before Neuro-Audio digital system setting the electrician must check the quality of
standard tripolar sockets and the integrity of the protective ground circuit.
Fig. 2.1. Neuro-Audio digital system placement sample when connecting to desktop PC
(see explanations below).
10
Technical Manual
Fig. 2.2. Neuro-Audio digital system placement sample when connecting to notebook PC
(see explanations below).
The following abbreviations are used for the figures:
C patient chair;
EU electronic unit;
Fs footswitch;
Kb keyboard;
M monitor;
Ms mouse;
Nb Notebook PC- based system;
P printer;
PB patient button;
PU notebook PC power unit which corresponds to IEC 601-1-88;
SU PC system unit;
T isolation transformer which corresponds to IEC 601-1-88.
11
2.3.
UNPACKING
AND
CHECK
OF
DELIVERY SET
If the box with Neuro-Audio digital system was under conditions of the excessive moisture or
low temperature which differs sharply from working conditions, it is necessary to place it in the room
and leave for 24 hours in normal conditions.
Unpack the box and extract Neuro-Audio digital system components. The delivery set should
correspond to list of components in the chapter Delivery Set of digital system registration certificate.
The computer equipment packed in the separate boxes should be opened according to user and
technical manuals for these products.
Check Neuro-Audio digital system components to make sure that there are no external damages.
12
Technical Manual
2.4.
MOUNTING
AND
CONNECTION
TO
PC
1. Install the work program on the desktop PC (see below). The software must be installed
before the first connection of Neuro-Audio digital system to computer.
Neuro-Audio digital system consists of several units; each of them has to be attached to USB
connector of PC. An electronic unit, a patient button, footswitch and a dedicated keyboard are shown
in the Fig. 2.3. The devices can be connected either directly or using USB-hub (it is not shown in the
Fig. 2.3). Remember that electronic unit and patient button must be attached to the same USB
controller, that is to the same USB-hub or to the alongside USB connectors or to several USB-hubs
attached to the same USB controller. The footswitch and the dedicated keyboard can be attached to any
USB connectors or USB-hub. The external USB-hub power supply unit must be plugged in 220/230 V
main through isolation transformer or special power unit. Do not use passive USB-hubs that are not
connected to the mains for Neuro-Audio digital system. The connection to USB connectors on PC
monitor and keyboard does not ensure the correct device operation. The number of units in
Neuro-Audio delivery set depends on delivery set variant.
Fig. 2.3
13
Fig. 2.4
If the message Neurosoft software has not been tested on the Windows XP compatibility
appears on the screen, press the button Continue.
14
Technical Manual
2.5.
1. If you purchase Neuro-Audio digital system together with the PC, the equipment is delivered
with installed and configured software. If you purchase the digital system separately, please study
carefully the following paragraphs.
Neuro-Audio digital system is provided with Neuro-MEP software. It can function properly on
any IBM compatible computer with the Intel Pentium Celeron 1 GHz processor and higher (Intel
Pentium IV is recommended), with not less than 128 Mb memory, and Windows 98/ME/2000/XP
operating system (Windows XP and higher are recommended). For software setup there should be 20
Mb of free hard disk space and 100 Mb of free hard disk space for the checkup archive
2. The results of checkups carried out with the use of Neuro-Audio digital system are saved on
the hard disk in a database common to all the Neurosoft Company systems.
3. The software is delivered on a compact disc (CD). If the software has been installed already
and you want to renew it, please, study carefully p.6 of this chapter.
4. The installation process is executed in the following order:
If you work with Windows 2000/XP, than log in the system as an administrator.
Insert CD to the disc drive and wait the installation program to start (Fig. 2.5). If the auto run
hasnt started and the picture (Fig. 2.5) hasnt appeared, find the AUTORUN.EXE file on CD
and start it.
Fig. 2.5
Locate the mouse cursor on Neuro-MEP line and click the left mouse button. Follow the
installation instructions.
5. For the software and equipment adjustment, start the program (see below) and execute the
menu command Setup|Program.
The process of adjustment is described in details in the user manual chapter Software and
Hardware Configuration Setting.
15
16
Technical Manual
3.
3.1.
S A F E T Y M E A S U R E S W H E N U S IN G N E U R O -A U D I O D IG I T A L S Y S T E M
To provide safety measures and exclude the possibility of medical staff or patient electric
trauma, the medical staff is PROHIBITED:
to use Neuro-Audio digital system mounting and setting of which was done incorrectly,
without following this manual instructions;
to connect Neuro-Audio digital system and surgical HF equipment to the patient (it can
cause patients flash-burn in the places of electrode placement and Neuro-Audio digital
system damage);
to connect any products, which are not included in Neuro-Audio digital system delivery set,
to electrode jacks;
to eliminate faults by opening of the components included in the delivery set;
to make checkup using Neuro-Audio digital system when the electronic unit box, computer
or other devices comprising digital system are open;
to connect patient electrodes to protective ground or other conducting surfaces.
3.2.
N E U R O -A U D I O D I G I T A L S Y S T E M S E T T I N G - U P P R O C E D U R E S
Operating Limitations:
Ambient temperature is from +10 to +35.
Relative humidity is to 80% at +25 temperature.
Atmospheric pressure (76030) mm Hg.
Before power supply switching on, it is necessary to make sure that Neuro-Audio digital
electronic unit and computer equipment boxes have no apparent mechanical failures which can
represent a danger.
Power Supply Switch on and Neuro-Audio Digital System Test.
Neuro-Audio digital system power supply switch on is done by pressing the key Power of
your PC. The electronic unit has no power supply switch and is constantly connected to PC. Power
supply switch on occurs after PC operating system loading and Neuro-MEP program start.
17
3.3.
TROUBLESHOOTING
If any problems with Neuro-Audio digital system are detected, first of all, check the connection
of all the units to the computer, and if the units are connected through the USB-Hub, than the USBHub connection to the computer and mains. The use of passive USB-Hubs (not connected to the
mains) is prohibited.
The list of some possible troubles and the ways of their removal is given below (Table 3.1). If
the trouble can't be removed by you, the device is to be repaired.
Table 3.1
Cause
Trouble Symptom
Way of Removal
the computer.
connected or defective.
the computer.
another program.
of Neuro-MEP program).
the computer.
device again.
18
Technical Manual
Continuation of Table 3.1
Cause
Trouble Symptom
Way of Removal
Installation. Computer
Requirements.
The program message:
Equipment error.
computer.
Windows XP.
amplifier.
19
Trouble Symptom
Way of Removal
digital system.
chapter 2).
switched off.
stimulus is absent.
command is ticked
20
Technical Manual
3.4.
C H E C K U P S E X E C U T I O N U S I N G N E U R O -A U D I O D I G I T A L S Y S T E M
For checkups execution using Neuro-Audio digital system, it is necessary to install the digital
system and other equipment according to user manual recommendations.
Checkup carrying out includes the following stages:
The electrodes and sensors set up.
The signals recording.
The results analysis and printing.
Before electrodes placement, it is necessary to degrease the patient's skin by alcohol. The use of
electrode abrasive paste for EP electrodes placement is preferable. Electrodes connection and
placement can be conducted when Neuro-Audio digital system is switched on. See more information
about electrodes in the user manual.
After surface electrodes placement it is necessary to control the electrode setting quality by
impedance measurement. For this the impedance measurement mode should be switched on (see user
manual).
The order of signal registration and records analysis is given in details in the user manual.
After finishing of the recording, the electrodes and sensors should be taken off the patient and
disinfected (see user manual).
If the next patient is not planned till the end of the working day, Neuro-Audio digital system
should be switched off. For that switch off Neuro-Audio digital system software and then do the same
with the computer and printer. If the long-term dwell in operation is planned (several days or more),
power supply plug of the isolation transformer is recommended to be disconnected to the mains.
3.5.
ACTIONS
IN THE
EMERGENCY
In the cases of electrical insulation disturbance of any Neuro-Audio digital system component
which causes the emergency (fire, mechanical failure, flood, medical staff evacuation) and threat of
patient or staff electrical shock, it is necessary to de-energize Neuro-Audio digital system completely.
21
4.
GENERAL REQUIREMENTS
Safety measures when servicing conforms to the ones described in the chapter Neuro-Audio
Digital System Function.
Qualification requirements to the medical staff are listed in the chapter Requirements to the
Personnel Conducting Neuro-Audio Digital System Installation.
Digital system servicing in the process of operation includes the external examination, check of
jacks and cables, removal of contaminations from the units surface using wet fabric.
Servicing of the bought articles included in Neuro-Audio digital system is conducted according
to user and technical manuals or typical rules.
When detecting the troubles it is recommended to use the information given in
Troubleshooting chapter. If the troubles cant be eliminated using Neuro-Audio digital system
control units or by restart, it should be switched off and checked by the specialist.
Type, volume and periodicity of the servicing except specified in this chapter, are not
determined.
The delivery set check is done by conformity to Delivery Set chapter of Neuro-Audio digital
system registration certificate.
4.2.
N E U R O -A U D I O D I G I T A L S Y S T E M C O N S E R V A T I O N
22
Technical Manual
5.
GENERAL REQUIREMENTS
Neuro-Audio digital system repair requires special training of the technical staff, special
equipment and service software which you can be provided by the manufacturer or the representative
of the firm. The repair connected with the electronic units opening is prohibited. The repair of
computer equipment can be conducted by dedicated establishments for computer equipment service.
Neuro-Audio digital system current repair includes the repair of component parts and cables.
If Neuro-Audio digital system is switched on, the component parts repair is prohibited.
When conducting current repair, all the digital units should be switched off.
5.2.
CABLES, ADAPTERS
AND
L I N K E R S R E P A IR
Cables are examined externally, and the circuits are checked for the break. In case of cable
failure, it should be replaced or repaired by shortening if the cable length is enough.
23
5.3.
C O M P U T E R I N T E R F A C E C A B L E R E P A I R (USB C A BL E )
Computer interface cable (Fig. 5.1) is examined externally, and the circuit is checked for short
circuit or break. In case of cable failure, it should be replaced or repaired by shortening the length.
When replacing it is necessary to pay attention to cable marking. The marking of wire size on cable
should be either 28AWG/2C+24AWG/2C, or 28AWG/2C+22AWG/2C, or 28AWG/2C+20AWG/2C.
XP1
1
Cont
1
2
3
4
3
4
Circuit
+5V
DD+
GND
red
white
green
black
Circuit
Cont
+5V
1
2
3
4
5
DD+
GND
XS1
24
Technical Manual
5.4.
Auditory stimulator (Fig. 5.2) is examined externally, and circuit resistance of dynamic head and
cable are measured. The measured value should be within the range from 90 up to 110 . When
detecting the break or short circuit it is necessary to open cable jack unit and check it. If the failure is
not discovered, open the auditory stimulator unit and measure each cable and coil of dynamic head. If
the cable break is detected, see the instruction on the USB cable repair. If the dynamic head failure is
detected, address to manufacturer for the further repair.
25
OAE P R O B E R E P A I R
OAE probe is examined externally for cable failure. Control of telephone circuits from connector
side is done according to schematic given on Fig. 5.3. Telephone resistance should be 395 10%. If
the break or short circuit is discovered, disassemble the cable connector case and examine it. If the
cable break is detected, see the instruction on the USB cable repair. If the failure is not detected,
address to manufacturer for the further repair.
26
Technical Manual
6.
Neuro-Audio digital system package should conform to the accepted one for manufacturing and
delivering. In case the factory package is damaged, but the long-term digital system storage and
transportation is expected, follow recommendations:
Neuro-Audio digital system with operational documentation should be packed in plastic
sachets and cardboard boxes.
The cardboard boxes should be covered by the paper tape or pressure sensitive adhesive.
Neuro-Audio digital systems can be transported by all kinds of covered carries (except nonheated airplane pods) according to rules of goods transportation for each mode of transport.
The digital system portage by sea transport should be done according to Safety Regulations for
Sea Transport of General Cargoes.
The shipment type is by containers and part-load consignment.
7.
27