DIGITAL NEUROPHYSIOLOGICAL SYSTEM FOR EP AND OAE
NEURO-AUDIO T ECHNICAL M ANUAL
NSFT 032999.001 TM
© Neurosoft
Ltd. (Ivanovo, Russia), 1995-2006
Technical Manual
TABLE OF CONTENT Introduction..................................................................................................................................... 4 Neuro-Audio Digital System Description and Operation................................................ 5
1.
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 Neuro-Audio Digital System Mounting and Installation ................................................. 9
2. 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 Neuro-Audio Digital System Proper Use....................................................................... 17
3. 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 Neuro-Audio Digital System Servicing ......................................................................... 22
4. 4.1.
General Requirements .................................................................................................... 22
4.2. Neuro-Audio Digital System Conservation ................................................................... 22 Neuro-Audio Digital System Current Repairs ............................................................... 23
5. 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
3
Digital Neurophysiological System Neuro-Audio
INTRODUCTION 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.
Attention! Do not start working with Neuro-Audio digital system before you have read this document!!!
You can send your responses and recommendations to the following address: P.O. Box 10, Ivanovo, 153000, Russia or by e-mail:
[email protected].
You can find additional information on Neurosoft products in Internet: www.neurosoft.ru or ask questions by phones: +7 (4932) 24-04-37 (Service Department), +7 (4932) 24-04-34.
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Technical Manual
N E UR O -A UDIO D IGITAL S Y S T E M D E S C R I P T I O N A N D O PERATION
1.
1.1.
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
2 200 Hz÷80 kHz A/D converter
16 bit
Input impedance
not less than 90 M Ω
Noise level
not more than 5 µV
High pass filter
0.02÷3000 Гц
Low pass filter
10÷10000 Гц
On/off notch filter 50 or 60 Hz (switchable) Common-mode rejection ratio
not less than 25 dB not less than 100 dB Auditory Stimulator
for ТА-01 − 0÷127 dB
Stimulation level
for TDH-39 − 0÷131 dB Stimulation frequency
0.05÷30 Hz
Tone stimulation: Tone
100÷8000 Hz Stimulus duration
5
0.125÷30 ms
Digital Neurophysiological System Neuro-Audio Continuation of Table 1.1
Parameters
Values
Click stimulation: Stimulus duration Left/right/double-sided stimulation
100÷30000 µs yes OAE Probe
Stimulus intensity
50÷80 dB Telephone bandpass flatness:
in the band 500 ÷2500 Hz in the band 2500 ÷4500 Hz Microphone bandpass flatness in the band 500 ÷4500 Hz Stimulus 3rd order intermodulation Microphone system noise
not more than 6 dB not more than 25 dB not more than 6 dB -80 dB -10 dB SPL @ 1 kHz (1 Hz BW)
General Specifications and Parameters
Interface
USB
Supply voltage: Electronic units Desktop PC-based system Notebook PC-based system
5 V DC 220\230V 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
190×140×50 mm 103х273х43 mm
Weight: Electronic unit Footswitch
not more than 1.0 kg not more than 1.0 kg BF type
Safety
Safety and Electromagnetic Compatibility. Electromagnetic compatibility (EMC) is provided by conformance to IEC 60601-2-1:2001 requir ements. As for safety, Neuro-Audio digital system satisfies IEC 601-1:1988 and IEC 60601-1-1:2000 standards requirements. Neuro-Audio digital system units are supplied by regulated power supply through USB interface, have double isolation and BF type work parts conforming to IEC 601-1:1988 standard requirements. I nterpretation of symbols on the electronic units: − attention:
consult operational documentation.
− work
parts of BF type conforming to IEC 601-1-88.
− mark
of conformance to Russian standards requirements.
− mark
of conformance to 93/42/EEC “Concerning Medical Devices” directive.
− mark
of conformance to 2002/96/EC
“On waste electrical and electronic equipment (WEEE)” directive. 6
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
Document label or main specifications
Number, pieces
1. Electronic unit Neuro-Audio
NSFT 032201.003
1 1)
2. Patient button
NSFT 028201.005
1
3. Footswitch
NSFT 028353.002
1
4. Assembled holder
NSFT 016201.021
1
NSFT 015305.001 (TA-01)
1
5.2 Headphones for audiometry
TDH-39
1
5.3 Insert earphones for audiometry
ER-5A
1
5.4 Set of disposable foam ear tips
ER3-14A
1
NSFT 032103.001
1
B-71
1
NSFT 032103.002
1
NSFT 006106.014 (SPEG-1)
5
NSFT 006106.018 (F8909Z)
1
NSFT 006355.002
1
ER 100-RPT
3
ER 34-KIT
1
NSFT 006201.008
1
TC 9398-011-34616468-2002
1
Every, Italy
1
NSFT 006999.001 SW
1
NSFT 006999.001 SW
1
Name
5 Auditory Stimulators and Accessories for them :
5.1 Auditory stimulator (headphones)
5.5 Adapter for headphones for audiometry 5.6 Bone vibrator 5.7 Adapter for bone vibrator 6. Asseccories for EP Study
6.1. Cup EP electrode with cable
2)
6.2. Pup-jack linker 7. Neuro-Audio Delivery Set
7.1. OAE probe 7.2. Replaceable tip for probe 7.3. Set of ear tips
2)
2)
7.4. Test cavity 8 Consumables:
8.1. Electrode adhesive paste
2)
8.2 Abrasive paste for skin preparation
2)
9. CD with Software 9.1. Neuro-MEP software 9.2. Automatically connected Neuro-OAE software module
7
Digital Neurophysiological System Neuro-Audio Continuation of Table 1.2
Document label or main specifications
Name
Number, pieces
10. Computer and Electronic Equipment
Intel Pentium Celeron processor 10.1. Desktop or Notebook PC
3)
1
(1 GHz and more) in the standard delivery set
10.2. Printer
3)
Laser or jet
1
10.3. Isolation transformer ТМ-630 4)
TC 3413-004-13218158-2004
1
10.4. Notebook PC special power unit
IEC 601-1-88
1
11.1. Registration certificate
NSFT 032999.XXX RC
1
11.2. Technical manual
NSFT 032999.XXX TM
1
11.3. User manual
NSFT 006999.XXX UM
1
11. Operational Documentation
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.
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Technical Manual
2.
N EURO -A UDIO D IGITAL S YSTEM M OUNTING 2.1.
REQUIREMENTS
TO THE
AND
I NSTALLATION
PERSONNEL CONDUCTING
N E U R O -A U D I O D I G I T A L S Y S T E M I N S T A L L A T I O N Neuro-Audio digital system mounting and installation should be c arried 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.
ROOM SELECTION
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 multi socket 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 mm 2 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.
9
Digital Neurophysiological System Neuro-Audio The typical schematics of the equipment location when connecting to desktop PC and notebook PC are given below (Fig. 2.1, Fig. 2.2).
Fig. 2.1. Neuro-Audio digital system placement sample when connecting to desktop PC (see explanations below).
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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
Digital Neurophysiological System Neuro-Audio
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.
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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
Digital Neurophysiological System Neuro-Audio 2. Place the holder as near as possible to the place of checkup carrying out and fix the amplifier unit on it. Connect all the necessary equipment. The electrical units can be connected to PC when the power supply is on or off. If the window shown on the Fig. 2.4 appears after Neuro-Audio digital system connection, press button
, without inserting the installation disk.
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.
S O F T W A R E I N S T A L L A T I O N. C O M P U T E R R E Q U I R E M E N T S
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 hasn’t started and the picture (Fig. 2.5) hasn’t 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
Digital Neurophysiological System Neuro-Audio 6. If the software is set up on the previous version (renewed), than, please, remember that previous files will be deleted including the files with medical norms databases. If you corrected the medical norms database and you want to keep it for the renewed software, than you should do the following: •
Before the software installation, copy the directory with medical norms from software catalogue in the other place. By default the software is installed in the catalogue C:\Program Files\Neurosoft\Neuro-MEP, the norms catalog name is NORMBASE.
•
Install the program as described above.
•
Copy the norms catalogue into the work directory of the software.
7. The examples of Neuro-Audio patient checkups are supplied on the same CD. To review the examples you should copy them into the database. It should be performed as follows: •
Start software (see user manual).
•
Select Checkup|Open menu command.
•
In the appeared dialog box Checkup selection press the
button ( from archive) and
choose EmgEpErg.pak file from the Neuro-MEP checkups directory on CD, after that press •
button.
To review the checkup examples, use the menu command Checkup|Open (see user manual).
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Technical Manual
3. 3.1.
N EURO -A UDIO D IGITAL S Y S T E M P R O P E R U S E
S A F E T Y M E A S U R E S W H E 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
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 patient’s 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 °С.
•
Relative humidity is to 80% at +25 °С temperature.
•
Atmospheric pressure (760±30) 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
Digital Neurophysiological System Neuro-Audio
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 program message:
Electronic unit of Neuro-Audio
Check whether the electronic unit
“Program supported Neurosoft
digital system is not connected to
is connected to computer. If there
devices are not detected”.
the computer.
are no connection errors, disconnect the electronic unit from the computer and connect again in several seconds. If it doesn’t work, reload the computer.
The program message:
Electronic unit of Neuro-Audio
Check whether the electronic unit
“Link error: Neuro-Audio is not
digital system is not connected to
is connected to computer. If there
connected or defective”.
the computer.
are no connection errors, disconnect the electronic unit from the computer and connect again in several seconds. If it doesn’t work, reload the computer.
The program message:
The other program using
End other programs using
“ Neuro-Audio is already used by
Neuro-Audio digital system is
Neuro-Audio digital system. If you
another program”.
opened (for example, second copy
can’t find such a program, reload
of Neuro-MEP program).
the computer.
Electronic unit shutdown fail.
End the operating program,
The program message: “ Neuro-Audio shutdown error.
disconnect the electronic unit from
Close program, unplug and plug
computer (USB-hub) and connect it
device again”.
again. If it doesn’t work, reload the computer.
18
Technical Manual Continuation of Table 3.1 Cause
Trouble Symptom
Way of Removal
The program message:
The computer was overloaded and
End all applications except Neuro-
“Processing error. The system is
could not receive the next data
MEP program (if they are started)
overloaded. Repeat starting”.
block from Neuro-Audio digital
and restart signal registration. If it
system. If this message appears
doesn't work, reload the computer.
rarely (not more 1-2 times per day),
If the trouble does not disappear,
it is not considered as trouble.
then probably, your computer processing speed is not enough. Minimal computer requirements are given in the chapter “ Software
Installation. Computer Requirements”. The program message:
Equipment error.
Start the registration of the signal
“Timeout error. The device does
again. If it fails, reload the
not transfer the data”.
computer.
The program message:
Neuro-Audio digital system was
Check the connection of Neuro-
“Error of transferring by USB.
disconnected during the signal
Audio digital system and start the
Check the devices connection and
registration or failed when
registration of the signal again. If it
repeat the start”.
exchanging through USB or it
fails, reload the computer.
failed during exchange through USB. The program message:
The first version of Windows XP
Install Windows XP Service Pack
“Service Pack 1 should be installed
installed in your computer contains
1, or the more late version of
for operation of the equipment with
the errors resulting in the improper
Windows (preferable), or, if it is
Windows XP”.
operation of USB devices.
not available, Windows ME.
High supply-line noise is in
Unused at the moment electrodes
Disconnect the unused at the
registered signal (frequency – 50
are connected to the amplifier,
moment electrodes from the
(60) Hz or divisible to it – 100
these are electrodes which are not
amplifier.
(120) Hz, 150 (180) Hz, etc.).
set on the patient and can cause the noise. The patient's electrodes are set bad.
Start the impedance measurement and obtain the accepted values. In case electrodes fault (for example, break), replace them.
19
Digital Neurophysiological System Neuro-Audio Continuation of Table 3.1 Cause
Trouble Symptom
Way of Removal
High supply-line noise is in
Bad grounding of Neuro-Audio
Ground the computer safely (see
registered signal (frequency – 50
digital system.
chapter 2).
(60) Hz or divisible to it – 100
The presence of powerful noise
Try to switch off or move off these
(120) Hz, 150 (180) Hz, etc.).
sources (X-ray equipment,
powerful devices on the bigger
physiotherapeutic room, powerful
distance. If it is impossible, try to
refrigerating systems, electric
obtain better parameters of the
motors, electric welding, etc.).
Neuro-Audio digital system grounding.
When starting the signal
The stimulation in the program is
Execute the command of the menu
registration in stimulus probes, the
switched off.
Setup| Stimulator| Turn on
stimulus is absent.
stimulator and make sure that this
command is ticked
.
The stimulation device (stimulus
Make sure that the stimulation
probe, headphones, etc.) is not
device is connected to the
connected (or connected unsafe) to
stimulator unit safely.
the stimulator unit. The connection between stimulator
Execute the command of the menu
and computer is broken.
Setup|Hardware reset and restart.
If it fails, reload the computer.
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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
Digital Neurophysiological System Neuro-Audio
4.
N EURO -A UDIO D IGITAL S Y S T E M S ERVICING 4.1.
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 can’t 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
Neuro-Audio digital system components including accessories and operational documentation should be packed in separate plastic sachets and then placed in a manufacturer package.
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Technical Manual
5.
N EURO -A UDIO D IGITAL S YSTEM C URRENT R EPAIRS 5.1.
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
LINKERS REPAIR
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
Digital Neurophysiological System Neuro-Audio
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 B L 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.
Connector BLS-5 view from he soldering side XP1
1 2 3 4
XS1
Cont
Circuit
1 2 3 4
+5V DD+ GND
red white green black
5
Circuit
Cont
+5V
1 2 3 4 5
DD+ GND
XS1
Fig. 5.1. Computer interface cable electrical schematic.
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Technical Manual 5.4.
AUDITORY STIMULATOR REPAIR
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.
Fig. 5.2. Auditory stimulator electrical schematic.
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Digital Neurophysiological System Neuro-Audio 5.5.
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.
Fig. 5.3. OAE probe electrical schematic.
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Technical Manual
6.
N EURO -A UDIO D IGITAL S Y S T E M PACKING
AND
T RANSPORTATION
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 non-
heated 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.
N EURO -A UDIO S TORAGE R EGULATIONS
Neuro-Audio digital system should be stored in manufacturer package in an enclosed space at +5-40°С and relative humidity 80% at +25 °С temperature. The air should be without any admixtures which can cause the corrosion. Neuro-Audio digital systems should be put on the shelves not more than in four lines.
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