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Hardware BIO-PC™
Rev.4
AKONIC S.A.
Av. Mosconi 2886
C1419EQU – Buenos Aires
ARGENTINA
Tel: 5411-4572-2593 - Fax: 5411-4573-2794
e-mail: akonic@arnet.com.ar
web: www.akonic.com
Bio-Pc Hardware - 2
GENERAL CONSIDERATIONS
The system has been developed for those graduated professionals and
experienced in the competition areas of this equipment, read carefuly this
manual, the personnel that uses the system too, it is advisable to carry a copy
of this manual, and in case of loss, the software allows its complete
impression.
The system possesses sensitive parts to the electrostatic discharges (ESD), to
avoid risks, the system should be connected as it is described in this manual,
previously to turn on the feeding source provided with the equipment and the
computer where the system will work.
Original parts, accessories and interconnection cables provided by AKONIC
S.A. or its authorized local representative should only be used. Otherwise, it
can put in risk the security and efficiency characteristics of the system.
Not use Electric Stimulator over implanted patients with electronics devices
(B.E. Heart stepper).
Not to place the electrodes has more than enough ulcerated skin and/or burnt.
It should verify the state of the accessories and the patient's cables regularly.
This verification can be carried out verifying in visual way simulating the use
of the accessories, or for its local representative. In electrodes it can verify the
continuity of the electrode with a multímeter.
If some error or defect is detected when using the system, contact with
AKONIC S.A. or its local representative, don't continue until the defect is
solved, repaired and verified.
The disposition of the replaced batteries will be carried out of agreement with
the effective legislation of each country where the system is used.
If the system isn’t going to use for more than 6 months has the caution of
moving away the batteries of the accessories, so that any eventual
deterioration of these doesn't affect the device.
Don't use the system when some of its cables cross doors or windows that can
close, through corridors or simply in case of the possibility that any person
can trip with them.
Don't use the system in places where children or visitors have access to it.
The use of the software and the sequence of operation of the system is
described in user's manual.
Verify in the possible software uptade which it is the effective manual, the
manual has in its cover revision number and/or date, in case of doubt please
contacts us, destroy any previous manual to avoid errors.
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INDEX
Content Page
General Considerations. 3
Index. 5
Part 1: Introduction. 6
Part 2: Normatives & System Specifications.
Part 3: General Specifications. 8
Part 4: Clasification. 12
Part 5: Computer Requeriments & Operating System. 12
Part 6: Storage. 13
Part 7: Transport. 13
Part 8: Cleaning. 13
Part 9: Maintenance 14
Part 10: Control & Calibration. 15
Part 11: Installation. 17
Part 12: System Connection. 21
Part 13: Device & Accesories Símbols. 36
Part 14: Troubleshootings. 38
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Part 1: INTRODUCTION.
FORESEEN PURPOSE:
AKONIC BIO-PC System is modular allowing different type of analysis in function of optionals
chossen.
BASIC SYSTEM:
Allow you to make long EEG studies with 21 eeg channels and 11 poligraphic channels
and then reviewing and printing in different speed, montages and sensitivity
OPTIONAL POLISOMNOGRAPHY:
Manual and Automatic analysis of poligraphical signal determining Sleep architecture and
apneas. All parameters tables and procedures defined by the user
OPTIONAL HOLTER:
Decode EEG signal from an AKONIC HOLTER ES8/16 making a file as EEG file.
EVOQUED POTENTIALS:
Allow obtein register averaging the input signal, by differents types of stimulation, may be
auditive (click / tones), visual (flash / pattern / BMP), somatosensitive o cognitive.
From 1 to 4 simultaneous channels, allow latencies measurements, mark them, posterior
review and printing of the results.
ELECTROMIOGRAPHY:
Allow the collection of Electromiographic signals, spontanous or sincronized to an electric
stimulus.
From 1 to 4 simultaneous channels, allow area presentation and latencies measurements and
nerve conduction velocities of peripheral nerves, a posterior analysis, reviewing and printing.
Bio-Pc Hardware - 7
OTOACOUSTIC EMISIONS:
Allow the collection of acoustics signals generated on the internal ear, spontaneous or evoqued
by auditive stimulation, and the distorsion product analysis of them.
With a probe of reduced dimensions, there are 1 auditive register channel and two auditive
stimulation channels.
Allow the obtention of curves depending of the intensity stimulation, and the posterior
reviewing and printing of the results.
NISTAGMOGRAPHY:
Allow the collection of electric signals generated by the eyes movements, this may be
spontaneous or evoqued by stimulus such as head movements, modification of the temperature
in the semicircular ear channels.
It is possible to do the correct measurement of the eyes movements with a movil target like a
leds bar, this bar is user programed with differents types of movements, senoidal, triangular,
Optoquinetic, Sacadic, etc with differents velocities.
From 1 to 4 simultaneous channels, allow analysis and graphic display by the method of
butterflies, Claussen and Freiss, a posterior analysis, reviewing and printing of the results.
DIGITAL AUDIOMETRY:
Allow the detection of the auditive umbral, using auditive stimulation of differents frequencies
(125, 250, 500, 750, 1000, 1500, 2000, 3000, 4000, 6000 y 8000 Hz.) an differents intensities
from 0 to 105 dB in steps of 5 dB.
Allow the display of graphics with the response and the posterior reviewing and printing of the
results.
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FORESEEN USE:
(* *) These graphic elements are accessed by the user through the computer monitor , and
through high resolution printer.
- Consume: 56VA
- Temperature: 5-30°C
- Relative humidity: <95% without condensation.
- Auto-Diagnoses: Generator of Calibration.
Electrodes Impedance measurement.
- Resolution A/D: 16 bits.
- Channel Number: 32 channels + System Referency.
- EEG Channels:
Input Impedance: >16 Mohm (Differencial mode)
Noise Level: 5 uV.
Hardware low frequency filter: 0.5 Hz.
Hardware high frequency filter: 100 Hz.
Hardware notch filter: 50/60 Hz.
High / low / notch digital filter :user selected
Sensibility: 0,88/896 uV/mm. user selected
CMRR: >80 dB at 50/60 Hz.
- EMG / EP Channels:
Input Impedance: >16 Mohm (Differencial mode)
Noise Level: 5 uV.
Hardware low frequency filter (Hz): .15, .5, 1.5, 5, 10, 30, 100, 300.
Hardware high frequency filter (Hz): 10000, 5000, 3000, 2000, 1000, 300, 100, 30.
Hardware notch filter: 50/60 Hz.
Sensibility 2 (uV): user selected.
CMRR: >80 dB at 50/60 Hz.
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- EKG Channel:
Input Impedance: >16 Mohm (Differencial mode)
Noise Level: 5 uV.
Hardware low frequency filter: 0.15 Hz.
Hardware high frequency filter: 25 Hz.
Hardware notch filter: 50/60 Hz.
Sensibility (max): 10 uV/mm. user selected
CMRR: >80 dB at 50/60 Hz.
- MIC Channel:
Input Impedance: >16 Mohm (Differencial mode)
Noise Level: 5 uV.
Hardware low frequency filter: 15 Hz.
Hardware high frequency filter: 300 Hz.
Filtro Notch por hardware: 50/60 Hz.
Sensibility (max): 10 uV/mm. user selected
CMRR: >80 dB at 50/60 Hz.
- Canales Ext1 – Ext2 (Use: Oximetry / pH / Pressure CPAP / Others signals DC):
Input Impedance: 50 Kohm.
Frequency Range: 0 – 100 Hz
Low/High/Notch Digital Filter: user selected
Maximum Voltage Input: +/- 5 Volts.
Input Voltage Range: user selected.
- OAE Channel:
High Lineality Microphone.
Input Sensibility: 20 – 70 dB SPL.
Microphone Noise: -20dB.
Auto-diagnoses: Verification ProbeTest.
- Event Button:
Accesory to detect the voluntary events of the patient.
Connect to the EVENT input of the system headbox.
- Audio Stimulator:
User selected: Click/Tone/Masking
Stimulation frecuency user selected from 0,5Hz a 30Hz
Range from 0db to 105dB, 5dB steps, user selected.
Optional: Tone Stimulator (P-300)
Stimulation frecuency user selected (Hz): 250, 500, 1000, 1500, 2000, 3000, 4000, 6000, 8000.
- Electric Stimulator:
Stimulation frecuency user selected from 0,5Hz to 50Hz
Stimulus amplitude 0 to 100mA
Stimulation durations user selected (mSeg): .1, .2, .5.
Electric Isolation 1.5kV.
- Leds Bar:
Bio-Pc Hardware - 12
- Photometer:
Visual Stimulus Light Intensity Meter.
Enabled and Used by EP Software.
- Digital Thermometer:
High Lineality superficial Sensor.
Range: 10 a 40°C.
Error: < 0,5°C.
Analog Output.
Display LCD 4 dígits with 1 decimal.
Power On Indicator.
Low battery indicator.
9 Volts standard battery power.
Dimensions (mm): 132 (Large) x 75 (Wide) x 22 (High).
Connect to EXT1 ór EXT2 input of BIO-PC system base.
- Serial Oximeter:
Possible to use independly of the EEG Software.
Many types of sensors availables.
Power On Indicator.
Low battery indicator.
9 Volts standard battery power.
Dimensions (mm): 132 (Large) x 75 (Wide) x 22 (High).
Connect to RS232 input or USB of the system computer.
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Part 4: CLASIFICATION.
Part 6: STORAGE.
The storage conditions are:
6.1- The equipment should be stored according to the packing indications in terms of the
position of the same one.
6.2- The ambient temperature of the storage place should not overcome the limits between 4
and 42 Centigrade degrees (ºC).
6.3- The ambient humidity of the storage place should not be higher than 50%.
6.4- If the system isn’t going to use for more than 6 months has the caution of moving away the
batteries of the accessories, so that any eventual deterioration of these doesn't affect the
device.
Part 7: TRANSPORT.
The transport conditions are:
Part 8: CLEANING.
The cleaning conditions are:
8.2- The electrodes and/or accessory in contact with the patient will be disinfected previous
use.This will be made according to the effective legislation in each country, where the
system is used.
8.3- It is advisable that , in case of using immersion in liquids for the patient electrodes
disinfection, leave them only the time that the supplier considers necessary, move them
away , dry them and preserve them in their containers. This prolongs the useful life of the
electrode.
8.4- The equipment and the accessories that are not in contact with the patient will be only
clean with volatile cleaning lather. Don’t use liquid and/or solvent .
8.5- The rhythm of the equipment and the accessories cleaning depend only on the conditions
they are, verify that the dirt doesn't deteriorate the connectors and/or interconnection
contacts among parts and patient.
Bio-Pc Hardware - 15
Part 9: MAINTENANCE.
The maintenance conditions are:
9.1- It will be verified the accessories and patient cables state regularly. This verification can be
carried out in visual way simulating the use of the accessories, or for our local
representative.
9.2- Statistically, it is not necessary a revision of verification of the system in periodic form, is
only advisable that AKONIC S.A. or its local representative verify that the system is inside
specification at least every 2 years.
9.3- It is recommended that after a long period of storage (bigger to 1 year) AKONIC S.A. or
its local representative verifies that the system is inside specification.
9.4- In electrodes, verify the continuity of the cables with a multímeter. This operation is very
simple of carrying out, and avoids errors and losses of time when carrying out the study.
9.5- The equipment doesn't possess accessible adjustment controls. If it detects some error or
defect when using the system, contact with AKONIC S.A.. or its local representative, don't
continue until the defect is solved, repaired and tested.
Only AKONIC S.A. and its authorized local representative has the capability of effective
service of the system, any intervention in this aspect for not authorized personnel,can put
in risk the security characteristics and system.efficiency
Bio-Pc Hardware - 16
Don't use the system when some of its cables cross doors or windows that can
close, through corridors or simply in case of the possibility that any person
can trip with them.
Don't use the system in places where children or visitors have access to it.
1.2. Caution should be had, especially in places with nylon carpets, and/or with very
low ambient humidity, in touching the electrodes or connected sensors to the
Neurotrace. It is convenient always to touch previously some connected element to
the ground, to discharge the electrostatic discharges.
It is also a factor of the electrostatic discharges increase the use of nylon overcoats,
specially associated to another dress of wool y/o cotton.
1.3. The place should be aired (ventilated) and with sources of heat generation t
(Stoves) far away.
If the ambient temperature is inside the specified range, it doesn't alter the security
of the product, but if the patient being studied presents for this reason an increase of
the perspiration, it should decrease the anbient temperature until perspiration is not
present, since it usually generate noises of low frequency in the data, comparable to
base line movements.
1.4. To avoid all type of illumination with fluorescent tubes, when these are not under
good conditions.
Bio-Pc Hardware - 19
1.5. The ROOM should be far from intense electromagnetic fields (i.e. electrotherapy
rooms, computed tomographs, x ray , etc.).
The intense magnetic fields can cause the presence in screen of signs of their same
generation frequency. The magnetic fields when meeting with the electrodes and
sensors cables generate an electric current interpreted as noise. It should be
avoided to work near very powerful equipment transformers, electric motors,
illumination fluorescent reactancies etc.
The near electric fields can cause noise of their same frequency during the data
acquisition. It should be avoided to work near electric cables, walls that conduct
especially if the same ones can have flaws of insulation. The patient should not
take contact with the walls while making the study.
locate PC monitors far from the headbox, electrodes and sensors cables, and from
the patient.
locate the Neurotrace source far from the headbox, electrodes and sensors cables,
and from the patient.
Not use Electric Stimulator over implanted patients with electronics devices
(B.E. Heart stepper).
Not to place the electrodes has more than enough ulcerated skin and/or burnt.
2.1. request the patient that washes the head with products free of detergents, (as being
shampoo and creams to rinse) it is recommended to use neuter soap.
2.2. explain to the patient the nature of the test to carry out.
2.3. the patient should be located in comfortable position, to avoid the muscular groups
contract that distort the layout.
2.4. clean with alcohol or similar the hairy leather, previous to place the electrodes, in
cases of intense dandruff, use cleaning cream
Bio-Pc Hardware - 20
2.6. Special ATTENTION should be paid to the electrodes placement because of this it
depends to achieve a good signal.
2.7. the patient should be connected with electrodes to the ground and to the system
reference
BIO-PC system can be connected to other products or sanitary equipments that have
analogical output, such as Oximetry / pH / Pressure CPAP / Other signs of AD, inside the
specified range.
The only inputs enabled for such case, are in the system headbox , identified as EXT1 and
EXT2.
The computer, devices and/or equipment to be used together with the BIO-PC system
will be normalized according to EN60601-1.
The system possesses sensitive parts to the electrostatic discharges (ESD), to avoid
risks, the system should be connected as it is described in this manual, previously to
turn on the feeding source provided with the equipment and the computer where the
system will work.
4. Working Conditions:
Verify the range selection of input line , according to the selection key in the
rear panel of the BIO-PC.
The Ground cable of the equipment should be used whose voltage regarding neuter line pole
doesn't overcome 5 Volts of AC.
Mensuration with a tester between the ground and each one of the poles of the feeding line.
The mensuration between the ground and the neuter line pole (identified to give the less
lecture) is recommended doesn't overcome the value given previously (5 Volts).
Bio-Pc Hardware - 22
6 7 8 9
1 2 3 4 5
7 8 9 10 11 12 13 14
1 2 3 4 5 6
POLIGRAPHY INPUTS
BIO-PC CONNECTION
Bio-Pc Hardware - 25
EMG/EP INPUTS
BIO-PC CONNECTION
Bio-Pc Hardware - 26
Front Panel Headbox - CH32 model Rear Panel - SLD Photic Stimulator
Front Panel Headbox - CH32 model Rear Panel SLD-W Photic Stimulator
Instalación del Sistema para estudios Polisomnografía con sensores APS ó ATS
CANULA INPUT
Frente cabezal modelo CH32
Front Panel - APS sensor
SENSOR INPUT
Front Panel Headbox - CH32 model Rear Panel – Photic Stimulator SLD
PHOTIC STIMULATOR
CABLE
Rear Panel Headbox - CH32 model
EARPHONES EVENT
BUTTON
HEADBOX CABLE
Front Panel Headbox - CH32 model Front Panel Headbox - CH4 model
EARPHONES
Front Panel Headbox - CH4 model Front Panel – SLD Photic Stimulator
TO SVGA MONITOR
COLOR
PATTERN CABLE
HEADBOX CABLE
Electromiography Connections:
Front Panel Headbox - CH4 model Skin Temperature Meter Front Panel
SENSOR
Electric Stimulator
HEADBOX CABLE
Nistagmography Connections:
Audiometry Connections:
EARPHONES
Fuse location.
SN Serial Number.
Fragile.
Footswitch connector.
Earphones connector.
Bio-Pc Hardware - 38
During stimulations, frontal yellow light - Verify if stimulators are power on.
not flash. - Verify connections regarding this manual.
- Verify in Menu Technical if hardware Akonic is
the correct one.