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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
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(THIS PAGE IS INTENTIONALLY WHITE)
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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 use Electric Stimulator over patient torax.
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 multmeter.
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 equipment won't be used jointly with heart Desfibrillator or Electrobistur
Dont use the equipment neither in bleakness, nor in presence of inflammable
gases (p.e. anesthetics).
Always use the connection of functional ground not only to obtain a good
signal, but also for the eventual risk of electric crash to the operator and/or
patient . not using it is a serious violation to the practices of electric security.
External connectors must be used only with devices provided by AKONIC
S.A. and/or autorized parts especified in this manual.
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INDEX
Content
General Considerations.
Index.
Part 1: Introduction.
Part 2: Normatives & System Specifications.
Part 3: General Specifications.
Part 4: Clasification.
Part 5: Computer Requeriments & Operating System.
Part 6: Storage.
Part 7: Transport.
Part 8: Cleaning.
Part 9: Maintenance
Part 10: Control & Calibration.
Part 11: Installation.
Part 12: System Connection.
Part 13: Device & Accesories Smbols.
Part 14: Troubleshootings.
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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 BRAIN MAPPING:
Transforms time domain eeg signals in Frequency domain Armonic components and
shows them in different scales, bands, and topographic maps.
OPTIONAL POLISOMNOGRAPHY:
Manual and Automatic analysis of poligraphical signal determining Sleep architecture and
apneas. All parameters tables and procedures defined by the user
OPTIONAL EVENT RELATED:
Using differents events (joystick, keyboard or foto stimulation) allows you to sinchronize
EEG signal, average and analize them throw topographic maps
OPTIONAL HOLTER:
Decode EEG signal from an AKONIC HOLTER ES8/16 making a file as EEG file.
OPTIONAL VIDEO RECORDING:
Allows to video record a patient while making an eeg study and then reviewing
sinchronized with the eeg study.
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.
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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:
Designed to be used by professionals in neurophisiologic diagnosis of patient in consulting
rooms, hospitals and clinics.
The obtained information allows to determine if they are inside limit of normality or
outside of it, typing in these cases the diverse pathologies according to the registered
graphic elements (* *) and the patient's clinic.
(* *) These graphic elements are accessed by the user through the computer monitor , and
through high resolution printer.
The equipment has been designed to be connected to a group of accessories (Sensors,
detectors and stimulators) of own production those which, together with the equipment,
fulfill the necessary characteristics of security for this product type.
It can also be connected to equipment or other makers' accessories through the external
entrances (EXT 1, EXT 2 and Photo), such as CPAPs, oximeters, pHmeters,
photostimulators, audiostimulators, sensors, etc.
WAY OF FORESEEN USE:
The way of foreseen use of operation is described in this user's manual.
The associate software is described in this user's manual.
The equipment havent accessible calibration adjustments to the user
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EN60601-1
EN60601-1-4
Input Line:
100/120V ~ @ 50/60 Hz
200-240V~ @ 50/60 Hz
Fuses:
Consume: 56VA
Temperature: 5-30C
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.
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-
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:
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256 red leds.
Stimulation Mode software user selected: Senoidal, Triangular, Right Optoquinetic, Left Optoquinetic,
Sacadic, Sacadic Aleatory by time, Sacadic Aleatory by position, Sacadic Aleatory by time &
position.
Velocity software user selected (Hz): 0,25 - 0,50 - 1,00 2,00.
Deflection angles, software user selected.
Dimensions (mm): 740 (Large) x 64 (High) x 20 (Deep).
Photometer:
Visual Stimulus Light Intensity Meter.
Enabled and Used by EP Software.
Digital Thermometer:
High Lineality superficial Sensor.
Range: 10 a 40C.
Error: < 0,5C.
Analog Output.
Display LCD 4 dgits 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 r 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.
According to the resolution A.N.M.A.T. 37/95
harmonized Register of medical products (Annex 2).
The BIO-PC equipment is a class I.equipment
According to EN60601-1 Security of electric medical equipment:
CLASE I
Aplicable Part Type B
ORDINARY DEGREE OF LIQUIDS PENETRATION
IT DOESN'T REQUIRE STERILIZATION
FOR USE IN NON INFLAMMABLE ENVIRONMENT
WAY OF CONTINUOUS OPERATION
Dont use the equipment neither in bleakness, nor in presence of inflammable gases
(p.e. oxigen, nitroso oxide, anesthetics).
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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 (C).
6.3-
The ambient humidity of the storage place should not be higher than 50%.
6.4-
If the system isnt 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:
7.1-
7.2-
Part 8: CLEANING.
The cleaning conditions are:
8.1-
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. Dont 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.
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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-
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 multmeter. 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
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1.3 Auditive Stimulator in dB.
Disconnect Earphones and headbox.
- Connect the specific accesory in both connectors.
- Go to Menu Tools > Auditive Stimulator.
- Dialog box will show the dB values of stimulation.
- If necesary, recalibrate it:
- Disconnet equipment form line and CPU.
- Remove the superior part of the cabinet with the screw of the botom.
- Connect all the equipment again without Earphones and headbox.
- Connect the dB measurement accesory.
- Go to Menu Tools > Auditive Stimulator.
- Move calibration preset P204 y P205, to calibrate to the correct value.
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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.
1.6. If there were metallic elements such as stretchers, bookcases, etc., it is
recommended to put them a good ground connexion.
1.7. The ambient should be with delicate illumination and silent.
2. Recommendations on the PATIENT
Not use Electric Stimulator over implanted patients with electronics devices
(B.E. Heart stepper).
Not use Electric Stimulator over patient torax
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
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4. Working Conditions:
Verify the range selection of input line , according to the selection key in the
rear panel of the BIO-PC.
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.
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 multmeter.
Always use the connection of functional ground not only to obtain a good
signal, but also for the eventual risk of electric crash to the operator and/or
patient . Not using it is a serious violation to the practices of electric security.
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BIO-PC Rear Panel
10
11
12
13
14
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EEG INPUTS
EMG/EP INPUTS
BIO-PC CONNECTION
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HEADBOX CABLE
TO PC PARALLEL PORT
SYSTEM GROUND
LINE CONNECTION
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HEADBOX CABLE
TO PC PARALLEL PORT
SYSTEM GROUND
LINE CONNECTION
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Instalacin del Sistema para estudios Polisomnografa con sensores APS ATS
CANULA INPUT
HEADBOX CABLE
TO PC PARALLEL PORT
SYSTEM GROUND
LINE CONNECTION
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PHOTIC STIMULATOR
CABLE
HEADBOX CABLE
EARPHONES
EVENT
BUTTON
TO PC PARALLEL PORT
SYSTEM GROUND
LINE CONNECTION
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EARPHONES
HEADBOX CABLE
TO PC PARALLEL PORT
SYSTEM GROUND
LINE CONNECTION
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TO SVGA MONITOR
COLOR
HEADBOX CABLE
PATTERN CABLE
TO PC PARALLEL PORT
SYSTEM GROUND
LINE CONNECTION
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HEADBOX CABLE
TO PC PARALLEL PORT
SYSTEM GROUND
LINE CONNECTION
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Electromiography Connections:
Skin Temperature Meter Front Panel
HEADBOX CABLE
Electric Stimulator
TO PC PARALLEL PORT
SYSTEM GROUND
LINE CONNECTION
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TO PC PARALLEL PORT
SYSTEM GROUND
LINE CONNECTION
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Nistagmography Connections:
Front Panel Oculography Bar
HEADBOX CABLE
TO PC PARALLEL PORT
SYSTEM GROUND
LINE CONNECTION
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Audiometry Connections:
EARPHONES
TO PC PARALLEL PORT
SYSTEM GROUND
LINE CONNECTION
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SN
Serial Number.
Use always the connection of functional ground not only to obtain a
good signal but also for avoid the eventual risk of electric crash to the
operator and/or patient. not using it is a serious violation to the
electric security practices.
Fragile.
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GND
AIRFLOW
Belt 1
Belt 2
MIC
1
2
3
4
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Corrective Action
- Verify fuses.
- Verify interlock.
- Change interlock cable.
- Verify position of key Power ON.