Enobio User manual Neuroelectrics
Contents
1. enobio BAIE enobio8 Input 5 W AC en0010 10 Assembling and using the kit 1 Install the electrode front ends in the neoprene cap or the neoprene band in the desired positions refer to the software instructions if you want to use a preset montage 2 Put the cap or the band on the subject s head with the electrode front ends installed 3 Place the NECBOX at the rear of the cap attached by means of the Velcro 4 Connect the device cable to the NECBOX ES WS Pos We en 010 5 Insert gel if using wet gel electrodes until it reaches the scalp of the subject 6 Prepare the connections cable provided The cable consists of eight EEG electrodes numbered 1 to 8 and two reference electrodes labelled DRL and CMS that act as drive circuit and common mode sensing WE NY YW YW VE pu a pu A A Nooo o o 1 4 C ia 0 a 0 en0010 8 Place the stick on electrodes at the mastoid Attach the DRL and CMS backends to the stick on electrode front ends Place the DRL and CMS electrodes as close as possible to each other O 9 Start the NIC software CHANNELS 00 00 00 00 00 00 Enobio 2G wet EC ixi 10 Refer to the software user manual for the usage of the NIC software enobio 11 System Requirements Windows XP Vista 32 64 bits or MAC OS X Intel gt Leopard 1GB RAM or more B2. Directive 93 42 CEE for medical devices UNE EN 60601 1 1993 A1 1996 A2 1996 A3 1997 A2 ERR 1999 UNE EN 60601 1 2 2008 UNE EN 60601 1 26 2004 3 Regulatory information Manufacturer Neuroelectrics Barcelona SL C Teodor Roviralta 45 08022 Barcelona Spain Telephone 34 93 254 03 70 Brand Enobio Models Enobio 8 Channels Enobio 20 Channels 4 Use environment The Enobio system has been designed for use in a clinical environment hospital or research center NE 3 eno BRAINWAVES MADE SIMPLE neuroelectrics 5 Safety Warnings A The results of the measurements must be analysed by a doctor or specialist No self medication should be done based on this results The device must never be opened or damaged The battery can only be replaced by authorized personnel Before using please check that the device is undamaged and the packaging has not been affected by transport or storage P BIBIE Before using the device please inform the prescribing clinician or operator of the presence of any pacemakers intracranial electrodes implanted defibrillators cranial pathologies e g holes plaques or any other prosthesis In these cases the use of the device could become unsafe In the case of malfunction immediately contact the manufacturer or the distributor The device is not protected against excessive moisture or immersion in liquid In the case of the device becoming wet or damp do not use
3. it and immediately contact the manufacturer Do not touch the device while EEG monitoring is on Always unplug the USB power supply from the device prior to connecting electrodes to the subject The device will not work when the battery is charging Never use the device or install the electrodes on the head of the patient while connected to the power network The device must be used only with Ag AgCl electrodes recommended by the manufacturer The device is not protected against other high frequency devices To avoid risks place the CMR DRL as far as possible from the s and return electrode of the high frequency device The device is wireless and might be affected by other RF devices The device needs special EMC precautions It needs to be used according to user manual information regarding EMC The EMC emissions and immunity has been tested using the 10 wire or 12 wire 34 cm cables provided with the system The use of cables or electrodes other than the ones delivered with the product might produce higher EMC emissions and less EMC immunity The device cannot be used beside or piled under other equipment If such usage is needed check the normal configuration P P P P PIP PIP Pl PIPI PIE The device can only be used on healthy skin without wounds NE 4 eno BRAINWAVES MADE SIMPLE neuroelectrics 6 Conditions of use Enobio must be used in normal temperature and pressure conditions T range 10 45 C humi
4. Warning signal according to UNE EN 60601 1 2008 Parts marked with this symbol are not protected against defibrillator ISO 7000 1641 read instructions before use symbol according to UNE EN 980 ISO 7000 2606 do not use device if product or packaging have been damaged symbol according to UNE EN 980 Do not throw Enobio in generic waste symbol WARNING When you want throw away the device NEVER throw it in the trash but go to the RECYCLABLE POINT or the nearest waste collection for further treatment thus contributing to environmental care CE marked device certified by the Notified Body n 0120 of the European Community eno BRAINWAVES MADE SIMPLE neuroelectrics 18 EMC information The Enobio is suitable for use in the specified electromagnetic environment The costumer and or user of the Enobio should ensure that is used in an electromagnetic environment as described below Electromagnetic Environment Guidance Emissions Test Compliance The Enobio uses RF energy only for RF Emissions its internal function Therefore its Group 1 RF emissions are very low and are CISPR 11 not likely to cause any interference in nearby electronic equipment RF Emissions Class B CISPR 11 D ee de ne The Enobio is suitable for use in all Harmonie Emissions f establishments including domestic Class A establishments and those directly IEC 61000 3 2 connected to the public low voltage power supply netwo
5. ating the Enobio b Over the frequency range 150 kHz to 80 MHz field strengths should be less than 3 V m NOTE 1 These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NE eno BRAINWAVES MADE SIMPLE neuroelectrics The Enobio is intended to be used in a controlled radiated RF environment The user of the Enobio can help to prevent electromagnetic interferences by keeping a minimum distance between the portable RF device transmitter and the Enobio as recommended below according to the maximum output power of the communications device Rated Maximum Separation distance metres Output Power of Transmitter to 800 MHz to 2 5 GHz watts d 1 2VP d 2 3VP 0 01 0 12 O12 0 23 0 1 0 38 038 0 73 1 2 1 2 2 3 10 3 8 38 7 3 100 12 12 23 For transmitters rated at a maximum output power not listed above the separation distance can be estimated using the equation in the corresponding column where P is the maximum output power rating of the transmitter in watts W according to the transmitter manufacturer NOTE These guidelines may not apply in all situations Electromagnetic propagation is affected by absorption and reflection from structures objects and people NE eno BRAINWAVES MADE SIMPLE neuroelectrics 19 Change record Issue Date Changes made Author 1 0 14 02 12 First version Gui
6. ave a limited life span This is caused by several processes such as corrosion the dissolving of the chloride in the pellets and the wearing of the pellet during the cleaning process Eventually the colour of the pellets will change from grey brown silver chloride to silver due to the loss of the chloride The AgCI slowly dissolves in gel and water during the cleaning Eventually this leaves only silver behind The resulting pure silver electrode has much higher drift and noise characteristics than the original Ag AgCl electrode At this point replacement is recommended 14 Neoprene cap cleaning and disinfecting instructions After each use the neoprene cap or the neoprene band should be cleaned and disinfected Use warm tap water to rinse the gel and some ivory soap to clean the cap Dry the cap carefully using a paper towel Spray the cap with disinfectant and let sit for 10 minutes Rinse cap thoroughly Hang up the cap to dry 15 NECBOX cleaning instructions After each use the NECBOX should be cleaned using a dry paper towel NE eno BRAINWAVES MADE SIMPLE neuroelectrics 16 Battery operating safety instructions 16 1 Charging the battery The battery can only be charged when the power ON switch is at the OFF position To charge the battery the following specifications have to be meet 5V nominal output 4 25 7 V 1 A current output Battery charger complies according Stardard IEC EN 60601 1 The batt
7. ctrodes behave like sponges they absorb water and electrode gel The deeper the water gel has penetrated the electrode the longer it will take afterwards for the water to evaporate As long as your electrodes are wet corrosion will take place This corrosion process will in the long run make your electrodes noisier That s why its important to clean the electrodes immediately after use and then let them dry Use warm tap water to rinse the gel from the electrodes make sure to keep the connector dry Warm water up to 50 degrees Celsius will dissolve the gel more quickly Use a soft brush for removing gel residues from the electrodes only if absolutely necessary Softly dry the electrodes with a paper towel or let them hang to dry Only use soap if water does not seem to clean the electrodes properly Never use solvents e g acetone acids or alkaline Do not let the electrodes dry without being cleaned first When the electrodes dry while covered with gel salt minerals the cleaning process will be more difficult After most electrode applications rinsing with distilled water will suffice Should the electrode surface be especially dirty or corroded a new surface can be exposed by gently sanding off with fine sandpaper or abrading with a pumice cleanser do not use ordinary cloth Follow by rinsing thoroughly with running water drying and storing to allow them to dry completely before the next use 13 4 Sterilization When sterili
8. dity 20 90 atmospheric pressure 700 1000 hPa 7 Contents of the box When you first open the box you will see the following items Neoprene cap Under the foam cover you will find the rest of the kit Neuroelectrics Control Box NECBOX 10 wire cable with the electrode back ends 12 wire cable with back ends only for 20 Channel device Electrode front ends Battery charger NE headband NE cap USB containing this manual and NIC software installer Neuroelectrics Instrument Control Software Curved syringe with gel mandatory for the PG PGF and optional for the electrodes 8 Technical Specifications EEG functionality Number of Channels 8 or 20 Channels Bandwidth O to 125 Hz Sampling rate 500 SPS Resolution 24 bits 0 05 microVolt Measurement Noise lt 1 uV RMS Input impedance 1000 Mohm minimum Allows for Stimulation simultaneously Other Technical Specifications Communication Bluetooth 2 1 Output EDF ASCII data files or tcp ip raw data streaming 3 Axes accelerometer MicroSD card for off line storage Operating time 8 hours for EEG only Dimensions 60 x 85 x 20 mm Weight 65 g Compatible with Windows 7 Windows Vista Windows XP MAC OS X NE 5 en0010 9 NECBOX Device description Description Neuroe Teodor Ro lectrics Barcelona viralta 45 08022 Barcelona Spain NES enc CHAX NE CE Input 5 W 4 25 7V 0120
9. en00IO BRAINWAVES MADE SIMPLE User manual v1 3 NE gt Table of Contents 1 Intended use 2 Safety Information 3 Regulatory information 4 Use environment 5 Safety Warnings 6 Conditions of use 7 Contents of the box 8 Technical Specifications 9 NECBOX Device description 10 Assembling and using the kit 11 System Requirements 12 Signal quality check 13 Silver Silver Chloride Ag AgCl electrode instructions 18 1 Precautions for handling electrodes 13 2 Conditioning 13 3 Cleaning 13 4 Sterilization 13 5 Darkening 13 6 Storage 13 7 Malfunction 13 8 Noisy electrodes 13 9 Life expectancy 14 Neoprene cap cleaning and disinfecting instructions 15 NECBOX cleaning instructions 16 Battery operating safety instructions 16 1 Charging the battery 17 Symbols used 18 EMC information 19 Change record A a ER ET En ok D N n wo Q Sy ek es oa E eno BRAINWAVES MADE SIMPLE neuroelectrics 1 Intended use Enobio is a wireless and portable EEG EOG ECG monitoring device The device is battery operated Its application must be controlled by specialized medical personnel able to guarantee the correct recording Read the User Manual carefully before using Enobio 2 Safety Information Enobio is a class lla device according to the classification in the Council Directive 93 42 CEE for medical devices It conforms to the following Standards and Directives
10. ery charger has to be connected to the microUSB connector located at the rear part of the NECBOX Ne The battery state of charge is measured by the software while the device is powered ON The charging LED located near the connector shows colour yellow when charging and green when it s fully charged It should be noted that the battery will be over discharged if the device is not used for a long time In order to prevent over discharging the battery should be charged periodically QOver discharging may cause loss of cell performance or damage battery function Expected life cycle gt 500 cycles gt 70 of initial capacity Charging with a higher voltage than specified may cause damage to cell The usual time to charge a battery from the cutoff voltage to the maximum capacity is around 2 hours but it depends on every specific battery battery life and memory is a function of time The system can be connected to any Class 2 electrical installation Storage NECBOX Operating temperature temperature electrical specifications Charging Voltage input nominal 5V DC Voltage input min max 4 25 7 V Power input 5 W Current output none Charging 0 C to 45 C 1 year Discharging 20 C to 60 C at 20 C to 35 C en0010 BRAINWAVES MADE SIMPLE neuroelectrics 17 Symbols used Simbol Description IEC 60417 5333 BF type applicable part according to UNE EN 60601 1 2008 ISO 7010 W001
11. llem Mitj ane de 7 dd on de ME neuroelectrics Teodor Roviralta 45 08022 Barcelona Spain Tel 34 93 254 08 66 mail www neuroelectrics com www neuroelectrics com
12. luetooth adapter or USB 2 0 port CPU Pentium D or better 12 Signal quality check Before any recording the quality of the signal should be checked to ensure the correct measurements Signal drift Before the EEG establishes a good redox reaction on each electrode the signal recorded might have a large DC drift This DC drift could affect the results recorded and should be avoided In the figure a signal with a significant amount of drift is compared to a normal signal Normal signal Signal with high drift Time Sec Time Sec Noisy electrodes If the signal shows too high drift or noise the electrodes might be at the end of their lives The figure shows a signal with a considerable noise oo oea Time Sec gt 10 eno BRAINWAVES MADE SIMPLE neuroelectrics 13 Silver Silver Chloride Ag AgCl electrode instructions 13 1 Precautions for handling electrodes Electrodes should not come into direct contact with metals as this may cause corrosion Avoid touching or contaminating the bare electrode surface as dirt can increase calibration times Use of corrosive chemicals will damage the electrodes 13 2 Conditioning To minimize DC offset and drift place the electrodes in the working position 5 minutes before starting the measurement The electrodes need some time to achieve electrochemical equilibrium with the skin and electrolytes in the human body 13 3 Cleaning Silver silver chloride Ag AgCl ele
13. r vohaqevanations for 5 cycles for 5 cycles of the Enobio requires continued on Son i operation during power main i PPY 70 U 70 U interruptions it is recommended eee 30 dip in U 80 dip in U that the the Enobio image intensifier for 25 cycles for 25 cycles be powered from an uninterruptible IEC 610097411 power supply or a battery lt 5 U lt 5 U gt 95 dip in i gt 95 dip in U for 5 sec U for 5 sec If image distortion occurs it may be necessary to position the the Power frequency i Enobio image intensifier further 50 60 Hz i from sources of power frequency magnetic field i 3A m i 3A m magnetic fields or to install magnetic shielding The power frequency IEC 61000 4 8 magnetic field should be measured i in the intended installation location to ensure that it is sufficiently low Note U is the A C main s voltage prior to application of the test level eno BRAINWAVES MADE SIMPLE neuroelectrics The Enobio is suitable for use in the specified electromagnetic environment The customer and or the user of the Enobio should ensure that it is used in an electromagnetic environment as described below IEC 60601 1 2 Test Level Compliance Electromagetic Level Environment Guidance Immunity Test 3 Vrms i Portable and mobile RF communications 50 kHz to 3 Vrms equipment should be used no closer 80 MHz i to any part of the Enobio incl
14. rk that supplies A s ries pense ansae buildings used for domestic purposes Voltage fluctuations flicker emissions Complies IEC 61000 3 3 NE eno BRAINWAVES MADE SIMPLE neuroelectrics The Enobio is suitable for use in the specified electromagnetic environment The customer and or the user of the Enobio image intensifier should ensure that it is used in an electromagnetic environment as described below IEC 60601 1 2 Compliance Electromagetic Immunity Test Test Level Level Environment Guidance Electrostatic Floors should be wood concrete discharge ESD ony comer Sky cantan or ceramic tile If floors are covered with synthetic material the relative EC61000 42 SVa R humidity should be at least 30 2 kV for power Electrical fast supply lines 2 kV for power Main power quality should be transient burst supply lines that of a typical commercial IEC 61000 4 4 1 kV for input N A and or hospital environment output lines 1 kV differential 4 ky differentia i Surge i mode 7 Main power quality should be that of a typical commercial IEC 61000 4 5 2 kV common N A and or hospital environment mode i lt 5 U i lt 5 U gt 95 dip in U i gt 95 dipinU for 0 5 cycle i for 0 5 cycle Voltage Main power quality should be that dips shed 40 U 40 U of atypical commercial and or ne bio 60 dip in U 60 dip in U hospital environment If the use
15. uding i cables than the recommended separation distance calculated from the equation appropriate for the frequency of the transmitter Conducted RF IEC 61000 4 6 Recommended Separation Distance d 1 2VP d 1 2VP 80 MHz to 800 MHz d 2 3VP 800MHz to 2 5 GHz where P is the maximum output power rating of the transmitter in watts W according to the i H transmitter manufacturer and d is the Radiated RF i 3 V m i 3 V m i recommended separation distance IEC 61000 4 3 80 MHz to 80 MHz to in metres m 2 5 GHz 1 GHz Field strengths from fixed RF transmitters as determined by an electromagnetic site survey a should be less than the compliance level in each frequency range b Interference may occur in the vicinity of equipment marked with the following symbol a Field strengths from fixed transmitters such as base stations for radio cellular cordless telephones and land mobile radios amateur radio AM and FM radio broadcast and TV broadcast cannot be predicted theoretically with accuracy To assess the electromagnetic environment due to fixed RF transmitters an electromagnetic site survey should be considered If the measured field strength outside the shielded location in which the Enobio is used exceeds the applicable RF compliance level above the Enobio should be observed to verify normal operation If abnormal performance is observed additional measures may be necessary such as re orienting or reloc
16. zation is required only gas or liquid agents should be employed Disinfectants containing mercury phenols bromine iodine zinc tin and organo metallic compounds should be avoided The electrodes and cable insulation will not withstand steam sterilization 13 5 Darkening Silver chloride is light sensitive Exposure to light will darken the electrode surface This will not impair the electrode performance since the largest interstitial Ag AgCl matrix is not reached by light he eno BRAINWAVES MADE SIMPLE neuroelectrics 13 6 Storage The electrodes should be handled with care They must not be stored in contact with metals especially active metals such as iron or aluminium Also substances that could affect their electrochemical characteristics should be avoided Bare electrodes should be stored in a clean dry and dark container plastic or glass 13 7 Malfunction If an electrode is not operating as specified and you experience noise then please follow the directions below concerning noisy electrodes 13 8 Noisy electrodes A continuously noisy electrode generally means that it has reached its end of life You can extend the life a little bit by using a grain 600 or higher waterproof abrasive paper to polish the electrode tip Use very soft circular movements preferably no more than 2 3 times on the same area removing an even very thin layer across the entire surface 13 9 Life expectancy Ag AgCl sintered electrodes h
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