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        neonatal manual for standard newborn care
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1.           16     17     Do not touch the device while EEG monitoring is on  Always unplug the USB power  supply from the device prior connecting electrodes to the subject    The device will not work when charging the battery    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 freguency 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 wires or 12 wires 34  cm cables provided with the system  The use of other cables or electrodes than the  ones delivered with the product might produce higher EMC emissions and less EMC  immunity    The device cannot be beside used or piled under other eguipment  If such usage is  needed  check the normal configuration    The device can only be used in healthy skin without wounds     Conditions of use    Enobio must be used in normal temperature and pressure conditions  T range 10 45  C   humidity 20 9096  atmospheric pressure 700  1000 hPa      Technical Specifications    EEG functionality     Number of Channels  8 or 20 Channels  
2.   Associate Professor  Department of Psychology  United  States International University  Nairobi  Kenya     Michelle de Haan     Expert Advisor  Reader in Developmental Cognitive Neuroscience   Institute of Child Health  University College London  London  UK     Aureli Soria Frisch     Technical  amp  Signal Processing Expert  Neuroelectrics  STARLAB   Barcelona  Spain     David Ibanez     Technical  amp  Signal Processing Expert  Neuroelectrics  STARLAB  Barcelona   Spain     Javier Acedo     Technical  amp  Signal Processing Expert  Neuroelectrics  STARLAB  Barcelona   Spain     Guillem Mitja     Technical Expert  Neuroelectrics  STARLAB  Barcelona  Spain     Morten Kringelbach     Expert Advisor  Director of Hedonia  Trygfonden Research Group   Department of Psychiatry  Warneford Hospital  University of Oxford  Oxford  UK     Source    Kihara M  Hogan AM  Newton CR  Garrashi HH  Neville BR  de Haan M  Auditory and visual  novelty processing in normally developing Kenyan children  Clinical Neurophysiology  2010   121  564 576     Further information  Dr  Michelle Fernandes  E michelle fernandes obs gyn ox ac uk  T    44 0 1865222936       2012 INTERGROWTH 21  Project  The Nuffield Department of Obstetrics  amp  5Gynaecology  The John Radcliffe Hospital  Oxford OX3 9DU  United Kingdom    www intergrowth 21st org uk    Introduction    An estimate of the prevalence for auditory processing disorders  APD  in childhood is 7     Hearing impairment s  arising from pathology of th
3.  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     28      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     Product Description  See Figure 19 to 21 below for product description     1  USB connector for charging battery  Must not be on when EEG recording is in progress     EE        a bc 2  Power ON switch            O indicates OFF position and allows for charging of the  battery  I indicated ON position  no charging possible         Figure 19  NECBOX USB connector and power switch     4  12 EEG connector and reference signals        5  8 EEG connector and reference signals     3  MicroSD card socket       Figure 20  NECBOX EEG connector  reference signals and MicroSD card socket     29    8  Technical specifications  label    6  LED indicates normal  operation f          T    NE                   7  Velcro to attach device  to cap       Figure 21  LED light  label and velcro support     30    References    Bamiou D E  Musiek FE  Luxon LM  Aetiology and clinical presentations of auditory  processing disorders   a review  Ar
4.  eliciting co operation from children in sitting still and not becoming  irritable during the recording      Specialist training required for setting up the electrodes and recording EEG signals      Difficulties in preparation of the child s scalp using gel      Difficulties in the placement of electrodes     In order to meet these challenges  we propose a novel  wireless  portable method of  recording EEG signals  the methodology for which is described below     The acquisition occurs over the first 2 years of life  predominantly between 18 and 24  months  Their analysis of electrophysiological brain activity in relationship to auditory  processing allows        To build a profile of auditory processing thresholds  including amplitudes and  latencies of responses  according to age    ll  To assess group and individual variability    lll  To assess the nature and pace of neurocognitive development in children     Testing procedure    Apparatus    EEG signals will be measured using a portable  wireless EEG recording system called the  Enobio  Figure 1      The Enobio is an 8 channel EEG system  with a bandwidth range of 0 to  125 Hz and a sampling range of 500 SPS  EEG signals are measured using  dry   gel free   electrodes and the signals are transmitted wirelessly to a processor     All EEG data is stored on the Enobio software  and a preliminary analysis is performed  instantly  In addition  the Enobio allows for signals to be uploaded to a cloud providing real  time access
5.  of data     The Enobio is being customized for use in the follow up of the INTERGROWTH 21  Project  by incorporating wireless headphones in to the neoprene cap  and the auditory novelty  program into its software to automate the presentation and recording of the same     Methods    Each child will be seated either on a chair or on his her mother s lap  in a partially lit  guiet  room  facing a computer monitor approximately 50 cm away     The Enobio cap containing 8  electrodes will be placed over the child s head and a reference electrode will be clipped to  the mastoid region of the Enobio cap  The Enobio was customized for the purpose of this  study to  a  fit the cranial dimensions of a two year old child and  b  integrate wireless  headphones into the cap     The Enobio cap will contain dry EEG placed at sites Fz  Cz  Pz  T3  T4  T5 and T6 according to  the international 10 20 system of electrode placement  Figure 2    Eye movements and  blinks will be monitored by the Fp2 electrooculogram electrode also integrated into the  Enobio cap     The child will be asked to watch a series of cartoon video clips on the computer screen  The  cartoons will have their audio clips removed and instead of the cartoon s audio  the  experimental auditory stimuli will be presented to the child via the wireless earphones  The  presentation of these stimuli  and the recording  digitization and processing of the EEG data  will be carried out automatically with the Enobio software  If the ch
6.  of the stimuli presentation is 11 minutes     Experimental Protocol    Assessment Kit    The assessment kit consists of    1  The Enobio     i e  the Neuroelectrics Control Box  NECBOX   10 wire cables with back   ends  electrode font ends  battery charger  NE headband  NE cap  USB connector    2  Alaptop containing the Enobio software    3  A computer  laptop or desktop   a television or a portable DVD player on which the  silent cartoons can be viewed  A colouring book and crayons in case the child doesn t  want to watch the cartoons    4  A comfortable chair for the mother and child     Set Up and Method of Assessment    1  Pre experiment tasks    a  Ensure battery of NECBOX is charged   b  Install front ends and back ends into cap according to pre defined format in the  table below  Figure 3      Back end number Position       Fp2  Fz  Cz  Pz  T4  T6  T3  T5    0 Y  dll BWN        c  Attach stick on electrodes to DRL and CMS cables  Figure 4     d  Ensure headphones and antenna are fixed on channel 1    e  Ensure the antenna transmitter is connected to the computer through the  headphone jack    f  Ensure computer volume is set on level 1 or 30    g  Ensure the computer is connected to the internet either via a broadband cable or  Wifi     2  Experiment    a  Cap    Place the cap on the child s head    Attach the 2 reference electrodes to the child s mastoid by peeling off  the back sticker  Both electrodes should be on the same mastoid  so  both on right or both on the 
7. 3     11 279 KB    20130710085327_ERP 04 33     10 B             201307 10085327 _ERP 04 3363 23 24 2011072  Type  Compressed  zipped  Folder   Date Modified  10 07 2013 04 34   Size  10 1 MB    20130709073908_ERP 04 33     JS KB       WWENWW    20130717080228_ERP 04 33     12 292 KB          Figure 17 e   Create a folder called    EEG extracted files   dd mm yy  add the date      Paste the zipped  files into this folder  Please paste ONLY the  zip files and not the  info files     NIC 1 2 mE    ERP PROTOCOL    FGLS Number   00   0000   Research code 1   28   Research code 2   28   Date of birth  DD MM YYYY   18 06 2012    Date of visit  DD MM YYYY   18 06 2014   mi  The child was part of the preterm follow up study     Baseline EEG recording time before experiment is presented   in seconds     120    Electrical ground position   remember to place CMS on the upper and the DRL on the lower stick electrode     ul Left mastoid    Start Experiment    Right mastoid    Annotations    Clear Form Upload to ftp    Portable wireless  brain monitoring    system 11 37 25    Bluetooth     Battery    88     Signal Monitoring   gt      ON         00 00 00  00 00 00  C UsersiIntergrowth21    stDocuments NIC 2014  0618113635_ERP 00 0    START    TCP Server  10 28 251 55 1234       Figure 18  Close the software     24    Maintenance    Silver Silver Chloride  Ag AgCl  electrode instructions    Precautions for handling electrodes   Electrodes should not come into direct contact with metals as t
8. INTERGROWTH 21   International Fetal and Newborn Growth  Standards for the 21 Century    The International Fetal and Newborn Growth Consortium    CORTICAL AUDITORY ERP MANUAL      June 2014    December 2013     aa  UNIVERSITY OF      OXFORD       Please read this manual carefully and refer to it throughout the study    if any clarification is needed       This Operations Manual was produced by the INTERGROWTH 21  Infant Development  Group  based on the 1  Meeting of the Group  Oxford  March 2012  This document reflects  the consensus reached by members of the group regarding the selection of tests to be  included in the INTERGROWTH 21  Neurodevelopment Package to be implemented by all  centers taking part in the INTERGROWTH 21  follow up study     INTERGROWTH 21  is a large project involving health institutions from eight geographically  diverse countries  It is therefore essential that all participating institutions follow a  standardized neurodevelopment protocol        Table of Contents    A DN DD DF DIO rii 4  SOU SE HR NON FR Y RI O EN A AG NG ia 5  IntrodUctiOn send Yd yy ded Fad ynde Yd ged des ddd da 6  TestingiprocedurT6 amp u  ul WR Lu ydeu TYGWYN A EE 7  APparatUS ee Rd Yd dd A Y Yd ir ld ddf 7  Methods    eu eu dn GYT td NYFODOL Y NR E A ATO Fw 7  Auditory Novelty P  rdi Moesiei Sd DDd deka Aa a a e AA AR USB 9  Experimental Protocol acta ceria di A Y Cd A Md AO 10  ASSESSMENT rica do A A ta ead stan Rd A I DAU 10  Set Up and Method of ASSCSSMENL         cc cccccc
9. Number   00   0000    Research code 1   28   Research code 2   28   Date of birth  DD MM YYYY     18 06 2012 18 06 2014    ol The child was part of the preterm follow up study     Baseline EEG recording time before experiment is presented     in seconds     120    Electrical ground position     remember to place CMS on the upper and the DRL on the lower stick electrode     Annotations    Clear Form Upload to ftp    EEG SETUP    Reference Channel      None    Time Domain     2  o  7 7  a a    ie   zs   gt     Voltage  uV                             Visualization Filters O    oo ooo TERR    ml    Date of visit  DD MMIYYYY        Figure 10  Click start experiment     NIC 1 2    Temporal Window 5 Seconds                                                            Time  Seconds     3 0Hz    9100110     Portable wireless  brain monitoring  system    Bluetooth    Battery    Signal Monitoring    ON        00 00 00    Record    00 00 00    Patient01    START    TCP Server  10 28 251 55 1234    ss  g   11 29 00  Bluetooth       Battery  93   Signal Monitoring   gt     ON     gt    00 00 34    Record    00 09 25    C JUsersiIntergrowth21  st Documents NIC 2014  0618112826_ERP 00 0       STOP    TCP Server  10 28 251 55 1234        DELTA THETA ALPHA    BETA GAMMA   DEFAULT       Figure 11  Go to EEG tab  Make sure all eight channels  blue circles  are recording     18    3 Portable wireless  ERP PROTOCOL eno 10 brain monitoring  system    FGLS Number Bluetooth  a    00   0000  Research co
10. as elapsed is remaining for the experiment        FGLS Number   00   0000   Research code 1   28   Research code 2   28   Date of birth  DD MM YYYY   18 06 2012    Ll The child was part of the preterm follow up study     NIC 1 2    ERP PROTOCOL    Date of visit  DD MM YYYY  Post EEG notes  18 06 2014  Please include some post EEG notes        Baseline EEG recording time before experiment is presented     in seconds     120    Electrical ground position   remember to place    E    Start Experiment    eft mastoid    Annotations    Clear Form    FGLS Number   00   0000  Research code 1   28   Research code 2   28   Date of birth  DD MM YYYY   18 06 2012    E The child was part of the preterm follow up study     S on the upper and the DRL on the lower stick electrode     Right mastoid    Upload to ftp    Figure 14 a   Text box for post EEG notes     NIC 1 2    ERP PROTOCOL    Date of visit  DD MM   18 06 2014    Post EEG notes    Please include some post EEG notes        The child was crying and pulled off the cap at 00 20     Baseline EEG recording time before experiment is presented     in seconds     120    Electrical ground position   remember to plac    Ll Left mastoid    Start Experiment    Annotations    Clear Form    CMS on the upper and the DRL on the lower stick electrode     Right mastoid    Upload to ftp    BEE    Portable wireless  brain monitoring  ystem    2700 010     Bluetooth    Battery  91   Signal Monitoring     ON      00 01 48    00 08 11  C  UsersiIntergrow
11. cal 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     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    Use environment    The Enobio system has been designed for the use in a clinical environment  hospital or  research centre     Safety Warnings   1  The results of the measurements must be analysed by a doctor or specialist    2  No self medication should be done based on these results    3  The device must never be opened or damaged    4  The battery can only be replaced by authorized personnel    5  Before using  please check that the device is undamaged and the packaging has not  been affected by the transport or storage    6  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  The use of the device could  result  in these cases  unsafe    7  Inthe case of malfunction  immediately contact the manufacturer or the distributor    8  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 it and immediately contact the  manufacturer     27    9     10  11               12     13           14     15 
12. cesssssssssecececessessaeeeeececessesesaesesecesesseaeaeeeeeesseeseaeaeeeeeens 10  Maintenance nenn oridi aE oaa dA E aA a E e O i a o iA LOT OG adwy do 25  Safety and Regulatory InformatioN           cccccconoooononnnnnnnnononononnnnnnnnononanononnnnnnnnnnnnnnonnnnnnnnnnnnnnnnns 27  Use environment Iys nidad dede 27  Safety  Warnings siscveticke ts tt A A efyn YG e 27  Conditions ofUse AAA A AA NG Y adie 28  Technical SpecificationSs  aaa 28  Product Description ne i Bn gd AN GY Y NY WN 29  Rd ee ee ee e e e e YN 31    Credits    This manual was prepared by members of the INTERGROWTH 21  Infant Development  Group and reflects the general consensus reached during the Infant Development Group  Meeting  Oxford  23 March 2012 regarding the selection of tests to be included in the  INTERGROWTH 21  Neurodevelopment Package     The following people made important contributions to this final version  for which we thank  them     Michelle Fernandes     Group Coordinator  Nuffield Department of Obstetrics and  Gynaecology  the John Radcliffe Hospital  University of Oxford  Oxford  UK     Alan Stein     Senior Advisor  Section of Child and Adolescent Psychiatry  Department of  Psychiatry  Warneford Hospital  University of Oxford  Oxford  UK     Charles Newton     Senior Advisor  Department of Psychiatry  Warneford Hospital  University  of Oxford  Oxford  UK and Senior Clinical Research Fellow  KEMRI Wellcome Trust Research  Programme  Kilifi  Kenya     Michael Kihara     Expert Advisor
13. chives of Disease in Childhood  2001  85 5   361 5     Kihara M  Hogan AM  Newton CR  Garrashi HH  Neville BR  de Haan M  Auditory and  visual novelty processing in normally developing Kenyan children  Clinical  Neurophysiology  2010  121 4   564 76     Neuroelectrics  Enobio  Available at  http   www neuroelectrics com enobio   Accessibility verified June 18  2014     Attias J  Urbach D  Gold S  Shemesh Z  Auditory event related potentials in chronic  tinnitus patients with noise induced hearing loss  Hearing Research  1993  71 1 2    106 13     Haenschel C  Baldeweg T  Croft RJ  Whittington M  Gruzelier J  Gamma and beta  frequency oscillations in response to novel auditory stimuli  A comparison of human  electroencephalogram  EEG  data with in vitro models  Proceedings of the National  Academy of Sciences  2000  97 13   7645 50     31    
14. de 1    28 87     Research code 2  28 Signal Monitoring          Date of birth  DD MM YYYY  Date of visit  DD MM YYYY   18 06 2012 18 06 2014    11 32 57    Battery    ON       Record                   Baseline EEG recording time before experiment is presented 00 00 13   in seconds    00 09 46  C Users lntergrowth21    Electrical ground position  st Documents NIC 2014  iber to place CMS on the upi  d the DRL on the lower stick electrode    remember to place CMS on the upper and the DRL on the lower stick electrode 0618113244 ERP 00 0    v    120                            TOP  Stop Experiment Recording EEG baseline     AI      TCP Server  Annotations  10 28 251 55 1234    Figure 12  Click    STOP experiment    to terminate experiment prematurely     u Portable wireless  ERP PROTOCOL QT 10  110  brain monitorin   yin 11 32 57    FGLS Number Bluetooth  a  00   0000  Research code 1    28 87     Research code 2  28 Signal Monitoring Gap    Battery    Date of birth  DD MM YYYY  Date of visit  DD MM YYYY  Elapsed and remaining time  18 06 2012 18 06 2014    ON       Record                Baseline EEG recording time before experiment is presented 00 00 13   in seconds    120 00 09 46  Electrical ground position C Users Intergrowth21   remember to place CMS on the upper and the DRL on the lower stick electrode  AR    WA                            TOP  Stop Experiment Recording EEG baseline     SIO      TCP Server  Annotations  10 28 251 55 1234    Figure 13  Checking how much time h
15. ditory processing between individuals      Be easy to administer without specialist training      Be internationally valid      Be rapid to administer   lt 15 minutes      Of the tests of auditory processing considered  the measurement of ERPs to auditory stimuli  was found to meet the criteria mentioned above  Measurement of ERPs to an auditory  novelty paradigm was found to have a high degree of sensitivity in detecting subtle  differences in auditory processing in children  Audiometry was not found to be suitable for  children less than 4 years of age  The measurement of acoustic reflex thresholds and  otoacoustic emissions assessed solely middle ear function  and not the entire auditory  pathway  In addition  these tests required a probe to be placed in the child   s ear for up to 3  minutes  This was found to pose considerable difficulties in compliance in the field     The measurement of ERPs to auditory stimuli was selected to measure auditory processing  in 2 year olds in the follow up study of the INTERGROWTH 21  Project  This was selected  because ERPs response to deviance and or novelty reflects the child   s ability to detect and  assimilate novel events  and this has been found to be fundamental to cognitive  development     Technical issues related to the measurement of electroencephalography   EEG  in the field included       Difficulties in obtaining consent from parents because of the presentation of the EEG  and the child with electrodes      Difficulties in
16. e brain may have detrimental  conseguences on a child s life if untreated  however  diagnostic and management strategies  for these    central    hearing impairments in childhood are rarely implemented  These  auditory deficits have been collectively termed    auditory processing disorders     in order to  incorporate in the term the interaction between peripheral and central pathways    Disturbances in auditory processing are an important indicator of disturbances in sensory  neurodevelopment in children and measurement of a child   s ability to detect and assimilate  novel auditory stimuli may be used to examine subtle differences in auditory processing     In  addition  higher prevalence of auditory processing disorders are reported in preterm babies   children with a family history of deafness  intra uterine infections and epilepsy        A number of tests to assess auditory function in children were considered  These included  the use of audiometry  acoustic reflex thresholds  otoacoustic emissions  communication  inventories and the measurement of evoked response potentials  ERPs  to auditory stimuli   It was decided that for use in the follow up study of the INTERGROWTH 21st Project  the  test of auditory assessment should       Be suitable for use on children at 24 months of age      Assess the entire auditory pathway and not just elements of the same      Yield information about an auditory threshold  amplitude and latency of responses     Assess subtle changes in au
17. e metals as iron or aluminium  Also  substances that could affect the  electrochemical characteristics should be avoided  Bare electrodes should be stored in a  clean  dry and dark container  plastic or glass      Malfunction  If an electrode is not operating as specified and a noisy signal is experienced  please follow  the directions below concerning noisy electrodes     Noisy electrodes    A continuously noisy electrode generally means that it has reached its end of life  The life of  the electrode can be extended a little by using a grain 600 or higher waterproof abrasive    25    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     Life expectancy   Ag AgCl sintered electrodes have 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 AgCl 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     Neoprene Cap and NECBOX cleaning and disinfecting instructions    After each use t
18. er towel dipped in distilled water    ii  Drying immediately with a soft paper towel   2  Wipe cap and cover clean using disinfectant wipe   3  The electrodes are very delicate     they corrode in contact with metal  air  water   light and solvents  They are also very expensive  Ensure that they are stored in  their own envelope and placed in the black box     Charging eguipment   1  Charge the NECBOX via the MicroUSB connector located at the rear part of the  NECBOX when the battery falls below 5096  You can check the battery strength  on the software    2  Charge the headphones via the transmitter once in 4 assessments     Supplies  Please inform Michelle Fernandes if the stock of disposable electrodes is running  low  Please give her 6 weeks to pace the order and courier them to you     Test Duration Details    Set up  1 3 minutes    Test duration  10 minutes   Termination   lt 1 minute    Total duration  12 14 minutes     Enobio EEG placemen ts       Disposable electrodes  attached to DRL and CMS       Figure 4  Stick on electrodes to DRL and CMS cables     On off switch       Figure 5  NECBOX on  yellow light comes on when you put it on      15    a  Mozila Firefox       elm  oe  lmHRaew ns Ra       wa       Figure 6  Launching NIC software on desktop     Trying to connect with device NE ENOBIOS  00 07 80 58 9C 28                Pa to al 0 e 3 18 06 2014    Figure 7  NIC software opening after double clicking icon     16    NIC 1 2    FGLS Number    Research code 1    Re
19. he Neoprene Cap and NECBOX should be cleaned and disinfected  The  surfaces of the neoprene cap and NECBOX may be wiped clean using a disinfectant wipe   and left to air dry     Battery operating safety instructions    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 met       5VDC 4 25    7 V      1 A current output      Power input  5W      Battery charger complies according to standard IEC EN 60601 1     It has to be connected to the microUSB connector located at the rear part of the NECBOX   Fig  11   Charging with a higher voltage than specified may cause damage to the cell  The  usual time to charge a battery from the cut off voltage to the maximum capacity is around 2  hours  The expected life cycle is  gt  500 cycles with  gt  70   of initial capacity     The battery state of charge is measured by the software while the device is powered ON  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  Over   discharging may cause loss of cell performance  or damage battery function     26    Safety and Regulatory 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     Directive 93 42 CEE for medi
20. his 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     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 eguilibrium with the skin and electrolyte in the human body     Cleaning   Silver silver chloride  Ag AgCl  electrodes  if wet  will corrode  This corrosion process will  in  the long run  make the electrodes noisier  It is important to clean and dry the electrodes  immediately after use  Wipe the electrodes clean with distilled water and dry the  electrodes will a soft paper towel  Never use solvents  e g  acetone   acids or alkaline  or  soap water to clean the electrodes     Sterilization  When sterilization is reguired  only gas or liguid 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     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     Storage   Electrodes should be handled with care  They must not be stored in contact with metals   especially such activ
21. ild prefers not to watch  the video  a colouring book and crayons will be provided  Care will be taken to ensure noise  levels are kept to a minimum in the room and the child mother will be encouraged to not  speak loudly  Electrical sources of sounds  like ceiling fans  will be switched off     The Enobio s electrodes take 2 minutes to calibrate when placed on the child s head  during  which a baseline EEG is recorded for 2 minutes before the auditory novelty paradigm is  presented  The EEG data will be recorded at a sampling rate of 500 Hz with a system band  pass between O and 100 Hz        Figure 1  The Enobio wireless EEG monitoring system  Lt  posterior view  Rt  lateral view         Figure 2  Schematic representation of electrode placement on the Enobio for the assessment of    auditory processing     Auditory Novelty Paradigm    The auditory paradigm is composed of 3 types of sounds presented through the wireless  headphones attached to the Enobio  1096 of these sounds are infreguent tones  2kHz  200  ms long  5 ms rise and fall time and 70 dB SPL   1096 are novel noises such as a dog bark  bell  ring  drum roll etc   while the remaining 8096 are freguent sinusoidal tones  1 5 kHz  200 ms  long  5 ms rise and fall time  70 dB SPL     Two blocks of 700 stimuli each were presented   560 freguent  70 infreguent and 70 novels   There were 14 different novel stimuli  and  these were repeated no more than 5 times each during the course of the experiment  The  total duration
22. lder    EEG DATA NAGPR  by double clicking     22        2  EEG DATA   NAGPUR    4 C  Documents and SettingsimcfernandeziMy Documents Dropbox EEG DATA   NAGPUR             dropbox  DROPBOX File  1 KB       9 Make a new Folder     3  Publish this Folder to the  Web EEG software  E Share this Folder             Figure 17 c   Access folder called    EEG data           m EEG DATA       ADN          Make a new folder    Publish this folder to the  Web       Fager EEG EXTRACTED FILES 5 144ug13  Files             EZ Share this Folder          Figure 17 d   Access folder called    zipped files    by double clicking     23    G   Zipped files          File Edit View Favorites Tools Help       S    El          peck M    z Y   O Search Folders   EEE    l Folder Sync             Address    C  Documents and Settings mcfernandez My Documents Dropbox EEG DATA   NAGPURAEEG DATAZipped files             File and Folder Tasks 2  a B       Make a new Folder    A Publish this Folder to the  web    EZ Share this Folder    7 KB              EEFEE    Other Places 11 851 KB    Details    9 311 KB    9 937 KB    a    2 KB             12 264 KB       EEG EXTRACTED FILE   5 144uq13       20130713080536_ERP 04 33       20130713114012_ERP 04 33       20130724110520_ERP 04 33       20130710131608_ERP 04 33       20130709082954_ERP 04 33       20130720121953_ERP 04 33       20130710092831_ERP 04 33       20130713100258_ERP 04 33     7 KB       20130724111953_ERP 04 33     8 761 KB    20130710115311_ERP 04 3
23. left mastoid  and they should ideally be  as close together as possible  Please paste the electrodes on the  mastoid  and not on the angle of the jaw or the neck    Put the headphones on  you will see a red light come on     Double check that the transmitter is connected to the computer via  the headphone jack of the computer  you will see a green light on the  transmitter base     One and a half minute into the recording  after you perform the steps  below   please recheck that the green light is still on on the  transmitter base  If it goes off  please disconnect the transmitter cable  from the headphone jack and reconnect it  the green light will come  on  You must check this at 1 5 minutes into the recording before the  sounds are presented  as if the green light is not on  the sounds will  not be presented to the child     b  Software    vi   vii     viii     Put the NECBOX on  Figure 5     Go to the desktop of the computer and launch the NIC software by  double clicking on the icon  Figure 6    Note  Do not open the NIC  software before putting the NECBOX on  as the Bluetooth of the  software will search for the NECBOX and if it does not find it the  software will hang     you will then have to shut down and restart the  computer     The NIC software will open  Figure 7     Go to the ERP protocol tab  Figure 8     Enter all the data of the child  Figure 9   Please mention where you  have placed the electrodes i e  on the right or left mastoid    Click    Start Experimen
24. nd the room was  noisy     If the assessment was uneventful  please write    NONE    or     UNEVENTFUL    in the box  Once you type something in  click    OK      Figure 15     Once you click    OK    in the text box  an output file will be  automatically generated and a pop up box will appear to tell you  about this  Figure 16     The zipped files will be saved in a specific folder location within the  NIC program    Copy the files from this folder    Go to the dropbox folder called EEG Data     Nagpur  Inside this open  the folder called    EEG data     gt     Zipped files     Create a folder called     EEG extracted files   dd mm yy  add the date      Paste the zipped files  into this folder  Please paste ONLY the    zip    files and not the    info     files  Figure 17 a to e     Close the software  Figure 18     Put the NECBOX off     3  Post experiment tasks    Dano    Take off the reference electrodes from the child s skin with care   Turn the NECBOX off and remove it from the cap    Take the cap off the child s head    Turn the headphones off on the cap  Red light must go off      Disconnect the cables carefully  Disentangle any tangled cables and stored    the cables carefully in the black box     f  Remove the front and back ends of the electrodes and store them in the  black box   g  Place the cap in the black box     Other points to note    Cleaning of electrodes and cap  1  Clean and dry the electrodes immediately after assessment by    i  Wiping with a clean pap
25. s     120    Electrical ground position     remember to plac    LU  eft mastoid Right mastoid    S on the upper and the DRL on the lower stick electrode     Start Experiment    Annotations    Clear Form Upload to ftp    218 0 0  8    Figure 16  Output file generation notification     Portable wireless  brain monitoring  system    Bluetooth      gt   00 00 31  00 09 28  C  Users Intergrowth21    stDocuments NIC 2014  0618113532_ERP 00 0    START    TCP Server  10 28 251 55 1234       Portable wireless  brain monitoring    Bit 11 36 47  Bluetooth _    Battery  89   Signal Monitoring   gt   ON       00 00 00  00 00 00  CUsers ntergrowth21    stDocuments NIC 2014  0618113635_ERP 00 0    START    TCP Server  10 28 251 55 1234       21       a HO  18 CIOSG the sartware  Page 140115   Words 1318   gS Eng o   Bes    Asl   Gil Fs   Wl Feds Cty  i rato for caring LJ Dpto    Figure 17 a   Launch dropbox by double clicking dropbox icon           mr o  U 0040198 00                               O  Help   A  rch  a Folders   i Folder Sync   mcfernandez My Documents Dropbox had G    8  Familia Fernandes o82 FHR FM data  pei FM outputs ei FoetoH  A d INTERGROWTH    sei Interbio placement   Fangfang Li ei Neurodevelopment  ei FHR full data ei EEG DATA   NAGPUR  cei Intergrowth  1  ei Intergrowth apps  pI ICR sei NeuroAPP   all sites NEW  cei Neurodevelopment   UK  amp  Photos  po Public ei Raw Data MR    e Sleep software ei Systematic literature  review_Xiao    Figure 17 b   Access dropbox fo
26. search code 2    Date of birth  DD MM YYYY  Date of visit  DD MM YYYY     18 06 2014    E The child was part of the preterm follow up study     Baseline EEG recording time before experiment is presented   in seconds     120    Electrical ground position     remember to place CMS on the upper and the DRL on the lower stick electrode      __  Left mastoid  __   Right mastoid    Annotations    Clear Form Upload to ftp    3 Portable wireless  enobjo Saas   sinis 11 25 10    Bluetooth    This yellow bar tells you Gn   7    Bluetooth is connected 90     This tells you how much A eTrrh   gt     of the battery is left  ON  Record   co   00 00 00    00 00 00    Patient01    START    TCP Server  10 28 251 55 1234       Figure 8  Go to ERP protocol tab     NIC 1 2    FGLS Number   00    0000    Research code 1   28   Research code 2   28   Date of birth  DD MM YYYY   18 06 2012    Date of visit  DD MM YYYY   18 06 2014  ol The child was part of the preterm follow up study     Baseline EEG recording time before experiment is presented   in seconds     120    Electrical ground position   remember to place CMS on the upper and the DRL on the lower    ol Left mastoid    Start Experiment    Right mastoid    Annotations    Clear Form Upload to ftp    BEE    11 27 29  Bluetooth    Battery    Signal Monitoring  ON      00 00 00  00 00 00    Patient01    START    TCP Server  10 28 251 55 1234       Figure 9  Entering the data of the child in the ERP tab     17    NIC 1 2    ERP PROTOCOL    FGLS 
27. t     Figure 10     Go to the EEG tab  Figure 11     Make sure all 8 channels are recording  If one or two channels are not  recording press them so that they make contact with the child s scalp   Then recheck whether all 8 channels are recording  If the signals do  not look correct  please check the reference electrodes to make sure  they have not fallen off or are stuck to the child s hair rather than the  child s skin     it is important that these electrodes are in the right    Xi     xii     xiii     xiv   XV     xvi     xvii     position on the child s mastoid and are in contact completely with the  skin    If you need to terminate the experiment prematurely  click    STOP  EXPERIMENT    under the mastoid data entry tab  Do not stop  recording on the grey right hand column  as this column is not related  to the ERP experiment  Figure 11     If you do not terminate the experiment  it will run for 10 minutes  you  can see how much time has elapsed and how much time is remaining  on the software  Figure 13     Once the experiment is over  because 10 minutes are up or because  you clicked    STOP EXPERIMENT     you will be presented with a text  box  Figure 14 a and b  and asked to add    POST EEG NOTES     You will  have to type something in this text box otherwise the software will  not allow you to proceed with the upload  Please include all  comments such as    the child was eating during the assessment        the  child was crying        the mother was talking loudly a
28. th21    stDocuments NIC 2014  0618112826_ERP 00 0    START    TCP Server  10 28 251 55 1234        O    Portable wireless  brain monitoring  system    2100     11 36 03  Bluetooth      Battery    88     Signal Monitoring    ON       gt   00 00 31    Record    00 09 28    C  UsersiIintergrowth21  stDocuments NIC 2014  0618113532_ERP 00 0    START    TCP Server  10 28 251 55 1234       Figure 14 b   Entering text into the text box  the ok button appears      20    NIC 1 2    ERP PROTOCOL    FGLS Number  00   0000  Research code 1  28   Research code 2  28    Date of birth  DD MM YYYY  Date of visit  DD MM YYYY  Post EEG notes    18 06 2012 18 06 2014  Please include some post EEG notes        El The child was part of the preterm follow up study   The child was crying and pulled off the cap at 00 20     Baseline EEG recording time before experiment is presented   in seconds        m    Electrical ground position   remember to place CMS on the upper and the DRL on the lower stick electrode     El Left mastoid Right mastoid  Start Experiment    Annotations    Clear Form Upload to ftp    9100110     Figure 15  Click ok once you enter text into text box     NIC 1 2    ERP PROTOCOL    FGLS Number   00   0000   Research code 1   28   Research code 2   28   Date of birth  DD MM YYYY  Date of visit  DD MM YYYY     18 06 2012 18 06 2014 Output file generation    Ll The child was part of the preterm follow up study     Baseline EEG recording time before experiment is presented   in second
    
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