BIOPAC Systems B-ALERT X10 User manual

UserManual



42AeroCamino
Goleta,CA93117
805685‐0066
http://www.biopac.com/
Distributed by BIOPAC Systems, Inc. Manufactured by Advanced Brain Monitoring, Inc.

TableofContents
Chapter1:IntroductionandSafetyInformation...................................3
A. AbouttheB‐ALERTX10....................................................................................................... 3
B. IntendedUse....................................................................................................................... 3
C. Safety .................................................................................................................................. 4
D. MinimumSystemRequirements ....................................................................................... 6
E.ItemsRequiredforUse ........................................................................................................ 7
Chapter2:SensorHeadsetUse...............................................................8
A. Charging .............................................................................................................................. 8
B. Preparation ......................................................................................................................... 9
C. Application ........................................................................................................................ 11
D. AdditionalECGPlacements............................................................................................... 14
E. ReadytoCollect ................................................................................................................ 14
F. Post‐sessionClean‐up ....................................................................................................... 15
A. CommonHeadsetandSensorIssues................................................................................ 17
Chapter4:Specifications.......................................................................19
A. B‐AlertX10 ........................................................................................................................ 19
B. EnvironmentalConditions ................................................................................................ 20
Chapter5:Compliance ..........................................................................21
A. FCC .................................................................................................................................... 21
B. GeneralCompliance.......................................................................................................... 23
C. SoftwareLicenseAgreement............................................................................................ 24
D. ProductLimitedWarranty ................................................................................................ 24
E. ReturnsandService .......................................................................................................... 25
F. TrademarkAcknowledgements........................................................................................ 25
BIOPAC Systems, Inc.B-Alert X10 User Manual| 2

Chapter1:IntroductionandSafetyInformation

A.AbouttheB‐ALERTX10

TheB‐ALERTX10isaninternallybatterypoweredFDA‐classifiedTypeBFdeviceintended
forcontinuoususe(7‐9hours).TheB‐ALERTX10providesanintegratedapproachforwireless
acquisitionandrecordingofelectroencephalographic(EEG),electrooculographic(EOG)and
electrocardiographic(ECG)signals.ThesystemutilizesthepatentedB‐AlertSensorHeadset
andEEGsensors,whichrecordhighqualityEEGthatcanbeobtainedinfive‐minutesofset‐up
timewithnoscalppreparation.Thewirelesstechnologyallowstheusertobeuntetheredand
movearoundtheclinic(orinthefield)whilerealtimedataiscollected,displayed,and
analyzed.

TheB‐ALERTX10acquiresninechannelsofmonopolarEEGrecordingswithalinked
mastoidreference.The10thchannelisaprogrammablegainoptionthatcanbeusedforEOG
orECG.TheB‐ALERTX10consistsof:HeadandHostUnitsforbi‐directionaltransmissionof
digitizedphysiologicalsignals,aNeopreneStrap,andaSensorStripwithEEGsensorsitesinthe
frontal(Fz,F3andF4),central(Cz,C3andC4)andparietal‐occipital(POz,P3,andP4)regions.

TheSensorHeadsetcollectsphysiologicalsignalsfromthesensorsplacedontheuser
samplingat256Hz.Theheadsetperformsanalog‐to‐digitalconversion,encoding,formatting
andtransmittingofallsignals.Thesignalscommunicateusinga2.4to2.48GHzradio
transmitter.B‐AlertAcquisitionutilizesthebi‐directionalcapabilitiesofthesystemtoinitiate
scalp‐electrodeimpedancemonitoring,andmonitorsthebatterycapacityintheHeadUnit.A
customUSBHostDevice(B‐AlertDongleorESU‐MC)isusedasthebaseunitaffixedtothePC
workstation.

B‐AlertAcquisitionsoftwareconsistsofseveralmodulesthatallowtheusertoacquire,
store,view,andanalyzephysiologicalsignalsacquiredbythewirelesssystem.Thesoftware
providesasimplegraphicalinterfaceforestablishingandcontrollingdataacquisition.Patented
algorithmscanbeselectedtomonitorartifactsthatimpactsignalqualityinrealtime,and
provideusersfeedbackwhenthresholds(forartifact)areexceeded.EEGPowerSpectral
Densities,EEGclassifications,andHeartratemeasurescanbegeneratedinreal‐timeoroff‐line.


B.IntendedUse

TheB‐AlertX10systemisintendedforuseinclinicalandresearchsettings,bytrained
technicians,tomeasureandrecordtheelectricalactivityoriginatingfromthebrain(EEG),the
BIOPAC Systems, Inc.B-Alert X10 User Manual| 3

heart(ECG),andtheeyemuscles(EOG),andstorethedatainanebsoredfformat.Thesystem
isintendedfordatacollectiononly,andisnotintendedfortreatmentand/oranytypeof
monitoringofpatientsinamedicalenvironmentsuchassurgery,intensivecareunit,etc.Any
medicaldiagnosisrelatedtotheEEGshouldonlybederivedbyacertifiedPhysicianusing
medicallyapprovedsoftware.TheECGandEOGarenotintendedtobeusedforanytypeof
diagnosisortreatment.

CAUTION!Readthismanualcarefullybeforeusingthe
B‐ALERTX10.
C.Safety

TheB‐ALERTX10isdesignedtobeappliedbyatrainedtechnician.Thereareanumberof
warningsandcautionsthroughoutthismanual.Readthemcarefully:theyareimportantto
theuseoftheproduct.Theinformationinthismanualhasbeencarefullycheckedandis
believedtobeaccurate.


CONTRAINDICATIONS
DonotusetheB‐ALERTX10inanMRIenvironment.
DonotusetheB‐ALERTX10whenalarmsbasedonEEGclassificationarerequired.
B‐ALERTX10hasnoalarmsclassifications(suchasdrowsiness).Thereareonlyalarms
forindicationsofexcessiveartifact.
DonotusetheB‐ALERTX10asasubstituteforclinicalECG.TheB‐AlertX10isa
recordingdevice,notamonitoringdevice.
DonotusetheB‐AlertX10withhighfrequency(HF)surgicalequipment.
DonotusetheB‐ALERTX10inanenvironmentwhereDefibrillationiscommon.

WARNINGS
ExplosionHazard.DonotusetheB‐ALERTX10inanexplosiveatmosphere.
ExplosionHazard.DonotusetheB‐ALERTX10inthepresenceofflammableanesthetics
orgases.
ExplosionHazard.DonotusetheB‐ALERTX10batteryrechargingsystemwithnon‐
rechargeablebatteries.
EEGLeads,StripsandSensorinterfacesarenotprotectedagainsttheeffectsof
defibrillation.Damagetothedeviceispossibleifwornduringdefibrillation.
NotDefibrillatorProof.
Additionalequipmentconnectedtothepatientmustcomplywiththerequirementsof
IEC60601‐1‐1.
ThePCusedwithB‐ALERTX10mustbeplacedoutsidethepatient/clientenvironment
(morethan3metersor10feet),orthePCmustcomplywithIEC60601‐1.1
BIOPAC Systems, Inc.B-Alert X10 User Manual| 4

PermanentDamageand/orWarrantyVoidance.B‐ALERTX10mustberepairedby
authorizedpersonnelonly.Anyevidenceofopeningthesystem,fieldservicebynon‐
authorizedpersonnel,tampering,oranykindofsystemmisuseorabuseshallvoidthe
warranty.
SynapseConductiveElectrodeCreamisrecommendedforusewiththeEEGsensors.
Useofanyconductivegel,creamorelectrolyteotherthanSynapsemayaffectsignal
qualityoraccuracy,ordamagetheEEGsensor.
AvoidplacementofEEGsensorsorSynapsecreamdirectlyintoanopenwound.


CAUTIONS–General
TheB‐ALERTX10shouldonlybeappliedbyatrainedtechnician.Thismodelis
notintendedforin‐homeusewithouttheassistanceofatechnician.
PositionconductivepartsoftheEEG,ECGandEOGsensorssothattheydonot
contactotherconductivepartsandearth.
Donotspray,pour,orspillanyliquidontheB‐ALERTX10,itsconnectors,
switches,oropenings,asthiswillcausepermanentdamageandvoidthe
Warranty.
DonotusecausticorabrasivecleaningagentsontheB‐ALERTX10orontheEEG
sensors,asthiswillcausepermanentdamageandvoidtheWarranty.
Thisdevicehasbeentestedandfoundtocomplywiththelimitsformedical
devicestotheIEC60601standards.Thesestandardsaredesignedtoprovide
reasonableprotectionforsafetyandagainstharmfulinterferenceinatypical
medicalinstallation.
Tominimizethepossiblehazardcausedbythesummationofleakagecurrents
whenseveralequipmentsareinterconnected,theB‐ALERTX10shouldbeusedin
wirelessmodeonlyandshouldneverbechargedwhilebeingwornbythe
patient.
Verifythatallvisibleindicatorsilluminateduringthestartup(initialization)
sequence.Ifanyindicatorisnotlit,donotusetheB‐ALERTX10.Contact
BIOPACCustomerSupport(pg.24)forrepairorreplacement.


CAUTIONS–Batteries
DonotchargethebatterieswhilewearingtheSensorHeadset.
Donotrechargebatteriesthathavebeenfullycharged.
Followlocalordinancesandrecyclinginstructionsregardingdisposalorrecycling
ofthedeviceanddevicecomponents,includingbatteries.Batteriesmayleakor
explodeifusedordisposedofimproperly.
TheinternalLi‐Polymerbatteriesshouldonlybereplacedbytheservice
department!
BIOPAC Systems, Inc.B-Alert X10 User Manual| 5




D.MinimumSystemRequirements

Personalcomputer(PC)withminimumPentiumTM2.4GHzprocessor;
Minimumof1GBofinstalledRAMmemoryand4MBvirtualmemory;
WindowsXPorWindows7operatingsystem;
.NETframeworkversion3.5installed;
Minimumof50MBharddiskspaceper5‐hoursession;
OneCD‐ROMdrive;
VGAorhigherresolutionvideoadapter;
OneavailableUSBport.
Monitorsizebetween15”and21”requiredforBaselineacquisition.
BIOPAC Systems, Inc.B-Alert X10 User Manual| 6

E.ItemsRequiredforUse
CDwithinstallation,
manual,andtraining
videos
B‐AlertX10Sensor
Headset
SensorStrip
FoamSensors
12ccSyringe
ECGLeads(left)
Mastoid(right)
DisposableElectrodes
SynapseGelBottle
&Tube
CleaningTools‐Tweezers&
ElectrodeBrush
ABMUSBHostdevice
B‐AlertDongle(left)
OptionalESU‐MC(right)
NeopreneStrap TapeMeasure
Zip‐LinqWallCharger&
X10CableAdapter
BIOPAC Systems, Inc.B-Alert X10 User Manual| 7

Chapter2:SensorHeadsetUse


Note:Thischapterpresentsadetailed,writtenprocessofastandardsubjectsetup.Foran
additionaldemonstration,refertotheinstructionalvideosprovidedwiththeincludedsoftware.
Brainma
p
ofa9‐electrodestri
p
.
Back
Front
A. Charging

TheB‐AlertSensorHeadsetshouldarrivefullychargedandreadyforuse.Forongoingusage,it
isrecommendedthatyouchargetheheadsetthenightbeforeusing.Fullychargedheadsets
canrecordforatminimum8hrs.Ittakes2‐3hrstofullychargeaheadset.Torechargethe
Headsetfollowthestepsbelow.

1. VerifytheHeadsetisintheoffposition.InserttheX10cableadapterintothesensor
headset.
2. PlugtheMini‐BconnectorintotheX10cableadapterand
theUSB‐Aconnectorintoyourcomputer’sUSBport
3. Oncepowerisrecognized,thesensorheadsetwill
automaticallybegincharging,confirmedbyadouble
blinkinggreenLEDpatternonthefrontoftheheadset.
4. Chargingwillautomaticallyterminateoncethebatteries
arefullycharged,confirmedbyasingleblinkinggreenLED
pattern.
CableAda
p
ter
Mini‐B
LEDIndicator
BIOPAC Systems, Inc.B-Alert X10 User Manual| 8

B. Preparation
MastoidLeads
Fuzz
y
sideofneo
p
rene Trian
g
leStri
p
Connector

1. PreparingSensorHeadset
a. Ensurethatthefuzzysideofthe
Neopreneisfacingout,andthe
stripconnectortriangleis
pointingup.
b. UsingacleanNeopreneStrap,feedtheStrapendsthrough
eachsideoftheSensorHeadsetstrapholdersandfasten
theVelcro.Dothisequallytobothsides,butleaveloose
foreasyapplicationtosubjectlater.
c. VerifythattheMastoidLeadsarepluggedintothesystem.


2. PreparingStrip
a. InspecttheStripandverifytherearenoripsorhardcreasesontheStripitself.
Checktheentirestrip,payingspecialattentiontospots(circledinred)proneto
ripsandcreases.

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b. Attachthefoampiecestothesensorsites.
Ensurethefoamiscenteredwithintheblack
circletomaximizethecontactsurface
betweenthesensorsiteandthefoam.
c. Usingtheprovidedsyringeswithcurvedtip
applied,filleachfoampiecewithsynapsegel
inoneoftwoways:

i. Placethesyringeintheholeofthefoamanddispensegel.Youshouldsee
thegelbeginfillingthecenterofthefoam.

ii. Thegelcanalsobedispensedintothefoamfromthesidesbypushing
thetipintoeithersideofthefoamuntilitbeginstofillthecenter.

ii.
i.

d. Makesuretocompletelyfillfoam
piece.Eachsensorwillhold0.4‐0.6cc
ofsynapsegel.

e. Thefoamshouldbesaturatedwithgel
andthecenterholeshouldbefilledto
thetop.





SizeNas ium‐Inion
Small32.0–34.5cm
Medium>34.5cm
BIOPAC Systems, Inc.B-Alert X10 User Manual| 10

C. Application

3. SensorHeadsetandNeopreneStrap
a. Measurethedistancefromthenasiontothe 
inion(occipitalbone).
Inion Nasion
a.
b. Useanalcoholswabtowipedownareaswhere
thesensorswillbeplaced.AlsocleanMastoid
andECGlocationswithanalcoholswab.
c. PlacetheSensorHeadsetontothesubject’s
headandtightentheNeopreneStrapto
provideasnugfit.c.
d. VerifythattheNeopreneStrapiscenteredon
thesubjectandthatitisnotrestingonthe
ears.
e. Whileholdingthestripinfrontofthesubject,
withthefoampiecesfacingawayfromthe
face,attachtheStriptothefrontofthe
NeopreneStrapbyfeedingtriangulartip
throughtheholeadjacenttositeFz.
d
f. CarefullybringtheStripoverthetopofthe
subject’shead,verifyingthattheStripis
centeredandthatthesubject’sinionisbelow
thealignmenthole.(Seepictureonnext
page).
e

BIOPAC Systems, Inc.B-Alert X10 User Manual| 11

f.
g. WhileholdingtheStripinplaceovertheinion,
takethetwoStripArmsclosesttotheinionand
attachthemtotheNeopreneStrap.
h. TightentheremainingStripArmsinpairs,from
thebackoftheheadtothefront,sothattheStrip
sitsflatagainstthesubject’shead,while
maintainingthecorrectalignmentonthescalp.


g.
h.
h.
i. Verifythatallsensorsitesarecontacting
theheadandadjuststrapsifnecessary.
j
.
j. Gentlyplugconnectoronthebackofthe
StripintotheSensorHeadset.The
connectionbetweenheadsetandstripis
snug;begentlewhen
plugging/unplugging.
k. Ifthesubjectcomplainsaboutdiscomfort
fromanyelectrode,loosenindividualStrip
Arms.
BIOPAC Systems, Inc.B-Alert X10 User Manual| 12

4. MastoidsandECGLeads
BIOPAC Systems, Inc.B-Alert X10 User Manual| 13

D. AdditionalECGPlacements
TheB‐AlertECGalgorithmsrelyonpeaktopeakmeasurementstocomputethebeatto
beat(andsecondtosecond)HeartRate.TheECGsignalisrobustandthesensor
placementissomewhatflexible.BIOPAC'srecommendedplacementistohavetheLeft
(bLue)ECGLeadonthelowermostribandtheRight(gRey)leadontherightcollarbone.
AlternativeECGplacementshowevercanbeusediftherecommendedconfigurationis
notidealforagivenapplication.ForalternativeECGplacement,theappropriateleads
mustbeplacedacrosstheheart(bLueleadALWAYSontheLeftsideofparticipantand
gReyleadalwaysontherightside).Theadhesiveelectrodesshouldbeplacedonboney
partsoftheparticipant,wherethereislittlepotentialformovement(frombreathingor
muscles)whichcancompromisesignalintegrity.ContactBIOPACforadditional
informationonalternativeECGplacement.
E. ReadytoCollect

1. PlugintheUSBHostDevice(B‐AlertDongleorESU)toanavailableUSBportonthe
computerrunningB‐AlertSoftware.

2. VerifytheSensorHeadsetissyncedtotheB‐AlertDonglebyswitchingontheSensor
HeadsetandviewingtheindicatorlightsonthefrontoftheSensorHeadset.TheSensor
Headsethasestablishedconnectionwhenthegreenindicatorlightturnssolidafter5‐
seconds.Iftheredindicatorlightstaysonwhilethegreenindicatorlightisblinking,the
headsetisnotproperlyconnecting.RefertotheOperationssectioninChapter7ofthe
B‐AlertSoftwareManualfordetailsonhowtore‐syncaHeadsettotheUSBHost
Device.
ConnectedNotConnected
3. MaintainingBTSignalQuality:
a. MakesuretheSensorHeadsetandB‐AlertDonglearewithin25feetofeach
other.
BIOPAC Systems, Inc.B-Alert X10 User Manual| 14

b. Minimizethenumberofobstructions(andavoidmetalobjects)intheline‐of
sightoftheheadandhostunits.
F. Post‐sessionClean‐up
1. RemovalofSensorHeadsetandElectrodes
BIOPAC Systems, Inc.B-Alert X10 User Manual| 15

2. CleaningtheSensorStripandNeopreneStrap
BIOPAC Systems, Inc.B-Alert X10 User Manual| 16
CLEANINGCAUTIONS:
Foroptimalrecordings,cleanthestripimmediatelyafteruse.
Donotreusefoamsensors.
Stripsarerecommendedfor25‐30uses.
DonotaggressivelyscrubtheSensorpadswhencleaning.
IfSensorpadisremovedfromstripdiscontinueuseofstrip.
Whenremovingthesensorstripfromtheheadset,DONOTpullorjerkthe
connector.

Chapter3:AcquisitionTroubleshooting
A. CommonHeadsetandSensorIssues

Thefollowingtopicsdescribecriticaltroubleshootingmethodstoundertakewhenencountering
problemsduringthesetupsessionofasubject.

Handsshouldbe
awayfromFace!
Partthickhair
andaddcream.
BIOPAC Systems, Inc.B-Alert X10 User Manual| 17

BIOPAC Systems, Inc.B-Alert X10 User Manual| 18
NOTE:Therecommendationsarenotnecessarilylistedinalogicalsequence.Usebest
judgmenttodeterminewhichtrouble‐shootingtipsaremostrelevanttotheproblem(s).

Chapter4:Specifications
A. B‐AlertX10
SystemSpecifications‐forHeadandHostUnits
BTSpecificationsoftheB‐AlertX10
RFBand2.4to2.48GHz(ISMband)
AntennaOn‐board
TransmissionModeBi‐Directional
DataTransmissionRange~30feet,lineofsight
AverageDataLoss <0.1%
TransmissionPower~1mW
SystemSpecificationsoftheB‐AlertX10
PowerSupplyUpto4x250mAh3.7VoltLi‐PolymerBatteries
OperatingTime7.0hoursbetweencharges
PowerConsumption~40mA@3.7V
BatteryChargerExternal,interfaceviaChargingJack
UserControlON/OFF
IndicatorLEDsGreen
Red
NumberofchannelsTen
SamplingRate256samples/second
DynamicRange+1,000μV,sufficientforeitherEEGorEOG
Resolution 16bit

BandpassCharacteristics
0.1Hzand65Hz(at3dBattenuation)obtaineddigitallywithSigma‐
DeltaA/Dconverter
Noise3.2mVpeaktopeakoutto100Kohmsresistance
On‐lineImpedanceMonitoringInitiatedbyhostcomputerusingbi‐directionallinkforEEGChannels
only
InputImpedance100Gohm
ConnectorInterface22‐pinJSTconnectorforSensorHeadset
HeadUnitDimensions5”longx2.25”widex1”deep
HeadUnitWeight4.0ounceswithbatteries
CaseMaterialABS
BluetoothDongleHostUnitBluetoothVersion2.0,class1B‐Alertdongle
Software

Compatibility
Personalcomputerwith1.5MHzorhigherprocessor1GBofRAM
runningWindowsXP
EstimatedFileSizeperMinute~30KB/Min/channel
RechargingBatteriesonHeadUnit
ProvidedbyUSBPortonHost
Workstation
500mA@5Volts
BIOPAC Systems, Inc.B-Alert X10 User Manual| 19

RechargingCable1meterUSBAtomini‐BconnectiontoChargingAdapter
HeadsetandSensorStripMedium=Nasion to Inion ~36 cm.From Inion : POz=7.2 cm,Cz =
18cmandFz=25.2cm.
SensorsPETStripwithSilver‐SilverChloridesensorsitesinterfacedwith100
ppifoam.

ElectrodeCream
Highlyconductive,electrolytesandpreservativesinnon‐ionic,hypo‐
allergicbase,bufferedtoskinpH
B. EnvironmentalConditions

Environmental
Condition

Operation

Transportation

Storage
Temperature5oCto40oC
41oFto104oF
‐20oCto70oC
‐4oFto140oF
‐20oCto70oC
‐4oFto140oF
Altitude‐390mto3012m
‐1254ft.to9,882ft.
‐390mto3012m
‐1254ft.to9,882ft
‐390mto3012m
‐1254ft.to9,882ft
Atmospheric
Pressure
70kPato106kPa
20.6in.Hgto31.3in.Hg
70kPato106kPa
20.6in.Hgto31.3in.Hg
70kPato106kPa
20.6in.Hgto31.3in.Hg
RelativeHumidity15%to95%non‐condensing
tobecompliantwithIEC
60601‐1,sub‐clause44.5

15%to95%non‐
condensing

15%to95%non‐
condensing


Note:PreliminarySpecifications,subjecttochange.
BIOPAC Systems, Inc.B-Alert X10 User Manual| 20