GE CARESCAPE - BIS indications for use; BIS measurement limitations; BIS points to note

Bispectralindex
CAUTION
WhenconnectingordisconnectingBIS,takecarenottotouch
theexposedcontactsofeitherconnector.Damagedueto
electrostaticdischargemayresulttotheequipment.
BISindicationsforuse
TheBISmoduleisintendedforusebypersonneltrainedinitsproperuse.Itisintended
foruseonadultandpediatricpatientswithinahospitalormedicalfacilityproviding
patientcaretomonitorthestateofthebrainbydataacquisitionofEEGsignals.
TheBispectralindex(BIS),aprocessedEEGvariable,andonecomponentoftheBIS
module,maybeusedinadultsasanaidinmonitoringtheeffectsofcertainanesthetic
agents.TheBispectralindexisacomplextechnology,intendedforuseonlyasan
adjuncttoclinicaljudgementandtraining.Inaddition,theclinicalutility,risk/benet,
andapplicationofBIShavenotundergonefullevaluationinthepediatricpopulation.
BISmeasurementlimitations
●ThismeasurementisnotavailableintheNICUsoftwarepackage.
●E-modulesusedforthismeasurementarenotsuitableforusewithneonatal
patients.
●BISisacomplexmonitoringtechnologyintendedforuseonlyasanadjunctto
clinicaljudgmentandtraining.Clinicaljudgmentshouldalwaysbeusedwhen
interpretingBISinconjunctionwithotheravailableclinicalsigns.RelianceonBIS
aloneforintraoperativeanestheticmanagementisnotrecommended.
●BISvaluesshouldbeinterpretedcautiouslywithcertainanestheticcombinations,
suchasthoserelyingprimarilyoneitherketamineornitrousoxide/narcoticsto
produceunconsciousness.
●Externalradiatingdevicesmaydisturbthemeasurement.
●PoorsignalqualitymayleadtoinappropriateBISvalues.
●ArtifactmayleadtoinappropriateBISvalues.Potentialartifactmaybecausedby
unusualorexcessiveelectricalinterferenceorhighEMGactivitylikeshivering,
muscleactivityorrigidity,sustainedeyemovements,headandbodymotion.Also,
impropersensorplacementandpoorskincontact(highimpedance)maycause
artifactandinterferewiththemeasurement.
●Duetolimitedclinicalexperienceinthefollowingapplications,theBISvalueshould
beinterpretedcautiouslyinpatientswithknownneurologicaldisordersandthose
takingpsychoactivemedications.
BISpointstonote
●Makesurethatthesensorconnectorsofthepatientinterfacecablearenotin
contactwithuids.
●BISsensorsaredisposable,forsinglepatientuseonly,andnotmadewithnatural
rubberlatex.
●Checkthesensorexpirationdateonthesensorpackage.
●Donotuseasensorformorethan24hours.
●UseonlyCovidienBISsensors.
2062971-001CARESCAPEModularMonitors395